COMMISSION STAFF WORKING PAPER SITUATION IN THE DIFFERENT SECTORS
Date: 2011-09-29
Institutions: European Commission
Subjects: EU control, EU statistics, administrative offence, case study, information analysis, infringement procedure (EU), national implementing measure, sanction (EU)

EUROPEAN COMMISSION 

Brussels, 29.9.2011 
SEC(2011) 1093 final 

COMMISSION STAFF WORKING PAPER 

SITUATION IN THE DIFFERENT SECTORS 

Accompanying the document 

REPORT FROM THE COMMISSION 

28th ANNUAL REPORT ON MONITORING THE APPLICATION OF EU LAW 
(2010) 

{COM(2011) 588 final} 
{SEC(2011) 1094 final} 

 
 
 
 
  
 
1. 

1.1. 

1.2. 

1.3. 

ENTERPRISE and INDUSTRY............................................................................... 2 

General introduction.................................................................................................. 2 

Automotive Industry.................................................................................................. 4 

Chemicals .................................................................................................................. 10 

1.3.1.  REACH....................................................................................................................... 10 

1.3.2.  Other chemicals legislation........................................................................................ 14 

1.4. 

The Transparency Directive.................................................................................... 21 

1.5.  Mechanical, electrical and telecommunications equipment................................. 23 

1.6. 

Gas appliances, pressure equipment and legal metrology ................................... 24 

1.6.1.  Gas appliances ........................................................................................................... 24 

1.6.2.  Pressure equipment.................................................................................................... 26 

1.6.3.  Legal metrology ......................................................................................................... 28 

1.7. 

1.8. 

1.9. 

Construction products ............................................................................................. 30 

Textiles/clothing, footwear and wood..................................................................... 31 

Toys............................................................................................................................ 32 

1.10. 

Food industry............................................................................................................ 32 

1.11.  Cultural goods .......................................................................................................... 34 

1.12.  Weapons .................................................................................................................... 34 

1.13. 

Product liability........................................................................................................ 34 

1.14.  Defence goods ........................................................................................................... 35 

1.15.  Non-harmonised area............................................................................................... 35 

1.16. 

Preventive rules of Directive 98/34/EC .................................................................. 37 

2. 

2.1. 

2.2. 

2.3. 

3. 

COMPETITION ...................................................................................................... 38 

Current Position ....................................................................................................... 38 

Evaluation Based on the Current Situation........................................................... 41 

Evaluation Results - Priorities and Planned Action.............................................. 42 

EMPLOYMENT, SOCIAL AFFAIRS and INCLUSION ................................... 42 

3.1. 

Free movement of workers and coordination of social security systems ............ 42 

3.1.1.  Current Position......................................................................................................... 42 

3.1.2.  Evaluation of the current situation ............................................................................ 47 

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3.1.3.  Evaluation results....................................................................................................... 50 

3.1.4. 

Summary..................................................................................................................... 51 

3.2. 

Labour Law .............................................................................................................. 51 

3.2.1.  Current position ......................................................................................................... 51 

3.2.2.  Evaluation based on the current situation ................................................................. 55 

3.2.3.  Evaluation results....................................................................................................... 56 

3.2.4. 

Summary..................................................................................................................... 57 

3.3. 

Health and safety at work........................................................................................ 57 

3.3.1.  Current position ......................................................................................................... 57 

3.3.2.  Evaluation based on the current situation ................................................................. 60 

3.3.3.  Evaluation results....................................................................................................... 61 

3.3.4. 

Summary..................................................................................................................... 62 

4. 

AGRICULTURE AND RURAL DEVELOPMENT............................................. 63 

4.1. 

Current position ....................................................................................................... 63 

4.1.1.  General introduction.................................................................................................. 63 

4.1.2.  Report of work done in 2010...................................................................................... 65 

4.2. 

Evaluation ................................................................................................................. 79 

4.2.1.  General evaluation..................................................................................................... 79 

4.2.2. 

Sector based remarks ................................................................................................. 80 

4.3. 

4.4. 

5. 

Evaluation results - Priorities and actions planed 2011 ....................................... 83 

Summary................................................................................................................... 86 

ENERGY................................................................................................................... 88 

5.1. 

ENERGY - INTERNAL ELECTRICITY AND GAS MARKET ......................................... 88 

5.1.1.  Current position ......................................................................................................... 88 

5.1.2.  Evaluation of the current position.............................................................................. 91 

5.1.3.  Evaluation results....................................................................................................... 91 

5.1.4. 

Sector summary.......................................................................................................... 92 

5.2. 

ENERGY – Coal and oil .......................................................................................... 92 

5.2.1.  Current position ......................................................................................................... 92 

5.2.2.  Evaluation of the current position.............................................................................. 94 

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5.2.3.  Evaluation results....................................................................................................... 95 

5.2.4. 

Sector summary.......................................................................................................... 96 

5.3. 

ENERGY - Renewable energy sources .................................................................. 96 

5.3.1.  Current position ......................................................................................................... 96 

5.3.2.  Evaluation of the current position.............................................................................. 97 

5.3.3.  Evaluation results....................................................................................................... 97 

5.3.4. 

Sector summary.......................................................................................................... 98 

5.4. 

ENERGY – ENERGY EFFICIENCY ............................................................................ 98 

5.4.1.  Energy performance of buildings............................................................................... 98 

5.4.2.  Energy efficiency of products................................................................................... 100 

5.4.3.  Energy end-use efficiency and energy services........................................................ 102 

5.4.4.  Combined heat and power generation (CHP, cogeneration) .................................. 105 

5.5. 

ENERGY - NUCLEAR ENERGY .............................................................................. 107 

5.5.1.  Current position ....................................................................................................... 107 

5.5.2.  Evaluation of the current situation .......................................................................... 112 

5.5.3.  Evaluation Results.................................................................................................... 112 

5.5.4. 

Sector summary........................................................................................................ 112 

6. 

MOBILITY and TRANSPORT............................................................................ 113 

6.1. 

Passenger rights...................................................................................................... 113 

6.1.1.  Current position ....................................................................................................... 113 

6.1.2.  Report on the work done .......................................................................................... 114 

6.1.3.  Evaluation of the current position............................................................................ 115 

6.1.4.  Evaluation results..................................................................................................... 115 

6.1.5. 

Sector summary........................................................................................................ 116 

6.2. 

Inland Waterway Transport ................................................................................. 116 

6.2.1.  Current position ....................................................................................................... 116 

6.2.2.  Evaluation of the current position............................................................................ 117 

6.2.3.  Evaluation results..................................................................................................... 118 

6.2.4. 

Sector summary........................................................................................................ 118 

6.3.  Maritime Transport - Internal market ................................................................ 118 

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6.3.1.  Current position ....................................................................................................... 118 

6.3.2.  Evaluation of the current position............................................................................ 119 

6.3.3.  Evaluation results..................................................................................................... 120 

6.3.4. 

Sector summary........................................................................................................ 120 

6.4.  Maritime Safety...................................................................................................... 120 

6.4.1.  Current position ....................................................................................................... 120 

6.4.2.  Evaluation of the current position............................................................................ 123 

6.4.3.  Evaluation results..................................................................................................... 123 

6.4.4. 

Sector summary........................................................................................................ 124 

6.5.  Maritime Security .................................................................................................. 124 

6.5.1.  Current position ....................................................................................................... 124 

6.5.2.  Evaluation of the current position............................................................................ 126 

6.5.3.  Evaluation results..................................................................................................... 126 

6.5.4. 

Sector summary........................................................................................................ 127 

6.6. 

Inland Transport.................................................................................................... 127 

6.6.1.  Current position ....................................................................................................... 127 

6.6.2.  Evaluation ................................................................................................................ 131 

6.6.3.  Evaluation results..................................................................................................... 132 

6.6.4. 

Sector summary........................................................................................................ 134 

6.7. 

Sector: Air Transport ............................................................................................ 135 

6.7.1.  Current position ....................................................................................................... 135 

6.7.2.  Evaluation of the current position............................................................................ 143 

6.7.3.  Evaluation results..................................................................................................... 145 

6.7.4. 

Sector summary........................................................................................................ 148 

7. 

CLIMATE ACTION.............................................................................................. 149 

7.1. 

Emission Trading Scheme (ETS Directive) ......................................................... 149 

7.1.1.  Report of work done in 2010.................................................................................... 150 

7.1.2.  Evaluation based on the current situation ............................................................... 154 

7.1.3.  Perspectives.............................................................................................................. 156 

7.2.  Monitoring and Reporting .................................................................................... 158 

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7.2.1. 

Introduction.............................................................................................................. 158 

7.2.2.  Report of work done in 2010.................................................................................... 158 

7.2.3.  Perspectives.............................................................................................................. 159 

7.3. 

Ozone depleting substances and Fluorinated Gases ........................................... 160 

7.3.1. 

Introduction.............................................................................................................. 160 

7.3.2.  Report of work done in 2010.................................................................................... 160 

7.4. 

Transport related emissions .................................................................................. 161 

7.4.1. 

Introduction.............................................................................................................. 161 

7.4.2.  Report of work done in 2010.................................................................................... 162 

7.5. 

Other climate related legislation........................................................................... 164 

7.5.1.  Carbon Capture and Storage (CCS) ........................................................................ 164 

7.5.2.  EU Effort Sharing Decision (ESD) .......................................................................... 165 

7.5.3.  Land use, land-use change and forestry (LULUCF) ............................................... 166 

8. 

ENVIRONMENT................................................................................................... 166 

8.1. 

Nature Conservation.............................................................................................. 166 

8.1.1.  Current position ....................................................................................................... 166 

8.1.2.  Evaluation based on the current situation ............................................................... 170 

8.1.3.  Evaluation results..................................................................................................... 171 

8.1.4. 

Sector summary........................................................................................................ 172 

8.2.  Waste Management................................................................................................ 174 

8.2.1.  Current position ....................................................................................................... 174 

8.2.2.  Evaluation based on the current situation ............................................................... 182 

8.2.3.  Evaluation results..................................................................................................... 183 

8.2.4. 

Sector summary........................................................................................................ 184 

8.3. 

Environmental Assessment of Plans, Programmes and Projects ...................... 185 

8.3.1.  Current position ....................................................................................................... 185 

8.3.2.  Evaluation based on the current situation ............................................................... 190 

8.3.3.  Evaluation results..................................................................................................... 191 

8.3.4. 

Sector summary........................................................................................................ 192 

8.4. 

Protecting Water and Marine Resources............................................................. 192 

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8.4.1.  Current position ....................................................................................................... 192 

8.4.2.  Evaluation based on the current situation ............................................................... 199 

8.4.3.  Evaluation results..................................................................................................... 201 

8.4.4. 

Sector summary........................................................................................................ 203 

8.5. 

Air quality and environmental noise .................................................................... 204 

8.5.1.  Current position ....................................................................................................... 204 

8.5.2.  Evaluation based on the current situation ............................................................... 207 

8.5.3.  Evaluation results..................................................................................................... 208 

8.5.4. 

Sector summary........................................................................................................ 210 

8.6. 

Industrial installations ........................................................................................... 210 

8.6.1.  Current position ....................................................................................................... 210 

8.6.2.  Evaluation based on the current situation ............................................................... 214 

8.6.3.  Evaluation results..................................................................................................... 215 

8.6.4. 

Sector summary........................................................................................................ 216 

8.7. 

Chemicals and Biocides ......................................................................................... 217 

8.7.1.  Current position ....................................................................................................... 217 

8.7.2.  Evaluation based on the current situation ............................................................... 222 

8.7.3.  Evaluation results..................................................................................................... 223 

8.7.4. 

Sector summary........................................................................................................ 226 

8.8. 

Governance ............................................................................................................. 226 

8.8.1.  Current position ....................................................................................................... 226 

8.8.2.  Evaluation based on the current situation ............................................................... 231 

8.8.3.  Evaluation results..................................................................................................... 232 

8.8.4. 

Sector summary........................................................................................................ 233 

8.9. 

Environmental Liability ........................................................................................ 234 

8.9.1.  Current position ....................................................................................................... 234 

8.9.2.  Evaluation based on the current situation ............................................................... 235 

8.9.3.  Evaluation results..................................................................................................... 236 

8.9.4. 

Sector summary........................................................................................................ 236 

9. 

INFORMATION SOCIETY and MEDIA........................................................... 237 

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9.1. 

9.2. 

General Overview................................................................................................... 237 

Electronic communications ................................................................................... 237 

9.2.1.  Current position ....................................................................................................... 237 

9.2.2.  Evaluation based on the current situation ............................................................... 244 

9.2.3.  Evaluation results: priorities and planned action (2011 and beyond) .................... 244 

9.3. 

The Audiovisual and Media .................................................................................. 245 

9.3.1.  Current position ....................................................................................................... 245 

9.3.2.  Evaluation based on the current situation ............................................................... 247 

9.3.3.  Evaluation results: priorities and planned action (2011 and beyond) .................... 247 

9.4. 

Public Sector Information ..................................................................................... 247 

9.4.1.  Current Position....................................................................................................... 247 

9.4.2.  Evaluation based on the current situation ............................................................... 249 

9.4.3.  Evaluation results..................................................................................................... 249 

9.4.4. 

Sector summary........................................................................................................ 249 

9.5. 

Electronic Signatures ............................................................................................. 250 

9.5.1.  Current Position....................................................................................................... 250 

9.5.2.  Evaluation based on the current situation ............................................................... 250 

9.5.3.  Evaluation results: priorities and planned action (2011 and beyond) .................... 251 

10. 

MARITIME AFFAIRS AND FISHERIES.......................................................... 251 

10.1.  General introduction.............................................................................................. 251 

10.2.  Report of work done in 2010 ................................................................................. 252 

10.3.  Evaluation based on the current situation ........................................................... 253 

10.4.  Evaluation results................................................................................................... 254 

10.4.1.  Priorities .................................................................................................................. 254 

10.4.2.  Planned action (for 2011 and beyond)..................................................................... 254 

10.5. 

Summary................................................................................................................. 254 

11. 

INTERNAL MARKET AND SERVICES ........................................................... 255 

11.1. 

Freedom to provide services and freedom of establishment (other than financial 
services) ................................................................................................................... 255 

11.2. 

Financial Services................................................................................................... 269 

11.2.1.  Banking .................................................................................................................... 269 

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11.2.2.  Insurance and occupational pensions...................................................................... 271 

11.2.3.  Securities .................................................................................................................. 274 

11.2.4.  Asset management.................................................................................................... 279 

11.2.5.  Payments and retail financial services .................................................................... 282 

11.3. 

Free movement of capital (Articles 63 et seq. TFEU) ......................................... 285 

11.4. 

Public procurement................................................................................................ 290 

11.5. 

Professional qualifications..................................................................................... 295 

11.6.  Company law, corporate governance and anti-money laundering ................... 299 

11.7.  Auditing – statutory audits.................................................................................... 303 

11.8.  Accounting .............................................................................................................. 306 

11.9. 

Protection of rights................................................................................................. 307 

12. 

REGIONAL POLICY ........................................................................................... 310 

12.1.  Current situation.................................................................................................... 310 

12.1.1.  General introduction................................................................................................ 310 

12.1.2.  Report of work done in 2010.................................................................................... 312 

12.2.  Evaluation based on the current situation ........................................................... 314 

12.2.1.  Assessment of the current situation (satisfactory or problematic nature of the current 
situation) .................................................................................................................. 314 

12.2.2.  Importance of the impact of the identified problems on the objectives of the acquis

.................................................................................................................................. 315 

12.2.3.  Underlying reasons for problematic areas .............................................................. 315 

12.2.4.  Responsibility for the problems and their correction .............................................. 315 

12.2.5.  Corrective action required (priority character, timing and scale) .......................... 315 

12.3.  Evaluation results................................................................................................... 316 

12.3.1.  Priorities .................................................................................................................. 316 

12.3.2.  Planned action (2011 and beyond) .......................................................................... 316 

13. 

TAXATION and CUSTOMS UNION.................................................................. 317 

13.1. 

Situation in the sector of CUSTOMS ................................................................... 317 

13.1.1.  Current position ....................................................................................................... 317 

13.1.2.  Evaluation based on the current situation ............................................................... 319 

13.1.3.  Evaluation results..................................................................................................... 319 

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13.1.4.  Sector summary........................................................................................................ 320 

13.2. 

Situation in the sector of INDIRECT TAXATION ............................................ 320 

13.2.1.  Current position ....................................................................................................... 320 

13.2.2.  Evaluation based on the current situation ............................................................... 329 

13.2.3.  Evaluation results..................................................................................................... 330 

13.2.4.  Sector summary........................................................................................................ 332 

13.3. 

Situation in the sector of DIRECT TAXATION................................................. 332 

13.3.1.  Current position ....................................................................................................... 332 

13.3.2.  Evaluation based on current situation ..................................................................... 335 

13.3.3.  Evaluation results..................................................................................................... 336 

13.3.4.  Sector summary........................................................................................................ 337 

14. 

EDUCATION AND CULTURE ........................................................................... 338 

14.1.  Current position ..................................................................................................... 338 

14.1.1.  General introduction................................................................................................ 338 

14.1.2.  Report of work done in 2010.................................................................................... 342 

14.2.  Evaluation based on the current situation ........................................................... 343 

14.2.1.  Education and training ............................................................................................ 343 

14.2.2.  Sport ......................................................................................................................... 344 

14.3.  Evaluation results................................................................................................... 344 

14.3.1.  Priorities .................................................................................................................. 344 

14.3.2.  Planned action (2011 and beyond) .......................................................................... 344 

15. 

HEALTH AND CONSUMERS ............................................................................ 345 

15.1. 

Introduction ............................................................................................................ 345 

15.2. 

Public health ........................................................................................................... 346 

15.2.1.  Blood and tissues...................................................................................................... 346 

15.2.2.  Tobacco .................................................................................................................... 349 

15.2.3.  Pharmaceuticals....................................................................................................... 350 

15.2.4.  Medical devices........................................................................................................ 352 

15.3.  Consumers .............................................................................................................. 356 

15.3.1.  Report of work done in 2010.................................................................................... 356 

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15.3.2.  Evaluation, Priorities & Perspectives...................................................................... 364 

15.3.3.  Summary of the Consumer activities' field............................................................... 365 

15.4. 

Food safety and animal health and welfare ......................................................... 365 

15.4.1.  General Introduction................................................................................................ 365 

15.4.2.  Enforcement of the rules applicable to the food chain ............................................ 367 

15.4.3.  GMO Food and Feed ............................................................................................... 368 

15.4.4.  Transmissible spongiform encephalopathies ........................................................... 375 

15.4.5.  Food additives.......................................................................................................... 376 

15.4.6.  Food enzymes ........................................................................................................... 378 

15.4.7.  Food flavourings ...................................................................................................... 379 

15.4.8.  Residues of veterinary medicinal products .............................................................. 381 

15.4.9.  Contaminants in food ............................................................................................... 383 

15.4.10. Plant Protection Products – Pesticide Residues...................................................... 387 

15.4.11. Extraction Solvents................................................................................................... 389 

15.4.12. Food Labelling ......................................................................................................... 390 

15.4.13. Nutrition and Health Claims.................................................................................... 392 

15.4.14. Dietetic foods ........................................................................................................... 394 

15.4.15. Novel foods............................................................................................................... 398 

15.4.16. Food contact materials ............................................................................................ 400 

15.4.17. Plant Health ............................................................................................................. 402 

15.4.18. Plant reproductive material – Plant Variety Rights – Plant Genetic Resources..... 404 

15.4.19. Animal Health – including non food-borne zoonotic diseases................................. 406 

15.4.20. Zootechnics .............................................................................................................. 410 

15.4.21. Animal by-products .................................................................................................. 411 

15.4.22. Feed.......................................................................................................................... 412 

15.4.23. Import controls on live animals and food from animal origin................................. 415 

15.4.24. Animal welfare ......................................................................................................... 418 

15.5.  Overall evaluation .................................................................................................. 423 

15.5.1.  Better application of the health and consumer acquis is everyone's concern ......... 423 

15.5.2.  Prevention ................................................................................................................ 424 

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15.5.3.  Regular review of legislation ................................................................................... 425 

15.5.4.  Audits, Inspections and market surveillance............................................................ 426 

16. 

HOME AFFAIRS................................................................................................... 427 

16.1. 

Immigration and integration................................................................................. 427 

16.1.1.  Current position: General introduction ................................................................... 427 

16.1.2.  Current position: Report on work done in 2010 ...................................................... 428 

16.1.3.  Evaluation based on the current situation ............................................................... 429 

16.1.4.  Evaluation results: Priorities................................................................................... 430 

16.1.5.  Evaluation results: Planned action (2011 and beyond)........................................... 430 

16.1.6.  Summary................................................................................................................... 430 

16.2.  Asylum..................................................................................................................... 431 

16.2.1.  Current position: General introduction ................................................................... 431 

16.2.2.  Current position: Report on work done in 2010 ...................................................... 432 

16.2.3.  Evaluation based on the current situation ............................................................... 432 

16.2.4.  Evaluation results: Priorities and planned action (2011 and beyond).................... 433 

16.2.5.  Summary................................................................................................................... 434 

16.3.  European visa policy .............................................................................................. 434 

16.3.1.  Current situation: Report on work done in 2010 ..................................................... 434 

16.3.2.  Evaluation based on the current situation ............................................................... 434 

16.3.3.  Evaluation results: Priorities and planned action (2011 and beyond).................... 435 

16.4.  Document Security (European passport and residence permits) ...................... 435 

16.4.1.  Current situation: Report on work done in 2010 ..................................................... 435 

16.4.2.  Evaluation results: Priorities and planned action (2011 and beyond).................... 435 

16.5.  Border management and return policy................................................................ 436 

16.5.1.  Current position: General introduction ................................................................... 436 

16.5.2.  Current position: Report on work done in 2010 ...................................................... 436 

16.5.3.  Evaluation based on the current situation ............................................................... 437 

16.5.4.  Evaluation results: Priorities................................................................................... 438 

16.5.5.  Evaluation results: Planned action (2011 and beyond)........................................... 438 

16.6. 

Security.................................................................................................................... 439 

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16.6.1.  Data Retention Directive.......................................................................................... 439 

16.6.2.  European Programme for Critical Infrastructure Protection ................................. 440 

16.6.3.  Directive on preventing and combating trafficking in human beings, and protecting 

victims, replacing Framework Decision 2002/629/JHA.......................................... 441 

16.6.4.  Third pillar instruments ........................................................................................... 441 

17. 

JUSTICE................................................................................................................. 442 

17.1. 

Free movement of persons..................................................................................... 442 

17.1.1.  Current Position....................................................................................................... 442 

17.1.2.  Evaluation based on the current situation ............................................................... 444 

17.1.3.  Evaluation results..................................................................................................... 445 

17.1.4.  Summary................................................................................................................... 445 

17.2.  Citizenship .............................................................................................................. 446 

17.2.1.  Current position ....................................................................................................... 446 

17.2.2.  Evaluation based on the current situation ............................................................... 447 

17.2.3.  Evaluation results..................................................................................................... 447 

17.2.4.  Summary................................................................................................................... 448 

17.3. 

Fundamental rights................................................................................................ 448 

17.3.1.  Current Position....................................................................................................... 448 

17.3.2.  Evaluation based on the current situation ............................................................... 449 

17.3.3.  Evaluation results..................................................................................................... 449 

17.3.4.  Summary................................................................................................................... 450 

17.4. 

Protection of personal data ................................................................................... 450 

17.4.1.  Current position ....................................................................................................... 450 

17.4.2.  Evaluation based on the current situation ............................................................... 451 

17.4.3.  Evaluation results..................................................................................................... 451 

17.4.4.  Summary................................................................................................................... 452 

17.5. 

Judicial cooperation in civil matters .................................................................... 452 

17.5.1.  Current position ....................................................................................................... 452 

17.5.2.  Evaluation based on the current situation ............................................................... 454 

17.5.3.  Evaluation results..................................................................................................... 455 

17.5.4.  Summary................................................................................................................... 456 

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17.6.  Consumer and marketing law............................................................................... 456 

17.6.1.  Current position ....................................................................................................... 456 

17.6.2.  Evaluation based on the current situation ............................................................... 460 

17.6.3.  Evaluation results..................................................................................................... 460 

17.6.4.  Summary................................................................................................................... 461 

17.7. 

Judicial cooperation in criminal matters ............................................................. 462 

17.7.1.  Current position ....................................................................................................... 462 

17.7.2.  Evaluation based on the current situation ............................................................... 464 

17.7.3.  Evaluation results..................................................................................................... 464 

17.7.4.  Summary................................................................................................................... 465 

17.8.  Antidiscrimination and gender equality .............................................................. 465 

17.8.1.  Current position ....................................................................................................... 465 

17.8.2.  Evaluation based on the current situation ............................................................... 468 

17.8.3.  Evaluation results..................................................................................................... 469 

17.8.4.  Summary................................................................................................................... 469 

18. 

19. 

TRADE.................................................................................................................... 470 

ENLARGEMENT .................................................................................................. 470 

19.1.  Current position – Most important legal instruments and related work and 

reporting on 2010 ................................................................................................... 470 

19.2.  Evaluation based on the current situation ........................................................... 471 

19.3.  Evaluation results................................................................................................... 471 

19.4. 

Summary................................................................................................................. 471 

20. 

EUROSTAT............................................................................................................ 471 

20.1.  General introduction.............................................................................................. 471 

20.2.  Report of work done in 2010 ................................................................................. 472 

21. 

HUMAN RESOURCES and SECURITY............................................................ 473 

21.1.  Current position – Most important legal instruments and related work and 

reporting on 2010 ................................................................................................... 473 

21.1.1.  General introduction................................................................................................ 473 

21.1.2.  Report of work done in 2010.................................................................................... 473 

21.2.  Evaluation based on the current situation ........................................................... 474 

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21.3.  Evaluation results................................................................................................... 474 

21.3.1.  Priorities .................................................................................................................. 474 

21.3.2.  Planned action ......................................................................................................... 474 

22. 

BUDGET................................................................................................................. 475 

22.1.  Current situation.................................................................................................... 475 

22.1.1.  General introduction................................................................................................ 475 

22.1.2.  Report of work done in 2010.................................................................................... 475 

22.2.  Evaluation ............................................................................................................... 475 

22.3.  Evaluation results................................................................................................... 476 

22.4. 

Summary................................................................................................................. 476 

23. 

Annex I - List of measures in force and other relevant instruments referred to in 
the text of the document ........................................................................................ 476 

I. 

ENTERPRISE AND INDUSTRY......................................................................... 476 

I.1. 

REACH..................................................................................................................... 476 

I.2 Classification, labelling and packaging: .......................................................................... 477 

I.3 Pyrotechnic Articles and Explosives................................................................................. 477 

I.4 Drug precursors................................................................................................................ 477 

I.5 Detergents ......................................................................................................................... 477 

I.6 Fertilisers.......................................................................................................................... 477 

I.7 Textiles/clothing, footwear and wood ............................................................................... 477 

I.8 Non-harmonised area ....................................................................................................... 477 

II. 

EMPLOYMENT, SOCIAL AFFAIRS AND INCLUSION ............................... 478 

II.1. 

Free movement of workers and coordination of social security schemes ......... 478 

II.1.1.  Free movement of workers ....................................................................................... 478 

II.1.2 

Social Security.......................................................................................................... 478 

II.2. 

Labour Law ............................................................................................................ 480 

II.2.1.  Working conditions .................................................................................................. 480 

II.2.2. 

Information and consultation of workers................................................................. 480 

II.2.3.  Protection of workers............................................................................................... 481 

II.3. 

Health and safety at work ........................................................................................ 482 

III  

ENERGY................................................................................................................. 484 

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III.1. 

Legislation in force .................................................................................................. 484 

III.2. 

Legislation adopted in 2010..................................................................................... 486 

III.3.  New measures proposed or in preparation in 2010................................................. 488 

IV  

V. 

V.1  

V.2  

V.3 

VI 

MOBILITY and TRANSPORT............................................................................ 489 

TAXATION and CUSTOMS UNION.................................................................. 490 

Situation in the sector of CUSTOMS ....................................................................... 490 

INDIRECT TAXATION ............................................................................................ 491 

DIRECT TAXATION ................................................................................................ 493 

EDUCATION AND CULTURE ........................................................................... 494 

VII 

HEALTH AND CONSUMERS ............................................................................ 494 

VII.1 

Public Health ........................................................................................................... 494 

VII.2  Consumers................................................................................................................ 497 

VII.3 

Food Safety............................................................................................................... 499 

GMO 

.................................................................................................................................. 499 

FOOD HYGIENE................................................................................................................... 501 

FOOD 

.................................................................................................................................. 503 

PLANT HEALTH.................................................................................................................... 508 

SEEDS – PLANT VARIETY.................................................................................................... 509 

ANIMAL HEALTH ................................................................................................................. 513 

FEED 

.................................................................................................................................. 517 

ANIMAL WELFARE............................................................................................................... 519 

VIII 

BUDGET................................................................................................................. 519 

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1. 

ENTERPRISE AND INDUSTRY 

1.1. 

General introduction 

Responsibility for ensuring the free movement of goods within the Single Market is entrusted 
to  the  Directorate-General  for  Enterprise  and  Industry  which  manages  a  large  part  of  the 
European  Union  (EU)  acquis  consisting  of  Articles  34  to  36  TFEU  in  the  non-harmonised 
area and a large quantity of subordinate EU legislation (regulations, directives and decisions) 
in the harmonised area. The acquis of the EU under the management of Directorate-General 
for Enterprise and Industry” (the latest version of the “Pink Book”) is listed on the internet at 
the following address: 

http://ec.europa.eu/enterprise/policies/single-market-goods/files/pink-book_en.pdf  

As ‘harmonising’ rules are adopted in more and more sectors of the Single Market, the non-
harmonised  area  is  gradually  shrinking.  But  some  25%  of  the  market  is  still  not  subject  to 
harmonised  rules  and,  here,  Articles  34-36  TFEU  ensure  the  easy  cross-border  exchange  of 
goods. 

Generally  speaking,  the  EU  acquis  governing  the  free  movement  of  goods  is  stable  and 
effective, although the highly technical nature of much of the legislation means that there is 
always considerable activity adapting it to technological progress.  

The  Commission's  legislative  activity  in  the  "Enterprise  and  Industry"  sector  is  fully  in 
accordance  with  Better  Regulation  principles  with  preference  being  given  to  regulations 
which  require  less  effort  in  relation  to  their  transposition.  This  sector  also  regards  the 
simplification  and  codification  of  existing  legislation  as  important  tools  in  achieving  better 
implementation of EU law.  

The  New  Legislative  Framework  (NLF)  adopted  in  2008  consists  of  two  complementary 
instruments, Regulation (EC) No 765/2008 on accreditation and market surveillance relating 
to  the  marketing  of  products  and  Decision  768/2008/EC  on  a  common  framework  for  the 
marketing of products. The Regulation has been in force since 1 January 2010. It sets out the 
provisions for the European policy on accreditation (control of the competence of laboratories 
and certification/inspection bodies for the mutual recognition of certificates in the EU) and for 
the policy in the field of market surveillance and controls of products from third countries (for 
safe products whatever their origin)  

The Decision contains elements of product legislation which are commonly used throughout 
directives  and  provides  a  horizontal  harmonised  framework  for  that  legislation.  The 
systematic use of the Decision will make the regulatory framework more coherent and user-
friendly  for  economic  operators  and  national  authorities.  It  is  a  tool  of  the  Commission’s 
Better Regulation policy, eliminating unnecessary disparities in product legislation. 

Existing legislation is being aligned with the NLF both as when it comes up for revision (e.g. 
the toys directive, the Restriction of the use of certain Hazardous Substances in electrical and 
electronic  equipment  (RoHS)  Directive  and  the  Radio  and  telecommunications  terminal 

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equipment  (R&TTE)  Directive)  and  as  part  of  an  alignment  package  involving  ten  new 
approach directives1.  

Alignment with the NLF Decision concerns the following elements of the directives: 

(cid:131) 

(cid:131) 

(cid:131) 

(cid:131) 

(cid:131) 

Horizontal definitions (e.g. placing on the market) 

Obligations of economic operators and traceability requirements 

Conformity assessment and CE marking 

Rules on notified bodies and notification process 

Safeguard mechanisms (Common procedures to deal with non-compliant products) 

The NLF also strengthens market surveillance to protect consumers from unsafe products, and 
shelter  businesses  from  unfair  competition  (from  operators  not  complying  with  EU  law).  A 
multi-annual action plan on market surveillance, forming part of both the Single Market Act 
and the Commission’s industrial policy, is under preparation. 

Directive  2009/43/EC  of  the  Council  and  the  European  Parliament  simplifying  intra-EU 
transfers of defence-related products is the first internal market instrument on these products 
and will enable operators to benefit from smoother and more predictable supply chains while 
improving  security  of  supply  for  EU  armed  forces  relying  on  cross-border  deliveries.  The 
transposition deadline was set for 30 June 2011 and will fully apply from 30 June 2012.  

The  Directorate-General  for  Enterprise  and  Industry  also  manages  EU  regulation  under  the 
Common agricultural policy and the common commercial policy (Articles 43 and 207 TFEU) 
in relation to trade in certain goods resulting from the processing of agricultural products. 

The Commission provides guidance and other assistance to help Member States transposing 
and  implementing  new  directives  on  time.  Assistance  is  given  using  a  variety  of  different 
tools (e.g. interpretative documents, bilateral meetings and Committee meetings). 

A  very  valuable  tool  for  dealing  in  advance  with  possible  technical  barriers  to  the  free 
movement of goods in the non-harmonised area is Directive 98/34/EC, which requires the 27 
Member  States,  the  EFTA  countries  and  Turkey  to  notify  all  national  technical  regulations 

1 The 10 directives are: 
1.  Low  Voltage  Directive:  Directive  2006/95/EEC  on  the  harmonisation  of  the  laws  of  Member  States  relating  to  electrical 

2. 

equipment designed for use within certain voltage limits; 
Simple  Pressure  Vessels  Directive:  Council  Directive  2009//105/EC  on  the  harmonisation  of  the  laws  of  the  Member  States 
relating to simple pressure vessels;  

3.  Non-automatic  Weighing  Instruments  Directive:  Council  Directive  90/384/EEC  on  the  harmonisation  of  the  laws  of  the 

Member States relating to non-automatic weighing instruments;  

4.  Civil Explosives Directive: Council Directive 93/15/EEC on the harmonisation of the provisions relating to the placing on the 

market and supervision of explosives for civil uses; 

5.  ATEX  Directive:  Directive  94/9/EC  of  the  European  Parliament  and  the  Council  on  the  approximation  of  the  laws  of  the 

Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres;  

6.  Lifts Directive European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the 

7. 

Member States relating to lifts; 
Pressure Equipment Directive: Directive 97/23/EC of the European Parliament and of the Council on the approximation of the 
laws of the Member States concerning pressure equipment; 

8.  Measuring  Instruments  Directive:  Directive  2004/22/EC  of  the  European  Parliament  and  of  the  Council  on  measuring 

instruments;  

9.  Electromagnetic  Compatibility  Directive:  Directive  2004/108/EC  on  the  approximation  of  the  laws  of  the  Member  States 

relating to electromagnetic compatibility and repealing Directive 89/336/EEC; 

10.  Pyrotechnic articles Directive 2007/23/EC on the placing on the market of pyrotechnic articles. 

EN 

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concerning  products  and  Information  Society  Services  at  the  draft  stage.  The  steady  high 
number  of  notifications  (843  in  2010)  and  reactions  from  the  Commission  (124)  and  the 
Member States (220) underlines the importance of Directive 98/34/EC in preventing barriers 
to  intra-EU  trade  -  and  also  in  promoting  better  regulation  since  it  provides  a  forum  for 
making  suggestions  to  improve  the  quality  of  national  legislation.  It  often  means  that 
infringement procedures can be avoided. 

The  Directorate-General  for  Enterprise  and  Industry  monitors  the  correct  application  of  the 
acquis  under  its  responsibility  and  opens  infringement  procedures  against  Member  States  if 
necessary. However, great importance is attached to resolving problems as quickly as possible 
using methods other than infringement proceedings. The most significant of these is the EU 
Pilot project, designed to clarify and solve problems concerning the application of EU law in 
cooperation with the participating Member States. It has significantly contributed to reducing 
the number of formal infringement proceedings for those Member States which participate in 
the project. 

Other methods include “package meetings” and bilateral meetings with the Member States to 
provide advice to national authorities to help ensure the correct application of EU law.  

In the context of infringement proceedings, non-communication cases and article 260 TFEU 
cases  are  dealt  with  as  quickly  as  possible,  given  their  priority  status  under  the  2007 
Communication.  In  accordance  with  the  other  criteria  set  out  in  the  Communication,  since 
2009 priority status in this sector has been given to the following cases:  

Non-harmonised area 

•  The  failure  by  a  Member  State  to  notify  national  technical  rules  in  draft  form  under 
Directive 98/34/EC. Such failure renders the rules liable to be declared null and void. 

• Breaches of Articles 34-36 TFEU raising horizontal questions about the functioning of the 
market (e.g. the registration of vehicles). 

Harmonised area 

Breaches  of  key  directives,  in  particular  new  legislation,  which  is  adopted  in  response  to  a 
clearly  identified  need  to  correct/enhance  market  performance  and  should  be  enforced  in  a 
manner commensurate with the risk of failing to achieve that aim. 

The significant part of the EU acquis dealt with by the Commission services responsible for 
the "Enterprise and Industry" sector covers a wide variety of product domains, in relation to 
each of which are set out below: 

- a description of the current state of the legislation in force;  

- an evaluation of the effectiveness of regulatory framework in the domain concerned; and  

- an indication of plans for the future.  

Information is also provided about infringement proceedings pursued in each product domain.  

1.2. 

Automotive Industry 

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Current position 

General introduction 

The  harmonised  legislative  framework  in  the  automotive  sector  covers  three  categories  of 
vehicles:  motor  vehicles  and  their  trailers,  motorcycles  (two  and  three-wheelers  as  well  as 
certain quadricycles), and agricultural or forestry tractors. This legislation lays down common 
requirements designed to achieve environmental and safety objectives. It is based on a system 
of  whole-vehicle  type-approval  which  allows  manufacturers  to  have  a  vehicle  "type" 
approved in one EU Member State  and then to market vehicles of that type in all other EU 
Member  States  without  further  tests.  It  deals  with  a  multitude  of  detailed  technical 
specifications for different vehicle systems and components which are frequently modified to 
adapt them to technical progress while reducing the regulatory burden on industry.  

There are three main framework instruments in relation to type-approval of new vehicles: 

o 

o 

o 

Directive 2007/46/EC establishing a framework for the approval of motor vehicles and 
their trailers, and  of  systems,  components and separate technical units intended for such 
vehicles; 

Directive  2002/24/EC  relating  to  the  type-approval  of  two-or  three-wheel  motor 
vehicles; (to be replaced by a Regulation on the approval and market surveillance of two- 
or three-wheel vehicles and quadricycles which is currently being discussed in the Council 
and the European Parliament); and  

Directive 2003/37/EC relating to the type-approval of agricultural or forestry tractors, 
their  trailers  and  interchangeable  towed  machinery,  together  with  their  systems, 
components and separate technical units (to be replaced by a Regulation on the approval 
of agricultural or forestry vehicles which is also currently under discussion in the Council 
and the European Parliament). 

The  above  legislation  provides  for  the  obligatory  EU  whole  vehicle  type-approval  but,  in 
certain cases, a national approval system for certain vehicle categories remains in parallel. In 
addition  to  these  framework  instruments,  separate  legislative  acts  lay  down  harmonised 
technical  requirements  for  the  type-approval  of  individual  parts  and  characteristics  of  a 
vehicle. 

In line with better regulation and simplification policies and to increase the competitiveness of 
EU  industry  on  the  global  market,  as  a  result  of  the  CARS  21  exercise  the  regulatory 
framework  in  the  automotive  sector  has  been  and  continues  to  be  reformed  along  the 
following  lines:  (i)  the  introduction  of  the  split-level  approach:  (a  "framework"  act adopted 
under  the  ordinary  legislative  procedure  lays  down  fundamental  provisions  while  technical 
specifications  are  set  out  using  the  comitology  procedure);  (ii)  the  adoption  of  Regulations 
instead  of  Directives;  and  (iii)  international  harmonisation  (whenever  possible,  EU  acts  are 
replaced by UNECE Regulations compliance with which is made mandatory).2  

Work done in 2010 

2 

UNECE  Regulations  are  harmonized  technical  regulations  regarding  new  motor  vehicles  and  motor 
vehicle equipment that are adopted pursuant to the 1958 Agreement under the auspices of the United 
Nations  Economic  Commission  for  Europe  (www.unece.org).  As  a  contracting  party  to  the  1958 
UNECE Agreement, the European Union can decide to apply a Regulation. 

EN 

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Various steps were taken in 2010 to implement, simplify and update the technical legislation 
in the sector. 

A proposal for a Regulation revising the regulatory framework on the approval of agricultural 
or  forestry  vehicles  was  adopted  by  the  Commission  on  23  July  20103 and a proposal for a 
Regulation  revising  the  regulatory  framework  for  the  approval  of  two  and  three-wheel 
vehicles  and  quadricycles  was  adopted  on  4  October  20104.  These  proposals  were 
subsequently  discussed  -  under  the  ordinary  legislative  procedure  -  with  the  European 
Parliament and the Council. 

The first half of 2010 also saw the adoption of a Directive on spray-suppression systems of 
certain categories of motor vehicles5 and two Regulations, one amending several Annexes to 
Framework  Directive  2007/46/EC6  and  the  other  on  type-approval  of  hydrogen-powered 
motor  vehicles7.    This  was  followed  in  July  by  the  first  measure  implementing  Regulation 
(EC) No 661/2009 on the general safety of motor vehicles (“the GSR”)8, namely a Regulation 
on  windscreen  defrosting  and  demisting  systems9.  Then,  in  November,  the  Commission 
adopted  four  more  regulations  implementing  the  GSR,  concerning  rear  registration  plates10, 
towing  devices11,  windscreen  washers  and  wipers12  and  wheel  guards13.  Later,  two 

3  

4  

5 

6  

7 

8 

9  

10  

11  

Proposal for a Regulation (EU) No …/… of the European Parliament and of the Council on the 
approval of agricultural or forestry vehicles - http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0395:FIN:EN:PDF  

Proposal  for  a  Regulation  (EU)  No  .../2010  of  the  European  Parliament  and  of  the  Council  on  the 
approval and market surveillance of two- or three-wheel vehicles and quadricycles 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0542:FIN:EN:PDF  

Directive 2010/19/EU of 9 march 2010 amending, for the purposes of adaptation to technical progress 
in  the  field  of  spray-suppression  systems  of  certain  categories  of  motor  vehicles  and  their  trailers, 
Council  Directive  91/226/EEC,  and  Directive  2007/46/EC  of  the  European  Parliament  and  of  the 
Council (OJEU L72, 20.3.2010, p. 17). 

Regulation  (EC)  371/2010  of  16  April  2010  replacing  Annexes  V,  X,  XV  and  XVI  to  Directive 
2007/46/EC  establishing  a  framework  for  the  approval  of  motor  vehicles  and  their  trailers,  and  of 
systems, components and separate technical units intended for such vehicles (Framework Directive) – 
(OJEU L 110, 1.5.2010, p. 1). 

Regulation  (EC)  No  406/2010  of  26  April  2010  implementing  Regulation  (EC)  No  79/2009  on  type-
approval of hydrogen-powered vehicles (OJEU L 122, 18.5.2010, p. 1). 

Regulation  (EC)  No  661/2009  of  the  European  Parliament  and  of  the  Council  of  13  July  2009 
concerning  type-approval  requirements  for  the  general  safety  of  motor  vehicles,  their  trailers  and 
systems, components and separate technical units intended therefor (OJEU L 200, 31.7.2009, p.1).  

Regulation (EU) No 672/2010 of 27 July 2010 concerning type-approval requirements for windscreen 
defrosting  and  demisting  systems  of  certain  motor  vehicles  and  implementing  Regulation  (EC)  No 
661/2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers 
and systems, components and separate technical units intended therefor (OJEU L 196, 28.7.2010, p. 5). 

Regulation  (EU)  No  1003/2010  of  8  November  2010  concerning  type-approval  requirements  for  the 
space  for  mounting  and  the  fixing  of  rear  registration  plates  on  motor  vehicles  and  their  trailers  and 
implementing  Regulation  (EC)  No  661/2009  concerning  type-approval  requirements  for  the  general 
safety  of  motor  vehicles,  their  trailers  and  systems,  components  and  separate  technical units  intended 
therefor (OJEU L 291, 9.11.2010, p.22). 

Regulation (EU) No 1005/2010 of 8 November 2010 concerning type-approval requirements for motor 
vehicle  towing  devices  and  implementing  Regulation  (EC)  No  661/2009  concerning  type-approval 
requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended 
therefor (OJEU L 291, 9.11.2010, p.36). 

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Regulations on spray suppression systems and statutory plates were adopted by the Technical 
Committee – Motor Vehicles. 

By  virtue  of  the  GSR,  UNECE  Regulations  adopted  in  accordance  with  the  1958  UNECE 
Agreement  will  become  compulsory  for  the  majority  of  items  currently  subject  to  EU  type-
approval  requirements,  thereby  contributing  significantly  to  the  simplification  of  the  EU 
regulatory  system.  Against  this  background,  preparatory  work  began  on  a  Regulation 
implementing  the  GSR  and  listing  62  compulsory  UNECE  Regulations14  –  among  them, 
UNECE  Regulation  No  100  on  electrical  safety  -  particularly  important  in  view  of  the 
development of electric vehicles. This required very careful translation of numerous UNECE 
regulations  into  all  EU  languages  with  the  aim  of  publishing  them  all  in  the  OJ.  Work  on 
other  measures  implementing  the  GSR  (tyre  installation,  gear  shift  indicators,  masses  and 
dimensions, lane warning departure systems and advanced emergency braking systems) was 
also carried out. 

A  Regulation  on  Individual  Vehicle  Approval  was  endorsed  by  the  Technical  Committee  – 
Motor Vehicles on 17 September 201015. The impact assessment for a new proposal replacing 
Directive  70/157/EEC  on  motor  vehicle  noise  was  finalised  in  December  2010.  Finally,  a 
proposal  for  a  Directive  amending  Directive  2000/25/EC  as  regards  provisions  for  tractors 
placed  on  the  market  under  the  flexibility  scheme  was  adopted  by  the  Commission  on  27 
October 201016 and a proposal for a Directive on emission from narrow tractors was finalised 
at the end of 201017. 

The  TAAEG  (Type-Approval  Authorities  Expert  Group)  –  established  by  the  Commission 
services in October 2009 in the form of a consultative body composed of representatives of all 
national type-approval authorities18 – met on 12 April 2010 and discussed the enhancement of 
market surveillance in the automotive sector, the application of Directive 2006/40/EC relating 
to emissions from air-conditioning systems in motor vehicles and the delivery of certificates 

12  

13  

14  
15  
16  
17  
18  

Regulation  (EU)  No  1008/2010  of  9  November  2010  concerning  type-approval  requirements  for 
windscreen wiper and washer systems of certain motor vehicles and implementing Regulation (EC) No 
661/2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers 
and systems, components and separate technical units intended therefor (OJEU L 292, 10.11.2010, p. 
2). 

Regulation (EU) No 1009/2010 of 9 November 2010 concerning type-approval requirements for wheel 
guards  of  certain  motor  vehicles  and  implementing  Regulation  (EC)  No  661/2009  of  the  European 
Parliament  and  of  the  Council  concerning  type-approval  requirements  for  the  general  safety  of  motor 
vehicles, their trailers and systems, components and separate technical units intended therefor Text with 
EEA relevance (OJEU L 292, 10.11.2010, p. 21). 

http://ec.europa.eu/enterprise/sectors/automotive/files/application-unece-regulations_en.pdf  

http://ec.europa.eu/enterprise/sectors/automotive/files/directives/draft_regulation_iva_en.pdf  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0607:FIN:EN:PDF  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2011:0001:FIN:EN:PDF  

Bearing  in  mind  that  EU  whole  vehicle  type-approval  will  gradually  become  mandatory  by  October 
2012  for  new  types  of  all  categories  of  motor  vehicles,  the  aim  of  the  TAAEG  is  to  ensure  uniform 
application of the relevant technical requirements within the EU type-approval system. Several tasks are 
envisaged,  including  the  monitoring  of  the  enforcement  of  EU  legislation  by  national  authorities  and 
solving the issue of the diverging views concerning type-approval in order to ensure mutual recognition. 

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of  conformity  of  EU  type-approved  vehicles  (enforcement  of  Article  18  of  Framework 
Directive 2007/46/EC). 

As regards clean and energy efficient vehicles, the Commission organised a public hearing on 
11 March 2010 and adopted a Communication on 28 April 201019. This document sets out a 
comprehensive  strategy  for  encouraging  the  development  and  uptake  of  clean  and  energy 
efficient  ("green")  heavy-duty  (buses  and  trucks)  and  light-duty  vehicles  (cars  and  vans)  as 
well as two- and three-wheelers and quadricycles. 

In October 2010 the CARS 21 process (Competitive Automotive Regulatory System for the 
21st century) – initially launched in 2005 - was re-launched. The re-launch was effected more 
formally  than  the  original  launch,  through  a  Commission  Decision  adopted  on  14  October 
201020.  CARS  21  aims  to  make  recommendations  for  the  short-,  medium-,  and  long-term 
public policy and regulatory framework of the European automotive industry. This framework 
enhances global competitiveness and employment, while sustaining further progress in safety 
and  environmental  performance  at  a  price  affordable  to  the  consumer.  The  CARS  21  High 
Level  Group  met  for  the  first  time  on  10  November  2010.  Further  meetings  are  planned 
throughout 2011. 

Seven infringement cases were opened during 2010 in relation to EU legislation in this sector 
(compared to 32 cases in 2009) and 25 cases were closed. All of these cases were opened as a 
result of late communication of national measures transposing EU Directives which generally 
contained  technical  updates  of  the  acquis.  The  Member  States  concerned  by  these  non-
communication  cases  were  Austria,  Bulgaria  (two  proceedings),  the  Czech  Republic, 
Hungary,  Ireland  and  Portugal.  Most  of  these  cases  were  closed  after  national  transposition 
measures were communicated by the Member States  concerned (but  one 2009 case remains 
open and is currently before the Court of Justice). In around 70% of cases opened in 2010 and 
subsequently  closed  in  the  same  year,  national  measures  were  communicated  before  the 
reasoned opinion stage. However, in only 40% of all open cases that were closed in 2010 did 
communication take place before that stage. 

During 2010 the Commission services continued to deal with a steady number of questions, 
complaints  and  queries  in  relation  to  legislation  in  the  automotive  sector.  Complaints  or 
requests for information were also periodically sent via the petition procedure. Most inquiries 
were submitted by individuals or SMEs. In many cases, the issues raised could be dealt with 
by giving guidance on the Commission service's interpretation of the relevant EU legislation. 
Where the complaint turned out to be unsubstantiated, the matter was closed and the reasons 
for doing so were explained.  

Evaluation 

The  current  situation  regarding  compliance  by  Member  States  with  the  EU  acquis  in  the 
automotive  sector  is  generally  satisfactory.  Nevertheless,  there  are  delays  in  the  timely 

19  

20  

EN 

http://ec.europa.eu/enterprise/sectors/automotive/competitiveness-cars21/energy-
efficient/communication_en.htm  

Commission  Decision  of  14  October  2010  re-launching  of  the  CARS  21  High  Level  Group  on  the 
Competitiveness  and  Sustainable  Growth  of  the  Automotive  Industry  in  the  European  Union,  OJEU 
C280 of 16.10.2010, p.32.  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:280:0032:0034:en:PDF  

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transposition of certain Directives (for example, in the context of amendments to framework 
Directive  2007/46/EC,  where  only  15  EU  Member  States  communicated  national 
transposition measures prior to the expiry of the deadline – one case was brought before the 
Court  of  Justice  in  2010).  In  this  regard,  the  constant  evolution  of  the  technical  legislation 
means  that  it  is  important  to  pay  close  attention  to  timely  transposition  and  effective 
enforcement to ensure that policy objectives are met.  

Through  the  CARS  21  process,  the  Commission  has  developed  a  medium  to  long-term, 
coordinated  and  predictable  policy  framework  for  the  automotive  industry  based  on 
continuous  dialogue  and  consultation  with  all  main  stakeholders.  In  this  regard,  in  the 
preparation of legislative proposals and policy initiatives, the Commission is assisted by two 
types of advisory bodies: comitology committees and working groups. In the case of technical 
amendments to legislation, the Commission acts in close cooperation with EU Member States 
on  implementation  issues  under  the  comitology  procedure.  Likewise,  the  informal  working 
groups, which may consist not only of national experts but also experts or stakeholders from 
business, NGOs, trade unions, academia, etc., provide expert advice to the Commission. 

There is close cooperation between the Commission and EU Member States, notably through 
the TAAM (Type-Approval Authorities Meeting) forum, which met at the beginning of June 
2010 in Sofia, Bulgaria and discusses questions regarding the interpretation of EU directives 
in  the  automotive  sector  as  well  as  the  equivalent  UNECE  Regulations  with  a  view  to 
ensuring their common and harmonised application.  As a result of this, significant problems 
regarding conformity or incorrect application are relatively rare. Nevertheless, the complexity 
of  the  legislation  in  this  sector  and  the  constant  development  of  new  technologies,  for 
example  on  hybrid  and  electric  vehicles  (and  the  corresponding  adaption  of  legislation), 
means that problems of interpretation are ever-present. On occasion, the Commission has set 
out its interpretation of the legislation in order to maintain a harmonised approach. It may still 
be  that  Member  States  take  measures  which  could  potentially  compromise  the  harmonised 
approach. 

In  many  cases,  due  to  the  technical  nature  of  the  legislation,  EU  Member  States  transpose 
technical  amendments  by  reference  to  EU  acts.  Where  this  is  not  the  case,  the  use  of 
correlation tables is very helpful. 

Finally,  the  approach  taken  regarding  legislation  harmonising  vehicle  standards  under  the 
ordinary  legislative  procedure  now  tends  towards  the  adoption  of  regulations  rather  than 
directives (e.g. a proposal for framework Regulations on two and three wheel vehicles and on 
tractors). One exception to this is framework Directive 2007/46/EC on type-approval of motor 
vehicles. No transposition of regulations is required and this should increase overall efficiency 
by significantly lowering the number of infringement cases based on non-communication of 
national transposition measures. 

Evaluation results 

(1) 

Priorities 

The main priority in the automotive sector remains the proper implementation, management 
and  enforcement  of  legislation.  In  particular,  there  has  to  be  long-term  regulatory  clarity  as 
well as an accurate quantification of the costs and benefits of legislative activity, notably by 
recourse to impact assessments where appropriate. Given the impact of the economic crisis, 
the Commission will continue to weigh up the costs and benefits of new legislative initiatives 

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and seek, as far as possible, to avoid creating new economic burdens. 

(2) 

Planned action (2011 and beyond) 

A significant proportion of the work in the automotive sector in 2011 and beyond will focus 
on  the  recasting  of  the  legislative  framework  (and  its  subsequent  completion)  and  the 
implementation of new technical legislation.  

In particular, the revised regulatory framework for type-approval legislation in relation to two 
and three-wheeled vehicles and tractors will progress under the ordinary legislative procedure 
(this revised legislation will update and replace the present framework Directives on two and 
three-wheeled  vehicles  and  on  tractors  and  separate  completing  directives).  Delegated  and 
implementing  acts  for  the  revised  regulatory  frameworks  regarding  two  and  three-wheeled 
vehicles and tractors will be prepared. 

The  Commission  will  also  work  on  various  proposals  to  complete  framework  Directive 
2007/46/EC (e.g. notably to take into account UNECE Regulations replacing EU Directives) 
as well as implementing measures on type-approval of hydrogen vehicles, Euro VI, the GSR, 
the  Strategy  of  2007  on  CO2  and  the  strategy  on  clean  and  energy  efficient  vehicles.  A 
proposal replacing Directive 70/157/EEC on noise of motor vehicles is to be adopted by the 
Commission  in  2011  and  submitted  to  the  European  Parliament  and  Council  under  the 
ordinary legislative procedure. Finally, the Commission will participate actively in activities 
relating to the ITS (Intelligent Transport Systems) action plan including eCall. 

1.3. 

Chemicals 

1.3.1.  REACH 

Current position 

General introduction 

Regulation  No  1907/2006  (REACH),  most  parts  of  which  began  to  apply  in  June  2008, 
constitutes the horizontal framework and cornerstone of the EU’s new chemicals legislation. 
REACH includes four main processes - registration, evaluation, authorisation and restriction 
of  chemical  substances.  Registration  of  chemicals  with  the  European  Chemicals  Agency 
(“ECHA”) is designed to generate information on manufactured and imported substances in 
order  to  ensure  that  industry  implements  adequate  measures  to  ensure  their  safe  use. 
Subsequent  evaluation  by  ECHA  includes  compliance  checks  on  registration  dossiers  and 
examination  of  testing  proposals.  Certain  substances  may  undergo  ‘substance  evaluation’, 
where  national  authorities  can  request  further  information  from  industry  about  a  given 
substance  on  a  risk  basis  and  further  regulatory  measures  may  be  considered.  Substances 
giving rise to very high concern may be required to obtain Commission authorisation before 
being  placed  on  the  market  or  used  under  stipulated  conditions.  Finally,  the  manufacture, 
import and use of substances that pose unacceptable risks to human health or the environment 
may be partially or totally restricted. 

Work done in 2010 

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The main goal of the Commission in 2010 was to contribute to the successful registration by 
industry of the highest volume and most hazardous substances by 30 November 2010. To this 
end,  in  January  2010,  a  dedicated  high-level  Directors’  Contact  Group  (DCG)  was 
established, composed of the representatives of the Commission, ECHA and several industry 
associations. The objectives of the DCG are to monitor the overall preparedness of companies 
and  to  identify  and  resolve  issues  of  priority  concern  in  relation  to  meeting  registration 
obligations. Special attention is also paid to securing the supply of high volume substances to 
downstream  users.  By  the  30  November  2010  deadline,  ECHA  had  received  nearly  25.000 
registration files covering around 3.400 substances. Overall, the results are satisfactory.  

Commission Regulation (EU) No 453/2010 was adopted with a view to adapting Annex II to 
REACH, which contains a guide to the compilation of safety data sheets, to the new criteria 
for classification and other relevant provisions laid down in Regulation (EC) No 1272/2008 
and  to  the  rules  for  safety  data  sheets  of  the  United  Nations  Globally  Harmonised  System 
(GHS). 

The Test Methods Regulation (Commission Regulation (EU) No 1152/2010) was also adapted 
to  technical  progress  by  including  two  new  in-vitro  test  methods  to  reduce  the  number  of 
animals used for experimental purposes.  

The  Commission  prepared  amendments  to  Annex  XIII  to  REACH  (criteria  for  the 
identification  of  persistent,  bio-accumulative  and  toxic  substances  and  very  persistent  and 
very bio-accumulative substances) and to Annex XIV (the first list of substances to be subject 
to Commission authorisation).  

The  Commission  adopted  an  amendment  to  REACH  to  introduce  into  Annex  XVII  all 
restrictions  adopted  under  the  previous  legislation  (Commission  Regulation  (EU)  No 
276/2010). The Commission also prepared two new amendments to Annex XVII relating to 
transitional provisions. These concern the use of acrylamide in grouting applications and the 
use of cadmium in plastics, jewellery and brazing fillers. The Commission further requested 
ECHA to prepare a file in accordance with Annex XV to restrict the use of mercury in some 
measuring  devices  and  to  analyse  whether,  in  the  light  of  new  scientific  information,  the 
existing restrictions in Annex XVII concerning phthalates need to be revised. 

The REACH Regulation is complemented by a comprehensive package of technical guidance 
published by ECHA to ensure its uniform and consistent interpretation. Most of the guidance 
was already in place by mid 2008. However, the existing guidance is constantly being updated 
to  address  implementation  needs.  Throughout  2010,  the  Commission  assisted  ECHA  in 
developing  new  guidance  (e.g.  Guidance  on  authorisation  applications)  and  updating  the 
existing guidance documents (notably those necessary to facilitate compliance with the 2010 
registration deadline). 

Many implementation problems faced by industry were resolved in collaboration with ECHA, 
which  has  developed  various  tools  to  help  operators  to  fulfil  their  REACH  obligations 
(guidance  package,  Navigator  tool,  helpdesk,  FAQs  etc.).  National  REACH  helpdesks  are 
also functioning satisfactorily. The Commission actively participated in numerous meetings of 
ECHA committees and in workshops. 

The  Commission  called  for  a  study,  which  analysed  and  compared  penalties 

for 

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infringement  of  REACH  in  all  Member  States  with  a  view  to  assessing  their  effectiveness, 
proportionality  and  dissuasiveness.  As  the  study  did  not  address  how  the  penalties  are 
implemented in practice, it provides only an overview. As a follow-up to the study results, the 
Commission held a workshop on national penalties for REACH enforcement. Later in 2010, 
the Commission received reports from Member States under Article 117 on the operation of 
REACH containing information on enforcement, which is currently under consideration.  

The Commission  actively  participated in,  and  contributed to the work of, the ECHA Forum 
for  the  Exchange  of  Information  on  Enforcement  which  coordinates  a  network  of  national 
authorities  responsible  for  enforcement.  The  Forum  evaluated  the  first  EU  coordinated 
enforcement project (REACH-EN-FORCE 1) and extended it for the rest of 2010 and beyond. 
The project is an important step towards the harmonisation of enforcement practices. 

The Commission continued to hold regular dialogues on various implementation issues with 
Member States’ competent authorities and other stakeholders via three meetings of its expert 
group  “Competent  Authorities  for  the  REACH  and  CLP  Regulations  (CARACAL)”  and  its 
subgroups, notably the subgroup on nanomaterials.  

In addition, the Commission worked to clarify and smooth the transition of materials between 
different  EU  regulatory  regimes  (e.g.  the  development  of  end-of-waste  criteria  and  the 
implications  of  REACH  for  these  materials  and  the  involvement  of  customs  authorities  in 
REACH enforcement). 

In 2010, the Commission received two complaints regarding REACH compliance by Member 
States' authorities in the area of restrictions, which are currently under investigation.   

Evaluation 

REACH  being  a  Regulation,  directly  applicable  in  the  Member  States  with  no  need  for 
transposition,  the  role  of  the  Commission  is  limited  to  monitoring  its  consistent  application 
and ensuring that the Member States enforce it through a system of official controls and other 
appropriate activities. 

Given  the  early  stages  of  its  implementation,  the  objectives  of  REACH  will  be  realised  in 
successive  stages  by  2020.  Different  obligations  will  be  phased-in  successively  during  this 
period.  This is relevant mainly for registration (where deadlines are set for 2010, 2013 and 
2018).  Authorisation  requirements  apply  in  accordance  with  transitional  arrangements 
specifically  provided  for  each  substance  listed  in  Annex  XIV  (the  first  “sunset  date”  is 
scheduled for the second half of 2014). Authorisation is a gradual process, whereby additional 
substances of very high concern will be included in Annex XIV over time, in accordance with 
the procedures laid down in Articles 58 and 59 of REACH. 

As the first deadline for registration expired as recently as 1 December 2010, enforcement of 
this  obligation  will  begin  in  earnest  in  2011.  The  Commission  has  not  yet  received  any 
complaints regarding the enforcement of the registration obligation. 

Obligations  on  the  provision  of  information  in  the  supply  chain  and  to  consumers  already 
apply and should be enforced by Member States. The Commission has not yet received any 
complaints in this respect.  

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The enforcement of restriction obligations came under the umbrella of REACH in the second 
half  of  2009.  The  change  from  Directive  76/769/EEC  to  REACH  allows  more  coherent 
implementation of the restrictions in the Member States.  

The Commission will study the information received in the Member State reports mid 2010 in 
order to prepare its own report in mid 2012 and any necessary follow-up on penalties.  

Evaluation results 

 (1)   Priorities 

The priorities indicated in the 2009 Annual Report largely remain. The Commission monitors 
the  effective  and  consistent  application  of  the  obligations  that  are  already  applicable.  The 
highest priorities are the enforcement of registration and restriction obligations. Launching the 
first review of certain aspects of REACH is a new priority.  

 (2) 

Planned action (2011 and beyond) 

The Commission will begin its first review of various aspects of REACH. The results of this 
review are due by mid 2012. REACH specifically requires three reviews: a review of ECHA, 
a  review  of  the  requirements  for  low  tonnage  substances  and  a  review  to  assess  whether  to 
amend  the  scope  of  REACH  to  avoid  overlaps  with  other  EU  legislation.  In  addition,  the 
Commission will start the preparatory work for the first general report on experience acquired 
with the operation of REACH, due in mid 2012. The Commission has decided to carry out a 
larger  review  exercise  covering  some  additional  elements  of  REACH  (a  report  on  the  first 
lessons learned, paying particular attention to costs, administrative burdens and other impacts 
on innovation). The various reviews and reports will be presented as a package by June 2012.  

The Commission will continue to prepare for one of its main tasks under REACH – granting 
authorisations for the placing on the market and the use of substances of very high concern, 
listed in Annex XIV. The first applications may be received by ECHA as soon as 2011. The 
Commission will also prepare a new draft regulation with a view to adding more substances to 
Annex XIV. 

On  the  basis  of  opinions  from  ECHA  committees  (the  Committee  for  Risk  Assessment  and 
the Committee for Socio-economic analysis) expected in 2011, the Commission will prepare 
the  following  substances: 
amendments 
dimethylfumarate,  mercury  in  measuring  devices,  phenylmercury  compounds  and  lead  in 
jewellery. 

to  Annex  XVII  relating 

to  restrictions  of 

The  Commission  will  continue  to  monitor  how  Member  States  enforce  REACH  in  order  to 
ensure transparency, impartiality and consistency in enforcement throughout the EU. To this 
end, the Commission will in particular continue to work closely with the ECHA Forum for the 
Exchange  of  Information  on  Enforcement.  The  Commission  will  also  review  the  Member 
States reports and later on, the ECHA report on the operation of REACH due by mid 2011.  

The Commission will continue other activities, including enhancing cooperation, coordination 
and exchange of information with national authorities and ECHA, extending the mandate of 
the  existing  DCG  group,  holding  meetings  with  industry  stakeholders,  providing  assistance 

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with interpretation problems and participating in workshops to ensure timely implementation.  

Summary 

As  the  new  horizontal  regulatory  framework  for  chemicals,  REACH  has  the  long-term 
objectives of providing a high level of protection of human health and the environment while 
ensuring  the  free  circulation  of  substances  on  the  internal  market  and  enhancing 
competitiveness  and  innovation.  The  objectives  of  the  acquis  should  be  largely  attained  by 
2020.  The  correct  implementation  of  REACH  obligations  will  be  critical  for  the  chemical 
industry sector in the coming years. It will only be possible to evaluate to what extent these 
objectives are being met over time, whereupon corrective action will be taken if necessary. 

Links to legislation 

REACH and its implementing legislation are available through the following link: 
http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/index_en.htm 

REACH and its links to previous legislation on restriction is available here:  
http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/archives/market-
restrictions/index_en.htm 

1.3.2. 

Other chemicals legislation 

1.3.2.1.  Classification, labelling and packaging 

Current position 

General introduction 

Regulation (EC) No  1272/2008 on classification, labelling and packaging of substances and 
mixtures (the CLP Regulation) aligns previous EU legislation on this topic with the Globally 
Harmonised System of Classification and Labelling of Chemicals (GHS). Its main objectives 
are to facilitate international trade in chemicals and to maintain existing levels of protection of 
human health and the environment. The GHS is a United Nations system designed to identify 
hazardous chemicals and to inform users about these hazards through standard symbols and 
phrases on packaging labels and through safety data sheets. 

The  CLP  Regulation  entered  into  force  on  20  January  2009.  According  to  the  Regulation, 
substances and mixtures must be classified, packaged and labelled according to its provisions. 
After  a  transitional  period,  the  CLP  Regulation  will  replace  current  rules  on  classification, 
labelling  and  packaging  of  substances  (Directive  67/548/EEC)  and  mixtures  (Directive 
1999/45/EC).  From  1  December 2010 substance classification and labelling have to comply 
with the new rules, whilst for mixtures the transitional period will end on 1 June 2015.  

The 1st Adaptation to Technical Progress (ATP) of the CLP Regulation came into force on 25 
September 2009, inserting the harmonised classifications adopted in the 30th and 31st ATPs of 
Directive 67/548/EEC into Annex VI to the CLP Regulation.  

Report of work done in 2010 

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The main priority in 2010 was to contribute to the proper implementation of the legislation, in 
particular  the  application  by  industry  of  the  new  rules  regarding  the  classification,  labelling 
and  packaging  of  dangerous  substances.  For  that  purpose,  the  Commission  has  used  the 
communication structures already created under REACH to ensure constructive dialogue with 
ECHA, national authorities and industry associations. The main goal was to provide support 
to  solve  concerns  related  to  meeting  classification  and  labelling  obligations,  and  also 
notification obligations. All manufacturers and importers of substances (whether as such or in 
mixtures)  had  to  notify  the  classification  and  labelling  applicable  from  1  December  to  the 
European  Chemicals  Agency  (ECHA)  by  3  January  2011.  ECHA  has  received  3.114.835 
notifications for 107.067 substances. 

To  facilitate  correct  and  uniform  implementation  of  the  CLP  Regulation,  several  technical 
guidance documents were published by ECHA. In 2010, the Commission assisted ECHA in 
revising  existing  guidance  documents  and  developing  new  ones,  providing  information  to 
reply to Frequently Asked Questions and participating in ECHA committees and workshops 
related  to  the  CLP  Regulation,  including  in  particular  meetings  of  the  Risk  Assessment 
Committee  (RAC)  when  proposals  for  the  harmonised  classification  and  labelling  of 
dangerous substances were discussed. 

The Commission prepared the draft 2nd ATP, which will incorporate into the CLP Regulation 
the changes introduced by the 3rd revision of the GHS.  

The Commission has also received information from Member States regarding the penalties 
adopted at national level for non compliance with the obligations of the Regulation. Although 
most Member States have implemented national provisions, some notifications of the national 
measures are still missing.  

The  Commission  has  continued  to  contribute  to  work  done  in  the  framework  of  the  United 
Nations to further revise the GHS.  

In addition, Commission Regulation (EU) No 440/2010 on the fees payable to the European 
Chemicals  Agency  pursuant  to  the  CLP  Regulation  (Articles  24(1)  and  37(3))  entered  into 
force on 25 May 2010. 

Evaluation  

Since the deadlines for applying the new classification and labelling provisions to substances 
and for notification in the C&L Inventory only expired on 1 December 2010 and 3 January 
2011 respectively, it is premature to conduct an evaluation. However, the fact that more than 
3 million notifications for over 107.000 substances have been submitted is an indication that 
industry can successfully cope with the new requirements. 

Evaluation results 

(1) 

Priorities 

The Commission will monitor enforcement and official controls reported by Member States. 
It will also support the work of the national authorities responsible for market surveillance in 
the  framework  of  the  Enforcement  Forum  coordinated  by  ECHA  and  will  follow-up 
information on the C&L Inventory managed by ECHA. The Commission will assess the need 
to  initiate  infringement  procedures  for  non  communication  of  national  measures  concerning 

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penalties for those Member States who have not yet notified their measures. 

(2) 

Planned action (2011 and beyond) 

The Commission will proceed with the final adoption and publication of the 2nd ATP to the 
CLP  Regulation  and  will  continue  to  support  ECHA,  national  authorities  and  industry  in 
various  fora  and  in  the  development  of  information  and  guidance  documents  that  will  be 
required  by  industry  to  ensure  that  mixtures  comply  with  the  provisions  of  the  CLP 
Regulation by June 2015. 

The  Commission  will  also  assess  the  opinions  on  the  proposals  for  the  harmonised 
classification  and  labelling  of  certain  substances  submitted  by  ECHA  to  assess  whether  to 
include  them  in  the  list  of  harmonised  classification  and  labelling  in  Annex  VI  of  the  CLP 
Regulation.  

Discussions will start with national experts and stakeholders on incorporating the 4th revision 
of the GHS at EU level in a future ATP of the CLP Regulation. 

 Summary 

Given  that  the  obligations  of  the  legislation  related  to  substances  became  compulsory  on  1 
December  2010  and  the  provisions  for  mixtures  will  only  become  compulsory  in  2015  the 
CLP Regulation is in a very early stage of implementation. A great deal of work in support of 
correct implementation has been accomplished. Compliance with the deadline for submitting 
notifications of classification and labelling information to ECHA by 3 January 2011 seems to 
have been satisfactory. A more detailed analysis will take place in 2011. 

Links to legislation 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/index_en.htm 

1.3.2.2.  Pyrotechnic Articles and Explosives  

Current position 

General introduction 

Directive 2007/23/EC protects consumers by requiring that pyrotechnic articles meet essential 
safety  requirements.  It  also  creates  an  internal  market  for  those  articles  that  meet  these 
requirements.  The  Member  States  had  to  transpose  the  Directive  by  early  2010.  Directive 
93/15/EEC  regulates  the  placing  on  the  market  and  the  supervision  of  intra-EU  transfers  of 
explosives for civil uses and has been applied since January 1995. 

Report of work done in 2010 

On  19  June  2010,  the  Commission  adopted  Decision  2010/347/EU  amending  Commission 
Decision 2004/388/EC of 15 April 2004 on an intra-EU transfer of explosives document. The 
new  Decision  allows  Member  States  to  use  an  electronic  system,  which  will  significantly 
reduce  the  time  taken  to  grant  transfer  approvals  to  companies  manufacturing  or  trading 

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explosives. 

The Commission continued to follow up the transposition of Directive 2008/43/EC, setting up 
a  system  for  the  unique  identification  and  full  traceability  of  explosives  for  civil  use  from 
manufacturing/import to final use in order to protect the general public from illicit use. Of 10 
infringement  procedures  launched  at  the  tail  end  of  2009,  9  were  closed  during  2010  after 
communication of the required national transposition measures.  

CEN  has  delivered  the  necessary  standards  for  the  correct  implementation  of  Directive 
2007/23/EC. However, objections to a few very specific parts of the standard have been raised 
by  two  Member  States,  which  have  been  dealt  with  and  appropriate  solutions  have  been 
found. 

Evaluation  

Overall,  the  situation  is  satisfactory  with  regard  to  the  Explosives  Directive.  However,  the 
industry  sector  concerned  has  signalled  that  more  time  will  be  required  to  fully  implement 
Directive  2008/43/EC  due  to  the  need  to  develop  complicated  IT  systems  and  because  an 
exemption  for  certain  small  articles  will  be  necessary.  The  implementation  of  Directive 
2007/23/EC is still at an early stage. 

Evaluation results 

(1) 

Priorities 

Finding  solutions  to  the  request  to  postpone  the  taking  effect  of  Directive  2008/34/EC  and 
defining  articles  for  which  an  exemption  could  be  acceptable.  Updating  certain  parts  of  the 
standards for pyrotechnic articles to overcome the objections raised by some Member States. 

(2) 

Planned action  

At the end of 2010 the Commission launched a study to assess whether Directive 2007/23/EC 
on pyrotechnic articles has been correctly transposed by all Member States and the outcome 
will be evaluated by the Commission in 2011. 

Summary 

Overall, the situation with regard to the Directive on explosives is satisfactory; the Directive 
does not require major modifications. The Directive on pyrotechnic articles is at an early stage 
of  implementation  and  finalising  all  required  standards  as  well  as  monitoring  its  correct 
implementation by the Member States will be important in the near future.  

Links to legislation 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/index_en.htm 

1.3.2.3.  Drug precursors 

Current position 

General introduction 

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Drug  precursors  are  chemicals  with  wide  and  varied  legitimate  uses,  for  example  in  the 
production of plastics, pharmaceuticals, cosmetics, perfumes, detergents or aromas. However, 
these chemicals may  be  diverted  from legal  trade for use in the illicit manufacture of drugs 
such  as  cocaine,  heroin,  ecstasy  or  methamphetamines.  European  drug  precursor  legislation 
establishes measures to monitor trade in drug precursors, aiming at striking a balance between 
preventing their diversion into drug manufacture and allowing their legitimate trade without 
creating unnecessary administrative burdens. 

Report of work done in 2010 

The  Commission  has  continued  to  support  better  implementation  of  drug  precursor 
legislation,  for  instance  by  organising  a  best  practice  workshop  with  Member  States  and 
stakeholders  in  June  2010.  The  Commission  also  presented  a  paper  setting  out  possible 
changes  to  the  existing  legal  framework  and  collected  information  to  prepare  an  impact 
assessment on options for legislative amendments. 

Work  also  continued  on  infringement  procedures  against  Member  States  for  non- 
communication of national implementing measures. Of 8 infringement cases begun in 2007, 
only  one  remained  open.  In  that  case,  the  European  Court  of  Justice  ruled  that  the  Member 
State  in  question  had  not  met  its  obligations  under  drug  precursor  legislation  by  failing  to 
communicate national transposition measures.  

Evaluation  

On 7 January 2010, the European Commission adopted a Report on the implementation and 
functioning  of  the  EU  legislation  on  monitoring  and  controlling  trade  in  drug  precursors21. 
The report concludes that the legislation has functioned well overall, but also identifies some 
weaknesses in the current system and sets out recommendations for further improvement.  

In reaction to the Commission's Report, the Council adopted conclusions which recognise the 
importance of continuing active co-operation between authorities and industry and improving 
the  implementation  of  existing  legislation.  The  Council  invited  the  Commission  to  set  up  a 
work  programme  to  address  weaknesses  identified  in  the  legislation  in  co-operation  with 
Member States and to propose legislative amendments before the end of 2011 after carefully 
assessing their potential impact on national authorities and economic operators. 

Evaluation results 

(1) 

Priorities 

The  Commission  services  are  giving  priority  to  addressing  the  weaknesses  identified  in  the 
above mentioned report, with the aim of preventing diversion of drug precursors from legal 
trade  to  the  production  of  illicit  drugs.  This  includes  the  exchange  of  best  practices  among 
Member States and the preparation of a review of the existing legislation. 

(2) 

Planned action  

21  

COM (2009) 709 

EN 

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One action the Commission services will take to address these weaknesses is the preparation 
of  an  impact  assessment  in  relation  to  different  options  for  the  amendment  of  existing 
legislation with a view to presenting a legislative proposal, if justified, by the end of 2011. In 
parallel, efforts to support a better implementation of the existing legislation will continue. 

Summary  

Whilst the acquis with regard to drug precursors overall functions rather well, an evaluation 
has  identified  certain  weaknesses,  which  might  lead  to  some  legislative  modifications  if 
justified following an impact assessment on various options. 

Links to legislation 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/index_en.htm 

1.3.2.4.  Detergents  

Current position 

General introduction 

Regulation (EC) No 648/2004 on detergents ensures that only detergents with surfactants that 
are fully biodegradable are placed on the market and that detergents are appropriately labelled 
to protect the health of consumers, especially against allergies. 

Report of work done in 2010 

In  accordance  with  the  requirements  of  Article  16(1)  of  the  Regulation,  the  Commission 
submitted a report to the Parliament and the Council on the use of phosphates in detergents in 
2007. Subsequently, a study was done to gather more scientific evidence on the contribution 
of  detergents  to  the  eutrophication  of  EU  waters.  The  study  was  completed  in  2009  and 
reviewed  by  the  Scientific  Committee  of  Health  and  Environmental  Risks  (SCHER).  In  the 
course of 2010, the Commission prepared an impact assessment for a range of policy options 
regarding the use of phosphates in detergents. Based on the impact assessment, a legislative 
proposal  to  restrict  the  use  of  phosphates  and  phosphate-containing  compounds  in  laundry 
detergents was adopted by the Commission on 4 November 2010 (COM(2010) 597 final) and 
was  forwarded  to  the  European  Parliament  and  the  Council  for  adoption  under  the  ordinary 
legislative procedure.  

In  accordance  with  Article  15(1)  (safeguard  clause)  of  Regulation  (EC)  No  648/2004,  the 
German  Competent  Authorities  for  Detergents  notified  a  national  measure  prohibiting  the 
placing on the German market of a specific lime-scale and rust remover containing up to 25% 
nitric acid due to the risk to human health. Shortly thereafter, the Belgian authorities notified a 
similar  measure.  The  Commission  consulted  all  Member  States  and  other  stakeholders  and 
will prepare a Commission Decision in accordance with Article 15(2).  

An  infringement  proceeding  opened  against  Luxembourg  for  the  non-implementation  of 
Regulation  (EC)  No  648/2004  on  detergents  was  closed  in  2010  after  Luxembourg  adopted 
penalties for non-compliance with the Regulation.  

Evaluation 

EN 

 19 

   EN 

 
 
 
 
 
The situation with regard to the Detergents Regulation and its implementation is satisfactory. 

Evaluation results 

(1) 

Priorities 

Following  delivery  of  all  required  reports  in  earlier  years,  the  main  priority  will  be  the 
effective and consistent application of the Regulation.  

(2) 

Planned action  

A  Commission  Decision  under  Article  15(2)  is  planned  for  the  first  quarter  of  2011  in 
response to the use of the safeguard clause by Germany.  

Summary 

The  acquis  with  regard  to  detergents  is  effective  and  does  not  require  significant 
modifications, except for additional measures to restrict the use of phosphates and phosphate-
containing compounds in laundry detergents.  

Links to legislation 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/index_en.htm 

1.3.2.5.  Fertilisers 

Current position 

General introduction 

The  purpose  of  Regulation  (EC)  No  2003/2003  on  mineral  fertilisers  is  to  allow  the  free 
circulation within the internal market of ‘EC fertilisers’. 

Report of work done in 2010 

In 2010, the Commission prepared the 5th adaptation to technical progress (ATP) to include 
new types of fertilisers that can be marketed as ‘EC fertilisers’ and to introduce new CEN test 
methods  that  will  facilitate  compliance  with  the  provisions  of  the  Regulation.  The  draft 
Commission  Regulation  received  a  favourable  opinion  from  the  relevant  regulatory 
committee.  

As  recommended  in  the  Risk  Reduction  Strategy  on  cadmium  established  under  Regulation 
(EC) No 793/93, the Commission continued to assess the possibility of reducing the content 
of  cadmium  in  phosphate  fertilisers.  Meetings  were  organised  with  stakeholders  and 
Competent Authorities to understand the impact of potential measures and gather information 
for  the  Impact  Assessment  required  prior  to  action  at  EU  level.  Work  on  the  impact 
assessment progressed well throughout 2010. 

Evaluation  

An  ex-post  evaluation  of  Regulation  (EC)  No  2003/2003  was  carried  out  by  an  external 
consultant to analyse the strengths and weaknesses of the current legislation and its potential 

EN 

 20 

   EN 

 
 
 
 
 
 
 
 
for improvement. The evaluation concluded that that Regulation represents an important step 
towards the harmonisation of mineral fertilisers, but that an important and growing part of the 
market is not covered. Mutual recognition of 'national fertilisers' is perceived as problematic. 
For most stakeholders, EU legislation needs to be broader in scope.  

Evaluation results 

(1) 

Priorities 

No  change  compared  to  earlier  years:  activity  will  continue  to  adapt  the  Regulation  to 
technical progress, notably to include new fertiliser types in Annex I and simplify analytical 
methods in Annex IV. In parallel, the necessary preparatory work for a fundamental review of 
the Regulation will begin to extend its scope and achieve full harmonisation of the sector. 

(2) 

Planned action (2011 and beyond) 

After adoption of the 5th ATP, work on a 6th ATP will continue to include additional types of 
fertilisers and to replace some national standards by common EU-wide standards. The aim is 
full harmonisation of the fertiliser market. 

In preparation for full harmonisation of the fertiliser market, a study has been commissioned 
by  the  Directorate-General  for  Enterprise  and  Industry  to  collect  information  about  national 
regulatory  frameworks  on  fertilisers.  Some  policy  options  for  the  revision  of  fertilisers 
legislation will be proposed having regard to their impact on the environment, human health 
and  the  economy  as  a  whole.  The  results  of  the  study  will  feed  into  an  impact  assessment 
report accompanying the future legislative proposal. 

Summary 

The current fertiliser Regulation has been effective in achieving its main objective, namely to 
simplify  and  harmonise  the  regulatory  framework  in  relation  to  mineral  fertilisers.  The 
Regulation appears to be less effective in meeting two other objectives such as the protection 
of the environment and the promotion of innovation. Mutual recognition of national fertilisers 
is not well perceived by a majority of Member States as industry is either unaware of it, or 
very  sceptical  about  its  use.  These  legal  uncertainties  should  be  overcome  in  the  future 
revision  of  the  fertiliser  Regulation,  which  should  significantly  extend  its  scope  to  cover  a 
broader range of fertilising materials and related products (such as soil improvers and growing 
media) and reduce administrative burdens for companies and authorities.  

Links to legislation 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/index_en.htm 

1.4. 

The Transparency Directive 

Current position 

In accordance with the Treaty, pharmaceutical pricing and reimbursement policies fall within 
the responsibility of the Member States. However, Directive 89/105/EEC, commonly referred 
to as the "Transparency Directive", lays down a series of procedural requirements to ensure 
the transparency of national pricing and reimbursement measures. Its provisions do not affect 
the capacity of Member States to determine the organisation and financing of their healthcare 

EN 

 21 

   EN 

 
 
 
 
 
 
 
systems. In particular, each Member State is free to set the prices of medicines and to decide 
on  their  reimbursement  status  in  the  framework  of  national  or  regional  health  insurance 
schemes. 

Report of work done in 2010 

In 2010, three infringement proceedings related to the incompatibility of national legislation 
with the requirements of the Directive were closed.  

Discussions  with  the  Member  States  on  the  application  and  interpretation  of  the  Directive 
were also pursued in the framework of the Transparency Committee which was held in March 
2010. 

Evaluation  

Directive 89/105/EEC is  a peculiar instrument under EU law because it lies at the interface 
between EU competences (free movement of goods within the internal market) and national 
responsibilities  (organisation  of  social  security  systems).  The  directive  only  provides  for 
partial  harmonisation,  based  on  the  underlying  principle  of  minimum  interference  in  the 
organisation  by  Member  States  of  their  domestic  social  security  policies.  In  other  words, 
Member States are free to establish their own regulatory framework, provided that the rules 
and procedures chosen include certain guarantees of transparency. This has consequences for 
the  management  of  infringement  proceedings:  the  investigations  always  require  a  case-by-
case  analysis  of  complex  national  systems  and  the  exercise  is  often  complicated  by  regular 
reforms or adjustments of social security schemes introduced by many Member States to curb 
rising  public  health  expenditure.  Where  compliance  issues  arise,  Member  States  must 
implement their own solutions because they remain responsible for the organisation of their 
social security system. In addition, pharmaceutical pricing and reimbursement is a politically 
sensitive  area  in  all  Member  States  due  to  the  impact  of  national  measures  on  healthcare 
budgets. Consequently, the resolution of problems always requires dialogue and a sustained 
cooperation with the competent national authorities. 

The  Commission  has  significantly  stepped-up  its  efforts  to  ensure  the  enforcement  of  the 
Directive in recent years. Indeed, after enlargement, it became apparent that several Member 
States  had  adopted  pricing  and  reimbursement  measures  at  odds  with  the  principles  of  the 
Transparency Directive. Different issues relating to compliance with the time-limits and other 
procedural  obligations  were  identified  by  the  Commission  on  the  basis  of  complaints  from 
economic operators. A majority of these issues were resolved through constructive dialogue 
with  the  competent  national  authorities.  This  enabled  the  Commission  to  put  an  end  to 
infringement proceedings in a dozen cases between 2005 and 2009. 

Evaluation results 

An impact assessment for the review of Directive 89/105/EEC is currently being carried out. 
A review is included in the Commission Legislative Work Programme 2011. 

(http://ec.europa.eu/atwork/programmes/docs/cwp2011_annex_en.pdf).  

One of the aims of the review is to update the text of the Directive so as to incorporate the 
case-law  of  the  Court  of  Justice  and  tackle  some  ambiguous  or  out-of-date  wording  in  the 
Directive. This would provide a solution to various interpretation and implementation issues 

EN 

 22 

   EN 

 
which regularly arise.  

Summary 

Given the rapid evolution of health insurance systems and the recent multiplication of cost-
containment  measures  in  many  Member  States,  the  compatibility  of  national  measures  with 
Directive 89/105/EEC continues to require constant scrutiny. The Commission will therefore 
continue to investigate complaints indicating potential incompatibilities of national measures 
with  the  Directive.  Priority  will  be  given  to  solve  problems  of  insufficient  or  incorrect 
implementation of the procedural requirements of the directive into national law which could 
entail significant barriers to trade in medicinal products. 

1.5.  Mechanical, electrical and telecommunications equipment 

Current position 

General introduction 

The  Machinery  Directive  2006/42/EC,  published  on  9th  June  2006,  began  to  apply  on  29 
December  2009,  replacing  Directive  98/37/EC.  The  new  Directive  aims  to  consolidate 
previous achievements in terms of free circulation and safety, while improving the application 
of the legislation. The scope of the new Directive is wider, since construction-site hoists and 
cartridge-operated  fixing  and  other  impact  machinery  are  no  longer  excluded.  The  new 
Directive  has  already  been  amended  to  introduce  environmental  protection  requirements  for 
new machinery placed on the market for use in the application of pesticides. 

Report of work done in 2010 

An  infringement  case  brought  under  Directive  98/37/EC  had  been  referred  to  the  Court  in 
2009. Following amendment of the legislation by the Member State concerned to comply with 
the  requirements  of  the  Directive,  the  case  was  closed  in  2010.  By  the  end  of  2010,  all 
infringement  proceedings  for  non-communication  of  national  measures  implementing 
Directive 2006/42/EC were closed following receipt of the national transposition measures.   

In  2010,  Commission  Directive  2010/26/EC  was  adopted,  amending  Directive  97/68/EC  on 
the approximation of the laws of the Member States relating to measures against the emission 
of gaseous and particulate pollutants from internal combustion engines to be installed in non-
road mobile machinery. The amendment is an adaptation to technical progress relating to type 
approval testing procedures for certain larger diesel engines.   

Finally, as concerns the lifts Directive (95/16/EC), one infringement case was closed when the 
Member  State  introduced  required  changes  to  national  legislation  following  a  reasoned 
opinion sent by the Commission.  

Evaluation  

The existing acquis is well established and is not expected to require substantial development.  
Compliance  by  Member  States  with  the  law  in  this  sector  is  satisfactory.  The  situation  is 
stable, manageable and acceptable. The volume of problems arising is limited and no specific 
corrective action is required. 

EN 

 23 

   EN 

 
Evaluation results 

(1) 

Priorities 

As in 2009, priorities were the non-communication cases. In 2010, Directive 2006/42/EC was 
fully transposed and no other non-communication cases remain open. 

(2) 

Planned action  

Following adoption of Decision No 768/2008/EC on a common framework for the marketing 
of  products,  and  repealing  Council  Decision  93/465/EEC,  some  existing  directives  must  be 
revised,  in  particular  Directive  2006/95  relating  to  electrical  equipment  designed  for  use 
within certain voltage limits, Directive 2004/108/EC on the approximation of the laws of the 
Member  States  relating  to  electromagnetic  compatibility,  Directive  94/9/EC  regarding 
equipment intended for use in potentially explosive atmospheres and Directive 95/16/CE on 
lifts.  This revision process began in 2010.   

An increase in work on the amendment of existing legislation is therefore expected. 

A  Commission  proposal  for  a  Directive  of  the  European  Parliament  and  Council  amending 
Directive  97/68/EC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
measures against the emission of gaseous and particulate pollutants from internal combustion 
engines  to  be  installed  in  non-road  mobile  machinery,  as  regards  the  provisions  for  engines 
placed on the market under the “flexibility scheme” was adopted in 2010.  Negotiations with 
the European Parliament and the Council are underway. 

Summary 

Future  work  will  include  the  revision  of  some  directives,  to  align  them  with  Decision  No 
768/2008/EC on a common framework for the marketing of products.  However, the acquis is 
relatively  well  established  and  the  situation  is  stable.  The  mechanical,  electrical  and 
telecommunications equipment sectors all function smoothly.   

1.6. 

Gas appliances, pressure equipment and legal metrology 

Gas  appliances,  pressure  equipment,  and  metrology are technically complex sectors that are 
regulated by EU harmonisation legislation to a certain extent. 

1.6.1.  Gas appliances 

Current position 

General introduction 

The gas appliances sector is mainly regulated by Directive 2009/142/EC relating to appliances 
burning gaseous fuels (a codified version of Directive 90/396/EEC). It aims to ensure the free 
movement  of  gas  appliances  through  technical  harmonisation  with  regard  to  hazards  due  to 
gas and to ensure a high level of safety and health protection by imposing mandatory essential 
safety requirements and conformity assessment procedures. 

Other EU harmonisation legislation, covering other aspects, may also apply to gas appliances 
(or their parts). 

EN 

 24 

   EN 

 
 
Report of work done in 2010 

Infringement  proceedings  and  issues  relating  to  the  correct  implementation  of  the  Directive 
2009/142/EC  were  priority  issues  for  the  Commission  services  in  2010.    A  case  against 
Greece  for  incorrect  implementation  of  the  Directive  with  regard  to  gas  appliances  was 
resolved following clarification by the Greek authorities.  

Most  inquires  and  complaints  in  the  sector  related  to  problems  with  the  installation  and 
putting  into  service  of  gas  appliances  due  to  their  incompatibility  with  the  gas  supply 
conditions at the place of installation (a non-harmonised aspect). The Commission intervened 
where incorrect implementation of the Directive (harmonised aspects) was detected. Another 
group  of  problems  concerned  the  simultaneous  application  of  other  directives,  in  particular 
Directive 89/105/EC on construction products, to exhaust gas facilities placed on the market 
as integral parts of a gas appliance operating as a complete system. 

Concerns have also been raised about measures taken by some Member States in relation to 
energy efficiency which have the effect of restricting the free  movement of certain types of 
gas appliances. As this involves the application of other pieces of EU legislation, in particular 
legislation  on  the  promotion  of  renewable  energies,  the  matter  is  being  examined  by  the 
Commission services involved. 

Evaluation  

Directive  2009/142/EC  has  been  operational  and  functioning  satisfactorily  for  more  than 
fifteen years. However, experience with its implementation, together with technical progress 
and  innovation,  have  made  it  necessary  to  revise  the  Directive.  Currently,  the  Commission 
services  together  with  the  Member  States  Working  Group  on  Gas  Appliances  and  the  sub 
working group on Revision, are examining the different options for revision and will prepare 
a working document with a proposal. The Gas Appliances Expert Group met once this year 
mainly to discuss progress made on preparation for the revision and the outcome of the work 
of the Working Group GAD Revision, which met seven times. 

The revision of the Directive was also the main topic in the meetings of the Gas Appliances 
Directive Advisory Committee (GADAC) and the Notified Bodies Gas Appliances (NBGA), 
both composed of representatives of notified bodies. 

Discussion  centred  on  the  possible  extension  of  the  scope  of  the  Directive  to  cover  not 
appliances  “burning  gaseous  fuels”  but  appliances  “using  gaseous  fuels”  and  to  cover  some 
components for gas installations. The limitations of the harmonisation of the gas appliances 
themselves are recognised, since gas types and supply pressures (which are very important for 
the safe functioning of appliances) are not harmonised. As consequence, a gas appliance must 
not  only  comply  with  the  EU  harmonisation  legislation  but  must  also  be  suitable  for  gas 
supply  conditions  at  the  place  of  installation.  The  alignment  of  Directive  2009/142/EC  to 
Decision 768/2008/EC on a common framework for the marketing of products will be part of 
its revision.  A Commission legislative proposal is expected at the end of 2012. 

The ex-post evaluation of the Gas Appliances Directive is under preparation. The study aims 
to  assess  whether  the  Directive  has  achieved  its  objectives  and  whether  it  is  cost-effective. 
The  evaluation  will  greatly  assist  the  revision  process,  in  particular  by  identifying  possible 
needs  for  further  improvement  of  the  framework  conditions  for  products  covered  by  the 
Directive or for bringing new products within its scope. 

EN 

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   EN 

 
 
 
 
Evaluation results 

(1) 

Priorities 

The revision of Directive 2009/142/EC is a priority for the Commission services. 

(2) 

Planned action (2011 and beyond) 

The  correct  and  effective  implementation  of  the  Directive  (including  infringement 
proceedings and safeguard clauses) will continue to be monitored in 2011. 

Summary 

Directive  2009/142/EC  functions  smoothly  and  there  are  no  major  problems.  In  general, 
Member States apply the acquis correctly and those  problems that do arise tend to relate to 
non-harmonised aspects, such as gas types and supply pressures. However, experience with its 
implementation,  together  with  technical  progress  and  innovation,  have  made  it  necessary  to 
revise the Directive. The revision process is a priority for the Commission. 

1.6.2.  Pressure equipment 

Current position 

General introduction 

The pressure sector deals with protection of health and safety in relation to risks presented by 
pressure equipment, covering an area ranging from the simple pressure cooker to the largest 
chemical  installation.  EU  harmonisation  legislation  covers  pressure  equipment  mainly 
through  Directive  97/23/EC  on  pressure  equipment  and  Directive  2009/105/EC  (a  codified 
version  of  Directive  87/404/EEC)  on  simple  pressure  vessels.  This  legislation  regulates  the 
design, manufacture and conformity assessment of the products defined as falling within their 
scope. Directive 97/23/EC covers pressure equipment as regards pressure hazards. 

Directive 75/324/EEC on aerosol dispensers lays down the safety and labelling requirements 
that aerosol dispensers must satisfy in order to be placed on the market.   

Other EU harmonisation legislation, covering other aspects, may also apply to these products. 

Finally,  four  old  directives  on  pressure  vessels  (framework  directive  76/767/EEC  and  three 
specific  instruments  on  gas  cylinders,  namely  Directives  84/525/EEC,  84/526/EEC  and 
84/527/EEC), were repealed by Directive 2010/35/EU on transportable pressure equipment. 

Report of work done in 2010 

• 

 Management of infringement proceedings 

Infringement proceedings and issues relating to the correct implementation of the Directives 
were  priority 
the  non-
communication of national transposition measures. 

infringement  proceedings  concerned 

in  2010.  Most 

issues 

EN 

 26 

   EN 

 
 
Directive 2008/47/EC of 8 April 200822, adapted Directive 75/324/EEC to technical progress 
and has applied since 29 April 2010. Following communication of the national transposition 
measures, 10 infringement proceedings out of 13 were closed.  

A case against Greece relating to obstacles to the free circulation of steam boilers was closed 
following a reasoned opinion, when the contested provisions were repealed. 

•  Expert groups 

Two regular meetings of the Working Group on Pressure took place in 2010. Issues relating to 
the  implementation  of  the  directives  were  discussed  and  guidelines  are  adopted  in  order  to 
ensure, where necessary, the coherent interpretation of the directives by all concerned parties. 
There  were  also  meetings  of  the  Coordination  Group  of  Notified  Bodies  to  ensure  that 
conformity assessment procedures are correctly applied by all parties involved. 

2010 saw improved cooperation between Member States through the meetings of the ADCO 
Group  (Administrative  Cooperation  Group)  which  addressed  matters  such  as  the  exchange 
and  quality  of  information  on  market  surveillance  issues,  with  a  view  to  ensuring  better 
implementation of the Directives.  

Evaluation  

(a) 

(b) 

(c) 

Directives  97/23/EC  and  2009/105/EC  need  to  be  aligned  with  Decision  No 
768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July  2008  on  a 
common  framework  for  the  marketing  of  products.  A  legislative  proposal  to  this 
regard is scheduled for 2011. 

The repeal of Directive 67/548/EEC on the classification, labelling and packaging of 
dangerous  substances  on  1  June  2015  by  Regulation  (EC)  No  1272/2008  on 
classification, labelling and packaging of mixtures (CLP Regulation) affects Directive 
97/23/EC as the classification of pressure equipment is determined by reference to that 
Directive.  Therefore,  an  alignment  of  Directive  97/23/EC  is  necessary  to  take  into 
account (from 1 June 2015) the new classification of dangerous substances introduced 
by the CLP Regulation. This is expected to take place together with the alignment of 
this Directive with Decision No 768/2008/EC. 

Furthermore,  as  the  CLP  Regulation  also  sets  out  labelling  requirements  for  aerosol 
dispensers,  it  is  necessary  to  align  Directive  75/324/EEC  with  these.  At  present, 
Directive  75/324/EEC  contains  references  to  Directive  67/548/EEC  and  takes  up  the 
flame  symbol  and  some  safety  phrases  from  that  Directive.  However,  the  flame 
symbol has been changed and the safety phrases slightly modified. To avoid confusion 
and  ensure  legal  clarity  and  consistency,  it  is  therefore  necessary  to  do  an  ATP  for 
Directive  75/324/EEC.  At  the  same  time,  some  other  technical  adaptations  are 
necessary,  mainly  concerning  plastic  aerosol  dispensers  and  the  maximum  allowable 
pressure  for  aerosols  using  non-flammable  propellants.  A  proposal  is  scheduled  for 
2011. 

Summary 

22  

Directive  2008/47/EC  amending,  for  the  purposes  of  adapting  to  technical  progress,  Directive 
75/324/EEC on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 
96, 9.4.2008, p.15).  

EN 

 27 

   EN 

 
                                                 
The  pressure  equipment  sector  functions  smoothly  and  there  are  no  major  problems.  In 
general, Member States apply the acquis correctly and there are no particular problems with 
regard  to  the  free  circulation  of  pressure  equipment,  simple  pressure  vessels  and  aerosol 
dispensers. Infringement proceedings and issues relating to the correct implementation of the 
Directives  will  continue  to  be  priority  issues  for  the  Commission  services  in  the  pressure 
sector  in  2011,  as  well  as  the  alignment  of  Directives  97/23/EC  and  2009/105/EC  with 
Decision No 768/2008/EC and the CLP Regulation. 

1.6.3.  Legal metrology 

Current position 

General introduction 

Legal  metrology  covers  units  of  measurement  and  the  metrological  requirements  that  pre-
packed products and measuring instruments must satisfy in order to be legally placed on the 
market and put into service. 

The  main  directives  relating  to  the  design  and  manufacture  of  measuring  instruments  are 
Directive  2009/34/EC  relating  to  common  provisions  for  both  measuring  instruments  and 
methods of metrological control (a recast of Directive 71/316/EEC), Directive 2009/23/EC (a 
codified  version  of  Directive  90/384/EEC)  on  non-automatic  weighing  instruments  and 
Directive 2004/22/EC on measuring instruments. 

Units  of  measurement  are  harmonised  at  EU  level  by  Directive  80/181/EEC  on  units  of 
measurement which creates a harmonised regulatory framework throughout the EU with the 
aim of eliminating trade barriers between Member States.  

Report of work done in 2010 

• 

 The  transposition  of  Commission  Directive  2007/13/EC  of  7  March  200723  which 
modified Annex II to Directive 71/316/EEC to include drawings of the distinguishing 
letters of some Member States used for the EEC initial verification mark affixed on a 
measuring instrument and indicating that the latter conforms to EEC requirements is 
complete.  Four  remaining  infringement  proceedings  for  non-communication  of 
national  transposition  measures  were  closed  in  2010  by  the  Commission  following 
communication of the measures.  

•  Directive  2007/45/EC  of  the  Council  and  the  European  Parliament  of  5  September 
2007,  laying  down  rules  on  nominal  quantities  for  pre-packed  products,  repealing 
Council  Directives  75/106/EEC  and  80/232/EEC  and  amending  Council  Directive 
76/211/EEC24,  aims  to  liberalise  nominal  quantities  of  pre-packaged  products  within 
the  EU  in  line  with  ECJ  jurisprudence,  with  the  exemption  of  wine  and  spirits  for 
which nominal quantities will continue to be defined at EU level. All Member States 
have  now  communicated  their  national  transposition  measures  and  the  last  opened 
infringement proceeding has been closed in 2010. 

23  

24  

Commission  Directive  2007/13/EC  amending  Annex  II  to  Council  Directive  71/316/EEC  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  common  provisions  for  both  measuring 
instruments and methods of metrological control (OJ L 73, 13.3.07, p.10). 
OJ L 247, 21.9.2007, p.17. 

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•  Directive  80/181/EEC  was  modified  by  Directive  2009/3/EC  of  the  European 
Parliament and of the Council of 11 March 2009, which. Member States should have 
transposed  by  31  December  2009.  Ten  infringement  cases  relating  to  non 
communication  of  national 
following 
communication of the measures.  

transposition  measures  were  closed 

•  Directive  2009/137/EC  of  10  November  2009  amending  Directive  2004/22/EC  in 
respect  of  the  exploitation  of  the  maximum  permissible  errors,  as  regards  the 
instrument-specific  annexes  MI-001  to  MI-005  should  have  been  transposed  by 
Member  States  by  1  December  2010.  At  the  end  of  2010,  18  Member  States  had 
communicated national transposition measures.  

Evaluation  

(a) 

Discussions  in  Council  and  in  the  European  Parliament  continued  on  a  Commission 
legislative proposal (COM(2008)801) for a Directive of the European Parliament and 
of the Council repealing 8 old metrology Directives25 which were adopted under old 
framework  Directive  71/316/EEC  and  co-existed  with  national  provisions.  Technical 
progress  and  innovation  with  regard  to  the  measuring  instruments  covered  by  these 
Directives  was  reflected  either  by  the  voluntary  application  of  international  and 
European  standards  or  by  the  application  of  national  provisions  implementing  such 
new specifications. It was felt that free movement of these products within the internal 
market  would  be  ensured  by  Articles  34  to  36  TFEU  and  the  mutual  recognition 
principle. However, the new legislative proposal explains that the existing Directive on 
Tyre Pressure Gauges for Motor Vehicles (Directive 86/217/EEC) is virtually obsolete 
technologically.  In 
international  standard,  a 
standardisation  mandate  in  the  field  of  type  pressure  gauges  for  motor  vehicles  and 
tyre  pressure  management  systems  (measuring  instruments)  has  been  issued  to  the 
European  Standardisation  Organisations.  The  European  Parliament  adopted  the 
proposal on first reading on 18 December 2010. 

the  absence  of  an  up-to-date 

(b) 

A  report  on  the  implementation  of  Directive  2004/22/EC  is  being  prepared  in 
accordance with Article 25 of the Directive (the revision clause) and will contain inter 
alia, conclusions as to whether the Directive needs to be revised. 

Evaluation results 

(1) 

Priorities 

The transposition of the Directives will continue to be the priority for 2011. 

(2) 

Planned action (2011 and beyond) 

•  Following up cases against the two remaining Member States (Portugal and Austria) 
who have not yet communication transposition measures for Directive 2009/3/EC, will 
be a priority in 2011.  

25  

The Directives that are proposed to be repealed are Directives 71/317/EEC, 71/347/EEC, 71/349/EEC, 
74/148/EEC, 75/33/EEC, 76/765/EEC, 76/766/EEC and 86/217/EEC.  

EN 

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•  Following  up  notifications  of  transposition  measures  for  Directive  2009/137/EC  and 
infringement  proceedings  where  such  measures  have  not  been 

launching 
communicated will be a priority in 2011. 

Summary 

The measuring instruments sector is operating smoothly and presents no major problems with 
regard to the free circulation of measuring instruments. In general, Member States apply the 
acquis properly. In 2011 priority will be given to the correct implementation of the Directives 
and to the follow-up of remaining transposition problems. 

1.7. 

Construction products 

Current position 

General introduction  

Directive 89/106/EEC on construction products (“the CPD”) has not been amended recently, 
which has allowed steady development of its implementation within the Member States.  

Report of work done in 2010 

Harmonisation through European standards, published in the OJ has proceeded and conditions 
for  enterprises  operating  in  this  sector,  whether  as  manufacturers  or  users  of  construction 
products,  have  seen  stable  progress  during  2010.  However,  certain  fundamental  problems 
remain  unresolved,  resulting  in  different  transpositions  among  the  Member  States  and 
consequent inefficiencies in the harmonisation. 

The revision of the CPD proceeded during 2010. The Council reached political agreement on 
its position in May and formally adopted the first reading position in September. The second 
reading  agreement  on  the  text  was  reached  in  December.  The  final  adoption  of  the  CPR  is 
thus  expected  during  the  spring  of  2011  and  it  should  be  fully  applicable  from  mid-2013 
onwards. In spite of certain delays in adoption and, consequently, entry into force of the CPR, 
the outcome will be a simplified and clarified regulatory structure for the future. 

Progress with infringement proceedings has been patchy, complicated by the fact that the new 
Regulation is designed to address certain interpretative ambiguities with the CPD which are 
often at the centre of the complaints leading to infringements. Nevertheless, during 2010, one 
longstanding case against the UK was closed and another case against France was opened.  

Evaluation results 

Accelerating progress in the remaining open infringement cases under the CPD is a priority 
for 2011. 

Summary 

Pending  the  introduction  of  the  CPR,  legal  uncertainties  relating  to  the  interpretation  of  the 
CPD  will  remain,  making  enforcement  difficult.  However,  the  intention  is  to  continue  to 
reduce the number of open infringement cases and to deal with any new cases more swiftly 
and  efficiently  than  before.  Closer  contacts  with  Member  States,  including  in  the  EU  Pilot, 

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will undoubtedly be of assistance in reaching these objectives. 

1.8. 

Textiles/clothing, footwear and wood 

Current position 

General introduction  

Textiles  and  clothing  are  regulated  by  recast  Directive  2008/121/EC  on  textile  names, 
adopted  on  14  January  2009  and  repealing  Directive  96/74/EC.  It  incorporates  Commission 
Directives  97/37/EC,  2004/34/EC,  2006/3/EC  and  2007/3/EC  which  amended  Directive 
96/74/EC. Directive 2008/121/EC has been amended by Commission Directive 2009/121/EC.  

Other legislation in the textiles field is Directive 96/73/EC (adapted to technical progress by 
Commission  Directives  2006/2/EC,  2007/4/EC  and  2009/122/EC)  and  Directive  73/44/EEC 
specifying  testing  methods  for  the  sampling  and  analysis  of  fibre  mixtures  in  order  to 
determine  the  conformity  of  information  given  on  a  label  in  accordance  with  Directive 
96/74/EC.  Due  to  the  technical  nature  of  the  textiles  directives,  the  Committee  for  textile 
names and labelling (composed of experts from Member States and other interested parties) 
assists the Commission in adapting them to technical progress.  

In  the  footwear  area,  legislation  (Directive  94/11/EC  on  the  labelling  of  materials  used  in 
consumer footwear) is well-established and stable. Unlike the clothing and textile area, it is 
not necessary to amend this legislation often in the light of technical developments. There is 
no committee work in this area.  

In the wood sector, there is no legislation at EU level.  

Report of work done in 2010 

In  the  textiles  and  clothing  sector,  eight  letters  of  formal  notice  were  sent  to  four  Member 
States  in  November  2010  in  relation  to  the  non-communication  of  national  measures 
transposing Directives 2009/121/EC and 2009/122/EC.  

The  Commission  Proposal  for  a  Regulation  on  textile  names  and  related  labelling  of  textile 
products  [COM(2009)  31  final],  adopted  on  30  January  2009,  followed  the  ordinary 
legislation procedure in 2010.  

The  European  Economic  and  Social  Committee  having  adopted  a  favourable  opinion  at  the 
end of 2009, the European Parliament adopted its first reading opinion on 18 May 2010 and 
the Council adopted its common position on 6 December 2010. 

Evaluation results 

The major legislative work in the textiles sector will be the continuation of the work on the 
proposal  for  a  Regulation  on  textile  names  and  related  labelling  and  the  monitoring  of  its 
implementation and application once in force. 

The infringement cases opened for the non-communication of national measures transposing 
Directives 2009/121/EC and 2009/122/EC will be followed-up in 2011. 

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Summary 

The acquis is stable and poses few enforcement difficulties.  

Links to legislation  

http://ec.europa.eu/enterprise/sectors/textiles/single-market/textiles-names-
legislation/index_en.htm 

1.9. 

Toys 

Current position 

General introduction  

The  new  toy  safety  directive,  Directive  2009/48/EC,  came  into  force  on  20  July  2009. 
Member  States  had  to  adopt  and  publish  implementing  provisions  by  20  January  2011  and 
must  apply  them  from  20  July  2011.  The  later  date  of  20  July  2013  is  laid  down  for  the 
application of chemical requirements. 

The  objective  of  the  new  Directive  is  to  ensure  a  high  level  of  safety  of  toys,  ensuring  the 
health  and  safety  of  children,  whilst  guaranteeing  the  functioning  of  the  internal  market  by 
setting  harmonised  safety  requirements  for  toys  and  minimum  requirements  for  market 
surveillance.  The  Directive  applies  to  products  designed  or  intended,  whether  or  not 
exclusively, for use in play by children under 14 years of age.  

The main changes to the current legal framework concern: enhanced requirements, especially 
in relation to the use of chemicals in toys, mandatory safety assessment prior to the marketing 
of toys and stringent obligations for economic operators.  

In  July  2009,  the  Commission  issued  a  mandate  to  CEN  (European  Committee  for 
Standardisation) and CENELEC (European Committee for Electro-technical Standardisation) 
to review the existing harmonised standards and  adapt them to the requirements of  the new 
directive.  

Report of work done in 2010 

The process has still been under way in 2010 and revised standards should be available before 
Member States must begin applying the new provisions.  

General  and  specific  guidance  documents  aimed  at  facilitating  the  application  of  the  new 
directive are currently being prepared and are available on the Commission website. 

1.10. 

Food industry 

Current position 

General introduction 

EU legislation governing the trade regime for non-Annex I goods (commonly referred to as 
processed  agricultural  products)  devolves  primarily  from  Council  Regulation  (EC)  No 
1216/2009  of  30  November  2009.  This  Regulation  provides  a  general  framework  for  trade 

EN 

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arrangements  applicable  to  certain  goods  resulting  from  the  processing  of  agricultural 
products.  

It  can  be  divided  into  trade  arrangements  governing  imports  from  third  countries  and  rules 
governing the payments of export refunds on exports to third countries. : 

1.  Trade  arrangements  on  imports  cover  preferential  import  arrangements  including 

TRQs, methods of analysis and special Inward Processing arrangements.  

2.  Rules governing the payment of export refunds on exports cover the determination of 
quantities, refund rates, methods of analysis, statistics and special rules for pasta.  

The specific rules governing trade in processed agricultural products are established in close 
cooperation with the Management Committee on processed agricultural products in which all 
Member States are represented. 

(2) 

Report of work done in 2010 

a)  Replacement  of  Regulation  (EC)  No  1043/2005  on  the  implementation  of  Council 
Regulation  (EC)  No 1216/2009  as  regards  the  system  of  granting  export  refunds  for  certain 
agricultural products exported in the form of goods not covered by Annex I to the Treaty, and 
the criteria for fixing the amount of such refunds. 

b)  Amendment  of  Regulations  (EC)  No  900/2008  and  904/2008  on  the  analysis  of  imported 
and  exported  processed  agricultural  products  respectively  in  order  to  replace  the  analysis 
method for starch in imported and exported. 

c) Screening of the EU acquis and its simplification.  

In  the  context  of  the  ongoing  simplification  of  the  acquis  and  the  adaptation  of  the  current 
acquis to the Lisbon Treaty, a comprehensive screening of the acquis in relation to processed 
agricultural  products  was  undertaken  and  identified  3  Council  acts  and  59  Commission  acts 
that are no longer relevant and can be removed from the EU acquis.  

Evaluation results 

(1) 

Priorities 

The  ongoing  simplification  of  the  acquis  and  the  adaptation  of  the  EU  acquis  in  the  non-
Annex I sector to the Lisbon Treaty are the two main priorities. As regards the non-Annex I 
sector,  the  priority  will  be  to  implement  the  important  changes  introduced  by  the  Treaty  on 
European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) and 
in  particular  the  extension  of  the  ordinary  legislative  procedure  to  the  trade  arrangements 
applicable  to  processed  agricultural  products  and  the  adoption  of  new  rules  on  the 
Commission's  delegated  and  implementing  powers.  The  TFEU  contains  two  provisions 
(Articles  290  and  291  TFUE)  which  entail  modification  of  existing  comitology  procedures, 
which govern decisions in the area of trade in processed agricultural products. 

(2) 

Planned action (2011 and beyond) 

a) Ongoing simplification of the acquis 

EN 

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   EN 

 
In 2011 as a result of the screening exercise: 

- Two Council acts will be formally repealed by a Council act or by an act of the Council and 
the  Parliament,  as  appropriate,  while  43  Commission  acts  will  be  declared  obsolete  by  the 
Commission. 

- In addition one Council act and 16 Commission acts modifying other acts already repealed 

or to be declared obsolete will be withdrawn from the EU acquis. 

b) Adaptation of the EU acquis in the non-Annex I sector to the Lisbon Treaty 

Pursuant  to  the  adoption  of  the  Commission  Communication  of  09/12/2009  on  the 
Implementation  of  Article  290  TFUE  (COM  (2009)  673  final),  the  Commission  will 
progressively align non-Annex I legislation with the new mechanisms of delegated acts and 
implementing acts. 

1.11.  Cultural goods 

In  2010,  the  acquis  in  this  area  remained  stable.  It  consists  of  Directive  93/7/EEC  on  the 
return  of  cultural  objects  unlawfully  removed  from  the  territory  of  a  Member  State,  as 
modified by Directives 96/100/EC and 2001/38/EC. 

In accordance with the conclusions of the third report reviewing the application of Directive 
93/7/EEC  by  the  Member  States (2009),  the  "Return  of  cultural  goods"  working  group  was 
created,  composed  of  national  authorities  responsible  for  the  Directive.  During  its  mandate, 
the  working  group evaluated  the  application  of  the  Directive,  identified  the  main  problems 
and suggested modifications with a view to the possible revision of the Directive. 

The responsible service intends to proceed with a revision of Directive 93/7/EEC in 2012. 

1.12.  Weapons 

The  report  on  placing  on  the  market  of  replica  firearms,  one  of  the  tasks  given  to  the 
Commission under the Directive has been prepared (COM/2010/404). The second meeting of 
the  Contact  Group  of  national  experts  on  Firearms,  set  up  by  the  directive,  took  place  on  8 
March 2010, allowing a useful exchange of information to take place on the implementation 
of the Directive. 

Enforcement  action  is  ongoing  in  relation  to  several  infringement  proceedings  for  non-
communication of national transposition measures, due on 28 July 2010. 

1.13. 

Product liability 

Directive  85/374/EEC  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States concerning liability for defective products is a consolidated 
tool that strikes a fair balance between citizens and producers, assuring citizens of the safety 
of  products  put  into  circulation  in  the  internal  market.  In  2010,  the  Commission's  services 
began  the  preparation  of  the  fourth  report  on  the  Directive  by  sending  a  questionnaire  to 
Member States and to the members of the advisory groups on liability for defective products. 

The Commission plans to submit the fourth report in 2011. The report will examine how the 

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27 EU Member States implemented the Directive between 2006 and 2010.  

1.14.  Defence goods 

A working group of Member States’ officials met several times to discuss common guidelines 
on the certification of defence-related undertakings. The discussions of this group led to the 
adoption  on  11  January  2011  of  Commission  Recommendation  2011/24/EC  on  the 
certification of defence undertakings under Article 9 of Directive 2009/43/EC of the European 
Parliament and of the Council simplifying terms and conditions of transfers of defence-related 
products within the EU (OJ L11 of 15.1.2011, p. 62). 

1.15.  Non-harmonised area 

Current position 

General introduction  

Articles  34-36  TFEU  ensure  the  easy  cross-border  exchange  of  goods  within  the  Internal 
Market  in  areas  that  are  not  subject  to  harmonisation  by  EU  legislation.  The  Commission 
monitors the correct application of these rules and related Regulations and opens infringement 
proceedings against Member States when necessary. 

Report of work done in 2010 

In 2010, the Commission managed a total of 52 infringement proceedings in the various non-
harmonised  fields  covered  by  Article  34-36  TFEU.  This  is  a  decline  compared  with  the 
figures of previous years: 67 in 2009 and 73 in 2008. 

The  main  areas  of  concern  remain  national  rules  on  the  registration  of  motor  vehicles, 
obstacles to the free movement of pharmaceutical products and medical devices (in particular, 
parallel  imports),  obstacles  to  the  free  movement  of  food  supplements  and  problems  with 
customs controls and the transportation of goods. 

In 2010, several infringement cases were closed after the Commission and the Member States 
found solutions to the problems complained of: 

(cid:190)  Belgium amended its legislation in 2010 concerning the importation, exportation and 
transit of certain species of wild birds, in order to provide for the mutual recognition 
of markings permitted by other Member States. 

(cid:190)  Poland modified its legislation on the protection of antiquities of more than 55 years 
of  age,  which  required  the  production  of  a  certificate  showing  that  the  antiquity  in 
question should not be subject to a previous authorisation procedure. 

(cid:190)  Spain modified its legislation to remove obstacles to the importation and marketing of 

structural concrete. 

(cid:190)  New regulations entered into force in the UK in April 2010 increasing the maximum 

width for certain trailers from 2.3 metres to 2.55. 

The Court of Justice of the European Union delivered a judgment on 9 December 2010 in a 

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preliminary ruling in case C-421/09 Human plasma, which concerned the free movement of 
goods.  The  Court  was  asked  about  the  compatibility  with  Articles  34-36  TFEU  of  national 
rules prohibiting the importation of blood products provided from donations which were not 
entirely  unpaid.  The  Court  held  that  "Article  34  TFEU,  read  in  conjunction  with  Article  36 
TFEU,  must  be  interpreted  as  precluding  national  legislation  which  provides  that  the 
importation of blood or blood components from another Member State is permitted only on 
the  condition,  which  is  also  applicable  to  national  products,  that  the  donations  of  blood  on 
which those products are based were made not only without any payment being made to the 
donors but also without any reimbursement of the costs incurred by them in connection with 
those donations".  

The hearing in case C-462/09 Stichting de Thuiskopie took place on 15 December 2010. This 
case concerns several infringement cases concerning copyright levies and the free movement 
of  goods.  In  a  case  touching  upon  copyright  levies  (C-467/08  SGAE),  a  Spanish  court  had 
asked  the  Court  of  Justice  for  guidance  on  the  interpretation  of  the  Copyright  Directive 
2001/29/EC  in  relation  to  Spanish  requirements  on  copyright  levies.  The  judgment  of  the 
Court of 21 October 2010 clarified several points relating to a number of infringement cases 
on  copyright  levies,  declaring  that  they  should  be  analyzed  in  the  context  of  Directive 
2001/29/EC. 

The  Commission  continued  to  look  for  pro-active  solutions  outside  or  in  parallel  with 
infringement  proceedings  under  Article  258  TFEU  through  the  SOLVIT  problem-solving 
network  and  the  preventive  mechanism  of  Directive  98/34/EC  (whereby  Member  States  are 
obliged to notify new national technical rules to the Commission at the draft stage). 

Regulation  (EC)  764/2008  (the  “Mutual  Recognition  Regulation”)  completed  a  full  year  of 
application in 2010 following its entry into force on 13 May 2009. The Regulation sets out 
procedural requirements for Member States that refuse to apply mutual recognition.  It defines 
the rights and obligations of national authorities on the one hand and, on the other, enterprises 
wishing  to  sell  in  one  Member  State  products  lawfully  marketed  in  another,  when  the 
competent authorities intend to take restrictive measures in relation to the product.  Member 
States  must  notify  to  the  Commission  decisions  affecting  the  marketing  of  products  already 
lawfully  marketed  in  another  Member  State.  During  2010,  a  total  of  800  notifications  were 
received from the Member States.  

The  first  annual  reports  of  national  authorities  on  the  application  of  the  Regulation  were 
analysed and discussed at the 2nd meeting of the Advisory Committee on Mutual Recognition 
held on 19 November 2010. To date, all Member States have submitted reports, a necessary 
step in preparing the evaluation of the Regulation that is due to be presented by 13 May 2012. 

In 2010, the area of free movement of goods was the subject of 9 petitions to the European 
Parliament, and 23 parliamentary questions. 

Evaluation  

Articles  34-36  TFEU  remain  the  essential  legal  basis  for  tackling  obstacles  to  trade  among 
Member  States.  As  these  provisions  apply  only  to  the  non-harmonised  area,  their  ambit 
fluctuates in accordance with developments in secondary EU legislation. 

In  2010,  the  trend  observed  in  previous  years  towards  a  decrease  in  the  number  of  open 
States  continued.  The  success  rate  for  problem-
infringements 

against  Member 

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solving in EU Pilot contributed significantly to this reduction for those Member States which 
participated in this system. Other reasons are a determined effort to address a backlog of old 
cases  and  the  pursuit,  when  possible,  of  alternative  solutions  through  dialogue  and 
cooperation  with  the  Member  States  outside  the  infringement  procedure.  Nevertheless,  the 
volume  of  complaints  and  enquiries  received  show  that  there  is  still  a  significant  degree  of 
non-compliance with the principle of the free movement of goods and a lack of understanding 
of  the  concept  of  mutual  recognition,  resulting  in  practical  barriers  to  cross-border  trade  in 
goods. 

As regards mutual recognition, Regulation (EC) No 764/2008 is helping to raise awareness of 
the  principle  both  among  economic  operators  and  national  administrations  in  the  Member 
States.  

Evaluation results 

(1) 

Priorities 

In  the  light  of  positive  results  observed  so  far,  the  Commission  is  encouraged  to  engage  in 
further  dialogue  with  Member  States  with  a  view  to  reaching  quicker  solutions  to  free 
movement of goods issues. 

The updated version of the ‛Guide to the application of Treaty provisions governing the free 
movement of goods’ was published in 2010 and distributed to a large external audience. The 
Guide  has  become  a  useful  tool  to  explain  the  fundamental  principle  of  free  movement  of 
goods  and  the  latest  interpretations  handed  down  by  the  Court  of  Justice  of  the  European 
Union. 

Summary 

The continued arrival at the Commission of complaints and requests for information confirms 
that  monitoring  the  application  of  the  free  movement  of  goods  principle  in  the  non 
harmonised area remains an important task. The Treaty and related regulations are adequate 
tools  to  ensure  that  the  fundamental  freedom  of  free  movement  of  goods  is  safeguarded. 
While  any  breach  of  this  fundamental  freedom  must  be  pursued,  priorities  will  continue  to 
reflect any grouping of cases (for example the registration of vehicles) and areas having the 
greatest impact on intra-EU trade. 

Legislation 

Treaty provisions: 
http://ec.europa.eu/enterprise/policies/single-market-goods/files/treaties/tfeu_en.pdf#page=15  

Regulation Mutual recognition regulation: 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0021:0029:en:PDF  

Guide to the application of Treaty provisions governing the free movement of goods: 
http://ec.europa.eu/enterprise/policies/single-market-goods/files/goods/docs/art34-
36/new_guide_en.pdf  

1.16. 

Preventive rules of Directive 98/34/EC 

Important  preventive  work  continued  under  Directive  98/34/EC  with  advice  and  guidance 

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provided  by  the  Commission  and  Member  States  on  over  800  national  draft  technical 
regulations  of  the  27  Member  States,  the  EFTA  countries  and  Turkey  concerning  non-
harmonised  products  and  information  society  services.  The  Committee  on  Standards  and 
Technical  Regulations  established  by  the  Directive  met  twice  during  2010  to  discuss  its 
functioning  and  a  working  group  composed  of  representatives  of  Member  States  met  three 
times  to  evaluate  the  notification  procedure  and  consider whether  any  adjustments  or 
amendments should be made. 

2. 

COMPETITION 

2.1. 

Current Position 

(1) 

General Introduction  

During  the  course  of  2010  Directorate-General  for  Competition  dealt  with  around  30  active 
infringement cases, with 23 remaining at the end of the year. Although these cases obviously 
follow  the  standard  infringement  procedure  (under  Article  258  TFEU),  cases  in  this  sector 
differ from other sectors in that many of these cases concern the infringement of Commission 
decisions, rather than Directives or Regulations. Where the decision in question concerns the 
non-recovery of State aids, cases are based on Article 260 TFEU. These proceedings, which 
account for ca. 25% of infringement cases in competition field, are initiated where a Member 
State  does  not  comply  with  a  Commission  decision  requiring  the  recovery  of  incompatible 
State  aid.  They  therefore  serve  the  purpose  of  ensuring  that  an  infringement  of  the 
competition  rules  by  a  Member  State  is  remedied,  and  that  the  distortion  of  competition 
caused  by  the  incompatible  aid  is  removed.  The  procedure  in  these  cases  differs  to  some 
extent from the standard infringement procedure. In a first step, the Commission may refer the 
Member State directly to the Court under Article 108(2) TFEU, in derogation of Article 258 
TFEU. If the Member State still fails to recover the aid, although the Court has held that this 
failure constitutes an infringement, the Commission may refer the Member State to the Court 
for the second time, this time pursuant to Article 260 TFEU. This Annual Report only covers 
the last stage of the recovery proceedings, i.e. from the sending of the Letter of Formal Notice 
under Article 260 TFEU onwards.  

The majority of Article 258 cases have their origin in a complaint submitted by undertakings 
or citizens that are based on a breach of Article 106(1) TFEU in conjunction with Articles 101 
and/or  102  TFEU  by  a  Member  State,  with  the  remainder  cases  concerning  the  incorrect 
transposition of directives or non communication of implementing measures. 

The relatively low number of infringement cases dealt with could be explained by the fact that 
the  acquis  in  this  sector  has  been  very  stable,  with  no  new  Directives  or  implementation 
deadlines  in  recent  years.  The  two  remaining  cases  on  the  implementation  of  the  Financial 
Transparency  Directive  in  the  field  of  State  aid  (80/723/EEC,  as  amended),  against  the  UK 
and Belgium, were referred to the Court. The current emphasis is on the correct application of 
the  Directive  on  Competition  in  the  Markets  for  Electronic  Communications  and  Services 
(2002/77/EC)26.  

26  

OJ L 249, 17.9.2002, p. 21–26. 

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As regards complaints in 2010, Directorate-General for Competition was the lead service for 
94 files. However, 58 of these are part of a group complaint concerning copyright collecting 
societies  in  Spain,  and  should  therefore  not  be  counted  individually.  It  was  decided  to  deal 
with  all  these  complaints  jointly  by  publishing  a  full  reply  in  the  Official  Journal27.  The 
remaining 36 cases concern a broad range of issues and sectors.  

(2) 

Report of Work Done in 2010 

The application of the competition rules plays an important role in sectors which have been 
recently liberalised or are in the process of liberalisation, such as energy or postal services, as 
well  as  in  the  media  and  electronic  communication  sectors.  This  is  reflected  in  the 
infringement work carried out in 2010. 

Postal Sector 

The  infringement  proceedings  under  Article  258  TFEU  against  the  Slovak  Republic  for  the 
non-implementation  of  the  Commission  Decision  of  7  October  2008  remained  open28. 
Following  the  issue  of  a  Reasoned  Opinion  on  29  October  200929,  the  Slovak  authorities 
remained in discussions with the Commission on the measures to remedy the infringement as 
well as the proper implementation of the Third Postal Directive. The aim is to fully liberalize 
the Slovak postal market as of January 2012, i.e. one year ahead of the deadline imposed by 
the  postal  directive.  The  Commission  closely  follows  the  developments  on  the  draft 
liberalisation law.  

Energy Sector 

On  31  January  2008,  the  European  Commission  sent  Spain  a  Letter  of  Formal  Notice  for 
failure to comply with a Commission Decision of 5 December 2007, finding that Spain had 
breached  Article  21  of  the  Merger  Regulation30  by  subjecting  the  approval  decision  of  the 
acquisition  of  control  over  Endesa  by  Enel  and  Acciona  to  a  number  of  conditions,  thereby 
unduly interfering with the Commission's exclusive competence to decide on a concentration 
with  Community  dimension.  By  withdrawing  the  contested  conditions,  the  Commission 
decided to close the infringement procedures against Spain in relation to Art. 21 of the Merger 
Regulation  on  17  March  2010.  With  this  decision,  the  Spanish  authorities  finally  complied 
with the Commission Decisions which considered illegal the conditions imposed by Spain on 
the E.ON/Endesa and the Enel/Acciona/Endesa mergers. 

Electronic Communications Sector 

The  introduction  of  digital  terrestrial  television  broadcasting  (DTT)  is  freeing  substantial 
spectrum  resources  (the  ‘digital  dividend’)  that  can  be  used  for  authorizing  further  digital 
television channels. Moreover the digital dividend represents a unique opportunity for the re-
use  of  a  premium  part  of  the  radio  frequency  spectrum  for  new  electronic  communications 
services such as broadband wireless telecommunication.  

27  
28  
29  
30  

OJ C353, 28.12.2010 p. 17. 
OJ C 322, 17.12.2008, p. 10–11. 
IP/09/1632. 
OJ 2004, L 24/1.  

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The DTT platform provides television services to over 75 million households across Europe 
and is in many EU Member States the pre-dominant television reception platform. The DTT 
platform is the only platform throughout Europe that guarantees nearly all viewers access to a 
broad range of both public service and commercial television services.  

In the context of the transition to digital broadcasting and the availability of spectrum for new 
electronic  communications  services,  several  complaints  have  been  received  against  Member 
States  that  have  assigned  parts  of  the  “digital  dividend”  to  incumbent  broadcasters  under 
procedures which do not appear, prima facie, to be based on transparent, objective and non-
discriminatory criteria. The broadcasting spectrum concerned is assigned for periods of 15 to 
20  years.  Therefore,  unless  properly  monitored,  the  current  procedures  could  fundamentally 
distort the competitive structure of the EU media markets over the longer term. 

In  September  2010,  under  the  ongoing  infringement  procedure  concerning  the  Italian 
broadcasting legislation, the Italian Authority for Communications put forward a draft laying 
down criteria and rules aimed at ensuring that a certain number of frequencies resulting from 
the “digital dividend” are assigned to newcomers and smaller existing companies. The tender 
for such frequencies should be launched in 2011. 

In  addition  to  the  ongoing  infringement  procedure  against  Italy,  the  Commission  also 
investigated  in  2010,  as  a  priority,  several  complaints  under  the  Competition  Directive 
relating to the spectrum assignment procedures in other Member States. 

In this context, the Commission sent in November 2010 a letter of formal notice to the French 
authorities regarding the 2007 French law granting to existing analogue TV broadcasters the 
possibility  to  obtain  an  additional  national  TV  channel  in  the  digital  switchover.  In  the 
absence of convincing evidence that such possibility was granted to TV broadcasters based on 
objective,  transparent,  non-discriminatory  and  proportionate  criteria,  the  Commission 
considered the French rules to be in breach of EU law.  

Taking into account the importance of ensuring undistorted competition in the framework of 
the  digital  switchover,  the  Commission  will  continue  to  monitor  the  assignment  procedures 
for  broadcasting  spectrum  as  well  as  for  spectrum  for  electronic  communications  services 
other than, and in addition to, broadcasting services as a priority in the course of 2011. 

Article 260 TFEU Cases  

On 31 January 2008, the Commission issued a Reasoned Opinion against Italy for failure to 
comply  with  a  judgment  of  the  Court31,  condemning  Italy  for  non-execution  of  the 
Commission's recovery decision of 11 May 1999 regarding employment aid.  As no sufficient 
progress  was  made  in  the  recovery  of  incompatible  aid,  on  25  June  2009,  the  Commission 
decided  to  refer  Italy  for  the  second  time  to  the  Court  and  to  propose  the  imposition  of 
financial  penalties  against  Italy  (Article  260  TFEU).  The  written  phase  of  the  Court 
proceedings was concluded by the end of 2010. 

In  a  similar  case,  which  concerns  the  non-recovery  of  aid  granted  to  publicly-owned  utility 
companies  (“municipalizzate”),  the  Commission  sent  a  Reasoned  Opinion  to  Italy  on  1 
February 2008. This was based on the fact that the Court had condemned Italy on 1 June 2006 

31  

C-99/02, Commission v Italy. 

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for failure to comply with the obligations stemming from the Commission's recovery decision 
of  5  June  200232.  Following  the  judgment,  Italy  had  still  not  managed  to  implement  the 
recovery successfully. Considering these circumstances, on 23 October 2010 the Commission 
took the decision to refer the matter to the Court of Justice for the second time with financial 
penalties (Article 260 TFEU).  

In a first series of six fiscal measures implemented in the Basque provinces, more than 9 years 
after the adoption of the Decisions and 4 years after the Court judgment, Spain had still not 
completed the full recovery of the aid. A Reasoned Opinion against Spain had already been 
issued  on  26  June  2008  (for  failure  to  comply  with  the  Court's  judgment  of  14  December 
2006).  On  24  November  2010,  the  Commission  therefore  decided  to  refer  the  matter  to  the 
Court of Justice for the second time with financial penalties (Article 260 TFEU).  

On  20  November  2009,  the  Commission  sent  a  Letter  of  Formal  Notice  pursuant  to  Article 
260  TFEU  to  Spain  for  failure  to  comply  with  a  judgment  of  the  Court  of  July  200233 
condemning Spain for non-execution of the Commission's recovery Decision of 20 December 
1989 as regards the four companies of the Magefesa Group. As the incompatible aid was not 
recovered, on 30 September 2010 the Commission decided to refer Spain to the Court for the 
second  time  with  financial  penalties  (Article  260  TFEU).  The  Court  action  was  filed  on  22 
December 2010. 

On 13 November 2008 the Court of Justice condemned France for failure to implement within 
the  prescribed  period  the  Commission's  recovery  decision  of  16  December  2003  on  the  aid 
scheme implemented by France for the takeover of firms in difficulty (Article 44septies CGI). 
Since  following  that  judgment  France  still  did  not  implement  the  recovery  decision,  the 
Commission  adopted  on  7  May  2010  a  letter  of  formal  notice  against  France  for  failure  to 
comply with a judgment of the Court under Article 260 TFEU. 

It is worth mentioning that in the area of recovery of incompatible state aid, the Commission 
has made significant progress with respect to the execution of recovery decisions by Member 
States.  The  amount  of  illegal  and  incompatible  aid  recovered  has  increased  from  EUR  2.3 
billion  in  December  2004  to  EUR  10.9  billion  at  31  December  2010  (i.e.  86%  of  the  total 
amount to be recovered). Accordingly, the percentage of illegal and incompatible aid still to 
be  recovered  at  the  end  of  2010  has  fallen  from  75%  to  14%.  This  is  due  to  the  efficient 
enforcement of recovery decisions by the Commission prompting Member States to recover 
incompatible aid from the beneficiaries.  

2.2. 

Evaluation Based on the Current Situation 

Against  the  background  of  the  stable  acquis  in  the  competition  law  field  and  the  relatively 
constant  if  not  decreasing  number  of  pending  infringement  cases,  the  situation  can  be 
described  as  stable  and  relatively  satisfactory  on  the  whole,  not  indicating  any  particular 
problems that would require urgent attention or the modification of priorities. Likewise, there 
are neither new measures  due to be adopted in the near future, nor relevant implementation 
plans, guidelines, expert group meetings, transposition workshops or management networks.  

32  
33  

C-207/05, Commission v Italy. 
Case C-499/99, Commission v Spain. 

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In the area of state aids, infringement cases will continue to be pursued on the basis of Article 
260  TFEU  to  recover  all  incompatible  state  aid.  This  is  necessary  to  ensure  a  level  playing 
field  between  competitors  and  a  market  of  undistorted  competition  –  a  requirement  which 
becomes  all  the  more  important  in  the  current  economic  circumstances  where  companies 
struggle  to  stay  on  the  market  even  in  conditions  of  undistorted  competition.  As  already 
explained  before,  a  very  good  track  record  has  been  achieved  in  the  recovery  field.  The 
enforcement action can therefore focus on those instances where Member States have not yet 
shown  the  desired  results  in  their  recovery  efforts,  mainly  because  of  national  legislation 
creating obstacles to effective recovery.   

The  priorities  for  2010  as  set  out  in  the  27th  Annual  Report  –  the  improvement  of  the 
competitive  conditions  in  the  liberalised  markets  –  have  been  fully  taken  up  in  the 
infringement work. There has been significant progress in some key infringement procedures 
in the energy and postal sectors. 

In the field of electronic communications and the correct implementation of the Directive on 
Competition  in  the  Markets  for  Electronic  Communications  and  Services  (2002/77/EC), 
efforts  are  continued  to  ensure  effective  competition,  for  example  by  actively  monitoring 
changes to the relevant provisions in the broadcasting market of Member States.  

2.3. 

Evaluation Results - Priorities and Planned Action 

In 2011, focus will continue on sectors that have been recently liberalised or are in the process 
of liberalisation, such as energy or postal services, as well as the media sector.  

Emphasis will also be placed on the correct application of the Directive on Competition in the 
Markets for Electronic Communications and Services. 

Finally, long standing non-recovery cases will continue to be referred to the Court pursuant to 
Article  260  TFEU  with  a  view  to  imposing  a  lump  sum  and  daily  penalty  payments  on  the 
Member State concerned, to ensure effective recovery of the incompatible aid granted. 

3. 

EMPLOYMENT, SOCIAL AFFAIRS AND INCLUSION 

3.1. 

Free movement of workers and coordination of social security systems 

3.1.1.  Current Position 

3.1.1.1.  Introduction 

In  the  field  of  free  movement  of  workers  and  coordination  of  social  security  systems,  the 
Commission deals with problems linked to incorrect application of the relevant provisions of 
the Treaty on the functioning of the European Union34 and of secondary law existing in that 
area. Over the years, problems have been brought to the attention of the Commission through 
individual  complaints,  petitions  of  citizens  to  the  European  Parliament  and  Parliamentary 
questions  which  has  led  the  Commission  to  increase  its  recourse  to  problem-solving 
mechanisms and it intensifies communication to prevent problems. 

34 

Articles 45 and 48 TFEU. 

EN 

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   EN 

 
                                                 
3.1.1.2.  Report on progress made in 2010 regarding free movement of workers 

In 2010, the number of active long-lasting infringement cases in the field of free movement of 
workers was significantly reduced (5 out of 8 cases older than 3 years that were still open at 
the  beginning  of  2010  were  closed  during  the  year).  Along  the  lines  set  out  by  the 
Commission in 2007, priority was given to the handling of the two procedures under Article 
260  TFEU  that  were  ongoing  and  contacts  with  the  two  Member  States  concerned  were 
intensified. 

The major issues dealt with in 2010 were the following: 

The  Commission  carried  out  in  the  past  years  a  systematic  review  of  the  legislation  of  all 
Member  States  following  two  preliminary  judgments  of  the  CJ  regarding  the  nationality 
condition  for  posts  of  master  and  chief  mate  of  ships  where  the  prerogatives  of  public 
authority are exercised by private sector workers. Out of 20 procedures opened on this issue 
in  2004,  2  were  still  ongoing  in  2010.  After  the  Court  of  Justice  confirmed  its  previous 
judgments also against Spain (in 2008)35 and Greece (in 2009)36 the Commission started the 
procedure  to  ensure  compliance  with  those  rulings  (Article  260  TFEU).  The  case  against 
Spain was closed in 2010 as the Spanish authorities adopted new rules that in the opinion of 
the Commission were in conformity with EU law on free movement of workers. As regards 
the case against Greece, the Greek authorities announced a reform of the legislation, which is 
being closely monitored by the Commission.  

With a view to ensuring the correct transposition of the provisions of Directive 2004/38/EC, 
the  Commission  services  kept  monitoring  the  relevant  national  legislation  and  organised 
bilateral  contacts  with  Member  States.  In  the  situation  of  economic  crisis,  more  and  more 
replies had to be provided concerning the rights of jobseekers and people retaining the status 
of a worker and their family members – e.g. questions on how long they are entitled to stay in 
the host Member State, or whether they have access to social benefits and social assistance.  

A  recurring  topic  of  queries  was  again  the  application  of  transitional  arrangements  for 
workers  from  EU8  and  EU2.  There  were  requests  for  information  and  complaints  about  the 
existence of restrictions as such (by citizens) and calls to end them (parliamentary questions). 
On  this  basis,  the  Commission  services  identified  an  incorrect  application  of  transitional 
arrangements  concerning  eligibility  for  benefits  that  is  linked  to  a  wider  problem  of 
compatibility with EU law in the UK legislation. Employment in the public sector represents 
in many Member States an important part of the labour market. Therefore, the action of the 
Commission in this field has a significant effect on the migrant workers' rights; in particular, 
there is a lot of labour mobility in the public teaching and health sectors. 

The Commission dealt in particular with the following issues: 

•  Abolition of nationality conditions for access to posts in the public sector in line with the 
jurisprudence  of  the  Court  on  Article  45  (4)  EC.  In  2010,  two  infringement  procedures 
against Luxembourg were closed. 

35 
36 

C-94/08 Commission v. Spain, judgment of 20.11.2008. 
C-460/08 Commission v. Greece, judgment of 10.12.2009. 

EN 

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•  The  follow-up  of  the  Burbaud-judgment37  led  to  the  opening  of  the  internal  recruitment 
competition for many posts in the French public sector to fully qualified migrant workers 
with  a  certain  length  of  work  experience.  The  infringement  against  France  regarding  in 
particular the teaching sector was closed in 2010 following the adoption of the appropriate 
administrative rules. 

•  The issue of taking into account periods of employment acquired in another Member State 
for the purposes of access to the public sector and for determining working conditions (e.g. 
salary,  grade)  in  the  same  way  when  comparable  experience  is  acquired  in  the  host 
Member State. 

•  Other  complaints  regarding  the  public  sector  concerned:  discriminatory  conditions  of 
access to posts and discriminatory working conditions (unrelated to the issue of recognition 
of  professional  experience),  absence  of  equal  treatment  in  relation  to  the  taking  into 
account of foreign diplomas for the purpose of access to the public sector (e.g. additional 
points  awarded  in  a  recruitment  procedure)  and  for  determining  working  conditions, 
disproportionate language requirements in access to posts. 

Sport: for many years the Commission has been dealing with the issues of EU law related to 
free movement of  professional sportsmen  and  sportswomen. On the basis  of several  queries 
and complaints, the Commission services focused in particular on the issue of the quotas on 
nationality applied in professional sport.  

Residence conditions for access to employment and access to social advantages were also the 
subject of queries and complaints in 2010. A case concerning the access to social advantages 
in  the  Netherlands  (study  grants  for  children  of  migrant  workers)  was  still  pending  at  the 
Court38. New complaints on this issue were received in 2010. 

Regarding the issue of equal treatment of third country nationals, citizens from countries with 
which  the  European  Union  has  signed  an  international  agreement  containing  an  equal 
treatment  clause,  the  Commission  ensured  the  follow-up  of  the  case-law  of  the  Court  of 
Justice, namely in the cases Pokrzeptowicz-Meyer39, Kolpak40, and Simutenkov41, where the 
Court stated that non-discrimination as regards conditions of employment and pay has direct 
effect  and  workers  covered  by  such  a  clause  in  an  agreement,  once  legally  employed  in  a 
Member  State,  have  a  right  to  equal  treatment  as  regards  conditions  of  employment.  An 
infringement  against  the  United  Kingdom  on  the  discrimination  of  EU  but  also  non-EU 
seafarers covered by such an equal treatment clause in international agreements as regards pay 
was ongoing in 2010. 

Citizens' complaints concerned also the violation of their rights as migrant workers by private 
employers  such  as  discriminatory  treatment  in  access  to  work  or  working  conditions. 
However, as in this case the Commission cannot intervene, it can only limit itself to provide 
the  information  about  the  migrant's  rights  and  advise  them  to  seek  solutions  through  means 

37 
38 
39 
40 
41 

C-285/01, judgment of 9.09.2003. 
C-542/09. 
C-162/00, ECR 2002 I-1049. 
C-438/00. 
C-265/03. 

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available  at  the  national  level.  The  Commission  notes  however  that  enforcement  of  these 
rights at a national level is often problematic. 

3.1.1.3.  Report on progress made in 2010 in the field of social security coordination 

In 2010, the Commission services have received many queries and complaints concerning the 
application  of  Regulation  (EEC)  No  1408/71  and  its  implementing  Regulation,  as  well  as 
Regulation (EC) No 883/2004 and its implementing Regulation, which entered into force on 1 
May 2010. Most queries and complaints concerned social security rights of migrant workers, 
e.g.  which  legislation  applies  to  them,  their  entitlement  to  sickness  insurance  benefits  and 
family benefits, how to apply for a pension. Complaints concerned also residence clauses in 
national  legislation  for  various  kind  of  social  security  benefits,  incorrect  application  of  the 
principle  of  aggregation  of  insurance  periods,  cumbersome  or  incorrect  administration  of 
cases involving an EU element. 

In the area of applicable legislation, the queries mainly concerned persons who took up a new 
activity  in  another  Member  State  and  who  inquired  which  legislation  would  be  applicable 
according to the new rules on coordination of social security systems. The Practical Guide on 
applicable  legislation  has  been  developed  by  the  Commission,  in  cooperation  with  the 
Member States, to be of assistance to citizens in the area of posting and activities in two or 
more Member States.  

Major issues concerning sickness insurance benefits in 2010 were the following.  

As in the previous years, the Commission services received many queries about the European 
Health Insurance Card (EHIC), namely how to apply for it or how to use it. As regards the 
procedures for issuing of the EHIC, at this stage, there is no common EU approach and it is 
up  to  the  issuing  Member  State  to  determine  the  rules  for  issuing  the  EHIC.  Similarly, 
institutions of the Member State determine the period of validity of the cards they issue. The 
Member  States  agreed  that  the  period  of  validity  of  the  EHIC  should  take  into  account  the 
presumed  duration  of  the  insured  person’s  entitlement.  Currently,  there  is  no  automatic 
mechanism to verify the validity of entitlement of a person. Moreover, some Member States 
issue cards with very limited validity period. The Commission is aware of the effects of such 
short validity periods of the EHIC for the persons concerned. An ongoing discussion is taking 
place  within  the  Administrative  Commission  for  the  coordination  of  social  security  systems 
and  the  possible  scenarios  for  addressing  this  limitation  will  be  examined  within  the 
framework of the system of the Electronic Exchange of Social Security Information (EESSI), 
which  is  currently  under  development.  In  addition,  the  Commission  will  further  investigate 
the  medical  professionals,  cases  of 
reported  cases  of  refusal  of  valid  EHIC  by 
disproportionate administrative procedures for issuing an EHIC and cases of non-acceptance 
of EHIC as a sufficient document for providing access of insured persons staying abroad to 
necessary healthcare and medicine under the same conditions as to insured nationals. 

In  the  area  of  long-term  care  cash  benefits,  coordinated  as  sickness  cash  benefits  (therefore 
exportable),  the  Commission  has  pursued  an  infringement  procedure  against  the  UK 
concerning export of benefits for disabled persons. In 2009, more than 50 persons contacted 
the Commission services to signal the application of a so called "past presence test" which in 
most cases prevents the exportability of these benefits from the UK. The "past presence test" 
is also subject of a preliminary ruling in front of the Court of Justice of the EU (C-503/09), for 
which a judgment will be delivered in the course of 2011.  

EN 

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Another  sensitive  issue  dealt  with  by  the  Commission  concerns  the  rules  of  access  for  EU 
nationals to the French universal sickness benefits scheme (Couverture Maladie Universelle – 
CMU). The rules for admission require the person to have "regular and stable residence" in 
France.  The  Commission  has  been  in  active  contact  with  the  French  authorities  to  find  a 
suitable solution, which would be in line with the principle of equal treatment.  

As  regards  the  export  of  pensions,  the  Commission  received  various  complaints  about  the 
payment  of  pensions  into  the  beneficiary's  bank  account  in  his  or  her  Member  State  of 
residence. It seems that certain Member States have problems with such payments in another 
Member State. The SEPA (Single Euro Payment Area) should be the answer to this problem 
as  regards  countries  in  the  Eurozone.  The  Commission  opened  an  infringement  procedure 
against  Belgium,  where  national  legislation  does  not  allow  the  payment  of  the  pension 
directly to an account without having the foreign bank guarantee that it will repay the amount, 
should  payments  have  been  wrongly  made.  An  infringement  procedure  was  opened  against 
Greece, where difficulties were reported when pensions are exported, such as the obligation to 
open a bank account at the Greek national Bank and to be obliged to pay higher bank fees for 
payments  outside  Greece  than  within  the  country,  which  is  in  breach  of  EU  social  security 
coordination rules and EU payment rules (Regulation (EC) No 924/2009). 

With  regard  to  unemployment  benefits,  in  view  of  the  economic  recession  and  the  rise  of 
unemployment rates, the Commission services received a large number of queries concerning 
the  right  of  migrant  workers  to  unemployment  benefits  under  Union  law.  Migrant  workers 
were  in  particular  asking  in  which  State  they  can  claim  unemployment  benefits,  method  of 
calculation of the benefit's rate, special regime for frontier workers and the possibility to have 
benefits exported in case they were interested to look for work in other Member States. Some 
of  the  migrants  complained  about  the  cumbersome  and  time-consuming  administration  of 
cases involving an EU aspect. 

In 2010, the Commission follow-up on complaints received from EU citizens, mostly EU-10 
nationals,  who  were  previously  employed  or  self-employed  in  the  UK  and  who  were  not 
granted certain social security benefits. The Commission sent a letter of formal notice to the 
UK  authorities  and  encouraged  the  UK  to  eliminate  this  restriction  to  the  access  to  the 
national benefits falling within the scope of Regulation (EC) No 883/2004.  

In  the  area  of  family  benefits  it  has  been  reported  to  the  Commission  that,  if  two  Member 
States  are  competent  for  providing  family  benefits,  the  determination  of  primary  competent 
State and possible payment of so called "differential supplement" from secondary competent 
State  takes  a  long  time.  This  is  due  to  the  fact  that  the  national  administrations  need  to 
exchange information concerning the composition and situation of the family and the benefits 
provided in the primary competent Member State. The situation can be mitigated by a better 
cooperation  of  national  administrations  and,  in  the  future,  also  the  electronic  exchange  of 
data.  Also,  in  some  Member  State  the  understanding  of  "a  family  member"  is  based  on  the 
national  legislation  and  the  situation  within  one  state  only,  without  taking  into  account  the 
specific  situation  of  migrant  workers,  where  one  parent  may  be  often  active  in  another 
Member State than the state of the family's residence.  

Modernised regulatory framework for the coordination of social security systems 

In 2010, progress was made in view of the entry into application of the new Regulations (EC) 
No  883/2004  and  No  987/2009  (Implementing  Regulation)  on  the  1  May  2010,  which 

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implied: 

•  adoption  of  the  new  Regulation  (EC)  No  1231/2010,  which  entered  into  force  on  1st 
January 2011 and extended the modernised social security regulations, Regulation (EC) No 
883/2004 and Regulation (EC) No 987/2009, to third country nationals not already covered 
by  these  regulations  and  falling  within  the  scope  of  the  coordination  rules.  Regulation 
1231/2010 replaces Regulation (EC) No 859/2003 for all Member States where it applied, 
except  the  United  Kingdom,  which  will  continue  to  apply  Regulation  (EC)  No  859/2003 
(and by extension the rules in Regulation (EEC) No 1408/1971 and Regulation (EEC) No 
574/1972)42.  

The principles contained in Regulation (EC) No 1231/2010 are in essence the same as those 
contained  in  Regulation  (EC)  No  859/2003.  Regulation  1231/2010  is  a  "bridge"  that  allows 
the EU coordination rules to apply to nationals of third countries who fall within its scope. 

Regulation 1231/2010, unlike Regulation (EC) No 859/2003, does not contain derogations for 
Germany and Austria from the principle of equal treatment with regard to family benefits.  

•  intensive  work  to  provide  legal  interpretation  and  guidance  accompanying  the  entry  into 
force of the new Regulations; within the framework of the Administrative Commission for 
the coordination of social security systems (Article 71 of Regulation (EC) No 883/2004); 

•  adoption of three new interpretative decisions for the application of the new Regulations;  

•  adoption of a Guide on Applicable Legislation, which should be considered as a reference 
document  by  the  national  administrations  when  interpreting  the  provisions  of  the  new 
Regulations concerning posting and activity in two or more Member States; 

•  adoption  of  the  Portable  Documents  (replacing  former  E-forms)  and  preparation  of 

guidelines on Portable Documents for citizens. 

The  new  coordination  rules  were  designed  with  an  electronic  exchange  of  social  security 
information between the national institutions. The Commission has been preparing a system 
of e-administration (EESSI), which will enable 31 countries to exchange electronically social 
security  information  among  their  administrations  thereby  fulfilling  the  ultimate  aim  of 
strengthening  the  protection  of  mobile  citizens'  social  security  rights.  This  will  in  turn 
facilitate and speed up the decision-making process for the actual calculation and payment of 
benefits to citizens who move around Europe. 

3.1.2.  Evaluation of the current situation 

•  Complaints and inquiries 

EU  Regulations  on  the  coordination  of  social  security  systems  do  not  harmonise,  but  only 
coordinate Member States' social security system. This leads inherently to a high number of 
requests  and  complaints  from  citizens  about  the  application  of  these  Regulations  to  27 
different national social security systems. 

42 

Note  that  Denmark,  Iceland,  Liechtenstein,  Norway  and  Switzerland  did  not  apply  Regulation  (EC) 
no859/2003 and similarly do not apply Regulation (EC) No 1231/2011. 

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In  2010,  the  entry  into  application  of  the  new  regulatory  framework,  Regulations  (EC)  No 
883/2004  and  987/2009,  as  from  the  1st  of  May  2010  lead  to  an  increase  of  the  number  of 
queries due to requests for clarification.  

In the field of free movement, the nature of the queries remains more or less identical than in 
previous  years  but  takes  into  account  the  entry  into  force  of  Directive  2004/38/EC  and  the 
development of the economic crisis, followed by austerity measures in many Member States. 

Therefore, a total of 239 cases were registered in the new complaint handling system (CHAP) 
for both sectors. 

A number of complaints where Member States requiring further clarification or information 
about  the  national  legislation  or  practice  have  been  dealt  with  through  EU  Pilot,  prior  to 
initiating an infringement procedure. In the field of social security, the exchange though EU 
Pilot  supplements  the  system  of  cooperation  with  the  Member  States  in  the  framework  of 
Administrative Commission put in place in 2005. 

•  Management of infringements 

The  infringement  procedures  dealt  with  by  the  Commission  services  in  relation  to  the  EU 
rules  on  free  movement  of  workers  concern  the  non-conformity  of  national  legislation  with 
article  45  TFEU,  Regulation  (EEC)  1612/68  and  Directive  2004/38/EC  and  the  incorrect 
application of these rules by national authorities. In relation to coordination of social security, 
the  infringements  concern  the  incorrect  application  by  the  national  authorities  of  Article  48 
TFEU and of existing Regulations in that area, namely Regulations 883/2004 and 987/2009 
on social security coordination. 

In that context, the Commission services use the work done by networks of academic experts, 
whose reports on the application of Community law in the field of free movement of workers 
and coordination of social security are published on a website43. 

In  the  field  of  free  movement  of  workers,  the  current  infringement  procedures  deal  mainly 
with  problems  linked  to  access  to  posts  (e.g.  nationality  and  residence  conditions,  language 
requirements),  transitional  arrangements,  working  conditions,  access  to  social  advantages 
(e.g. study grants for children of migrant workers) and employment in the public sector (e.g. 
taking  into  account  of  professional  experience  and  seniority  for  access  to  posts  and  for 
determining working conditions; taking into account of professional qualifications). 

In  2010,  7  infringement  procedures  were  closed,  and  9  new  cases  were  registered.  Only  a 
limited number of complaints were dealt with successfully through EU Pilot without initiating 
an infringement procedure.  

In  the  field  of  social  security  coordination,  the  infringement  procedures  deal  with  problems 
linked  to  sickness  insurance  benefits,  including  the  European  Health  Insurance  Card, 
residence  clauses  for  eligibility  for  social  security  benefits,  calculation  and  payment  of  old-
age pension, discriminatory practices for the payment of certain social security benefits.  

43 

Network of experts on free movement of workers: 
http://ec.europa.eu/social/main.jsp?catId=475&langId=enTress network: http://www.tress-
network.org/TRESSNEW/  

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In 2010, 6 infringement procedures were closed, while 9 new procedures were open. 

At the end of 2010, the Commission services were dealing with 51 infringement procedures 
(compared to 46 procedures at the end of 2009): 18 in the field of free movement and 33 in 
the field of social security coordination. 

•  Guidelines and information 

In line with its obligation to promote good practices and increased knowledge of EU rules on 
the ground and to step up the dissemination of information to EU citizens about their rights, 
the Commission undertook the following actions in 2010: 

1.  In  view  of  the  very  high  number  of  queries,  substantial  effort  was  made  in  terms  to 
supplement  monitoring  with  improved  communication  tools  to  better  inform  the  citizens 
about their rights as regards free movement of workers and social security coordination.  

2.  In the field of free movement, the Commission adopted the Communication "Reaffirming 
the  free  movement  of  workers:  rights  and  major  developments"44,  which  provides  an 
overview  of  the  rights  that  EU  migrant  workers  enjoy  and  which  updates  the  previous 
Communication of the Commission from 2002  by taking into account  the legislative and 
the  case-law  developments  in  this  field.  The  Communication  was  supplemented  by  the 
Commission Staff Working Document "Free movement of workers in the public sector"45. 

3.  In  the  field  of  social  security,  the  website  has  been  redesigned  and  its  content  has  been 
updated in order to fully reflect the new regulatory framework46. Several brochures have 
been  updated  and  posted  on  the  website:  "The  Community  provisions  on  social  security 
brochures:  "The  EU  provisions  on  social  security  -  Your  rights  when  moving  within  the 
European  Union  -  Update  2010)"  and  "Practical  guide  -  Part  1  &  2:  The  legislation  that 
applies to workers in the EU, the EEA and Switzerland".  

4.  The  Commission  published  on  the  website  a  set  of  Explanatory  notes,  which  give 
background and explanation of certain provisions and key concepts in the new rules. The 
notes are being constantly updated and complemented.  

5.  For  the  first  time  in  2010,  the  Commission  published  a  call  for  proposals  to  financially 
support  transnational  actions,  promoting  the  administrative  exchange  of  social  security 
information among EU countries, with a view to assisting them in their implementation of 
Regulations  (EC)  No  883/2004  and  987/2009;  promoting  transnational  cooperation 
between  institutions  dealing  with  social  security,  exchanges  of  experience,  dissemination 
of  best  practices  and  training  initiatives  developed  at  the  national  level;  and  raising 
awareness and providing a better service to the public. As a result the Commission has co-
financed four transnational actions involving 12 different Member States. The call will be 
renewed,  with  an  increased  budget,  in  2011  and  will  support,  among  others,  also  actions 
aiming to implement a new system of electronic exchange of data. 

44 
45 

46 

COM(2010) 373 final, of 13.07.2010. http://ec.europa.eu/social/main.jsp?catId=25&langId=en 
SEC(2010)1609 of 14.12.2010. 
http://ec.europa.eu/social/main.jsp?langId=en&catId=89&newsId=956&furtherNews=yes  
http://ec.europa.eu/social/main.jsp?langId=en&catId=849  

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6.  The  Commission  has  set  up  an  information  campaign  on  the  new  social  security 
coordination rules targeting on the one hand the European citizens and on the other hand 
the  social  security  institutions  of  the  Member  States  which  have  to  apply  the  new 
provisions.  The  campaign  was  launched  in  November  2010.  As  an  intermediate 
assessment,  it  can  be  said  that  the  advertisement  campaign  in  the  media  of  seven  target 
countries  was  able  to  reach  an  estimated  readership  of  25  million  (November/December 
2010).  

3.1.3.  Evaluation results 

Priorities  set  up  for  2010  have  in  general  been  met.  Many  infringements  procedures  were 
successfully  closed  and  many  issues  resolved  through  problem-solving  mechanisms.  The 
forthcoming  year  should  follow  the  same  trend  with  the  positive  impact  of  the  preventive 
approach  based  on  administrative  cooperation  and  on  an  increased  communication  towards 
citizens and national authorities.  

As stated in the 2010 EU Citizen's Report, the Commission should further focus on improving 
information to citizens in order to increase their awareness of their rights and in order to allow 
them  to  enforce  them  better.  Therefore,  to  supplement  monitoring  activities  in  2011,  the 
Commission  will  put  a  strong  emphasis  and  carry  on  improving  information  to  citizens  in 
order  to  increase  their  awareness  of  their  rights  and  in  order  to  allow  them  to  enforce  them 
better.  The  Commission  will  also  further  promote  Your  Europe  website  and  improve 
cooperation with Europe Direct.  

The  Commission  will  also  assess  the  possibilities  of  proposing  a  new  legislative  instrument 
that  would  help  EU  citizens  enforce  the  rights  they  enjoy  according  to  EU  law  on  free 
movement of workers. 

3.1.3.1.  Priorities regarding free movement of workers 

In  addition,  the  Commission  sees  all  infringement  procedures  concerning  the  transitional 
arrangements  as  a  priority  and  will  pay  particular  attention  to  the  question  of  access  of  EU 
migrant workers and members of their family to study grants.  

As regards the working methods, the current tools will continue to be used. The expertise of 
the network of academic experts in the field of free movement of workers will also be used in 
order to obtain information about the national rules applicable.  

3.1.3.2.  Priorities regarding social security coordination 

The  objective  in  the  area  of  social  security  is  to  monitor  the  correct  application  of  the  new 
Regulations  883/2004  and  987/2009  which  came  into  force  on  the  1st  May  2010,  by  the 
national institutions. In accordance with what is set out in the 2010 EU Citizen's Report, the 
Commission will, in order to facilitate the free movement of EU citizens, continue to act to 
ensure  that  the  principle  of  non-discrimination  is  strictly  enforced  for  EU  citizens  and  their 
family members. This continues to be a point of particular importance in the social security 
field. 

As  regards  its  working  methods,  the  Commission  will  better  channel  the  individual  cases 
though different ways of contact with Member States, namely EU Pilot and the cooperation 
with the Administrative Commission, to use the potential of both mechanisms. When dealing 

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with  complaints  it  will  carry  on  using  the  expertise  of  the  network  of  academic  experts 
(trESS) in order to obtain information on national legislation and context.  

The  Commission  will  continue  to  focus  on  finalising  the  development  of  the  system  for 
electronic  exchange  of  social  security  information  (EESSI)  to  enable  the  implementation  of 
the  new  coordination  rules.  The  EESSI  system  will  enable  countries  to  exchange 
electronically social security information between their administrations thereby fulfilling the 
ultimate aim of strengthening the protection of mobile citizens' social security rights.  

During  the  first  semester  2011,  the  Commission  plans  to  publish  a  Communication  on  the 
external dimension of the EU social security coordination rules, which amongst other things 
will look at the effect of the EU rules on the rights of migrants from third countries to receive 
pensions  from  EU  countries  when  they  leave  the  territory  of  the  EU.  Regulation  (EC)  No 
1231/2010 (and its predecessor, Regulation (EC) No 859/2003), which extend the principle of 
equal treatment to third country nationals within their scope, already have some effect in this 
respect.  The  Commission  will  therefore  work  to  ensure  a  better  enforcement  of  these  rights 
for migrants from third countries. 

The  Commission  will  also  release  a  Communication  on  the  social  security  protection  of 
groups  of  workers  with  high  levels  of  intra-EU  mobility  (highly  mobile  workers).  This 
communication  will  explain  and  interpret  the  flexibility  and  limits  of  the  EU  rules  on 
coordination  of  social  security  schemes  that  determine  the  applicable  social  security 
legislation to groups of workers with high levels of intra-EU mobility and describe tools and 
initiatives to support, inform and guide on these issues.  

3.1.4.  Summary 

The  new  system  for  complaints  handling  (CHAP)  has  demonstrated  the  high  number  of 
individual  complaints  and  requests  for  information  in  this  field  of  EU  law.  Therefore,  the 
Commission  is  putting  a  strong  emphasis  and  investments  on  improving  information  to 
citizens  in  order  to  increase  their  awareness  of  their  rights  and  in  order  to  allow  them  to 
enforce them better.  

The  forthcoming  years  should  follow  the  trend  presented  above  with  the  positive  impact  of 
the  preventive  approach  based  on  administrative  cooperation  and  on  an  increased 
communication towards citizens and national authorities. The objective for 2011 is to monitor 
a correct application of the new system of coordination by the Member States, with a focus on 
the new aspects of the Regulations on social security coordination. 

3.2. 

Labour Law 

3.2.1.  Current position 

3.2.1.1.  Introduction 

The 23 Directives applicable in the area of labour law cover a variety of issues and subjects, 
such  as  collective  redundancies,  European  Works  Council,  information  and  consultation  of 
employees, posting of workers in the context of the provision of services, fixed term and part-
time work, temporary agency work, transfer of undertakings, employer insolvency, protection 
of young people at work, and working time. Some of these Directives implement framework 
agreements  concluded  between  general  cross-industry  organisations  at  European  level  or 

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organisations representing management and labour in specific sectors. 

At  present,  in  the  area  of  labour  law,  the  deadline  for  transposition  has  expired  for  all 
directives in force, with the exception of the following three: 

•  Directive 2008/104/EC on temporary agency work47, for which the transposition deadline 

will expire by 5 December 2011; 

•  Council  Directive  2009/13/EC  implementing  the  Agreement  concluded  by  the  European 
Community  Shipowners'  Associations  (ECSA)  and  the  European  Transport  Workers' 
Federation  (ETF)  on  the  Maritime  Labour  Convention,  2006  and  amending  Directive 
1999/63/EC48  for  which  the  transposition  deadline  will  expire  not  later  than  12  months 
after the date of entry into force of the Maritime Labour Convention, 2006. 

3.2.1.2.  Report of work done in 2010 

Monitoring the application of labour law implies different activities at various levels, such as 
the initiating and management of infringement procedures, the management of complaints, the 
preparation  of  monitoring  and/or  implementation  reports  and  the  involvement  of  various 
committees and expert groups. 

•  Management of infringements 

Increased efforts continued in order to close a considerable number of open infringements for 
non communication and non conformity: 20 out of the 59 outstanding infringements could be 
closed in 2010.  

With  regard  to  non  communication  cases,  the  only  outstanding  infringement  proceedings 
against  Member  States  which  failed  to  notify  the  national  measures  concern  Directive 
2005/47/EC49  of  18  July  2005  on  the  Agreement  between  the  Community  of  European 
Railways (CER) and the European Transport Workers’ Federation (ETF) on certain aspects of 
the working  conditions of mobile workers engaged in interoperable cross-border services in 
the  railway  sector,  due  to  be  transposed  by  27  July  2008.  16  out  of  the  17  infringement 
proceedings for non communication initially launched against Member States that had failed 
to  take  the  necessary  transposition  measures  within  the  required  time  limit,  could  be  closed 
following the adoption of the necessary national measures in 2010.  

As regards problems of non-conformity of the national transposition measures of Directives in 
the area of labour law, a number of proceedings in progress continued or could be closed. For 
example,  the  case  against  Luxembourg  for  incorrect  transposition  of  Directive  96/71/EC 
('posting of workers') continued under Article 260 TFEU following the judgment of the Court 
of Justice50: an Article 260 TFEU letter of formal notice was sent and the case could finally be 
closed following the adoption of the necessary measures. The cases against Spain concerning 
the  non  transposition  of  the  working  time  Directive  2003/88/EC  in  respect  of  non-civilian 

47 
48 
49 
50 

OJ L 327, 05.12.2008. 
OJ L 124, 20.05.2009. 
OJ L 195, 27.7.2005, p. 15–17. 
Judgment 19.6.2008, case C-319/06, Commission vs. Luxembourg. 

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personnel  in  public  authorities  (Guardia  civil)  remained  open  under  article  260  TFEU 
following the judgment of the Court of Justice51.  

•  Monitoring reports 

In order to have a comprehensive picture regarding labour law in Member States, a series of 
studies  were  commissioned,  with  a  view  to  taking  stock  of  the  state  of  play  regarding  the 
transposition and application in the national legal orders of EU 10 member States of all labour 
law directives and finalised in 2009.  

The contents of these studies has been used in the drafting of implementation reports required 
by  Directives  and  the  analysis  has  enabled  the  Commission  to  identify  a  number  of 
outstanding  issues  where  correct  and  full  transposition  of  the  Directive's  requirements  by 
Member States may be at stake, necessitating further clarification or verification. These issues 
raise either questions of interpretation of the Directive or doubts as regards the compliance of 
implementing measures with the Directive. On that basis, three implementation reports were 
prepared,  submitted  to  Member  States  social  partners  and  adopted  in  2010,  on  the 
implementation  of  Directive  94/33/EC  (Young  People  at  Work),  of  Directive  2001/86 
(employee  involvement  European  company  statute),  as  well  as  of  Directive  2003/72/EC 
(Employee Involvement in the European Cooperative Society).  

As regards the working time Directive, Commission's Report on the legal implementation of 
the working time Directive in the Member States52 and its accompanying Working Paper of 
the  Commission  services53  completed  in  2008,  cross-checked  against  expert  reports,  and 
provided to member states and social partners for comments in 2009, could finally be adopted 
at the same time as the consultation paper launching the second stage consultation of social 
partners at EU level54 in accordance with article 154 (3) TFEU, on the possible content of a 
forthcoming EU action.  

As  a  follow-up  to  a  Staff  Working  Document55  examining  the  implementation  of  Article  8 
(concerning  old-age  benefits  under  supplementary  company  or  inter-company  pension 
schemes)  and  related  provisions  of  Directive  80/987/EC  ('employer's  insolvency'),  the 
Commission services finished in 2010 the investigation started in 200956. A study was carried 
out and published relating to the protection of supplementary occupational pensions for book 
reserve  schemes  and  defined  benefit  schemes.  The  Commission  services  also  collected 
information  directly  from  Member  States  as  to  the  protection  of  contributions  to  defined 
contributions  schemes.  These  two  outputs  will  feed  in  the  follow  up  of  the  Green  Paper  on 
pensions57. 

•  European network of legal experts in the field of labour law 

51 
52 
53 
54 
55 
56 

57 

Judgment 20.5.2010 , case C-158/09, Commission vs. Spain. 
COM (2010) 802 final, 21.12.2010. 
SEC (2010) 1611 final. 
Communication 'Reviewing the Working Time Directive', COM (2010) 801 final, 21.12.2010. 
SEC (2008) 475 of 11 April 2008. 
Focussing on the following issues (1) how to protect employees and retired persons against the risk of 
under-funding  of  the  pension  schemes,  and  to  what  extent;  (2)  how  to  guarantee  any  unpaid 
contributions to the pension schemes; and (3) how to deal with cases where the supplementary pension 
scheme is managed by the employer himself. 
COM 2010(365). 

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To  complete  the  horizontal  analysis  of  conformity  of  labour  law,  the  European  Network  of 
Labour  Law  Experts  created  as  of  23.12.2007,  produced  quarterly  flash-reports  providing 
information on recent key legal developments in the area of labour law, particularly in those 
areas  that  are  most  relevant  for  the  control  of  EU  legislation.  This  systematic  reporting  and 
monitoring  of  recent  developments,  carried  out  under  Commission  supervision  allowed  the 
Commission  services  to  identify  problems  encountered  in  the  national  legislation,  its 
application and administrative practice, if any. The 2010 thematic report and the Conference 
organised in November 2010 focussed on trends, problems and challenges for labour law in 
time  in  crisis,  restructuring  and  transition  under  the  headings  'protection,  involvement  and 
adaptation'. 

•  Strengthening pro-active co-operation: committee of experts 

The  four  new  expert  groups  created  in  2009  continued  their  activities  in  2010.  Two  are 
informal groups whose aim is to assist Member States in the transposition and implementation 
of Directives 2009/38 (' European Works Councils') and 2008/104 ('temporary agency work'). 
Their official mandate will end in 2011. A report finalised in December 2010 comprises the 
results  of  the  activities,  working  documents  and  discussions  of  the  Expert  Group 
accompanying the transposition of the European Works Councils' Directive. Another informal 
group  was  created  with  the  aim  of  discussing  the  issues  raised  by  the  conclusion  and 
implementation of transnational company agreements. 

Moreover,  as  regards  the  posting  of  workers,  the  formal  expert  committee  set  up  by  the 
Commission in 2008 continued its activities in 2010 examining a large number of questions 
and  difficulties  arising  with  respect  to  the  implementation,  application  and  enforcement  in 
practice  of  Directive  96/71/EC  concerning  the  posting  of  workers  in  the  framework  of  the 
provision  of  services  on  the  basis  of  a  rolling  work  programme.  A  sub-group  was  set  up  in 
particular  to  carry  out  preliminary  examinations  in  order  to  develop  possible  options  for  a 
specific  information  exchange  system  in  order  to  reinforce  and  enhance  administrative 
cooperation. 

•  "Fitness check" 

As  part  of  Work  Programme  2010,  the  Commission  has  started  to  review  the  body  of  EU 
legislation  in  selected  policy  fields  through  so  called  "fitness  checks".  One  of  the  pilot 
exercises  launched  in  2010  concerns  the  area  of  employment  and  social  policy,  covering  in 
particular the area of information and consultation of workers. The aim is to carry out a robust 
review of the following 'family' of Directives in this area: 

1.  Directive 98/59/EC on collective redundancies58; 

2.  Directive 2001/23/EC on transfers of undertakings, focusing on Article 759; 

58 

59 

Council  Directive  98/59/EC  of  20  July  1998  on  the  approximation  of  the  laws  of  the  Member  States 
relating to collective redundancies. OJ L 225 of 12.8.98, p.16. 
Council  Directive  2001/23/EC  of  12  March  2001  on  the  approximation  of  the  laws  of  the  Member 
States  relating  to  the  safeguarding  of  employees'  rights  in  the  event  of  transfers  of  undertakings, 
businesses  or  parts  of  undertakings  or  businesses,  OJ  L  82  of  22.03.2001,  p.16.  Article  7  deals  with 
information and consultation of workers' representatives in cases of transfers of undertakings. 

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3.  Directive  2002/14/EC  establishing  a  general  framework  relating  to  information 

and consultation of workers in the EC60. 

The review will rely on an evidence based approach and integrate legal, economic and social 
effects of the existing legislation. An extensive set of studies exists already in this area which 
will  be  complemented,  where  necessary,  by  additional  research  and  stakeholders' 
consultations. 

Thematic  discussions  involving  stakeholders  are  equally  a  very  important  element  in  the 
fitness  check  exercise.  The  first  event  in  this  regard,  i.e.  a  European  Labour  Law  Network 
Seminar, was held in The Hague on 11-12 November 2010. It brought together labour lawyers 
and academics as well as Member States' and social partners' representatives. 

A  second  step  is  the  setting  up  of  an  ad  hoc  Working  Group  on  ICW  bringing  together 
Member  States'  and  Social  partners'  representatives  foreseen  for  2011.  This  could  meet  3 
times  in  2011  (first  meeting:  17.02.2011).  The  Working  Group  would  examine  and  discuss 
the  different  studies  on  ICW  and  bring  out  the  different  national  experiences  with  the 
implementation of the Directives in line with a work programme. 

3.2.2.  Evaluation based on the current situation  

The importance of labour law for workers in Member States, as well as its importance for the 
perception  of  the  European  Union  as  a  whole,  has  justified  a  horizontal  analysis  of  the 
implementation  of  the  Directives  in  Member  States.  Thanks  to  that  systematic,  horizontal 
analysis  of  the  implementation  of  all  labour  law  Directives,  launched  in  2005,  and  to  the 
contribution  of  the  experts'  network  and  other  expert  groups,  the  Commission  has  a  fairly 
good view of the legal situation in all Member States as regards the implementation of those 
Directives. While, by and large, all Directives are now transposed in all Member States, and 
the  responsible  Commission  services  have  continued  to  make  visible  progress  in  2010  to 
prioritise  and  accelerate  the  handling  of  open  infringements  (see  above),  there  are  still  a 
number of areas where the application of Community law is not yet satisfactory and needs to 
be improved.  

First and foremost, this is the case with the Working Time directive, where the law or legal 
and  administrative  practice  in  many  Member  States  does  not  comply  with  jurisprudence  or 
certain  provisions  of  the  Directive  2003/88/EC  (in  particular  as  regards  on-call  time, 
compensatory  rest,  multiple  contracts,  doctors  in  training,  public  sector  workers  and  the 
individual  opt-out).  Therefore,  a  very  substantial  action  has  been  undertaken  in  order  to 
clarify the application  of the Directive, to ensure effective  conformity across the  EU and to 
provide  a  response  to  the  numerous  complaints  introduced  by  citizens  or  professional 
organisations.  

Moreover, the implementation of Directive 96/71/EC concerning the posting of workers in the 
framework of cross-border service provision has raised some critical issues, given the variety 
of industrial relations systems, particularly in the light of recent case-law (Viking-Line, Laval, 
Rûffert and Commission vs. Luxembourg) which will be necessary to be closely followed.  

60 

Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a 
general  framework for  informing  and  consulting  employees  in  the  European  Community.  OJ  L  80 of 
23.3.2002, p. 29. 

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The analysis of the implementation of Directives 99/70/EC on fixed-term work and 97/81/EC 
on part-time work, both resulting from agreements between social partners, revealed a number 
of deficiencies which are having being addressed via EU Pilot or administrative letters, had to 
be pursued under an infringement procedure.  

Finally, the current economic crisis has put to a severe test those legal provisions which aim at 
providing protection to workers in the event of major restructuring operations. This is the case 
in  particular  of  the  Directives  on  information  and  consultation  of  workers,  collective 
dismissals, transfer of undertakings and the protection of employees in the case of insolvency. 
It seems justified to inquire whether the objectives of such provisions have been effectively 
reached in 2010. Analysis of these and similar issues will be continued in 2011 either in the 
context of the 'fitness check' and/or the envisaged consultation of social partners on the more 
horizontal issue of restructuring. 

3.2.3.  Evaluation results 

Two  reports  are  expected  to  be  adopted  in  spring  2011.  One  concerns  Directive  91/383/EC 
(health  and  safety  of  a-typical  workers),  the  other  on  Article  25  of  Directive  2003/88/EC 
(working time of fishermen). Such reports may identify situations in Member States deserving 
further examination and eventually may justify the launch of infringements. 

The  Commission  will  equally  continue  its  efforts  to  bring  further  clarity  to  the 
implementation, application and enforcement in practice of Directive 96/71/EC on posting of 
workers.  Promoting  exchange  of  information  and  debate  on  the  implementation  of  the 
Directive  in  the  framework  of  the  Expert  Committee  which  was  launched  in  line  with  the 
Commission  Decision  of  19  December  2008,  will  continue  in  2011:  The  report  of  the  sub-
group providing recommendations with respect to the most appropriate solution was approved 
by  the  Expert  Committee  and  sent  to  the  SQWP  of  the  Council.  Following  the  adoption  of 
Council Conclusions (foreseen during the EPSCO Council in March 2011) a pilot project will 
be  launched  to  further  develop  a  separate  and  specific  module  of  the  Internal  Market 
Information  (IMI)  system  for  the  purpose  of  implementing  the  administrative  cooperation 
provisions in the posting of workers Directive. Commission services will continue to provide 
the necessary support and assistance to the Member States during the follow-up process.  
Furthermore, the first results of the ex-post evaluation studies on the application of the posting 
of workers Directive in all Member States, including the social,  economic  and legal aspects 
and impact focusing on sectors with high numbers of posted workers launched in 2009 were 
received late 2010. These will be complemented by a complementary legal study as well as an 
ex ante impact assessment in 2011 in view of the preparation of a legislative initiative by the 
end of 2011. 

Actions  undertaken  on  the  basis  of  the  contents  of  the  implementation  reports  drafted 
following  examination  of  the  legal  situation  in  the  Member  States  after  the  2004 
enlargement, follow-up actions of clarification with respect to the fixed term work (Directive 
99/70/EC), as well as part time work (Directive 97/81/EC) will be continued in 2011 (through 
bilateral contacts, via EU-PILOT or in the context of infringements). These activities will be 
supplemented by an ex-post evaluation and assessment of the impact of both Directives on the 
basis of a study to be launched in 2011. Specific reference will be given to the education and 
public  sector  for  the  fixed  term  Directive  and  the  scope  of  coverage  of  the  part-time  work 
Directive. 

Knowledge by management and labour of their respective rights and obligations in the area of 
indispensable  prerequisite  for  the  full  and 
an 
information 

consultation 

and 

is 

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effective exercise of these rights in the workplace. Therefore the Commission also intends to 
undertake action geared to awareness-raising, as well as to promote exchange of best practices 
and  to  enhance  capacity-building  of  all  stakeholders,  by  way  of  seminars,  training  courses, 
studies  and  financial  support  for  projects  submitted  by  representatives  of  employers  and 
employees. 

In addition, the Commission services will finalise the report on the implementation of certain 
provisions  of  the  employer's  insolvency  Directive  which  was  submitted  to  consultation  of 
Member States and social partners at the end of 2010. The expert working group established 
to  discuss  a  number  of  outstanding  issues  regarding  the  application  of  the  insolvency 
Directive (Council Directive 80/987/EEC and its codified successor European Parliament and 
Council  Directive  2008/94/EC)  in  transnational  situations  contributed  to  this  work  and 
pursued its works for the enhancement of administrative transnational cooperation. 

The Commission services will equally continue to provide technical assistance to the Member 
States  in  the  process  of  transposition  and  implementation  of  the  recently  adopted  Directive 
2008/104/EC  on  temporary  agency  work.  A  group  of  governmental  experts  has  been  set  up 
for this purpose which should finalise its activities in 2011.  

3.2.4.  Summary 

With  all  the  ongoing  initiatives,  including  the  establishment  and  running  of  several  expert 
groups, the Commission has increased its capacity to analyse and identify problematic issues, 
pursue  its  activities  of  control  of  European  legislation  as  well  as  to  strengthen  the  range  of 
preventive measures available. 

Increased  emphasis  has  been  given  to  obtaining  extensive  knowledge  concerning  the 
implementation,  control,  enforcement  and  evaluation  of  the  legislation  either  via  the 
launching of ex-post evaluation or in the context of the fitness check of important parts of the 
acquis in the area of labour law. 

This  should  further  improve  the  implementation,  application  and  enforcement  in  practice  of 
the relevant acquis, with a special focus on the critical areas identified above. However, the 
sensitive  and  often  highly  controversial  nature  of  the  issues  at  stake  may  hamper  achieving 
effective progress. 

3.3. 

Health and safety at work 

3.3.1.  Current position 

3.3.1.1.  General Introduction  

Under Article 153 of the Treaty on the Functioning of the European Union, the Union shall 
support  and complement  the activities of  the Member States in the field  of improvement of 
the  working  environment  to  protect  workers'  health  and  safety.  To  this  end,  the  European 
Parliament and the Council may adopt minimum requirements by means of directives.  

Health  and  safety  at  work  is  the  most  developed  corpus  of  legislation  in  the  field  of 
employment and social affairs, with a multitude of directives (see Annex). Its application over 
the last 15 years contributed in particular to a substantial reduction of the accidents at work 
and thus to an improvement of the quality of work. 

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3.3.1.2.  Report of work done in 2010 

•  Preparation of new legislation 

In  the  framework  of  the  preparation  of  a  proposal  of  the  Commission  amending  Directive 
2004/40/EC  on  the  minimum  health  and  safety  requirements  regarding  the  exposure  of 
workers to the risks arising from physical agents (electromagnetic fields), a comprehensive 
Impact  Assessment  related  was  prepared  and  submitted  to  the  Impact  Assessment  Board  in 
December. 

Work was also carried out on the minimum health and safety requirements on ergonomics at 
work  particularly  to  prevent  work-related  musculoskeletal  disorders  and  display  screen 
vision  conditions 
to  review  Council  Directive  90/269/EEC  and  Council  Directive 
90/270/EEC.  More  specifically,  as  a  preliminary  study  completed  in  2008  was  not 
satisfactory,  new  data  collection  was  launched  in  2010  through  a  Multiple  Framework 
Contract study, focussing on cost/benefit ratio of the options considered.  

The  analysis  and  evaluation  of  the  health,  social,  economic  and  environmental  impact  of  a 
possible EU initiative on the protection of workers' health from risks related to exposure to 
Environmental Tobacco Smoke (ETS) was undertaken.  

On  10  May  2010,  the  Council  adopted  Directive  2010/32/EU  implementing  the  Framework 
Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded 
by HOSPEEM and EPSU61. 

•  Main actions being taken to control the correct application of the law 

EU legislation needs to be supplemented by other policy tools and interventions designed to 
reinforce the impact of regulatory provisions and to provide the suitable context for practical 
application  and  enforcement.  The  adoption  of  practical  guides  contributes  extensively  to 
this  objective  and  in  2010  the  correctness  of  the  different  guides  prepared  as  regards  the 
relevant EU Directives was actively checked. 

The  Advisory  Committee  on  Safety  and  Health  at  Work  (ACSH)  adopted  the  Guide  to 
improve  the  application  of  Directive  92/57/EEC  on  "Construction",  and  the  Guide  to 
prevention and good practice in the Healthcare Sector. 

The  Guidance  for  employers  on  OSH  and  REACH  aspects  for  controlling  risks  from 
chemicals was published and the drafting of the Guidance on nanomaterials and the potential 
risks to workers' health and safety was undertaken. 

Work  continued  as  regards  the  non-binding  guide  for  the  protection  of  workers  in  the 
agricultural and forestry sectors and the non-binding guide for the protection of workers in the 
fishery sector on board vessels less than 15 metres long, with the help of a contractor and in 
close collaboration with the Advisory Committee on Safety and Health at Work.  

In addition, on a request of the ACSH, a working group was set up to examine the impact of 
existing guides to good practice in different sectors of activity, to evaluate the possibility of 

61 

OJ L 134, 1.6.2010, p. 66. 

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developing  a  blue-print  to  ensure  uniformity  and  quality  improvement  in  the  establishment 
and dissemination of these guides and to formulate proposals concerning the priorities to be 
established  for  the  development  of  future  guides,  with  an  indicative  schedule  for  action.  A 
report  was  presented  to  the  ACSH  during  the  June  plenary  meeting  and  endorsed  by  the 
Committee. This report will serve as a basis for the preparation of future guides. 

The monitoring of the progress made by the EU candidate and potential candidate countries in 
transposing the EU acquis on health and safety at work continued with particular emphasis on 
the assessment of the national law of Croatia and the former Yugoslav Republic of Macedonia 
where an external contractor submitted the results of the study in this respect. 

•  Management of the acquis through committees and expert groups 

The  Committee  of  Senior  Labour  Inspectors  (SLIC)  assists  the  Commission  on  problems 
relating  to  the  enforcement  of  Community  law  on  health  and  safety,  and  encourages  its 
effective enforcement, notably by means of a closer cooperation between the national labour 
inspection services.  

One  mechanism  to  fulfil  its  tasks  is  the  rapid  exchange  of  inspection-related  problems  and 
solutions  amongst  the  EU-27  Member  States  and  EFTA  countries.  The  Committee  has 
developed  an  instrument  called  KSS  (Knowledge  Sharing  System),  where  questions  can  be 
put to all the Labour Inspections participating.  

The European information and risk awareness raising campaigns launched under the initiative 
of the Senior Labour Inspectors Committee (SLIC)62 largely contribute to better compliance 
with EU legislation. European campaigns are indeed an effective means by which the labour 
inspection services can cascade a common message to stakeholders. In 2010, SLIC initiated a 
campaign  designed  to  enhance  risk  management  of  dangerous  substances  in  small-  and 
medium-sized  enterprises.  It  concentrates  on  4  workplace  activities:  motor  vehicle  repair, 
furniture  making,  bakeries  and  cleaning,  all  widespread  activities  which,  if  not  properly 
controlled, pose risks of serious ill-health e.g. from respiratory and skin disorders. 

•  Enquiries, problems and complaints management 

During  2010  progress  was  made  as  regards  the  analysis  of  complaints  for  bad  application 
mainly  linked  to  Framework  Directive  89/391/EEC:  one  case  could  be  closed  against  the 
Netherlands  and  the  analysis  of  some  complaints  against  Spain,  Italy  and  Greece,  raising 
complex legal issues progressed. The analysis of some complaints resulted in the opening of 
files in EU Pilot with a view to receiving information from the Member States concerned and 
in one case, an infringements procedure had to be launched. 

Two EU Pilot cases concerning transposition of some provisions of Directive 89/391 in Italy 
have  been  open  and  the  replies  of  Italian  authorities  are  under  examination  by  the  service. 
One  of  these  files  is  likely  to  result  in  the  launching  of  an  infringement  procedure  against 
Italy. 

It  was  also  possible  to  progress  with  other  EU-Pilot  files.  For  instance,  regarding  the 
transposition of Directive 93/103/EC (fishing vessels) into Italian law, the national authorities 

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communicated  draft  legislation  which  envisages  certain  amendments  to  the  existing 
legislation  transposing  the  Directive.  In  a  case  involving  the  transposition  of  Directive 
92/29/EEC (medical assistance on board vessels) in the Netherlands, a meeting was held and 
information was received that the legislation would be brought in line with the Directive. 

The  management  of  complaints  continued.  Some  of  the  complaints  revealed  violations  of 
Health and safety EU law and therefore infringements procedures were launched. As regards 
a  complaint  against  Sweden  in  respect  of  the  implementation  of  Directive  89/391/EEC,  a 
reasoned opinion was notified in January 2010. Management of infringements 

The  monitoring  of  the  conformity  of  transposition  of  EU  legislation  focused  on  the  non-
communication of national measures due to transpose one Directive as well as the analysis of 
the conformity of the transposition measures of Directives in the highest risk sectors. 

• 

Non-communication infringement cases: 

As Directive 2006/25/EC63 of the European Parliament and of the Council of 5 April 2006 on 
the  minimum  health  and  safety  requirements  regarding  the  exposure  of  workers  to  risks 
arising from physical agents (artificial optical radiation) was due for transposition on 27 April 
2010, 14 cases were opened in 2010 and 11 of these were closed during the year, further to 
the  notification  by  the  Member  States  of  the  national  measures  implementing  Directive 
2006/25/EC.  Reasoned  opinions  were  sent  to  Poland  and  the  United  Kingdom  for  the 
incomplete  transposition  of  this  Directive  and  the  case  against  Austria  will  also  have  to  be 
pursued. 

• 

Non-conformity infringement cases: 

There  are  currently  several  non-conformity  infringement  cases  open,  including  several 
regarding  Directive  92/57/EEC  on  construction  sites.  Other  cases  concern  the  Framework 
Directive 89/391/EEC, Directive 93/103/EEC on fishing vessels and Directive 2003/18/EC on 
asbestos.  In  2010,  two  cases  were  closed  further  to  a  reasoned  opinion  under  Article  260 
TFEU,  when  the  necessary  national  measures  were  adopted  in  Italy  and  France  and 
communicated to the Commission. 

3.3.2.  Evaluation based on the current situation  

It is essential that the European Union acquis is implemented effectively in order to protect 
the  lives  and  health  of  workers  and  to  ensure  that  the  companies  operating  within  the  large 
European market are placed on an equal footing. 

Accidents  at  work  and  work-related  diseases  are  a  heavy  burden  in  social  and  economic 
terms, and action to improve health and safety standards at work offers great potential gains 
not only to employers, but also to individuals and society as a whole. 

The implementation of the EU directives, in the field of health and safety at work, is bearing 
fruit at European level. Between 2000 and 2007 a reduction trend of 32.6% in the incidence of 
fatal  and  28.7%  in  non-fatal  accidents  at  work  in  the  EU-15  was  observed  according  to  the 
harmonised  data  on  accidents  at  work  that  are  collected  in  the  framework  of  the  European 

63 

OJ L 114, 27.4.2006, p.38. 

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Statistics on Accidents at Work (ESAW)64. However, the statistics of 2007 show that around 
3.8 million accidents at work resulting in more than three days of absence from work occurred 
in the EU-15. 

3.3.3.  Evaluation results 

3.3.3.1.  Priorities 

A major priority for 2010 was the follow-up of the respect of the deadline for transposition of 
Directive  2006/25/EC  (artificial  optical  radiation)  in  April  2010  and  the  resulting  non-
communication infringements. This priority will remain, as regards the 3 cases which are not 
yet closed. 

Other  priorities  for  2010  were  the  ongoing  analysis  of  the  conformity  of  The  Framework 
Directive  89/391/EEC  and  the  5  individual  directives  related  to  the  highest  risk  sectors: 
the  maritime  sector  (directives  92/29/EEC  and 
construction  (directive  92/57/EEC), 
93/103/EC)  and  extractive  industries  (directives  92/91/EEC  and  92/104/EEC),  as  well  as 
further  analysis  of  the  transposition  of  the  Asbestos  Directive  2003/18/EC  as  exposure  to 
asbestos is still a major concern for the protection of workers' health. These priorities remain. 

Priorities set for 2010 were largely met but it should be borne in mind that the work planning 
has to be constantly adapted to new priorities introduced during the year which has an impact 
on the priorities set regarding the control and monitoring of the application of EU law. 

While  all  health  and  safety  at  work  Directives,  except  one,  are  transposed  in  all  Member 
States  and  the  Commission  has  made  visible  progress  in  2010  to  accelerate  the  handling  of 
open  infringements  and  to  go  further  with  the  priorities  set,  major  efforts  should  still  be 
deployed to progress with the priorities established. 

3.3.3.2.  Planned action (2011 and beyond) 

As previously mentioned, the analysis of the conformity of all the health and safety at work 
directives will continue to be a priority issue as an incorrect transposition could be a source of 
occupational accidents or diseases, with particular serious negative consequences in terms of 
human  lives  or  physical  integrity  and/or  important  economic  impact  for  the  society  and  the 
concerned  enterprises.  Moreover,  such  analysis  is  also  required  due  to  the  fact  that  often 
Member States are legislating in the fields covered by these Directives and there is a need to 
constantly  follow-up  the  legislative  developments  that,  sometimes,  are  not  notified  to  the 
Commission. 

As the analysis of the transposition of all provisions and annexes of the health and safety at 
work directives is a highly time-consuming task requiring highly specialised human resources 
(not only lawyers but also doctors, chemical engineers, mining engineers, etc.), a prioritisation 
is essential and the development of preventive actions is intensified such as the adoption of 
non-binding  guidelines.  In  this  context,  also  with  a  view  to  avoiding  court  proceedings, 
bilateral meetings with national authorities will be held where needed in 2011. 

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The  analysis  of  the  conformity  of  the  transposition  of  Framework  directive  89/391/EEC, 
which  establishes  the  main  principles  of  prevention  of  occupational  risks  that  apply  to  all 
sectors  of  activity,  continues  to  be  a  major  priority  for  2011,  in  particular  as  regards  the 
correct transposition in the 12 new Member States. 

In  2011,  the  Commission  will  continue  the  analysis  of  the  conformity  of  5  individual 
directives related to the highest risk sectors: construction (directive 92/57/EEC), the maritime 
sector (directives 92/29/EEC and 93/103/EC) and extractive industries (directives 92/91/EEC 
and 92/104/EEC). In addition, it is also the intention to further analyse the transposition of the 
Asbestos  Directive  2003/18/EC  as  an  exposure  to  asbestos  is  still  a  major  concern  for  the 
protection of the workers' health. 

These priorities are in line with the main objectives of the Community Strategy 2007-2012 on 
Health  and  safety  at  Work65  in  particular  those  of  reducing  occupational  accidents  and 
diseases and guaranteeing the proper implementation of EU legislation. 

The  publication  of  a  practical  non-binding  guide  on  the  construction  sites  Directive 
92/57/EEC  is  also  foreseen,  which  will  contribute  decisively  to  the  dissemination  of  good 
practices, being an assistance tool for better application of the EU legislation, with a view to 
improving application and consistency of the EU Directive among Member States.  

A  major  priority  mainly  for  2012  will  be  the  follow-up  of  the  respect  of  the  deadline  for 
transposition  of  Directive  2009/161/EU  (third  list  of  indicative  occupational  exposure  limit 
values) in December 2011 and the resulting non-communication infringements. 

In  addition,  as  regards  the  monitoring  of  the  transposition  of  EU  directives  on  health  and 
safety at work in the EU candidate countries, a call for tenders will be launched, in 2011, to 
carry out a study on the transposition of the EU acquis concerned into the Icelandic national 
law. 

3.3.4.  Summary 

The  Commission  has  continued  to  develop  several  initiatives  to  strengthen  the  preventive 
measures  with  a  view  to  significantly  improving  the  level  of  effective  and  complete 
implementation,  application  and  enforcement  of  the  EU  health  and  safety  at  work  acquis. 
Therefore,  successful  results  were,  for  example,  the  closing  of  virtually  all  non-
communication infringements or the reduction trend in the accidents at work.  

Further to the Resolution of the European Parliament of 15 January 2008 on the Health and 
Safety  Strategy  2007-201266,  which  expressly  requests  to  the  Commission  to  intensify  its 
works  on  the  monitoring  of  the  transposition  of  the  health  and  safety  at  work  directives, 
progress in this area has been intensified and the prioritising approach above indicated as well 
as  the  preventive  initiatives  undertaken,  should  allow  to  deal  with  a  workload  which  is 
constantly increasing and therefore requesting major efforts to adequately manage it. 

65 
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COM(2007) 62. 
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4. 

AGRICULTURE AND RURAL DEVELOPMENT 

4.1. 

Current position 

4.1.1. 

 General introduction 

Since  1962  the  Common  Agricultural  Policy  (CAP)  has  established  a  comprehensive  legal 
framework for European agriculture aiming to achieve the objectives set out in TFEU. As a 
fully integrated common policy it replaces a significant amount of national legislation. It has 
largely  accomplished  its  objectives  while  alleviating  the  social  impact  of  agricultural 
restructuring. As a corollary, farmers and administrations have to deal with a complex set of 
rules and measures contained in 1436 acts of secondary law currently in force. Most of those 
acts  are  Council  or  Commission  Regulations  that  are  "binding  in  their  entirety  and  directly 
applicable  in  all  Member  States".  Access  to  agricultural  legislation  has  been  improved  by 
developments in IT tools. All EU legislation is now freely available via the EUR-Lex website. 
Consolidation and codification of legal texts both make the acquis more accessible to citizens 
and improves legal certainty. 

The CAP is unique in the extent to which it is regulated and financed at EU level. Its common 
approach, in particular, to the single market, makes it possible to guarantee the functioning of 
an internal market of agricultural products. An EU framework ensures that rural development 
programs are carried out under common rules without creating unfair competitive advantages. 
Basic  standards  in  the  field,  for  example,  of  organic  farming  and  labelling  are  settled  on  a 
common  basis.  This  requires  robust  legislation,  and  effective  financing  and  monitoring 
mechanisms to protect the public interest and ensure accountability. 

Taking  into  account  the  significant  volume  of  agricultural  law  and  the  more  than  50  years 
history of the CAP (Stresa Conference dated July 1958), it may be considered as a quite stable 
acquis  that,  on  the  one  hand,  is  subject  to  frequent  technical  modifications  under  the 
Comitology  procedure,  and  on  the  other  hand,  undergoes  on  a  regular  basis,  much  more 
profound modifications. The last one of these, the 2003 reform, brought about radical change 
to  the  CAP,  especially  its  income  support  policy.  It  established  the  single  payment  scheme 
and  the  single  area  payment  scheme  where  direct  income  support  for  farmers  is  largely 
decoupled  from  production  and  introduced  the  cross-compliance  system  (see  Council 
Regulation  (EC)  No  1782/200367  repealed  by  Regulation  (EC)  N°  73/2009).  It  also 
established  comprehensive  common  rules  for  direct  support  in  most  sectors.  The  effect  of 
these  reforms  has  been  reviewed  in  the  "Health  Check"  2008,  on  which  basis  the  Council 
decided on adjustments in policy and budgetary priorities by Regulations (EC) No 72/200968 

67 

68 

Council  Regulation  (EC)  No  1782/2003  of  29  September  2003  establishing  common  rules  for  direct 
support  schemes  under  the  common  agricultural  policy  and  establishing  certain  support  schemes  for 
farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) 
No 1454/2001, (EC) 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 
2358/71 and (EC) No 2529/2001. 
Council  Regulation  (EC)  No  72/2009  of  19  January  2009  on  modifications  to  the  Common 
Agricultural Policy  by  amending  Regulations  (EC)  No  247/2006,  (EC)  No 320/2006,  (EC)  No 
1405/2006,  (EC)  No  1234/2007,  (EC)  No  3/2008  and  (EC)  No 479/2008  and  repealing  Regulations 
(EEC) No 1883/78, (EEC) No 1254/89, (EEC) No 2247/89, (EEC) No 2055/93, (EC) No 1868/94, (EC) 
No 2596/97, (EC) No 1182/2005 and (EC) No 315/2007. 

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and  73/200969.  Agricultural  policy  also  contributed  significantly 
the  regulatory 
simplification process notably in 2007 - 2008 by the adoption of the Single Common Market 
Organisation  Regulation.  A  common  market  organisation  (CMO)  in  the  agricultural  sector 
governs  21  sectors  which  until  2007  were  individual  CMOs.  It  provides  a  single  legal 
framework  governing  the  domestic  market,  trade  with  third  countries  and  rules  regarding 
competition70. 

to 

The policy is divided into two pillars: the first pillar consists of a framework for supporting 
the  income  of  farmers  through  the  payment  of  direct  aid  and  a  system  for  managing  and 
supporting  agricultural  markets.  The  second  pillar  of  the  CAP  provides  a  framework  to 
support the development of rural areas of the EU. The first pillar is 100% financed by the EU 
budget, whereas the second pillar is co-financed by the EU budget and those of the Member 
States.  Beginning  on  1  January  2007  the  programmes  for  rural  development  have  been 
implemented  on  the  basis  of  a  new  strategic  planning  model  based  on  an  EU  framework 
position and national strategic plans (see Council Regulation (EC) No 1698/200571). 

To  these  two  principal  pillars  could  be  added  another  important  element  of  the  policy 
consisting  of  the  quality  policy:  notably  four  specific  EU  quality  schemes  have  been 
introduced to develop geographical indications, organic farming, traditional specialities, and 
products  from  the  outlying  regions  of  the  EU.  These  schemes  identify  products  having 
specific qualities resulting from a particular origin and/or farming method. 

Since the 2007 financial year the financing of the CAP is regulated by Regulation (EC) No 
1290/200572,  which  introduced  two  distinct  funds.  The  first  pillar  is  now  financed  by  the 
European Agricultural Guarantee Fund (EAGF) and the second pillar (rural development) is 
financed by the European Agricultural Fund for Rural Development (EAFRD). 

The  implementation  of  the  CAP  is  a  joint  responsibility  of  Member  States  and  the 
Commission, referred to as shared management. While the Commission is responsible for the 
overall legal framework and for implementation of the budget, under the shared management 
concept,  the  responsibility  for  implementation  at  the  level  of  final  beneficiaries  has  been 
delegated to the Member States. The extent of the responsibilities of the Members States may 
in particular be considered very extensive as regards the implementation of the measures of 
the  second  pillar  for  which  a  "bottom  up"  approach  has  been  followed  that  leaves  to  the 

69 

70 

71 

72 

Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support 
schemes for farmers under the common agricultural policy and establishing certain support schemes for 
farmers,  amending  Regulations  (EC)  No 1290/2005,  (EC)  No  247/2006,  (EC)  No  378/2007  and 
repealing Regulation (EC) No 1782/2003. 
Council  Regulation  (EC)  No 1234/2007  of  22 October  2007  establishing  a  common  organization  of 
agricultural  markets  and  on  specific  provisions  for  certain  agricultural  products  (Single  CMO 
Regulation). 
Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the 
European Agricultural Fund for Rural Development (EAFRD) – See also Commission Regulation (EC) 
No  1974/2006  of  15  December  2006  laying  down  detailed  rules  for  the  application  of  Council 
Regulation (EC) No 1698/2005 on support for rural development by the European Agricultural Fund for 
Rural  Development  (EAFRD)  and  Commission  Regulation  (EC)  No  1975/2006  of  7  December  2006 
laying  down  detailed  rules  for  the  implementation  of  Council  Regulation  (EC)  No  1698/2005,  as 
regards  the  implementation  of  control  procedures  as  well  as  cross-compliance  in  respect  of  rural 
development support measures. 
Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural 
policy. 

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Member  States,  regions  and  Local  Action  Groups  much  more  latitude  in  adjusting  the 
programmes to local needs.  

As already mentioned, the CAP has been the subject of a continuing and regular process of 
reform.  A  new  process  of  change  has  been  launched  in  2010.  Indeed,  the  new  financial 
framework  for  the  EU  and  the  "Europe  2020"  strategy  priorities  of  smart,  sustainable  and 
inclusive growth  offer an opportunity  to define the vision for European agriculture by 2020 
and to prepare a reform path for the Common Agricultural Policy accordingly.  

In  this  context,  through  its  response  to  the  new  economic,  social,  environmental,  climate-
related  and  technological  challenges  facing  our  society,  the  CAP  can  contribute  more  to 
developing  intelligent,  sustainable  and  inclusive  growth.  The  CAP  must  also  take  greater 
account  of  the  wealth  and  diversity  of  agriculture  in  the  EU’s  27  Member  States.  The 
Commission  Communication  of  18/11/2010  on  the  "Common  Agricultural  Policy  towards 
2020.  Meeting  the  food,  natural  resources  and  territorial  challenges  of  the  future" 
(COM(2010)  672  final)  already  highlighted  the  key  challenges  and  the  major  policy  issues 
regarding EU agriculture and rural areas and outlined possible policy orientations and options 
for the future. A new reform of the CAP has now to be decided. 

4.1.2. 

 Report of work done in 2010 

(a) New legislation 

2008 ended with the successful outcome of the "Health check" reflection process on how to 
improve  the  efficiency  of  the  Common  Agricultural  Policy  in  the  future.  2009  has  been 
characterised by a very active legislative activity dedicated to the formalisation of the political 
agreement  reached  at  the  end  of  2008.  In  2010,  with  the  entry  into  force  of  the  Treaty  of 
Lisbon, the main legislative task for the Commission consisted aligning of an important part 
of the existing legislation to the new legal bases. Indeed, the Treaty on the Functioning of the 
European  union  (TFEU)  establishes  a  clear  distinction  between  on  the  one  hand  the 
competence  delegated  to  the  Commission  in  order  to  adopt  non  legislative  acts  (delegated 
acts),  which  supplement  or  modify  certain  non-essential  elements  of  the  legislative  act  as 
provided by Article 290 TFUE, and, on the other, competence conferred to the Commission in 
order  to  adopt  implementing  acts  pursuing  to  Article  291.  In  fact,  Member  States  are 
responsible for the implementation of the legally binding acts  of  the European  Union  but if 
the application of the legislative acts requires uniform conditions for implementation, it is up 
to the  Commission  to  adopt  them  by  means of  implementing acts.  Pursuing the adoption of 
the Commission Communication of 09/12/2009 on the Implementation of Article 290 TFUE 
(COM  (2009)  673  final),  the  Commission  has  to  align  progressively  agricultural  legislation 
with  the  new  mechanisms  of  delegated  acts  and  implementing  acts,  including  in  particular 
Regulation  (EC)  N°  1234/2007  establishing  a  common  organisation  of  agricultural  markets 
and on specific provisions for certain agricultural products (Single CMO Regulation). 

Reform of specific market instruments 

2010 saw several legislative initiatives adopted regarding specific sectors or horizontal rules. 
Concerning  the  latter,  the  single  CMO  provides  a  sound  basis  for  grouping  similar  market 
management procedures applicable in different sectors in horizontal Commission Regulations. 

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It offers the opportunity to reconsider and harmonise the different variations in so far as this is 
considered to be useful, thereby achieving a degree of simplification.  

In  2010  this  resulted  in  replacing  in  the  horizontal  regulations  on  physical  checks  and  on 
export  refunds  the  written  control  findings  by  standard  numerical  codes,  and  in  11 
Regulations  the  Member  States'  notifications  to  the  Commission  were  standardised  and 
transferred  to  the  ISAMM  electronic  network.  Besides  simplification  of  CMO  rules,  the 
acquis concerning several sectors was modified to a greater or lesser extent in 2010.  

As  far  as  the  food  distribution  programme  to  the  most  deprived  persons  of  the  European 
Union  is  concerned,  the  Commission  adopted  a  new  amended  proposal  (COM  (2010)  486 
final)  in  line  with  new  provisions  enshrined  in  the  Lisbon  Treaty  and  that  took  on  board 
certain  implementation  adjustments  requested  by  the  EP  such  as  the  possibility  to  grant  a 
priority to food produced in the EU and the obligation for distribution points to clearly display 
the  participation  of  the  EU.  Furthermore,  in  an  attempt  to  make  the  implementing  rules 
clearer, these rules were codified through Commission Regulation (EU) N° 807/201073.  

As for the milk and milk sector, the Commission has adopted the proposal for the Council and 
European  Parliament  on  the  contractual  relations  in  the  sector  (COM  (2010)  728final  of 
10.10.2010) in line with the conclusion of the Council Presidency (27.09.2010) and following 
the first four recommendations of the High Level Experts Group for Milk (delivered on June 
15, 2010).  

In  the  wine  sector,  legislation  has  been  clarified,  simplified  and  sometimes  solved  specific 
problems  linked  to  particular  situations  (see  notably  Commission  Regulation  (EU)  No 
772/2010 of 1 September 2010 amending Regulation (EC) No 555/2008 laying down detailed 
rules for implementing Council Regulation (EC) No 479/2008 on the common organisation of 
the  market  in  wine  as  regards  support  programmes,  trade  with  third  countries,  production 
potential and on controls in the wine sector). The problem of illicit plantings addressed in the 
reform  regulations  is  being  dealt  with.  Penalties  on  vine  growers  who  do  not  regularise  or 
grub-up illegal vineyard plantings  are provided for including possible sanctions on Member 
States  if  they  do  not  provide  information  in  a  timely  fashion.  As  regards  PDO  (protected 
designation  of  origin)/PGI  (protected  geographical  indication),  only  a  few  product 
specifications  relating  to  existing  wine  names  where  received  by  the  Commission  services, 
whereas,  around  1800  files  must  be  communicated  to  the  Commission  by  the  end  of  2011. 
This  will  represent  an  important  workload  for  the  Commission  in  2011.  Furthermore, 
authorization  of  wine-making  practices  has  been  simplified  –  in  general  taking  over  those 
recommended  by  the  OIV  and  the  analytical  methods  of  the  OIV  will  likewise  be  used  for 
analysis  in  the  European  Union.  As  regards  the  German  Alcohol  Monopoly,  a  progressive 
phasing-out of this State aid was decided by the Council and the European Parliament. This 
measure will definitively cease in 2013 for small distilleries and in 2017 for the others. For 
hops, in the absence of a new monitoring system to replace the present system of collecting 
information  regarding  the  contracts,  it  has  not  been  possible  to  eliminate  the  compulsory 
registration  of  contracts.  Therefore  efforts  to  find  a  suitable  solution  and  to  achieve 
simplification will continue in 2011. 

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Commission  Regulation  (EU)  No  807/2010 of  14  September  2010  laying  down detailed  rules  for  the 
supply of food from intervention stocks for the benefit of the most deprived persons in the Union. 

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In the tobacco sector, the 2004 reform providing to completely decouple production and aid, 
and which was again confirmed by the health check regulation in 2009, was implemented as 
foreseen in January 2010.  

In the fruit and vegetable sector, the fruit juice Directive (2001/112/EC74) has been amended 
by Directive 2009/106/EC75. Adaptation was needed to take account of technical progress and 
developments  in  relevant  international  standards,  in  particular  the  Codex  Standard  for  fruit 
juices  and  nectars  (Codex  Stan  247-2005)  which  was  adopted  by  the  Codex  Alimentarius 
Commission  during  its  28th  session  on  4-  9  July  2005  and  the  Code  of  Practice  of  the 
European Fruit juice Association (AUN).  

A proposal for a second amendment of this Directive has been adopted by the Commission in 
September 2010 (COM (2010) 490 final). 

Direct payments and cross compliance 

In  2010  the  legislative  activity  concentrated  on  the  alignment  of  the  Commission  powers 
included  in  Council  Regulation  (EC)  No  73/200976  to  the  differentiation  introduced  by  the 
TFUE between delegated and implementing powers. This sorting out into the two categories 
of existing Commission powers was done on the basis of a thorough screening of the Council 
basic  act  and  the  relevant  Commission  implementing  acts  already  in  force  (Commission 
Regulations  (EC)  No  1120/2009,  No  1121/2009  and  No  1122/200977).  Their  delegated  or 
implementing character was decided on the basis of objective legal criteria on the basis of the 
definitions in Articles 290 and 291 of the TFEU.  

The result of this work was the Commission proposal amending Council Regulation (EC) No 
73/2009  of  29  September  2009  (COM(2010)539  final)  that  was  submitted  to  the  European 
Parliament and the Council at the end of September .  

74 

75 

76 

77 

Council  Directive  2001/112/EC  of  20  December  2001  relating  to  fruit  juices  and  certain  similar 
products intended for human consumption, OJ L 10, 12.1.2002, p. 58–66. 
Commission  Directive  2009/106/EC  of  14 August  2009  amending  Council  Directive  2001/112/EC 
relating  to  fruit  juices  and  certain  similar  products  intended  for  human  consumption,  OJ  L  212, 
15.8.2009, p. 42–44. 
Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support 
schemes for farmers under the common agricultural policy and establishing certain support schemes for 
farmers,  amending  Regulations  (EC)  No 1290/2005,  (EC)  No  247/2006,  (EC)  No  378/2007  and 
repealing Regulation (EC) No 1782/2003. 
Commission  Regulation  (EC)  No  1120/2009  of  29 October  2009  laying  down  detailed  rules  for  the 
implementation  of  the  single  payment  scheme  provided  for  in  Title III  of  Council  Regulation  (EC) 
No 73/2009  establishing  common  rules  for  direct  support  schemes  for  farmers  under  the  common 
agricultural policy and establishing certain support schemes for farmers - Commission Regulation (EC) 
No 1121/2009 of 29 October 2009 laying down detailed rules for the application of Council Regulation 
(EC) No 73/2009 as regards the support schemes for farmers provided for in Titles IV and V thereof.-
Commission  Regulation  (EC)  No  1122/2009  of  29  October  2009  laying  down  detailed  rules  for  the 
implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and 
the integrated administration and control system, under the direct support schemes for farmers provided 
for  that  Regulation,  as  well  as  for  the  implementation  of  Council  Regulation  (EC)  No  1234/2007  as 
regards cross-compliance under the support scheme provided for the wine sector in Council Regulation 
(EC) No 479/2008. 

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Delegated acts were used in all cases of "quasi legislative acts" in the sense that they regulate 
non essential elements of the legislative act, are of general application and amend or complete 
the  legislative  act.  Implementing  acts  were  used  for  all  acts  of  an  "executive"  nature  in  the 
sense  that  Member  States  are  responsible  for  the  implementation  and  there  is  a  need  for  a 
uniform application. 

In  addition  to  the  alignment  exercise,  the  proposal  also  includes  some  elements  of 
simplification  in  the  area  of  cross-compliance.  In  particular,  the  possibility  for  the  Member 
States not to require the declaration of all the agricultural areas of their holding for farmers 
with a total area of the holding lower than 1 hectare is provided for. 

Rural development 

During year 2010, the legal procedures to align Council Regulation (EC) No 1698/2005 78 on 
support for rural development by the European Agricultural Fund for Rural Development to 
the  provisions  of  the  Lisbon  Treaty  (TFEU)  were  launched.  The  proposal  also  contains  a 
number of simplification proposals.  

Commission Regulation (EC) No 1975/200679, which concerns control procedures and cross-
compliance  in  rural  development  operations,  was  recast  as  a  follow-up  of  the  Commission 
staff  working  document  on  simplification.  The  main  objective  was  to  clarify  a  number  of 
points  and  to  increase  the  transparency  of  the  text.  The  new  Regulation  (EC)  No  65/201180 
was adopted in January 2011. 

Commission Regulation (EC) No 1974/200681 laying down detailed rules for the application 
of Council Regulation (EC) No 1698/2005 on support for rural development by the European 
Agricultural  Fund  for  Rural  Development  (EAFRD)  was  amended  to  include  detailed 
implementation rules for payments related to the Water Framework Directive82.  

During  the  year,  significant  effort  was  also  put  into  the  development  of  the  future  Rural 
Development  Policy  and  the  Commission  Communication  on  the  future  of  the  CAP.  The 
work continues in 2011. 

Quality policy 

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80 

81 

82 

Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the 
European Agricultural Fund for Rural Development (EAFRD). 
Commission Regulation (EC) No 1974/2006 of 15 December 2006 laying down detailed rules for the 
application  of  Council  Regulation  (EC)  No 1698/2005  on  support  for  rural  development  by  the 
European Agricultural Fund for Rural Development (EAFRD). 
Commission  Regulation  (EU)  No 65/2011  of  27 January  2011  laying  down  detailed  rules  for  the 
implementation  of  Council  Regulation  (EC)  No 1698/2005,  as  regards  the  implementation  of  control 
procedures as well as cross-compliance in respect of rural development support measures. 
Commission Regulation (EC) No 1974/2006 of 15 December 2006 laying down detailed rules for the 
application  of  Council  Regulation  (EC)  No 1698/2005  on  support  for  rural  development  by  the 
European Agricultural Fund for Rural Development (EAFRD). 
Commission  Regulation  (EU)  No 108/2010  of  8 February  2010  amending  Regulation  (EC) 
No 1974/2006 laying down detailed rules for the application of Council Regulation (EC) No 1698/2005 
on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) 

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Quality 

Building  on  the  strategic  orientations  for  a  coherent  and  comprehensive  food  quality  policy 
set out by Communication (COM(2009)234) adopted in 2009, an impact assessment exercise 
(including the establishment of an Impact Assessment Inter-Service Group) was carried out in 
the first semester of 2010 in view of the adoption of appropriate legislative proposals.  

On 10 December 2010 the Commission adopted the "Quality package" covering all facets of 
agricultural  product  quality  policy.  The  "Quality  Package"  includes:  a)  two  legislative 
proposals  on  agricultural  product  quality  schemes  and  marketing  standards,  respectively;  b) 
two Communications one of which established voluntary guidelines on labelling of foodstuffs 
with PDO-PGI ingredients (OJ C 341, 16.12.2010, p. 3) and on the other of which was on the 
best practice for voluntary certification schemes for agricultural products and food stuffs (OJ 
C 341, 16.12.2010, p. 5).  

In  2010  the  "Standing  Committee  on  Protected  Geographical  Indications  and  Protected 
Designations  of  Origin"  (Art.  15  of  Regulation  (EC)  No  510/200683)  and  the  "Standing 
Committee  on  Traditional,  Specialities  Guaranteed"  (Art.  18  of  Regulation  (EC)  No 
509/200684)  gave  favourable  opinions  respectively  on  a  number  of  Draft  Commission 
Regulations  entering  names  in  the  Register  of  PDOs-PGIs  and  of  Draft  Commission 
Regulations  entering  names  in  the  Register  of  TSGs  (traditional  speciality  guaranteed). 
Favourable opinions were also given on a number of cancellation of registration of names in 
the register of PDOs-PGIs. 

Organic 

The Community organic farming legislation framework is composed by Council Regulation 
(EC)  No  834/2007  on  organic  production  and  labelling  of  organic  products85  and  by 
implementing  regulations  (Regulations  (EC)  No  889/200886  on  production,  labelling  and 
control  and  Regulation  (EC)  No  1235/200887  on  import  of  organic  products).  It  was  further 
developed in 2010 with the adoption of amending Regulation (EC) No 271/201088 on the EU 
organic production logo, which became compulsory for pre-packaged organic food produced 
in the EU as from 1st July 2010. In the area of relations with 3rd countries, the Commission 

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84 

85 

86 

87 

88 

Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications 
and designations of origin for agricultural products and foodstuffs. 
Council  Regulation  (EC)  No 509/2006  of  20  March  2006  on  agricultural  products  and  foodstuffs  as 
traditional specialities guaranteed. 
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labeling of organic 
products and repealing Regulation (EEC) No 2092/91. 
Commission  Regulation  (EC)  No  889/2008  of  5  September  2008  laying  down  detailed  rules  for  the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labeling of organic 
products with regard to organic production, labeling and control.. 
Commission  Regulation  (EC)  No 1235/2008  of  8 December  2008  laying  down  detailed  rules  for 
implementation  of  Council  Regulation  (EC)  No 834/2007  as  regards  the  arrangements  for  imports  of 
organic products from third countries. 
Commission Regulation (EU) No 271/2010 of 24 March 2010 amending Regulation (EC) No 889/2008 
laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007, as regards 
the organic production logo of the European Union.  

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examined  the  information  submitted  by  Japan  and  decided  to  include  it  in  the  list  of  third 
countries recognised as having standards equivalent to the EU organic farming standards89.  

With a view to align the organic farming legislation to the provisions of the Lisbon Treaty, the 
Commission  adopted  on  17  December  2010  a  proposal  to  amend  Council  Regulation  No 
834/200790.  

(b) Preventive measures and actions taken to control the correct application of 

the law 

In  the  field  of  prevention  the  Commission  continues  to  be  active  as  the  following  actions 
demonstrate. 

Meetings  with  the  Member  States  in  the  context  of  Comitology  – 

Guidelines - Interpretations 

In the agricultural sector, preparatory working contacts between experts, review of problems 
arising  and  multilateral  and/or  bilateral  exchange  of  information  all  help  to  ensure  and 
promote correct implementation and identifying and addressing potential problems as early as 
possible.  Furthermore,  the  Management  and  Regulatory  Committees,  which  meet  regularly, 
acts not only as a body delivering its opinion on legal proposals for Commission regulations, 
but  also  serves  as  a  privileged  forum  for  the  exchange  of  information  and  best  practice 
between  the  Member  States  and  the  Commission,  thus  playing  a  key  role  in  preventing 
implementation problems.  

Where  needed,  missions  to  Member  States  capitals  to  get  a  global  view  of  procedures  and 
practices at national level were also organised. “Bilaterals” with Member States provided the 
competent  services  of  the  Commission  with  the  opportunity  to  deal  positively  with  some 
recurrent problems encountered by Member States in the drafting of applications as well as in 
the  interpretation  of  a  number  of  legislative  provisions.  The  Commission  also  provided 
practical suggestions to improve the quality of applications, for instance in the quality sector, 
for  registration  and  amendments.  This  contributed  to  reducing  time-consuming  formal 
exchanges  concerning  Commission  requests  for  additional  information,  in  particular  in  the 
agricultural  quality  policy  sector.  The  wine  sector  regularly  reviews  the  acquis  in  the 
Management Committee and where appropriate the Regulatory committee for certain aspects 
of the PDO/PGI/TSG decisions and wine-making practices. Stakeholders and the Commission 
services  deal  with  issues  in  the  Advisory  Group  and  the  Expert  Group  on  wine-making 
practices  deals with  technical questions. All  these  measures provide a stable and clear legal 
framework  for  the  sector  for  the  coming  years.  They  will  contribute  to  improving 
competitiveness,  increase  subsidiarity  by  enabling  Member  States  to  select  the  measures  in 
their  national  support  programmes  most  suited  to  their  conditions.  The  gathering  of 

89 

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Commission Regulation (EU) No 471/2010 of 31 May 2010 amending Regulation (EC) No 1235/2008, 
as  regards  the  list  of  third  countries  from  which  certain  agricultural  products  obtained  by  organic 
production must originate to be marketed within the Union.  
Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation 
(EC) no 834/2007 on organic production and labelling of organic products – COM(2010) 759 final. 

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information  to  monitor  the  sector  has  also  been  adequately  provided  for  to  ensure  early 
detection of market movements and trends.  

The Commission also provides guidelines in order to ensure consistent implementation of the 
rules  throughout  the  EU  and  prevent  deceptive  and  misleading  practices,  e.g.  in  the  wine, 
quality policy and organic farming sectors. For instance, guidelines relating to Articles 9, 10 
et al of Regulation (EC) No 110/200891 of the European Parliament and of the Council on the 
definition,  description,  presentation,  labelling  and  the  protection  of  geographical  indications 
of  spirit  drinks  were  provided  to  Member  States  in  the  Spirit  Drinks  Committee  and  to  the 
stakeholders  in  the  Advisory  Group  on  Spirit  Drinks  with  a  view  in  particular  to  ensuring 
consistent  implementation  of  the  rules  throughout  the  EU  and  prevent  deceptive  and 
misleading practices. 

Moreover, a register of interpretative notes on agricultural law (called RIPAC) has existed for 
a  long  time  and  new  interpretative  notes  are  regularly  being  created  and  put  in  that  register 
which  is  accessible  for  the  Member  States.  The  notes  are  usually  drawn  up  as  a  result  of  a 
written or oral question posed by a Member State. 

Technical standards Directive (Directive 98/34/EC) 

Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998  laying 
down  a  procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and 
regulations  requires  Member  States  and  Members  of  the  European  Free  Trade  Association 
who  have  signed  the  Agreement  on  the  European  Economic  Area  plus  Switzerland  and 
Turkey to give each other and the Commission prior notification of all draft rules containing 
technical  standards  or  rules  in  order  to  avoid  creating  new  barriers  to  trade  in  the  internal 
market. As such, this Directive can be considered as an ideal preventive instrument enabling 
the filtering of any national technical rule that could jeopardize the functioning of the internal 
market.  

In this context, in 2010 the relevant departments of Directorate-General for Agriculture and 
Rural Development were formally consulted on 106 notifications relating to the agricultural 
sector.  Examination  of  these  draft  texts  subsequently  led  to  the  issuing  of  2  comments,  2 
detailed opinions and one blockage.  

Simplification 

The  Commission  strategy  for  simplifying  the  regulatory  environment  [COM(2005)  535]  set 
out an ongoing simplification programme of measures to be adopted with a view to improving 
the quality and effectiveness of the acquis. As far as the agricultural sector is concerned, the 
Communication on Simplification and Better Regulation for the Common Agricultural Policy 
[COM(2005)509] set out an ambitious programme for a significant simplification of the CAP. 
The  Communication:  "A  simplified  CAP  for  Europe  -  a  success  for  all  (COM(2009)  128 

91 

Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the 
definition,  description,  presentation,  labelling  and  the  protection  of  geographical  indications  of  spirit 
drinks and repealing Council Regulation (EEC) No 1576/89. 

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final)  takes  stock  and  looks  at  what  has  been  accomplished.  It  highlights  the  activities  that 
have  been  carried  out  since  2005,  and  gives  indications  of  the  resulting  reduction  in  the 
administrative  burden  for  farmers  and  administrations.  The  2005  Communication  led  to  the 
creation of the rolling Common Agricultural Policy Simplification Action Plan, which is used 
to  identify,  plan  and  monitor  the  implementation  of  simplification  projects  within  the 
agricultural sector. Launched at the end of 2006, it has evolved from 20 to around 62 projects; 
55 projects have already been implemented (as removal of the obligation to have a licence for 
beef exports without export refunds, end of the obligation for a farmer to have a plot of land at 
his disposal for at least 10 months in order to apply for direct payments, for imports, licence 
requirements  were  reduced  from  500  to  65  and  for  exports,  only  43  licence  requirements 
remain,  etc).  On  technical  aspects,  it  is  interesting  to  mention  that  in  order  to  increase  the 
transparency of EU law, which is an essential element of the better lawmaking strategy that 
the Institutions are implementing, Council Regulations (EC) No 1128/200992 and 1139/200993 
repealed  33  Council  acts  that  had  become  obsolete.  At  the  end  of  2010,  the  Commission 
adopted  two  other  legislative  proposals  looking  to  repeal  another  45  obsolete  Council  acts. 
These  proposals  follow  a  Commission  Communication  which  declared  more  than  360 
Commission acts obsolete. The adoption of the single CMO replaced 21 individual common 
market organisations with one, reducing the number of articles from around 1080 to around 
350 and repealing 86 Council acts. At the end of 2009, the Commission's services presented a 
Staff  Working  Document  SEC  (2009)1601,  on  the  assessment  of  39  simplification 
suggestions submitted at the Agricultural Council of April 2009. The document provides an 
assessment of every simplification suggestion and, where possible, presents a solution to the 
problem raised. Most of the solutions have already been incorporated, for example in the new 
implementing  regulations  for  direct  payments  or  in  the  simplification  package,  which  was 
adopted by the Commission at the end of September 2010. The Commission has adopted in 
November a Communication declaring a substantial number of Commission acts obsolete and 
on 20 December two legislative proposals repealing a number of Council acts related to the 
CAP. Together, these two exercises represent a considerable cleaning up and a step forward in 
simplifying the agricultural acquis. 

Sectoral preventive measures 

The following examples illustrate preventive actions taken in some agricultural sectors.  

Quality 

Controls of obligations of Member  States under Regulation (EC) No 510/2006 remained an 
important  issue  in  need  of  attention.  The  Commission  services  assessed  the  Multi  Annual 
National Control Plans (MANCP) presented pursuant to the provisions of Regulation (EC) No 
882/2004  and  the  annual  reports  submitted  on  the  implementation  of  these  plans.  The 
Commission  services'  analysis  provided  the  necessary  feedback  to  the  Member  States  on 
controls of PDOs and PGIs.  

The Commission services informed the Member States regarding the interpretative note (No 
2010-01) on the use in translation of a name registered under Regulation (EC) No 510/2006. 

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Council Regulation (EC) No 1128/2009 of 20 November 2009 repealing certain obsolete Council acts 
in the field of the common agricultural policy. 
Council Regulation (EC) No 1139/2009 of 20 November 2009 repealing certain obsolete Council acts. 

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The  note  clarified  the  distinction  between  names  as  entered  in  the  register  and  names  in 
translation.  

In order to contribute to the smooth application of the  existing  legislation on PDO/PGI and 
TSG, bilateral meetings with Member States were organised in the margin of the Committees 
meetings.  Such  “bilaterals”  provided  the  Commission  services  with  the  opportunity  to 
continue the productive dialogue established in the last few years and tackle effectively some 
problems encountered by Member States in the drafting of applications.  

A  constructive  exchange  of  views  on  general  improvements  needed  to  the  processes  and 
registration  procedures  for  PDO,  PGI  and  TSG  applications  took  place  also  in  the 
Committees'  meetings,  exceptionally  in  the  presence  of  the  Commissioner.  Procedural 
questions  were  discussed  with  the  Member  States  experts  directly  responsible  for  the 
implementation of EU sectoral legislation at national level. 

The  preparation  of  a  guide  for  applicants  of  PDO/PGI  applications  was  started  in  2010, 
benefiting also from the contributions of Member States. 

Organic farming legislation – monitoring guidelines 

Regarding  the  implementation  of  the  EU  rules  on  organic  products,  discussions  take  place 
between the Commission and the Member States in the framework of the Standing Committee 
on  Organic  Farming  (SCOF)  and  bilaterally.  The  legislative  framework  in  place  clearly 
delimitates  competences  between  the  Commission  and  the  Member  States  and  makes 
provision  for  a  series  of  information  and  reports  that  are  submitted  regularly  to  the 
Commission.  

With  regard  to  controls,  the  responsibility  lies  with  the  Member  States.  Controls  of  the 
organic production are logically placed under the responsibility of the Official Food and Feed 
Control (OFFC) set up by Council Regulation (EC) No 882/200494. To foster more efficient 
control systems, the Commission developed a document on control guidelines with a view to 
disseminate  knowledge  and  appropriate  guidance  to  the  competent  authorities,  and  possibly 
the control bodies, clarifying the relationship between the controls requirements deriving from 
the OFFC and those deriving from the regulations in the organic sector. The document, which 
will also help the Commission in its supervisory role, was finalised in December 2010 and is 
expected  to  be  disseminated  in  the  first  quarter  of  2011.  In  2010,  the  Commission  sent  one 
letter to a Member State requesting it to provide a solution without delay to a deficiency in its 
control  system.  A  solution  was  provided  by  the  competent  authority  of  the  Member  State 
concerned  within  a  reasonable  delay  and  the  performance  of  its  control  system  was 
subsequently improved.  

Concerning  the  introduction  of  the  new  EU  logo,  a  series  of  tools  to  assist  operators  were 
developed,  namely  a  series  of  Frequently  Asked  Questions,  a  user  manual  and  a  document 
describing the terms and conditions for its use.  

94 

Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on 
official  controls  performed  to  ensure  the  verification  of  compliance  with  feed  and  food  law,  animal 
health and animal welfare rules. 

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In the area of support to organic farmers a study on "the use and efficiency of public support 
measures addressing organic farming" was launched at the end of the year.  

Rural development preventive measures 

Preventing tasks under shared management with the Member States are permanent core task 
of  Commission  Rural  Development  services.  Preventing  tasks  include  regular  monitoring 
through  participation  in  Annual  Review  meetings  and  Monitoring  Committee  meetings,  as 
well as the thorough analysis of Annual Progress Reports, Mid-Term Evaluation reports and 
summary  reports  of  National  Strategic  Plans.  Furthermore,  preventing  tasks  include 
consultations regarding Rural Development Programme modifications, when the Commission 
must  assess  the  compliance  of  the  modifications  with  EU  law.  Moreover,  numerous  legal 
interpretations and guidelines were given to Member States in the form of exchange of letters.  

During the year, increased attention was paid to policy implementation. Since 2010 was the 
mid-point  of  the  programming  period  2007-2013,  taking  stock  of  the  Rural  Development 
programme  achievements  so  far  was  highlighted  in  the  work  of  Member  States  and  the 
Commission. The Member States submitted strategic summary reports on the progress made 
in the National Strategy Plan implementation to the Commission. Furthermore, the Member 
States  conducted  mid-term  evaluations  of  their  Rural  Development  programmes  and 
submitted them to the Commission.  

In  September,  a  seminar  on  ensuring  good  management  of  the  Rural  Development 
programmes was organised in Brussels. The focus of the seminar was on knowledge-sharing 
amongst the Member States and illustrating best practises. The seminar brought together the 
policy  planning  and  implementing  authorities  from  the  Member  States,  staff  from  the 
Commission services and the European Court of Auditors. 

Clearance of accounts 

EAGF  and  EAFRD  expenditure  is  implemented  under  shared  management  through  a 
comprehensive management and control system based on four levels consisting of95: 

• 

• 

95 

A  compulsory  administrative  structure  at  the  level  of  the  Member  States: 
management  and  control  of  expenditure  is  entrusted  to  dedicated  paying  agencies, 
which prior to their commencement of operations must be accredited by the Member 
States on the basis of a comprehensive set of accreditation criteria laid down in EU 
law; 

Detailed systems for ex-ante controls and dissuasive sanctions: These systems are to 
be  applied  by  the  paying  agencies  and  contain  some  common  features  and  special 
rules tailored to the specificities of each aid regime. The systems generally provide 
for exhaustive ex-ante administrative controls of 100% of the aid applications, cross-
checks  with  other  databases  where  this  is  considered  appropriate  as  well  as  pre-
payment  on-the-spot  checks  of  a  sample  of  transactions  ranging  between  1%  and 
100%,  depending  on  the  risk  associated  with  the  regime  in  question.  If  the  on-the-
spot checks reveal a high number of irregularities, additional checks must be carried 

For  more  explanations  on  the  management  of  the  agricultural  budget  and  its  audit  tools,  see: 
http://ec.europa.eu/agriculture/fin/clearance/factsheet_en.pdf 

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out.  In  this  context,  by  far  the  most  important  system  is  the  IACS  (Integrated 
Administration and Control System). To the extent possible, the IACS is also used to 
manage and control rural development measures relating to parcels or livestock. 

Ex-post checks: in addition to the ex-ante controls, all aid measures other than direct 
payments  covered  by  the  IACS  are  subject  to  ex-post  checks  under  either  Council 
Regulation  (EC)  No  485/2008  or,  for  rural  development  measures,  Commission 
Regulation (EC) No 1965/2011. Moreover, the paying agencies' annual accounts and 
the functioning of their internal control procedures are verified and certified on an ex-
post basis by the certification bodies. 

Clearance of accounts: the clearance of accounts through the Commission consists of 
both an annual financial clearance and a multi-annual conformity clearance. 

• 

• 

Taken  together,  these  four  levels  are  designed  to  ensure  the  legality  and  regularity  of 
transactions at the level of the final beneficiaries. In the current context of the report on the 
application of EU law, the conformity clearance mechanism is particularly worth mentioning 
as it pertains to the correct application of the legislation establishing the common agricultural 
policy. 

Indeed,  while  the  financial  clearance  covers  the  integrality,  accuracy  and  veracity  of  the 
paying agencies' accounts, the conformity clearance relates to the legality and regularity of the 
underlying transactions. It is designed to exclude from EU financing expenditure which has 
not  been  executed  in  compliance  with  EU  rules,  thus  shielding  the  EU  budget  from 
expenditure  that  should  not  be  charged  to  it  (financial  corrections).  In  contrast,  it  is  not  a 
mechanism by which irregular payments to beneficiaries are recovered, which according to the 
principle  of  shared  management  is  the  sole  responsibility  of  Member  States.  Financial 
corrections are determined on the basis of the nature and gravity of the infringement and the 
financial damage caused to the EU. Where possible, the amount is calculated on the basis of 
the loss actually caused or on the basis of extrapolation. Where this is not possible, flat-rates 
are  used  which  take  account  of  the  severity  of  the  deficiencies  in  the  national  monitoring 
systems  in  order  to  reflect  the  financial  risk  for  the  EU.  Where  undue  payments  can  be 
identified as a result of the conformity clearance procedures, Member States are required to 
follow them up by recovery actions against the final beneficiaries. However, even where this 
is  not  possible  because  the  financial  corrections  only  relate  to  deficiencies  in  the  Member 
States'  management  and  monitoring  systems,  financial  corrections  are  an  important  means  to 
improve these systems and, thus, to prevent or detect and recover irregular payments to final 
beneficiaries.  The  conformity  clearance  thereby  contributes  to  the  legality  and  regularity  of 
the transactions at the level of the final beneficiaries. 

In 2010, the Commission adopted three conformity clearance decisions: 

• 

• 

EN 

Ad hoc Decision 32: Commission decision No 2010/152/EU of 11/03/2010 excluding 
EUR 351.8 million from EU financing. 

Ad hoc Decision 33: Commission decision No 2010/399/EU of 15/07/2010 excluding 
EUR 271.9 million from EU financing. 

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• 

Ad hoc Decision 34: Commission decision No 2010/668/EU of 4/11/2010 excluding 
EUR 579.2 million from EU financing. 

Moreover,  in  2010,  the  Commission  carried  out  156  on-the-spot  missions  in  the  Member 
States and launched 129 desk checks. 

While  the  financial  consequences  will  only  be  determined  at  the  end  of  the  conformity 
clearance  procedures,  the  results  of  the  audits  are  already  known  throughout  the  year  in 
question.  Most  of  the  audits  performed  in  2010  have  not  revealed  any  deficiencies  in  the 
monitoring systems which would suggest that those systems are ineffective in determining the 
eligibility of claims or preventing irregularities96. However, as regards direct payments, serious 
deficiencies have been detected in the IACS of 3 Member States. Those Member States have 
put  in  place  action  plans  which  are  being  closely  followed  by  the  Commission  services.  In 
parallel, the Commission is protecting the EU financial interests through conformity clearance 
procedures which are expected to result in significant financial corrections. 

In the rural development sector, following the extensive audit program (37 audit missions of 
EAFRD financing in 2010) in the Member States and their systematic follow-up in terms of 
recommendations on controllability of measures or other weaknesses of the RD programmes, 
the  Member  State  have  taken  various  actions.  Until  end  of  October  2010  a  total  of  46 
significant findings from audit reports relating to the weaknesses in implementation of the RD 
programs,  compliance  issues  and  controllability  of  measures  were  found.  24  of  those  cases 
have been closed from the follow-up after problems have been solved either by changing the 
RDP or by other  means.  The  national rural development programs have been  modified  in 9 
cases and the national framework in one case, which led to modifications into most regional 
programs  of  that  Member  State.  The  geographical  units  are  continuously  following  new 
reports and taking new findings to the follow-up table when necessary. From the ECA reports 
12 findings have been followed-up. One has been closed. Furthermore, action has been taken 
in  several  cases  to  clarify  national  implementing  rules  as  well  as  to  modify  national 
legislation.  

c) Management of the acquis through committees and experts groups 

In the legal context prevailing in 2010, before the Commission adopts an act in the area of the 
Common Agricultural Policy, based on powers conferred upon it by the Council, it normally 
has to consult with Member State representatives and may also consult within expert groups.  

In  the  case  of  consultation  with  the  Member  States  representatives  (Comitology),  the 
Commission proposes the draft measure to a committee established by Council legislation and 
composed of representatives of the Member States. Committees give their opinion to almost 
every implementing act drafted by the Commission. In relation to the CAP, the management 
committee procedure is the type of procedure that applies almost exclusively and only in very 
few  cases  is  the  regulatory  procedure  applied  with  or  without  scrutiny  by  the  European 
Parliament. This process gives multiple possibilities for consultation on different solutions for 

96 

For a more detailed description of the conformity clearance activities, see 2009 Annual Activity Report 
in the domain of agriculture. 

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the implementation of agricultural law. It also has the effect that Member States are reminded 
of  their  duty  to  comply  with  EU  law.  Comitology  has  a  long  tradition  in  the  agricultural 
sector, especially in the system of the management of the agricultural markets but Comitology 
also  applies  to  the  implementation  of  rural  development  and  direct  payments.  It  should 
however  be  noted  that  as  of  1  December  2009  (entry  into  force  of  the  Lisbon  Treaty)  new 
Treaty  provisions  are  in  force  on  the  kind  of  competences  which  can  be  conferred  by  the 
legislator upon the Commission. However, pending the necessary adaptations of the existing 
Commission  competences  by  the  European  Parliament  and  the  Council,  they  have  not  yet 
taken effect so far and will gradually be introduced probably as of mid-2011. Meanwhile, the 
CAP continues to be implemented in accordance with the old (existing) rules provided in the 
Council Decision 1999/468/EC97. 

In  2010,  143  meetings  of  14  management  and  regulatory  committees  presented  the 
opportunity to discuss the implementation of CAP legislation with the representatives of the 
Member  States.  By  securing  the  discussion  of  all  market  management  related  issues  in  a 
single  Committee,  discussions  have  benefited  from  cross-sectoral  expertise  and  enhanced 
harmonisation and so the resulting implementing rules are simpler for Member States to put 
into practice.  

The Commission therefore cooperates with  Member States in  a sophisticated manner which 
presents the opportunity to discuss and prepare the implementation of common rules and to 
prevent or solve problems related to their application at an early stage. 

In addition the Commission administrates around 70 expert groups (56 active), including Civil 
Society  Dialogue  groups,  dedicated  to  agriculture  policies.  These  groups  are  not  only 
composed of national administration experts but also by agricultural organisations, academics 
and independent experts. A major proportion of these groups are advisory groups where the 
Commission consults on measures with stakeholders such as producers, exporters, importers, 
wholesalers,  retailers,  nature  preservation  NGOs,  consumers  and  other  concerned  parties. 
Article 3(1) of Commission Decision 391 of 23 April 200498 provides that all socio-economic 
organisations participating in the advisory groups must be listed in the Commission's register 
of interest groups. In 2010 all socio-economic organisations have been registered. 

In 2010 the Commission was assisted by a number of advisory and working groups, as well as 
permanent  and  temporary  groups'  meetings  of  experts  (in  total  138)  with  a  view  to  better 
adapting policies and implementing rules to the real situation. Above all, these groups provide 
the Commission with agricultural markets data and current production circumstances. A High 
Level Group of Experts in milk met ten times from October 2009 to June 2010 and produced 
a report with policy recommendations in June 2010. A dairy stakeholder conference was also 
held in March 26, allowing a wider range of actors in the supply chain to express their views. 

d) Enquiries, problems and complaints management 

Complaints from citizens and businesses (77 files related to the agricultural sector registered 
in the CHAP database in 2010) and internally detected cases led the Commission to examine  
cases  of  potential  breaches  of  EU  law  covering  various  fields  of  the  Common  Agricultural 

97 

98 

1999/468/EC:  Council  Decision  of  28  June  1999  laying  down  the  procedures  for  the  exercise  of 
implementing powers conferred on the Commission. 
2004/391/EC:  Commission  Decision  of  23  April  2004  on  the  advisory  groups  dealing  with  matters 
covered by the common agricultural policy, OJ L120/50 of 24.4.2004. 

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Policy. In several cases the Commission referred questions relating to the application of EU 
law  to  Member  States  using  the  EU  Pilot  system.  In  2010,  61  cases  were  dealt  in  EU  Pilot 
system and concerned different sectors of the CAP. 

Particular attention was drawn to the correct application of EU legislation in the field of direct 
payments, organic production and quality policy.  

e) Petitions 

In  2010  the  Commission  received  6  Petitions  related  to  agriculture  which  covered  a  wide 
range of issues.  

Four of them concerned EU support (rural development and the use of EU funds in Doñana 
National  Park  in  Romania,  support  for  young  farmers  in  Bulgaria,  aid  for  yak  cows).  The 
other two concerned legislation on the compulsory purchase of land and modernisation of a 
forest track on the 'Valea Șardului' ecosystem. 

f) Management of infringements 

In the area of agriculture and rural development, monitoring the application of EU law under 
the Article 258 TFEU procedure focuses on two main objectives: removing barriers to the free 
movement  of  agricultural  products  and  ensuring  that  the  more  specific  mechanisms  of 
agricultural regulations are applied effectively and correctly. 

In  2009,  the  Commission  had  to  intervene  in  the  context  of  the  last  objective  by  sending  a 
reasoned  opinion  to  the  Czech  Republic  for  the  use  of  the  sales  designation  "Pomazánkové 
máslo"  (in  English  –    'butter  spread')  for  a  dairy  product  which  does  not  comply  with  the 
requirements laid down in the Annex XV to Council Regulation (EC) No 1234/2007. Since no 
solution  was  found,  the  Commission  decided  to  refer  the  case  to  the  Court  of  Justice  in 
September 2010.  

Moreover, specific attention continued to be paid in 2010 to the application of the milk quota 
regime. Particular attention was devoted to its application in new Member States and to the 
situation prevailing in Italy regarding the recovery of levy due by milk producers. 

Furthermore,  the  Commission  intervened  in  the  wine  sector  in  order  to  ensure  the  correct 
implementation  of  EU  rules  regarding  "protected  geographical  indication"  that  limit  to 
exceptional  cases,  the  possibility  for  the  names  of  Member  States  to  be  protected  as 
geographical indications (see Article 118(b) of Regulation (EC) No 1234/2007).  

Particular attention has also been paid to the treatment of  instances of non-compliance  with 
Court  judgments.  In  2010,  the  Commission  monitored  the  progress  made  by  Portugal  to 
implement a judgment of the Court in which the Court declared that, by levying charges on 
beneficiaries  during  the  programming  period  1994-1999  which  were  neither  voluntary  nor 
optional  and  which  did  not  constitute  remuneration  for  services  rendered  by  the 

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administration,  the  Portuguese  Republic  failed  to  fulfil  its  obligations  under  Council 
Regulation  (EEC)  No  4253/88,  as  amended  by  Council  Regulation  (EEC)  No  2082/9399. 
Portugal presented a plan programming the reimbursement of the amounts resulting from the 
charges illegally collected from the beneficiaries. The execution of the plan should be ended 
in 2011 by the payment of interests on the capital.  

Furthermore the Commission continued monitoring the application of the so-called "Breakfast 
directives", which lay down particular compositional and labelling requirements for products 
including honey, chocolate, jams and fruit juices100. More specifically, concerning chocolate 
(Directive 2000/36/EC101), the Commission ensured the monitoring of the implementation by 
Italy of the judgement of the Court of Justice in case C-47/09 where the Court took the view 
that,  by  providing  that  the  adjective  ‘pure’  may  be  added  to  the  sales  name  of  chocolate 
products which do not contain vegetable fats other than cocoa butter, the Italian Republic had 
failed to fulfil its obligations under the Directive..  

4.2. 

 Evaluation 

4.2.1. 

 General evaluation 

Taking  into  account  the  volume  of  EU  law  currently  in  force  in  the  agricultural  sector,  the 
acquis in the agricultural sector may be considered as globally stable and manageable subject 
to technical up-dating or clarification effected through Comitology (see above). This updating 
is  not  generally  expected  to  be  controversial  or  difficult  to  implement  due  to  the  well-
established and well-understood framework in which this will take place and in the light of 
previous experience of the relatively smooth adoption and timely entry into effect of this type 
of measure. 

In  the  agricultural  sector  it  may  be  considered  that  preparatory  working  contacts  between 
experts, review of problems arising and multilateral and/or bilateral exchange of information 
constitute proportionate and sufficient means to ensure correct implementation. Furthermore, 
besides  its  role  in  the  adoption  of  implementing  rules,  the  Management  Committees,  which 
meet  regularly,  are  a  privileged  forum  for  the  exchange  of  information  and  best  practise 
between Member States and the Commission. 

99 

100 

101 

Judgement  of  5  October  2006  in  case  C-  84/04,  Commission  v.  Portuguese  Republic,  Rec  2006,  p.I-
9843. 
The list of products is not exhaustive. The products referred to above due to their nature and constant 
consumption  require  particular  supervision  of  the  application  of  the  following  directives:  Council 
Directive 2001/110/EC of 20 December 2001 relating to honey , Directive 2000/36/EC of the European 
Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for 
human consumption,Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies 
and marmalades and sweetened chestnut purée intended for human consumption and Council Directive 
2001/112/EC  of  20  December  2001  relating  to  fruit  juices  and  certain  similar  products  intended  for 
human consumption. 
Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa 
and chocolate products intended for human consumption. 

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In  any  case,  as  already  explained,  the  agricultural  sector  makes  use  of  the  clearance  of 
accounts mechanisms to monitor through its audits the application of secondary agricultural 
legislation and in particular the management and control systems thereof. 

4.2.2. 

 Sector based remarks 

(a) Market instruments 

As regards the functioning of this sector-based acquis, no major problems were encountered 
in 2010 as regard the application of the existing rules. The acquis can be considered as stable 
providing a generally satisfactory situation. 

The simplification of horizontal regulations contributed to the aim of harmonised application 
and interpretation of Union law in all Member States. The discussions in the Committee on 
legal and technical issues and on the annual report on physical checks contributed to realising 
these  aims  as  well.  The  audits  performed  in  2010  generally  show  a  very  high  degree  of 
conformity  by  Member  States.In  line  with  the  priorities  defined  in  the  27th  report  to  EP  for 
agricultural sector, the priorities indicated in the wine sector were realised. The grubbing-up 
scheme in the wine sector met with considerable success between 2008 and 2011. Only half 
the  demand  could  be  satisfied  by  the  available  budget.  The  national  support  programmes 
budgets  were  also  almost  completely  allocated,  indicating  the  attainment  of  many  of  the 
objectives set out. Member States fully used the possibility given in the wine reform in 2008 
to  establish  their  national  support  programmes  with  the  measures  necessary  for  the 
modification of their own wine sector. The budget execution reached 98, 5% of the available 
funds for 2010. The main measures remain restructuring measures (44%) and distillation (37, 
5%).  The  part  of  the  budget  used  for  distillation  should  diminish  in  2011  and  onwards  and 
therefore this part of the budget will be dedicated to other measures such as investments and 
promotion in third countries.  

(b) Direct payments and cross compliance 

Direct payments scheme 

The acquis in the direct payments sector is stable and its application by the Member States in 
2010  was  generally  satisfactory.  However  some  specific  issues  have  created  implementing 
difficulties  for  Member  States,  for  example  regarding  the  assessment  of  the  eligibility  of 
certain marginal areas. 

The  legislation  defines  the  agricultural  area  eligible  for  payments  under  the  single  payment 
scheme  (SPS)  and  the  single  area  payment  scheme  (SAPS)  as  well  as  what  is  considered 
agricultural  activity.  Following  the  principle  of  decoupling  introduced  by  previous  reforms, 
no production is required on the eligible hectares. This has lead to certain grey zones where it 
can be difficult for both farmers and national authorities to determine in practice whether the 
area in question is actually agricultural or whether the character and main purposes of the area 
are rather to be considered as natural, recreational or forest. 

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To help Member States face this challenge and also in reply to a request raised by the Member 
States  in  the  context  of  the  simplification  exercise,  the  issue  of  eligibility  was  thoroughly 
examined  in  the  Management  Committee  for  Direct  Payments.  The  examination  which  had 
already  started  in  2009  included  presentations  by  the  Member  States,  written  description  of 
the Member States implementation of eligibility rules and exchange of view and experiences 
as regards challenging situations as well as the best practices and methods to deal with such 
situations. In order to obtain more extensive background knowledge on the subject in view of 
possible  future  developments  a  number  of  without  commitment  alternative  scenarios  to  the 
current  eligibility  rules  were  analysed  as  well.  The  Commission  services  elaborated  a 
discussion paper resuming the main issues arising from the discussions. It appeared that the 
challenges  were  of  a  limited  character  and  the  best  practices  to  deal  with  these  challenges 
were identified. 

During the year 2010, the Commission services have continued working in close cooperation 
with Member States to ensure the correct application of the rules governing specific support 
(Articles 68 to 72 of Regulation (EC) No 73/2009). The Commission services examined new 
measures  notified  by  01/08/2010  by  two  Member  Sates  to  be  implemented  from  2011  and 
these  services  sent  comments  to  them  in  order  to  ensure  a  correct  application  of  the  EU 
legislation,  in  particular  as  far  as  potential  overlapping  with  supports  under  other  CAP 
instruments and consistency with CAP measures were concerned. 

Cross compliance 

Regarding cross compliance the work undertaken during 2010 concerned the follow-up of the 
exercise  of  simplification  of  the  system  of  management  and  control  started  in  2009.  On  the 
bases  of  the  simplification  proposals  made  by  Member  States  the  remaining  proposals  have 
been transformed into legislative or quasi-legislative. In this respect a first set of amendments 
of  Commission  Regulation  (EC)  No  1122/2009102  has  been  drafted  in  order  to  improve 
controls  and  sanction  rules  as  well  as  to  adapt  the  system  of  maintenance  of  permanent 
pasture  to  better  reflect  the  reality.  A  second  set  of  amendments  of  the  same  Commission 
Regulation  has  been  finalised  early  in  2010  in  the  Management  Committee  for  Direct 
Payments in order to better take into account the certification schemes in the control system 
and to better make use of specific control systems. Certain simplification initiatives concern 
working documents which have been modified accordingly. Finally simplification proposals 
concerning  Council  Regulations  (EC)  N°73/2009  and  1698/2005  were  dealt  with  under  the 
Lisbon Treaty procedures in the course of 2010. 

(c) Rural development 

102 

Commission Regulation (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the 
implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and 
the integrated administration and control system, under the direct support schemes for farmers provided 
for  that  Regulation,  as  well  as  for  the  implementation  of  Council  Regulation  (EC)  No 1234/2007  as 
regards cross-compliance under the support scheme provided for the wine sector. 

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The  main  risk  factors  identified  in  the  rural  development  sector  relate  to  error  rates.  The 
control statistics reported by the Member States for rural development measures under Axis 2 
in 2009 show an error rate significantly above the materiality threshold presently used by the 
European Court of Auditors (2%). 

All of the 90 Rural Development Programmes are up and running. However, there were been 
substantial delays in the implementation of certain measures in a number of programmes. The 
rate of budget implementation varies between Member States, the four thematic Axes of the 
policy, as well as between different measures within the Axes. By the end of 2010, Member 
States have implemented between 23% and 58% of their allocated EAFRD funds (including 
advance  payments).  The  expenditure  declared  by  the  Member  States  so  far  focuses  on 
measures related to improving the environment and the countryside. The differences in budget 
implementation between different measures clearly show that investment measures (Axis 1, 3, 
and  Leader)  are  slower  to  get  started  than  area  or  animal-related  payments.  Leader,  in 
particular,  has  experienced  a  slow  start,  but  the  implementation  has  accelerated  in  2010. 
Otherwise, the experience is not enough to base clear conclusions on the possible problems. 

(d) Quality policy 

Quality 

EU agricultural product quality legislation constitutes a fairly stable acquis characterised by a 
globally satisfactory situation.  

The  reflection  process  leading  to  the  2009  Communication  and  the  following  impact 
assessment  exercise  showed,  however,  the  need  for  enhancing  the  overall  coherence  of  the 
food quality policy. Simplification and streamlining of existing EU quality schemes were also 
considered necessary to improve the schemes’ take up and visibility in the market place.  

The Quality package adopted in December 2010 intends to provide solutions to these needs. 

Organic 

The overall application of the organic production rules may be considered as stabilised and on 
the  whole  satisfactory.  Legislation  concerning  the  new  EU  organic  logo  was  successfully 
introduced  (see  above).  With  regard  to  organic  wine,  the  Commission  launched  the 
discussions  within  the  Standing  Committee  for  Organic  Farming,  the  European  Parliament 
and stakeholders.  

(e) Technical standards directive (Directive 98/34/EC) 

Following the information available to the Commission the functioning of Directive 98/34/EC 
in  the  agricultural  sector  appears  to  be  satisfactory.  In  2009  there  were,  for  example,  no 
infringement  procedures  launched  against  the  Member  States  for  not  following  detailed 

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opinions. 

4.3. 

Evaluation results - Priorities and actions planed 2011 

(a) Legislative and management priorities and action programming 2011 

General comments 

The  main  priority  as  regards  legislative  activity  in  the  agricultural  sector  will  be  the  legal 
drafting  of  the  proposals  required  for  the  adoption  and  implementation  of  the  new  CAP 
reform.  The  Commission,  after  extensive  consultation  of  the  stakeholders  will  prepare 
legislative  proposals  to  be  presented  in  2011.  These  will  follow  the  ordinary  legislative 
procedure  applied  for  the  first  time  to  a  reform  of  the  CAP.  This  reform  should  enter  into 
force in 2014.  

One  of  the  other  main  priorities  for  the  Commission  as  regards  legislative  activity  in  the 
agricultural sector will still be to implement the important changes introduced by the Treaty 
on European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) 
and  in  particular  the  extension  of  the  ordinary  legislative  procedure  (co-decision)  to 
agriculture and the adoption of new  rules  on  the Commission's delegated and implementing 
powers  (Comitology).  The  alignment  process  of  the  CAP  legislation  to  the  new  legal  bases 
resulting  from  Lisbon  Treaty  will  be  continued:  the  aligned  legal  proposals  adopted  by  the 
Commission in 2010 will be dealt with by the Council and Parliament in 2011. Furthermore, 
Commission will adopt the legal proposals for the alignment of the legal acts of the CAP not 
included by the proposals adopted in 2010.  

Market instruments 

Besides  the  ongoing  pursuit  of  legal  and  operational  simplification,  the  Commission  will 
continue  to  work  on  the  improvement  of  the  acquis  in  order  to  be  ready  to  adapt  to  the 
challenges it faces notably regarding the animal products sector where it will proceed to the 
follow up of the responses to the recommendations of the High Level Experts Group for Milk 
(report  delivered  on  June  15,  2010  amid  the  Council  Presidency  Conclusion  of  the 
27.09.2010). The Commission's legislative proposals for the milk package were adopted on 9 
December 2010. The adoption by the EP and the Council is expected during 2011. 

As regards wine, reports to be delivered by the Commission to the Council and the European 
Parliament one shall be delivered in 2011 relating to wine promotion measures, and a second 
one will be delivered in 2012 relating to the wine implementation of the reform of 2008. In 
addition, an external evaluation of the wine sector will be carried out in 2011 and discussions 
will  be  pursued  to  secure  a  Council  mandate  to  negotiate  membership  of  the  OIV  for  the 
European Union and to successfully complete those negotiations. 

Many product specifications on wine PDO/PGI and spirit drinks GI will have to be examined 
in accordance with EU law. Around 1800 files are expected to be received and then analysed. 

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On  alcohol,  the  discussion  on  the  Combined  Nomenclature  should  be  opened.  Spirit  drinks 
regulation  will  need  to  be  modified  for  the  sake  of  a  better  legal  clarity.  The  working 
document  on  compound  term  could  be  legally  adopted.  The  codification/recast  of  Council 
Regulation  (EEC)  No 1601/91  laying  down  general  rules  on  the  definition;  description  and 
presentation of aromatized wines, aromatized wine based drinks and aromatized wine product 
cocktails was not finally adopted in the co-decision procedure. The outcome was that a new 
proposal  had  to  be  prepared  by  the  Commission.  This  proposal  is  scheduled  in  2011. 
Legislation  on  seeds  could  be  revised  in  2011.  Continuation  of  the  effort  to  achieve 
simplification by eliminating the registration of hops contracts will require a modification to 
the Council CMO Regulation (EC) No 1234/2007103. 

In  the  fruit  and  vegetable  sector,  in  order  to  ensure  the  smooth  functioning  of  the  acquis,  a 
recast of the implementing rules (Commission Regulation No1580/2007) which incorporates 
interpretative  notes  and  some  technical  adjustments  was  launched.  Several  issues  are 
addressed  such  as  price-reporting,  the  new  crisis  prevention  and  management  tools  for 
producer  organisations  and  the  annual  reporting  of  sector  specific  data  by  Member  States. 
Adoption of the recast is scheduled for Spring/Summer 2011. 

As  regards  horizontal  rules,  revision  and  introduction  of  operational  simplifications  of 
existing horizontal Regulations will be initiated in the field of tariff rate quotas, licences, and 
export refunds / trade mechanisms. 

The financial and economic situation in Member States and globally are having an impact on 
agricultural products. An additional priority for the moment is to monitor the market situation 
for  each  of  the  products  concerned.  Price  volatility  requires  close  market  monitoring  and 
quick reactions by using the existing market measures as reviewed under the "Health check". 

Direct payments and cross compliance 

A priority for 2011 will be to participate in the ordinary legislative procedure in order for the 
Council and the European Parliament to adopt the Commission proposal amending Regulation 
(EC) No73/2009. 

The main task in 2011 will be the preparation of the legislative proposal for the new Direct 
payments scheme. 

Rural development 

The  main  task  in  2011  will  be  the  preparation  of  the  legislative  proposals  for  the  Rural 
Development  Policy  after  2013,  including  an  adapted  Common  Monitoring  and  Evaluation 
Framework (CMEF) and the Common Strategic Framework (CSF) with the structural funds. 
Having already started in 2010, the impact assessment process will be completed during 2011. 

103 

Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of 
Council  Regulations  (EC)  No 2200/96,  (EC)  No 2201/96  and  (EC)  No 1182/2007  in  the  fruit  and 
vegetable sector , OJ L 350, 31.12.2007, p. 1–98. 

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Drafting and discussing of corresponding legal texts will constitute a major part of the work 
relating to future Rural Development Policy for the year.  

The  Commission,  together  with  Member  States,  will  also  further  continue  the  process  of 
reducing  the  error  rates  in  rural  development.  This  will  be  done  by  identifying  and  sharing 
best practises regarding control issues, expanding audit activity, enhancing collaboration with 
geographical rural development units and by improving the verifiability and controllability of 
rural development measures in general and those under Axis 2 in particular.  

Quality policy 

Quality 

The adoption of the Quality package on agricultural product quality policy adopted in by the 
Commission  in  December  2010  has  opened  the  way  to  inter-institutional  discussions  on  the 
content of the EU initiative on food quality. The presentation of the legislative proposal in the 
Council and the Parliament, within the context of the ordinary legislative procedure, will be at 
the centre of Commission’s efforts to reinforce and improve the EU food quality policy. 

Whilst  progressing  through  the  legislative  procedure,  the  ongoing  activities  to  ensure  an 
efficient application of the Regulations in force will continue.  

Building on continuous improvements in scrutinizing techniques applied to applications, the 
efforts  made  in  accelerating  the  rate  of  reaching  the  final  decision  on  applications  -  while 
ensuring the respect of sectoral EU legislation - will continue.  

The  scrutiny  of  third-country  applications  will  contribute  to  the  finalisation  of  international 
agreements on the protection of geographical indications.  

The  assessment  of  the  Food  Quality  legislations  of  candidate  countries  and  associated 
countries against EU legislation will also be carried out. 

Organic 

According to the provisions of the organic farming legislation, the Commission will present in 
2011 a report to the European Parliament and to the Council reviewing the experience gained 
from the application of the organic farming legislation. 

The Commission hopes that an agreement will be reached between the European Parliament 
and the Council on its proposal to align the organic farming legislation with the provisions of 
the Lisbon Treaty. 

With regard to imports from third countries, the Commission intends to publish the first list of 
control bodies recognised for the purpose of equivalence. 

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Clearance of accounts 

For 2011, the annual work plan foresees 119 conformity audits with missions and several desk 
checks of which the number is estimated to be around 20 based on last years' experience. For 
the conformity audits, the work program is based on a central risk analysis in which all the 
Directorate auditors were actively involved. 

32  audits  are  planned  of  various  market  measures  including  the  sugar  restructuring  fund, 
Article 69/68, wine, POSEI and fruit and vegetable operational funds. 

24 audits will take place for area aids and entitlements of which 2 each to EL, BG, RO and PT 
of which the latter 3 have action plans in place for the IACS. 10 cross-compliance audits will 
take place. For non area coupled aids, 9 audits will be carried out covering animal premium 
schemes and Article 69. 

44 audits will be carried out on Rural Development measures of which 12 cover Axes 1 and 3 
and measures with flat rate support and 16 cover Axis 2 focusing on the "Agro-environment" 
and  "Natural  Handicaps"  measures,  additional  4  audits  concern  the  SAPARD  programme. 
Furthermore there will be 12 ex-post audits on rural development expenditure regarding the 
2000-2006 programming period for EAGGF-Guidance.  

(b) Enforcement priorities 

As  already  mentioned,  in  the  area  of  agriculture  and  rural  development,  monitoring  the 
application  of  EU  law  under  the  Article  258  TFEU  (ex  Article  226  TEC)  procedure 
concentrates on two main objectives: removing barriers to the free movement of agricultural 
products  and  ensuring  that  the  more  specific  mechanisms  of  agricultural  regulations  are 
applied effectively and correctly. 

Regarding  recourse  to  the  infringement  procedure,  priority  will  be  granted  to  cases  which 
raise  issues  concerning  the  compatibility  of  Member  States'  legislative,  regulatory  or 
administrative  measures  with  EU  agricultural  rules  and  to  cases  where  Member  States 
concerned  refrain  from  applying  the  common  rules  referred  to  above,  thus  jeopardizing  the 
effectiveness  of  important  mechanisms  of  the  common  agricultural  policy,  particularly 
regarding the 1st pillar. 

For the year 2011, the Commission will in particular be vigilant in pursuing infringements of 
the type described in the previous paragraph challenging the application of the CMO's reform 
in the wine sector and those which would affect the application of the direct payment regime , 
and in particular "cross compliance". 

4.4. 

Summary  

Taking  into  account  the  significant  volume  of  agricultural  law  and  its  more  than  50  years 
history,  it  may  be  considered  as  a  quite  stable  acquis  that,  on  the  one  hand,  is  subject  to 
frequent  technical  modifications  under  the  Comitology  procedure,  and  on  the  other  hand, 
undergoes, on a regular basis, much more profound modifications. The last one of these was 
the 2003 reform that was subject to the "Health check" process.  

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The policy is divided into two pillars: the first pillar consists of a framework for supporting 
the  income  of  farmers  through  the  payment  of  direct  aid  and  a  system  for  managing  and 
supporting  agricultural  markets.  The  second  pillar  of  the  CAP  provides  a  framework  to 
support the development of rural areas of the EU. 

The  implementation  of  the  CAP  is  a  joint  responsibility  of  the  Member  States  and  the 
Commission,  known  as  shared  management  under  which 
for 
implementation at the level of the final beneficiaries has been delegated to the Member States. 
In the agricultural sector, preparatory working contacts between experts, review of problems 
arising  and  multilateral  and/or  bilateral  exchange  of  information  all  help  to  ensure  correct 
implementation.  Furthermore,  the  Management  Committees,  which  meet  regularly,  acts  not 
only as a body delivering its opinion on legal proposals for Commission regulations, but also 
serves  as  a  privileged  forum  for  the  exchange  of  information  and  best  practice  between  the 
Member States and the Commission,  thus  playing  a  key  role  in  preventing  implementations 
problems.  

responsibility 

the 

The detailed overview of the implementation of EU law in the agricultural sector shows that it 
can generally be considered as satisfactory while any problem with the implementation of the 
rules in the Member States is closely followed through the audit mechanisms and clearance of 
accounts procedure which acts as a direct incentive to Member States to comply with EU law.  

Even so, the agricultural acquis is regularly subject to reforms and/or modifications in order 
to adapt the CAP to its new challenges. By Commission Communication of 18/11/2010 on the 
"Common  Agricultural  Policy  towards  2020.  Meeting  the  food,  natural  resources  and 
territorial challenges of the future", a new process of reform has now been launched. In 2010, 
the  main  challenges  that  prompted  action  from  the  Commission  as  regards  this  acquis 
consisted  of  the  alignment  process  of  the  CAP  legislation  to  the  new  legal  bases  resulting 
from Lisbon Treaty. This process will be carried on: the aligned legal proposals adopted by 
the  Commission  in  2010  will  be  dealt  with  by  the  Council  and  Parliament  in  2011. 
Furthermore, Commission will adopt the legal proposals for the alignment of the legal acts of 
the CAP not included in the proposals adopted in 2010.  

Nevertheless deficiencies and infringements in the application of EU law by Member States in 
the agricultural sector occur and can be dealt with through infringement proceedings. The use 
of  these  proceedings  concentrates  on  two  main  objectives:  removing  barriers  to  the  free 
movement  of  agricultural  products  and  ensuring  that  the  more  specific  mechanisms  of 
agricultural regulations are applied effectively and correctly. 

Regarding  the  recourse  to  infringement  proceedings,  priority  will  be  given  to  cases  which 
raise  issues  concerning  the  compatibility  of  Member  States'  legislative,  regulatory  or 
administrative  measures  with  EU  agricultural  rules  and  to  cases  where  the  Member  States 
concerned refrain from applying these common rules, thereby jeopardizing the effectiveness 
of  important  mechanisms  of  the  common  agricultural  policy,  particularly  regarding  the  1st 
pillar. 

For the year 2011, the Commission will in particular be vigilant in pursuing infringements of 
the type described in the previous paragraph challenging the application of recently reformed 
important CMO in the wine sectors and those which would affect the application of the direct 
payment regime, and in particular "cross compliance". 

In  the  agricultural  sector,  the  Commission  will  continue  to  make  use  of  the  clearance  of 

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accounts  procedure  to  convince  Member  States  to  adapt  their  management  and  control 
systems  in  the  event  that  an  infringement  could  be  detected  through  conformity  audit 
mechanisms. 

5. 

ENERGY 

The EU acquis in the field of energy has a daily impact on citizens and businesses in Europe. 
The Commission's services ensure that this legislation is properly applied and enforced so as 
to guarantee that citizens fully benefit from the existing legal framework, competitiveness is 
encouraged and a fully functioning internal energy market becomes a reality. Priorities focus 
on actions ensuring secure and competitive energy supplies and having a significant impact on 
the fight against climate change.  

To safeguard the effective implementation of the acquis in 2010, the Commission's services 
continued  to  apply  a  combination  of  infringement  actions  and  preventive  mechanisms,  such 
as,  for  example,  guidance  to  the  Member  States  on  the  interpretation  and  application  of  the 
legislation. Efforts to foster cooperation with the Member States and support national action 
persisted.  Infringements  proceedings  remained  a  crucial  tool  for  enforcing  the  existing 
framework.  Cases  of  non-communication  of  national  transposition  measures  were  swiftly 
dealt  with  by  launching  systematically  infringement  proceedings  against  the  respective 
Member  States.  Identified  non-conformity  cases  have  been  tackled  through  initiating 
infringement action, based on developed and consistently applied prioritisation criteria.  

In parallel to enforcement measures, considerable work towards streamlining and advancing 
the regulatory framework by adopting new legislation was carried out. New legislative actions 
came as a reaction to identified limitations of the existing legal  framework or global events 
calling for coherent reply at EU level, e.g. the Deepwater Horizon. 

5.1. 

ENERGY - INTERNAL ELECTRICITY AND GAS MARKET 

5.1.1.  Current position 

5.1.1.1.  General introduction  

The completion of the internal market for electricity and gas enabling European companies to 
compete Europe-wide is one of the Commission's priority areas of its strategy for sustainable, 
competitive  and  secure  energy.  The  second  regulatory  package  adopted  in  2003  introduced 
important  changes  in  the  internal  energy  market  such  as  legal  unbundling  of  TSOs,  the 
preparation  of  the  full  opening  of  the  market  and  the  obligation  of  installing  national 
regulators  and  reinforcing  their  powers.  Several  Member  States,  however,  so  far  failed  to 
properly implement it. The package comprised Directives 2003/54/EC and 2003/55/EC of 26 
June  2003  concerning  common  rules  for  the  internal  market  in  electricity  and  gas, 
respectively  and  Regulation  1228/2003  of  26  June  2003,  on  conditions  for  access  to  the 
network for cross-border exchanges in electricity. A similar regulation was adopted for gas at 
a later stage, i.e. Regulation 1775/2005 of 28 September 2005 on conditions for access to the 
natural gas transmission networks.  

The third package of legislative measures adopted in 2009 aims at responding to most of the 
problems  identified  in  the  failure  of  application  of  the  second  package.  A  demonstration  of 
Member  States'  commitment  to  the  internal  energy  market  will  be  the  timely  and  correct 

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implementation of this third package into national law. The Commission will assist Member 
States  in  implementing  the  third  package  and  will  continue  to  pursue  the  full  and  correct 
implementation  of  the  second  package,  including  through  formal  infringement  procedures. 
The  main  aim  of  these  efforts  is  to  develop  the  internal  energy  market  and  to  favour 
competition on the market.  

Directives 2009/72/EC and 2009/73/EC, which form part of the third internal energy market 
package,  are  already  in  force  and  should  be  transposed  by  the  Member  States  by  3  March 
2011.  Regulation  (EC)  713/2009  establishing  an  Agency  for  the  Cooperation  of  Energy 
Regulators  (ACER),  Regulation  (EC)  714/2009  on  cross-border  exchange  in  electricity  and 
Regulation (EC) 715/2009 on cross-border network access in gas are fully applicable as of 3 
March 2011, except the organisational provisions on ACER which became applicable with the 
entry into force on 3 September 2009.  

5.1.1.2.  Report of work done in 2010 

Enquiries, problems and complaints 

Several  complaints  were  received  in  2010.  Problems  reported  mainly  refer  to  the  supplier 
switching  processes,  price  issues  and  the  monopolistic  structure  of  some  national  markets, 
malfunctioning  of cross-border trade and network  access in the electricity sector. In the gas 
sector,  problems  were  reported  as  regards  the  access  to  the  gas  network  and  generally  the 
malfunctioning of the gas market.  

One of the issues raised by several complaints is the malfunctioning of the supplier switching 
processes and the fact that companies do not pass on reductions of wholesale market prices to 
customers. Therefore, overbilling might happen. This is still due to a lack of competition on 
energy markets, in particular where a major incumbent has a dominant position on the market. 

The  third  legislative  package  has  been  adopted  with  the  aim  to,  inter  alia,  ensure  real  and 
effective  choice  of  supplier  to  the  benefit  of  all  EU  consumers.  It  places  consumer  choice, 
competitive  prices  and  security  of  supply  at  the  centre  of  its  approach.  The  proper 
implementation of the legislation is thus of great importance for safeguarding the interests of 
consumers in the gas and electricity markets. 

Management of infringements 

In  order  to  complete  the  internal  electricity  and  gas  market  and  prepare  the  ground  for  the 
implementation  of  the  third  legislative  package,  it  is  essential  that  the  rules  of  the  second 
legislative package are implemented correctly. Therefore, the European Commission issued in 
June 2010 a reasoned opinion against 19 Member States for electricity and 16 Member States 
for  gas  in  the  infringement  cases  which  were  opened  in  June  2009.  The  key  violations 
identified  remained  the  same:  lack  of  transparency,  insufficient  coordination  efforts  by 
transmission system operators to make maximum interconnection capacity available, absence 
of  regional  cooperation,  lack  of  enforcement  action  by  the  competent  authorities  in  the 
Member States and lack of adequate dispute settlement procedures for consumers.  

The Court of Justice of the European Union gave its final judgment on a case in relation to 
regulated prices on the Italian gas market (Federutility case C-265/08, 20.4.2010). The Court 
stated that regulated prices can be in line with the Gas Directive provided that they are strictly 
proportionate and limited in time. The infringement proceedings already opened against some 

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Member  States  still  applying  regulated  prices  for  gas  and  electricity  are  being  reassessed  in 
the light of this case law and will be continued where necessary.  

Petitions 

During 2010, 4 petitions were dealt with raising issues related to the internal market for gas 
and electricity. 

New legislation 

Following the adoption of the third legislative package in 2009, less new legislation followed 
in  2010.  However,  the  European  Commission  adopted  on  10  November  2010  a  set  of  new 
transparency rules for the European gas market(104). In relation with cross-border exchanges 
in electricity, the European Commission adopted also guidelines on inter-transmission system 
operator compensation (ITC) and on transmission charging105.  

In  addition,  the  European  Commission  adopted  on  8th  December  2010  its  Proposal  for  a 
Regulation  on  Energy  Market  Integrity  and  Transparency  (COM(2010)726)  in  order  to 
prevent market manipulation and insider trading on energy markets. The draft Regulation was 
adopted under Article 194(2) TFEU, its final adoption by co-legislators is expected for 2011. 

As regards the security of supply for gas, the prevention and crisis response mechanisms were 
considerably  strengthened  through  the  adoption  of  Regulation  (EC)  No  994/2010  of  the 
European  Parliament  and  of  the  Council  of  20  October  2010  concerning  measures  to 
safeguard  security  of  gas  supply  and  repealing  Council  Directive  2004/67/EC(106)  which 
entered  into  force  on  2nd  December  2010.  The  Commission  started  immediately  to  work  in 
close  cooperation  with  Member  States  on  the  implementation  of  the  new  Regulation.  First 
steps  have  already  been  taken  to  speed  up  the  implementation,  notably  with  regard  to  the 
investments  for  enabling  bi-directional  capacity  in  the  cross  border  interconnections.  In  this 
regard,  the  Commission  together  with  the  European  Network  of  Transmission  System 
Operations for gas (ENTSOG) is to prepare an inventory to take stock of the situation and to 
examine  the  capacity  needed.  To  assist  Member  States  in  their  implementation,  the  issue  is 
discussed as a permanent point in the agenda of the meetings of the Gas Coordination Group 
(GCG). In addition, the Commission closely monitors the steps taken by the Member States to 
fulfil the provisions included in the Regulation and reports to the GCG. The Group is also a 
useful  platform  to  exchange  best  practices  in  the  preparation  of  the  risk  assessment  and  the 
Emergency and Preventive Action Plans.  

104 

105 

106 

Commission Decision of 10 November 2010 amending Chapter 3 of Annex 1 to Regulation (EC) No 
715/2009  of  the  European  Parliament  and  of  the  Council  on  conditions  for  access  to  the  natural  gas 
transmission networks (OJ L 293, 11.11.2010, p. 67). 
Commission Regulation (EU) No 774/2010 of 2 September 2010 on laying down guidelines relating to 
inter-transmission  system  operator  compensation  and  a  common  regulatory  approach  to  transmission 
charging (OJ L 233, 3.9.2010, p. 1); Commission Regulation (EU) No 838/2010 of 23 September 2010 
on  laying  down  guidelines  relating  to  the  inter-transmission  system  operator  compensation  and  a 
common regulatory approach to transmission charging (OJ L 250, 24.9.2010, p. 5). 
OJ L 295, 12.11.2010, p.1. 

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5.1.2.  Evaluation of the current position 

Following the adoption of the third legislative package, first steps were taken during 2010 in 
relation to the implementation of this legislation in order not to loose 18 months until its full 
application as this could be detrimental to the development of the internal energy market. The 
European  Regulators  Group  for  Electricity  and  Gas  (ERGEG)  was  tasked  –  for  the  interim 
period – to develop draft framework guidelines on several issues in gas and electricity. These 
will  provide  the  basis  for  the  development  of  network  codes  by  the  ENTSOs,  which  could 
then be made legally binding and would allow the internal market to be completed. In parallel, 
the organs of the new Agency, i.e. the Administrative Board, the Board of Regulators and the 
Director,  were  installed  and  took  up  their  functions.  First  staff  members  were  recruited  and 
the necessary agreements were made with the host country Slovenia to enable ACER to start 
full operation on 3 March 2011. The Commission is also assisting the Member States in the 
transposition of the third legislative package. 

Regional  initiatives  were  again  an  important  tool  for  making  progress  towards  the  internal 
energy market. Focus was on improving congestion management allocation  and calculation, 
in  particular  in  electricity  where  several  market  coupling  projects  were  implemented, 
improving  and  harmonising  transparency,  improving  security  of  supply  in  the  gas  sector, 
access to pipeline capacity and other issues. In order to further improve the functioning of the 
regional  initiatives,  the  European  Commission  launched  a  public  consultation  to  get  input 
from  the  market  where  adaptations  are  needed  in  order  to  enhance  the  efficiency  and 
effectiveness of the regional markets for them to deliver an integrated energy market by 2014. 
Although  the  energy  markets  are  developing  and  become  more  integrated  and  more 
competitive, progress is still slow and the full potential of liberalisation has still to be realised. 
Therefore,  it  was  also  important  to  progress  with  the  work  foreseen  in  the  third  package 
before  it  had  to  be  legally  applied.  A  lot  of  work  has  been  done  during  this  interim  period 
already on the so-called framework guidelines and network codes. In order to partially remit 
this slow progress, the European Commission continued the infringement procedures started 
in 2009 in relation to the second legislative package. This is necessary to ensure the correct 
implementation of EU legislation at national level, in particular as regards the electricity and 
gas Regulations and the Annexes to the electricity and gas Directives.  

5.1.3.  Evaluation results  

Infringement  proceedings  initiated  in  the  gas  and  electricity  sector  have  been  successfully 
carried out and will be continued in 2011. As a consequence of the infringement procedures 
launched by the Commission in 2009, some Member States finally transposed the directives 
properly  into  their  national  laws.  Consequently,  for  these  countries  the  infringement 
procedures were closed. 

The  third  energy  package  responds  to  most  of  the  problems  identified  in  the  failure  of 
application  of  the  second  package.  The  European  Commission  will  closely  follow  the 
implementation of the third energy package by the Member States and will assist the Member 
States  in  order  to  ensure  timely  and  proper  implementation  of  the  package.  To  support  this 
process,  the  Commission  has  published  interpretative  notes  on  unbundling,  national 

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regulatory authorities (NRAs), retail issues and gas storage107. Where necessary, infringement 
procedures will be launched. 

5.1.4.  Sector summary 

While the situation in more mature markets is demonstrating the potential benefits of energy 
market liberalisation, there are still a number of areas and Member States where significant 
obstacles  to  the  efficient  functioning  of  the  electricity  and  gas  market  persist.  The  need  for 
new legislation was evident and led to the adoption of the third energy package. 

The  Commission's  efforts  concentrated  and  will  continue  concentrating  on  an  efficient 
implementation of the existing and new legislation in both, the electricity and gas sector, by 
combining the following actions: 

-  Remedial  action:  Continue  to  pursue  infringement  procedures  so  as  to  ensure  proper 
implementation  of  the  electricity  and  gas  legislation  in  the  main  areas  where  failures  were 
registered  such  as:  penalties,  transparency  and  capacity  allocation  of  networks,  third  party 
access and consumer protection, all in both sectors. This action will continue in 2011 for both 
sectors. 

- Preventive action: In the context of the adoption of the third energy package, the services of 
the Commission will assist the Member States in the implementation of the legislation. 

5.2. 

ENERGY – Coal and oil 

5.2.1.  Current position 

5.2.1.1.  General introduction 

With  regard  to  the  legislation  in  the  domains  of  coal  and  oil,  the  largest  part  of  the 
Commission's  work  in  EU  law  management  in  2010  consisted  in  facing  the  challenge  to 
reinforce  the  safety  of  offshore  oil  and  gas  activities,  which  led  to  the  adoption  of  a 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council 
(COM(2010) 560 final; 12.10.2010). 

The  main  relevant  legislation  for  the  oil  sector  is  Council  Directive  2009/119/EC  (Council 
Directive  2009/119/EC  of  14  September  2009  imposing  an  obligation  on  Member  States  to 
maintain minimum stocks of crude oil and/or petroleum products; OJ L 265, 9.10.2009, p.9). 

Although  Directive  2009/119/EC  repeals  Directive  73/238/EEC,  Directive  2006/67/EC  and 
Decision  68/416/EEC,  it  does  so  only  with  effect  from  31  December  2012.  Therefore 
currently applicable legislation still include Council Directive 2006/67/EC (Council Directive 
2006/67/EC of 24 July 2006 imposing an obligation on Member States to maintain minimum 
stocks of crude oil and/or petroleum products – Codified version; OJ L 217, 8.8.2006, p 8), 
Council  Directive  73/238/EEC  of  24  July  1973  on  measures  to  mitigate  the  effects  of 
difficulties in the supply of crude oil and petroleum products (OJ L 228, 16.08.1973, p 1 -2) 
as  well  as  Council  Decision  68/416/EEC  of  20  December  1968  on  the  conclusion  and 
implementation of individual agreements between Governments relating to the obligation of 

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http://ec.europa.eu/energy/gas_electricity/interpretative_notes/interpretative_note_en.htm  

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Member  States  to  maintain  minimum  stocks  of  crude  oil  and  /or  petroleum  products  (OJ  L 
308, 23.12.1968, p.19). 

Directive 94/22/EC (Directive 94/22/EC of the European Parliament and of the Council of 30 
May  1994  on  the  conditions  for  granting  and  using  authorizations  for  the  prospection, 
exploration and production of hydrocarbons; OJ L 164, 30.6.1994, p 3) also continued to form 
part of the acquis in the sector. 

5.2.1.2.  Report of work done in 2010 

Infringements - complaints 

With regard to the application of Directive 94/22/EC, the Commission's services continued to 
welcome  publication  demands  received  from  Member  States  but  also  followed  the 
implementation  of  those  provisions  by  the  Member  States.  Further  procedural  steps 
concerning  two  infringements  procedures  were  executed  in  2010.  Namely,  infringement 
proceedings  opened  against  Belgium  for  failure  to comply with its obligation  to duly notify 
competent authorities and for other grievances were closed as finally the Member State met 
the requirements set out by the Commission. An infringement case against Poland concerning 
national procedures for granting rights over oil and gas resources, in which the Commission 
sent a reasoned opinion to the Polish authorities in 2008, was referred to the Court of Justice 
of  the  European  Union.  Although  the  Commission  continued  contacts  with  the  Polish 
authorities  in  the  course  of  2010,  no  effective  progress  without  resort  to  litigation  could  be 
reached. 

New legislation 

Directive  2009/119/EC  foresees  a  transition  period  until  31/12/2012  by  which  date  all 
Member  States  shall  have  to  ensure  compliance  with  the  Directive  and  the  currently 
applicable  Directive  2006/67  will  be  repealed.  Consequently  and  with  respect  to  oil,  the 
activities in 2010 included active dialogues with Member States. 

As the new system of emergency oil stocks brings EU rules much closer to IEA practices and 
provides better assurances of the availability and verifiability of the stocks, the Commission's 
services ensured that the necessary meetings or contacts with the services of IEA as well as 
with those of Eurostat took place. 

The  seriousness  of  the  Deepwater  Horizon  accident  led  the  Commission  to  launch  in  May 
2010  an  appraisal  of  safety  in  offshore  exploration  and  production  activities  in  European 
waters. On the basis of a review of applicable legislation as well as of consultations with both 
industry and competent authorities, the Commission identified in July five main areas where 
action is needed and adopted on 12th October 2010 the Communication "Facing the challenge 
of the safety of offshore oil and gas activities" (COM(2010) 560 final). 

Tasks effected in relation to coal  

As regards coal, regular monitoring of the coal sector and market continued as foreseen in the 
applicable  provisions  (namely,  Regulation  (EC)  405/2003).  Information  on  import  price 
indexes as well as coal import, production and consumption volumes were collected, analysed 
and  discussed  with  stakeholders  through  the  National  Coal  Experts  committee  and  in  the 
annual Coal Dialogue. The half-yearly price indexes and annual market report were published 

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in 2010 as foreseen108. 

5.2.2.  Evaluation of the current position 

Work has continued on amending the current oil stocks reporting procedures and instruments 
to provide for the use of a single reporting tool by the end of the transition period. The new 
reporting  will  be  based  on  the  Monthly  Oil  Stock  (MOS)  questionnaire  which  needs  some 
update/streamlining in order to be suitable for the purposes of the new Directive, including the 
reporting  of  commercial  stocks.  In  2010,  Eurostat  and  Directorate-General  for  Energy 
prepared a detailed proposal including the tables and definitions which is now discussed with 
the  IEA.  The  possibility  of  developing  an  electronic  tool  is  also  envisaged  to  allow  the 
consultation of the Coordination Group by electronic means, without convening a meeting in 
Brussels. 

Furthermore,  a  specific  external  study  of  the  feasibility  of  increasing  the  frequency  of 
commercial  oil  stocks  reporting  to  weekly  has  come  to  its  end  in  2010.  The  study  found 
limited and mostly unquantifiable benefits; no evidence for reduced volatility or lower prices 
was found. 

In oil (or gas) upstream, in the frame of the assistance given to Member States in the course of 
their  implementation  of  Directive  94/22,  some 46  demands  for  publications  of  notices  from 
Member States were dealt with in 2010 under the provisions of the Directive.  

Concerning offshore oil activities, the European Parliament has issued a resolution calling on 
the Commission to bring forward a comprehensive legal framework ensuring uniformly high 
safety  standards  apply  across  the  EU  and  third  countries  and  including  proposals  covering 
inter alia accident prevention, disaster response and liability (Resolution on EU action on oil 
exploration and extraction in Europe adopted on 7 October 2010).  

In  its  communication  of  12th  October  2010,  the  Commission  presented  some  initial  steps 
towards such objective: 

Namely,  the  Commission  proposes  to  work  towards  a  revised  and  more  coherent  legal 
framework ensuring  the  application  of state-of-the-art practices across the whole of the EU. 
The main requirements for the licensing of hydrocarbon exploration and production need to 
be defined at EU level. The existing environmental legislation, as well as the health and safety 
framework should also be reviewed, and the feasibility to apply EU product safety legislation 
to equipments used on mobile offshore units needs to be examined. Proposals to amend the 
Environmental  Liability  Directive  should  be  made  and  a  new  guidance  document  should 
address the applicability of the Waste Framework Directive to oil spills. The Commission also 
called upon the Member States to apply a precautionary approach in the licensing of complex 
operations and to assess the need to suspend such licensing, until the European safety regimes 
have  been  assessed  in  the  light  of  the  Deepwater  Horizon  accident.  The  EU's  intervention 
capacity for offshore accidents would need to be reinforced, and further actions will also need 
to be promoted at the levels of the industry, of the regulatory and supervisory authorities as 
well as of EU neighbours. 

108 

Commission Staff Working Document – The Market for solid fuels in the Community in 2008 and 
Estimates for 2009 (SEC(2010)996,24.8.2010); 
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The  Commission  also  announced  that  it  will  work  with  Member  States,  industry  and  other 
stakeholders  to  provide  the  public  with  easy  access  to  continuously  updated  information  on 
safety measures, risk management, contingency plans and company-specific statistics on key 
safety indicators. 

As  regards  coal,  Council  Regulation  (EC)  405/2003  has  expired  on  31  December  2010  as 
stipulated  in  its  Article  12.  The  average  coal  import  prices  for  the  2nd  half  of  2010  will 
therefore  be  the  last  information  published  on  the  topic  by  Directorate-General  for  Energy. 
Information  on  coal  production,  imports/exports  and  consumption  will  in  the  future  still  be 
available via Eurostat. 

Regulation (EC) 405/2003 had originally been agreed in parallel with the current State aid for 
coal Regulation which also expired on 31 December 2010. While drafting the proposal for a 
new  Regulation  on  State  aid  for  coal,  the  Commission's  services  have  analysed  the 
information  requirements  and  concluded  that  the  new  coal  State  aid  regime  will  no  longer 
necessitate the collection of data and elaboration of import price index up to then done on the 
basis  of  Regulation  (EC)  405/2003.  Furthermore,  according  to  the  reactions  received  to  a 
questionnaire  sent  to  Member  States'  coal  experts,  the  use  of  the  price  index  seems  to  have 
been rather limited in the coal sector. It has therefore been decided that maintaining such EU-
wide reporting requirements on coal importers and Member States would not be justified. 

5.2.3.  Evaluation results 

The Commission's resources will need to remain concentrated on the preparation and drafting 
of the package of measures to enhance offshore safety, as well as on the implementation of 
the new oil stocks legislation, both at EU level and at the level of Member States. 

In 2010 the Commission carried out intensive stakeholder dialogues and an assessment of the 
regulator and industry practices in the European offshore oil and gas sector and the legislative 
framework  applicable  to  the  prevention,  mitigation  and  liability  for  accidents  on  offshore 
installations.  The  issue  was  raised  also  during  dialogues  with  key  third  countries  such  as 
Norway.  The  review  of  EU  minimum  standards  for  occupational  health  and  safety, 
environmental liability, product safety, disaster response and  hydrocarbon licensing resulted 
in a list of topics where further action should be taken to improve legislation and bring about 
more coherent offshore safety practices across the EU. The structure of the 2011 package of 
measures  to  enhance  offshore  safety  is  likely  to  comprise  a  comprehensive  legislative 
proposal based on the best existing practices in Europe ,a proposal for the EU to become party 
to the Offshore Protocol to Barcelona Convention and the issuance by Directorate-General for 
Environment of guidelines on the application of the Waste Directive. 

Concerning oil stocks, the main tasks that will deserve attention and follow-up in 2011 will be 
as follows: 

•  The revised Monthly Oil Stock (MOS) questionnaire has to be finalised and agreed first by 
the IEA and then by Member States. Eurostat is planning to start the comitology procedure 
in order to amend the Energy Statistics Regulation in the second half of the year. 

•  The review of internal emergency procedures, given the more active and central role given 

by the new Directive to the Commission in case of supply disruptions. 

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•  Continuing  the  preparation  of  an  electronic  tool  to  allow  the  consultation  of  the 

Coordination Group by electronic means. 

•  Assisting Member States with the transposition of the Directive; a discussion workshop is 

envisaged to share experience and discuss questions. 

•  The  examination  of  methodologies  and  standards  for  reviewing  emergency  preparedness 

and stockholdings of/in Member States. 

5.2.4.  Sector summary 

The Commission continued its work related to the implementation of the oil stocks Directive 
which was adopted in 2009. In addition to assisting Member States, the Commission's efforts 
focused on the development of an oil stock reporting system which meets the requirements set 
in the Directive. In 2011, other aspects will be also addressed, including the preparation for its 
reinforced  role  in  the  coordination  of  emergency  procedures  and  the  reviews  of  emergency 
preparedness and stockholding of Member States. 

In the field of offshore safety, a review conducted following the Deepwater Horizon accident 
has  shown  that  the  regime  governing  the  offshore  oil  and  gas  activities  in  the  EU  is  very 
fragmented and leaves areas of legal uncertainty. Legislative action appears to be needed to 
ensure the spread of best practices across the EU and filling the identified gaps. Therefore, in 
2011  the  services  of  the  Commission  will  hold  further  consultations  with  stakeholders 
regarding proposed initiatives in view of tabling proposals for concrete measures. 

5.3. 

ENERGY - Renewable energy sources 

5.3.1.  Current position 

5.3.1.1.  General introduction 

Renewable energy is a key component of the EU energy strategy. Recognising that renewable 
energy  will  form  the  heart  of  any  future  low  carbon  energy  sector,  the  EU  introduced  a 
comprehensive and robust supportive legislative framework. 

Main pieces of EU acquis are: 

–  Directive  2001/77/EC  of  the  European  Parliament  and  of  the  Council  of  27  September 
2001  on  the  promotion  of  electricity  from  renewable  energy  sources  in  the  internal 
electricity market109 

–  Directive 2003/30/EC of the European Parliament and of the Council of 8 May 2003 on the 

promotion of the use of biofuels or other renewable fuels for transport110. 

–  Directive 2009/28/EC of the European Parliament and of the Council of 5 June 2009 on the 
promotion  of  the  use  of  energy  from  renewable  sources  and  amending  and  subsequently 
repealing Directives 2001/77/EC and 2003/30/EC111. 

109 
110 

OJ L 283, 27.10.2001, p. 33. 
OJ L 123, 17.5.2003, p. 42. 

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5.3.1.2.  Report on the work done in 2010 

All  existing  complaints  or  cases  launched  under  Directive  2001/77/EC  or  Directive 
2003/30/EC  were  either  pursued  or  closed  in  the  course  of  2010.  Overall,  69  infringement 
proceedings  and  complaints  relating  to  the  renewable  energy  sources  EU  acquis  were  dealt 
with during year 2010, 47 of which were closed. At the end of 2010, 22 of these infringement 
cases or complaints were still ongoing. 

Directive  2009/28/EC,  which  entered  into  force  on  June  25th  2009  and  contained  some 
preliminary reporting requirements (National Renewable Energy Action Plans), was due to be 
implemented  by  5  December  2010.  Enforcement  of  the  reporting  requirements  is  ongoing 
(infringements  for  non-reporting  were  opened,  evaluation  of  plans  began,  followed  by 
clarifying letters to some Member States). Scrutiny of national transposition began and will 
continue  in  2011  (technical  study  launched  in  January  to  assist  examination  of  national 
legislation).  

To facilitate timely and correct implementation of the Directive the Commission undertook a 
number of studies and worked with stakeholders. Stakeholder "roadmaps" were produced to 
help  Member  States  prepare  their  National  Renewable  Energy  Action  Plans,  a  "Concerted 
Action"  network  of  Member  State  officials  was  launched,  with  active  Commission 
participation, to enable discussion of best practice in implementing the Directive.  

5.3.2.  Evaluation of the current position 

The  new  legal  framework  of  Directive  2009/28/EC  will  replace  Directives  2001/77/EC  and 
2003/30/EC which  have been partially  repealed  as  of  April  1st 2010 and  will  be completely 
repealed  on  1  January  2012.  The  Commission  is  firmly  committed  to  close  monitoring  and 
enforcement of Directive 2009/28/EC. 

The  earlier  need  to  pursue  Member  States  for  non-reporting  and  the  inflow  of  complaints 
received  suggests  that  several  Member  States  have  not  been  implementing  the  relevant 
Directives  in  a  complete  or  appropriate  manner.  Continued  failures  of  this  nature  risk  to 
undermine the 2020 targets, and thus the EU's whole energy and climate strategy. 

The Commission's Communication on renewable energy of 31/1/2011112 included a progress 
report and highlighted Member States' failure to achieve the 2010 targets. It also highlighted 
the  need  for  major  efforts  to  correctly  and  fully  implement  the  new  Directive  2009/28/EC. 
Continued  close  monitoring  and  enforcement  action  by  the  Commission  is  therefore 
warranted. 

5.3.3.  Evaluation results 

5.3.3.1.  Priorities 

Strong and rapid measures to encourage Member States to properly implement and apply the 
acquis continue to be needed.  

111 
112 

OJ L 140, 5.6.2009, p. 16. 
COM(2011)31 final, 31.1.2011. 

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5.3.3.2.  Planned action 

During  2011,  the  Commission  will  complete  its  evaluation  of  National  Renewable  Energy 
Action  Plans,  undertake  infringements  and  pursue  complaints  as  appropriate.  It  will  also 
scrutinise national legalisation to ensure complete and correct transposition of the Directive.  

The  Commission  continues  to  do  its  utmost  to  assist  Member  States  in  implementing  the 
Directive. In addition to the national action plan template published in 2009113, it will prepare 
a template for Member States to help them to comply with their 2011 reporting requirements 
under the Directive.  

A range of communications, guidance notes and studies will also be produced to help ensure 
Member  States  implement  the  Directive  fully  and  appropriately.  This  includes  the  ongoing 
work  of  the  "Concerted  Action"  project114  in  the  framework  of  the  Intelligent  Energy  for 
Europe Programme.  

Member States' reporting requirements for 2011 include submission of progress reports. The 
Commission will thoroughly evaluate all these reports and take action against those Member 
States that fail to provide them. 

5.3.4.  Sector summary 

The  Commission  continues  to  vigorously  enforce  the  acquis  on  renewable  energy.  The 
Commission's progress reports over the years, the non-reporting of several Member States and 
the  complaints  received  from  industry  stakeholders  all  indicate  that  there  continue  to  be 
problems  hampering  the  development  of  renewable  energy  and  failures  to  take  sufficient 
measures, in accordance with the acquis. Removing barriers and encouraging the growth of 
renewable  energy  by  the  Commission  will  continue  to  be  an  important  priority  of  the 
Commission, as renewable energy development is a crucial and integral element of the EU's 
whole  energy  and  climate  strategy.  In  2011  it  will  continue  to  monitor  and  help  Member 
States in implementing the acquis, notably Directive 2009/28/EC.  

5.4. 

ENERGY – ENERGY EFFICIENCY 

5.4.1.  Energy performance of buildings  

5.4.1.1.  Current position 

a) General introduction 

Buildings  are  responsible  for  40%  of  energy  consumption  and  36%  of  EU  CO2  emissions. 
Energy  performance  of  buildings  is  key  to  achieve  the  EU  Climate  &  Energy  objectives, 
namely the reduction of a 20% of the Greenhouse gases emissions by 2020 and a 20% energy 
savings  by  2020.  Improving  the  energy  performance  of  buildings  is  a  cost-effective  way  of 
fighting  against  climate  change  and  improving  energy  security,  while  also  creating  job 
opportunities, particularly in the building sector. 

113 
114 

http://ec.europa.eu/energy/renewables/background_documents_en.htm 
http://www.ca-res.eu/  

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The main piece of the EU acquis is Directive 2002/91/EC of the European Parliament and of 
the Council of 16 December on the energy performance of buildings115. The recast Directive 
2010/31/EU  on  the  energy  performance  of  buildings  was  adopted  in  May  2010116.  It  will 
repeal the old Directive as of February 2012. 

b) Report on the work done in 2010  

The main achievement in the field of energy efficiency in the building sector in 2010 was the 
adoption of the recast Directive on energy performance of buildings (hereafter: "EPBD") on 
19 May 2010 and its entry into force on 8 July 2010. The proposal intended to simplify and 
strengthen the provisions of the EPBD and thus to increase the energy efficiency of Europe's 
building stock, to tackle climate change and to contribute to an increased security of energy 
supply.  

Implementation  efforts  regarding  the  existing  Directive  continued  in  2010  with  meetings  of 
the  'Concerted  Action'  in  Amsterdam  in  January  2010  and  in  Ljubljana  in  September  2010, 
hence  continuing  the  work  done  in  previous  years.  This  instrument  is  intended  to  promote 
dialogue and exchange of best practice. Being an active forum of national authorities from 29 
countries, it focuses on finding common approaches to the most effective implementation of 
this piece  of EU  legislation.  In the meantime,  Concerted Action is being  replicated in other 
policy areas - such as energy services and renewable energy sources - as it has proven to be a 
successful instrument.  

This  effort  in  dissemination  and  consultation  was  continued  with  the  launch  of  an  internet 
based platform as an initiative to increase awareness of all parties in the building chain.  

Infringement proceedings continued. In January 2010, eight cases were open, two of them for 
non-communication  and  six  for  incomplete/incorrect  transposition.  Five  cases  out  of  these 
eight have been closed in 2010: the two non-communication cases as well as three of the non-
conformity  cases.  Of  particular  importance  was  the  closure  of  the  two  non-communication 
cases as a result of the adoption of additional transposition legislation by the two concerned 
Member States. Directive 2002/91/EC is therefore now transposed in all 27 Member States. 

The work of the Commission in 2010 focused on the completion of the conformity check of 
the  Directive  2002/91/EC.  The  main  problems  detected  concern 
the  correct 
transposition/application  of  the  Directive's  provisions  regarding  the  issue  of  energy 
performance  certificates  and  the  inspection  of  boilers  and  air-conditioning  systems.  The 
Commission received several complaints concerning the lack of issue of energy performance 
certificates  in  some  Member  States.  As  a  result  of  it  the  Commission  sent  complementary 
letters of formal notice concerning two cases already open, and opened one new infringement 
case  and  five  EU  Pilot  files.  Additionally,  two  information  letters  have  been  sent  to  the 
countries not being at that moment members of the EU Pilot system. 

Petitions 

One petition was received concerning the independence of experts in charge of inspections for 
which a final response was given. 

115 
116 

OJ L 1, 4.1.2003, p. 65. 
OJ L 153, 18.6.2010, p. 13. 

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5.4.1.2.  Evaluation of the current position 

The Commission's ambitious recast proposal that strengthens the current legislation relating to 
the  energy  performance  of  buildings  has  been  adopted  on  19  May  2010  (Directive 
2010/31/EU)  and  has  already  entered  into  force.  Member  States  have  until  9  July  2012  to 
adopt  transposition  measures.  In  the  meanwhile,  the  Commission  will  follow-up  the  open 
infringement  cases  on  the  Directive  2002/91/EC  and  continue  to  monitor  its  correct 
transposition.  

5.4.1.3.  Evaluation results 

a) Priorities 

Attention will focus on the enforcement of the existing legislation and the preparation of the 
subsequent implementation of the new Directive. After finalising the conformity assessment, 
more infringement procedures might be launched in 2011. 

b) Planned Action 

The  Commission  will  adopt  in  2011  a  delegated  act  setting  a  methodology  framework  to 
assist Member States in setting cost-optimal minimum performance requirements. It also aims 
at  adopting  an  implementing  decision  to  establish  an  EU  voluntary  certification  scheme  for 
the energy performance of non-residential buildings. 

5.4.1.4.  Sector summary 

The  Energy  Performance  of  Buildings  Directive  (EPBD)  is  the  main  EU  legal  tool  that 
provides  for  a  holistic  approach  towards  efficient  energy  use  in  the  buildings  sector.  The 
EPBD's  main  objective  is  to  promote  the  cost-effective  improvement  of  the  overall  energy 
performance of buildings. Improving the energy performance of buildings is a cost-effective 
way of fighting against climate change and improving energy security, while also creating job 
opportunities, particularly in the building sector. 

The Commission's activities in this field are concentrated in the enforcement of the existing 
acquis while assisting the Member States in the correct and timely transposition of the recast 
Directive. 

5.4.2.  Energy efficiency of products 

5.4.2.1.  Current Position 

a) General Introduction 

The main pieces of legislation in this field are the following: (i) Directive 2009/125/EC of 21 
October 2009 establishing a framework for the setting of ecodesign requirements for energy-
using products; (ii) Directive 2010/30/EU of 19 May 2010 on the indication by labelling and 
standard  product  information  of  the  consumption  of  energy  and  other  resources  by  energy-
related  products,  and  (iii)  Decision  2006/1005  on  the  coordination  of  energy-efficiency 
labelling programmes for office equipment in the EU and USA ("Energy Star"). 

b) Report of work done in 2010 

EN 

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The work covered three distinct areas: 

On  ecodesign,  the  implementation  of  Directive  2009/125/EC117  continued.  Three  detailed 
measures implementing the Directive were adopted in 2010 as regards: 

–  domestic dishwashers (Commission Regulation (EU) No 1016/2010)118; 

–  domestic washing machines (Commission Regulation (EU) No 1015/2010)119; 

–  amendment of Commission Regulation (EC) No 245/2009120 on fluorescent lamps without 
integrated ballast, for high intensity discharge lamps and for ballasts and luminaires able to 
operate such lamps (Commission Regulation (EU) No 347/2010)121

 . 

In  addition  to  the  adoption  of  legislative  measures  there  was  on-going  work,  such  as 
preparatory  studies,  impact  assessments,  stakeholder  meetings  for  the  preparation  of 
additional  implementing  measures  for  some  12  product  groups.  Member  States  had  to 
transpose the Directive by 20 November 2010. 

On  labelling,  the  recast  of  Framework  Directive  92/75/EEC  has  been  adopted  on  19  May 
2010  as  Directive  2010/30/EU122  on  the  indication  by  labelling  and  standard  product 
information of the consumption of energy and other resources by energy-related products. The 
measure  extended  the  scope  to  include  labelling  of  commercial  and  industrial  products, 
regulated the layout and unauthorised use of the label, and simplified the legislation to ensure 
a  uniform  implementation  on  the  internal  market  by  using  (directly  applicable)  Regulations 
instead of Directives. Member States have to transpose the Directive by 20 July 2011. 

On  energy  labelling,  the  implementation  of  Directive  2010/30/EU  continued.  Four  detailed 
delegated acts implementing the Directive were adopted in 2010 as regards: 

–  domestic 

refrigerators/freezers 

(Commission  Delegated  Regulation 

(EU)  No 

1060/2010)123; 

–  televisions (Commission Delegated Regulation (EU) No 1062/2010)124

 ; 

–  domestic dishwashers (Commission Delegated Regulation (EU) No 1059/2010)125; 

–  domestic washing machines (Commission Delegated Regulation (EU) No 1061/2010)126. 

On  requirements  on  the  labelling  of  tyres  with  respect  to  fuel  efficiency  and  other  essential 
parameters,  the  regulatory  committee  voted  on  the  implementing  regulation  of  the  Tyre 

117 
118 
119 
120 
121 
122 
123 
124 
125 
126 

OJ L285 of 21.10.2009, p.10. 
OJ L293 of 11.11.2010, p.31. 
OJ L293 of 11.11.2010, p.21. 
OJ L76 of 24.3.2009, p.17. 
OJ L104 of 24.04.2010, p.20. 
OJ L153 of 18.06.2010, p.1. 
OJ L314 of 30.11.2010, p.17. 
OJ L314 of 30.11.2010, p.64. 
OJ L314 of 30.11.2010, p.1. 
OJ L314 of 30.11.2010, p.47. 

EN 

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   EN 

 
                                                 
Labelling  Regulation  1222/2009127.  This  implementing  regulation  is  replacing  the  current 
testing  method  of  wet  grip  of  C1  tyres  (tyres  mainly  fitted  to  passenger  cars)  by  a  more 
accurate  testing  method.  The  aim  is  to  improve  accuracy  of  testing  for  the  purpose  of  tyre 
labelling.  

Petitions 

During 2010, one petition was dealt with regarding Eco-design, but has not yet been closed. 

5.4.2.2.  Evaluation of the current position 

The  activities  carried  out  in  2010  resulted  in  the  adoption  of  a  significant  number  of 
legislative acts together with considerable development of legislative proposals for additional 
legislative activity in 2011. 

5.4.2.3.  Evaluation results 

a) Priorities 

The  twin  priorities  will  be  to  ensure  the  enforcement  of  the  existing  legislation,  as  well  as 
adopting further implementing measures to extend the scope of measures to products not yet 
covered by ecodesign and labelling requirements. 

b) Planned action 

Work  will  be  concentrated  on  the  development  and,  where  appropriate,  adoption  of 
implementing  acts  or  voluntary  agreements  for  air  conditioners,  domestic  lighting,  personal 
computers,  imaging  equipment,  complex  set-top  boxes,  fans,  pumps,  water  heaters,  boilers, 
laundry dryers, vacuum cleaners and commercial refrigerators. 

5.4.2.4.  Sector summary 

In  the  context  of  the  Second  Strategic  Energy  Review  adopted  in  November  2008,  the 
Commission's  activities in  the field of energy efficiency of products are  concentrated in the 
enforcement  of  the  existing  acquis.  It  is  also  anticipated  that  the  Commission  will  continue 
adopting  several  implementing  measures  under  Directive  2009/125/EC  and  Directive 
2010/30/EU. 

5.4.3.  Energy end-use efficiency and energy services 

5.4.3.1.  Current position 

a) General introduction 

The European Union (EU) has adopted a framework for energy end-use efficiency and energy 
services.  Among  other  things,  this  includes  an  indicative  energy  savings  target  for  the 
Member  States,  obligations  on  national  public  authorities  as  regards  energy  savings  and 
energy efficient procurement, and measures to promote energy efficiency and energy services. 
The  main  piece  of  the  EU  acquis  in  this  field  is  Directive  2006/32/EC  of  the  European 

127 

OJ L 342 of 22.12.2009, p.46. 

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Parliament  and  the  Council  of  5  April  2006  on  energy  end-use  efficiency  and  energy 
services128. 

b) Report on the work done in 2010 

With  regard  to  energy  end-use  efficiency  and  energy  services,  the  efforts  on  the 
implementation of the existing legislation were continued. The focus was on the development 
of  common  methods  and  indicators  for  measurement  and  verification  of  energy  savings  as 
well as the template for the second National Energy Efficiency Action Plans (NEEAPs). For 
that  purpose,  the  Commission  organised  two  Energy  Demand  Management  Committee 
meetings  and  a  number  of  bilateral  meetings  and  other  exchanges  with  relevant  Member 
States. Because of the lack of the consensus between Member States, formal harmonisation of 
methods  and  indicators  for  measuring  energy  savings  was  not  possible.  However,  the  work 
has led to the development of a recommended set of indicators and formulas for measurement 
and verification of final energy savings.  

The  Commission  also  prepared  an  extended  template  for  the  second  NEEAP,  which  covers 
now  reporting  obligations  arising  from  Directive  2006/32/EC,  Directive  2010/31/EU129,  as 
well as other areas covered by national energy efficiency policies. In October and November 
2010 the Commission organised training workshops for officials from all EU Member States 
as  well  as  Croatia  and  Norway  on  the  preparation  of  the  second  NEEAP.  Also  a  special 
telephone helpline and an internet helpdesk were set up to provide Member States with on-
line assistance with the preparation of their new NEEAPs. 

Follow-up on the implementation of Directive 2006/32/EC and exchanges on good practices 
are carried out through regular exchanges supported and facilitated by the Commission in the 
framework of the Concerted Action on Directive 2006/32/EC. In 2010 three meetings of the 
Concerted Action were held. 

Regarding  transposition  of  the  Directive,  at  the  end  of  2008  the  Commission  started 
infringement proceedings for non-communication against 24 Member States. In January 2010, 
ten of these cases were still open. In order to have a better insight on how the transposition 
had been made, the Commission engaged at the end of 2009 in regular bilateral discussions 
with  those  Member  States  not  having  completed  the  transposition  of  the  Directive.  These 
bilateral  meetings  continued  in  2010.  In  December  2010  the  number  of  the  Member  States 
having not completed the transposition was reduced to four.  

Petitions 

During 2010, answers were provided for two petitions relating to individual metering and are 
still under examination by the European Parliament's Petitions Committee. 

5.4.3.2.  Evaluation of the current position 

Despite  significant  efforts,  consensus  between  the  EU  Member  States  on  harmonisation  of 
methodologies for measurement and verification of energy savings on the basis of the Annex 

128 
129 

OJ L 114, 27.4.2006, p. 64. 
Directive 2010/31/EU  of  the European Parliament  and of  the  Council  of 19  May 2010 on  the  energy 
performance of buildings (recast), OJ L 153, 18.6.2010, p. 13. 

EN 

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IV  of  Directive  2006/32/EC  could  not  be  reached.  As  such,  the  Commission  came  to  the 
conclusion that the methodology for the measurement of verification of energy savings should 
be extended beyond the current scope of Directive 2006/32/EC to all energy savings including 
measurement  of  the  progress  in  Member  States  towards  the  strategic  objective  of  20%  by 
2020. 

Concerning the establishment of the Second NEEAPs, the key issue is related to reporting on 
already  achieved  energy  savings.  As  indicated  in  various  Communications  from  the 
Commission130  131, the NEEAPs should become a central tool for Member States as regards 
planning  and  reporting  on  national  measures  and  achieved  energy  savings.  This  has  been 
already confirmed in recent parallel EU legislation: e.g. the recast of the Energy Performance 
of Buildings Directive refers to NEEAPs as the main reporting tool. In 2010 the Commission 
proposed  a  common  template  for  the  second  NEEAP,  due  by  end  of  June  2011,  which 
extended the scope of reporting beyond the scope of energy savings as currently defined by 
Directive  2006/32/EC  to  energy  savings  and  energy  saving  measures  addressing  all  sectors 
(end-use energy efficiency, energy transmission/distributions and energy generation). 

Based on parallel studies carried out on the occasion of the preparation of the new EU Energy 
Efficiency  Plan  as  well  as  feedback  from  the  Member  States  on  problems  with  the 
implementation  of  their  first  NEEAPs,  it  has  become  clear  that  the  impact  of  the  current 
Directive 2006/32/EC to achieve EU 2020 target for energy efficiency is insufficient. In order 
to  cover  all  the  potential  for  energy  savings  in  all  sectors  and  strengthen  the  existing 
framework for the development of energy services market the Commission will analyse ways 
for a possible recast of Directive 2006/32/EC. 

5.4.3.3.  Evaluation results 

a) Priorities 

Primary  attention  will  be  paid  to  the  assessment  of  the  impact  of  the  Directive  2006/32/EC 
and  identification  of  ways  to  strengthen  the  current  EU  framework  legislation  on  energy 
savings. At the same time, the Commission will continue encouraging Member States to adopt 
strong and comprehensive second NEEAPs. 

b) Planned Action 

Efforts  will  be  concentrated  on  the  preparation  of  a  legislative  proposal  for  the  revision  of 
Directive  2006/32/EC.  The  Commission  will  investigate  possible  strengthening  of  this 
legislation  including  investigating  on  the  creation  of  a  suitable  legal  basis  for  the  20% 
strategic objective for primary energy savings by 2020. 

In parallel, the Commission will continue providing its assistance to the Member States in the 
preparation of the second NEEAPs and the use of recommended methods and indicators for 
the measurement and verification of energy savings. In the second part of 2011, after receipt 

130 

131 

Communication  from  the  Commission  to  the  Council  and  the  European  Parliament  on  Energy 
efficiency: delivering the 20% target, COM(2008) 772 final. 
Commission Staff Working Document, Synthesis of the complete assessment of all 27 National Energy 
Efficiency Action Plans as required by Directive 2006/32/EC on energy end-use efficiency and energy 
services. Moving forward together on saving energy, SEC(2009) 889 final. 

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of the second NEEAPs, the Commission will start thorough analysis of each national Action 
Plan. 

5.4.3.4.  Sector summary 

Efforts on the implementation of the existing legislation were continued with a focus on the 
development of common methods and indicators for measurement and verification of energy 
savings and a template for the second National Energy Efficiency Action Plans.  

Consensus  between  the  EU  Member  States  on  harmonisation  of  methodologies  for 
measurement  and  verification  of  energy  savings  on  the  basis  of  the  Annex  IV  of  Directive 
2006/32/EC could not be reached. It has become clear that the impact of the current Directive 
2006/32/EC to achieve EU 2020 target for energy efficiency is insufficient. Preparations of a 
legislative  proposal  for  the  revision  of  Directive  2006/32/EC  are  underway,  which  will 
investigate in a possible strengthening of this legislation. 

5.4.4.  Combined heat and power generation (CHP, cogeneration) 

5.4.4.1.  Current position 

a) General introduction 

The main piece of legislation is Directive 2004/8/EC of 11 February 2004 on the promotion of 
cogeneration  based  on  a  useful  heat  demand  in  the  internal  energy  market  ("CHP 
Directive")132, complemented by two Commission Decisions - one on harmonised efficiency 
reference values for the separate production of  electricity and heat (2007/74/EC)133, and the 
other  one  containing  detailed  guidelines  for  the  calculation  of  electricity  from  cogeneration 
(2008/952/EC)134. 

b) Report on the work done in 2010 

Efforts  on  enforcing  the  transposition  and  implementation  of  the  CHP  Directive  have 
continued in 2010. In the beginning of 2010, 18 infringements procedures were ongoing for 
failure to implement the Directive's provisions (non-communication of transposition measures 
and no submission of the reports required). At the end of 2010 all Member States completed 
the transposition, but there were still five cases open for failure to communicate the necessary 
reports. 

Discussions with Member States and stakeholders started on the future development of CHP 
policy,  on  the  potential  of  CHP  and  on  the  review  of  the  reference  values  for  separate 
production  of  electricity  and  heat  (in  accordance  with  Article  4  of  the  CHP  Directive). 
Preparatory  works  have  been  launched  to  complement  the  analysis  of  the  Commission  on 
these issues. 

132 
133 
134 

OJ L 52, 21.2.2004, p. 50. 
OJ L 32, 6.2.2007, p. 183. 
OJ L 338, 17.12.2008, p. 55. 

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5.4.4.2.  Evaluation of the current position 

From a legal perspective, the situation regarding cogeneration is evolving positively. Most of 
the Member States have been completing the transposition of the Directive and providing the 
information required by the Directive.  

However, from an operational perspective, the situation of the CHP sector is not improving in 
real terms.  According  to  statistical  data135,  there  is  no  real  development  of  the  sector  at  EU 
level since the adoption of the CHP Directive in 2004. 

5.4.4.3.  Evaluation results 

a) Priorities 

Primary attention will be paid to the enforcement of the existing legislation. In addition, it will 
be  necessary  to  work  further  on  how  to  strengthen  the  current  EU  framework  legislation  in 
order to significantly support the development of CHP in the EU, and consequently contribute 
as much as possible to the future EU energy saving objective. 

b) Planned action 

The Commission will continue its efforts with regard to the follow-up and enforcement of the 
existing legislation, including an analysis of conformity of the notified legislation.  

The  Commission  will  review  the  reference  values  for  the  separate  production  of  electricity 
and heat. 

The  Commission  will  also  prepare  a  report  on  the  implementation  of  the  Directive  and 
present,  if  appropriate,  further  proposals  to  foster  cogeneration,  in  relation  to  the  future 
Energy Efficiency Plan.  

5.4.4.4.  Sector summary 

Monitoring  of  the  implementation  continues.  Infringement  procedures  have  been  opened  to 
support  this  objective.  The  level  of  transposition  and  implementation  in  Member  States  is 
improving. 

The reference values for the separate production of electricity and heat will be reviewed. 

A  report  on  the  implementation  of  the  Directive  will  be  prepared  and  further  proposals  to 
foster cogeneration will be indicated if appropriate. 

135 

Eurostat - annual statistics based on data submitted by Member States according to Article 10(3) of the 
Directive 2004/8/EC. 

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5.5. 

ENERGY - NUCLEAR ENERGY 

5.5.1.  Current position 

5.5.1.1.  General introduction 

The Commission has significant responsibilities under the Euratom Treaty on nuclear safety 
and  security.  In  particular,  the  Commission  has  to  monitor  nuclear  material  used  for  civil 
purposes so that it is only used for the uses their users have declared them to be used for (i.e. 
nuclear  security);  and  to  protect  citizens  against  the  dangers  from  ionising  radiation  by 
ensuring the respect of EU legislation on radioprotection and by having a high level of nuclear 
safety  in  all  Member  States.  Nuclear  energy  can  play  a  role  in  enhancing  competitiveness, 
promoting  sustainable  development,  fighting  climate  change  and  reducing  external  energy 
dependence.  While  it  is  up  to  the  Member  States  to  choose  whether  or  not  to  use  nuclear 
energy, the role of the EU is to develop in the interest of all Member States the most advanced 
legal  framework  for  nuclear  energy,  meeting  the  highest  standards  for  safety,  security  and 
non-proliferation. 

The Lisbon Treaty amended the Euratom Treaty by its Protocol No 2. The Euratom provisions 
continue to have their full legal effect and Euratom keeps its own legal personality outside the 
framework of the EU. The amendments are only intended to adapt the Euratom Treaty to the 
new rules laid down in the Lisbon Treaty, in the institutional and financial fields, which were 
inserted to the TFEU and made applicable to Euratom Treaty through new Article106a of the 
Euratom  Treaty.  In  particular,  Articles  141  to  143  of  the  Euratom  Treaty  defining  the 
infringement  procedure  are  repealed  and  Articles  258  to  260  TFEU  are  now  applicable  for 
Euratom.  Accordingly,  Article  82  of  the  Euratom  Treaty  also  refers  to  new  Articles  258  to 
260 TFEU. 

Most  of  the  activities  in  the  nuclear  field  are  based  on  Chapter  3  (Health  and  Safety)  and 
Chapter 7 (Safeguards) of the Euratom Treaty and on the acquis derived thereof. 

A comprehensive list of primary and secondary legislation applicable in the field of nuclear 
energy is given in Annex. 

5.5.1.2.  Report of work done in 2010 

Management of the acquis, in particular through committees and expert groups: 

The Group of Experts (GoE) provided for in Article 31 adopted its opinion in February 2010 
on the revision and recast of the Euratom Basic Safety Standards Directive. As the five years 
mandate  of  this  group  expired,  a  newly  nominated  Group  of  Experts  met  twice  in  June  and 
November  2010.  Main  topics  were  medical  exposures  and  the  revision  of  the  international 
Basic Safety Standards. 

As  regards  the  European  Nuclear  Safety  Regulators  Group  (ENSREG), 
the  main 
achievements  of  the  Group  were:  (i)  the  launching  of  the  dedicated  ENSREG  Website 
(www.ensreg.eu),  where  the  activities  of  the  Group  are  presented  in  detail  and  (ii)  the 
presentation to the Commission of expert advice on the then envisaged Euratom legislation in 
the area of radioactive waste and spent fuel management. This guidance has been reflected in 

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the  November  2010  Commission  proposal  for  a  Directive  on  the  management  of  spent  fuel 
and  radioactive  waste136.  Also,  during  2010,  several  activities  were  initiated  (to  be  further 
pursued in 2011), e.g. (i) the support for the transposition and implementation of the Nuclear 
Safety  Directive,  by  suggesting  a  unified  structure  for  the  Member  States'  Reports  on  the 
implementation of the Directive, facilitating the consultation and cooperation of the national 
regulatory  authorities,  establishing  a  common  methodology  for  the  periodic  safety  self-
assessments  and  a  system  for  the  coordination  of  the  international  peer-review;  (ii)  the 
elaboration  of  Guidelines  for  regulators'  transparency  and  (iii)  the  preparations  for  the  first 
European Nuclear Safety Conference (28-29 June 2011, Brussels). 

The  European  Nuclear  Energy  Forum  (ENEF)(137)  is  conceived  as  a  platform  to  promote  a 
broad  discussion  among  all  relevant  stakeholders  on  the  opportunities  and  risks  of  nuclear 
energy. In 2010, during the fifth ENEF plenary meeting held in Bratislava in May 2010, the 
role  of  nuclear  in  the  gradual  transition  of  Europe  towards  a  low-carbon  economy  was 
discussed  also  taking  into  account  security  of  supply  and  competitiveness  considerations. 
ENEF  called  for  improved  transparency  of  nuclear  energy  and  reflected  good  practices  in 
siting  decisions  for  geological  repositories  showing  how  important  early  and  open 
involvement of the public in such a long-term process is. 

As  regards  risks  of  nuclear  energy  ENEF  has  recognised  the  need  for  a  legally  binding 
Euratominstrument  for  radioactive  waste.  Among  the  essential  elements,  ENEF  underlines 
that each Member State should develop and implement an adequate national plan for nuclear 
waste management in line with the subsidiarity principle. It is equally important to ensure a 
sufficient level of training and qualified staff, in particular for technicians and engineers in the 
nuclear industry, but also for radioprotection and medical applications of nuclear. 

On the opportunities of nuclear energy ENEF discussed the contribution of nuclear to a low-
carbon economy. 

A concrete result of preparatory work is the European Nuclear Energy Leadership Academy 
(ENELA) founded in early 2010. 

Chapter  7  (Safeguards)  of  the  Euratom  Treaty:  The  Commission  continued  to  satisfy  itself 
that  in  the  territories  of  the  Member  States  nuclear  materials  were  not  diverted  from  their 
intended  use  as  declared  by  the  users  and  that  the  international  safeguards  obligations 
assumed  by  Euratom  were  complied  with.  On  1st  May  2010,  Romania  acceded  to 
INFCIRC/193,  the  trilateral  safeguards  agreement  between  the  Euratom  Community,  the 
IAEA  and  the  EU's  non-nuclear  weapons  states.  From  March  2010  all  EU  operators  of 
nuclear facilities make their regular reports of nuclear material holdings and transactions in a 
manner  which  complies  fully  with  the  requirements  set  out  in  Regulation  (Euratom)  No 
302/2005.  

A  nuclear  liability  workshop  was  held  in  June  2010  with  the  aim  to  explore  possibilities  to 
harmonise  the  nuclear  liability  regime  in  the  EU.  As  a  conclusion  of  the  workshop,  it  was 
suggested to create an expert group to build consensus for a possible legislative proposal. 

136 
137 

COM(2010)618, 3.11.2010. 
Detailed information on the ENEF activity is available at 
http://ec.europa.eu/energy/nuclear/forum/forum_en.htm 

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The  European  Commission  hosted  a  Meeting  on  the  Security  of  Supply  of  Medical 
Radioisotopes in EU Member States held in Luxembourg on 4-5 May 2010. The purpose of 
the  meeting  was  to  provide  a  forum  to  exchange  information  on  possible  medium-term 
solutions  and  on  details  of  the  most  promising  reactor  opportunities  for  securing 
Molybdenum-99 (Mo-99) production in the long term. 

Management of the acquis (incl. enquiries, problems and complaints) 

The  submission  of  draft  texts  under  Article  33  Euratom  Treaty  allows  the  Commission  to 
make  appropriate  recommendations  before  the  finalisation  of  the  national  procedure  for  the 
adoption  of  transposition  measures,  so  that  possible  instances  of  non-compliance  can  be 
identified even before the texts are adopted. In 2010, 19 notifications were dealt with under 
Article  33.  Most  of 
implementation  of  Council  Directive 
the 
2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety 
of  nuclear  installations.  Likewise,  other  notifications  aim  at  updating  Member  States' 
legislation transposing previous Euratom Directives, e.g. Basic Safety Standard Directive and 
Directive 97/43/Euratom. 

them  concerned 

Under  Article  35  of  the  Euratom  Treaty,  Commission  services  conducted  7  verification 
missions. The purpose was to provide an independent assessment on the adequacy of facilities 
intended to monitor levels of radioactivity in the environment. All verifications started with a 
preliminary  audit  of  the  monitoring  and  inspection  activities  carried  out  by  the  relevant 
national authorities and of the legal framework in force. 

Eleven  opinions  were  drafted  by  the  Commission  in  accordance  with  Article  37  of  the 
Euratom Treaty, concerning plans for the disposal of radioactive material. 

An  update  of  the  nuclear  illustrative  programme  (PINC  2010)  is  being  prepared  –  in  the 
context  of  the  2050  Roadmap  –  in  order  to  review  the  latest  situation  regarding  Member 
States' policies, nuclear investment decisions and requirements, as well as to highlight some 
key aspects for future investments. 

Articles 41-43 of Euratom Treaty establish notification procedure on nuclear investments: in 
2010  2  new  notifications  were  received,  8  were  under  examination  and  8  were  finalised,  in 
particular the Commission point of views on Cernavoda nuclear power plant. 

Article  103  is  part  of  the  Euratom  Treaty's  Chapter  on  external  relations.  It  establishes  a 
procedure for the preliminary examination by the Commission of the compatibility with the 
Euratom Treaty of draft agreements or contracts which are about to be concluded, within the 
scope  of  the  Euratom  Treaty,  between  a  Member  State  and  a  third  party.  In  2010,  15 
notifications pursuant to Article 103 Euratom, were dealt with. 

Management of infringements 

Concerning the complaints management, 6 new complaints were received in 2010. 

In  2010,  the  two  remaining  infringement  cases  initiated  in  2009  for  non  communication  of 
final  transposing  measures  for  Council  Directive  2006/117/Euratom  were  closed  as  the 
Member States concerned completed the transposition. 

Monitoring of the safeguards situation continued in the case of a Commission Directive based 

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on  Article  82  Euratom  Treaty,  concerning  another  installation  on  the  Sellafield  site.  To  this 
end,  a  detailed  work  programme  to  improve  the  situation  was  prepared  by  the  United 
Kingdom  and  accepted  by  the  Commission  services  in  the  first  half  of  2010.  If  progress 
continues to be satisfactory (the UK has provided 13 progress reports so far), the Commission 
will refrain from referring the case to the Court of Justice.  

Petitions 

During 2010, 15 petitions in total concerning the nuclear energy sector were dealt with. For 
all petitions, an adequate answer was provided (often in close cooperation with other DGs). 
However, the European Parliament's Petitions Committee did not analyse all answers yet and 
could therefore not accept the closure of these cases. Hence, most petitions take several years 
before being formally closed.  

New legislation 

DG  Energy  has  contributed  to  the  development  of  an  even  more  advanced  EU  legal 
framework  for  nuclear  energy  meeting  the  highest  standards  of  safety,  security  and  non-
proliferation.  On  3  November  2010  the  Commission  has  adopted  a  revised  proposal  for  a 
Council  Directive  on  the  management  of  spent  fuel  and  radioactive  waste.  The  general 
objective  of  the  proposal  is  the  establishment  of  Euratom  framework  for  the  responsible 
management  of  spent  fuel  and  radioactive  waste,  ensuring  that  Member  States  provide  for 
appropriate national arrangements guaranteeing a high level of safety while maintaining and 
promoting  public  information  and  participation.  EU  will  become  the  first  regional  nuclear 
actor having binding rules for nuclear safety and waste management. This proposal is planned 
to be adopted by June 2011.  

In  2010  a  Council  Regulation138  has  been  adopted  as  new  legal  basis  for  the  extension  of 
financial EU support to the Kozloduy Programme (Bulgaria) with an additional commitment 
of €300 million for the period 2010 – 2013. On the implementation of the EU support, a total 
sum  of  €255  million  has  been  made  available:  €155  million  to  the  European  Bank  for 
Reconstruction and Development (EBRD) and €100 million to the Lithuanian Central Project 
Management Agency (CPMA). 

A  Communication  from  the  Commission  to  the  European  Parliament  and  the  Council  on 
medical applications of ionizing radiation and security of supply of radioisotopes for nuclear 
medicine139 was adopted by the Commission in August 2010. The Communication proposes a 
way  forward  to  resolve  the  urgent  issue  of  shortage  of  supply  of  radioisotopes  for  nuclear 
medicine. The Council adopted Conclusions on 6 December 2010. 

The  revised  Commission  Recommendation  on  the  application  of  Article  37  of  the  Euratom 
Treaty was adopted in October 2010140. It improves some terminology to ensure consistency 
and clarity of the provisions and simplifies the general data to be provided by Member States 
to the essential information necessary for the Commission to issue its opinion. In addition, it 
excludes  from  the  scope  of  Article  37  a  limited  number  of  trivial  operations  having  no  or 

138 

139 
140 

Council Regulation on the extension of financial support to Bulgaria for the decommissioning of units 1 
to 4 of the Kozloduy Nuclear Power Plant and for the mitigation of the economical consequences. 
COM/2010/0423 and SEC/2010/0974. 
2010/635/Euratom, OJ L 279, 23/10/2010 p. 36 – 67. 

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negligible  radiological  impact  in  other  Member  States.  It  strengthens  the  assessment  of 
accidental  situations  by  introducing  a  new  requirement  for  safety  related  information  on 
unplanned  releases  from  nuclear  reactors  and  reprocessing  plants.  Concerning  dismantling 
operations,  in  addition  to  nuclear  reactors  and  reprocessing  plants,  a  submission  of  general 
data for the dismantling of mixed-oxide fuel fabrication plants is now required. 

The  Agreement  between  the  European  Atomic  Energy  Community  and  the  Government  of 
Canada  for  cooperation  in  the  peaceful  uses  of  atomic  energy  is  now  being  renegotiated 
based on the Council mandate adopted on 27 July 2009. The initial Agreement was signed in 
1959 and, due to the continuous development of nuclear trade between the Parties, has been 
amended five times. 

The  Agreement  between  the  European  Atomic  Energy  Community  and  Australia  is  due  to 
expire in January 2012. The Council adopted the negotiating mandate for a revised agreement 
between  the  European  Atomic  Energy  Community  and  the  Government  of  Canada  for 
cooperation in the peaceful uses of atomic energy on 12 July 2010, and the renegotiations of 
the existing agreement were finalised. The scope of the agreement covering only transfers of 
nuclear  materials  was  extended  to  transfers  of  equipment  and  technology,  and  nuclear 
cooperation in general. The text of the agreement will be submitted to Council for approval 
during the 1st quarter of 2011. 

Negotiations  for  a  new  Agreement  between  the  European  Atomic  Energy  Community  and 
South Africa are ongoing. The negotiating mandate was adopted by the Council on 25 October 
2010.  A  new  agreement  between  Euratom  and  South  Africa  will  create  a  stable  long-term 
framework  for  co-operation  between  the  two  Parties  and  their  governments  and  industrial 
operators in the peaceful uses of nuclear energy. 

Preparatory  meetings  took  place  resulting  in  the  start  of  the  negotiations  of  a  new  and 
comprehensive cooperation agreement in peaceful  uses of nuclear energy between Euratom 
and  the  Russian  Federation,  setting  up  an  overall  framework  for  political,  technical  and 
industrial cooperation. 

In  the  framework  of  the  continuing  cooperation  with  Ukraine  on  energy  and  nuclear  safety 
matters, a joint European Commission-IAEA-Ukraine project on the evaluation of the nuclear 
safety of the Ukrainian Nuclear Power Plants was finalised in 2010. 

Preventive measures being taken in relation to newly adopted legislation 

In 2010, Directorate-General for Energy ensured support and oversaw the correct and timely 
transposition  of  the  Directive  2009/71/Euratom  (the  'Nuclear  Safety  Directive')  into  the 
Member  States'  legislation,  through  a  continuous  cooperation  with  the  responsible  national 
authorities. In addition, DG Energy has organised in Luxembourg on 7 May 2010, a seminar 
where the Member States' experts were invited to raise, seek clarifications and  discuss  with 
the  Commission  any  legal  issues  that  they  considered  of  relevance  in  the  transposition 
process.  The  dialogue  with  the  Member  States  has  also  been  ensured  at  the  level  of  the 
Council Atomic Questions Group, where several transposition procedural clarifications were 
presented,  as  well  as  at  the  level  of  the  European  Nuclear  Safety  Regulators  Group 
(ENSREG) to whose activities Directorate-General for Energy actively contribute. 

Implementation of EU energy policy priorities 

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The priorities in the field of energy focus on actions having a significant impact on the fight 
against climate change and ensuring secure and competitive energy supplies. 

The implementation of the Euratom acquis generally benefits both objectives: it regulates the 
use  of  an  energy  source  which  has  virtually  no  carbon  emissions  and  it  contributes 
substantially to the security of supply.  

The Strategic Energy Technology Plan of the EU is the technology related "implementation 
tool" to meet the ambitious 3x20 Energy Policy Target. The SET Plan recommends launching 
European  Industrial  Initiatives  to  develop  and  bring  to  the  market  innovative  low  carbon 
energy  technologies.  The  Nuclear  Initiative  under  the  SET  Plan  is  fostering  the  long  term 
sustainable  contribution  of  nuclear  energy  to  the  low  carbon  energy  mix,  by  proposing  the 
building  of  prototype  fast  breeder  reactors  and  closed  fuel  cycle.  The  first  prototypes  are 
foreseen to start operation in 2020. This is directly related to one of the axis of actions of the 
Sustainable  Nuclear  Energy  Technology  Platform,  the  two  other  ones  being  connected  with 
the plant lifetime management and waste management of existing installations, and with the 
production of nuclear heat via cogeneration and the potential of High Temperature Reactors. 

The  European  Sustainable  Nuclear  Energy  Initiative  has  been  officially  launched  on  15 
November 2010 under the Belgian Presidency. 

5.5.2.  Evaluation of the current situation 

a) The current situation for the control of the existing acquis is stable.  

b) Cases could all be managed in the normal timeframe and fell roughly under the same level 
of priority, i.e. normal. 

5.5.3.  Evaluation Results 

5.5.3.1.  Priorities and Planned Actions 

Assist  the  Member  States  to  comply  with  their  legal  obligation  for  a  timely  and  correct 
transposition of the Nuclear Safety Directive. 

Complete the adoption of a Council Directive on safe management of radioactive waste and 
spent fuel followed by correct transposition.  

5.5.4.  Sector summary 

In  the  nuclear  sector  the  Commission  is  called  to  accompany  the  expected  massive 
development  with  an  advanced  legal  framework  for  nuclear  energy  based  on  the  Euratom 
Treaty  that  maintains  and  improves  the  high  standard  of  regulation  achieved  in  the  EU 
Member States. The Commission's priority is to be up-to-date concerning the legislation for 
the protection of the health and for nuclear security and to fully use our competences in the 
field of nuclear safety. As main achievement to be mentioned is the adoption of the Nuclear 
Safety Directive. 

The key action in the near future, for which a lot of work was already achieved during 2010, 
is therefore the follow-up of proposal for a Council Directive (Euratom) on safe management 
of radioactive waste and spent fuel which was adopted on 3 November 2010.  

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On  the  other  hand,  the  recast  of  the  Basic  Safety  Standards,  which  will  consolidate  the 
legislation in the field and set modern, unified standards for the protection of the health of the 
citizens in the EU made good progress. 

(see also Annex I - List of measures in force and other relevant instruments referred to in the 
text of the document) 

6. 

MOBILITY AND TRANSPORT 

6.1. 

Passenger rights 

6.1.1.  Current position 

6.1.1.1.  General introduction 

Since  the  2001  White  Paper,  where  the  Commission  announced  the  establishment  of 
passengers’  rights  in  all  modes  of  transport  and  its  intention  to  place  users  at  the  heart  of 
transport policy, four Regulations are in force by the end of 2010, in the sectors of aviation 
and rail transport: 

• 

• 

• 

• 

Regulation (EC) No 889/2002 of the European Parliament and of the Council of 13 
May 2002 amending Council Regulation (EC) No 2027/97 on air carrier liability in 
the event of accidents 

Regulation  (EC)  Nº  261/2004,  establishing  common  rules  on  compensation  and 
assistance to passengers in the event of denied boarding and of cancellation or long 
delay of flights;  

Regulation (EC) Nº 1107/2006 concerning the rights of disabled persons and persons 
with reduced mobility when travelling by air; 

Regulation (EC) Nº 1371/2007 on rail passengers’ rights and obligations, applicable 
as from December 2009. 

Furthermore,  in  the  field  of  maritime  transport,  Regulation  (EU)  1177/2010  on  passenger 
rights  in  maritime  and  inland  waterways  transport  has  been  adopted  and  will  apply  as  from 
December 2012 and, in the field of road transport, Regulation (EU) No 181/2011 concerning 
the rights of passengers in bus and coach transport has been published in February 2011 and 
will apply as from March 2013. 

The overall regulatory background on air passenger rights also includes other legislation, for 
example:  Regulation  1008/2008,  on  common  rules  for  the  operation  of  air  services  in  the 
Community; Directive 96/67, which defines the conditions for access to the ground-handling 
market at European airports, and therefore could be used as leverage to improve the quality of 
baggage handling in order to prevent baggage damage or mishandling; and Regulation (EC) 
No 2111/2005 of the European Parliament and of the  Council of 14  December 2005 on the 
establishment  of  a  Community  list  of  air  carriers  subject  to  an  operating  ban  within  the 
Community  and  on  informing  air  transport  passengers  of  the  identity  of  the  operating  air 
carrier, and repealing Article 9 of Directive 2004/36/EC. 

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6.1.2.  Report on the work done 

The  Commission  continued  its  efforts  to  guarantee  the  correct  implementation  of  the 
provisions protecting passengers' rights in the following modes of transport: 

Rail Transport  

Two meetings with NEB in charge of the application of Regulation 1371/2007 took place in 
January and November. 

Preliminary  interpretative  guidelines  of  the  main  provisions  of  Regulation  1371/2007  have 
been prepared.  

Maritime and inland waterways Transport  

Regulation (EU) 1177/2010 on passenger rights in maritime and inland waterways transport 
has been adopted and published in December 2010. It will apply as from December 2012. 

Coach and Bus Transport 

After an agreement was reached on 30 November 2010 in conciliation between the Council 
and the European Parliament, Regulation (EU) 181/2011 concerning the rights of passengers 
in bus and coach transport has been published in February 2011 and will apply as from March 
2013.  

Air Transport  

legislation, 

Regarding  Passengers  rights 
towards  a 
homogeneous  application  of  the  relevant  Regulations  in  all  the  Member  States.  The 
Commission  has  been  constantly  in  contact  with  Member  States  to  ensure  the  good 
application of all legal developments in the field of APR, in the light of the recent case law 
from the European Court of Justice (rulings C-402/07 and C-432/07, Sturgeon and Others and 
follow up of the case C-549/07, Wallentin-Hermann). 

the  Commission  kept  working 

As a consequence of the ash cloud crisis of April 2010 and in order to alleviate its impact on 
the  industry,  interpretative  guidelines  on  the  application  of  Regulation  261/2004  in  the 
framework of the ash crisis have been agreed with all NEBs (National Enforcement Bodies). 
Two ad-hoc meetings in the framework of the volcano crisis as well as a regular meeting took 
place with NEBs of Regulation 261/2004; one meeting took place with NEBs of Regulation 
1107/2006.  

Three studies on air passenger rights (APR) legislation have been concluded in 2010: 1) study 
on  the  application  of  Regulation  261/2004,  2)  study  on  the  application  of  Regulation 
1107/2006, 3) study on national penalty schemes on Regulation 1107/2006. 

Two  Commission  communications  on  APR  have  been  prepared  for  adoption  in  2011:  a 
communication  (ex  post  assessment)  on  Regulation  261/2004  as  well  as  a  communication 
(application  report)  on  Regulation  1107/2006.  The  communication  on  Regulation  261/2004 
will  be  accompanied  by  a  staff  working  paper  on  national  measures  of  enforcement  of  the 

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Regulation.  

A  public  consultation  on  five  pieces  of  APR  legislation,  which  was  launched  in  December 
2009,  was  carried  out  in  early  2010.  A  stakeholder  hearing  to  present  the  results  was 
organised on 28/6.  

Public Service Obligations (Regulation 1370/2007)  

A general contract on a study concerning the application of the Regulation has been launched 
and  followed  up.  A  specific  contract  on  the  interpretation  of  the  main  provisions  of  the 
Regulation has been executed.  

There  have  been  regular  contacts  with  national  authorities  (+/-  10  Member  States)  and 
stakeholders. 

Information Campaign on passenger rights 

A  Europe  wide  information  campaign  to  raise  citizen's  awareness  of  their  rights  when 
travelling was launched in Brussels  on  29  June. The information  campaign is  carried out in 
cooperation with a contractor and includes the setting up of a specific website, the production 
of  video  clips,  information  brochures  and  gadgets  such  as  luggage  tags  as  well  as  the 
participation in events such as travel fairs etc. Four events in Member States capitals (DE, SE, 
UK, BG) have already been organised between September and December 2010.  

6.1.3.  Evaluation of the current position 

The  Commission  works  actively  to  promote  the  application  and  enforcement  of  the  current 
regime  of  protection  of  passenger  rights  by  monitoring  national  authorities  and  by  enabling 
them to exchange best practice. Meetings and workshops are organized on a regular basis with 
stakeholders. Inquiries from citizens received are analysed either by the Commission services 
themselves or by the Europe Direct Contact Centre (EDCC) with whom the Commission has 
concluded  a  specific  contract  in  order  to  cope  with  the  high  number  of  citizens'  inquiries, 
mainly  in  the  field  of  air  and  rail  passenger  rights.  In  addition,  the  Commission  monitors 
studies and consultations to have a better view of the opinion of the public on these matters. 

However, the outcome of these actions show that full implementation and enforcement of the 
regulations  protecting  passenger  rights  is  not  yet  sufficiently  ensured  in  all  situations  and 
Member  States  and  further  efforts  are  requested  both  by  national  authorities  and  by  the 
industry. 

6.1.4.  Evaluation results 

Air transport 

The results from the various studies, consultations, surveys etc. have provided valuable which 
can  be  generally  summarized  in  the  following  three  main  conclusions:  1.)  Given  the 
complexity of the Regulation and a lack of definition of some controversial terms, there is still 
a  lack  of  uniform  interpretation  by  co-legislators  (although  the  CJEU  rulings  as  well  as  the 

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interpretative guidelines from the Commission have provided some clarity); 2.) Enforcement 
throughout  the  EU  is  still  not  carried  out  in  a  uniform  manner,  although  it  has  improved 
thanks  to  the  Commission  efforts  and  increasing  cooperation  between  and  from  NEB.  3.) 
There  is  still  a  lack  of  awareness  by  passengers  about  their  rights  and  how  to  claim  them 
through easily accessible complaint handling procedures and effective means of redress (this 
is one of the reasons for the launch of the information campaign for passengers in 2010). 

Rail Transport 

The information campaign with the aim of informing all EU passengers on the rights that they 
enjoy  pursuant  to  EU  legislation  on  passengers'  rights  highlights  in  particular  the  EU  rail 
passenger rights which derive from Regulation 1371/2007.  

The Commission has continued to keep close contacts with the NEBs ("National Enforcement 
Bodies")  already  designated  and  has  requested  those  Authorities  that  are  lagging  behind  to 
designate  NEBs  in  order  to  ensure  an  effective  enforcement  of  rail  passengers'  rights  as 
established by the Regulation.  

6.1.5.  Sector summary 

In  line  with  the  overall  Commission  political  strategy  to  put  citizens  at  the  heart  of  Europe 
and also according to the priorities set out in the future White Paper on Transport Policy the 
priority  for  passenger  rights  remains  guaranteeing  the  full  and  effective  application  of 
passenger rights in all modes of transport. With the adoption of legislation for maritime and 
land transport (bus and coach) in 2010, a legislative framework providing a minimum set of 
rights in all modes has now been achieved. The objective of the White Paper on Transport of 
2001 to put the citizen at the heart of this policy has hence been achieved. 

This  legislative  framework  offers  a  more  and  more  effective  regime  of  protection  to 
passengers within the EU. The  main objective for 2011 consists in the consolidation of this 
framework, by harmonising application and enforcement across Member States, by providing 
interpretative  guidance  to  all  relevant  parties  and  by  raising  awareness  among  passengers 
about their rights. An impact assessment will be launched in 2011 to evaluate the impact of 
various  policy  options  regarding  the  application  of  Regulation  261/2004,  including  the 
implications of recent case law of the ECJ. 

6.2. 

Inland Waterway Transport 

6.2.1.  Current position 

6.2.1.1.  General introduction 

Inland waterway transport plays an important role for the transport of goods in Europe. More 
than 37 000 kilometres of waterways connect hundreds of cities and industrial regions. Some 
20  out  of  27  Member  States  have  inland  waterways,  12  of  which  have  an  interconnected 
waterway networks. The potential for increasing the modal share of inland waterway transport 
is  significant.  Compared  to  other  modes  of  transport  which  are  often  confronted  with 
congestion  and  capacity  problems,  inland  waterway  transport  is  characterized  by  its 
reliability, its low environmental impact and its major capacity for increased exploitation.  

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The main pieces of acquis in this field are the following:  

• 

• 

Directive  2006/87/EC  of  the  European  Parliament  and  of  the  Council  of  12 
December 2006 laying down technical requirements for inland waterway vessels, as 
amended.  It  establishes  harmonised  conditions  for  issuing  technical  certificates  for 
inland waterway vessels. It is aimed at increasing the safety of passengers and freight 
transport  by  inland  waterway  in  Europe.  This  Directive  repealed  and  replaced 
Directive 82/714 as from 30th December 2008; 

Directive  2005/44/EC  on  harmonised  river  information  services  (RIS)  on  inland 
waterways in the EU. It established a framework for the deployment and use of RIS 
in  the  EU  and  for  the  establishment  and  further  development  of  technical 
requirements  and  specifications  for  harmonised  and  interoperable  RIS.  It  defines 
further  the  minimum  requirements  to  be  fulfilled  by  Member  States  to  enable  the 
setting-up of RIS.  

6.2.1.2.  Report on the work done in 2010 

In 2010, the acquis was further developed. 

A  follow-up  of  the  transposition  of  Directive  2005/44  was  performed  and  continuous 
monitoring  of  the  implementation  of  the  Directive  was  ensured  via  frequent  meetings  with 
Member States' authorities and stakeholders, expert group meetings and conformity checks. A 
Commission  Regulation  defining  technical  specifications  was  discussed  and  amendments  of 
existing  Commission  Regulations  defining  technical  specifications  were  prepared.  The 
process of ensuring the proper implementation of the Directive will continue along the same 
line. 

The  technical  Annexes  to  Directive  2006/87/EC  laying  down  technical  requirements  for 
inland  waterway  vessels  continued  to  be  further  aligned  with  legislation  agreed  in  the 
framework  of  the  Central  Commission  for  Navigation  on  the  Rhine.  For  this  purpose  4 
meetings of the Joint meeting of experts from EU Member State and the Central Commission 
for Navigation on the Rhine were held. A study has been commissioned and finalised on the 
subject of approval of three classification societies.  

For the proper implementation of the Directive, regular communication with Member States is 
maintained. Workshops have been attended in Member States and a number of questions from 
citizens and inspection bodies were answered. Good cooperation with the International River 
Commissions  and  the  UN-ECE  on  technical  requirements  for  inland  waterway  vessels  was 
kept.  

6.2.2.  Evaluation of the current position 

The  situation  keeps  evolving,  and  an  increased  workload  is  foreseen  due  to  necessary 
legislative developments. Four infringement procedures had been launched (United Kingdom, 
Poland,  Luxembourg  and  Germany)  due  to  the  fact  that  the  transposition  deadline  for  new 
directives  had  elapsed.  Due  to  positive  reactions  from  the  mentioned  Member  States,  these 
procedures have been closed. 

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6.2.3.  Evaluation results 

As in the past, priority will be given to strengthening the competitive position of the inland 
waterway transport in the transport system and to facilitate its integration into the intermodal 
logistics chain.  

Directive  2006/87/EC  should  be  amended  following  the  agreement  reached  on  several 
subjects in the technical working party which will be adopted after a favourable opinion of the 
Committee. The procedure for the recognition of classification societies has to be completed. 
The  relation  with  the  River  Commissions,  and  especially  the  shared  secretariat  of  the  Joint 
Working Group, should be reflected upon. A seminar on the interpretation of requirements in 
the annexes of Directive 2006/87/EC is to be organised. This was already the subject of the 
seminar in 2008 in Budapest to prepare Inspection Bodies from Member States. The Directive 
is in force since the end of 2008 and experiences from inspection bodies with difficulties in 
interpreting the requirements are appearing. This requires again a Joint Seminar of Inspection 
Bodies from the Member State of the Danube Commission, the Central Commission for the 
Navigation  on  the  Rhine  and  the  EU.  Such  seminar  was  foreseen  in  2010  but  has  been 
postponed till 2011. 

Infringement procedures have been closed against Member States not having transposed the 
Directive 2006/87 and its amendments. 

6.2.4.  Sector summary 

With a view to strengthening the competitive position of the inland waterway transport in the 
transport system, and to facilitate its integration into the intermodal logistic, the Commission 
will  consider  reinforcing  its  administrative  capacity  in  order  to  keep  developing  the 
harmonisation of additional technical requirements on zone 1 and 2, on the one hand, and to 
monitor the individual implementation of Directive 2006/87, as amended, on the other hand. 

6.3.  Maritime Transport - Internal market 

6.3.1.  Current position 

6.3.1.1.  General introduction 

The  principle  of  freedom  to  provide  services  had  been  applied  to  the  maritime  transport 
services gradually. The liberalisation of intra-EU maritime transport preceded by a few years 
the liberalisation of maritime transport within Member States (maritime cabotage). The main 
pieces of the acquis in this field are the following: 

• 

Council Regulation (EEC) No 4055/86 of 22 December 1986 applying the principle 
of  freedom  to  provide  services  to  maritime  transport  between  Member  States  and 
between  Member  States  and  third  countries  (OJ  L  378  of  31.12.1986,  p.1-3).  The 
Regulation  gives  Member  State  nationals  (and  non-EU  shipping  companies  using 
ships  registered  in  a  Member  State  and  controlled  by  Member  State  nationals)  the 
right to  carry  passengers or goods by sea between any port of a Member  State  and 
any port or off-shore installation of another Member State or of a non-EU country.  

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• 

Council Regulation (EEC) No 3577/92 of 7 December 1992 applying the principle of 
freedom  to  provide  services  to  maritime  transport  within  Member  States  (maritime 
cabotage),  (OJ  L  364  of  12.12.1992,  p.  7-10).  This  Regulation  grants  freedom  to 
provide maritime transport services within a Member State (maritime cabotage) for 
EU ship owners operating ships registered in a Member State and flying the flag of 
that  Member  State,  subject  to  these  ships  complying  with  all  the  conditions  for 
carrying  out  cabotage  within  that  Member  State.  While  liberalising  the  cabotage 
services, the Regulation takes into account the issue of public service obligations, in 
view  of  ensuring  that  islands  and  far  distant  maritime  regions  have  adequate 
connections with the mainland territories. 

6.3.1.2.  Report on the work done in 2010 

During 2010 the Commission continued monitoring the correct application of Regulation N° 
4055/86.  In  terms  of  thematic  areas,  the  Commission  focused  on  ensuring  respect  of  the 
principle of non-discrimination in regard to port dues. In the framework of this exercise, the 
Commission  decided  to  take  action  before  the  Court  of  Justice  and  on  4  February  2010  the 
Court  issued  its  judgment  sanctioning  the  discriminatory  system  of  port  dues  charged  by 
Spain (Case C-18/09).  

As regards Regulation N° 3577/92, following the complaints it has received, the Commission 
scrutinised national legislation of four Member States with the objective to ensure compliance 
with the principle of non-discrimination between ship owners, and assisted Member States in 
aligning their legislation with the provisions of the Regulation. 

In  2010  the  Commission  continued  to  support  accession  countries,  in  particular  Croatia,  in 
their efforts to align to and implement the relevant acquis. 

Furthermore, work has started on preparing a new interpretative communication on maritime 
cabotage. The Commission has published its first interpretative communication on maritime 
cabotage in 2003 (amended in 2006). However, following the consultation on the fifth report 
on  maritime  cabotage  undertaken  in  2009,  it  became  apparent  that  the  interpretation  of 
Regulation  3577/92  still  raises  questions  and  requires  further  clarification.  The  new 
communication will update the 2003 communication in line with the experience gained during 
practical application of Regulation and include recent developments in the EU law and case-
law.  

6.3.2.  Evaluation of the current position 

Compared  to  the  liberalisation  of  intra-EU  maritime  transport,  which  traditionally  has  been 
rather liberal and open to competition across the EU even before the adoption of Regulation 
N°4055/86,  the  liberalisation  of  maritime  cabotage  required  substantial  changes  in  the 
legislation of several Member States which used to reserve the provision of cabotage only to 
national ship owners.  

After the end of transitional periods in 2004, Regulation No 3577/92 has been fairly evenly 
implemented  across  the  EU.  However,  there  still  exists  a  need  to  monitor  the  national 

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provisions concerning public service contracts and obligations in order to ensure full respect 
of the principle of non-discrimination between ship owners. 

6.3.3.  Evaluation results 

6.3.3.1.  Priorities 

The  priorities  for  the  Commission  in  achieving  the  internal  market  in  maritime  transport 
services  consist  in  continuing  monitoring  and  helping  Member  States  to  implement  the 
relevant acquis.  

6.3.3.2.  Planned action 

The main objective for 2011 is to publish a new interpretative communication (updating and 
clarifying the one of 2003) and the fifth report on the application of Regulation No 3577/92.  

6.3.4.  Sector summary 

The  priority  remains  guaranteeing  the  full  application  of  the  freedom  to  provide  services  to 
maritime transport between Member States and within Member States (maritime cabotage). 

6.4.  Maritime Safety 

6.4.1.  Current position 

6.4.1.1.  General introduction 

The  maritime  safety  EU  acquis  aims  at  enhancing  the  safety  of  ships  in  European  waters, 
protecting the marine environment and ensuring appropriate living and working conditions on 
board. The main relevant pieces of legislation in this area are: 

• 

• 

Directive  2009/15/EC  of  the  European  Parliament  and  of  the  Council  of  23  April 
2009  on  common  rules  and  standards  for  ship  inspection  and  survey  organisations 
and for the relevant activities of maritime administrations, (OJ L 131 of 28.5.2009, p. 
47).  This  directive  addresses  the  responsibility  of  Member  States  as  flag  States  by 
establishing  measures  to  be  followed  by  the  Member  States  and  organisations 
concerned with the inspection, survey and certification of ships for compliance with 
the international conventions on safety at sea and prevention of marine pollution; 

Council Directive 95/21/EC of 19 June 1995 on port State control of shipping (OJ L 
157 of 7.7.1995, p.1), repealed on 31/12/2010 and replaced by Directive 2009/16/EC 
of the European Parliament and of the Council of 23 April 2009 on port State control 
(OJ  L  131  of  28.5.2009,  p.  57).  The  directive  sets  out  rules  applicable  to  Member 
States  in  their  capacity  of  port  States.  It  provides  for  increased  compliance  with 
international  and  relevant  Community  legislation  on  maritime  safety,  protection  of 
the marine environment and living and working conditions on board ships of all flags 
and  for  the  establishment  of  common  criteria  for  control  of  ships  by  the  port  State 
and harmonised procedures on inspection and detention; 

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• 

Directive  2002/59/EC  of  the  European  Parliament  and  of  the  Council  of  27  June 
2002 establishing a Community vessel traffic monitoring and information system (OJ 
L  208  of  5.8.2002,  p.  10),  recently  amended  by  Directive  2009/17/EC  of  the 
European Parliament and of the Council of 23 April 2009 (OJ L 131 of 28.5.2009, 
p.101).  The  system  established  in  accordance  with  this  directive  aims  at  improving 
the  response  of  the  authorities  to  incidents,  accidents  and  potentially  dangerous 
situations at sea, including search and rescue operations, and at better preventing and 
detecting pollution by ships.  

Other relevant legislation includes directives on: 

•  marine equipment (Directive 96/98/EC as amended),  

•  harmonised  safety 

rules  and  standards 

for  passenger  ships 

(Directive 

2009/45/EC),  

•  safety regime for fishing vessels (Directive 97/70/EC), 

•  safe loading and unloading of bulk carriers (Directive 2001/96/EC),  

•  registration of persons on board passenger ships (Directive 98/41/EC),  

•  mandatory  surveys  for  the  safe  operation  of  regular  ro-ro  ferry  and  high  speed 

passenger craft services (Directive 99/35/EC),  

•  enforcement of seafarers hours of work (Directive 1999/95/EC),  

•  stability requirements for ro-ro passenger ships (Directive 2003/25/EC),  

•  accident investigation (Directive 2009/18),  

•  insurance of ship owners for maritime claims (Directive 2009/20/EC),  

•  compliance with flag State requirements (Directive 2009/21/EC). 

The following Regulations are also part of the acquis: 

•  accelerated phasing-in of double hull or equivalent design oil tankers (Regulation 

(EC) n° 417/2002),  

•  prohibition of organotin compounds on ships (Regulation (EC) n° 782/2003),  

•  transfer  of  cargo  and  passenger  ships  between  registers  within  the  Community 

(Regulation (EC) n° 789/2004),  

•  common  rules  and  standards  for  ship  inspection  and  survey  organisations 

(Regulation (EC) No 391/2009),  

•  liability of carriers of passengers by sea (Regulation (EC) No 392/2009).  

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Finally,  environment-related  directives  on  port  reception  facilities  for  ship-generated  waste 
(Directive 2000/59/EC) and on ship-source pollution and on the introduction of penalties for 
infringements  (Directive  2005/35/EC  as  amended  by  Directive  2009/123)  should  also  be 
listed. 

6.4.1.2.  Report of the work done in 2010 

The  Committee  on  Safe  Seas  (COSS)  set  up  under  Regulation  (EC)  no.  2099/2002  met  in 
March,  May,  July,  September  and  December.  The  meetings  provided  the  opportunity  for 
Commission services to discuss with representatives of Member States virtually all aspects of 
maritime  safety.  Favourable  opinions  were  issued  on  several  proposed  texts  (marine 
equipment,  recognition  of  classification  societies,  port  State  control,  implementation  of  the 
International Safety Management Code, training of seafarers, establishment of criteria for the 
use by LNG carriers of technological methods as an alternative to using low sulphur marine 
fuels and vessel traffic monitoring system). 

Regular  meetings  on  maritime  policy  took  place  in  2010    with  Member  States.  These 
meetings also provided an opportunity to foster clarification and better implementation of the 
acquis.  

The  High  Level  Steering  Group  on  SafeSeaNet,  set  up  in  July  2009  in  accordance  with 
Directive 2002/59/EC on vessel traffic monitoring141, also met in June and in October 2010 to 
discuss issues related to this maritime information exchange system with a view to improving 
its effectiveness.  

The European Maritime Safety Agency continued its broad program of inspection visits in the 
Member States. This program was initiated in 2004 at the request and in co-operation of the 
Commission  and  it  currently  covers  the  following  areas:  classification  societies,  training  of 
seafarers,  port  State  control,  port  reception  facilities  and  vessel  traffic  monitoring  and 
information systems (started in March 2009). The reports produced by the EMSA teams serve 
as basis for further Commission follow-up with the Member States either through requests for 
clarification or the launching of infringement procedures. In an area where there is a reduced 
number  of  complaints  received  from  citizens  or  enterprises,  these  inspections  are  of  great 
value  to  the  Commission  as  they  allow  it  to  assess  how  the  EU  maritime  safety  acquis  is 
implemented in the Member States. 

The number of infringement procedures declined in 2010 from around 40 at the beginning of 
the year to around 20 at the end of 2010. This was essentially due to the corrective measures 
introduced by Member States in order to improve the quality of the transposition of the acquis 
and its implementation, following pre-judicial initiatives by the Commission. The remaining 
procedures concern essentially port State control issues. They will be affected by the change 
of  legislation  on  1  January  2011  (date  of  implementation  of  the  new  port  State  control 
Directive n°2009/16/EC). 

141 

Commission Decision of 31 July 2009 establishing the High Level Steering Group on SafeSeaNet (OJ L 
201 of 1/8/2009, p.63). 

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6.4.2.  Evaluation of the current position 

The  EU  maritime  safety  law  is  relatively  young.  This  is  all  the  more  true  as  it  was 
significantly completed and renewed in May 2009 with the publication of the Third Maritime 
Safety  package  comprising  two  Regulations  and  six  Directives,  two  of  which  had  to  be 
transposed  by  the  end  of  2010.  It  is  however  based  on  international  conventions  and  other 
instruments,  for  some  of  which  there  is  considerable  implementation  experience  in  the 
Member  States.  Current  implementation  situation  thus  ranges  from  relatively  stable,  whilst 
not  yet  entirely  acceptable  (for  instance,  for  Directive  95/21/EC  on  port  State  control  of 
shipping which is closely related to the rules of the Paris MOU to which most Member States 
have been party to for several years) to more difficult cases as Directive 2000/59/EC on port 
reception facilities, where key provisions such as those on the coverage of costs by all ships, 
the  monitoring  of  deliveries  and  the  performance  of  inspections  are  still  implemented 
unevenly throughout the EU. 

The  situation  tends  to  become  more  complex  as  it  is  imperative  to  ensure  a  smooth 
implementation of the Third Maritime Safety Package. This package covers a broad range of 
issues,  some  of  which  consist  of  improvements  of  current  acquis  (port  State  control,  vessel 
traffic  monitoring  and  information  system,  classification  societies),  while  others  are 
essentially  new  (accident  investigation,  Flag  State  obligations,  liability  of  carriers  of 
passengers by sea, insurance of ship owners).  

6.4.3.  Evaluation results 

6.4.3.1.  Priorities 

There  is  a  clear  continuity  in  the  efforts  to  ensure  an  appropriate  transposition  and 
implementation of the maritime safety acquis. In terms of thematic areas, emphasis continues 
to  be  put  on  the  traditional  areas  of  the  monitoring  of  classification  societies  and  of  the 
implementation  of  directives  on  the  training  of  seafarers,  port  State  control,  vessel  traffic 
monitoring  and  information  system,  port  reception  facilities  and  ship  source  pollution  and 
penalties. Particular attention was given to the effort by Member States to ensure timely and 
adequate  transposition  and  implementation  of  the  Third  Maritime  Safety  Package.  Member 
States lagging behind will be pursued in 2011 and the transposition measures adopted will be 
checked.  The  Commission  will  also  continue  to  rely  on  the  systematic  assessment  of 
implementation in the Member States based on the inspections by EMSA to be followed by 
contacts with Member States and, when appropriate, direct pre-judicial initiatives.  

A pre-emptive approach is also taken in relation to the alignment to and implementation of the 
acquis  by  accession  countries,  in  particular  Croatia,  through  dialogue  and  assessment  of 
administrative capacity (visit of EMSA at the end of 2010). 

6.4.3.2.  Planned action 

Contact  with  national  administrations  will  be  ensured  through  COSS  meetings  as  well  as 
meetings of the High Level Steering Group on SafeSeaNet. Particular attention will be given 
to the transposition and implementation of the newest legislation. 

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Follow-up of EMSA inspection reports will be ensured leading to clarification actions and/or 
infringement procedures in the key areas mentioned under point 1. 

6.4.4.  Sector summary 

The  monitoring  and  promotion  of  the  implementation  of  the  maritime  safety  acquis 
concentrates  on  the  traditional  key  areas  (classification  societies,  training  of  seafarers,  port 
State control, vessel traffic monitoring and information system and port reception facilities). 
Dialogue with Member States continues in different fora (COSS, meetings with the Directors-
Generals  of  national  administration,  SSN,  technical  co-operation  through  EMSA).  When 
appropriate, infringement procedures are also undertaken. Considerable effort is to be devoted 
to  controlling  the  implementation  of  the  new  acquis  (Third  Maritime  Safety  Package 
published  in  May  2009)  with  a  view  to  ensuring  its  correct  implementation  by  all  Member 
States. 

6.5.  Maritime Security 

6.5.1.  Current position 

6.5.1.1.  General introduction 

The  main  objective  of  the  EU  legislation  on  Maritime  Security  is  to  implement·  measures 
aimed  at  enhancing  ship,  port  facility  and  port  security  in  the  face  of  the  threats  posed  by 
intentional  unlawful  acts.  The  EU  legislation  intends  to  provide  a  basis  for  harmonised 
interpretation  and  implementation  of  international  measures  to  enhance  maritime  security 
adopted by the International Maritime Organization (IMO) in 2002, with the establishment of 
the International Ship and Port Facility Security Code (ISPS Code) and the ILO142/IMO Code 
of Practice on Security in Ports. 

The main pieces of Community acquis in this field are the following: 

• 

• 

142 
143 

144 

Regulation (EC) No 725/2004143 of the European Parliament and of the Council of 
31  March  2004  on  enhancing  ship  and  port  facility  security:  The  Regulation  takes 
into account amendments to the 1974 International Convention for the Safety of Life 
at Sea (the SOLAS Convention). The maritime security measures established by the 
Regulation are only some of the measures necessary in order to achieve an adequate 
level  of  security  across all  parts  of  maritime  transport.  The  Regulation  is  limited  in 
scope to security measures onboard vessels and the immediate ship/port interface. 

Directive 2005/65/EC144 of the European Parliament and of the Council of 26 October 
2005  on  enhancing  port  security:  The  Directive 
the 
recommendations contained in the ILO/IMO Code of Practice on Security in Ports. 

is  mainly  based  on 

International Labour Organization. 
Regulation  (EC)  No  725/2004  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on 
enhancing ship and port facility security, OJ L 129, 29.4.2004, p. 6. 
Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing 
port security, OJ L 310, 25.11.2005, p. 28. 

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• 

The  Directive  completes  the  mechanism  provided  for  under  the  Regulation  by 
establishing  a  security  system  for  all  port  areas,  in  order  to  ensure  a  high  and 
comparable  level  of  security  for  all  European  ports.  The  aim  of  the  Directive  is  to 
improve security in port areas not covered under the Regulation and to ensure that the 
enhancement  of  port  security  will  support  the  security  measures  taken  under  the 
Regulation, without creating additional obligations in areas already governed by the 
Regulation. 

Regulation (EC) No 324/2008145 of 9 April 2008 laying down revised procedures for 
conducting  Commission  inspections  in  the  field  of  maritime  security:  In  2005,  in 
order to monitor the application by Member States of the Regulation and to verify the 
effectiveness of national maritime security measures, procedures and structures, the 
Commission  adopted  Regulation  (EC)  No  884/2005146,  laying  down  procedures  for 
conducting  Commission  inspections  in  the  field  of  maritime  security.  On  9  April 
2008,  the  Commission  adopted  Regulation  (EC)  No  324/2008  laying  down  revised 
procedures for conducting Commission inspections in the field of maritime security, 
which  also  laid  down  “procedures  for  the  monitoring  by  the  Commission  of  the 
implementation  of  Directive  2005/65/EC  jointly  with  the  inspections  at  the  level  of 
Member States and port facilities in respect of ports...”. This Regulation, repealing 
Regulation (EC) No 884/2005, came into force on 1 May 2008. 

6.5.1.2.  Report on the work done in 2010 

During the year 2010 the work done on monitoring the application of Community law in the 
field of maritime security had considerable developments. 

• 

• 

The  Maritime  Security  Committee  (MARSEC)  met  5  times  which  provided 
occasions to discuss with the Member States issues in the common interpretation of 
the security standards defined at the international level. The common interpretation 
issues are recorded in a manual regularly updated. Furthermore, these issues are also 
addressed  with  the  stakeholders  from  the  advisory  group  on  maritime  security 
(SAGMaS). 

Concerning  the  implementation  of  the  Port  Security  Directive,  the  majority  of  the 
Member States required to transpose the provisions of the Directive only did it after 
the deadline (15 June 2007) had passed. Taking into account the initial delays in the 
transposition into national laws, it occurs clearly that the effective implementation in 
all the EU ports could not be entirely completed within particularly short times. 

Upon  request  of  some  Member  States,  the  Commission  organised,  on  21  October  2010,  a 
seminar  on  the  implementation  of  the  Port  Security  Directive,  which  19  Member  States 
attended (plus Norway, Iceland and the EFTA Surveillance Authority). This seminar was the 
second  event  after  a  first  workshop  held  in  September  2006  in  order  the  help  the  Member 
States in implementing the Directive. The purpose of the seminar was to give Member States 

145 

146 

Commission  Regulation  (EC)  No  324/2008  of  9  April  2008  laying  down  revised  procedures  for 
conducting Commission inspections in the field of maritime security, OJ L 98, 10.4.2008, p. 5. 
Commission  Regulation  (EC)  No  884/2005  of  10  June  2005  laying  down  procedures  for  conducting 
Commission inspections in the field of maritime security, OJ L 148, 11.6.2005, p. 25. 

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an opportunity  for  exchanging views, experiences and information  as  well  as  for discussing 
pertinent issues with regards the implementation of Directive 2005/65/EC.  

• 

In  2010,  the  Commission's  services  carried  out  126  inspections  in  the  field  of 
maritime  security.  The  inspections  permitted  to  check  the  implementation  of  the 
security  legislation  on  the  ground  by  the  operators  concerned,  as  well  as  the 
supervision of it by the Member States. The inspections have been focused mainly on 
port  facilities  and  ships  in  order  to  check  that  assessments  and  security  plans  have 
been  drawn  up  in  line  with  Regulation  (EC)  No 725/2004,  that  they  have  been 
effectively  implemented  on  the  ground,  and  that  the  national  authorities  are 
conducting the necessary inspections and checks.  

6.5.2.  Evaluation of the current position 

• 

• 

• 

Considering  the  implementation  of  the  Port  Security  Directive,  it  should  be  noted 
that the delays in preparing and adopting national transposition measures in a variety 
of  Member  States  have  had  a  knock-on  effect,  in  that  the  relevant  port  authorities 
were not able to implement the Directive until the national measures had been finally 
approved  and  adopted.  However,  on  request  of  the  Commission,  action  plans  and 
progress reports are regularly asked to Member States to understand the achievement 
of key provisions of the Directive. 

Since the end of 2008, the Commission carried out inspections for the monitoring of 
the  implementation  of  Directive  2005/65/CE  in  accordance  with  the  provisions  of 
Regulation  (EC)  No  324/2008.  These  inspections  are  conducted  jointly  with  the 
inspections to the level of Member States and port facilities. These inspections were 
carried out in 53 ports of 19 Member States. The principal failures are related to the 
port security assessments and the definition of the boundaries of the port. 

Regarding  Regulation  (EC)  No 725/2004,  the  inspection  team  reported  on  several 
occasions  a  lack  of  control  exerted  by  the  Member  States  to  check  the  correct 
application of EU legislation in the port facilities and ships under their competence. 
This will remain a priority in 2011. 

6.5.3.  Evaluation results 

The  EU  inspections  are  mainly  intended  to  verify  whether  the  legal  requirements  are  being 
properly and effectively implemented by the Member States.  

In 2010, the Commission conducted 126 inspections (71 port facilities, 15 ports, 33 ships and 
7 national administrations). Maritime security inspections have again proved to be particularly 
useful.  On  the  one  hand,  inspections  have  permitted  to  further  increase  compliance  of  the 
objects  inspected.  On  the  other  hand,  statistical  analysis  could  identify  areas  where  non-
compliance  occurs  above  average  and  maritime  security  policy  took  adequate  steps  as  a 
remedy; best practices identified during inspections were disseminated to all Member States 
as  a  very  cost-effective  way  of  further  improving  maritime  security;  the  participation  of 
national inspectors at inspections outside of their country also contributed to the exchange of 
best practice and to mutual trust building.  

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The  inspections  have  a  double  benefit.  They  highlight  vulnerabilities  and  the  remedies 
required regarding the EU legislation on maritime security. It has been noted an improvement 
of the situation following the inspections carried out.  

Furthermore,  the  working  programme  for  the  performance  of  maritime  security  inspections 
carried  out  by  the  Commission  systematically  includes  a  section  for  verifying  that  the 
procedures for monitoring the application of the Directive have been correctly applied. 

6.5.4.  Sector summary 

While  the  situation  in  maritime  security  sector  is  demonstrating  the  benefits  of  harmonised 
rules,  enhancing  ship,  port  facility  and  port  security  in  the  face  of  the  threats  posed  by 
intentional unlawful acts, there are still a number of areas where some obstacles to efficient 
maritime security persist. 

The efforts are concentrating in ensuring an efficient implementation of the existing maritime 
security legislation, by combining action in two fields: 

• 

• 

permanent contact with national administrations on the one hand through the work of 
the Maritime Security Committee and on the other hand in the context of preparation 
and follow up of inspections; 

based on the results of the inspections carried out by the Commission and on the on-
going  conformity  checks,  an  action  plan  identifying  the  main  areas  where  there  is 
failure  to  comply  with  the  Directive  and  Regulation  will  be  the  basis  for  initiating 
different actions, including infringement proceedings as necessary. 

6.6. 

Inland Transport 

6.6.1.  Current position 

6.6.1.1.  Road Transport sector 

In road transport the control of the application of EU law centred on the correct transposition 
by  Member  States  of  the  social  rules,  including  working  time  (Directive  2006/22/EC147, 
Directive  2009/4/EC148,  Directive  2009/5/EC149,  Directive  2002/15/EC150),  of  rules  on  road 
charging (Directive 2006/38/EC151 amending the Directive 1999/62/EC152) and of rules on the 
mutual  recognition  of  professional  qualifications  and  freedom  of  establishment  (Directive 
96/26/EC153). 

147 
148 
149 
150 
151 
152 
153 

OJ L 102, 11 April 2006, p. 35. 
OJ L 21, 24 January 2009, p. 39. 
OJ L 29, 31 January 2009, p. 45. 
OJ L 80, 23 March 2002, p. 35. 
OJ L 157, 9 June 2006, p. 8. 
OJ L 187, 20 July 1999, p. 42. 
OJ L 124, 23 May 1996, p. 1. 

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As regards the transposition of Directive 2006/22/EC the Commission pursued infringement 
proceedings  initiated  in  the  previous  years  against  five  Member  States  who  failed  to 
communicate  the  transposition  measures  or  who  did  not  properly  transpose  the  measures  of 
the Directive154. The proceedings against one of those Member States were initiated because 
of failure to implement the Directive which had been already declared by the Court in 2009. 
The Member States in question at last communicated their transposition in the course of the 
year and the cases have been closed. 

As  regards  working  time  in  road  transport,  the  Commission  continued  the  control  of 
implementation  concerning  the  Directive  2002/15/EC  where  only  one  Member  State  (The 
Netherlands)  was  not  in  conformity  and  this  led  to  initiating  infringement  proceedings  in 
2008. The case was assessed in-depth and could be closed in 2010. 

In 2008 the Commission had adopted a proposal to modify Directive 2002/15/EC. The aim of 
this  proposal  was  four-fold:  to  clearly  put  false  self-employed  drivers  in  the  category  of 
mobile  workers,  to  exclude  genuine  self-employed  drivers  from  the  directive,  to  make  the 
enforcement  more  harmonised  and  to  clarify  the  night  time  provisions.  Since  the  European 
Parliament rejected the Commission proposal in June 2010, the Commission started enquiries 
with  Member  States  about  the  transposition  of  the  Directive  2002/15/EC  concerning  the 
application to self-employed drivers. 

As regards Directive 2009/4/EC and Directive 2009/5/EC on social rules and tachograph the 
Commission  has  opened  infringement  proceedings  against  four  Member  States155  but  all  of 
them  had  been  closed  since  the  Member  States  communicated  the  transposition  measures 
already in the course of 2010. 

As  regards  Directive  96/26/EC  on  admission  to  the  occupation  the  Commission  continued 
proceedings against two Member States156 where the cases are still under proceeding. 

6.6.1.2.  Rail Transport sector 

Rail Transport sector 

Member  States  had  to  transpose  the  Directives  of  the  first  railway  package  (91/440/EEC  as 
amended, 95/18/EC as amended and 2001/14/EC) by 15 March 2003 or upon accession in the 
case of the new Member States. The first railway package defines basic requirements such as 
the independence of the essential functions of an infrastructure manager from rail operators, 
the charging scheme for infrastructure charges, the setting up of rail regulatory bodies. On this 
basis, it provides for the opening of the rail freight market to all EU-licensed operators, from 
2003 on the Trans European Rail Freight Network, from 1 January 2006 for all international 
rail freight transport and from 1 January 2007 for all rail freight transport. 

154 

155 

156 

Italy, Malta, Austria, Luxembourg were not in conformity. Portugal did not communicate the measures 
and a procedure under Art. 260 TFEU was initiated since there was a previous judgment under Art. 258 
TFEU. 
Bulgaria, Cyprus and Czech Republic for Directive 2009/4/EC and Bulgaria, Cyprus and Slovakia for 
Directive 2009/5/EC. 
Germany and Belgium. 

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The Commission adopted on 3 May 2006 a report on the implementation of the 1st railway 
package  (COM(2006)  189  final)  which  contained  important  findings  on  the  state  of 
implementation in the Member States and announced the criteria that the Commission would 
apply  for  controlling  implementation  in  each  individual  member  state,  in  particular  on  the 
issue of independence of essential functions.  

In  order  to  complement  the  general  findings  of  the  report  with  concrete  data  from  Member 
States, and to evaluate whether these Directives had been correctly and completely transposed 
into  Member  States'  law  and  regulations,  questionnaires  were  sent  out  to  Member  States  in 
June and November 2007. After analysing the replies to these questionnaires, the Commission 
sent letters of formal notice to 24 Member States on 27 June 2008. 

After  sending  these  letters,  the  Commission  services  met  with  representatives  from  all  24 
Member States to discuss possibilities to remedy the shortcomings identified in these letters. 
On the basis of these meetings, the replies of Member States to the letters and formal notice, 
and  after  changes  have  been  made  in  some  Member  States,  the  Commission  sent  reasoned 
opinions to 21 Member States on 6 October 2009. These reasoned opinions addressed in many 
cases a reduced number of infringements in relation to the letters of formal notice due to the 
efforts of some Member States in the meanwhile to remedy some of the infringements. 

After the analysis of the replies of the Member States to which reasoned opinions had been 
sent out in 2009, the Commission decided on 24 June 2010 to refer 13 of these Member States 
to the Court of Justice. 

Member States had to transpose the Directives on the interoperability of the rail system within 
the EU (2008/57/EC and 2009/131/EC) by 19 July 2010. The Commission opened 41 cases of 
non-communication  (letters  of  formal  notice  sent  on  20  September  2010)  concerning  these 
two directives.  

6.6.1.3.  Road Safety and Transport of Dangerous Goods sector 

The legislation on road safety covers the driving licence, the initial qualification and periodic 
training of professional drivers, roadworthiness testing, the compulsory use of safety belts, the 
registration of vehicle documents, the safety of tunnels and the safety of road infrastructure. 

The main pieces of legislation in this area are therefore: 

• 

• 

• 

• 

Directive  91/439/EEC  of  29  July  1991  on  driving  licences  as  amended  as  well  as 
Directive 2006/126/EC on driving licences (recast) as amended. 

Directive  2003/59/EC  of  15  July  2003  on  the  initial  qualification  and  periodic 
training of drivers as amended. 

Directive  2000/30/EC  of  6  June  2000  on  the  technical  roadside  inspection  as 
amended. 

Directive 2009/40/EC of 6 May 2009 on roadworthiness tests for motor vehicles and 

EN 

129 

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their trailers (recast) as amended. 

• 

• 

• 

Directive  91/671/EEC  of  16  December  1991  relating  to  compulsory  use  of  safety 
belts in vehicles of less than 3,5 tonnes as amended. 

Directive 2004/54/EC of 29 April 2004 on minimum safety requirements for tunnels 
in the Trans-European Road Network. 

Directive  2008/96/EC  of  19  November  2008  on  road  infrastructure  safety 
management. 

In  July  2010  the  Commission  adopted  a  Communication  "Towards  a  European  road  safety 
area:  policy  orientations  on  road  safety  2011-2020"  (COM(2010)389  final).  The  proposed 
policy  orientations  up  to  2020  take  full  account  of  the  results  obtained  during  the  3rd  road 
safety action programme 2001-2010 and aim to provide a general governance framework and 
challenging  objectives  which  should  guide  European,  national  and  local  strategies  for 
implementation, in line with the principle of subsidiarity.  

The year 2010 was also largely devoted to the Council negotiations on the proposed Directive 
facilitating  cross-border  enforcement  in  the  field  of  road  safety  (which  was  adopted  by  the 
Commission in March 2008). Although the discussions were blocked in Council since the end 
of 2008, work resumed under Belgian presidency in the second half of 2010 and brought to a 
positive  political  conclusion  in  first  reading  at  the  December  meeting  of  the  Transport 
Council. This breakthrough in the negotiation is an important step towards the fulfilment of 
the strategic objective concerning the increased enforcement of traffic rules, in line with the 
policy orientations on road safety for the decade 2011-2020. When adopted, this new piece of 
legislation is expected to have a strong deterrent effect by encouraging all drivers to respect 
traffic law and therefore to contribute to a further reduction of fatalities on EU roads. 

Several  committee  meetings  were  organized  by  the  Commission  during  2010  and  provided 
the opportunity for the Commission services to discuss with representatives of Member States 
their  preparation  as  regards  the  transposition  of  Directive  2006/126/EC  on  driving  licences 
and Directive 2008/96/EC on road infrastructure safety management, in view of the upcoming 
deadlines for both Directives (respectively 19 December 2010 for Directive 2008/96/EC and 
19 January 2011 for Directive 2006/126/EC). 

With  regard  to  the  Driving  License  Committee,  the  meetings  organized  during  2010  were 
focused on the state of preparation for the transposition. In addition, Member States were also 
requested  to  report  back  to  the  Commission  possible  implementation  difficulties  at  an  early 
stage. 

In the road safety sector, two past infringements were closed in 2010, namely one relating to 
the  late  transposition  of  an  amendment  to  Directive  91/439/EEC  on  driving  licences 
introduced  by  Directive  2008/65/EC,  the  other  concerning  the  incorrect  application  of 
Directive 2000/30/EC of 6 June 2000 on technical roadside inspection. 

30 new infringement proceedings were however open in 2010, all for non-communication of 
the  national  measures  transposing  Directive  2009/112/EC  of  25  August  2009  amending 

EN 

130 

   EN 

 
Council  Directive  91/439/EEC  on  driving  licences  (14  infringements)  and  Directive 
2009/113/EC  of  25  August  2009  amending  Directive  2006/126/EC  of  the  European 
Parliament  and  of  the  Council  on  driving  licences  (16  infringements).  Both  Commission 
Directives introduce amendments to the Annex III of Directive 91/439/EEC and of Directive 
2006/126/EC  regarding  minimum  standards  of  physical  and  mental  fitness  for  driving  a 
power-driven vehicle to include additional minimum requirements on eyesight, diabetes and 
epilepsy. 

6.6.2.  Evaluation 

6.6.2.1.  Road Transport 

In 2009 the legislator successfully completed the revision of the EU road transport legislation 
with the adoption of the "road package" comprising of three new regulations. Regulation (EC) 
1071/2009157 establishes common rules that road transport operators have to fulfil in order to 
be allowed  to engage in the profession. Regulation (EC) 1072/2009158 governs the rules for 
access to the international road haulage market and  in particular also the rules on cabotage. 
Finally,  Regulation  (EC)  1073/2009159  lays  down  the  rules  for  carrying  out  international 
passenger transport services by road. The new rules will apply as from December 2011 with 
the exception of the cabotage rules which became applicable in May 2010. 

Following  the  adoption  of  Commission  Regulation  1266/2009160  on  digital  tachograph,  the 
Commission organised a number of initiatives to facilitate its smooth implementation as from 
October 2011 and 2012. 

In  July  2010  the  Commission  adopted  Regulation  581/2010161  on  the  maximum  periods  for 
the  downloading  of  relevant  data  from  vehicle  units  and  from  driver  cards  in  relation  to 
Regulation (EC) No 561/2006 on harmonisation of certain social rules. The new rules apply 
as from end of July 2010. 

In  December  2010  the  Commission  adopted  Regulation  (EU)  1213/2010162  on  the  ERRU 
(European  Register  of  Road  Transport  Undertakings)  so  that  the  exchange  of  information 
through ERRU will become operational by 2013 as foreseen by the legislation. 

6.6.2.2.  Rail Transport sector 

In  the  railway  sector  the  reasoned  opinions  sent  to  21  Member  States  for  incorrect 
transposition  of  the  first  railway  package  targeted  three  main  shortcomings:  1)  the  lack  of 
independence  of  the  infrastructure  manager  in  relation  to  railway  operators,  2)  insufficient 
implementation of the rules of the Directive on track access charging, such as the absence of a 
performance  regime  to  improve  the  performance  of  the  railway  network  and  the  lack  of 
incentives of the infrastructure manager to reduce costs and charges and 3) the failure to set 

157 
158 
159 
160 
161 
162 

OJ L 300, 14 November 2009, p. 51. 
OJ L 300, 14 November 2009, p. 72. 
OJ L 300, 14 November 2009, p. 88. 
OJ L 339, 22 December 2010, p. 3. 
OJ L 168, 2 July 2010, p. 16. 
OJ L 335, 18 December 2010, p. 21. 

EN 

131 

   EN 

 
                                                 
up an independent regulatory body with strong powers to monitor competition in the railway 
sector and rule on complaints. 

6.6.2.3.  Road Safety and Transport of Dangerous Goods sector 

Despite continuous efforts undertaken by the Commission, in particular in the driving licence 
committee to underline the obligation from Member States to notify their national measures 
within  the  agreed  deadlines,  the  Commission  is  faced  with  a  regular  situation  of  late 
transposition of Directives by a significant number of Member States. 

In view of encouraging a timely transposition of Directive 2008/96/EC on road infrastructure 
safety  management  and  of  Directive  2006/126/EC  on  driving  licences,  the  Commission 
organised several committee meetings with representatives of the 27 Member States to remind 
them  of  their  transposition  obligations.  These  meetings  were  also  devoted  to  identifying, 
together with the Member States, possible implementation problems at an early stage; under 
this perspective, it was decided to set-up an expert group to review the Annexes of Directive 
2006/126/EC, which will meet several times in 2011. 

Apart  from  the  infringement  procedures,  the  Commission  is  requested  to  take  positions  on 
numerous  petitions  on  road  safety  addressed  by  citizens  to  the  European  Parliament.  They 
mainly concern the non-recognition of driving licences and the respect of road traffic laws. 

6.6.3.  Evaluation results 

6.6.3.1.  Road Transport 

For the road transport sector, following the adoption of the "road package", in May 2010 new 
amended  rules  became  applicable  in  two  areas:  road  cabotage  and  driving  times  and  rest 
periods  for  occasional  service  of  international  carriage  of  passengers.  In  both  areas  the 
Commission will continue to closely monitoring the application of the new rules by Member 
States and assists Member States' authorities as well as operators in correctly applying these 
new  regimes.  The  Commission  will  also  pay  a  particular  attention  to  the  correct 
implementation as of 10 October 2011 of the new specifications on tachograph introduced by 
Regulation 1266/2009. 

In  addition,  as  regards  the  road  transport  Directives  special  attention  will  be  given  to  the 
following areas: 

• 

• 

163 

Directive 2006/38 amending Directive 1999/62/EC on the charging of heavy goods 
vehicles  for  use  of  certain  infrastructures.  The  control  of  the  correct  application  of 
the new rules which had to be transposed by June 2008 will continue163. 

Directive 2002/15 on the organisation of working time of persons performing mobile 
road  transport  activities  as  a  consequence  of  the  rejection  of  the  Commission 
proposal by the European Parliament. 

The  following  Member  States  are  currently  under  review  as  regards  their  tolling  arrangements: 
Bulgaria, Czech Republic, France, Greece, Portugal, Romania, Slovenia, Spain, UK.  

EN 

132 

   EN 

 
                                                 
• 

• 

• 

Directive 2006/22 determining the minimum level of enforcement for the European 
provisions on driving times and rest periods, and on the use of the tachograph. After 
all Member States' transposing measures have been verified, attention will be given 
to the functioning of risk rating systems. Further potential infringement actions will 
be taken against two Member States164 who have not yet notified to the Commission 
the introduction of such system in accordance with Art. 9 of the Directive. 

Commission Decision 2009/750/EC on the definition of the European Electronic Toll 
Service (EETS) and its technical elements, and implementing Directive 2004/52/EC 
on the interoperability of electronic road toll systems. The Decision lays down rights 
and obligations on Member States, EETS providers and toll chargers. Attention will 
be given to the availability of the elements necessary for EETS to be deployed and 
enter into operation, such as the possibility for an organisation to become registered 
as  an  EETS  provider,  the  designation  or  establishment  of  Conciliation  Bodies  in 
order  to  facilitate  mediation  between  EETS  providers  and  toll  chargers.  Member 
States  having  national  electronic  toll  collection  systems  must  ensure  that  EETS  is 
available  for  all  vehicles  exceeding  3,5  tonnes  or  allowed  to  carry  more  than  nine 
passengers at the latest three years after Decision 2009/750/EC entry into force and 
for  all  other  types  of  vehicle,  at  the  latest  five  years  after  the  Decision’s  entry  into 
force. Decision 2009/750/EC entered into force the 8 October 2009. The respective 
deadlines are thus 7 October 2012 for the heavier vehicles and 7 October 2014 for all 
the other vehicles. 

Directive 2010/40/EU on the framework for the deployment of Intelligent Transport 
Systems  in  the  field  of  road  transport  and  for  interfaces  with  other  modes  of 
transport.  The  Directive  empowers  the  Commission  to  adopt  delegated  acts  in 
accordance with Article 290 of the TFEU in respect of the adoption of specifications 
for actions within the 4 priority areas referred to in Article 2 of the Directive, as well 
as for the development, where appropriate, of necessary standards. Attention will be 
given to the transposition of the Directive by 27 February 2012, and to the provision 
by  Member  Sates  of  reports  referred  to  in  article  17(1)  and  (2)  of  the  Directive. 
According to the Decision (C(2011) 289 final) of 15 February 2011 concerning the 
adoption  of 
implementation  of  Directive 
2010/40/EU,  the  Commission  will  work  in  priority  on  the  specifications  for  the 
priority actions eCall, free minimum universal information services and information 
services  for  safe  and  secure  parking,  including  appropriate  consultations  with 
Member  States  experts.  The  Commission  will  also  continue  the  implementation  of 
the  ITS  Action  Plan165,  i.a.  by  launching  several  studies  related  to  the  24  priority 
actions and supporting the work of the Urban ITS Expert Group. 

the  Working  Programme  on 

the 

6.6.3.2.  Rail Transport sector 

The  Commission  services  will  follow  the  cases  in  the  Court  of  Justice  in  order  to  achieve 
positive decisions of the Court on the interpretation of the rules of the First Railway Package. 

164 
165  

Italy and Portugal. 
COM(2008)887. 

EN 

133 

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6.6.3.3.  Road Safety and Transport of Dangerous Goods sector 

In  the  legislative  field,  the  priority  will  be  to  build  on  the  progress  made  in  2010  on  the 
negotiations  regarding  the  proposed  Directive  facilitating  cross-border  enforcement  in  the 
field of road safety, the main objective for the Commission being to facilitate an agreement in 
second reading between the two co-legislators. 

With  regard  to  infringements,  a  close  follow-up  will  be  given  by  the  Commission  to  the 
infringement  procedures  launched  in  2010  for  non-communication  of  the  national  measures 
transposing  two  Directives,  namely  Directive  2009/112/EC  of  25  August  2009  amending 
Council Directive 91/439/EEC on driving licences and Directive 2009/113/EC of 25 August 
2009  amending  Directive  2006/126/EC  of  the  European  Parliament  and  of  the  Council  on 
driving licences. 

In  addition,  two  Directives  will  require  special  attention  in  2011,  namely  Directive 
2008/96/EC on road infrastructure safety management and Directive 2006/126/EC on driving 
licences so as to ensure a timely and appropriate transposition by the Member States. Contact 
with  national  administrations  will  be  ensured  through  regular  committee  meetings  and  a 
follow-up meeting regarding the transposition of Directive 2006/126/EC will be organised in 
the  course  of  2011  (in  the  form  of  a  committee  meeting).  This  meeting  will  also  be  the 
opportunity  to  examine  with Member States possible implementation difficulties at an early 
stage. Expert group meetings on the Annexes of Directive 2006/126/EC will also be organised 
in 2011. 

6.6.4.  Sector summary 

6.6.4.1.  Road Transport 

The majority of the new rules regulating market access for transport of goods and passengers 
by  road  will  become  applicable  in  2011.  By  then  the  regulatory  framework  of  the  road 
transport sector will be modernised and streamlined. The Commission will continue to control 
the implementation and application of the social rules in close cooperation with the Member 
States.  It  will  also  continue  to  monitor  the  tolling  arrangements  in  each  individual  Member 
State.  

6.6.4.2.  Rail Transport sector 

In the rail sector and on the basis of the replies of Member States to the reasoned opinions (1st 
railway  package),  and  information  on  legislative  changes  or  commitments,  the  Commission 
will  consider  in  which  cases  it  is  necessary  to  initiate  court  procedures  in  relation  to  the  8 
cases for which no referral decision was taken yet.  

Conformity  assessments  of  national  legislation  transposing  the  Railway  Safety  Directive 
2004/49/EC  were  initiated  in  2009  and  have  been  progressing  during  2010.  Requests  for 
clarifications  of  the  national  legislation  will  be  made  to  individual  Member  States  either 
through administrative letters or the submission of queries through EU Pilot during 2011.  

The  non-communication  cases  concerning  the  interoperability  Directives  will  be  further 

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134 

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followed-up in 2011.  

6.6.4.3.  Road Safety and Transport of Dangerous Goods sector 

In  the  road  safety  sector,  special  attention  will  be  dedicated  to  the  main  issue  of  late 
notification by Member States. Efforts will continue to be undertaken to remind the Member 
States  of  their  transposition  obligations  within  the  agreed  deadlines  and  to  point  out  that 
timely,  correct  and  complete  notifications  are  a  priority  for  the  Commission  to  ensure  the 
proper functioning of EU law. Therefore, a close follow-up will be given to the infringements 
procedures initiated in 2010 for non-communication of the national measures. 

Finally, priority will also be given to the finalisation of the inter-institutional negotiation on 
the Directive facilitating cross-border enforcement in the field of road safety. 

6.7. 

Sector: Air Transport 

6.7.1.  Current position 

6.7.1.1.  General Introduction  

Single Sky and Modernisation of air traffic control 

The creation of the Single European Sky aims at achieving a better performing and seamless 
sky in Europe and is based on two successive packages of basic regulations adopted in 2004 
and completed in 2009: Regulations No 549/2004 laying down a framework for the creation 
of the Single European Sky (SES), Regulation No 550/2004 on the provision of air navigation 
services, Regulation No 551/2004 on the organisation and use of the airspace, Regulation No 
552/2004 on interoperability.  

These initial Regulations have been amended by Regulation 1070/2009 which introduced new 
concepts  such  as  a  performance  scheme  for  air  navigation  services  or  the  centralisation  of 
network management functions at European level.  

As a result of the ash cloud crisis in April 2009, the Single European Sky has been accelerated 
in order to complete the regulatory work by end of 2010 and deliver benefits at the latest by 
2012. More than twenty implementing rules have been adopted since 2004 to complement the 
basic regulations.  

The efforts of the Commission will focus in the future on the implementation of the measures.  

Air safety 

The main activities in the sector of EU air safety policy, based on Article 100(2) of the TFEU, 
are  the  revision  and  completion  of  EU  rules  in  the  field  of  air  safety,  monitoring  the 
implementation of the EU legislation and the continuous improvement of safety in the EU and 
abroad. 

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A  description  of 
http://ec.europa.eu/transport/air/safety/safety_en.htm. 

the  different 

components  of 

this  policy 

is 

available 

at 

Infrastructures and airports 

This  sector  implements  and  supervises  the  implementation  of  the  "action  plan  for  airport 
capacity, efficiency and safety" that the Commission adopted in 2007 to increase the output of 
the existing infrastructures and to optimize the planning of new infrastructures, whilst raising 
safety standards at highest levels and enhancing the environmental compatibility of airports. 
Within  this  context,  the  sector  notably  supervises  the  Community  Observatory  on  airport 
capacity which it set up in 2008. 

The sector also involves the implementation of the following legal regulatory instruments: 

• 

• 

• 

• 

Council  Regulation  (EEC)  N°  95/93  of  18  January  1993  on  common  rules  for  the 
allocation of slots at Community airports; 

Council  Directive  96/67/EC  of  15  October  1996  on  access  to  the  groundhandling 
market at Community airports; 

Directive  2009/12/EC  of  the  European  Parliament  and  of  the  Council  of  11  March 
2009 on airport charges; 

Some  of  the  requirements  of  Regulation  (EC)  No  1008/2008  on  common  rules  for 
the operation of air services in the Community (Recast). 

Aviation security 

Regulation  (EC)  No  300/2008  of  the  European  Parliament  and  of  the  Council  of  11  March 
2008  establishes  common  rules  in  the  field  of  civil  aviation  security.  It  applies  since  April 
2010  and  replaces  the  previous  aviation  security  legislation  under  Regulation  (EC)  No 
2320/2002. The Regulation is complemented by detailed implementing rules taking the form 
of  several  Commission  Regulations  and  a  Commission  Decision.  A  list  of  applicable 
legislation  is  contained  in  the  Annex.  In  particular,  the  rules  require  Member  States  to 
establish  and  implement  a  national  civil  aviation  security  programme  complemented  by  a 
quality control programme in order to ensure the application of the common basic standards 
on  aviation  security.  Member  States  also  have  to  designate  a  single  appropriate  authority 
responsible  for  the  coordination  and  the  monitoring  of  the  implementation  of  the  common 
basic  standards  and  ensure  the  availability  of  sufficient  resources  to  monitor  compliance. 
Regulation (EC) No 300/2008 also requires from the Commission to carry out inspections of 
national administrations and a suitable sample of airports in all Member States.  

6.7.1.2.  Report on the work done in 2010 

Internal Market, Air transport Agreements and Multilateral relations 

• 

Non-conformity of the bilateral Air Services Agreement (ASA) between the Member 

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States and the Russian Federation with EU law 

Following the 'Open Skies' judgements of the European Court of Justice (ECJ) of 5 November 
2002  and  the  adoption  of  Regulation  (EC)  No  847/2004  on  the  negotiation  and 
implementation  of  air  service  agreements  between  Member  States  and  third  countries, 
Member States need to bring their bilateral agreements with third countries in line with EU 
legislation. While this process is well advanced in the case of the agreements with most third 
countries, the bilateral agreements with the Russian Federation have to date not been modified 
and continue to infringe EU law in two respects.  

Firstly,  according  to  the  ASA  with  Russia,  a  carrier  established  in  an  EU  Member  State  of 
which substantial ownership or effective control do not remain with this Member State or its 
nationals does not have the right to exercise the traffic rights granted under the ASA. Such a 
restriction  of  the  right  to  establish  and  manage  an  undertaking  is  not  compatible  with 
Article 49 of the Treaty on the Functioning of the European Union (TFEU) as confirmed by 
the judgments of the ECJ of 5 November 2002.  

Secondly,  the  ASAs  of  Member  States  with  Russia  include  provisions  which  violate 
competition  law.  In  particular,  the  ASA  mandates  the  designated  airlines  to  enter  into 
commercial agreements to specify additional details of their commercial relationship. In many 
cases, the ASA mandates the airlines to agree on the Siberian over-flights charges as well as 
on other tariff elements. By prescribing such commercial agreements between the designated 
airlines and encouraging them to agree on certain charges and price elements, Member States 
seems  to  have  enacted  measures  which  jeopardise  the  functioning  of  the  internal  aviation 
market  and  undistorted  competition  therein  contrary  to  Article  4(3)  TFEU  in  combination 
with Article 101 TFEU. 

Since the adoption  of Regulation No  847/2004, the Commission has continuously reminded 
Member  States  to  bring  their  ASAs  with  Russia  in  line  with  EU  legislation.  Whenever 
Member  States  have  notified  air  service  negotiations  with  Russia  to  the  Commission 
according  to  Regulation  847/2004,  the  Commission  has  reminded  them  in  writing  of  their 
obligations.  

In  June  2010,  the  Commission  invited  all  Member  States  to  comment  on  these  issues  and 
most  Member  States  responded  to  this  request.  The  responses,  however,  confirmed  the 
continuous infraction of EU law so that - in October 2010 - it was decided to launch formal 
infringement  procedures  against  four  Member  States.  Similar  proceedings  against  all 
remaining Member States shall be launched by mid-2011.  

• 

Allocation of limited air traffic rights 

On  17  January  2011,  the  European  Commission  has  sent  a  Reasoned  Opinion  letter  against 
Poland for non compliance with Regulation 847/2004 and the absence of a non-discriminatory 
procedure for the allocation of limited air traffic rights in Poland. The article 5 of Regulation 
847/2004  obliges  Member  States  to  lay  down  transparent  and  non-discriminatory  national 
procedures  for  the  allocation  of  limited  air  traffic  rights.  Six  years  after  the  adoption  of  the 
Regulation,  Poland  has  still  not  laid  down  such  procedure  and  is  the  last  EU  Member  state 

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without any rules regarding the allocation of limited traffic rights 

The absence of such a procedure in Poland prevents an EU air carrier, coming from another 
Member  state  that  Poland,  to  compete  for  traffic  rights  between  Poland  and  third  countries. 
The non implementation of Article 5 of Regulation 847/2004 allows a potential exclusion of 
other  EU  air  carriers  desiring  to  operate  from  an  establishment  in  Poland  and  infringes  the 
very basic rules of the aviation common market.  

Single Sky and Modernisation of air traffic control 

As a result of the acceleration of the Single European Sky in 2010, the Single Sky Committee 
(Article 5 of Regulation No 549/2004) met seven times in plenary sessions and nine times in 
working sessions on dedicated regulatory issues. The Industry Consultation Body (Article 6 of 
Regulation No 549/2004) met six times during last year.  

This  considerable  work  led  to  the  adoption  of  major  measures  contributing  to  building  and 
reinforcing the Single European Sky, notably:  

•  The establishment of a performance scheme, with the adoption of Regulation No 
691/2010 laying down a performance scheme for the air navigation services, the 
amendment  of  Regulation  No  1794/2006  on  a  common  charging  system,  the 
adoption  of  a  Commission  Decision  on  the  designation  of  the  Performance 
Review  Body,  the  nomination  of  a  Chairman  for  this  Body  and  the  adoption  of 
EU-wide performance targets binding on the EU States; 

•  the  acceleration  of  the  creation  of  functional  airspace  blocks  (FABs),  to  be 
achieved by end of 2012, with the adoption of a Regulation on the information to 
be  provided  before  the  establishment  and  modification  of  a  functional  airspace 
block  (not  yet  published),  the  production  of  Guidance  Material  for  the 
establishment and modification of FABs, as required by Article 9a of Regulation 
No 550/2004 and the nomination of a FAB Coordinator; 

•  the  centralisation  of  European  Air  Traffic  Management  network  functions, 
including  network  crisis  management 
the  preparation  of  an 
implementing  rule  on  the  network  functions,  of  a  Commission  Decision  on  the 
nomination of a Network Manager; 

through 

, 

•  The  consolidation  of  relations  with  Eurocontrol,  through  the  signature  of  two 
specific contracts under a Framework Agreement for provision of support to the 
implementation  of  the  Single  European  Sky  and  other  EU  aviation  policies,  the 
creation of a European Aviation Coordination Crisis Cell, the opening of an EU 
Liaison  Office  and  the  coordination  of  tasks  between  the  Commission,  the 
European Aviation Safety Agency and Eurocontrol on safety regulatory activities; 

•  Preparation of a strategy for the deployment of SES new technologies, including 

scenarios for the governance and the financing.  

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Air safety 

On 20th October 2010, the European Parliament and the Council adopted Regulation (EU) No 
996/2010 on the investigation and prevention of accidents and incidents in civil aviation that 
repealed  Directive  94/56/CE.  The  main  objectives  of  this  Regulation  are  to:  enhance  the 
investigating capacity of the EU and independence of accident investigation; clarify the role 
of  European  Safety  Aviation  Agency  (EASA)  in  accident  investigation;  strengthen 
implementation  of  safety  recommendations;  alleviating  potential  tensions  between  accident 
investigation  and  judicial  proceedings,  while  maintaining  separation  and  independence  of 
investigation. This Regulation came into force on 10 November 2010. 

In  the  field  of  continuing  airworthiness  (maintenance)  of  aircraft,  Commission  Regulation 
(EC)  No  2042/2003,  was  amended  twice,  on  5  February  and  26  October  2010,  in  order  to 
enhance the existing rules and the corresponding levels of safety. 

The  implementation  by  Member  States  of  Directive  2004/36/EC  regarding  the  conduct  of 
ramp inspections on aircraft using Community airports (SAFA) is satisfactory and in constant 
improvement, mainly due to a number of supporting activities carried out by the Commission 
and  EASA:  in  2010  the  SAFA  steering  committee  met  three  times.  In  2010,  efforts  were 
undertaken to improve the functioning of the EU SAFA programme, in particular through the 
carrying  out  of  quality  review  analysis  of  SAFA  reports  or  by  the  initiation  of  a 
Standardisation  programme,  which  in  fine  aims  at  ensuring  that  all  SAFA  inspections  are 
done in a standardised manner in all countries. 

The  transposition  of  Directive  2008/49/EC  regarding  the  procedures  for  conduct  of  ramp 
inspections  was  completed  by  the  EU  Member  States  in  2010  and  the  3  infringement 
procedures pending were duly closed. 

The  Commission  has  worked  together  with  EASA  to  ensure  a  correct  and  harmonised 
implementation  of  the  acquis  under  the  scope  of  the  EASA  (so  called  "standardisation 
inspections")  with  special  attention  to  those  safety  areas  which  revealed  problematic.  For 
example,  the  Commission  analysed  some  150  reports  stemming  from  120  standardisation 
inspections  carried  out  by  the  Agency  in  2010  and  ensured  the  appropriate  follow-up.  This 
allowed  the  Commission  to  identify  a  number  of  significant  non-compliances  to  the  safety 
rules and to request urgent action from the Member States concerned. 

On  11  January  2010,  the  Commission  presented  a  report  on  the  application  of  Regulation 
(EC)  No  2111/2005  on  the  establishment  of  a  Community  list  of  air  carriers  subject  to  an 
operating ban within the Community over the past three years. The application of the EC list 
has demonstrated that it is a successful tool to contribute to ensuring a high level of safety in 
the Community but the report recommends to promote the exchange of verifiable and reliable 
information at the international level as well as to better coordinating efforts to grant technical 
assistance to those States where it is mostly needed. In relation with the implementation of the 
Regulation (EC) No 2111/2005, the EU list of air carriers subject to an operating ban was up-
dated 4 times (Regulations 1071/2010, 791/2010, 590/2010 and 273/2010). These updates are 
the  outcome  of  a  fruitful  cooperation  between  the  Commission,  the  Member  States  and 
EASA. More than 450 air carriers were examined during the year.  

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The  Commission  has  treated  in  2010  an  important  number  of  derogations  and  exemptions 
from  the  provisions  of  Regulations  (EEC)  No  3922/91  (13  cases)  and  (EC)  No  216/2008 
(around 39 cases) notified by Member States. This has been done with the support of EASA. 
The  control  of  such  cases  is  essential  for  the  harmonised  implementation  of  the  common 
rules. 

In 2010, the EASA Committee established by Regulation (EC) No 216/2008 met 5 times with 
the following objectives: analysing and agreeing on amendments to current legislation in the 
fields  of  airworthiness  and  on  new  EU  rules  in  the  area  of  pilot  licences;  discussing  on 
interpretation  issues  related  to  current  legislation  and  discussing  on  the  strategy  for 
forthcoming rulemaking activities.  

3  formal  complaints  were  treated  in  2010  by  the  European  Commission  in  the  field  of  air 
safety and a number of queries and parliamentarian questions related to the implementation of 
the acquis or to forthcoming new legislation, mainly related to flight time limitations, quality 
of  air  in  aircraft  cabins,  seat  pitch,  pilot  licences,  accident  investigation  and  trans-boundary 
private flights. 

–  Infrastructures and airports 

–  The Action Plan for airport capacity, efficiency and safety 

The  Community  Observatory  on  airport  capacity  continued  to  work  on  the  slot  allocation 
process, on airport capacity assessment methodologies and on the potential of intermodality in 
fighting airport congestion and linking different transport modes at airports. 

Measures  aiming  at  enhancing  the  consistency  between  airport  slots  and  flight  plans  which 
had  been  approved  by  the  "Single  Sky  Committee"  in  December  2009  were  adopted  by  the 
Commission with the Regulation (EU) No 255/2010 of 25 March 2010 laying down common 
rules  on  air  traffic  flow  management166.  The  new  Regulation  will  apply  from  September 
2011.  Its  Article  9  contains  provisions  to  enhance  the  consistency  between  flight  plans  and 
airport  slots  which  will  permit  a  proper  implementation  of  Article  14(1)  of  Regulation 
95/93/EC:  such  a  mechanism  will  allow  airports  to  ask  for  the  rejection  of  flight  plans  of 
aircraft intending to operate without slots in the meaning of Regulation 95/93. 

–  Capacity 

–  In relation to the creation of an inventory of airport capacity, the Commission launched the 
preliminary  works,  while  pertinent  works  on  the  related  cartography  had  been  finalized 
before. A test questionnaire on airport capacity was sent to all Member States with a view 
to  its  possible  use  as  an  inventory  tool  in  the  future.  The  Commission  received  answers 
from 23 Member States covering 59 airports. These responses were then analysed from the 
point  of  view  of  assessing  the  quality/utility  of  the  questionnaire  which  was  revised 
accordingly.  

–  Slots 

166 

OJ L80, 26.3.2010, p. 10. 

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The main objective for 2010 was to carry out an in-depth assessment of the functioning of the 
Slot  Regulation167.  In  this  sense,  the  following  actions  were  undertaken:  An  online  public 
consultation  was  carried  out  and  a  stakeholders'  hearing  took  place  in  November.  A  study 
undertaken  by  an  external  consultant  has  been  launched  to  feed  into  an  impact  assessment 
process. 

Another  key  objective  was  to  ensure  the  proper  implementation  by  Member  States.  The 
situation at several airports was assessed notably by asking annual reports for the majority of 
slot coordinators. 

Several  investigations  on  possible  infringements  took  place.  One  case  was  closed  and  three 
others are under investigation. 

–  For the first time since 1993, the provision of the Slot Regulation relating to the external 
dimension of the slot regime has been successfully activated. After receiving a complaint 
from  the  Austrian  authorities  regarding  the  situation  of  Austrian  airlines  in  Ukraine  and 
their difficulty in securing slots, the Commission intervened urgently to create and convene 
the Slot Comitology Committee. The action at the EU level proved very valuable since the 
matter was solved in cooperation with the Ukrainian authorities after receiving unanimous 
support of the Member States. 

–  Airport Charges/taxes 

Directive  2009/12  EC  on  airport  charges  was  adopted  by  the  Council  and  European 
Parliament  on11  March  2009  (OJ  L  70,  14.3.2009,  p.  11).  This  Directive  aims  to  require 
transparency,  user  consultation  and  the  application  of  the  principle  of  non-discrimination 
when calculating charges levied on users. The Directive lays down minimum requirements in 
the  calculation  and  levying  of  airport  charges  at  all  airports  with  more  than  5  million 
passenger  movements  per  year,  in  addition  to  the  largest  airport  in  each  Member  State. 
Member States have previously signed up to the principles behind the Directive (transparency, 
non-discrimination and cost-relatedness of airport charges) at international level (ICAO).  

Member  States  are  currently  preparing  implementation  measures  (Deadline  set  by  the 
Directive: 15.03.2011) 

In  2010,  a  number  of  files  have  been  analysed  regarding  the  compatibility  of  taxes/charges 
with  the  EU  law,  in  particular  with  Regulation  1008/2008  and  existing  case-law.  One  case 
was  closed,  another  was  opened,  and  two  complaints  were  received  by  the  Commission 
towards the end of the year. 

Groundhandling 

167 

Council Regulation (EEC) N° 95/93 of 18 January 1993 on common rules for the allocation of slot at 
Community airports. 

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Efforts  to  ensure  the  proper  implementation  of  Directive  96/67/EC  by  Member  States  were 
intensified and the situation at several airports was assessed. As a result eight Member States 
were affected as follows: 

Four reasoned opinions were sent to four of them. In one case the Member State concerned 
started  immediately  to  implement  the  corrective  actions  proposed  by  the  Commission  and 
accepted to amend accordingly the relevant national law. Pending this modification the case 
has been suspended. The three other cases were still under scrutiny at the end of 2010; 

A letter of formal notice was sent to one Member State, and preliminary investigations into 
another one started; 

In  the  aftermath  of  Commission's  intervention,  two  Member  States  have  implemented 
corrective  actions  to  comply  with  the  Directive:  the  corresponding  cases  were  therefore 
closed. 

In  addition,  further  work  has  been  carried  out  in  2010  to  assess  the  functioning  of  the 
groundhandling  market,  notably  through  a  public  consultation  (December  2009-February 
2010). 

Aviation security 

The  Commission  continued  to  fulfil  its  monitoring  obligations  and  conducted  inspections 
(including follow-up inspections) of 5 national administrations and 21 airports.  

Two  letters  of  formal  notice  were  sent  following  inspections  of  national  administrations.  In 
one  case,  the  concerned  Member  State  failed  to  maintain  its  national  aviation  security 
programme while the second case relates to the application of the EU rules at small airports. 
Two  infringement  cases  were  closed  following  rectification  of  the  identified  shortcomings. 
Three infringement cases remained open during the year and were being closely followed. In 
all these cases, several informal contacts with the Member States have already taken place in 
order  to  assist  them  in  a  swift  rectification  of  deficiencies  and  good  progress  has  been 
observed. 

In  order  to  achieve  a  reduction  in  the  number  and  severity  of  deficiencies  identified  during 
Commission inspections the following measures have been taken in 2010: 

•  Detailed implementing rules complementing Regulation (EC) No 300/2008 were 
developed  in  close  cooperation  with  all  stakeholders.  These  new  implementing 
rules  apply  since  April  2010.  This  major  revision  improves  clarity  and 
consistency, thus paving the way for an even higher compliance level. 

•  The change in applicable rules was accompanied by several workshops assisting 

Member States in preparing the transition. 

•  The Commission organised three training courses for national auditors of Member 
States on the new compliance monitoring requirements and provided them with a 
new hand book including guidance. 

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•  The  implementation  of  a  peer-review  system  with  an  active  participation  of 
national  auditors  from  all  Member  States  in  Commission  inspections  was 
continued. 

6.7.2.  Evaluation of the current position 

Single Sky and Modernisation of air traffic control  

Annual  reports  on  the  SES  implementation:  in  application  of  Article  12  of  Regulation  No 
549/2004  and  Article  7  of  Commission  Regulation  No  2150/2005,  Member  States  have  the 
obligation to submit to the Commission annual reports on their implementation of the actions 
required by the SES legislative package.  

The  second  reporting  exercised  covered  the  year  2009  and  allowed  to  collect  information 
from the 27 EU Member States as well as from Norway and Switzerland. The national reports 
were  collected,  consolidated  and  analysed  in  a  General  Report  on  the  SES  legislation 
implementation prepared with the support of Eurocontrol. Some of the national reports were 
subject to a follow-up by a letter through correspondence. 

Overall, this exercise has been deemed very useful to assess the exact stage of implementation 
of  the  SES  legislation  at  national  level,  to  raise  awareness  on  the  importance  given  to  this 
matter by the European Commission and to attract the Commission's attention on deficiencies 
and on areas requiring support action at European level.  

Infringement procedures  

Only one infringement case remains open out of the five still pending early 2010.  

This  case  concerns  a  "non-conformity"  infringement  procedure  against  Greece  for  non-
compliance  with  basic  Single  European  Sky  legislation,  in  particular  for  the  absence  of 
establishment of en effective and independent national supervisory authority.  

The annual reports from the Member States as well as the decrease in the number of pending 
infringement  procedures  indicate  an  overall  enhanced  compliance  with  the  Single  European 
Sky legislation.  

Some  areas  still  need  to  be  improved,  for  instance  the  resources  and  capability  of  national 
supervisory  authorities,  the  legal  frameworks  for  cross-border  provision  of  air  navigation 
services,  the  certification  of  these  services,  the  implementation  of  effective  flexible  use  of 
airspace and civil-military coordination and the establishment of Functional Airspace Blocks.  

Air safety 

Overall, transposition of the acquis in the fields of air safety and environmental requirements 
is good at present. 

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Concerning the day to day implementation of the legislation, the situation could be considered 
preoccupying  in  a  limited  number  of  Member  States  concerning  mainly  the  requirements 
related  to  air  operations  and  continuing  airworthiness.  The  main  causes  are  linked  with  the 
insufficient  capacity  of  national  competent  authorities  to  oversee  the  entities  under  their 
responsibility,  either  due  to  lack  of  adequate  number  or  qualified  staff  or  to  deficient 
procedures. In some cases, the entities themselves are circumventing EU rules either due to 
incorrect  understanding  or  on  purpose,  for  administrative  or  commercial  reasons.  This  has 
been identified and corrective actions have been requested. 

The consequences of the non compliances with regard to technical safety requirements under 
the  scope  of  EASA  are  the  decline  of  the  safety  level,  which  can  be  corrected  through 
appropriate  measures  ranging  from  action  plans  to  revocation  of  certificates  or  even 
withdrawal  of  the  mutual  recognition  or  fines  imposed  by  Member  States.  In  case  of 
persistency,  an  infringement  procedure  against  the  Member  State  concerned  can  also  be 
initiated. The Commission is closely following any such potential safety threat but no formal 
infringement procedure has been required up to now. 

The  national  competent  authorities  are  always  the  ultimate  body  responsible  for  overseeing 
the entities under their jurisdiction as well as for taking the necessary corrective actions. The 
Commission and EASA should be able to detect some type of deficiencies with the different 
tools  for  oversight  on  their  hands  (inspections,  ramp  checks,  complaints,  etc)  and  when 
identifying  cases  of  concern,  get  in  contact  with  the  competent  authorities  and  take  any 
actions necessary in order to put an end to the potential breach, as explained above. 

In some cases, the need to clarify or amend the EU rules is identified. The Commission works 
continuously with EASA and the Member States, in the context of the relevant Committees, 
with  a  view  to  address  these  cases.  In  the  fields  of  air  operations  and  pilot  licensing  the 
situation should improve with the upcoming adoption of new harmonised rules by 2012. 

Regarding  the  implementation  of  the  EU  acquis  concerning  occurrence  reports  in  civil 
aviation (Directive 2003/42/EC and its implementing rules), the situation has improved but is 
not yet optimal. The Commission acted in 2010 against 5 Member States (3 via EU Pilot and 
2 letters of formal notice), which served to put an end to the incompliance. 

Infrastructures and airports 

In 2011, priority will be granted to the Strategic initiative on airports in accordance with the 
European  Commission's  work  programme  for  2011  ('Airport  package')  as  well  as  to  the 
correct implementation process of the Airport charges Directive. 

Groundhandling 

The  implementation  of  the  Directive  on  groundhandling  is  under  close  monitoring.  The 
situation  has  improved  after  action  of  the  Commission  but  remains  essential  to  continue  a 
close surveillance of Member State's transposition instruments and the way they are applied. 

The  implementation  of  the  Directive  still  raises  a  number  of  questions.  To  this  end,  an 

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evaluation  of  the  current  functioning  of  the  Directive  has  been  undertaken  and  an  impact 
assessment process has been launched. 

Slots 

The implementation of the Regulation on airport slots raises a number of questions. To this 
end,  the  European  Commission  is  assessing  the  situation  at  several  Member  States  airports 
and  is  working  to  an  evaluation  of  the  current  functioning  of  the  Slot  Regulation  has  been 
undertaken and an impact assessment process has been launched. 

Airport Charges 

Member States are obliged to transpose the Directive168 into national law by 15 March 2011. 
The  Commission  is  therefore  closely  monitoring  this  process  and  will  intervene  in  cases  of 
incorrect or delayed implementation. 

Aviation security 

Since the introduction of Community rules in 2002 and of Commission inspections in 2004, 
results  of  aviation  security  inspections  have  steadily  improved.  The  compliance  with  main 
provisions during aviation security inspections of airports rose from 62% to 85% in 2009. Due 
to  the  fact  that  security  provisions  in  the  new  aviation  security  regulations  have  been 
regrouped and combined the figure of the compliance rate for 2010 is not directly comparable 
to the figures of previous years which was based on a higher number of individual provisions. 
In  2010  the  compliance  rate  was  80%  which  still  constitutes  a  very  encouraging  result.  It 
confirms that the transition to the new regulatory framework went smoothly.  

It  is  expected  that  the  improved  aviation  security  legislation  and  clearer  rules  on  national 
quality  control  will  further  improve  compliance  levels  in  the  European  Union.  However,  a 
continued effort in inspections, enforcement and advice will remain vital to ensure a positive 
evolution. In particular, the Commission will have to closely follow availability of sufficient 
resources  for  compliance  monitoring  to  fulfil  national  quality  control  obligations.  The 
Commission will therefore continue to take a strict and coherent approach to the rectification 
of deficiencies identified during Commission inspections.  

6.7.3.  Evaluation results 

6.7.3.1.  Priorities 

Single Sky and Modernisation of air traffic control 

The  priorities  for  the  Commission  in  the  field  of  ATM  do  not  change,  they  consist  in 
developing a total-system approach in line with the gate-to gate concept to ultimately improve 

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charges. 

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the  performance  of  the  European  Aviation  System  in  key  areas  such  as  the  environment, 
capacity and cost-efficiency, having due regard to the overriding safety objectives.  

The legislative package will be soon completed and the Commission will focus in 2011 on the 
effective implementation of the concepts defined and the actions required by the regulations.  

Air safety 

In 2010, the main priorities, which remain valid, were:  

•  the revision and completion of EU rules in the field of air safety; 

•  monitoring the implementation of the EU legislation; and 

•  the adoption of a safety management system at EU level. 

Infrastructures and airports 

In 2011, priority will be granted to the Strategic initiative on airports in accordance with the 
European  Commission's  work  programme  for  2011  ('Airport  package')  as  well  as  to  the 
correct implementation process of the Airport charges Directive. 

Aviation security 

The priorities for the Commission in the field of aviation security remain unchanged, namely 
to  further  develop  harmonised  rules  in  aviation  security  that  provide  an  adequate  level  of 
protection whilst limiting the negative impact on facilitation and to ensure the application by 
all Member States of the common basic standards contained in Regulation (EC) No 300/2008.  

6.7.3.2.  Planned action 

Single Sky and Modernisation of air traffic control 

The  Commission  plans  in  2011  to  support  the  effective  implementation  of  the  Single 
European Sky on the basis of five pillars: 

•  a  regulatory  pillar  with  the  implementation  of  the  performance  scheme,  of  the 
network Manager, the Functional airspace block as well as through consolidated 
relations  between  the  institutions  and  organisations  active  in  the  ATM  field 
(EASA, EU, SESAR JU and Eurocontrol); 

•  A safety pillar based on the extension of EASA's competences to ATM; 

•  A  technology  pillar,  related  to  the  development  and  deployment  of  the  ATM 

Master Plan under the aegis of the SESAR JU;  

•  An  airport  capacity  pillar  integrating  airports  in  the  performance  scheme,  the 

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adoption of measures coordinating ATFM and airport slots and contribution to the 
'Airport package'; 

•  A Human Factors pillar aimed at associating more effectively the social partners.  

Air safety 

The Commission intends to complete by end 2013 the adoption of all basic rules governing all 
the  areas  directly  linked  with  air  safety,  which  are  airworthiness  of  aircraft,  air  crew 
certification,  air  operations,  air  traffic  management,  air  navigation  services,  air  traffic 
controllers and aerodromes. This should allow to ensure consistency of rules applicable in the 
different  areas,  improved  safety  and  efficiency  by  the  completion  of  the  so  called  "total 
system approach". 

It  is  also  essential  to  improve  the  gathering  and  assessment  of  safety  relevant  information 
(mainly coming from accident investigation, occurrence reporting and SAFA) as well as the 
efficiency  of  EU  actions  in  the  field  of  air  safety  through  the  development  of  a  safety 
management system at EU level. The latter system should be launched in 2011, based on the 
technical  expertise  of  EASA  and  prepared  in  coordination  with  Member  States  and 
stakeholders concerned. 

New legislation  

•  Adoption  of  a  series  of  new  harmonised  rules  in  the  fields  of  flight  crew  licensing,  air 
collision avoidance system, air operations, air traffic management, air navigation services , 
air traffic controllers and aerodromes; and 

•  Amendment of the Directive 2003/42/EC on occurrence reporting in civil aviation, review 
of existing legislation related to aircraft airworthiness, inspections conducted by EASA and 
funding of EASA certification activities (fees and charges);  

•  Review of the airport noise directive (Directive 2002/30/EC on the establishment of rules 
and  procedures  with  regard  to  the  introduction  of  noise-related  operating  restrictions  at 
Community airports) with the view to enhance the consistent application of the ICAO so-
called  "balanced  approach"  and  clarify  the  relationship  with  the  environmental  noise 
directive  (Directive  2002/49/EC  relating 
the  assessment  and  management  of 
environment noise). The review of this Directive will be part of the airport package, whose 
adoption is planned for mid 2011. 

to 

Infrastructures and airports 

The Airports Package 

In  accordance  with  the  European  Commission's  work  programme  for  2011,  an  'Airport 
package'  will  be  presented  as  part  of  the  flagship  initiative  "Restoring  growth  for  jobs"  and 
more  particularly  of  the  thematic  area  "Tapping  the  potential  of  the  Single  Market  for 
growth".  

Depending  on  the  conclusions  of  ongoing  impact  assessments  the  package  could  include 

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comprise: 

•  A proposal on airport capacity assessment and inventory; 

•  The revision of Council Regulation (EEC) 95/93 of 18 January 1993 on common rules for 

the allocation of slots at Community airports; 

•  The revision of the Council Directive 96/67/ec on access to the groundhandling market at 

community airports; 

•  The revision of Directive 2002/30/EC of the European Parliament and of the Council of 26 
March 2002 on the establishment of rules and procedures with regard to the introduction of 
noise related operating restrictions at Community airports. 

Aviation security 

The  Commission  will  continue  to  apply  a  strict  compliance  monitoring  and  enforcement 
policy to ensure an adequate protection of its citizens. The Commission therefore intends to 
continue  its  inspections  at  a  frequency  comparable  to  previous  years  but  to  increase  the 
number  of  inspections  of  cargo  security  regimes,  which  have  shown  certain  vulnerabilities. 
Particular emphasis will be given to ensuring that Member States have an adequate number of 
resources to fulfil their obligations.  

In  order  to  assist  Member  States  in  its  compliance  monitoring  effort  the  Commission  will 
continue the implementation of its peer-review system and regularly inform Member States of 
non-compliances found during inspections in the Regulatory Committee on aviation security, 
which  meets  6  times  per  year.  These  updates  on  non-compliances  identified  during 
inspections help Member States to identify critical areas where deficiencies occur repeatedly. 

6.7.4.  Sector summary 

Single Sky and Modernisation of air traffic control 

The  priorities  of  the  commission  in  this  sector  remain  unchanged:  the  key  objective  is  the 
effective  implementation  of  the  requirements  of  the  Single  European  Sky  package.  Good 
progress has been made so far by the Member states and the various stakeholders concerned, 
but the action of the European Union needs to be reinforced in order to bring concrete support 
to  States  of  stakeholders  facing  difficulties  in  some  implementation  areas,  now  that  the 
legislative foundations are almost completely laid down.  

Air safety 

Objectives: 

•  Immediate reaction to safety threats identified (recurrent); 

•  Follow-up of the correct transposition and implementation of the acquis through a number 

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of different tools, including inspections (recurrent); 

•  Updating and complement the acquis whenever necessary (recurrent). 

–  Legislation in preparation 

•  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 
Directive 2003/42/EC on occurrence reporting in civil aviation to be presented in 2011.  

•  Commission  Regulation  concerning  fines  and  periodic  penalty  payments  for  non-
compliance with provisions of Regulation (EC) No 216/2008 and its Implementing Rules 
to be adopted in 2011. 

•  Commission  Regulations  in  the  fields  of  air  crew  licensing,  Air  Collision  Avoidance 
System,  Air  Operations,  Air  Traffic  Management,  Air  Navigation  Services,  Air  Traffic 
Controllers and Aerodromes, to be adopted between 2011 and 2013. 

Aviation security 

The priorities for the Commission in the field of aviation security remain unchanged, namely 
to  further  develop  harmonised  rules  in  aviation  security  that  provide  an  adequate  level  of 
protection and to ensure the application by all Member States of the common basic standards 
contained in Regulation (EC) No 300/2008.  

The  planned  key  actions  are  the  continuation  of  the  well  established  inspection  regime  at 
current  frequencies,  the  strict  enforcement  of  EU  rules  following  the  identification  of 
deficiencies  and  the  assistance  of  Member  States  in  applying  an  adequate  national  quality 
control system.  

7. 

CLIMATE ACTION 

7.1. 

Emission Trading Scheme (ETS Directive) 

The EU ETS legislation is the cornerstone of the Climate Change policy. Particular attention 
is therefore dedicated to this legislation within the present Report. 

The  EU  ETS  was  established  with  the  adoption  of  the  Emissions  Trading  (Directive 
2003/87/EC169).  It  is  a  market-based  instrument  aiming  at  gradually  reducing  emissions  in 
selected  sectors.  It  should  help  the  EU  and  the  Member  States  meet  their  Kyoto  Protocol 
commitments  to  reduce  greenhouse  gas  emissions  in  a  cost-efficient  manner.  The  EU  ETS 
started operating in January 2005. A revision of the ETS Directive (Directive 2009/29/EC170) 

169 

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Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a 
scheme for greenhouse gas emission allowance trading within the Community and amending Council 
Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32–46). 
Directive  2009/29/EC  of  the  European  Parliament  and  of  the  Council  of  23  April  2009  amending 
Directive  2003/87/EC  so  as  to  improve  and  extend  the  greenhouse  gas  emission  allowance  trading 
scheme of the Community (OJ L 140, 05.06.2009, p.63-87). 

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was  prepared  and  negotiated  in  2008  and  entered  into  force  in  June  2009.  This  revision 
broadly  amends  the  EU  ETS  design  as  from  1  January  2013  (i.e.  the  beginning  of  the  third 
trading period 2013-2020). In addition, Directive 2008/101/EC171, which amended Directive 
2003/87/EC by providing for the inclusion of the aviation sector in the EU ETS, entered into 
force in February 2009. 

7.1.1.  Report of work done in 2010 

In  2010  the  EU  ETS-related  work  continued  to  focus  on  two  main  sets  of  activities:  (a) 
ensuring  that  the  current  ETS  works  properly  and  that  its  rules  are  correctly  applied  by 
Member States and (b) preparing the implementing measures for the revised ETS Directive to 
be  implemented  from  2013  for  and  for  EEA-wide  implementation  of  aviation  activities 
covered by the EU ETS from 2012. 

(a) Ensuring proper implementation of the ETS by Member States  

Conformity assessments  

On  the  basis  of  conformity  assessment  initiatives  related  to  the  ETS  Directive,  the 
Commission  services  indentified  various  issues  requiring  clarification  in  respect  of  national 
legislation  transposing  the  Directive.  As  of  January  2010,  21  Member  States  had  replied  to 
administrative  letters  of  inquiry  sent  in  the  course  of  2009  asking  for  clarification  of  the 
national  legislation.  Following  further  exchange  of  views,  the  necessary  clarifications  were 
provided to the Commission.  

Implementation and legal enforcement  

Cases related to the ETS Directive - National Allocation Plans: 

The  individual  national  allocation  plans  (NAPs)  adopted  by  Member  States  fix  the  total 
number of emission allowances and set out the methodologies to allocate them to individual 
installations covered by the EU ETS. NAPs for the period between 2008 and 2012 are thus an 
important  element  in  the  Member  States'  strategies  for  achieving  their  relevant  emission 
reduction targets under the Kyoto Protocol. 

In 2007 several Member States opposed the Commission decision on their respective NAP. In 
essence,  they  claimed  that  the  upper  limit  set  by  the  Commission  on  the  total  quantity  of 
allowances they may allocate was too low, and that the Commission had exceeded the limits 
of its discretion when assessing the proposed NAPs by using its own methodology.  

Consequently, 9 Member States brought annulment actions on the basis of Article 263 TFEU 
before  the  European  Court  of  Justice.  The  Slovak  Republic  subsequently  withdrew  its  case, 
and  in  early  2010  the  following  cases  were  pending  before  the  General  Court:  T-221/07 
Hungary,  T-194/07  Czech  Republic,  T-369/07  Latvia,  T-368/07  Lithuania,  T-499-500/07 
Bulgaria, T-483-484/07 Romania. For each of these cases, the written procedure has ended. 

171 

Directive 2008/101/EC of the European Parliament and of the Council of 19 November 2008 amending 
Directive  2003/87/EC  so  as  to  include  aviation  activities  in  the  scheme  for  greenhouse  gas  emission 
allowance trading with the Community (OJ L 8, 13.01.2009, p.3-21). 

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In  Cases  T-183/07  and  T-263/07,  the  General  Court  annulled  the  Commission's  decisions 
rejecting  the  respective  NAP  on  23  September  2009.  The  Commission  lodged  appeals  to 
Cases T-183/07 and T-263/07 on 3 December 2009. Those appeals were still pending in 2010 
and are based on several legal grounds. Most importantly, the Commission considers that the 
General Court interpreted the powers of the Commission in the NAP assessment process too 
narrowly. The Commission also submits that the General Court did not sufficiently taken into 
account  the  fundamental  purpose  of  the  EU  ETS  –  to  reduce  overall  EU  emissions  of 
greenhouse gases – and the need to ensure the equal treatment of Member States during the 
NAP assessment process. 

As a result of the judgements in Cases T-183/07 and T-263/07 (see above), the Commission 
adopted new decisions on the originally notified Estonian and Polish NAPs on 11 December 
2009.  As  the  NAPs  were  rejected,  both  Estonia  and  Poland  had  to  submit  new  NAPs  for 
further  assessment  by  the  Commission.  Poland  notified  a  new  national  allocation  plan  on  8 
April  2010.  On  19  April  2010,  the  Commission  decided  not  to  raise  any  objections  with 
regard  to  this  NAP.  With  regard  to  the  Estonian  NAP,  at  the  end  of  2010,  the  Estonian 
authorities had not yet submitted a new NAP for assessment to the Commission. 

Some companies covered by the EU ETS also brought actions. By judgment of 2 March 2010, 
the General Court dismissed the action brought by Arcelor (T-16/04) for partial annulment of 
Directive  2003/87/EC  for  compensation  for  the  damage  suffered  by  the  applicant  following 
the  adoption  of  that  directive.  This  case  was  the  last  case  still  pending  before  the  General 
Court.  

In  its  judgment,  the  General  Court  found  that  Arcelor  was  not  individually  or  directly 
concerned  by  the  contested  provisions  of  Directive  2003/87/EC  within  the  meaning  of  the 
fourth paragraph of Article 263 TFEU and declared the application inadmissible. The claims 
for damages was considered admissible, but rejected as, according to the Court, Arcelor had 
failed to demonstrate that, in adopting the contested directive, the legislator acted unlawfully 
or  committed  a  sufficiently  serious  breach  of  a  rule  of  law  designed  to  confer  rights  on  the 
company. 

Other cases related to the ETS Directive  

Several administrative inquiry letters regarding the application of the EU ETS Directive were 
sent to Member States in 2010.  

One  inquiry  related  to  the  application  of  the  fine  provided  for  in  Article  16  of  the  EU  ETS 
Directive. Other inquiries concerned the adoption of tax law provisions or similar with respect 
to  EU  ETS  allowances.  Such  provisions  may    be  equivalent  to  a  non-permissible  ex-post 
adjustment  of  the  relevant  national  allocation  plan.  The  relevant  national  authorities  were 
therefore invited to provide further information on this legislation. Any appropriate follow-up 
will be decided in 2011. 

Cases related to the Aviation ETS Directive 

Infringement cases for non-communication of national measures of transposition for Directive 
2008/101/EC including aviation activities into the EU ETS were opened against 18 Member 
States after the expiration of the transposition deadline – 2 February 2010.  

Non- communication cases have progressed during year 2010 through closure or further steps 

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in  the  infringement  procedures  (seven  Reasoned Opinions against those Member States still 
lagging behind transposition were adopted and notified in November 2010). 

Communication  by  Member  States  in  early  2011  of  national  measures  of  transposition  for 
Directive 2008/01/EC will enable the Commission to close a number of the above mentioned 
cases.  In  parallel,  the  Commission  will  be  proposing  the  continuation  of  the  infringement 
procedures against those Member States still lagging behind full transposition by the end of 
the third trimester of 2011.  

(b) Preparing the timely implementation of the revised EU ETS 

Before  2013,  15  comitology  procedures,  7  legislative  proposals  and  a  variety  of  reporting 
requirements are foreseen to implement the EU ETS for the third trading period.  

During 2010, the Commission continued to hold a number of separate stakeholder and expert 
meetings  regarding  the  list  of  (sub-)sectors  deemed  to  be  exposed  to  a  significant  risk  of 
carbon leakage, the auctioning regulation, the harmonised rules for transitional free allocation 
(benchmarks),  the  need  for  measures  to  prevent  market  abuse  and  the  regulations  on 
monitoring  and  reporting  of  emissions  and  on  verification  of  emission  reports  and 
accreditation of verifiers.  

In  2010,  implementing  measures  and  further  guidance  for  the  revised  EU  ETS  from  2013 
were prepared in the following areas. 

Carbon leakage 

A list of sectors and subsectors deemed to be exposed to a significant risk of carbon leakage 
was adopted by the Commission on 24 December 2009 as Commission Decision 2010/2/EU. 

Benchmarking 

According to Article 10a(1) of the revised EU ETS Directive, the Commission has to adopt 
transitional  EU-wide  rules  for  harmonised  free  allocation  (benchmarks).  During  2010  the 
Commission  held  a  number  of  broad  stakeholder  meetings  and  bilateral  consultations  with 
industry and NGOs as well as expert meetings with Member States' representatives to ensure 
a thorough and correct understanding of the various technical issues to  be addressed in that 
Decision.  

The  relevant  text  was  proposed  by  the  Commission's  services  and  approved  by  the  Climate 
Change Committee on 15 December 2010. After scrutiny by the European Parliament and the 
Council  it  was  adopted  by  the  Commission  on  27  April  2011  (ref.  Commission  decision 
C(2011) 2772).  

Preparations for large-scale auctioning as from the 3rd trading period 

Article 10(4) of the revised EU ETS Directive requires the Commission to adopt a Regulation 
on the auctioning of allowances. The Commission adopted the Auctioning Regulation on 12 
November 2010. 

The  Commission  and  the  Member  States  have  now  begun  the  implementation  of  the 
Auctioning Regulation (e.g. the preparation of joint procurement agreements for the common 

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auction  platforms  and  for  the  single  auction  monitor,  an  amendment  of  the  Auctioning 
Regulation to determine the volume of 'early auctions'). 

Protection from insider dealing and market manipulation 

Article  12(1a)  of  the  revised  EU  ETS  Directive  provides  that  the  Commission,  by  31 
December  2010,  shall  examine  whether  the  market  is  sufficiently  protected  from  insider 
dealing  or  market  manipulation  and,  if  appropriate,  bring  forward  proposals  to  ensure  such 
protection.  

On  21  December  2010,  the  Commission  published  a  Communication  on  carbon  market 
oversight.  It  provides  for  an  assessment  of  the  carbon  market  structure,  the  level  of  market 
oversight,  the  level  of  protection  of  the  carbon  market  from  market  abuse  and  the  available 
options  (incl.  the  classification  of  allowances  as  a  financial  instrument).  The  Commission 
concluded that a major part of the carbon market is subject to appropriate oversight, but that 
more may be needed in the spot market. 

An  internet-based  stakeholder  consultation  will  be  conducted  in  the  first  half  of  2011,  the 
results  of  which  will  feed  into  a  thorough  impact  assessment.  This  work  will  inform  the 
decision on whether to come forward with a legislative proposal.  

Registries 

•  On 7 October 2010, the Commission adopted Regulation 920/2010 for a standardised and 
secured  system  of  registries  pursuant  to  Directive  2003/87/EC  and  Decision  No 
280/2004/EC. It mainly contains the rules and the technical modalities deemed necessary 
to  adapt  the  registries  system  and  particularly  the  EU  Registry  to  accommodate  the 
introduction  of  aviation  into  the  scheme  for  greenhouse  gas  emission  allowance  trading 
within the EU from 1 January 2012 onwards. Furthermore, it addresses the need to provide 
more detailed and robust rules to fight against fraud and other criminal activities. 

•  The revised EU ETS Directive provides that all allowances will be held in the Community 
Registry as from 2012. This will transfer the bulk of Member State-level ETS-related IT-
operations to the Commission, a process which will require a significant expansion of the 
Registry  related  IT-capacities  of  the  Commission.  Further  amendments  to  the  Registry 
Regulation  (Regulation  916/2007/EC)  are  therefore  currently  prepared  to  be  adopted  in 
2011. 

Quantitative restrictions on the use of JI/CDM credits 

•  Article  11a(9)  of  the  revised  EU  ETS  Directive  refers  to  the  measures  which  can  be 
applied to restrict the use project types. In 2010, the Commission prepared and proposed a 
Regulation  determining  certain  restriction  applicable  to  the  use  of  international  credits 
from  projects  involving  industrial  gases.  These  projects  raise  concerns  relating  to  their 
environmental  integrity,  value-for  –money  and  geographical  distribution.  The  aim  of  the 
Commission  proposal  is  to  ensure  a  better  quality  and  distribution  of  credits  in  the 
international carbon market. The proposal was adopted on 21 January 2011.  

EU ETS for aviation activities  

In  2010,  implementing  measures  and  further  guidance  for  the  revised  EU  ETS  for  aviation 

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activities (under the EU ETS from 2012) were prepared in the following areas: 

•  Updating of the list allocating aircraft operators to States for administrative purposes; 

•  Frequently asked questions addressing key issues encountered in the implementation of the 

system and guidance from the compliance forum regarding verification. 

•  Working on the extension of the aviation activities covered by the EU ETS to the EEA area 

according to the same timeline than the EU -27 ETS.  

Linking with other GHG trading schemes  

Article 25 of the revised EU ETS Directive enables the EU to conclude agreements with third 
countries  to  provide  for  the  mutual  recognition  of  allowances  between  the  EU  emissions 
trading  scheme  and  other  GHG  emissions  trading  schemes.  Such  agreements  may  be 
concluded with third countries that have implemented compatible mandatory GHG emission 
trading  systems  with  absolute  emissions  caps.  The  Commission  has  presented  in  2010  a 
Recommendation to the Council to authorise the Commission to open negotiations on linking 
with  the  Swiss  emissions  trading  system.  The  Council  adopted  its  authorisation  to  the 
Commission to start negotiations by a decision adopted on 21 December 2010. 

7.1.2.  Evaluation based on the current situation 

(a) Ensuring proper implementation of the ETS by Member States  

For the current ETS, the following problems and corrective actions were identified: 

Conformity assessments  

The  conformity  studies  on  the  transposition  by  Member  States  of  the  ETS  directive  as 
amended  by  Directive  2004/101/EC  of  the  European  Parliament  and  of  the  Council  of  27 
October  2004  and  the  administrative  letters  of  inquiry  that  were  issued  focussed  on  those 
provisions of the ETS Directive that were not likely to be modified as a consequence of the 
adoption of the revision of the ETS Directive in 2008 and 2009. The assessment of the replies 
received  revealed  a  few  issues  of  concern.  The  Commission  services  have  inquired  about 
these issues with the Member States concerned and will take the appropriate steps to ensure 
full compliance.  

Implementation and legal enforcement  

Despite  the  ongoing  court  cases  related  to  some  national  allocation  plans,  the  allowance 
market works properly. 

The  security  of  the  national  registries  from an  IT  perspective  has  become  more  and  more  a 
concern over the past few months. So-called phishing attacks, whereby the credentials of the 
administrators were stolen, have taken place in 2010. Immediate action was taken both by the 
Commission and by the national administrators as EU legislation requires that Member States 
take all necessary steps to ensure the security of their own registry.  

In order to counter the threat of so-called 'carousel fraud', whereby VAT and goods are passed 
around between companies and jurisdictions to exploit the way VAT is treated within multi-

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jurisdictional  trading,  in  the  context  of  emissions  allowances  trading,  the  Council  has 
amended Directive 2006/112/EC on the common system of value added tax in March 2010. It 
has  provided  for  an  optional  and  temporary  application  of  a  reverse-charge  mechanism  in 
relation to supplies of certain services, including namely the transfer of emission allowances 
under  the  EU  Emissions  Trading  Scheme  (EU  ETS),  susceptible  to  fraud.  The  aim  is  to 
reverse VAT liability for all types of emission allowances and making it payable by the buyer 
of the emission allowances. 

(b) Preparing the implementation of the revised EU ETS 

The  revised  EU  ETS  was  adopted  to  improve  some  specific  areas  of  the  current  EU  ETS. 
These  areas  for  improvement  were  identified  through  a  review  and  extensive  stakeholder 
consultations during the first trading period (2005-2007), as follow:  

•  Emissions trading can only exploit its environmental strength and justification, if there is 
scarcity  on  the  allowance  market.  However,  the  lack  of  verified  emissions  data  when 
setting  up  the  National  Allocation  Plans  (NAPs)  for  the  first  trading  period  (2005-2007) 
combined  with  over-optimistic  projections  of  emissions  led  to  the  issuance  of  more 
allowances than was justified to ensure the necessary scarcity on the market.  

•  Member States had different levels of ambition for the emission reductions required of the 
sectors  included  in  the  EU  ETS,  and  consequently  different  Member  States  set  different 
levels  of  allocation  for  the  same  sector.  They  also  applied  widely  differing  allocation 
methods.  

•  The  Commission's  approval  of  NAPs  turned  out  to  be  a  long-lasting,  cumbersome  and 

complex process.  

•  Some sectors pass the market value of the allowances through to their customers in their 

product prices and received significant free allocations. 

The issues identified during the review of the EU ETS justified a revision of the ETS design 
itself.  They  have  been  largely  addressed  in  the  revised  ETS  Directive.  The  Commission 
proposed a fully harmonised approach including an EU-wide and annually shrinking cap on 
allowances  -  to  replace  the  prevailing  bottom-up  approach  based  on  NAPs  -  leading  to  an 
emission reduction of 21% by 2020 as compared to 2005 levels, with reductions continuing 
thereafter. The Commission also proposed to phase-in auctioning over a period of time as the 
principal  allocation  method  for  all  operators,  and  provided  for  harmonised  rules  for  the 
transitional free allocation. These elements do not only guarantee that the required emission 
reductions  are  achieved,  they  also  increase  the  certainty  and  predictability  in  the  system, 
thereby fostering investments to reduce emissions.  

Thus, the ETS revised Directive sets up the general framework for the corrective action to the 
problems identified with the current ETS. In 2010, the European Commission has continued 
the preparatory work to define all the detailed implementing measures and further guidance to 
enable the revised ETS to work from 2013. Specific problems raised during the preparatory 
work  have  been  intensely  discussed  with  Member  States  (via  informal  meetings  and 
Comitology)  and  stakeholders  throughout  the  year.  The  Commission  will  endeavour  to 
address these problems in the measures and guidance that it will propose in 2011. 

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7.1.3.  Perspectives 

Transposition and implementation processes are well under way and according to plan. The 
Commission will continue to defend its decisions and the integrity of the EU ETS Directive in 
ongoing Court proceedings. 

With  respect  to  the  reverse-charge  mechanism  for  VAT,  the  Commission  will  reiterate  the 
importance  of  the  implementation  of  this  mechanism  and  plans  to  inquire  about  the 
implementation of Member States. 

During 2011, the following measures are planned to be adopted or implemented to ensure the 
proper and timely implementation of the ETS.  

A  proposal  for  the  harmonised  rules  on  transitional  free  allocation  (benchmarking)  was 
submitted to the Council and the European Parliament for scrutiny. It was adopted on 27 April 
2011. Ensuring harmonised implementation by Member States will be a priority for the rest of 
2011.  

By 30 September 2011, Member States are required to send their intentions in terms of free 
allocation  as  of  2013  for  each  installation  on  their  territory  to  the  Commission.  Upon 
submission, the Commission will assess the proposed allocation and may reject it. 

The Registries Regulation needs to be further amended to fully take account of the revised EU 
ETS. 

A Regulation for the monitoring and reporting of emissions and, where relevant, activity data, 
from  the  activities  listed  in  Annex  I,  as  well  as  for  the  monitoring  and  reporting  of  tonne-
kilometre data is to be adopted by 31 December 2011. 

Furthermore, a Regulation on accreditation and verification of emission reports is also to be 
adopted by 31 December 2011. 

Concerning  the  list  of  sectors  and  subsectors  deemed  to  be  exposed  to  a  significant  risk  of 
carbon leakage, the Commission has analysed further sectors and subsectors during 2010 and 
proposed to add a number of sectors and subsectors to the list. The proposal was agreed by the 
Climate Change Committee on 19 May 2011. The draft decision is now under scrutiny by the 
Council and the European Parliament. 

The  Commission  is  also  to  update  and  publish  the  total  quantity  of  allowances  for  the  year 
2013 and the estimated quantity of allowances to be auctioned as of 2013. 

With  regards  to  the  protection  from  insider  dealing  and  market  manipulation,  following  the 
organised  cyber-attacks  on  national  registries  between  November  2010  and  January  2011, 
protection  will  be  improved  by  means  of  continuously  adapting  security  measures based  on 
experience and new technologies. 

Furthermore,  transactions  in  the  EU  ETS  carbon  market  relate  both  to  the  allowances 
themselves  and  to  derivative  products  based  on  allowances,  e.g.  futures.  In  general,  such 
derivatives  qualify  as  financial  instruments  and  are  usually  traded  on  one  of  a  number  of 
specialised exchanges. Some of these exchanges qualify as regulated markets. This means that 
a  significant  part  of  the  trade  in  the  EU  ETS  carbon  market  is  already  covered  by  the 

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applicable financial markets legislation. However, financial market legislation does not apply 
to  the  spot  market,  and  for  some  of  the  provisions  there  are  exemptions  for  non-investment 
firms.  

The Commission's ongoing work in the field of financial markets regulation will also affect 
the level of protection of the EU ETS carbon market.  

The focus of the work going forward will be to assess whether additional measures are needed 
to  protect  the  types  of  transactions  in  the  EU  ETS  carbon  market  that  are  currently  not 
covered by existing legislation or legislation in the pipeline in the field of financial markets. 
Further analysis and stakeholder consultations will take place in 2011.  

Generally,  during  2011  the  Commission  plans  to  continue  holding  a  number  of  broad 
stakeholder  meetings  and  further  bilateral  consultations  with  industry  and  NGOs  as  well  as 
expert meetings with Member States' representatives on the implementation of the transitional 
EU-wide rules for harmonised free allocation (benchmarks) and on other issues, such as the 
regulations on monitoring and reporting and on accreditation and verification as well as on the 
security of the registries. 

EU ETS for aviation activities  

Year 2011  represents an important milestone concerning the implementation of EU ETS on 
aviation from January 2012 onwards.  

The following measures are planned to be adopted or implemented to ensure the proper and 
timely implementation of the ETS on aviation in 2011: 

• 

• 

• 

An  update  of  the  list  determining  the  aircraft  operators'  administering  State  in  an 
EEA-wide  area  is  to  be  finalised  and  published  further  to  the  inclusion  of  the 
Directive  2008/101/EC  into  the  EEA  agreed  in  April  2011,  so  as  to  ensure  the 
smooth functioning of the EU ETS for aviation, once the EEA EFTA countries are 
fully included in the system. 

Calculation of the EU 27 figures for allowances and the EEA wide benchmarks for 
the periods 2012 and 2013-2020 are also due by 30 September 2011. These will be 
derived from the verified benchmarking data (measured in "tonne-kilometres") being 
collected by aircraft operators for the year 2010 and reported to the Member States 
by 31 March 2011. 

Preparation  of  the  review  of  the  functioning  of  the  Directive  in  relation  to  aviation 
activities  (e.  g.  impacts,  functioning,  effectiveness,  special  reserve,  thresholds, 
exemptions) in the second trimester 2011 with the small emitters study. 

Negotiations  with  Switzerland  on  linking  with  the  EU  ETS  aviation  will  start  in  the  first 
trimester 2011.  

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7.2.  Monitoring and Reporting 

7.2.1. 

Introduction 

Together  with  the  Emissions  Trading  Directive,  Decisions  280/2004/EC172  (the  Monitoring 
Mechanism  Decision  –  MMD)  and  2005/166/EC173  are  among  the  most  important  cross-
cutting measures in this area of climate change. With the adoption of these decisions, the EU 
established a mechanism for the monitoring and reporting of the Member States' greenhouse 
gas (GHG) emissions and their projected progress towards GHG targets. This mechanism has 
enabled the Commission to more accurately, rigorously and regularly evaluate the (quality of 
the) progress made in reducing emissions under the UNFCCC and the Kyoto Protocol. As a 
result, Member States have improved timeliness and quality in the submission of their data. 

7.2.2.  Report of work done in 2010 

Monitoring and Reporting 

In  relation  to  the  implementation  of  the  Monitoring  Mechanism  Decision  (MMD),  the 
Commission continued its efforts to ensure the complete and timely submission of data by the 
Member  States.  Under  Article  3  (1)  of  Decision  280/2004/EC,  read  in  conjunction  with 
Decision 2005/166/EC, Member States must submit to the Commission by 15 January 2010, 
the  first  main  elements  of  their  national  greenhouse  gas  (GHG)  inventory  report  of  actual 
progress (NIR). By 15 March 2010, Member States must submit their complete NIR. These 
reports are required by the Commission so it can compile, in collaboration with the Member 
States  an  assisted  by  the  European  Environment  Agency  (EEA),  the  EU's  annual  inventory 
report on the EU's actual GHG emissions in compliance with the UN Framework Convention 
on  Climate  Change  and  the  Kyoto  Protocol  In  2010  there  was  no  reporting  obligation 
(biennial requirement) under Article 3(2) of the MMD. 

With respect  to  Monitoring and Reporting  in 2010 the Climate Change Committee voted in 
favour  of  amending  the  existing  Commission  Decision  2007/589/EC,  the  so-called 
Monitoring and Reporting Guidelines in order to include monitoring and reporting guidelines 
for  greenhouse  gas  emissions  from  new  activities  and  gases  pursuant  to  Directive 
2003/87/EC.  Apart  from  relatively  minor  changes  to  existing  annexes  to  the  Decision,  the 
current  amendment  adds  six  new  annexes  providing  activity-specific  guidelines  for  the 
production of: soda ash and sodium bicarbonate; ammonia; hydrogen and synthesis gas; bulk 
organic chemicals; ferrous and non-ferrous metals; primary aluminium. Final adoption by the 
Commission is planned in the first half of 2011. 

Enforcement: ensuring complete and timely reporting by the Member States 

In  early  2010,  the  Commission  has  closed  pending  infringement  cases  against  4  Member 
States  that  had  failed  to  submit  their  2008  annual  and  2007  biennial  reports.  New 

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173 

Decision 280/2004/EC of the European Parliament and of the Council of 11 February 2004 concerning 
a  mechanism  for  monitoring  Community  greenhouse  gas  emissions  and  for  implementing  the  Kyoto 
Protocol (OJ L 49, 19.2.2004, p. 1–8). 
Commission Decision 2005/166/EC of 10 February 2005 laying down rules implementing Decision No 
280/2004/EC  of  the  European  Parliament  and  of  the  Councilconcerning  a  mechanism  for  monitoring 
Community greenhouse gas emissions and for implementing the Kyoto Protocol (OJ L 55, 1.3.2005, p. 
57–91). 

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infringement cases had been launched in 2009 against 24 Member States on the ground that 
they  had  communicated  to  the  Commission  no  or  incomplete  2009  annual  reports  on  GHG 
emissions or 2009 biannual report on policies and measures.  

In  view  of  the  Copenhagen  Climate  Change  Conference  (COP  15/CMP  5)  the  Commission 
found it important to take a strict approach in this regard. In 2010 the Commission was able to 
close all cases. In 2010 some Member States still continued to submit incomplete data. Also 
in  2010,  the  enforcement  branch  of  the  UNFCCC  Compliance  Committee  concluded  that 
Bulgaria was in non-compliance with its UNFCCC obligations, resulting in the suspension of 
Bulgaria's eligibility to participate in the mechanisms under the Kyoto Protocol. 

Still,  it  is  the  Commission's  view  that  the  emphasis  of  its  enforcement  action  should  not  be 
exclusively  on  the  start  of  new  infringement  proceedings,  but  also  on  a  constructive 
collaboration  with  the  Member  States  resulting  in  the  Member  States  submitting  their 
complete reports on time. This is the approach that the Commission will continue to follow 
concerning  the  2011  annual  reports  due  for  15  January  2011  as  well  as  the  2011  biennial 
reports due for 15 March 2011. 

7.2.3.  Perspectives  

Ensuring timely and proper provision of climate-relevant data 

Accurate,  up-to-date  information  is  an  essential  basis  for  climate  change  policy.  Under 
Decisions 280/2004/EC and 2005/166/EC, Member States must provide the Commission with 
annual reports on their actual emissions of greenhouse gases and biennial reports on domestic 
climate change policies and measures and emission projections, so that the Commission can 
accurately report on the progress made by the EU as a whole. To that end the Commission has 
rigorously checked whether national reports are submitted on time and whether the data are 
correct and complete. As a result of the enforcement action, reporting continues to improve in 
terms of timing and content. 

One  of  the  challenges  for  the  Commission  will  therefore  be  to  ensure  that  reporting  of 
national  greenhouse  gas  emissions  improves  still  further,  so  that  all  Member  States 
communicate  complete  reports  to  deadline  to  ensure  an  effective  follow-up  to  the  United 
Nations Convention on Climate Change and its Kyoto Protocol. 

In line with the above, further studies were carried out to examine the revision of Decisions 
280/2004/EC and 2005/166/EC in the light of the adopted Climate and Energy Package and 
the  developments  at  international  level.  The  experience  gained  so  far  has  shown  that  the 
current system, although it has its merits, is not always fully effective and no longer suffices. 
As  the  EU's  commitments  become  more  stringent  and  its  emission  reduction  goals  more 
ambitious, it is imperative that the EU is able to deliver on those goals in a more effective and 
efficient manner. The revision of the Monitoring Mechanism Decision currently underway (se 
below) will significantly enhance the monitoring, reporting and review system that was first 
introduced  under  the  Kyoto  Protocol  and  it  will  ensure  that  the  EU  continues  to  lead  by 
example. 

Revision of the Monitoring Mechanism Decision 

The  adoption  of  a  new  monitoring  and  reporting  scheme  is  mandated  by  the  experience 
gained  through  the  implementation  of  the  Kyoto  Protocol,  which  shows  that  the  current 

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system is not fully effective, the implementation of the Climate and Energy package adopted 
by  the  European  Parliament  and  Council  in  December  2008  and  future  possible  reporting 
obligations  resulting  from  the  ongoing  international  discussions  and  negotiations  following 
the Copenhagen Accord. 

In 2010, the Commission identified and assessed policy options on the basis of previous and 
new  studies  and  took  preparatory  steps  to  launch  an  online  stakeholder  consultation  and  to 
complete  an  impact  assessment.  The  Commission  also  organised  a  workshop  with  Member 
States  to  discuss  the  main  issues  linked  to  the  revision  of  the  Monitoring  Mechanism 
Decision. 

In 2011, the Commission will also continue its work on the revision of Decision 280/2004/EC 
through an online stakeholder consultation, preparation of an impact assessment and of a legal 
proposal.  

Other implementing measures on monitoring and reporting under ETS 

In  2010,  preparatory  work  has  been  carried  for  drafting  a  new  Commission  Regulation  on 
ETS  Monitoring  and  Reporting  in  compliance  with  Article  14  of  Directive  2003/87/EC. 
Adoption by the Commission is expected by December 2011. 

A  new  Commission  Regulation  on  ETS  Accreditation  and  Verification  in  compliance  with 
Article  15  of  Directive  2003/87/EC  is  also  being  prepared.  Adoption  by  the  Commission  is 
expected by December 2011. 

7.3. 

Ozone depleting substances and Fluorinated Gases 

7.3.1. 

Introduction 

The Regulation on Ozone Depleting Substances sets out controls on production, importation, 
exportation,  supply,  use,  leakage,  recovery  and  lays  down  the  phasing-out  in  line  with  the 
obligations under the Montreal Protocol. Regulation (EC) No 1005/2009 recast and replaced 
Regulation (EC) No 2037/2000 as of 1 January 2010, clarifying, simplifying and streamlining 
the previous provisions and procedures to the extent possible. 

Regulation  (EC)  No  842/2006  on  certain  fluorinated  greenhouse  gases  (F-Gases)  aims  at 
reducing  emissions  of  three  groups  of  fluorinated  greenhouse  gases:  hydrofluorocarbons, 
perfluorocarbons  and  sulphur  hexafluoride  through  a  series  of  targeted  sector-specific 
measures  such  as  systematic  checks  for  leakage  and  recovery  from  equipment  by  certified 
personnel;  labelling  of  products  and  equipment;  the  prohibition  of  placing  on  the  market  of 
certain products containing  such gases  and of  the use of those gases in certain  applications. 
The Regulation is complemented by 10 Commission Regulations adopted between 2007 and 
2008. 

7.3.2.  Report of work done in 2010 

Revision of the existing legal framework 

The  Regulation  on  Ozone  Depleting  Substances  applies  since  1  January  2010  (Regulation 
(EC) No 2037/2000 was repealed from the same date). The Commission adopted Regulation 
(EU) No 744/2010 amending Regulation (EC) No 1005/2009 with regard to the critical uses 

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of halons, which introduces cut-off and end-dates for all exempted uses of these substances.  

The Regulation on F-Gases requires the Commission to publish a report in 2011 based on the 
experience  of  its  application  and,  where  necessary,  present  proposals  for  revision  of  the 
relevant  provisions  of  the  Regulation.  A  technical  study  was  launched  in  the  context  of  the 
preparatory  phase  of  the  review  and  a  targeted  Expert  Group  composed  of  Member  States 
authorities, industry organisations and environmental NGOs was also established to assist the 
Commission services, particularly in relation to the ongoing study. 

Compliance promotion and legal enforcement 

Implementation of the Regulation on Ozone Depleting Substances 

During  2010  no  new  infringement  cases  relating  to  the  Regulation  on  Ozone  Depleting 
Substances  were  launched.  Four  infringement  cases  (against  Cyprus,  Denmark,  Greece  and 
Italy)  were  closed  regarding  the  failure  to  fulfil  the  obligations  in  relation  to  the 
decommissioning of halons used in fire extinguishers of ships. One case on this issue (against 
Malta) was further pursued and referred to the Court of Justice. 

Implementation of the Regulation on F-Gases 

The Commission monitored attentively the implementation by the Member States of certain 
requirements laid down in the Regulation and in the implementing Commission Regulations. 
In particular, some delays observed in the establishment of national certification systems for 
personnel and companies working with F-Gases and in the adoption of rules on penalties by 
the Member States have required appropriate follow-up action from the Commission.  

Implementation of the Regulation on Ozone Depleting Substances 

Regarding  the  implementation  of  the  Ozone  Regulation,  Member  States  were  found  in 
compliance  with  the  Regulation  and  no  major  difficulties  have  been  encountered  with  the 
enforcement of the Regulation. 

7.4. 

Transport related emissions 

7.4.1. 

Introduction 

Commission strategy to reduce CO2 emissions from cars and vans 

The  European  Commission  has  a  comprehensive  strategy  (COM/2007/0019  final)  to  reduce 
CO2  emissions  from  new  cars  and  vans  sold  in  the  European  Union,  to  ensure  that  the  EU 
meets its greenhouse gas emission targets under the Kyoto Protocol and beyond. 

This  strategy,  which  was  adopted  in  2007,  aims  to  tackle  CO2  emissions  from  both  the 
production  and  consumer  sides  and  is  designed  to  help  the  EU  reach  its  long-established 
objective of limiting average CO2 emissions from new cars to 120 grams per km by 2012 - a 
reduction of around 25% from 2006 levels. 

Regulation (EC) 443/2009 (CO2 from cars Regulation) 

Regulation  (EC)  443/2009  of  the  European  Parliament  and  of  the  Council  setting  emission 

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performance standards for new passenger cars as part of the Community's integrated approach 
to  reduce  CO2  emission  from  light-duty  vehicles  is  the  cornerstone  of  the  EU's  strategy  to 
improve the fuel economy of cars and ensure that average emissions from new passenger cars 
in the EU do not exceed 120 gCO2/km. 

The  key  elements  of  that  legislation  are  the  limit  value  curve,  long-term  target,  phasing-in 
requirements,  excess  emissions  premiums,  eco-innovations,  pool  acting  jointly  to  meet 
emission targets, monitoring CO2 emissions from new passenger cars. 

Directive 1999/94/EC (Labelling Directive) 

Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 
relates  to  the  availability  of  consumer  information  on  fuel  economy  and  CO2  emissions  in 
respect of the marketing of new passenger cars. The main requirements of the Directive are 
the provision of information on CO2 emissions and fuel economy for all new cars at the point 
of sale: car label, a poster and a guide informing on CO2 emissions of all cars offered on sale; 
and mandatory consumer information regarding CO2 and fuel economy of new cars in printed 
advertisements. 

Directive 98/70/EC (Fuel quality Directive) 

As part of the integrated approach set out in the strategy, it was foreseen that a contribution to 
the 120g/km objective would come from use of low greenhouse gas fuels. In view of the fact 
that  complementary  measures  had  to  be  measurable,  monitorable  and  a  party  needed  to  be 
accountable for them, the Fuel quality Directive (Directive 98/70/EC) was modified to include 
a greenhouse gas reporting and reduction requirement. This modification set out in article 7a 
of the Directive requires a 6% reduction in the greenhouse gas intensity of the fuel supplied 
by 2020 as a contribution to the strategy to reduce greenhouse gas emissions from light duty 
vehicles. 

7.4.2.  Report of work done in 2010 

Commission strategy to reduce CO2 emissions from cars and vans 

The  Commission  has  adopted  a  progress  report  (COM/2010/0656  final)  in  November  2010, 
concluding  that  most  of  the  measures  contained  in  the  2007  strategy  have  already  been 
implemented  or  are  in  the  process  of  being  implemented.  The  goal  of  reducing  new  car 
emissions  to  120  gCO2/km  by  2012  is  however  not  likely  to  be  achieved  because  some 
measures have been implemented late. Despite a low probability of achieving the 2012 target, 
the  strategy,  and  the  measures  it  includes,  has  played  an  important  role  in  reducing  CO2 
emissions from light-duty vehicles. 

Regulation (EC) No 443/2009 (CO2 from cars Regulation) 

In  2010  the  work  was  focused  on  preparing  measures  implementing  Regulation  (EC)  No 
443/2009, including on monitoring of CO2 emissions, derogations for small volume and niche 
manufacturers and eco-innovations.  

Commission  Regulation  (EU)  No 1014/2010  on  monitoring  and  reporting  of  data  on  the 
registration of new passenger cars pursuant to Regulation (EC) No 443/2009 of the European 
Parliament and of the Council was adopted on 

10 November 2010.  

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Decision (EC) 1753/2000 of the European Parliament and of the Council establishing a 
scheme to monitor the average specific emissions of CO2 from new passenger cars 

The Commission also adopted as part of the implementation of Decision (EC) No 1753/2000 
a report on the monitoring of CO2 emissions from new passenger cars in 2009.  

Proposal for a regulation on CO2 from vans 

In 2010 the proposal on CO2 from vans, adopted by the Commission in October 2009, was in 
co-decision. Negotiations between the co-legislators were concluded by the end of 2010 in a 
series  of  informal  trilogue  discussions  leading  to  a  first  reading  agreement.  The  European 
Parliament voted on the compromise amendments in February 2011 and the formal approval 
by  the  Council  took  place  on  31  March.  The  main  provisions  of  the  Regulation  mirror 
Regulation (EC) 443/2009 on CO2/cars and include a 2-step approach to setting CO2 emission 
standards for new vans, i.e. a target of 175g/km in 2017 and 147g/km in 2020. In addition, the 
legislation includes other key elements from the cars Regulation such as the limit value curve, 
phasing-in  of  the  first  target,  excess  emissions  premiums,  eco-innovations,  pools  acting 
jointly  to  meet  emission  targets,  monitoring  CO2  emissions  from  new  light  commercial 
vehicles. 

Directive 98/70/EC (Fuel Quality Directive) 

Following  adoption  of  the  amendment  to  this  Directive  in  April  2009  a  number  of  issues 
required  further  work.  The  methodology  for  reporting GHG intensity of energy used within 
the  scope  of  the  Directive  other  than  biofuels  is  foreseen  in  the  Directive  to  be  adopted 
through Comitology. The Commission held a public consultation in September 2009 followed 
by  an  expert  meeting  early  in  2010  to  provide  input  to  this  work.  Following  extensive 
deliberations  a  draft  implementing  measure  has  been  the  subject  of  consultation  within  the 
Commission. Further information of relevance to this measure became available at that time 
with the completion of a study on the GHG intensity of fuel production from tar sands and oil 
shales. 

The  Directive  also  foresaw  the  need  to  correct  the  lack  of  accounting  for  greenhouse  gas 
emissions due to Indirect Land Use Change. The Commission adopted a report on its work in 
December 2010 in which it stated it will present an impact assessment if appropriate together 
with a legal proposal by July 2011. 

Compliance promotion and legal enforcement 

Directive 1999/94/EC (Labelling Directive) 

During  2010  no  new  infringement  cases  relating  to  Directive  1999/94/EC  were  launched. 
Three cases against Spain, Italy, and Belgium concerning the absence of enforcement by the 
authorities,  however,  remained  open  from  previous  years  and  were  further  pursued 
accordingly.  

Regulation (EC) 443/2009 (CO2 from cars Regulation) 

In 2010 the European Commission has started the preparatory work in order to develop all the 

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detailed  implementing  measures  and  further  guidance  where  required  to  enable  an  efficient 
monitoring system. In order to ensure that the data collected and reported by Member States 
to  meet  requirements  set  out  in  the  legislation,  the  Commission  followed  up  with  several 
Member States where missing data or data quality had proven to be an issue of concern.  

The Commission will continue to work closely with Member States to improve the quality of 
their reporting.  

Directive 1999/94/EC (Labelling Directive) 

Regarding  the  implementation  of  Directive  1999/94/EC,  it  can  be  said  that  while  a  limited 
number of infringement cases have remained open from previous years and individual issues 
may persist, in general Member States are in compliance with the Directive. 

Directive 98/70/EC (Fuel quality Directive) 

In  2010  the  Commission  has  continued  work  on  the implementation  measures.  In  particular 
this  concerns  the  methodology  for  reporting  GHG  intensity  of  energy  used  other  than 
biofuels.  It  has  also  continued  with  the  evaluation  of  vapour  pressure  derogation  requests 
under  Article  3(4)  of  the  Directive.  Fuel  Quality  reporting  required  under  the  Directive 
continues and the Commission has not identified any specific problems. 

7.5. 

Other climate related legislation 

7.5.1.  Carbon Capture and Storage (CCS) 

CCS Directive 

Directive 2009/31/EC on the geological storage of carbon dioxide (CCS Directive) is one of 
the world's first comprehensive legal frameworks for the regulation of the environmental risks 
of  carbon  capture,  transport  and  storage.  It  entered  into  force  on  25  June  2009.  Although  it 
covers the full chain of activities arising in CCS, carbon capture and transport are comparable 
to other activities already regulated at EU level. The CCS Directive therefore regulates these 
activities  by  introducing  them  into  the  scope  of  the  existing  legislation.  Carbon  capture  is 
regulated under  Directive 2008/1/EC  (IPPC Directive) and under Directive  85/337/EC (EIA 
Directive', and pipeline transport is regulated under the EIA Directive. 

The Directive establishes an authorisation regime for geological storage sites and covers site 
exploration, characterisation, selection, monitoring, closure and post-closure management, as 
well  as  composition  of  the  CO2  stream.  One  notable  provision  included  is  that  draft  permit 
decisions for storage sites (and also decisions on transfers of responsibility, see below) are to 
be submitted to the Commission, which is to issue - within 4 months - an opinion on whether 
the  draft  permit  decisions  meet  the  requirements  of  the  Directive.  The  Commission  has 
established a Scientific Panel to assist it in its assessment (see below). 

There are no implementing provisions required under the CCS Directive, but the Commission 
has in 2010 finalised a guidance document on a number of issues (composition of the CO2 
stream, conditions for transfer of responsibility to Member States, and financial contributions 
required of the operator at the point of transfer of responsibility).  

The Commission also intends to produce guidance on a number of other issues. 

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More  specifically,  monitoring  and  reporting  guidelines  (MRGs)  were  adopted174  for  CCS 
under  the  Emissions  Trading  Directive  for  the  purposes  of  quantifying  the  emissions  for 
which allowances must be surrendered for capture, transport and storage activities, including 
in the case of leakage  

Commission has also started working on the review of draft storage permits under article 10 
of the Directive. 

During 2010 the Commission also established a Scientific Panel to provide technical input 
into  the  Commission  opinions  on  draft  permit  decisions  and  decisions  on  transfer  of 
responsibility. Guidance documents on the key aspects of implementation were also adopted.  

In 2011, conformity checking will be carried out to check transposition of the CCS Directive 
in the Member States.  

7.5.2.  EU Effort Sharing Decision (ESD) 

Decision 406/2009/EC175 (Effort Sharing Decision, ESD) lays down binding annual targets 
for greenhouse gas emissions outside the scope of the ETS, for the period 2013-2020, for 
each  Member  State.  It  entered  into  force  on  25  June  2009.  About  60%  of  the  total  EU-27 
greenhouse gas emissions are covered by the ESD. The most important emitting sectors are 
transport  (about  30%  of  total  ESD  emissions),  private  households  and  services  (25%),  and 
agriculture (15%).  

By way of contrast with the EU ETS, which is EU-wide market-based instrument already in 
place  with  well  established  rules  and  procedures  for  installations  and  Member  States,  the 
Effort Sharing Decision is a new legal instrument with far-reaching consequences for Member 
States'  obligations  to  reduce  greenhouse  gas  emissions.  Though  the  ESD  will  rely  on  both 
EU-wide and national measures, the most mitigation actions will have to be prepared and 
implemented at Member State level. 

By 2013, the following key actions will be necessary to implement the ESD and prepare for 
the 2013-2020 compliance period: 

–  Determining  the  exact  targets  for  Member  States  for  the  period  between  2013  and  2020 

(comitology decision); 

–  Amending the Monitoring Mechanism Decision ( ordinary legislative procedure); 

–  Establish  modalities  for  transfers  of  emission  allocations  between  Member  States 

(comitology decision); 

–  Prepare for the inclusion of land use, land-use change and forestry (LULUCF) in the EU 

reduction commitment (co-decision, see below). 

174 

175 

Decision  345/2010/EC  of  the  European  Commission  of  08  June  2010  concerning  the  inclusion  of 
monitoring  and  reporting  guidelines  for  greenhouse  gas  emissions  from  the  capture,  transport  and 
geological storage of carbon dioxide (OJ L 155, 22.6.2010, p. 34-47). 
Decision  No.  406/2009/EC  of  the  European  Parliament  and  of  the  Council  of  23  April  2009  on  the 
effort of Member States to reduce their greenhouse gas emissions to meet the Community's greenhouse 
gas emission reduction commitment up to 2020. 

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In  2010  the  Commission  services  have  started  preparations  for  a  number  of  implementing 
provisions under the ESD for decision in 2011 / 2012. 

In 2011 the Commission will present a decision to be adopted through comitology procedure 
(including  a  vote  in  the  Climate  Change  Committee)  in  order  to  determine  the  annual 
emission allocations expressed in absolute tonnes of CO2 equivalents for the period between 
2013  and  2020  in  accordance  with  Article  3.2  of  the  Decision.  The  Commission  will  also 
prepare  for  a  Comitology  decision  to  establish  "modalities"  for  transfers  of  emission 
allocations between Member States and increase their transparency under the ESD as required 
by Article 3.6 of the Decision. 

7.5.3.  Land use, land-use change and forestry (LULUCF) 

Articles  8(1)  and  8(6)  of  the  ESD  and  Article  28(1)  of  the  ETS  Directive  require  the 
Commission  to  consider,  in  the  absence  of  an  international  agreement,  a  number  of  issues 
regarding LULUCF. The Commission will report in 2011 and assess options for the possible 
inclusion  of  emissions  and  removals  from  activities  related  to  LULUCF  in  the  Community 
reduction  commitment.  If  considered  necessary,  the  Commission  will  make  a  legislative 
proposal.  

8. 

ENVIRONMENT 

8.1. 

Nature Conservation 

8.1.1.  Current position 

8.1.1.1.  General introduction 

The  most  important  pieces  of  nature  conservation  legislation  are  the  Birds  Directive, 
2009/147/EC  (codified  version  replacing  Directive79/409/EEC176)  and  Habitats  Directive, 
92/43/EEC177. The former sets out measures for the protection, management and control of all 
species of naturally occurring European wild birds, as well as introducing rules to protect their 
habitats. The latter protects natural habitats and wild flora and fauna throughout the European 
Union and establishes a European ecological network known as “Natura 2000”. 

Nature conservation legislation constitutes a fairly stable part of the EC environmental acquis. 
Developments in this sector mainly concern the annexes to the Birds and Habitats Directives 
that  have  been  adapted  on  a  number  of  occasions  in  response  to  scientific  and  technical 
progress  and  to  the  successive  enlargements  of  the  European  Union.  The  most  recent 
adaptation is in response to the Accession of Bulgaria and Romania to the European Union on 
1  January  2007.  The  Union  is  at  present  very  close  to  the  completion  of  the  Natura  2000 
network and regulatory stability is required in order to focus on the sustainable management 
of the areas.  

176 

177 

Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds OJ L 103, 25.4.1979, 
p. 1-18. 
Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna 
and flora OJ L 206, 22.7.1992, p. 7–50. 

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8.1.1.2.  Report of work done in 2010 

Establishment  of  the  Natura  2000  network  and  designation  of  Special  Areas  of 
Conservation 

Further  progress  was  made  in  2010  in  the  establishment  of  the  Natura  2000  network, 
consisting  of  Special  Protection  Areas  (SPAs)  under  the  Birds  Directive  and  Sites  of 
Community  Importance  (subsequently  to  be  designated  as  Special  Areas  of  Conservation) 
under  the  Habitats  Directive.  On  10  January  2011,  the  Commission  adopted  six  Decisions 
updating  existing  Biogeographical  Lists  of  Sites  of  Community  Importance  (SCIs).  The 
additions  include  739  new  sites  and  a  total  area  of  27,000  km².  More  than  half  of  the  area 
added is made up of marine sites. This means that further significant progress has also been 
made  as  regards  the  designation  of  marine  areas.  Substantial  designations  of  marine, 
especially  offshore,  sites  are,  however,  still  expected  in  2011  and  2012.  Taking  also  into 
account new SPAs, the Natura 2000 now covers almost 18% of the EU’s landmass and almost 
180.000 km² of marine areas, making it the largest interconnected network of protected areas 
in the world.  

Several Member States have increased the number of designated areas following infringement 
procedures launched by the European Commission and several of these procedures have been 
closed  in  2010.  A  Marine  Biogeographical  Seminar  for  the  outstanding  sea  regions 
(Mediterranean, Black Sea, Macaronesian Atlantic) was organized in 2010 and the proposals 
of SCIs in these regions have been evaluated. 

Most Member States are still in a process of designating their Sites of Community Importance 
as Special Areas of Conservation (SACs) according to Article 4(4) of the Habitats Directive. 
This exercise includes the establishment of detailed conservation objectives for the individual 
sites and the design of appropriate management instruments according to Article 6(1) of the 
directive. Member States have to designate their SCIs as SACs not later than six years after 
the inclusion of the sites in a Community list. That deadline was 28 December 2007 for most 
sites  of  the  Macaronesian  biogeographical  region,  22  December  2009  for  most  sites  of  the 
Alpine  biogeographical  region  and  7  December  2010  for  most  sites  of  the  Atlantic  and 
Continental  regions.  An  infringement  procedure  was  launched  in  2008  against  Portugal  and 
Spain  for  not  having  designated  sites  in  that  region  as  SACs.  Following  this  procedure, 
Portugal adopted the necessary legal acts in order to approve the designation of SACs and the 
Commission took the decision to close the infringement case. On the contrary as the progress 
in the Spanish case was considered as insufficient, the Commission decided to refer the case 
to the Court of Justice (case C-90/10) and is currently awaiting its ruling.  

The  Commission  will  consider  launching  new  infringement  procedures  against  Member 
States  which  still  have  not  provided  sufficient  designations  for  the  Natura  2000  network  or 
which have not designated their SCIs as SACs  within the deadline required by the Habitats 
Directive. 

Non-conformity with the Birds and Habitats Directive 

In  2010,  the  Commission  pursued  infringements  dealing  with  non-conformity  of  national 
transposing legislation with the Birds and Habitats Directive. As regards the Birds Directive, 
the Commission decided in 2010 to address a complementary Letter of Formal Notice (under 
article  258  of  the  Treaty  on  the  Functioning  of  the  EU)  to  the  United  Kingdom,  and  a 

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Reasoned Opinion (under the same article) to Poland and Romania. Furthermore, on 15 July 
2010 the Court ruled that Italy has failed to adequately transpose the directive 

As regards the Habitats Directive, a Reasoned Opinion (under article 258 of the TFEU) was 
sent to Denmark and Poland.  

Insufficient designation of Special Protection Areas 

Under  the  Birds  Directive,  Member  States  are  obliged  to  designate  all  of  the  most  suitable 
sites as Special Protection Areas to conserve wild bird species. The designation must be based 
on  objective,  verifiable  scientific  criteria.  To  assess  whether  Member  States  have  complied 
with  their  obligation,  the  Commission  uses  the  best  available  ornithological  information. 
Where  the  necessary  scientific  information  provided  by  Member  States  is  lacking,  national 
inventories  of  Important  Bird  Areas  (IBA)  compiled  by  the  non-governmental  organisation 
Birdlife  International,  are  used.  While  not  legally  binding,  the  IBA  inventory  is  based  on 
internationally-recognised scientific criteria. The Court of Justice has already acknowledged 
its scientific value, and in cases where no equivalent scientific evidence is available, the IBA 
inventory is a valid basis of reference in assessing whether Member States have classified a 
sufficient number and size of territories as Special Protection Areas. 

In 2010, the Commission sent a complementary Letter of Formal Notice (under article 260 of 
the TFEU) against Greece for failing to designate enough Special Protection Area (SPA) on 
its territory. In 2010 the Court of Justice also ruled against Austria for not having designated 1 
SPA and for insufficiently designating another one.  

Bird Hunting 

Hunting  is  regulated  in  the  European  Union  by  the  Birds  Directive.  Although  the  Directive 
contains a general prohibition on the killing of wild birds, it does allow certain species to be 
hunted  provided  this  does  not  take  place  during  the  breeding  season  or  migration  periods. 
Hunting  periods  are  set  at  national  levels,  and  vary  according  to  species  and  geographical 
location. Exceptionally, Member States may allow the capture or killing of birds covered by 
the Directive outside of the normal hunting season for a limited number of reasons, although 
such derogations are only available when there is no alternative solution. 

As regards huntable species, the Commission has prepared further management plans on such 
species  with  an  unfavourable  conservation  status.  They  are  not  legally  binding  but  give 
guidelines to Members States to fulfil their obligations on species' conservation. 

The  Court  of  Justice  ruled  on  20  September  2009  (case  C-76/08)  that,  although  autumn 
hunting  did  not  in  the  specific  case  of  Malta  provide  a  satisfactory  alternative  solution  to 
spring hunting, Malta had nonetheless breached the specific conditions for derogation under 
Art 9 of the Birds Directive and the principle of proportionality in permitting spring hunting. 
Following this ruling, the Commission decided to pursue the infringement procedure and to 
send in 2010 a Letter of Formal notice (under article 260 TFEU) to Malta.  

In  2009,  the  Commission  decided  to  take  Italy  to  the  Court  of  Justice  in  relation  to  certain 
regional hunting legislation. On 11 November 2010, the Court ruled (case C-164/09) that the 
legislation passed by the region of Venice violates the obligations of the Member State under 
article 9 of the birds directive.  

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Species protection 

The  Habitats  Directive  comprises  an  important  pillar  which  is  related  to  the  protection  of 
species. In particular, Articles 12 and 16 are aimed at the establishment and implementation 
of a strict protection regime for animal species listed in Annex IV(a) of the Habitats Directive 
within  the  whole  territory  of  Member  States.  Focus  is  mainly  on  developing  guidance 
documents  such  as  the  Guidance  document  on  the  strict  protection  of  animal  species  of 
Community interest under the 'Habitats' Directive 92/43/EEC that was finalized in February 
2007.  Specific  guidance  documents  have  also  been  developed  for  the  protection  and 
management  of  large  carnivores.  An  initiative  for  preparing  species  protection  plans  for  a 
number of priority species has been further pursued. 

Furthermore,  the  Commission  is  preparing  further  new  or  revised  action  plans  for  globally 
threatened bird species. 

In  order  to  reduce  the  conflicts  between  Cormorants  and  fisheries,  the  Commission  is 
currently  finalising  guidance  on  the  appropriate  use  of  derogations  under  Article  9  of  the 
Birds  Directive  and  has  also  launched  a  contract  with  a  view  to  establishing  a  platform  for 
exchange of best practices on the issue and to gathering reliable monitoring population data. 

Further judgments of the Court of Justice in 2010 

In case C-491/08 of 19 June 2010, against Italy and concerning a planned tourist complex in 
Narbolia located in an SCI (site of Community importance), the Court found that Italy failed 
to  adopt  the  necessary  conservation  measures  and  measures  to  avoid  deterioration  of  the 
habitats for which the site is designated (breach of Art.6(2) of the Habitats directive). 

In case C-164/09 of 11 November 2010, against Italy, the Court concluded it (Venice region) 
did not respect the conditions of Article 9 of the Birds Directive by adopting and applying the 
present hunting derogations. 

In  its  judgement  C-308/08  the  Court  found  that  the  Commission  failed  to  prove  that  the 
implementation  of  the  road  upgrading  project  at issue  has  actually  had a  real  impact  on  the 
habitat  fragmentation  of  the  Iberian  lynx.  According  to  the  Court,  the  evidence  before  the 
Court  was  not  sufficient  for  it  to  find  that  the  project  for  upgrading  the  country  road, 
accompanied  by  the  corrective  measures,  constitutes  in  itself  intervention  of  a  kind  which 
places the Iberian lynx on the site concerned in danger of extinction and which, accordingly, 
risks  seriously  compromising  the  ecological  characteristics  of  that  site.  Therefore  the  Court 
dismissed the action. 

It should also be brought to the fore that by Order of 10 December 2009 (in case C-573/08) , 
the  Court  requested  that  Italy  suspends  the  application  of  a  Regional  hunting  law  in  one 
Lombardia  Region.  This  is  the  second  case  where  the  Commission  successfully  obtained 
interim measures against Italy. 

Finally, in a preliminary ruling (C-226/08) of 14 January 2010, the Court rejected an attempt 
by  the  municipality  of  Papenburg  in  Lower  Saxony  to  prevent  the  German  authorities  from 
designating parts of the Ems river as protected sites under the EU's Natura 2000 network. In 
this preliminary ruling the Court confirmed that member states can only refuse to include a 
site in the Natura network on environmental grounds, not for economic or social reasons. The 
Court also ruled, in this same case, that Article 6(3) and (4) of Directive 92/43, as amended by 

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Directive 2006/105,  must  be  interpreted  as  meaning  that  ongoing  maintenance  works  in 
respect of the navigable channels of estuaries, which are not connected with or necessary to 
the management of the site and which were already authorised under national law before the 
expiry of the time-limit for transposing Directive 92/43, as amended by Directive 2006/105, 
must, to the extent that they constitute a project and are likely to have a significant effect on 
the site concerned, undergo an assessment of their implications for that site pursuant to those 
provisions  where  they  are  continued  after  inclusion  of  the  site  in  the  list  of  sites  of 
Community importance pursuant to the third subparagraph of Article 4(2) of that directive. 

Petitions 

In  2010,  the  Commission  received  32  petitions  related  to  the  issue  of  nature  protection 
(Austria,  Bulgaria,  Denmark,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Poland, 
Portugal, Slovakia and Spain). The subjects raised in these petitions ranged from the measures 
for  the  protection  of  Natura  2000  sites  themselves  to  the  environmental  effects  of 
infrastructure  projects  on  designated  sites.  A  proportion  of  the  nature  protection  petitions 
concerned  projects  with  a  potential  impact  on  designated  sites  in  Spain,  Portugal  and 
Hungary. Responding to concerns raised within the Petitions Committee, Directorate-General 
for  Environment  organised  a  nature  conservation  seminar  for  Bulgarian  officials  in  Sofia  in 
spring 2010. 

8.1.2.  Evaluation based on the current situation  

Despite  the  small  number  of  legal  instruments  in  this  field,  nature  conservation  legislation 
accounts for between a fifth and a quarter of environmental infringements. The nature sector 
accounts  for  the  highest  number  of  open  environmental  cases.  The  high  number  of  cases  in 
the nature sector is due mainly to the extent of the network, which now includes around 26, 
000  sites:  there  are  Natura  2000  sites  in  the  vicinity  of  nearly  every  EU  citizen.  This  is 
positive  in  as  much  as  it  brings  the  EU  close  to  its  citizens  but  it  also  means  that  the 
Commission  receives  a  lot  of  complaints  about  threats  to  these  sites.  Although  the  demand 
from  citizens,  specialised  and  active  NGOs  and  the  European  Parliament  is  high,  the 
complaint  and  legal  enforcement  mechanisms  for  nature  conservation  in  the  Member  States 
are often weak or inappropriate.  

In  order  to  rationalise  the  handling  of  this  high  number  of  cases  and  ensure  the  effective 
implementation of the nature directives, the Commission has taken several measures, which 
can be divided into three categories: 

•  Focus on the main implementation priorities: the core obligations of the directives 
were  effectively  addressed  (i.e.  correct  and  complete 
transposition  and 
establishment  of  the  Natura2000  network),  while  systemic  problems  of  bad 
implementation were tackled (e.g. hunting derogations). 

•  Proactive  cooperation  with  Member  States:  this  includes  the  drafting  of 
interpretative guidance documents for the main provisions of the nature directives; 
the development of targeted guidance for economic sectors such as the port sector, 
wind  energy,  the  non-energy  extractive  industry,  and  inland  waterways,  which 
have particular challenges in relation to the legislation; training of the competent 
authorities;  regular  contacts  with  the  national,  regional  and  local  authorities, 
establishment of the “GreenEnforce Network“. 

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•  Improvements  in  the  handling  of  complaints:  specific  methods  have  been 
developed  with  the  purpose  of  helping  the  complainants  (i.e.  ad  hoc  nature 
supplementary  information  form,  which  guides  the  complainants  as  regards  the 
information  needed  to  evaluate  a  complaint)  and  making  more  effective  use  of 
complaints (i.e. grouping of complaints in order to focus on systemic breaches). 

Those  measures  have  had  a  significant  effect,  as  they  resulted  in  the  reduction  of  the 
implementation deficit. 

8.1.3.  Evaluation results  

8.1.3.1.  Priorities and Planned action (2011 and beyond) 

Priorities and planned actions will be the following:  

•  Completing  the  establishment  stage  of  the  Natura  2000  network.  The  terrestrial 
part of the Natura 2000 network is either established or close to establishment in 
accordance with the Habitats and Birds Directives. Habitats and species coverage 
still needs to be extended in places, mainly in the EU-12 Member States, and legal 
action  will  be  pursued  against  Member  States  when  necessary.  The  process  to 
finalise  the  establishment  of  marine  sites is well underway. In order  to facilitate 
the  marine  site  identification  process,  a  guidance  document  has  already  been 
prepared  by  the  Commission  services.  Marine  Biogeographic  Seminars  covering 
all  European  sea  regions  took  place  in  2009  and  2010.  The  Member  States  are 
expected to have made substantial marine designations, both for SCIs and SPAs, 
by 2012. 

•  Ensuring  a  systematically  correct  approach  to  Natura  2000  site  protection.  To 
enable the Natura 2000 network to achieve its goal of conserving key elements of 
Europe’s biodiversity, there needs to be proper scrutiny and minimisation of, the 
impacts  of  potentially  damaging  plans  and  projects  in  line  with  ECJ  case-law. 
Ensuring  application  of  best  scientific  knowledge  for  appropriate  assessments, 
examination  of  alternatives  and,  where  appropriate,  provision  of  compensatory 
measures are all major challenges. In this regard, the Commission services have 
issued  guidance  on  relevant  key  provisions  of  the  nature  directives.  In  2010  the 
Commission  issued  guidance  to  promote  best  practice  within  specific  economic 
sectors,  such  as  wind  energy  and  non-energy  extractive  industries;  further 
guidance  is  being  finalised  (port  development)  or  under  preparation  (inland 
waterway transport and agriculture). 

•  Ensuring  overall  positive  management  of  Natura  2000  network.  Apart  from 
vetting  potentially  damaging  plans  and  projects,  Member  States  need  to  set  up 
effective management systems for Natura 2000, supporting human activities such 
as  conservation-sensitive  farming  that  are  beneficial  to  conservation  objectives 
while  also  meeting  socio-economic  needs.  In  2009  a  new  expert  group  on  the 
management  of  Natura  2000  was  established.  Meetings  were  held  throughout 
2010 with an aim to develop and exchange information on best practice in Natura 
2000  management,  focusing  in  particular  on  SAC  designation,  integrated 
management  approaches  and  reconciling  nature  conservation  and  economic 
development objectives. The Commission intends in 2011 to launch a new process 

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at  biogeographical  level  in  order  to  address  jointly  with  Member  States  the 
conservation needs of the respective Natura 2000 sites. Work to assure adequate 
financing of Natura 2000 through EU funds is underway and a Communication on 
that issue is scheduled by mid-2011. 

•  Prioritisation of Commission’s legal enforcement work. In the coming years, the 
Commission will continue to pursue its legal enforcement action to help meet the 
main objectives of the nature conservation legislation. To this effect, high priority 
will  continue  to  be  given  to  pursuing  infringement  cases  concerning  significant 
non-conformity of national implementing legislation with the Birds and Habitats 
Directives, insufficient site designations (mainly in the EU-12 Member States and 
for  marine  sites),  including  lack  of  designation  of  SCIs  as  SACs  where  the 
deadline has expired, and the lack of adequate legal protection and management 
regimes  for  the  Natura  2000  sites.  Focus  will  also  be  on  addressing  breaches 
concerning big infrastructure projects or interventions involving EU funding that 
have  significant  adverse  impacts  on  Natura  2000  sites.  In  this  context,  the 
Commission will take into account considerations such as irreversible ecological 
damage and, where appropriate, seek interim measures from the European Court 
of  Justice178.  Infringements  concerning  unsustainable  hunting  practices  in  some 
Member  States  will  also  be  followed  up  closely.  In  order  to  better  handle 
individual  complaints  pointing  to  widespread  problems  of  bad  implementation, 
the established practice of launching horizontal infringement cases  will continue 
to be followed. The approach in implementing EU legislation in general is set out 
in the Commission Communication "A Europe of results – Applying Community 
law" (COM(2007)502 final)179. The approach to be taken in the implementation of 
the  Commission 
EC  environmental 
Communication  on  implementing  European  Community  Environmental  Law 
(COM(2008)773  final)180.  In  addition  to  legal  action,  the  Commission  is  taking 
several  proactive  actions  to  promote  enforcement,  including  dissemination  of 
good  practices,  awareness-raising  and  communication,  increased  integration  in 
other policies. 

in  particular 

laid  down 

law 

in 

is 

8.1.4.  Sector summary  

As regards the designation of Special Protection Areas and Sites of Community Importance as 
part of the Natura 2000 network,  further substantial progress  was  made in 2010. In January 
2011, the Commission adopted six decisions updating existing Biogeographic Lists of Sites of 
Community Importance (SCIs). The additions include 739 new sites representing a total area 
of 27,000 km². More than half of that is made up of marine sites, indicating further significant 
progress  as  regards  the  designation  of  marine  areas,  although  substantial  efforts  are  still 
needed, especially offshore.  

178 

179 
180 

In  the  last  3  years  the  Commission  has  three  times  sought  for  interim  measures  in  nature  protection 
cases. In cases C-503/06, Commission v. Italy and C-76/08, Commission v. Malta, the Court ordered the 
Member States to halt illegal hunting activities on 19 December 2007 and 24 April 2008 respectively. 
In  case  C-193/07,  Commission  v.  Poland,  the  Commission  sought  interim  measures  from  the  ECJ  to 
prevent  a  Polish  motorway  project  causing  serious  habitat  damage:  the  request  was  dropped  when 
Poland agreed to halt the relevant works pending an ECJ judgment 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0502:FIN:EN:PDF  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0773:FIN:EN:PDF  

EN 

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Most  Member  States  are  now  in  a  process  of  designating  their  Sites  of  Community 
Importance as Special Areas of Conservation (SAC) according to Article 4(4) of the Habitats 
Directive. Member States have to designate their SCI as SACs not later than six years after 
the inclusion of the sites in a Community list. The deadline for designation as SAC was 28 
December 2007 for most sites of the Macaronesian biogeographical region and 22 December 
2009 for most sites of the Alpine biogeographical region. For most sites of the Atlantic and 
Continental regions it was 7 December 2010.  

Effective management of Natura 2000 sites will be increasingly a priority in the coming years. 
In  that  regard  the  Commission  is  focusing  on  proactive  measures  such  as  exchange  and 
dissemination  of  best  practices,  awareness-raising  and  communication,  assuring  adequate 
financing of Natura 2000 needs, improved integration in other major EU policies. 

Species  protection  continues  to  constitute  a  challenge  when  implementing  the  Nature 
Directives. The species listed in the Directives shall be strictly protected but they can also be 
hunted provided the conditions in the Directives are fulfilled. The proper functioning of the 
Natura  2000-network  is  ensured  by  hunting  derogations  granted  on  correct  grounds  and  by 
appropriate  protection  regimes  and  management  of  protected  sites,  including  of  the  species 
present there. 

The priorities in the Nature sector have largely remained the same from previous years. Legal 
enforcement  work  in  this  sector,  as  in  other  environment  sectors,  must  be  prioritised  in  the 
interest of the efficient pursuit of the objectives of environment legislation. The approach to 
be  taken  in  the  implementation  of  EC  environmental  law  in  particular  is  laid  down  in  the 
Commission  Communication  COM(2008)773  final  on  implementing  European  Community 
Environmental Law. 

Therefore, in the coming years, the Commission will continue to pursue its legal enforcement 
action to help meet the main objectives of the nature conservation legislation. To this effect, 
high priority will continue to be given to pursuing infringement cases concerning significant 
non-conformity of national implementing legislation with the Birds and Habitats Directives, 
insufficient site designations (mainly in the EU-12 Member States) and the lack of adequate 
legal  protection  and  management  regimes  for  the  Natura  2000  sites,  including  the  lack  of 
designation of SCIs as SACs where the deadline has expired. Focus will also be on addressing 
breaches  concerning  big  infrastructure  projects  or  interventions  involving  EU  funding  that 
have significant adverse impacts on Natura 2000 sites. In this context, the Commission will 
take  into  account  considerations  such  as  irreversible  ecological  damage  and,  where 
appropriate,  seek  interim  measures  from  the  European  Court  of  Justice181.  Infringements 
concerning unsustainable hunting practices in some Member States will also be followed up 
closely.  In  order  to  better  handle  individual  complaints  pointing  to  widespread  problems  of 
bad implementation, the established practice of launching horizontal infringement cases will 
continue to be followed. 

181 

In the last two years the Commission has three times sought for interim measures in nature protection 
cases. In cases C-503/06, Commission v. Italy and C-76/08, Commission v. Malta, the Court ordered the 
Member States to halt illegal hunting activities on 19 December 2007 and 24 April 2008 respectively. 
In  case  C-193/07,  Commission  v.  Poland,  the  Commission  sought  interim  measures  from  the  ECJ  to 
prevent  a  Polish  motorway  project  causing  serious  habitat  damage:  the  request  was  dropped  when 
Poland agreed to halt the relevant works pending an ECJ judgment 

EN 

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8.2.  Waste Management 

8.2.1.  Current position 

8.2.1.1.  General introduction 

EU  waste  policy  aims  to  turn  the  EU  into  a  resource-efficient  recycling  society.  This  is  a 
policy area which has a huge potential to make the EU more resource-efficient. Collection and 
recycling  of  waste  save  the  use  of  virgin  materials  and  reduce  CO2  emissions.  Studies 
published  during  2010  and  in  the  beginning  of  2011  indicate  that  proper  implementation  of 
EU waste legislation could have significant economic, financial and social benefits in terms of 
increased  access  to  valuable  secondary  raw  materials,  less  unfair  competition  in  the  market 
and  strong  encouragement  for  innovative  equipment  manufacturers  and  services.  The 
significant  costs  of  having  to clean  up  after  illegal  dumping  and  its  negative  impacts  on  air 
and water could be avoided. In addition to the waste-related benefits, full implementation of 
EU  waste  legislation  would  reduce  emissions  of  greenhouse  gases,  including  methane  from 
landfills,  equivalent  to  almost  200  million  tons  of  CO2  a  year.  This  would  save  €2.5billion 
annually at a carbon price of around €13 per tonne.182  

EU waste legislation covers a large share of the entire EU environmental acquis and includes 
thirteen main legislative acts adopted by the European Parliament and the Council and a large 
number of related decisions adopted through comitology procedures.183 The overall scope of 
this  legislation  is  the  prevention  or  reduction  of  waste  production,  the  re-use,  the  recycling, 
other  types  of  recovery  than  recycling  and  the  disposal  of  different  categories  of  waste; 
permitting and control of disposal operations, mainly landfills; and shipments of waste within 
the EU as well as to and from third countries. 

Two  main  instruments  directly  addressing  waste  management  operations  are  the  new  EU 
waste  framework  directive  which  became  due  for  transposition  on  12  December  2010184 
(2008/98/EC)  and  the  EU  landfill  directive185  (1999/31/EC  and  Council  decision  on  waste 
acceptance  criteria  2003/33/EC).  The  waste  framework  directive  modernises  and  simplifies 
the EU waste acquis. This Directive, when properly implemented, will be an important tool to 
make the EU more resource-efficient. The directive contains key provisions on the prevention 
of waste (Articles 3.12 and 9), waste prevention programmes (Article 29 and Annex IV) and 
the establishment of waste management plans (Article 28). The EU waste framework directive 
sets  out  a  hierarchy  promoting  waste  prevention  over  its  recovery,  with  disposal  as  the  last 
recourse,  and  lays  down  basic  requirements  for  waste  management  including  permit 
obligations  for  waste  handling.  The  directive  obliges  Member  States  to  ensure  that  waste  is 

182 

183 
184 

185 

a 

of 

staff 

working 

document, 

Progress report on the thematic strategy on the prevention and recycling of waste, COM(2011)13 final, 
at 
Commission 
http://ec.europa.eu/environment/waste/pdf/Commission%20Working%20Doc.pdf, 
the 
feasibility 
body,   
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/10/113&format=HTML&aged=0&languag
e=EN&guiLanguage=fr  
http://ec.europa.eu/environment/waste/index.htm. 
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008pn waste, 
OJ L 312, 22.11.2008. 
Council  Directive  1999/31/EC  of  26  April  1999  on  the  landfill  of  waste,  OJ  L  182,  16.7.1999,  p.  1, 
Council decision of 19 December 2002 establishing criteria and procedures for the acceptance of waste 
at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC. 

available 
study 

implementation 

waste 

on 

EN 

174 

   EN 

 
                                                 
managed  without  endangering  human  health  and  the  environment,  and  prohibits  the 
abandonment,  dumping  or  uncontrolled  management  of  waste  (Art.  13,  36).  It  requires 
adequate networks of waste treatment installations (Art. 16).  

The EU landfill directive is intended to prevent or reduce the adverse effects of landfilling on 
the  environment,  particularly  on  surface  water,  ground  water,  soil,  air  and  human  health.  It 
specifies requirements for landfill sites and targets for diversion of biodegradable municipal 
waste  from  landfills  in  order  to  reduce  methane  emissions,  coupled  with  technical 
requirements for capture and treatment of landfill gas. 

Further,  EU  waste  legislation  contains  specific  rules  for  waste  shipments186  and  a  series  of 
directives  on  different  waste  streams:  waste  electrical  and  electronic  equipment;  end-of-life 
vehicles;  packaging  waste;  batteries;  persistent  organic  pollutants  (POPs);  including  e.g. 
polychlorinated biphenyls (PCBs); mining waste and sewage sludge.187 

8.2.1.2.  Report of work done in 2010 

The new waste framework directive 

Member  States  had  to  notify  the  transposition  of  the  new  waste  framework  directive  by  12 
December  2010.  The  Commission  monitored  the  transposition  of  the  directive  closely  and 
urged  Member  States  for  a  timely  transposition  indicating  that  it  would  take  the  necessary 
legal  steps  against  Member  States  failing  to  communicate  their  national  transposition 
measures. At the beginning of 2011 cases were launched against 23 Member States (all except 
Czech  Republic,  Denmark,  Italy  and  Austria)  for  failure  to  adopt  and  notify  transposition 
measures by the prescribed deadline.  

The  Commission  actively  supported  Member  States  with  the  transposition  of  the  waste 
framework  directive.  During  2010,  three  multilateral  meetings  were  organised  by  the 
Commission  with  the  Committee  of  the  Member  States  established  under  the  waste 
framework  directive.  Awareness-raising  events  and  information  exchanges  with  Member 
States and stakeholders were organised to take place in 15 Member States during 2010-2011 
concerning  the  implementation  of  the  EU  waste  framework  directive.  The  Commission's 
representatives  also  presented  the  directive  on  numerous  workshops  and  conferences  in 
Member States. 

The Commission prepared during 2010 a number of comitology decisions relating to the new 
waste  framework  directive,  in  particular  on  end-of-waste  criteria  (submitted  to  Council  for 
adoption), the calculation of targets set by the directive, an implementation questionnaire, the 
notification format for waste management plans and waste prevention indicators. Guidelines 
on  waste  prevention  programmes,  an  update  of  the existing guidance on waste management 
plans  and  guidance  on  life-cycle-assessments  were  also  prepared  in  order  to  be  published 
during 2011. 

The proposed recast of the WEEE Directive 

186 

187 

EN 

Regulation  (EC)  No  1013/2006  of  the  European  Parliament  and  of  the  Council  of  14  June  2009  on 
shipments of waste, OJ L 190, 12.7.2006, p.1. 
For  more 
specific 
information 
http://ec.europa.eu/environment/waste/index.htm 

regulations, 

decisions, 

directives 

and 

see 

on 

175 

   EN 

 
                                                 
The Commission's proposal for the recast of the WEEE Directive (Directive 2002/96/EC on 
waste electrical and electronic equipment) is in the co-decision process. The proposal aims to 
contribute  to  a  better  regulatory  environment  by providing  further  clarity  on  the  legislation, 
reducing  administrative  burden, 
legislation  and 
strengthening enforcement.  

improving  coherence  among  EU 

The Council has in first reading proposed to apply a definition of producer that builds on the 
concept  of  national  markets.  This  national  concept  can  lead  to  a  situation  of  multiple 
registration,  multiple  payments  for  the  same  product,  multiple  requirements  for  treatment 
information  and  marking  of  products,  as  well  the  obligation  for  producers  to  be  legally 
represented in more than one Member State. The Commission had proposed to clarify that a 
concept  based  on  the  Community  market  should  be  used  to  avoid  such  burdens,  and  still 
considers that a European approach to the producer obligations should be agreed. This applies 
especially to the obligations of cross-border distance sellers. 

The Commission proposal will also result in significant benefits for the environment. In order 
to  address  the  environmental  problem  caused  by  the  “leakage”  of  electronic  waste  to 
substandard treatment and to illegal exports, the Commission proposed a new waste collection 
rate in the WEEE Directive. The rate is proposed to be set at the level of 65% by weight of 
what has been placed on the market in the two preceding years on average, which implies an 
ambition level of 85% of WEEE generated. National targets would therefore take into account 
the economies of each individual Member State. The target would become binding by 2016.  

The collection target is one of the crucial issues of the Directive and needs to be ambitious, 
while at the same time it must be ensured that the reality of each Member State is reflected in 
the  appropriate  ambition  level.  This  is  especially  the  case  for  problematic  WEEE  fractions. 
The  Commission  proposed  that  the  option  of  a  specific  target  for  cooling  and  freezing 
equipment  should  be  looked  into  separately  at  a  later  date.  A  report  on  this  issue  could  be 
extended to include further categories such as mercury containing lamps, small equipment, or 
others. 

The  enforcement  of  the  WEEE  Directive  was  proposed  to  be  strengthened  in  order  to 
specifically  address  the  problem  of  illegal  waste  shipments.  The  WEEE  proposal  includes 
rules  to  avoid  illegal  shipments  of  electrical  and  electronic  waste,  especially  when  falsely 
declared  as  used  products.  Minimum  monitoring  requirements  for  shipments  of  WEEE  are 
proposed and minimum inspection requirements are reinforced. In order to improve effective 
border  controls  against  illegal  exports,  the  Commission  has  here  proposed  to  reverse  the 
burden of proof at the port of exit: exporters of "equipment for reuse" would in the future be 
obliged to show proof of testing through mandatory documentation. This would make it easier 
for officials at port authorities to decide whether equipment must be considered as e-waste or 
not, and to stop illegal exports effectively where necessary.  

The Commission proposed the recast procedure in order to tackle specific issues arising with 
the directive. An extension of the scope was not part of the Commission proposal nor of the 
impact assessment carried  out in the context of the Commission proposal. The  Commission 
does  not  support  to  amend  substantial  parts  of  the  Directive  without  a  proper  impact 
assessment.  An  open  scope  could  make  a  number  of  new  exclusions  necessary.  The 
establishment  and  interpretation  of  these  would  risk  increasing  un-clarity  compared  to  the 
current, well established, situation. 

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The Commission received in the second half of 2010 reports from Member States as regards 
implementation  of  the  WEEE  Directive  in  the  years  2007  and  2008.  The  Commission  is 
currently analysing this information, and will take the necessary steps as soon as possible. 

With  regard  to  the  transposition  of  the  WEEE  Directive,  conformity  is  achieved  for  13 
Member States. In 2010 the Commission continued legal enforcement actions opened in 2007 
horizontally against a number of Member States. As of end of 2010, infringement cases were 
open  for  11  Member  States  (Czech  Republic,  Denmark,  Finland,  France,  Ireland,  Italy, 
Lithuania,  Latvia,  Portugal,  Sweden  and  Slovakia).  A  case  was  open  in  2010  for  bad 
application  of  the  Directive  in  Romania.  In  2011,  the  Commission  in  cooperation  with  the 
remaining Member States (Malta, UK, Belgium) will  assess their national  legislation. Legal 
enforcement action will be taken in 2011 where necessary.  

The proposed recast of the RoHs Directive 

The RoHS Directive (Directive 2002/95/EC on the restriction of the use of certain hazardous 
substances  in  electrical  and  electronic  equipment)  sets  strict  limit  values  for  lead,  mercury, 
cadmium,  hexavalent  chromium,  polybrominated  biphenyls  or  polybrominated  diphenyl 
ethers in various specified types of electrical and electronic products. 

RoHS has prevented many thousands of tonnes of banned substances from being disposed of 
and  potentially  released  into  the  environment  since  it  came  into  force  in  2003.  It  has  led  to 
important  changes  in  product  design  in  the  EU  and  worldwide.  RoHS  has  also  served  as  a 
model  for  similar  laws  outside  the  EU.  RoHS  currently  covers  a  vast  spectrum  of  products 
that use electricity. 

In 2008, the Commission launched the recast of this Directive. A first reading agreement with 
the  European  Parliament  was  reached  on  24  November  2010.  Key  elements  included  the 
gradual  extension  of  the  scope  to  all  electrical  and  electronic  equipment;  a  mechanism  for 
reviewing  or  amending  the  list  of  banned  substances;  clearer  rules  for  granting  exemptions 
from  the  substance  ban;  coherence  with  REACH;  clarification  of  important  definitions;  and 
alignment with the legislative package for marketing of products. The Commission made four 
declarations on scope, review, nano-materials and correlation tables. 

The Commission prepared to launch studies for an impact assessment of the changes in scope 
that were not impact assessed, and to provide for potential new exemption requests under the 
current  scope.  In  order  to  facilitate  implementation,  the  Commission  gathered  ideas  for  an 
update of the RoHS Frequently Asked Questions (FAQ) document. 

With regard to the transposition of the RoHS Directive, correct transposition is achieved by 
27 Member States, for 11 of them after legal enforcement actions were launched. 

The RoHS Annex – Review of the current RoHS exemptions 

The  Annex  to  the  RoHS  Directive  lists  specific  applications  where  the  use  of  restricted 
substances under RoHS is allowed, as long as the substitution is technically or scientifically 
impracticable.  The  RoHS  Directive  requires  the  Commission  to  carry  out  a  review  of  all 
exemptions every four years to verify if the exemptions are still justified. 

Directorate-General  for  Environment  prepared  this  review  through  a  study  (technical  and 
scientific  assessment  of  29  exemptions)  accompanied  by  a  series  of  extensive  stakeholder 

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consultations.  The  review  was  subject  to  comitology  procedure  with  scrutiny  (vote  by  the 
Member  States  experts  in  the  Technical  Adaptation  Committee,  followed  by  three  months 
scrutiny of the European Parliament). The Commission proposal was fully based on technical 
and  scientific  evidence,  as  well  as  on  coherence  with  other  established  EU  policies  such  as 
Ecodesign  requirements.  The  reviewed  Annex  was  adopted  and  published  as  Commission 
Decision  2010/571/EU  of  24  September  2010  amending,  for  the  purposes  of  adapting  to 
scientific and technical progress, the Annex to the RoHS Directive as regards exemptions for 
applications  containing  lead,  mercury,  cadmium,  hexavalent  chromium,  polybrominated 
biphenyls  or  polybrominated  diphenyl  ethers  (OJ  L  251,  25.9.2010).  A  corrigendum  was 
published on 29 September 2010. 

Additionally,  Directorate-General  for  Environment  currently  review  five  new  requests  by 
industry for exemptions or modifications of existing exemptions. 

The waste shipment regulation 

In  order  to  strengthen  the  implementation  and  application  of  the  EU  waste  shipment 
regulation, support services were established including a forum, a help-desk and a Frequently 
Asked Questions (FAQ) site. The aim of these measures was to enable national authorities to 
rapidly exchange information/best practices and discuss questions concerning the day-to-day 
application  of  the  EU  waste  shipment  regulation,  including  also  matters  pertaining  to  the 
prevention of illegal shipments of waste. It is accessible to Member States and also open to 
other stakeholders. 

A  comitology  decision  was  adopted  extending  the  derogation  period  for  Bulgaria  to  raise 
objections  to  shipments  of  certain  waste  to  Bulgaria  for  recovery  under  the  EU  waste 
shipment regulation (OJ L210, 11.8.2010, p.35). 

The  Commission  completed  two  studies  regarding  criteria  and  requirements  for  waste 
shipment inspections in June 2010 and prepared a stakeholder consultation on the feasibility 
of strengthening EU legislation on these matters. Currently, inspections and controls of waste 
shipments appear to vary significantly between Member States. In some countries only very 
few and insufficient controls are carried out. The waste chain is only as strong as its weakest 
link  and  waste  is  suspected  to  be  illegally  exported  via  the  EU  sea-ports  having  the  least 
effective controls. The studies contain a detailed assessment of the environmental, economic 
and social impacts of the criteria which were considered as amongst the most appropriate, see 
http://ec.europa.eu/environment/waste/shipments/reports.htm. Council conclusions (JLS) of 3 
June 2010 invited the Commission to "consider strengthening the European requirements on 
inter  alia  inspections  and  spot  check  carried  out  under  Regulation  (EC)  No  1013/2006  on 
shipments  of  waste,  in  order  to  fight  illegal  waste  shipments"188  The  Commission  was  also 
invited to "suggest the development of additional measures to support Member States with the 
enforcement of Regulation (EC) No 1013/2006 on shipments of waste". 

The Regulation on Persistent organic pollutants (POPs) 

Following  a  comitology  decision,  the  EU  regulation  on  persistent  organic  pollutants 
850/2004/EC (the "POPs regulation") was amended by Commission regulation No 756/2010 
of 24 August 2010, as regards Annexes IV and V. By this amendment, new substances were 

188  

Council of the European Union, CRIMORG/ENV/ENFOCUSTOM/ENFOPOL, 3.06.2010 

EN 

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added  to  the  list  of  persistent  organic  pollutants.  As  a  consequence  of  substances  being 
covered by the POPs Regulation, their production, placement on the market and use will be 
severly restricted  and  the  management of wastes contaminated with these  persistent organic 
pollutants  is  strictly  regulated  (substances  exceeding  a  given  POP  concentration  have  to  be 
destroyed  or  treated  in  a  way  that  the  POPs  substances  are  irreversibly  transformed,  i.e.  in 
most cases they will have to be incinerated). 

The End-of-Life Vehicles Directive 

Directive 2000/53/EC on end-of-life vehicles (the "ELV directive"), prohibits the use of lead, 
mercury, cadmium or hexavalent chromium in materials and components of vehicles put on 
the market after 1 July 2003, Article 4(2)(a). Annex II to this directive lists vehicle materials 
and components exempted from the prohibition set out in Article 4(2)(a).The fourth revision 
of Annex II was adopted on 23 February 2010 amending Annex II. 

Commission  Decision  2008/689/EC  specified  that  in  the  case  of  solder  in  electronic  circuit 
boards and other electrical applications except on glass and solder in electrical applications on 
glass,  the  exemptions  in  Annex  II  should  be  reviewed.  Technical  and  scientific  assessment 
demonstrated  that  these  two  exemptions  should  be  split  into  10  more  specific  applications. 
Out of these, five materials and components containing lead should continue to be temporarily 
exempted from the prohibition set out in Article 4(2)(a) since the use of these substances in 
those  specific  materials  and  components  is  still  technically  or  scientifically  unavoidable.  It 
was therefore appropriate to prolong the expiry date of these exemptions until the use of the 
prohibited  substances  becomes  avoidable.  Five  other  materials  and  components  containing 
lead should continue to be exempted from the prohibition set out in Article 4(2)(a) without an 
expiry  date  since  the  use  of  these  substances  in  those  specific  materials  and  components  is 
technically or scientifically unavoidable and no viable alternatives are envisaged in the near 
future. These exemptions should be reviewed in 2014 in the light of technical and scientific 
progress  to  assess  when  the  use  of  these  substances  will  become  avoidable.  The  exemption 
concerning  lead  in  solders  in  electrical  glazing  applications  on  glass  except  for  soldering  in 
laminated glazing should be reviewed by 1 January 2012 since substitutes for this application 
exist but their technical properties need to be further tested and confirmed. In the case of lead 
and  lead  compounds  in  components  in  bonding  agents  for  elastomers  in  power-train 
applications containing up to 0,5 % lead by weight, the exemption should not be prolonged 
because the use of lead in this type of applications has become avoidable. In addition, it was 
considered  technically  impossible  in  certain  cases  to  repair  vehicles  with  spare  parts  other 
than original ones as this would require changes in dimensional and functional properties of 
entire  vehicle  systems.  Such  spare  parts  cannot  fit  into  the  vehicle  systems  originally 
manufactured  with  parts  containing  heavy  metals  and  these  vehicles  cannot  be  repaired  and 
may need to be prematurely disposed of. For reasons of consumer safety and environmental 
benefits  derived  from  the  extension  of  the  product’s  lifetime  it  was  therefore  appropriate  to 
allow the repair of these vehicle components with the original parts. 

A  further  proposal  as  regards  exemptions  under  Annex  II  (the  use  of  lead  in  automotive 
thermoelectric  materials  in  application  reducing  CO2  emissions  by  recuperation  of  exhaust 
heat) was opposed by the Council. Although the Council supported the substance of the draft 
Commission directive, a qualified majority of delegations opposed its adoption on the grounds 
that, by requiring member states to draw up correlation tables, the Commission had exceeded 

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the  implementing  powers  provided  for  in  the  basic  act,  i.e.  the  ELV  Directive.  A  new 
Commission Directive 2011/37/EU189 amending Annex II to the ELV Directive was adopted 
on 30 March 2011. 

With regard to the transposition of the ELV Directive, conformity has been achieved for 15 
Member States. In 2010 the Commission has continued enforcement actions concerning non-
conform  national  legislation.  As  of  December  2010,  12  infringement  procedures  were 
ongoing  (Belgium,  Czech  Republic,  France,  Italy,  Cyprus,  Lithuania,  Latvia,  Poland, 
Slovenia, Slovakia, Sweden and the United Kingdom).  

The Batteries Directive 

The  Batteries  Directive  (2006/66/EC)  prohibits  placing  on  the  market  of  batteries  and 
accumulators containing mercury and cadmium. This prohibition applies above set thresholds 
and is subject to a number of exemptions. One specific exemption is for use of cadmium in 
portable  batteries  and  accumulators  intended  for  use  in  cordless  power  tools  (for  example, 
tools used by consumers and professionals for turning, milling, cutting, drilling or gardening 
activities). 

The  Batteries  Directive  requires  the  Commission  to  review  the  exemption  for  the  use  of 
cadmium  in  cordless  power  tools.  The  Commission  submitted  a  report  to  the  European 
Parliament  and  to  the  Council  in  December  2010  and  concluded  that  at  this  stage,  although 
alternative technologies exist, it is not appropriate to bring forward proposals to withdraw the 
exemption for cordless power tools from the ban on cadmium in batteries and accumulators 
because not all the technical information  (notably  costs  and  benefits  of  the  use  of  cadmium 
and  its  substitutes  in  portable  batteries  and  accumulators  for  cordless  power  tools)  is  yet 
available  in  support  of  such  a  decision.  The  Commission  ordered  in  October  2010  a 
comparative  life-cycle  analysis,  to  gather  this  information  beyond  the  existing  scientific 
literature and including a peer review, as required by scientific quality standards, which will 
provide the missing information in order to decide on whether or not to keep the exemption 
for  the  use  of  cadmium  batteries  in  cordless  power  tools.  Based  on  that  information,  the 
Commission  will,  if  appropriate,  then  proceed  with  proposals  for  legislation  with  a  view  to 
prohibiting  cadmium  in  batteries  and  accumulators  in  cordless  power  tools  by  withdrawing 
the existing exemption.190 

Commission  Regulation  No  1103/2010  was  adopted  establishing,  pursuant  to  Directive 
2006/66/EC of the European Parliament and of the Council, rules as regards capacity labelling 
of portable secondary (rechargeable) and automotive batteries and accumulators. 

During  2010,  an  updated  document  on  Frequently  Asked  Questions  regarding  the  Batteries 
Directive was prepared for publication in 2011. 

With  regard  to  the  transposition  of  the  Batteries  Directive,  full  transposition  has  been 
achieved  by  all  Member  States.  The  last  infringement  cases  for  failure  to  communicate 

189  

190 

Commission Directive 2011/37/EU of 30 March 2011 amending Annex II to Directive 2000/53/EC of 
the European Parliament and of the Council on end-of-life vehicles, OJ L 85, 31.3.2011, p. 3. 
See more; Commission report of 2 December 2010 on the exemption from the ban on cadmium granted 
for portable batteries and accumulators intended for use in cordless power tools [COM(2010) 698 final - 
Not published in the Official Journal]. 

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measures  of  transposition  of  the  Directive  were  closed  in  2010,  for  two  of  those  after  a 
condemning judgment by the Court of Justice in cases C-512/09 against Greece and C-513/09 
against  Belgium.  The  deadline  for  Member  States  to  transpose  Directive  2008/103/EC 
amending the Directive 2006/66/EC on batteries and accumulators expired in January 2009. 
Full  transposition  has  been  achieved  by  all  Member  States.  In  2011  the  Commission  in 
cooperation  with  the  Member  States  will  carry  out  an  assessment  of  the  conformity  of 
national legislation of all Member States and take legal enforcement action where necessary. 

Bio-waste 

On  18  May  2010,  the  Commission  adopted  a  Communication  in  which  it  assessed  issues 
relating  to  bio-waste  and  proposed  a  set  of  measures  for  bio-waste  based  on  existing 
legislative  possibilities.  On  3  December  2010,  a  round  of  stakeholder  consultations  was 
launched in order to prepare an impact assessment (and potential proposal) aimed at setting a 
recycling targets for bio-waste as an element of modification of recycling targets in the waste 
framework  directive.  An  examination  of  end-of-waste  criteria  for  compost  (i.e.  compost 
standards) was initiated in accordance with the waste framework directive. 

Landfills Directive 

With regard to transposition of the Landfill Directive 1999/31/EC, as of December 2010 full 
conformity had been achieved in almost all Member States, except France, who was referred 
to the Court of Justice, the United Kingdom, whose final measures to achieve conformity are 
under assessment and Bulgaria whose legislation is under assessment. 

With regard to horizontal cases concerning structural illegal landfilling Greece was followed 
up  with  an  additional  letter  of  formal  notice  on  the  basis  of  Article  260  TFEU.  Cases  for 
illegal waste disposal were started or followed up against Greece, Spain, Ireland and Slovakia.  

With regard to the serious situations in Italy, specifically concerning deficient implementation 
of waste legislation in the Campania region, in 2010 the Commission has worked very closely 
with Italian authorities. In June 2007, the Commission launched legal action against Italy over 
the chronic waste crisis affecting Naples and the rest of the Campania region. In view of the 
continuation of the infringement, the Commission referred the case to Court of Justice in July 
2008. On 4 March 2010 the Court of Justice ruled that Italy had failed to set up an adequate 
and integrated waste management system in the Campania region and to guarantee that waste 
is collected, treated and disposed of without endangering human health and the environment. 
The Commission is now assessing the measures adopted by Italy to comply with the judgment 
and will decide the follow up of the case further the results of the ongoing assessment. 

Packaging Directive 

With  regard  to  the  Directive  94/62/EC  on  packaging  and  packaging  waste,  in  2010  the 
Commission  in  cooperation  with  the  Member  States  carried  out  an  assessment  of  the 
conformity of national legislation of all Member States but Italy and Cyprus. Legal action has 
been taken against two Member States (Latvia and Slovakia). The assessment will continue in 
2011 covering also the remaining Member States. 

Mining Directive 

Concerning the Directive 2006/21/EC on the management of waste from extractive industries 

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full transposition has been achieved for all Member States but France who was condemned by 
the Court of Justice in the case C-35/10 and the United Kingdom, condemned by the Court in 
the case  C-259/09.  In  2010,  as  a  horizontal exercise for 19 Member States the  Commission 
carried  out  an  assessment  of  the  conformity  of  national  legislation  in  cooperation  with  the 
relevant  Member  States.  The  Member  States  concerned  are  Denmark,  Hungary,  Italy, 
Lithuania,  Latvia,  the  Netherlands,  Poland,  Romania,  Slovenia,  Luxembourg,  Malta,  Spain, 
Slovakia, Bulgaria, Germany and Sweden. Legal action has been taken against three countries 
(Slovakia,  Slovenia  and  Latvia).  The  assessment  will  continue  in  2011  covering  also  the 
remaining Member States. 

Judgments of the Court of Justice in 2010 

In  2010  the  Court  delivered  judgment  in  nine  cases  related  to  waste  sector.  The  United 
Kingdom and  France  were condemned for failure to transpose the  Directive 2006/21/EC  on 
the management of waste from extractive industries (4 February 2010, C-259/09 Commission 
v United Kingdom and 29 July 2010, C-35/10 Commission v. France). Belgium and Greece 
were  condemned  for  failure  to  transpose  the  Directive  2006/66/EC  on  batteries  and 
accumulators  and  waste  batteries  and  accumulators  (15  July  2010,  C-512/09  Commission  v 
Greece;  29  July  2010,  C-513/09  Commission  v  Belgium).  France  was  condemned  for  non-
conform transposition of the Directive 2000/53/EC on end-of life vehicles (15 April 2010, C-
64/09 Commission v France). Italy was condemned for failure to fulfil its obligations under 
the Directive 2006/12/EC on waste over the waste crisis affecting Naples and the rest of the 
Campania  region  (4  March  2010,  C-297/08  Commission  v  Italy).  The  Court  concluded  that 
Italy has not fulfilled its obligations under the Waste Directive 2006/12/EC by failing to set 
up  an  integrated  and  adequate  network  of  disposal  installations  in  Campania  region  and  to 
ensure  that  waste  is  recovered  and  disposed  of  without  endangering  human  health  and  the 
environment. Portugal was condemned for failure to fulfil its obligations under the Directive 
2006/12/EC  on  waste  concerning  waste  tipping  in  disused  quarries  (10  June  2010,  C-37/09 
Commission v Portugal). In addition, the Court judged on a preliminary reference of an Italian 
court on the interpretation of the polluter pays principle in the framework of Article 10 of the 
Directive 1999/31/EC on the landfill of waste (25 February 2010, C-172/08 Pontia Ambiente) 
and of a Finnish court on the interpretation of the Directive 2000/76/EC on the incineration of 
waste (25 February 2010, C-209/09 Lahti Energia). 

Petitions  

During  2010,  almost  twenty petitions  concerned  alleged  infringements  of  EU  waste 
legislation, in particular the landfill directive and the waste framework directive. Majority of 
the  petitions  concerned  situations  in  Italy,  Spain  and  United  Kingdom.  These  petitions 
related to a number of cases of illegal waste disposal and, in the case of the waste framework 
directive, transposition of EU waste requirements in national law. 

8.2.2.  Evaluation based on the current situation 

Significant deficits in the implementation and enforcement of EU waste legislation remain in 
large  parts  of  the  EU,  particularly  as  regards  illegal  waste  dumping,  inadequate  waste 
disposal-  and  recovery  infrastructure  and  illegal  waste  shipments.  Implementation  of  EU 
waste legislation thus continues to be notoriously deficient, which is well reflected in the high 
number  of  infringements,  complaints,  court  proceedings,  petitions  and  questions  from  the 
European  Parliament.  Some  of  the  infringement  cases  and  court  proceedings  concern 

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horizontal cases on hundreds of illegal landfills in Europe.  

The  implementation  of  the  new  waste  framework  directive  which  is  crucial  for  modern 
European waste policy poses a new big challenge for implementation in the years to come. In 
addition, the implementation of the waste shipment  regulation, the  landfill directive and  the 
future  recast  of  the  WEEE-  and  RoHS  Directives  are  particularly  important  pieces  of 
legislation which could if properly implemented make significant progress towards achieving 
EU waste policy objectives. 

Overall  waste  generation  is  still  growing  although  this  is  now  at  a  rate  slower  than  GDP 
growth, showing a certain decoupling between waste generation and economic growth. Over 
the past 10 years, the recycling rate of municipal solid waste has doubled (from 19% to 38% 
between 1998 and 2007) and landfilling has decreased significantly.  

A  large  disparity  between  Member  States  on  how  EU  waste  requirements  are  applied  in 
practice  and  'on-the-ground'  was  shown  to  exist  through  information  exchanges  and 
awareness-raising  events  organised  with  national  authorities  and  stakeholders  as  well  as  in 
statistics  from  the  EEA  and  Eurostat.  For  example,  large  differences  exist  between  the 
recycling performances of Member States: from few percent to up to 60 to 70% for the most 
advanced Member States. In a first analysis, it seems that the most performing Member States 
have set in place a range of legal and economic instruments which were very efficient, such as 
landfill taxes, 'clever' charging systems linked with waste generation, producer responsibility 
schemes and landfill bans. 

8.2.3.  Evaluation results 

8.2.3.1.  Priorities 

Future focus should be on full implementation of existing legislation and support to Member 
States so that they can learn from each other. As proper waste management also has a huge 
potential  in  terms  of  reduction  of  greenhouse  gas  emissions  and  economic,  financial  and 
social benefits this should be followed up with specific measures, inter alia, linking climate 
and waste policies and ensuring consistency between product design and waste policies. 

It is key to ensure that the experiences from the most performing Member States beneficiate 
to other Member States notably for what concerns the application of performing instruments 
such as taxes or charges, landfill bans and application of producer responsibility principles. 

8.2.3.2.  Planned action (2011 and beyond) 

The Commission will continue and reinforce its up-stream support for Member States in the 
field of waste. It will also pursue an assessment of options on how to improve such support. A 
list of best-practices for permitting and inspections under the waste framework directive, the 
landfill  directive  and  the  WEEE-  and  RoHS  directives  will  be  drawn  up  and  tested  during 
2011.  

The  implementation  of  the  new  waste  framework  directive,  crucial  for  modern  European 
waste policy, will be closely monitored. It will be examined how to provide effective support 
to  Member  States’  development  of  waste  management  plans  and  waste  prevention 
programmes.  During  2011,  a  risk/fact-based assessment  of  waste  management  plans  will  be 
started  in  order  to  assess  and  improve  Member  States  performance.  An  update  will  also  be 

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made of the existing guidance on waste management planning. 

Life-cycle thinking could justify deviations from the  established waste hierarchy (Article 4) 
since  different  waste  treatment  methods  can  have  different  environmental  and  health 
outcomes.  The  Commission  will  use  the  life-cycle  assessment  tool  when  assessing  the 
national  waste  management  plans  and  will  in  2011  publish  a  set  of  guidance  documents  on 
how life-cycle methodology can be applied to decisions on waste management options. 

Member  States'  national  measures  transposing  the  new  waste  framework  directive  will  be 
assessed by the Commission with a view to ensure their conformity with the directive. 

Important cases concerning infringements by Member States of EU waste legislation, such as 
regards the serious situations in Italy's Campania region and in Sofia, Bulgaria, will be treated 
with  high  priority  by  the  Commission  until  satisfactory  solutions  are  achieved  and  the 
situations have been rendered in compliance with EU legislation. In addition, horizontal cases 
covering large numbers of individual waste disposal operations will also be treated with high 
priority. During 2010 such cases were pending regarding France, Italy, Spain, Ireland, Greece. 

The high rates of illegal waste shipments shall be brought down by effective measures and the 
feasibility of strengthening criteria and requirements at EU level will be examined. 

An  in-depth  assessment  of  the  economic,  financial  and  social  benefits  of  properly 
implementing  the  EU  waste  acquis  will  be  prepared.  This  will  contain  an  overarching 
assessment  of  the  entire  EU  waste  acquis  as  well  as  a  number  of  specific  case-studies  in 
Member  States.  A  detailed  overview  will  also  be  delivered  of  the  different  tasks  needed  to 
strengthen implementation and enforcement of this acquis and the appropriate arrangements 
to  carry  out  these  tasks.  The  Commission  will  thus  continue  to  assess  the  feasibility  of  a 
dedicated structure to support waste implementation. 

EU  waste  targets  have  to  be  reviewed  in  the  mid-term  in  order  to  face  the  challenge  of 
increasing  resource  demand  as  well  as  to  better  take  into  account  environmental  impacts  of 
materials to move towards 'sustainable material management'. This is also an opportunity in 
terms of activity and job creation. 

Member  States’  compliance  with  the  targets  set  in  the  landfill  directive  for  diverting 
biodegradable  waste  from  landfills  will  be  closely  monitored.  In  addition,  the  Commission 
will closely monitor Member States' closure of sub-standard landfills not complying with the 
requirements  of  the  landfill  directive  (deadline  by  16  July  2009,  see  Article  14  of  the 
directive). The Commission has already taken and will continue to take action as required in 
order to ensure that these key requirements are fulfilled. 

8.2.4. 

Sector summary 

The large disparity between Member States on application, implementation and enforcement 
of  EU  waste  requirements  continues  to  exist.  Overall  waste  generation  is  still  growing 
although at a rate slower than GDP growth. Future focus should be on full implementation of 
existing legislation and support to Member States. A detailed assessment is needed in order to 
be able to reap the economic, financial and social benefits from proper implementation of the 
EU waste acquis. The different tasks needed to strengthen implementation and enforcement of 
the EU waste acquis and the appropriate arrangements to carry out these tasks should also be 

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examined. 

8.3. 

Environmental Assessment of Plans, Programmes and Projects 

8.3.1.  Current position 

8.3.1.1.  General introduction 

There are two important pieces of legislation in this sector: Council Directive 85/337/EEC191 
on the assessment of the effects of certain public and private projects on the environment, as 
amended  by  Directives  97/11/EC192,  2003/35/EC193  and  2009/31/EC194  (known  as  the  EIA 
Directive) and Directive  2001/42/EC of the European Parliament and of the Council on the 
assessment of the effects of certain plans and programmes on the environment (known as the 
SEA Directive195). 

The  EIA  Directive  obliges  Member  States  to  carry  out  environmental  impact  assessments 
before  certain  types  of  public  and  private  projects  which  are  likely  to  have  a  significant 
impact  on  the  environment  are  authorised.  The  SEA  Directive  seeks  to  ensure  that  the 
environmental consequences of certain public plans and programmes that are likely to have 
significant  environmental  effects  are  identified  and  assessed  while  they  are  being  prepared 
and before they are approved. 

8.3.1.2.  Report of work done in 2010 

The EIA Directive 

The  Commission  is  continuously  assessing  the  conformity  of  the  national  transposition 
measures  communicated  and  initiates,  when  necessary,  infringement  procedures.  Due  to  its 
large  scope  of  application,  the  EIA  Directive  can  generate  a  relatively  high  number  of 
complaints. However, given the essentially procedural character of the obligations laid down 
by the Directive, only a small number of complaints lead to infringement cases. The majority 
of  the  infringement  cases  concern  bad  (incomplete  or  incorrect)  transposition  of  the 
Directive's  provisions  or  failure  of  the  Member  States  to  apply  the  screening  mechanism 
(article 4(2) and Annex III of the Directive). 

In 2010, the Commission opened in total 5 new infringement procedures on the basis of the 
EIA  Directive.  Cases  were  opened  against  Ireland,  Spain,  and  Portugal  concerning  bad 
application  of  the  EIA  Directive,  three  of  which  were  based  on  a  complaint.  One  case  was 
launched against Netherlands for non-conform transposition of the EIA Directive. Four cases 
out of those opened in 2009 and 2010 have already been closed.  

Article  2(3)  of  the  EIA  Directive  allows  Member  States  to  exempt  specific  projects  in 
exceptional circumstances (e.g. for unforeseen civil emergencies; threats to human health and 
the environment; security risks) from the provisions of the Directive in whole or in part, and 
to notify the Commission.  

191 
192 
193 
194 
195 

OJ L 175, 05.07.1985, p.40. 
OJ L 073, 14.03.1997, p.5. 
OJ L 156, 25.06.2003, p.17. 
OJ L 140, 5.6.2009, p.114. 
OJ L 197, 21.7.2001, p. 30. 

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In  2010,  this  provision  has  been  used  by  Spain.  On  12  November  2010,  the  Spanish 
authorities  informed  the  Commission  of  their  intention  to  exempt  the  project  "Emergency 
Works: recovery of sand from the beaches damaged by storms 2009-2010 in the province of 
Cadiz"  from  the  EIA  procedure.  According  to  the  information  received,  the  request  was 
justified by an exceptional circumstance – the emergency situation arising from the westerly 
storms,  which  have  affected  the  area  of  the  province  of  Cádiz  from  December  2009.  These 
storms have had an exceptional duration and have caused serious damage to beaches. The loss 
of  sand  caused  endangers  the  stability  of  the  beaches,  and  may  endanger,  in  turn, 
infrastructures close to them (boardwalks, access, etc...) and the safety of people. The Spanish 
authorities  have  indicated  that  no  EIA  would  be  carried  out  for  this  project  because  of  the 
emergency situation. They explained that another form of assessment has been done and that 
information  has  been  made  available  to  the  public  concerned  relating  to  the  exemption 
decision and the reasons for granting it. It should be stressed that, the recommendations of the 
Commission's Guidance document on the "Clarification of the Application of Article 2(3) of 
the EIA Directive"196 have been followed in this case.  

The EIA Directive has been identified as a potential instrument for a future simplification 
exercise197, the aim being to identify overlaps, gaps and potential for reducing regulatory and 
administrative burdens, in particular regarding transboundary projects. Adopted 25 years ago, 
the EIA Directive should be adapted to reflect the experience gained as well as changes in EU 
legislation and policy, and European Court of Justice case law.  

The process for the review of the EIA Directive started in 2009 through the adoption by the 
Commission  of  the  fourth  Report  on  the  application  and  effectiveness  of  the  EIA  Directive 
(COM(2009)378)198.  The  Commission's  report  confirms  that  the  objectives  of  the  EIA 
Directive have generally been achieved, indicates areas where improvements are needed (e.g. 
screening,  public  participation,  quality  of  the  EIA,  EIA  transboundary  procedures, 
coordination  between  the  EIA  and  other  environmental  directives  and  policies,  such  as 
climate  change  and  biodiversity)  and  presents  possible  recommendations  for  action.  The 
future  review  will  aim  to  improve  environmental  protection,  increase  the  degree  of 
harmonisation and simplify existing procedures (for instance a "one-stop-shop" procedure, i.e. 
possibility  for  coordination  of  assessment  procedures  resulting  from  the  existing  EU 
Directives under the EIA umbrella).  

In  June  2010,  a  wide  public  consultation  on  the  review  of  the  EIA  Directive  has  been 
launched,  on  the  basis  of  an  on-line  questionnaire,  which  was  translated  in  all  official 
languages of  the EU.  The consultation covered a  broad variety of issues (e.g. quality of the 
EIA process, harmonisation of assessment requirements between Member States, assessment 
of  transboundary  projects  or  projects  with  transboundary  effects,  role  of  the  environmental 
authorities, and development of synergies with other EU policies). More information on the 
consultation can be found on the website of Directorate-General for Environment199. 

The phase of public consultation was concluded by a Conference for the 25th anniversary of 
the  EIA  Directive.  The  European  Commission  organised  this  Conference  with  the  Belgian 
Presidency. The Conference took place on 18-19 November 2010 in Leuven (Belgium) under 

196  
197 
198 
199 

The Commission's Guidance can be found at: http://ec.europa.eu/environment/eia/pdf/eia_art2_3.pdf 
COM(2009)15. 
The report can be found at: http://ec.europa.eu/environment/eia/eia-support.htm 
http://ec.europa.eu/environment/consultations/eia.htm 

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the headline "25th Anniversary of the EIA Directive: Successes – Failures – Prospects". On 
18/11,  there  was  a  high  level  panel  of  stakeholders,  which  took  stock  of  the  25  years  of 
implementation  experience.  On  19/11,  the  Conference  concentrated  on  three  key  themes: 
scope of the EIA Directive, quality of the EIA process and links of the EIA with international 
conventions (mainly the Aarhus and Espoo Conventions). The speeches delivered during the 
Conference are available on the website of Directorate-General for Environment200.  

The SEA Directive 

The deadline for transposing the SEA Directive expired on 21 July 2004. The Commission's 
action  initially  focused  on  launching  non-communication  infringement  proceedings  against 
Member  States  which  had  failed  to  transpose  the  Directive  into  their  national  law. 
Subsequently,  the  Commission  started  a  systematic  assessment  of  the  conformity  of  the 
national  transposition  measures  communicated  and  initiated,  when  necessary,  infringement 
procedures for non-conform transposition. 

Thus, in 2008 infringement proceedings for non-conform transposition of the SEA Directive 
were  opened  against  the  following  eleven  Member  States:  Bulgaria,  Czech  Republic, 
Denmark, Estonia, Ireland, Latvia, Lithuania, Malta, Poland, Slovenia and United Kingdom. 
This  action  continued  in  2009  and  infringement  proceedings  for  non-conform  transposition 
were  opened  against  the  following  Member  States  Spain,  Belgium,  Germany,  Greece, 
Finland,  France,  Netherlands,  Sweden,  Slovakia,  Austria,  Italy  and  Portugal.  For  some 
Member  States  the  cases  have  been  already  closed  following  clarification  of  national 
authorities  and/or  adoption  of  necessary  amendments  ensuring  compliance  with  the 
Directive's  requirements.  Cases  are  still  open  against  Belgium,  France,  Italy,  Portugal, 
Slovakia,  Finland  and  Sweden.  In  three  cases  (Belgium,  Portugal  and  Slovakia),  the 
Commission continued the infringement procedure by issuing reasoned opinions. 

Petitions 

The EIA and SEA Directives generate a relatively high number of petitions, due to their large 
scope  of  application.  In  2010,  42  petitions  were  registered.  Most  of  them  are  related  to  the 
implementation of the Directives in Spain and Italy.  

On the basis of the experience in handling petitions, the Commission would like to draw the 
attention on the following general observations: 

Apart  from  the  nature  protection  legislation  (i.e.  Birds  and  Habitats  Directives),  it  appears 
that most of the petitions are related to the implementation of both the EIA/SEA Directives. 

There are still several open petitions concerning the implementation of the EIA Directive in 
the Member States which joined the EU in 2004 and 2007. These petitions are often linked to 
projects  which  have  been  initiated  or  approved  prior  to  the  accession  to  the  EU.  The 
Commission has constantly referred to the settled case-law of the Court, according to which 
the  principle  that  projects,  likely  to  have  significant  effects  on  the  environment,  must  be 
subjected  to  an  environmental  assessment  does  not  apply  where  the  application  for 
authorisation  for  a  project  was  formally  lodged  before  the  expiry  of  the  time-limit  for 

200 

http://ec.europa.eu/environment/eia/conference.htm  

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transposition of a Directive201. This implies that the EIA Directive does not apply to projects, 
for which the application for authorisation was formally lodged before 1 May 2004 (for the 10 
Member  States  which  joined  the  EU  at  this  date)  or  1  January  2007  (for  Bulgaria  and 
Romania).  The  Petitions  Committee  is  invited  to  carefully  assess  the  implications  of  the 
abovementioned settled case-law and draw the appropriate conclusions as regards the follow-
up of open petitions and the petitions to be received. 

The  petitions  related  to  the  Nord  Stream  pipeline  project  (952/2006  and  614/2007)  and  the 
resolution  adopted  in  Plenary  on  8  July  2008  gave  the  possibility  to  the  Commission  to 
explain the obligations under the EIA Directive and its own role in the EIA process.  

The  central  issue  of  the  petitions  and  of  the  resolution  was  the  alleged  need  for  the 
Commission  to  provide  for  an  independent  environmental  impact  assessment/study  of  the 
project to be discussed with all interested parties. In this regard, the Commission has stressed 
that  it  had  neither  the  competence  nor  the  responsibility  to  undertake  a  full  analysis  of  the 
environmental  issues  for  such  a  project  in  substitution  of  the  Member  States  who  are 
primarily responsible for ensuring that this private project complies with the requirements of 
the EU legislation. Indeed, it is the strict responsibility and obligation of Member States first 
to  assess  the  available  information  with  their  competent  environmental  services,  second  to 
organise extended consultations with the public, including transboundary ones as in this case, 
and third to decide with respect to granting or not the final development consent within their 
respective  territories,  making,  at  the  same  time,  available  to  the  public  all  relevant 
documentation justifying their decision. 

Another  important  issue  was  related  to  the  objectivity  of  the  studies  and  information, 
considering  that  it  is  the  private  developer  that  pays  the  consultant  to  prepare  the  EIA 
environmental  report.  The  Commission  recalled  that  the  EIA  legislation  is  a  procedural 
directive  which  sets  the  framework  for  a  complete  environmental  assessment  of  public  and 
private  projects.  The  Commission  explained  that  the  safeguards  for  the  objectivity  of  the 
studies and information prepared are to be found, on the one hand, in the description of the 
minimum information to be included in the environmental impact assessment documentation 
(Annex IV of the EIA Directive and Appendix II of the Espoo Convention) and, on the other 
hand,  in  the  consultations  with  the  competent  environmental  authorities  and  the  public, 
including the transboundary ones. Indeed, all the information provided by the developer has to 
be made available to the environmental authorities and the public, which have to be consulted. 
The accuracy of this information can be challenged at any point of the consultations, before 
the final decision is taken. This means that the competent environmental authorities can use 
their  own  capacity  to  proceed  with  a  proper  assessment  of  the  information  provided,  while 
NGOs or interested parties can – and very often do – challenge the whole assessment on the 
basis  of  the  data  provided,  in  case  they  do  not  reflect  the  real  situation  or  omit  clearly  to 
conform  to  the  requirements  of  the  EIA  provisions.  The  final  decision  to  grant  or  refuse 
development  consent  must  take  into  consideration  the  results  of  consultations  and  the 
information gathered and must contain the main reasons on which it is based. All this is also 
made available to the public.  

201 

See  Case  C-431/92,  Commission/Germany,  paragraphs  29  and  32,  and  Case  C-81/96  Gedeputeerde 
Staten van Noord-Holland, paragraph 23. 

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The Commission is confident that the abovementioned observations can facilitate the work of 
the Petitions Committee and will be duly taken into account when deciding on the follow-up 
to petitions. 

Judgments of the Court of Justice in 2010 

The Commission services have prepared a booklet which contains the statements of the most 
important  Court  ruling,  as  they  were  pronounced  in  each  particular  case,  concerning 
appropriate articles of the EIA Directive202. This document will be regularly updated with a 
view to facilitating the implementation of the EIA Directive.  

In 2010, the number of judgements delivered by the European Court of Justice in relation to 
the EIA Directive was relatively low. It is worth mentioning the Case C-378/09 (Judgement of 
10/6/2010)  concerning  the  failure  of  Czech  Republic  to  transpose  correctly  Article  10a  on 
access  to  justice.  The  Commission  initiated  an  infringement  procedure  because  the  national 
legislation was restricting the right of action of the public concerned, mainly NGOs, against 
decisions  in  the  environmental  field.  Given  that  the  Member  State  has  not  contested  the 
Commission's  action,  the  Court  declared  that  the  Czech  Republic  had  failed  to  fulfil  its 
obligations under the EIA Directive. In 2011, the Court is expected to deliver several rulings 
on Article 10a and the Aarhus Convention.  

In 2010, the Court has delivered its first important ruling as regards the interpretation of the 
SEA Directive. The Judgement of 17/6/2010 in Cases C-105/09 and C-110/09 will contribute 
to a better understanding of the definition of "plans and programmes" within the meaning of 
Directive 2001/42/EC.  

In  these  cases,  the  Court  replied  to  the  reference  for  a  preliminary  ruling  from  the  Belgian 
Conseil  d'État  and  clarified  the  requirements  under  Articles  2(a)  and  3(2)(a)  of  the  SEA 
Directive.  In  essence,  the  reference  for  a  preliminary  ruling  was  related  to  whether  a 
programme for the management of nitrogen in agriculture, which is required under Directive 
91/676/EEC  concerning  the  protection  of  waters  against  pollution  caused  by  nitrates  from 
agricultural sources, is liable to constitute a plan or programme covered by Article 3(2)(a) of 
Directive 2001/42. The Court ruled that an action programme adopted pursuant to Article 5(1) 
of Directive 91/676/EEC is in principle a plan or programme covered by Article 3(2)(a) of 
Directive  2001/42/EC,  since  it  constitutes  a  ‘plan’  or  ‘programme’  within  the  meaning  of 
Article  2(a)  of  the  latter  directive  and  contains  measures,  compliance  with  which  is  a 
requirement  for  issue  of  the  consent  that  may  be  granted  for  carrying  out  projects  listed  in 
Annexes I and II to Directive 85/337/EEC.  

First of all, the Court verified whether the action programme for the management of nitrogen 
was a plan within the meaning of Article 2(a) of the SEA Directive; hence, the Court found 
that that action programmes are (i) subject to preparation by an authority at national, regional 
or  local  level  or  prepared  by  an  authority  for  adoption,  through  a  legislative  procedure  by 
Parliament  or  Government,  and  (ii)  required  by  legislative,  regulatory  or  administrative 
provisions (paragraphs 35-42 of the Judgement). 

Subsequently,  the  Court  examined  whether  the  conditions  of  Article  3(2)(a)  of  Directive 
2001/42 were fulfilled. This provision provides that a systematic environmental assessment is 

202 

http://ec.europa.eu/environment/eia/pdf/eia_case_law.pdf  

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to be carried out for all plans and programmes which (i) are prepared for certain sectors and 
(ii) set the framework for future development consent of projects listed in Annexes I and II to 
the EIA Directive. With regard to the first condition contained in Article 3(2)(a) of Directive 
2001/42, it was apparent from the very title of Directive 91/676 that action programmes are 
prepared for the agricultural sector.  

The most relevant part of the ruling is the one where the Court assesses whether the second 
condition  is  fulfilled,  i.e.  whether  action  programmes  set  the  framework  for  future 
development consent of projects listed in Annexes I and II to Directive 85/337 (paragraphs 
45-55 of the Judgement). In this regard, the Court examines the content and purpose of those 
programmes, taking into account the scope of the environmental assessment of projects as 
provided  for  by  that  directive.  The  Court  concluded  that  the  action  programme  is  to  be 
regarded  as  setting  the  framework  for  future  development  consent  of  projects  listed  in 
Annexes I and II to Directive 85/337. It seems that the Court focused on the content of the 
action  programmes,  which  embody  a  comprehensive  and  coherent  approach  and  which 
contain specific and mandatory measures; in particular, the Court noted that "it is clear from 
Article  5(4)  of  Directive  91/676  that  action  programmes  adopted  under  Article  5(1)  must 
provide  for  a  set  of  measures  compliance  with  which  can  be  a  requirement  for  issue  of  the 
consent that may be granted for projects listed in Annexes I and II to Directive 85/337, and in 
respect of the definition of which Directive 91/676 gives Member States a certain discretion".  

This interpretation of the Court will be relevant when determining whether an SEA is needed 
for other types of plans and programmes, in particular as regards the condition according to 
which plans and programmes set the framework for future development consent of projects. 

8.3.2.  Evaluation based on the current situation 

8.3.2.1.  Implementation and enforcement of the EIA Directive 

In July 2009, the Commission adopted the fourth Report on the application and effectiveness 
of  the  EIA  Directive  (COM(2009)378)203.  The  Commission's  report  confirms  that  the 
objectives  of  the  Directive  have  generally  been  achieved.  In  some  areas,  improvements  are 
still  needed  (e.g.  screening,  public  participation,  quality  of  the  EIA,  EIA  transboundary 
procedures,  coordination  between  the  EIA  and  other  environmental  directives  and  policies, 
such as climate change and biodiversity). The majority of the infringement cases related to the 
EIA  Directive  concern  bad  (incomplete  or  incorrect)  transposition  of  the  Directive's 
provisions or failure of the Member States to apply the screening mechanism (Article 4(2) and 
Annex III of the EIA Directive).  

However,  in  terms  of  compliance  of  the  Member  States  with  the  EIA,  the  situation  is 
satisfactory.  The  principles  of  environmental  assessment  have  been  integrated  into  the 
national  EIA  systems.  All  Member  States  have  established  comprehensive  regulatory 
frameworks and implement the EIA in a manner which is largely in line with the Directive’s 
requirements; in many cases, Member States have built on the minimum requirements of the 
Directive  and  have  gone  beyond  them.  As  a  result,  environmental  considerations  are  taken 
into account in the decision-making process, which has become more transparent.  

203 

The report can be found at http://ec.europa.eu/environment/eia/eia-support.htm 

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With a view to adapting the Directive to the EU and international policy and legal contexts, 
the  Commission  has  initiated  the  review  process  (see  above).  In  the  meantime,  the 
Commission will develop guidance documents in order to facilitate the implementation of the 
EIA  Directive.  The guidance  documents  developed  by the Commission services in previous 
years  were  often  used  as  a  reference  in  contacts  with  national  authorities.  The  Commission 
services  prepare  two  new  guidance  documents:  the  first  one  will  be  related  to  the 
implementation  of  EIA  to  large-scale  transboundary  projects;  the  second  one  will  include 
practical  guidelines  and  methodologies  for  integrating  climate  change  and  biodiversity  into 
EIA/SEA.  

Implementation and enforcement of the SEA Directive 

In  September  2009,  the  Commission  adopted  the  first  Report  on  the  application  and 
effectiveness  of  the  SEA  Directive  (COM(2009)469)204.  According  to  the  Commission's 
Report,  it  appears  that  the  overall  picture  of  the  application  and  effectiveness  of  the  SEA 
Directive  across  all  Member  States  is  a  varied  one,  in  terms  of  the  institutional  and  legal 
arrangements of the SEA procedure, and in terms of how Member States perceive its role. The 
Directive is relatively recent and there is still not sufficient experience on its implementation.  

On  the  basis  of  the  implementation  experience,  it  seems  that  problems  in  the  correct 
application  of  the  SEA  Directive  are  similar  to  those  encountered  in  applying  the  EIA 
Directive  (i.e.  whether  smaller  plans  and  programmes  or  modifications  require  an  SEA  and 
definition  of  "plans  and  programmes").  The  Court  Judgement  delivered  in  June  2010  has 
provided  useful  clarifications.  In  addition,  the  Guidance  of  the  Commission  services  on  the 
implementation of the SEA Directive has been often used205.  

Despite  the  above  concerns,  in  terms  of  compliance  of  the  Member  States  with  the 
requirements  of  the  SEA,  the  situation  is  satisfactory.  This  has  also  been  confirmed  by  the 
Commission's  report  which  showed  that,  overall,  the  SEA  Directive  contributes  to  the 
systematic and structured consideration of environmental concerns in planning processes and 
better  integration  of  environmental  considerations  upstream;  in  addition,  the  SEA  Directive 
ensures  better  and  harmonized  planning  procedures,  and  contributes  to  transparent  and 
participatory decision making processes. 

8.3.3.  Evaluation results 

8.3.3.1.  Priorities 

In  2010,  the  Commission  services  continued  applying  the  broad  priorities206  which  were 
identified  in  the  previous  reports  and  which  were  highlighted  by  the  Commission  in  its 

204 
205 
206 

The report can be found at http://ec.europa.eu/environment/eia/sea-support.htm 
It can be found at http://ec.europa.eu/environment/eia/sea-support.htm (available in 11 languages). 
It should be recalled that those priorities include the following:Non-conformity of transposing measures 
for the EIA/SEA Directives likely to affect the attainment of the legislative objectives. These cases now 
mainly  concern  the  EU-12  Member  States;Breaches  concerning  big  infrastructure  projects  or 
interventions  involving  EU  funding;Breaches  linked  to  bad  transposition  of  certain  provisions  of  the 
environmental  impact  assessment  legislation  likely  to  affect  overall  the  attainment  of  the  legislative 
the 
objectives;Breaches 
environmental impact assessment legislation which could have a significant influence on the impact of 
the legislation that would justify seeking clarification from the Court of Justice. 

interpretation  problems  concerning  certain  provisions  of 

that  reveal 

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communication COM(2008)773 and the Commission staff working document accompanying 
the  communication.  Individual  breaches  of  certain  provisions  of  the  environmental  impact 
assessment  legislation,  which  are  not  covered  by  the  abovementioned  priorities,  should 
primarily be addressed through the existing review mechanisms at Member State level. 

On  the  basis  of  the  implementation  experience,  it  is  not  necessary  to  modify  the  priorities 
already  identified  regarding  the  enforcement  of  the  EIA  and  SEA  Directives.  The 
Commission  services  will  therefore  continue  implementing  the  priorities  identified  in  the 
sectoral  communication  COM(2008)773  and  the  Commission  staff  working  document 
accompanying it.  

8.3.3.2.  Planned action (2011 and beyond) 

EIA Directive 

The process for the review of the EIA Directive will continue. Following the adoption of the 
fourth Report on the application and effectiveness of the EIA Directive (COM(2009)378) in 
2009 and the public consultation in 2010, the Commission services will carry out the impact 
assessment of the future Commission proposal in 2011. The Commission's proposal is likely 
to be tabled in 2012. 

In  the  meantime,  the  Commission  services  will  continue  the  implementation  of  the  existing 
Directive on the basis of the priorities already identified. 

SEA Directive 

No legislative change is envisaged in the short term. The application of the SEA in Member 
States is still in its infancy and further implementation experience is needed. The next report 
on  the  application  of  the  SEA  Directive,  which  should  be  prepared  in  2013,  will  be  a  good 
opportunity to assess its effectiveness. 

In  the  meantime,  the  Commission  services  will  continue  the  implementation  of  the  existing 
Directive on the basis of the priorities already identified. 

8.3.4.  Sector summary  

The EIA Directive has achieved its objectives. However, since the development of EIA is an 
evolving process, the challenge of ensuring that the Directive is implemented in an effective 
and  consistent  manner  across  all  Member  States  is  continuous.  The  review  of  the  EIA 
Directive  has  started  and  the  legislative  impact  assessment  is  ongoing.  The  Commission's 
proposal can be expected in 2012. 

No legislative change is envisaged as regards the SEA Directive, which is still in its infancy.  

For  both  Directives,  the  Commission  services  will  continue  applying  the  implementation 
priorities identified in the sectoral communication COM(2008)773 and the Commission staff 
working document accompanying the communication.  

8.4. 

Protecting Water and Marine Resources  

8.4.1.  Current position 

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8.4.1.1.  General introduction  

Water  legislation  in  the  European  Union  entered  a  new  era  following  the  adoption  of  the 
Water Framework Directive207 which establishes a strategic framework for the protection of 
all  water  bodies,  i.e.  rivers,  lakes,  coastal  waters  and  groundwater  in  a  highly  integrated 
manner. As the cornerstone of EU water policy, the Water Framework Directive provides that 
all water bodies must meet the standard of “good status” as a rule by the end of 2015. To this 
end, Member States must draw up a river basin management plan (RBMP) and a programme 
of  measures  for  each  river  basin  district.  The  draft  plans  and  programmes  were  to  be 
submitted  to  the  public  for  consultation  by  December  2008  at  the  latest.  They  should  have 
been adopted by 22 December 2009 and reported to the Commission 3 months thereafter, at 
the latest.  

The  Water  Framework  Directive  (WFD)  will  repeal  several  pre-existing  EU  water  acts  by 
December 2013, except the Urban Waste Water Directive, Drinking Water Directive, Bathing 
Water  Directive  and  Nitrates  Directive.  The  implementation  of  the  Water  Framework 
Directive must not jeopardise the achievement of  the  objectives  of  these  EU  water  acts  and 
vice-versa. Under the WFD, complementary Directives have been adopted on the protection 
of  groundwater  against  pollution  and  deterioration  (Groundwater  Directive)208  and  on 
environmental quality standards (Environmental Quality Standards Directive)209 establishing 
the standards which constitute the chemical status criteria for the Water Framework Directive.  

The Urban Waste Water Directive210, in particular, is a key element of EU water policy for 
achieving the Water Framework Directive environmental objective of good status. The Urban 
Waste  Water  Treatment  Directive  requires  that  wastewater  generated  by  settlement  areas 
('agglomerations')  is  collected  and  made  subject  to  secondary  treatment  before  being 
discharged  into  the  natural  environment.  More  stringent  treatment  must  be  applied  when 
wastewater  is  discharged  into  so  called  sensitive  areas.  The  original  EU15  Member  States 
should have achieved the objectives of the Directive in 1998 for sensitive areas, in 2000 for 
large towns and cities discharging in normal areas and by 2005 for smaller towns discharging 
in  normal  areas.  Regarding  EU12  Member  States,  which  joined  the  EU  in  2004  and  2007 
respectively, the Accession Treaties provide for transitional periods similar to the compliance 
deadline  established  in  the  Directive  upon  adoption  in  1991.  The  transitional  periods  are 
staggered and go as a rule not beyond 2015, in the case of Romania for small agglomerations 
below 10000 until 2018. 

The  Drinking  Water211  and  Bathing  Water212  Directives  require  Member  States  to  meet 
binding  quality  standards  to  ensure  safe  drinkable  water  from  the  tap  and  clean  water  for 

207 

208 

209 

210 
211 

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 
framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1–73). 
Directive  2006/118/EC  of  the  European  Parliament  and  of  the  Council  of  12 December  2006  on  the 
protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19–31).  
Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16 December  2008  on 
environmental  quality  standards  in  the  field  of  water  policy,  amending  and  subsequently  repealing 
Council  Directives  82/176/EEC,  83/513/EEC,  84/156/EEC,  84/491/EEC,  86/280/EEC  and  amending 
Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84–97). 
Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991). 
Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ 
L330, 5.12.1998). 

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bathing, to monitor whether the standards are complied with and to inform consumers and the 
public accordingly.  

The  Nitrates  Directive213  is  also  an  important  instrument  which  deals  with  the  relationship 
between agriculture and water quality. In order to reduce and prevent water pollution caused 
by  nitrates  originating  from  agricultural  sources,  Member  States  must  monitor  waters, 
designate  so  called  nitrate  vulnerable  zones  and  then  adopt  and  implement  action  programs 
and codes of good agricultural practices with the aim of improving fertiliser management that 
should result in the prevention and reduction of nitrate leaching towards waters. Monitoring 
programs are required to be set up to assess the efficiency of these action programs.  

The directive on the assessment and management of flood risks (Floods Directive)214 requires 
Member  States  to  assess  flood  risks  and  to  establish  flood  risk  management  plans  by  2015, 
with the aim to reduce flood risk for human health, economic activity, the environment and 
cultural heritage.  

The Marine Strategy Framework Directive215 is the culmination of the thematic strategy on 
the  marine  environment  contained  in  the  6th  Environment  Action  Plan.  By  addressing  all 
marine waters, it completes the full water cycle throughout the European Union. It expands 
EU  environmental  law  to  a  geographical  area  equivalent  to  its  land  territory.  The  Directive 
establishes  a  strategic  framework  for  the  protection  of  the  marine  environment  in  a  highly 
integrated manner, based on the ecosystem approach. It provides that all marine waters must 
meet the standard of “good environmental status” as a rule by 2020, and that coordination and 
cooperation between Member States has to take place in shared marine regions. To this end, 
Member  States  must  carry  out  a  series  of  preparatory  stages  from  2012  (comprehensive 
assessment,  targets,  indicators,  monitoring  programmes)  and  draw  up  the  necessary 
programmes of measures by 2015. 

8.4.1.2.  Report of the work done in 2010 

Management of the acquis, new legislation and preventive measures 

In 2010, Directive 2000/60/EC establishing a Framework for Community action in the field of 
water  policy  (Water  Framework  Directive)  reached  a  crucial  milestone  in  implementation, 
with the publication of the 1st River Basin Management Plans (RBMPs) and their submission 
to  the  European  Commission,  which  was  due  by  22  March  2010  at  the  latest.  To  improve 
transparency and benchmarking, the status and content of the RBMPs has been made publicly 
available (and is regularly updated) at: 

http://ec.europa.eu/environment/water/participation/map_mc/map.htm  

212 

213 

214 

215 

Directive  76/160/EEC  of  8  December  1975  concerning  the  quality  of  bathing  water  (OJ  L031, 
5.2.1976).  This  Directive  is  in  the  process  of  being  replaced  by  Directive  2006/7/EC  of  15  February 
2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC (OJ L 
of 4.2.2006). 
Council  Directive  91/676/EEC  of  12  December  1991  concerning  the  protection  of  waters  against 
pollution caused by nitrates from agricultural sources, OJ L 375, 31.12.1991, p. 1–8. 
Directive  2007/60/EC  of  the  European  Parliament  and  of  the  Council  of  23  October  2007  on  the 
assessment and management of flood risks (OJ L 288, 6.11.2007, p. 27–34). 
Directive 2008/56/EC of 17 June 2008 establishing a framework for community action in the field of 
marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19-40). 

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The  main  aim  of  the  Water  Framework  Directive  (WFD)  is  to  achieve  good  status  in  all 
European  waters.  Member  States  are  required  to  include  in  their  River  Basin  Management 
Plans environmental objectives for all water bodies and a programme of measures to achieve 
these  objectives.  These  Programmes  of  Measures  have  to  be  operational  by  2012.  The 
majority of the Member States (fifteen) have delivered their RBMPs on time and carried out 
the required public  consultation process on the draft plans. For twelve Member States there 
have  been  delays  –  in  a  few  cases,  serious  ones-  and  the  Commission  has  therefore  started 
infringement  procedures.  At  the  end  of  2010,  the  most  serious  delays  were  those  affecting 
Spain, Portugal, Greece, Denmark and Belgium. 

In  the  meantime,  the  Commission  and  the  Member  States  continue  their  cooperation  in  the 
Common Implementation Strategy (CIS) for the Water Framework Directive. The Common 
Implementation  Strategy,  an  informal  process  set  up  in  2001,  has  delivered  extensive 
guidance to promote the implementation of the WFD. Its objective is to provide a forum for 
Member States, stakeholders and Commission's experts to work together towards a successful 
implementation  of  the  core  water  law  at  EU  level.  In  2010,  several  additional  guidance 
documents were agreed by the Water Directors in the framework of the CIS, including one on 
chemical monitoring of sediment and biota, and another one on risk assessment and the use of 
conceptual  models  for  groundwater.  In  the  framework  of  the  CIS  work  programme  for  the 
period 2010-2012, inter alia, 2 workshops were organised, one on biodiversity and water, and 
the other one on economic issues under the WFD. 

The  implementation  of  the  Water  Framework  Directive  has  also  been  further  promoted  in 
2010 as Member States had to bring into force on 13 July 2010 at the latest all the domestic 
laws, regulations and administrative provisions necessary to comply with the Environmental 
Quality Standards Directive (EQS). 

The  deadlines  for  notification  of  national  transposing  legislation  for  the  Groundwater 
Directive  expired  on  15  January  2009  and  for  the  Floods  Directive  on  26  November  2009. 
For the Floods Directive, compliance promotion took place in the form of the development of 
a  transposition  checklist,  which  was  circulated  to  Member  States.  A  transposition  checklist 
was also developed for the EQS Directive. The Commission furthermore adopted a Directive 
on technical specifications for chemical analysis and monitoring of water status216.  

On the Drinking Water Directive, the consultation process commenced in 2008 on the need 
for reviewing the parameters and values (obligation by the Commission under article 11(1)) as 
well  as  on  the  future  eventual  revision  of  the  Directive  was  in  2010  complemented  by  the 
compilation of data for compliance of larger supplies (serving >5000 consumers) and smaller 
supplies  (serving  50-5000  consumers),  as  well  as  an  economic  impact  assessment  study.  In 
conclusion,  compliance  with  quality  standards  is  very  high  for  larger  supplies,  however 
distinctly lower for smaller supplies, though in the latter case varying from region to region. 
The Commission published its Synthesis Report for 2005-2007 drinking water data reported 
by  Member  States  for  supplies  >5000  consumers217.  The  Commission  also  published  its 
annual report218 on bathing water quality data under the Bathing Water Directive. Under the 

216 

217 
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Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of 
the  European  Parliament  and  of  the  Council,  technical  specifications  for  chemical  analysis  and 
monitoring of water status. OJ L 201, 1.8.2009, p 36. 
http://ec.europa.eu/environment/water/water-drink/reporting_en.html 
http://ec.europa.eu/environment/water/water-bathing/report_2010.html  

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Urban Waste Water Directive, the next reporting exercise took place in 2009/2010, with the 
6th report on the implementation of the Directive foreseen for 2011. 

As  to  the  implementation  of  the  Nitrates  Directive,  the  Nitrates  Committee  made  up  of 
Commission  and  Member  State  representatives  was  convened  four  times  in  2010  mainly  to 
discuss derogation files for Ireland,  UK for the region of  Northern Ireland, Belgium for the 
region  of  Flanders  and  Italy.  These  meetings  resulted  in  positive  opinions  of  the  Nitrates 
Committee for draft Commission Decisions for Ireland and UK for Northern Ireland that will 
allow  those  Member  States  to  apply  higher  amounts  of  livestock  manure  to  land.  The 
procedure for final adoption of these two decisions was still ongoing at the end of 2010. The 
files related to derogations for Italy and Belgium were not yet mature for vote at the end of 
2010.  The  Commission  published  in  February  2010  its  four  yearly  implementation  report, 
referring  to  the  period  2004-2007219.  In  addition,  the  Commission  continued  to  assess  the 
implementation  of  the  Nitrates  Directive  in  the  various  Member  States  which  resulted  in 
several meetings and written exchanges with the Member States concerned.  

The  first  action  undertaken  under  the  Marine  Strategy  Framework  Directive  was  the 
adoption  by  the  Commission  of  a  Decision  on  criteria  and  methodological  standards  to 
achieve good environmental status in marine waters (Decision 2010/477/EU). This Decision 
was based on substantial scientific research and will be used by Member States in developing 
the next stages of implementation due from 2012 (comprehensive assessment, characteristics 
of good environmental status, targets and associated indicators). The Decision also recognises 
the  need  for  regular  update  based  on  scientific  information  and  adoption  of  management 
measures, in line with the 6-year cycle underlying the Directive.  

Because  it  is  a  recent  Directive,  the  Commission  set  up,  together  with  Member  States,  an 
informal Common Implementation Strategy, with a series of meetings (including a high level 
meeting of Marine Directors for each EU Presidency), to develop common understanding in 
the process of policy development. This is accompanied by increased activity by the European 
Commission  in  the  various  Regional  Sea  Conventions  around  Europe,  which  are  taken  the 
role  of  facilitating  regional  coordination  by  Member  States  in  the  implementation  of  the 
Directive.  

Management of complaints and of infringements 

Despite the close cooperation with the Member States, infringement actions were necessary in 
2010. 

Concerning the Water Framework Directive, infringement action was concerned in 2010 with 
both non-conformity and bad implementation issues.  

Assessment  of  conformity  of  national  legislation:  In  2010,  the  Commission  pursued  further 
the  infringements  that  were  open  against  19  Member  States  for  incorrect  and/or  incomplete 
transposition. In particular, four letters of formal notice (one of them being a complementary 
letter  of  formal  notice)  were  addressed  to  Germany,  Italy,  Ireland  and  the  United  Kingdom 

219 

Report from the Commission to the Council and the European Parliament on implementation of Council 
Directive  91/676/EEC  concerning  the  protection  of  waters  against  pollution  caused  by  nitrates  from 
agricultural  sources  based  on  Member  State  reports  for  the  period  2004-2007  (COM(2010)47final);  
Commission Staff Working Document, accompanying document to the Report from the Council and the 
Parliament COM(2010)47.  

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while  four  reasoned  opinions  were  sent  to  Belgium,  Denmark,  Finland  and  Poland. 
Conversely, five infringement procedures were closed as the Member States concerned – The 
Netherlands,  Hungary,  Lithuania,  France  and  Estonia  -  had  adopted  /  amended  national 
legislation that led to a correct and complete transposition of the Water Framework Directive. 
The  Commission  also  monitored  the  transposition  progress  made  by  other  Member  States, 
which may lead to a closure, in 2011, to relevant infringement cases.  

Bad  implementation:  Infringements  were  open  in  2010  against  twelve  Member  States  for 
having failed to submit on time their river basin management plans. While some Cases could 
be  rapidly  closed,  reasoned  opinions  proved  necessary  for  ten  Member  States:  Belgium, 
Cyprus, Denmark, Greece, Malta, Slovenia, Spain, Romania, Poland and Portugal. 

Complaints: A horizontal complaint submitted against 11 Member States, on the scope of the 
term "water services" is addressed by way of conformity cases.  

Court rulings: A letter of formal notice was sent to Spain under Article 260 of the Treaty as 
this Member State had not taken all necessary measures to comply with the Court ruling of 
7.5.2009  (Case  C-516-07)  on  the  implementation  of  Article  3  (designation  of  relevant 
competent authority in each river basin district) of the Water Framework Directive. By ruling 
of 22 December 2010 (Case C-351-09) the Court ruled against Malta for its failure to comply 
with the monitoring requirements of the WFD. 

The Environmental Quality Standards Directive (EQS) had to be transposed into the law of 
the Member States by 13 July 2010 at the latest. Infringement procedures have been initiated 
in  autumn  against  the  twenty-two  Member  States  that  had  not  communicated  its  national 
transposing measures to the Commission. While 2 Cases could already be closed in 2010, the 
Commission  envisaged,  by  the  end  of  2010,  in  the  light  of  the  information  provided  by 
Member States, to close in the first trimester of 2011 a majority of those non-communication 
cases.  For  reminder,  the  list  of  priority  substances  contained  in  this  Directive  is  being 
reviewed as required by the WFD and a Commission proposal is expected in 2011. 

In respect of the Groundwater Directive, letters  of formal notice for non-communication of 
national measures deemed to transpose it were sent to twenty Member States in April 2009. 
By the end of 2010, the transposing measures were communicated by all Member States with 
the  exception  of  Germany  and  the  Czech  Republic.  A  reasoned  opinion  was  addressed  to 
both, and a Court application has been lodged against the Czech Republic. Germany notified 
due legislation following the reasoned opinion. As concerns Czech Republic, by ruling of 22 
December  2010  (Case  C-276/10),  the  Court  ruled  in  favour  of  the  Commission.  The 
transposition  measures  are  being  systematically  checked  with  a  view  to  addressing  any 
instance of non compliance (bad transposition) in the first semester 2011.  

As  far  as  the  Floods  Directive  is  concerned,  the  transposition  deadline  was  26  November 
2009,  and  a  transposition  checklist  had  been  shared  with  the  Member  States  to  facilitate 
compliance.  In  January  2010,  a  number  of  non-communication  cases  were  opened.  By 
November  2010,  only  one  Member  State  had  not  transposed at all the Directive,  with  some 
Member States having partially transposed it. Reasoned opinions have been addressed to FI, 
FR, PL, CZ, AT, LU. Following the Reasoned opinion, Finland has notified the transposing 
legislation. Two applications to Court have been lodged, against Poland and France. 

Regarding  the  Urban  Waste  Water  Directive,  the  Commission's  enforcement  work  has 

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continued to focus firstly on ensuring full compliance with the Directive's obligation to ensure 
that  more  stringent  treatment  is  provided  to  discharges  from  agglomerations  into  areas 
designated as sensitive by the 31 December 1998 deadline set for the older EU 15 Member 
States.  In  June  2010,  the  Commission  took  the  decision  to  refer  Belgium  to  the  Court  of 
Justice for a second time under Article 260 of the TFEU with a request for financial penalties 
for its failure to ensure compliance with the earlier judgment of the Court of Justice in case C-
27/03.  In  June  2010,  the  Commission  also  decided  to  send  an  additional  Letter  of  Formal 
Notice  under  Article  260  of  the  TFEU  to  Luxembourg  for  its  failure  to  ensure  compliance 
with an earlier judgment of the Court of Justice in case C-452/02.  

The  Commission  secondly  continued  to  follow  up  compliance  with  the  31  December  2000 
deadline  in  the  Urban  Waste  Water  Directive  requiring  collecting  systems  and  appropriate 
treatment  to  be  provided  for  urban  waste  waters  discharges  emanating  from  larger 
agglomerations  of  over  15,000 population equivalent.  The Commission took the  decision in 
March 2010 to refer both France and Spain to the Court of Justice under Article 258 of the 
TFEU. Similarly, it was decided in November 2010 to refer Italy to the Court of Justice.  

In 2009 the Commission launched the first phase of legal action for the EU 15 Member States 
with regard to ensuring compliance with the collecting and treatment obligations for smaller 
agglomerations  of  2,000  to  15,000  population  equivalent  for  which  the  deadline  of 
compliance  was  31  December  2005.  Sweden  was  added  to  the  group  of  Member  States  for 
which  action  was  already  launched  in  2009,  with  a  letter  of  formal  notice  being  sent  in 
January 2010.  

In addition to this, an additional letter of formal notice was sent under the new Article 260 of 
the TFEU to Greece in May 2010 with regard to its failure to ensure compliance with the first 
judgment of the Court of Justice in case C-119/02. Furthermore, the Court of Justice gave its 
judgment  against  Portugal  in  case  C-526/09  in  December  2010  for  its  failure  to  ensure  that 
industrial  waste  waters  from  sites  in  the  town  of  Matoshinhos  were  adequately  treated  and 
authorised under Article 11 of the Urban Waste Water Directive.  

For the Drinking Water Directive, the Commission decided to refer Luxembourg to the Court 
of Justice in June 2010 (now case C-458/10) for its failure to fully and correctly transpose the 
Directive. A letter of formal notice was sent to Slovakia for the same failure. Furthermore, in 
2010 the Commission decided to close its case against Ireland after it was satisfied that the 
Member  State  had  sufficiently  implemented  Court  ruling  C-316/00  for  the  violation  of  the 
"old" Drinking Water Directive (80/778/EEC).220  

Concerning  the  new  Bathing  Water  Directive:  Non-communication  of  transposing  national 
measures: Member States were required to transpose the new Bathing Water  Directive and 
notify these transposing measures to the Commission by 24 March 2008 at the latest. At the 
end of 2009, only two Member States, the Czech Republic and Poland had still not notified 
full transposing measures and the Commission referred these two Member States to the Court 
of Justice. In the meanwhile, Poland notified transposition measures, while on 30 September 
2010, the ECJ declared (Case C–481/09) that by failing to adopt all the laws, regulations and 

220 

Council  Directive  80/778/EEC  of  15  July  1980  relating  to  the  quality  of  water  intended  for  human 
consumption  (OJ  L  229,  30.8.1980,  p.11).  Directive  80/778//EEC  was  repealed  and  replaced  by 
Directive 98/83/EC on 25 December 2003. 

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administrative provisions necessary to comply with Directive 2006/7/EC, the Czech Republic 
has failed to fulfil its obligations under that directive. 

Commission's  enforcement  work  in  2010  focused  on  the  analysis  of  the  conformity  of 
transposition  measures.  This  work  is  still  ongoing  as  regards    19  MS. The  Commission  is 
continuing  this  exercise  in  2011  and  depending  on  Member  States'  replies,  infringement 
proceedings for non-conformity might be launched. 

As to the Nitrates Directive, five Member States were involved in an infringement procedure, 
including  Luxembourg,  Spain,  Greece,  France  and  Poland.  In  its  ruling  of  29  June  2010 
against Luxembourg (case C-526/08), the Court declared that Luxembourg failed to adopt the 
laws, regulations and administrative provisions necessary to comply with Articles 4 and 5 of 
the  Nitrates  Directive.  Following  this  judgement  and  in  the  absence  of  information  on  the 
measures taken in order to correct the breach, a letter of formal notice was addressed under 
Article  260  of  the  TFEU  to  Luxembourg  in  November  2010  with  regard  to  its  failure  to 
ensure compliance with the judgement of the Court in case C-526/08. 

The  Commission  sent  in  October  2010  a  reasoned  opinion  to  Spain  regarding  its  non-
compliant  designation  of  vulnerable  zones  and  nitrates  action  programmes.  By  the  end  of 
2010 substantial progress was made by the Spanish authorities in amending legal texts but the 
required  amendments  to  legislation  were  not  yet  completed  for  all  regions  involved.  The 
Commission  sent  in  March  2010  to  Greece  a  letter  of  formal  notice  with  regard  to  its  non-
compliant  action  programmes.  The  Commission  sent  in  September 2010  a  letter  of  formal 
notice to Poland regarding its failure to a sufficient extent to designate the vulnerable zones 
and to adopt adequate nitrate action programmes. 

The Marine Strategy Framework Directive had to be transposed by 15 July 2010 at the latest. 
Infringement  procedures  have  been  initiated  against  eighteen  Member  States  that  had  not 
communicated its national transposing measures to the Commission. At the end of 2010, the 
Commission envisaged, in the light of the information provided by Member States, to close in 
the first trimester of 2011 several of those non-communication cases. The reason behind the 
delay  seems  to  be  the  difficulty  of  taking  forward  such  an  integrated  instrument,  which 
requires the agreement of a series of national institutions at various governance levels (from 
national to regional and local) and various sectors.  

Petitions 

In 2010, the Commission received 14 new petitions related to water quality management and 
resource protection. The petitions concerned Finland, France, Ireland, Hungary, Italy, Spain, 
Germany and the United Kingdom. While the overall number is stable, their content show an 
increased interest for flood related issues. 

8.4.2.  Evaluation based on the current situation 

Emission-oriented  legislation,  such  as  the  Urban  Waste  Water  and  Nitrates  Directives,  has 
achieved  great  progress  in  protecting  water  quality.  Much  progress  on  integrated  water 
management  has  been  made  with  the  gradual  implementation  of  the  Water  Framework 
Directive  and  the  publication  of  River  Basin  Management  Plans.  However,  considerable 
challenges  remain.  These  include  addressing  issues  of  water  scarcity,  droughts  and  floods, 
ensuring that waste water in the EU 12 and also originating from small towns in the EU 15 is 
about  the  achievement  of  good  chemical, 
properly  collected  and  treated  and  bringing 

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ecological and quantitative status by 2015 as required by the Water Framework Directive.  

On  the  implementation  of  the  Water  Framework  Directive,  the  situation  as  regards  the 
delivery of the 1st River Basin Management Plans, at the end of 2010, can be summed up as 
follows:  seventeen  Member  States  had  submitted  their  Plans,  five  had  started  public 
consultation  but  not  yet  submitted  their  plans,  and  five  had  not  even  started  public 
consultation. As this is a key milestone for achieving the environmental objectives in 2015, all 
instances of non compliance have been timely addressed by way of infringement procedures 
(summarised above, in the previous section).  

One  key  implementation  challenge  was  identified  in  the  2nd  implementation  report  on  the 
Water Framework Directive in relation to monitoring, i.e. the absence of exhaustive national 
methods  for  assessing  the  ecological  status  of surface water  bodies  or the existence of non-
compliant monitoring networks. This is an obstacle to the assessment of the ecological status. 

The  non-communication  cases  brought  forward  on  the  Groundwater  Directive,  have 
prompted  the  notification  of  almost  all  the  transposition  measures  to  the  Commission  (with 
only two Member States still missing). These are being the subject of conformity assessment 
aimed at addressing all instances of non conformity in 2011. The same approach and timing is 
being  followed  for  the  Floods  Directive.  Delays  in  transposing  the  Groundwater  Directive 
could  in  a  few  cases  lead  to  delays  in  the  implementation  of  certain  groundwater  related 
aspects  of  the  Water  Framework  Directive.  The  implementation  of  the  Groundwater 
Directive will be assessed in relation to the River Basin Management Plans referred to above. 

Water  quality  has  improved  following  EU  15  Member  States'  encouraging  progress  in 
implementing the Urban Waste Water Directive. Yet, there are still many agglomerations, for 
instance, in Belgium, Italy and Spain that lack complete waste water collecting systems and 
treatment  facilities  As  to  the  EU12  Member  States,  the  implementation  of  the  Directive  is 
characterized  by  staggered  transitional  periods  foreseen  in  the  Accession  Treaties  regarding 
the  building  of  the  necessary  waste  water  infrastructure,  by  the  fact  that  the  EU  has  made 
financial support available and by supportive action on capacity building and technical advice. 
However, the first of the staggered transitional deadlines for EU12 have expired by the end of 
2009 (Cyprus, Hungary, Latvia, Lithuania, Malta, Poland and Slovenia).  

Concerning  the  Bathing  Water  Directive,  monitoring  data  annually  published  show 
continuing  high  compliance  of  bathing  waters  with  the  legally  binding  standards,  with 
compliance  during  the  2009  bathing  season  reaching  95.6%  for  coastal  bathing  waters  and 
89.4%. Concerning the Drinking Water Directive, EU-wide data for larger supplies (serving 
>5000  consumers)  and  smaller  supplies  (serving  50-5000  consumers)  show  a  distinctly 
different pattern, with larger supplies showing very high compliance whilst smaller supplies 
in  many  regions  show  up  to  one  third  of  supplies  not  fully  complying,  thus  necessitating 
further targeted implementation and enforcement action. 

As to the Nitrates Directive, significant progress has been made in the recent years, including 
in  2010,  regarding  the  designation  of  "vulnerable  zones"  and  the  elaboration  and 
implementation  of  monitoring  programmes.  However,  further  improvements  are  clearly 
needed, in particular, with regard to the quality of action programmes as nitrate concentrations 
are  still  major  concerns  in  some  intensively  farmed  areas.  The  Commission  published  on  9 

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February 2010 its report221 to the European Parliament and Council on the implementation of 
the Directive for the period 2004-2007. 

The initial cycle of implementation of the Marine Strategy Framework Directive is showing 
to  be  challenging  for  several  reasons,  and  actions  are  being  taken  to  address  them  on  a 
continued  basis.  The  various  stages  and  deliverables  under  the  Directive  require  substantial 
conceptual  policy  development,  as  there  is  a  need  to  elaborate  on  the  basis  of  a  legislative 
instrument  which  was  crafted  as  a  framework  instrument.  In  addition,  the  Directive  aims  at 
addressing  a  range  of human activities affecting the marine environment, thereby tackling a 
multi-sectoral  challenge  involving  all  the  cumulative  impacts  on  the  marine  environment. 
This  requires  increased  coordination  efforts  and  enhanced  scientific  support  that  need  to  be 
gradually articulated. To address these challenges, the Commission is taking an active role in 
an  informal  Common  Implementation  Strategy  where  the  actions  of  Member  States,  and 
across  the  various  marine  regions,  are  being  coordinated  in  these  initial  stages  of  policy 
development.  

8.4.3.  Evaluation results 

8.4.3.1.  Priorities 

The Commission will prepare the third and major report on the implementation of the Water 
Framework Directive in 2012 (as required by article 18 of the Directive), including a review 
of how Member States have tackled their river basin management planning. This will be part 
of  the  Blueprint  to  Safeguard  Europe's  Waters,  which  will  also  include  a  review  of  the  EU 
policy on Water Scarcity & Droughts and an assessment of the vulnerability of environmental 
resources such as water, biodiversity and soil to climate impacts and man-made pressures. 

This review will consider issues such as Member States' implementation of river basin based 
management approaches, water pricing policies, including full account and internalisation of 
environmental and resource costs, cooperation on trans-boundary rivers, public consultations, 
land  use  changes,  setting  of  ecologically  based  objectives,  protected  areas,  analysis  of  all 
pressures  on  water  resources,  integration  of  water  concerns  into  sector  policies,  degree  of 
achievement  of  good  ecological  and  chemical  status,  good  ecological  potential  and  good 
groundwater, chemical and quantitative status by 2015, and the establishment of programmes 
of measures to reach the targets.  

Regarding the Drinking Water Directive, the Commission has in 2010 finalised its evaluation 
of a need for a revision of the Directive, assessing parameters and values, the coherence with 
other water-related legislation in particular the Water Framework Directive, streamlining data 
exchange and reporting and risk-based approaches for a holistic protection of drinking water 
from  the  source  to  the  tap  of  the  consumer.  The  Commission  will  in  2011  publish  its 
conclusions. 

For the Marine Strategy Framework Directive, the priority is to support actively a coherent 
policy  development  between  Member  States  in taking  forward  their  obligations,  taking  also 
into  account  cooperation  within  marine  regions.  Thus,  as  from  2012,  Member  States  must 

221 

Report from the Commission to the Council and the European Parliament on implementation of Council 
Directive  91/676/EEC  concerning  the  protection  of  waters  against  pollution  caused  by  nitrates  from 
agricultural sources based on Member States reports for the period 2004-2007. 

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elaborate comprehensive assessment, characteristics of good environmental status, targets and 
associated indicators. A priority to secure the success of these implementation milestones in 
the Directive is dependent on a successful integration of environmental concerns in a range of 
sectorial  policies,  such  as  the  Common  Fisheries  Policy,  the  Integrated  Maritime  Policy, 
transport, energy, agriculture, regional policy, research and international cooperation.  

For  the  Nitrates  Directive,  priority  will  be  given  to  the  assessment  of  files  from  Member 
States that request for a derogation on the limit for land application of livestock manure and to 
continuing  the  follow  up  of  implementation  of  the  Directive  in  the  Member  States,  in 
particular focusing on the fulfilment of obligations on the designation of "vulnerable zones" 
and the drawing up and updating of nitrates action programmes. Under the WISE umbrella, 
the  Commission  will  continue  its  work  on  streamlining  data  management  and  updating  the 
reporting guidelines for the next Member State reporting exercise in 2012.  

8.4.3.2.  Planned action (2011 and beyond) 

Given that the preservation, improvement and restoration of water quality is so closely linked 
to  the  Water  Framework  Directive  the  Commission  will  focus  on  ensuring  Member  States 
fully  meet  their  obligations,  including  in  particular  the  adoption  and  implementation  of 
appropriate River Basin Management Plans and programmes of measures for each river basin 
district and the development of national methods for assessing the ecological status of surface 
water  bodies.  Therefore,  and  in  view  of  the  above  mentioned  third  report  on  the 
implementation of the Water Framework Directive, the following actions are planned: 

-  Enforcing  the  adoption  of  the  1st  River  Basin  Management  Plans  and  carrying  out  the 
compliance  assessments  of  these  plans,  including  checking  the  implementation  of  the 
Groundwater and the Environmental Quality Standards Directives. 

-  Supporting  and  enforcing  the  transposition  of  the  Directives  on  Groundwater,  Floods  and 
Environmental Quality Standards, including starting conformity assessments.  

-  Continuing  the  development,  together  with  the  European  Environmental  Agency,  of  the 
Water  Information  System  for  Europe  (WISE)  in  2010  as  a  single  platform  for  water 
information and reporting to simplify and reduce the overall administrative burden involved 
in reporting. 

In  addition,  the  Commission  will  launch,  if  necessary,  appropriate  legal  enforcement  action 
against Member States that fail to comply with the obligations set out in these Directives. In 
this  respect,  the  Commission  will  continue  to  make  use  of  the  Common  Implementation 
Strategy  as  an  informal  platform  to  foster  better  implementation  and  to  exchange  good 
practice. 

As regards the Floods Directive, the first stage of implementation was the identification and 
notification  (in  2010),  of  units  of  management  and  competent  authorities,  if  these  are  other 
than those in charge of the Water Framework Directive, and 23 Member States reported new 
information. Compliance checking of the information is underway. The next implementation 
stages are the preliminary flood risk assessment by 2011, flood mapping by 2013 and flood 
risk  management  plans  by  2015.  For  these  stages,  the  development  of  reporting  formats  as 
well as information exchange between Member States is ongoing to support implementation 

Planned  new  legislation  includes  the  preparation  of  a  proposal  on  priority  substances 

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(amending  annex  X  of  the  Water  Framework  Directive)  and  the  establishment  of  related 
environmental quality standards. The list of priority substances and the environmental quality 
standards contained in that Directive are being reviewed as required by the Water Framework 
Directive and a Commission proposal is expected in 2011. 

The  Commission's  work  regarding  the  implementation  of  the  Urban  Waste  Water,  the 
Drinking  and  the  Bathing  Directives  will  be  based  on  a  twin-track  approach.  On  the  one 
hand, it will continue to promote the exchange of information, experience and cooperation at 
an informal level with Member States and stakeholders. On the other hand, the Commission 
will draw up and publish implementation reports, including a report an annual bathing water 
quality  and  also  a  tri-annual  EU-wide  synthesis  report  on  drinking  water  quality;  the  next 
implementation report on the Urban Waste Water Directive is foreseen for 2011. In addition, 
the  Commission  will  launch,  if  necessary,  appropriate  legal  enforcement  action  against 
Member  States  that  fail  to  comply  with  the  obligations  set  out  in  these  Directives.  For  the 
Urban Waste Water Directive, this is likely to involve the first steps in legal action against 
some  of  the  newer  EU  12  Member  States  where  extended  deadlines  for  compliance  in  the 
Accession Treaties have elapsed. For these Member States the Commission will also continue 
to focus on tracking the availability of EU funds and the quality of the forward planning of 
these countries for compliance with future deadlines through focused bilateral contacts with 
the Member States and in contacts between the relevant Commission Directorate Generals.  

The  Nitrates  Directive:  The  Commission's  work  to  ensure  compliant  implementation  will 
continue in 2011 on the basis of detailed assessments of the information provided by Member 
States in their 4-year implementation reports and via bilateral contacts. The assessments will 
focus  on  the  main  obligations  of  the  Nitrates  Directive,  namely  on  water  monitoring,  the 
designation  of  "vulnerable  zones"  and  the  drawing  up  and  updating  of  nitrates  action 
programmes. It will then need to be decided whether these assessments need to be followed 
up  with  infringement  action.  The  Commission  will  continue  to  organise  meetings  of  the 
Nitrates  Committee  on  Member  States'  derogation  requests  and  to  give  Member  States  the 
opportunity  to  exchange  information  on  implementation.  The  Commission  published  its  4 
yearly report221on implementation in February 2010. 

In  relation  to  the  Marine  Strategy  Framework  Directive,  the  planned  action  for  2011  and 
beyond will be the active organisation of the Common Implementation Strategy with Member 
States, to support a coherent policy development. In addition, increased participation will be 
required in Regional Sea Conventions. Future action will include increased efforts to integrate 
marine  environment  concerns  in  sectorial  policies,  such  as  for  instance  the  reform  of  the 
Common Fisheries Policy and the design of the new Financial Perspectives (considering that 
the  policy  for  the  protection  of  the  marine  environment  was  adopted  in  the  middle  of  the 
current cycle).  

The  new  Bathing  Waters  Directive  was  required  to  be  transposed  into  national  law  by  24 
March 2008. In 2010, the Commission continued to verify whether the transposition is both 
correct and complete. In September 2010, the European Court of Justice ruled that the Czech 
Republic  had  failed  to  transpose  the  Directive  (case  C-481/09).  The  Commission  will  take 
further enforcement action where necessary. 

8.4.4.  Sector summary 

Substantial  progress  regarding  the  implementation  of  EU  water  and  marine  law  has  been 

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observed in the past decade as a result of increased awareness among decision-makers of the 
critical importance of meeting water quality standards to preserve water and marine resources 
and  the  associated  natural  environment  and  to  protect  human  health.  Better  implementation 
has often been driven by informal and formal cooperation between Member States, industries, 
non-governmental organisations, consumers and the Commission as well as by infringement 
procedures. However, more efforts need to be made to ensure full compliance with EU water 
Directives. In respect of the Nitrates Directive, the Commission has noted that several regions 
within  the  EU  show  worrying  water  quality  trends  for  which  reinforced  action  programmes 
will need to be developed. With regard to the Urban Waste Water Directive, Member States 
must ensure that it is fully applied, including in the new EU 12 Member States and in smaller 
towns  for  all  27  Member  States.  With  regards  to  the  Drinking  Water  Directive,  targeted 
efforts  by  Member  States  will  be  required  to  ensure  compliance  for  those  smaller  supplies 
currently  delivering  drinking  water  not  fully  complying  with  quality  standards.  The 
implementation  of  EU  water  and  marine  legislation  and  the  enhancement,  preservation  and 
restoration of water quality will greatly depend on Member States meeting their obligation to 
take  all  required  measures  to  guarantee  the  achievement  by  2015  of  the  environmental 
objectives  of  "good  chemical  and  ecological  status"  for  surface  water  bodies  and  of  "good 
chemical and quantitative status" for groundwaters set in the Water Framework Directive. In 
the case of the marine waters, the programmes of measures due by 2015 will have to include 
the necessary actions to achieve "good environmental status" by 2020.The Commission will 
continue  to  focus  on  the  proper  transposition  of  European  water  and  marine  legislation, 
including  of  the  new  Floods  and  Marine  Strategy  Directives  and  their  implementation.  The 
Commission will continue its efforts to ensure that Member States fulfil their obligation under 
these  Directives  and  will  assist  them,  when  necessary,  via  formal  and  informal  cooperation 
channels. 

8.5. 

Air quality and environmental noise 

8.5.1.  Current position 

8.5.1.1.  General introduction  

Ambient air quality 

The  new  Directive  2008/50/EC  of  the  European  Parliament  and  of  the  Council  of  21 May 
2008  on  ambient  air  quality  and  cleaner  air  for  Europe  is  the  key  legal  instrument  in  this 
sector222. The Directive entered into force on 11 June 2008 and merges four Directives223 and 
one Council Decision224 into a single air quality instrument. It introduces new objectives for 
fine particles (PM2.5) but  does not change existing air  quality standards. Available evidence 
points to serious problems in complying with the air quality limit values in many European air 
quality zones; the new Directive does, however, give under certain conditions Member States 

222 
223 

224 

.OJ L 152, 11.6.2008, p. 1–44. 
The  four  directives  merged  into  the  new  directive  are:  Council  Directive  96/62/EC  of  27  September 
1996  on  ambient  air  quality  assessment  and  management;  Council  Directive  1999/30/EC  of  22  April 
1999  relating  to  limit  values  for  sulphur  dioxide,  nitrogen  dioxide  and  oxides  of  nitrogen,  particulate 
matter  and  lead  in  ambient  air; Directive  2000/69/EC of the  European Parliament  and  of  the  Council 
relating to limit values for benzene and carbon monoxide in ambient air; and Directive 2002/3/EC of 
the European Parliament and of the Council relating to ozone in ambient air. 
Council Decision 97/101/EC establishing a reciprocal exchange of information and data from networks 
and individual stations measuring ambient air pollution within the Member States. 

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greater  flexibility  in  meeting  some  of  these  standards  in  areas  where  they  have  difficulty 
complying. 

Under  the  new  Directive  2008/50/EC  Member  States  have  the  possibility  to  notify  an 
exemption from the application of the limit values for PM10 (and to postpone the limit values 
for nitrogen dioxide (NO2) which entered into effect in 2010) provided that certain conditions 
are satisfied. The Commission has nine months from the submission of a notification to assess 
it and to decide whether to raise objections or not. If no objections are raised, the notification 
will be tacitly approved at the expiry of the nine months assessment period. 

Product regulation 

There  are  several  legal  instruments  regulating  the  composition  of  products  which  aim  to 
prevent  or  reduce  the  emissions  of  certain  air  pollutants  at  source.  These  include  Directive 
98/70/EC relating to the quality of petrol and diesel fuels225, Directive 1999/32/EC relating to 
a  reduction  in  the  sulphur  content  of  certain  liquid  fuels226  and  the  Paints  Directive 
2004/42/EC  on  the  level  of  volatile  organic  compounds  in  paints,  varnishes  and  vehicle 
refinishing products227 . 

Environmental noise 

The Noise Directive228 , 2002/49/EC, lays down a common approach to avoiding, preventing 
or reducing on a prioritised basis the harmful effects of exposure to environmental noise. It 
requires  the  assessment  and  mapping  of  ambient  noise  in  large  agglomerations  and  in  the 
vicinity of major roads, railways and airports. 

National emission ceilings 

The National Emission Ceilings (NEC) Directive, 2001/81/EC229, plays an important role in 
defining  and  limiting  the  total  national  emissions  of  certain  air  pollutants  with  the  aim  to 
reduce  negative  effects  on  human  health  and  the  environment,  such  as  acidification, 
eutrophication  and  ground-level  ozone.  The  NEC  Directive  covers  air  emissions  of  all 
economic sectors and sources within the national territories. 

8.5.1.2.  Report of work done in 2010 

Ambient air quality 

225 

226 

227 

228 

229 

Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the 
quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 
58–68). 
Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in t he sulphur content of certain 
liquid fuels and amending Directive 93/12/EEC (OJ L 121, 11.5.1999, p. 13–18). 
Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation 
of  emissions  of  volatile  organic  compounds  due  to  the  use  of  organic  solvents  in  certain  paints  and 
varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, 
p. 87). 
Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the 
assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12–25). 
Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national 
emission ceilings for certain atmospheric pollutants (OJ L 309, 27.11.2001, p. 22). 

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Since 2005 when the PM10 limit values entered into force, a majority of Member States have 
reported as being in non-compliance. In 2008, around 280 zones in 22 Member States did not 
comply with these limits. The dilemma has been how to treat these breaches of existing EU 
law whilst recognising the explicit possibility for Member States to seek a time extension for 
compliance. The Commission's policy has been to launch infringement proceedings in respect 
of those situations which have not been the subject of a notification from the Member States 
or where the Commission has raised objections following a Member State notification. There 
are currently open infringement proceedings against 22 Member States in respect of PM10.  

Up  until  the  end  of  December  2010,  the  Commission  has  adopted  29  Decisions  on 
notifications coming from 19 Member States, concerning an exemption from the obligation to 
apply  the  PM10  limit  values.  As  the  daily  and  the  annual  PM10  limit  value  are  assessed 
individually, a zone might get an exemption for the one but not the other limit value. For that 
reason  the  figures  following  might  not  always  round  up.  For  around  19  %  of  these,  the 
Commission  did  not  raise  any  objection,  a  further  40  %  or  so  of  the  zones  were  already  in 
compliance whilst objections were raised for approximately 70% of the zones covered by the 
notifications. Member States are free to re-notify for zones where objections have been raised 
but any exemption must expire before 11 June 2011. 

Whilst  closing  some  bad  application  infringement  cases  in  2010  (PM10  cases  for  Malta  and 
Denmark, SO2 cases for Spain, France and Czech Republic), the Commission also continued 
to pursue infringement procedures it had launched in previous years (PM10 cases for Belgium, 
Romania,  Greece,  UK,  Slovakia,  Poland,  Austria,  Germany,  Hungary,  Czech  Republic, 
France, Slovenia, Sweden, Portugal, Italy, Spain, Cyprus, Latvia; SO2 case for Bulgaria) and 
has started some others against two Member States (PM10 case for Bulgaria and SO2 case for 
Romania)  that  have  shown  exceedances  of  the  relevant  limit  values  that  have  been  in  force 
since  1  January  2005.  New  exceedances  were  discovered  in  2009  and  reported  to  the 
Commission in 2010 as part of the formal reporting requirements. These excesses may also be 
the subject of further infringement proceedings in due course. 

The  deadline  for  transposing  the  Directive  2008/50/EC  was  on  11  June  2010.  By  that  time 
only  few  Member  States  had  transmitted  to  the  Commission  the  national  measures 
transposing the Directive into their national legal system. The Commission therefore launched 
infringement procedures against 21 Member States for non-communication of those national 
measures.  In  the  course  of  2010,  6  of  those  cases  could,  however,  already  be  closed  (Italy, 
Portugal, Austria, Bulgaria, Cyprus, Germany). 

Product regulation 

In  2010  the  Commission's  work  focused  on  the  preparation  of  the  review  of  the  Directive 
1999/32/EC  on  the  sulphur  content  of  certain  liquid  fuels.  The  last  amendment  of  the 
Directive  in  2005  contains  a  review  clause  which  requires  the  Commission  to  review  a 
number of general and specific issues following its experience with the implementation of the 
Directive  as  well  as  progress  made  at  the  IMO  level.  Since  2005,  revised  IMO  rules  were 
agreed for SO2 and for NOx in October 2008. These rules are contained in Annex VI of the 
Marine Pollution Convention 73/78 (MARPOL Annex VI). In addition to the verification of 
the  implementation  of  the  Directive  in  Member  States,  a  number  of  studies  have  been 
commissioned  in  order  to  assess  the  impact  of  a  revised  MARPOL  Annex  VI  on  the  EU 
shipping  industry.  In  addition,  the  Commission  has  regularly  consulted  stakeholders  on  the 
review  of  Directive  1999/32/EC,  including  an  on-line  public  consultation  (2010/2011) 

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addressed to all interested parties.  

Environmental noise 

Under  the  Noise  Directive,  the  Member  States  had  to  send  to  the  Commission  by  30 
December 2010 an update of the list of major roads, major railways and agglomerations. Most 
Member States delivered their reports on time, only Belgium and Italy have not reported yet. 
The reports are currently being assessed by the Commission.  

The infringement case against Malta on the failure to draw up noise maps in accordance with 
Article 7(1) of the Directive has been referred to the Court in 2010.  

NEC Directive 

According  to  the  NEC  Directive,  Member  States  shall  prepare  emission  inventories  and 
emission  projections  for  certain  air  pollutants  and  shall  submit  this  information  to  the 
Commission  and  the  European  Environmental  Agency  annually.  The  report  due  by  31 
December  2010  had  to  include  emission  inventories  for  2008  (final)  and  2009  (provisional) 
and updated emission projections for 2010.  

The analysis of the latest reports shows that a number of Member States are still projected to 
be above the ceilings for 2010. In a few cases the transgression is small and it is likely that the 
ceiling can be met in the course of the next years.  

For eight Member States (Austria, Belgium, France, Germany, Greece, Ireland, Luxemburg, 
Spain)  the  transgression  is  substantial,  ranging  from  10  to  42%  and  these  Member  States 
would have to make significant additional efforts to comply with their ceilings.  

The Commission is considering the most appropriate way to address these shortcomings and 
to ensure proper implementation of the Directive by the deadline of end 2010. 

Petitions  

In 2010 the Commission received 6 petitions related to air quality and environmental noise. 1 
petition was closed during 2010. Many petitions started in previous years required additional 
Communications  by  the  Commission  in  2010.  Very  often  the  petitions  do  not  address  only 
ambient  air  quality  but  raise  problems  linked  to  an  industrial  installation  or  a  planned 
construction  which  from  the  petitioners'  point  of  view  might  also  have  an  impact  on  the 
ambient air quality and/or the noise levels. Member States frequently concerned by petitions 
are Italy, Spain, Romania, Greece, Malta and Bulgaria as regards air quality and Germany as 
regards noise (petitions mainly relating to aircraft noise). The petitions did not lead to the start 
of  infringement  procedures  as  in  most  cases  either  the  Commission  could  not  identify  a 
breach of the relevant EU legislation or an infringement procedure had already been launched.  

8.5.2.  Evaluation based on the current situation  

Ambient air quality 

There remain widespread non-compliance with air quality limit values and particularly those 
for PM10 which is probably the pollutant of most concern given its adverse impacts on health. 
The limits for nitrogen dioxide entered into force in 2010 and it is likely that there will also be 

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widespread non-compliance for this pollutant (the information on exceedances in 2010 will be 
available by the end of September 2011). This is due in part to a lack of preparedness by the 
Member States to undertake the necessary assessments of air quality and to put into place the 
necessary plans and actions to improve air quality in good time. The ongoing "time extension" 
exercise  should  improve  the  capacity  of  the  Member  State  authorities  to  prepare  plans  and 
programmes.  The  Commission  will  also  start  the  work  of  the  review  of  the  air  quality 
Directive which is scheduled for 2013. Implementing measures in the pipeline for adoption on 
light and heavy duty vehicles will also help improve compliance. 

Product regulation 

The  assessment  of  the  implementation  of  Directive  1999/32/EC  highlighted  a  number  of 
problems.  In  particular,  as  regards  the  enforcement  of  the  Directive,  the  reports  on  sulphur 
content  of  fuels  submitted  to  the  Commission  by  Member  States  varied  significantly  in 
structure  and  content,  which  rendered  the  assessment  of  the  level  of  compliance  with  the 
Directive  very  difficult.  Member  States'  reports  also  showed  the  low  frequency  of  fuel 
samples  taken,  which  was  insufficient  for  a  proper  assessment  of  compliance  with  the 
Directive's requirements. Furthermore, following the adoption of the revised IMO's MARPOL 
Annex VI, there exist a discrepancy between the rules contained in the Directive 1999/32/EC 
and  the  IMO  rules,  which  results  in  legal  uncertainty  for  stakeholders.  Similarly,  several 
international  technical  standards  to  which  the  Directive  refers  have  been  amended.  In 
addition, experience shows that the interpretation of certain provisions of the Directive caused 
problems in practice and stakeholders suggested they could be clarified. 

Following  a  review  of  the  Paints  Directive  2004/42/EC  as  foreseen  in  Article  9  of  that 
Directive, the Commission is preparing a report to the Council and the European Parliament 
which should be ready in 2011. 

Environmental noise 

The  problems  identified  in  last  year's  report  still  remain  and  have  been  confirmed  by  an 
extensive evaluation report230 building on Member States responses finalised in 2010.  

8.5.3.  Evaluation results 

8.5.3.1.  Priorities 

Ambient air quality 

In  the  coming  years,  the  Commission  will  continue  to  monitor  closely  the  situation  with 
regard  to  compliance  with  air  quality  limit  values  in  all  Member  States.  It  will  continue  to 
follow its "horizontal approach", which allows air pollution problems to be addressed in a far 
higher number of places than would have been possible if it had only focused on individual 
cities or regions. Furthermore in the upcoming review a SWOT analysis will be done in order 
to analyse what is working and what is not and what could be further done in order to help 
Member States to reach compliance. 

230 

Study report on the "Review of the Implementation of the Environmental Noise Directive 2002/49/EC" 
(see http://ec.europa.eu/environment/noise/home.htm ) 

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Product regulation 

The  priority  is  to  align  the  Directive  1999/32/EC  with  the  revised  MARPOL  Annex  VI  as 
well  as  improve  enforcement  (monitoring  and  reporting)  and  compliance  with  the  Directive 
1999/32/EC.  

Environmental noise 

The  first  priority  is  to  improve  the  consistency  in  the  Member  States'  assessments  of 
environmental  noise  and  the  usefulness  of  the  reported  information.  A  second  priority  is  to 
improve  the  implementation  of  the  Directive  by  the  Member  States  by  providing  greater 
clarity and guidance. 

8.5.3.2.  Planned action (2011 and beyond) 

Ambient air quality 

Infringement  procedures  are  to  be  continued  against  Member  States  in  breach  of  the  limit 
values for PM10 which did not apply for a time extension or did not meet the conditions for 
obtaining such extension. In addition, the Commission will start monitoring more closely the 
implementation  of  the  limit  values  for  NO2  which  entered  into  effect  in  2010.  As  regards 
excessive SO2, the Commission will continue to pursue the legal enforcement action against 
those Member States which are still exceeding the limit values.  

Product regulation 

The amendment of Directive 1999/32/EC is planned for the first half of 2011.  

Environmental noise 

In 2011, the Commission will present a more detailed implementation report on this directive 
which is currently under preparation.  

In  addition,  the  Commission  intends  to  complete  the  work  on  the  harmonised  assessment 
methods which will be presented to the committee procedure later in 2011.  

NEC directive 

As  described  above,  some  Member  States  will  probably  fail  to  meet  the  national  emission 
ceilings  for  2010  for  one  or  several  pollutants  mainly  due  to  insufficient  measures  taken  in 
order to reach compliance. The Commission will continue to closely monitor the situation and 
take  action  as  appropriate.  The  possibility  of  launching  infringement  cases  cannot  be 
excluded. 

In 2011 the Commission will also focus on assessing the quality of national transposition of 
the NEC Directive in all the Member States. The Commission will take appropriate measures 
to  follow  up  with  the  Member  States  any  potential  deficiencies  identified  in  the  national 
transposition during this conformity-checking exercise.  

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8.5.4.  Sector summary 

In 2005 a set of legally binding EU air quality limit values became applicable, including limit 
values for particulate matter PM10, pollutant with very important adverse impacts on health. A 
widespread  non-compliance  with  PM10  limit  values  remains,  partly  due  to  challenging  and 
complex  nature  of  this  pollutant  and  the  lower  and  delayed  impact  of  certain  community 
measures. But the main reasons are serious delays in the implementation of the directives in a 
large number of Member States, mainly as regards the drawing up and implementation of the 
necessary  plans  to  ensure  that  air  quality  is  improved  in  good  time.  The  capacity  and 
awareness of the Member State authorities of the need to tackle air pollution at the source and 
to prepare plans and programmes should be increased through the procedure and conditions 
laid down in the new Directive 2008/50/EC on ambient air quality and cleaner air for Europe 
for extending the time required for achieving compliance with the limit values for PM10, NO2 
and benzene, joined with coherent and timely enforcement where appropriate.  

In the coming years, the Commission will continue to monitor closely the air quality situation 
in order to ensure long term and sustainable compliance with the limit values in all Member 
States.  In  particular,  it  will  be  a  priority  task  to  assess  further  time  extension  notifications 
(primarily  for  NO2)  or  re-notifications  (for  PM10)  as  well  as  to  follow-up  on  the  decisions 
adopted  by  the  Commission.  A  further  priority  will  be  to  ensure  a  timely  and  effective 
implementation  of  Directive  2008/50/EC.  Dissemination  of  information  to  the  public  and 
cooperation between the Member States and the Commission in order to develop appropriate 
policies should continue. 

As  regards  the  air  emissions  of  sulphur  dioxide  by  ships,  the  focus  will  be  on  the 
improvement of enforcement of the limits on sulphur content of marine fuels, in particular by 
providing Member States with guidance on monitoring and reporting and on the alignment of 
the EU rules to the relevant international rules (MARPOL Annex VI).  

8.6. 

Industrial installations 

8.6.1.  Current position 

8.6.1.1.  General introduction 

The most important piece of legislation relating to industrial emissions is Directive 2008/1/EC 
(IPPC Directive, codified version of Directive 96/61/EC)231. This Directive sets out common 
permit rules for industrial installations in order to prevent and control emissions into air, water 
or soil. Installations covered by the IPPC Directive are required to operate under an integrated 
permit  granted  by  the  competent  authorities  of  the  Member  States.  The  provisions  of  the 
directive were due to enter into effect either in October 1999 (for new installations) or before 
30 October 2007 (for existing installations). 

The Large Combustion Plants (or LCP) Directive, 2001/80/EC232, aims to reduce emissions of 
sulphur dioxide, nitrogen oxides and dust from combustion plants whose rated thermal input 

231 

232 

Directive  2008/1/EC  of  the  European  Parliament  and  of  the  Council  of  15  January  2008  concerning 
integrated pollution prevention and control (OJ L 24, 29.1.2008, p. 8). 
Directive  2001/80/EC  of  the  European  Parliament  and  of  the  Council  of  23  October  2001  on  the 
limitation of emissions of certain pollutants from large combustion plants (OJ L 309, 27.11.2001, p. 1) 

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is  equal  to  or  greater  than  50  MW.  The  control  of  emissions  from  such  plants  contributes 
significantly to the Union's efforts to protect the health of EU citizens and the environment by 
combating acidification, eutrophication and ground-level ozone as part of the overall strategy 
to reduce air pollution (see also NEC Directive).  

Further  important  legislation  relating  to  industrial  emissions  (other  than  greenhouse  gases) 
includes the Waste Incineration (WI) Directive, 2000/76/EC233, the VOC Solvent Emissions 
(SE) Directive, 1999/13/EC234 and the E-PRTR Regulation (EC) No 166/2006235.  

The Seveso II or Major Accident Hazards Directive, 96/82/EC236, applies to establishments in 
which  certain  dangerous  substances  are  present  in  sufficiently  large  quantities  to  create  a 
major accident hazard. It contains obligations on both operators and Member State authorities 
to take measures aimed at preventing major accidents and limiting their consequences. 

8.6.1.2.  Report of work done in 2010 

Revision of the existing legal framework 

The Directive on Industrial Emissions (IED), which is a recast of seven directives (including 
the IPPC, LCP, WI and SE Directives) was adopted on 17 December 2010 and entered into 
force on 6 January 2011. Member States need to transpose the directive to national legislation 
by 6 January 2013.  

Work  on  a  review  of  the  Seveso  II  Directive  resulted  in  a  Commission  legislative  proposal 
being adopted on 21 December 2010. Discussions on the proposal are currently ongoing.  

Compliance promotion and legal enforcement work 

In  the  course  of  2010  the  Commission  continued  to  carry  out  implementation  work 
concerning the IPPC Directive in line with the actions specified in its action plan which forms 
part  of  the  2007  Commission  Communication  "Towards  an  improved  policy  on  industrial 
emissions"237  

Transposition of the IPPC Directive 

In 2010 out of the ongoing two non-conformity infringement procedures regarding the non-
conform transposition of the IPPC Directive, the one against Lithuania was closed due to the 
adoption  of  legislative  amendments  addressing  the  shortcomings.  One  case  against  Estonia 
remains open, as the Commission awaits the confirmation from the Estonian authorities that 
the necessary legislative changes are carried out. 

233 

234 

235 

236 

237 

Directive  2000/76/EC  of  the  European  Parliament  and  of  the  Council  of  4  December  2000  on  the 
incineration of waste (OJ L 332, 28.12.2000, p. 91). 
Council  Directive  1999/13/EC  of  11  March  1999  on  the  limitation  of  emissions  of  volatile  organic 
compounds due to the use of organic solvents in certain activities and installations (OJ L 85, 29.3.1999, 
p. 1). 
Regulation  (EC)  No  166/2006  of  the  European  Parliament  and  of  the  Council  of  18  January  2006 
concerning  the  establishment  of  a  European  Pollutant  Release  and  Transfer  Register  and  amending 
Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1). 
Council  Directive  96/82/EC on  the  control of  major-accident  hazards  involving dangerous  substances 
OJ L 10, 14.1.1997, p. 13–33. 
COM(2007) 843 final. 

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Transposition of the LCP and WI Directives 

The Commission decided to channel the ongoing work regarding the transposition of the LCP 
and WI Directives in the transposition exercise of the Industrial Emissions Directive. 

IPPC permits for existing installations under Article 5(1) of the Directive  

By  30  October  2007,  all  existing  IPPC  installations  had  to  obtain  a  permit  issued  in 
accordance  with  the  requirements  of  the  Directive.  After  the  expiry  of  this  deadline,  the 
Commission  launched  eleven  infringement  procedures  in  2008  against  Belgium,  Bulgaria, 
Denmark, Estonia, Greece, Spain, Ireland, Italy, The Netherlands, Portugal and Slovenia and 
in  2009  against  Austria,  France,  Malta  and  Sweden.  Out  of  these  Member  States,  Belgium, 
Greece, Spain, Italy, Slovenia and Sweden have been referred to the Court of Justice of the 
European Union.  

Implementation of the IPPC and WI Directives  

Three-yearly implementation reports were to be sent by Member States to the Commission by 
30  September  2009  (covering  the  period  2006-2008).  The  Commission  has  initiated  an 
infringement procedure against Greece and Luxembourg who have not fulfilled this reporting 
obligation  even  after  several  reminders.  As  a  result  of  these  procedures,  all  reports  are 
received and the Commission has set up a study for the assessment of the reports with the aim 
of publishing it in the course of 2011. 

Implementation of the LCP Directive  

For  implementing  the  LCP  Directive  provisions  for  certain  existing  plants,  eight  Member 
States  have  chosen  to  apply  a  national  emission  reduction  plan  (NERP)  instead  of  setting 
individual  emission  limit  values:  the  Czech  Republic,  Greece,  Finland,  France,  Ireland, 
Portugal, Spain and the United Kingdom. 

The Commission has checked the compliance of these MS with the NERP ceilings but further 
communications with MS were necessary in order to validate the assessment. For those MS 
where breaches have been found, infringement procedures will be launched in the course of 
2011. 

The  Accession  Treaties  of  four  Member  States  (Lithuania,  Romania,  Bulgaria  and  Poland) 
include  transitional  derogations  for  some  provisions  of  the  LCP  Directive,  which  are 
conditional to meeting emission ceilings for all of the large combustion plants in the MS in 
certain specified years. The Commission has assessed  the 2008 and 2009  LCP emissions in 
these  MS  against  the  Accession  Treaty  ceilings  and  has  identified  potential  breaches  for 
Bulgaria.  Further  communication  with  Bulgaria  will  be  carried  out  in  2011  to  evaluate  the 
situation in view of possible infringement procedures. 

Implementation of the VOC Solvents Directive  

A summary report of the information submitted by Member States on their implementation of 
the  SE  Directive  during  the  period  2005-2007  will  be  finalised  in  the  course  of  2011  in 
conjunction with the implementation report on the IPPC Directive 2008/1/EC. 

Implementation of the E-PRTR Regulation  

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On 9 November 2009, the Commission and the European Environment Agency launched the 
new  European  pollutant  release  and  transfer  register  (E-PRTR).  The  register  contains 
information  about  the  quantity  and  location  of  pollutants  released  to  air,  water  and  land  by 
industrial  facilities  throughout  Europe.  It  includes  annual  data  for  91  substances  and  covers 
more than 24 000 facilities in 65 economic activities. It also provides additional information, 
such as the amount and types of waste transferred from facilities to waste handlers both inside 
and outside each country.  

The  Commission  has  been  working  on  a  questionnaire  for  the  three-yearly  implementation 
reports to be sent by Member States to the Commission, together with the information to be 
reported to the E-PRTR pursuant Article 7 of the Regulation by 31 March 2011.  

Transposition of the Seveso II Directive 

In  2010  the  Commission  pursued  infringement  procedures  against  a  number  of  EU-12 
Member  States  for  non-conform  transposition  of  Directive  96/82/EC  and  the  amending 
Directive  2003/105/EC  (the  Seveso  II  Directive).  During  the  course  of  the  year  several  of 
those  cases  were  closed.  At  the  end  of  2010,  cases  remained  open  against  Poland  and 
Lithuania. The Commission also closed several cases against EU-15 Member States. By the 
end  of  2010,  one  case  (Luxembourg)  relating  to  non-conform  transposition  of  amending 
Directive 2003/105/EC remained outstanding. 

External Emergency Plans under the Seveso II Directive 

The Commission also continued legal action before the Court against several Member States 
where  external  emergency  plans  for  so-called  upper-tier  establishments  were  lacking  in 
breach of the Seveso II Directive. During 2010 the Court issued a ruling against Spain (see 
below). Cases against Austria and Belgium were closed since the Member States concerned 
had taken steps to ensure that the necessary plans were in place. By the end of the year, two 
cases remained outstanding (failure of Portugal and Spain to comply with Court rulings). 

Petitions 

So  far,  the  Commission  received  4  new  petitions  related  to  industrial  emissions  with  a 
reference year of 2010. These petitions raised issues concerning France, Germany, Greece and 
Italy. In addition, the Commission has been dealing with those petitions which were received 
in  earlier  years,  but  follow-up  with  the  national  authorities  has  proved  necessary  to  enable 
sending  updated  information  to  the  Parliament.  Particular  attention  has  been  paid  on  cases 
where potential serious or persistent breach of EU law could have been identified. 

Judgements of the Court of Justice of the European Union in 2010 

In a judgement of 22 April 2010 (Case C-346/08), the Court found that by failing to apply the 
Large Combustion Plants Directive to the power plant operated by Rio Tinto Alcan Smelting 
and  Power  (UK)  Ltd  in  Lynemouth,  the  United  Kingdom  had  failed  to  fulfil  its  obligations 
under that directive. 

In  several  judgements  (Cases  C-258/09,  C-49/10,  C-48/10,  C-534/09,  issued  on  4  March 
2010,  7  October  2010,  18  November  2010  and  2  December  2010  respectively),  the  Court 
found  that  by  not  issuing  permits  to  all  existing  installations  by  the  deadline  of  30  October 
2007,  Belgium,  Slovenia,  Spain  and  Greece  failed  to  fulfil  their  obligations  under  that 

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directive. A number of Member States are being referred to the Court for the issue in the case 
of which the judgment is still pending. 

The Court also declared that Spain (Case C-392/08) was in breach of its obligations in relation 
to the drawing up of  external emergency plans pursuant to Article 11.1 (c)  of the Seveso II 
Directive (judgement of 25 March 2010). 

8.6.2.  Evaluation based on the current situation 

IPPC Directive 

The IPPC Directive still falls short of being fully applied and respected. The main problems 
relate to the important delays in issuing the IPPC permits, shortcomings in the implementation 
(in particular BAT), a need for increased clarity in the legislation, restrictions in its scope and 
insufficient enforcement of its application. While the new Directive on Industrial Emissions 
addresses the majority of these shortcomings, significant progress has already been achieved 
in  terms  of  permitting,  due  to  increased  support  to  Member  States,  and  due  to  the 
infringement  procedures  and  the  resulting  judgements  of  the  Court  where  necessary.  The 
Commission  is  continuing  its  in-depth  assessment  of  the  implementation  by  Member  States 
through  the  investigation  of  the  permits  and  operational  conditions  of  some  specific 
installations.  To  this  end,  a  new  study  was  launched  in  2010,  which  will  also  consider  the 
implementation of some of the sectoral Directives (see below).  

LCP Directive 

The Commission has assessed the quality of national transposition of the LCP Directive in all 
the  Member  States.  The  results  of  this  assessment  have  been  communicated  to  the  Member 
States  with  a  request  for  further  information  and  clarification  on  a  number  of  transposition 
issues. As a result of this exercise, several MS have made commitments in terms of adopting 
new  legislation  to  ensure  full  compliance  with  the  Directive's  provisions.  The  Commission 
will continue to monitor transposition of the relevant provisions within the framework of the 
transposition exercise of the Industrial Emissions Directive.  

As  set  out  under  point  1.1.1.2,  the  Commission  has  identified  issues  concerning  the 
application  of  the  Directive  in  a  number  of  Member  States,  in  particular  concerning 
compliance of the emissions with the ceilings defined under the NERP and with the ceilings 
under  the  Accession  Treaty.  In  case  of  confirmation  of  the  identified  breaches,  the 
Commission will launch infringement procedures in the course of 2011. 

In  addition,  the  correct  application  of  the  Directive  at  individual  installations  will  be 
considered in the framework of the study mentioned in the context of the IPPC Directive. 

Waste Incineration Directive and VOC Solvents Directive 

The correct application of these Directives at individual installations will be considered in the 
framework of the study mentioned in the context of the IPPC Directive. 

Seveso II Directive 

Overall,  the  Directive  is  being  satisfactorily  applied  and  complied  with.  The  level  of 
transposition and implementation of the Directive has continued to improve, and the number 

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of  outstanding  legal  proceedings  has  continued  to  fall. As  noted  above,  a  review  of  the 
Directive  has  recently  been  completed.  This  confirmed  that  overall  the  Directive  is  fit  for 
purpose  and  that  no  major  changes  are  required.  The  Commission  proposal  for  a  new 
Directive represents essentially a technical adaptation of the existing rules. The main change 
proposed  is  the  adaptation  of  Annex  1  to  the  Directive,  which  defines  its  scope,  to  new 
international  and  Union  rules  on  the  classification  of  dangerous  substances.  Certain  other 
amendments are proposed to update or clarify existing provisions to improve implementation 
and the existing high levels of protection. 

8.6.3.  Evaluation results 

8.6.3.1.  Priorities 

Industrial emissions 

Continued attention needs to be paid to improved respect for the existing provisions and to a 
strong follow-up on their full implementation.  

Priority is therefore attached to: 

•  Providing assistance to Member States and ensuring full transposition of the relevant 
Community legislation regarding the recently adopted Industrial Emissions Directive; 
• 
Increased assistance to Member States on implementation; 
•  Ensuring that Member States fulfil their reporting obligations; 
•  A  more  systematic  approach  concerning  the  breaches  of  the  IPPC  Directive  and 

launching of infringement procedures; 

•  Annual reporting on progress in implementation of the Action Plan and its revision as 
part of the next Commission's report on IPPC implementation (in the course of 2011) 
(see further information below); 

•  Development of transposition checklist and interpretative guidance documents on the 
new  IED  to  provide  early  support  to  Member  States  in  transposition  and 
implementation 

On  the  basis  of  these  priorities  and  the  work  programming  set  out  below,  it  is  hoped  to 
improve substantially compliance with the existing provisions at the latest by 2012, by which 
time the focus of attention will move to the implementation of the new legislative framework. 

Seveso II Directive 

Regarding the Seveso II Directive, the main priority at present is to conclude the discussions 
on the legislative proposal as quickly as possible so that the new Directive can be adopted and 
transposed  by  Member  States  in  good  time  to  provide  the  necessary  legal  certainty  before 
2015, when the new Union rules on classification of dangerous substances become definitive. 
However  importance  also  continues  to  be  attached  to  ensuring  the  full  transposition  and 
implementation of the existing Directive. 

8.6.3.2.  Planned action (2011 and beyond) 

The  Commission  will  continue  to  prioritise  work  on  its  current  collective  infringement 
proceedings, covering a large number of deficiencies in several Member States. Infringement 
proceedings could also be opened against those Member States showing a significant delay in 

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fulfilling their reporting obligations. 

The Commission will strengthen its monitoring and supporting mechanisms by revising and 
refocusing the previous IPPC Action Plan on Implementation for the time period 2008-2010 
as set out below.  

•  Ensure full transposition of the legislation on industrial emissions 

The success of the existing legislation relies first of all on effective transposition by 
Member  States  in  their  national  legal  systems.  In  the  course  of  2011,  the 
Commission will focus on providing assistance to Member States in order to ensure 
timely  and  full  transposition  of  the  Industrial  Emissions  Directive.  Infringement 
proceedings  to  ensure  full  and  correct  transposition  of  the  industrial  emissions 
legislation will be considered only necessary if Member States fail to fully transpose 
the IED into national law (deadline for that exercise: 6 January 2013). 

•  Support Member States in their implementation of the legislation 

This  will  include  enhanced  information  exchange,  the  development  of  guidance, 
visits  to  authorities  and  training.  This  support  will  continue  throughout  the 
introduction and implementation of the revised legislation. 

•  Enhanced monitoring and compliance checks  

The  Commission  will  continue  to  monitor  the  number  of  IPPC  permits  issued  and 
updated and, where required, investigate the system of monitoring and inspection at 
IPPC installations. Such investigation will cover specific industrial installations and 
sectors, the use of general binding rules, and the analysis of complaints. 

•  Improve data collection for the review of BREFs and BAT conclusions and create 

stronger links with the Research Framework Programme 

The  Commission  will  continue  to  organise  the  exchange  of  information  between 
experts from Member States, industry and environmental organisations resulting in 
the BAT Reference Documents (BREFs) and BAT conclusions. 

Seveso II Directive 

The Commission will continue to monitor implementation of the Seveso II Directive and take 
action  as  appropriate.  Ongoing  work  in  relation  to  the  proposed  new  Directive  will  also 
continue in 2011 as necessary. 

8.6.4.  Sector summary 

Both  the  transposition  and  the  implementation  of  the  legislation  related  to  industrial 
installations  and  air  emissions  (in  particular  the  IE,  IPPC  and  the  LCP  Directives)  pose 
difficulties for Member States. The Commission, while supporting Member States in different 
ways  (transposition  assistance,  interpretational  guidance,  studies,  workshops),  carries  out 
enforcement actions to ensure full compliance.  

The capacity and awareness of competent authorities of the need to tackle pollution should be 
increased throughout the EU. 

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In the coming years, the Commission will continue to monitor closely the implementation of 
the  existing  legislation,  giving  priority  to  the  transposition  and  preparation  of  the 
implementation of the incoming Directive on Industrial Emissions. 

8.7. 

Chemicals and Biocides  

8.7.1.  Current position 

8.7.1.1.  General introduction 

Chemicals 

The  REACH  Regulation  (1907/2006)238,  which  entered  into  force  on  1  June  2007,  is  the 
cornerstone of the EU’s new chemicals legislation. REACH, which is more far-reaching than 
previous  legislation,  deals  with  the  registration,  evaluation,  authorisation  and  restriction  of 
chemicals. Registration means the process by which information on the safety of chemicals is 
submitted  for  registration  to  a  central  database,  managed  by  ECHA.  Evaluation  includes  a 
quality check of the registration dossiers and an examination of testing proposals and this is 
also  carried  out  by  ECHA;  it  also  includes  a  more  thorough  examination  of  specific 
substances,  where  Member  States  play  an  important  role.  Substances  of  very  high  concern 
will  require  authorisation  for  use  and  before  being  placed  on  the  market.  There  is  also  a 
procedure for restriction of manufacturing, placing on the market or use of certain substances 
where there is an unacceptable risk to health or the environment, which needs to be addressed 
on a community wide basis. 

Regulation  (EC)  No  (1272/2008)239  on  the  Classification,  Labelling  and  Packaging  of 
Substances and Mixtures was adopted in 2008 and incorporates the UN GHS (United Nations 
Globally  Harmonised  System)  into  Community  law  and  will  replace,  after  a  transitional 
period, certain provisions of the current directives related to the classification, packaging and 
labelling  of  dangerous  substances  (Directive  67/548/EEC240)  and  preparations  (Directive 
1999/45/EC241).  Provisions  of  these  Directives  shall  be  repealed  with  effect  from  1  June 
2015. 

Two  other  pieces  of  legislation  should  be  mentioned  here.  Firstly,  persistent  organic 
pollutants  (“POPs“)  are  governed  by  Regulation  (EC)  No  850/2004242.  This  legislation 
implements the commitments to which the Community has signed up to under the 1998 UN-
ECE  Protocol  on  POPs  and  the  UNEP  Stockholm  Convention  on  POPs.  The  Regulation 
contains  requirements  to  eliminate  and/or  restrict  POPs  substances  to  a  level  equal  to  or 
stricter  than  foreseen  under  international  agreements.  The  obligations  from  the  two 

238 

239 
240 
241 
242 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No.  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC. 
OJ L 353, 31.12.2008, p. 1 
OJ L 196, 16.08.1967, p. 1. 
OJ L 200, 30.07.1999, p. 1. 
OJ L 158, 30.4.2004, p. 7. 

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international agreements have thus been completely transported into Community Law and are, 
as such, enforceable according to these rules. 

Secondly,  basic  provisions  concerning  the  protection  of  laboratory  animals  used  in 
experiments  are  contained  in  the  newly  adopted  Directive  2010/63/EU,  which  updates  the 
1986 Directive 86/609/EEC on the protection of animals used for scientific purposes. The aim 
of the new Directive is to strengthen legislation, and improve the welfare of those animals still 
needed  to  be  used,  as  well  as  to  firmly  anchor  the  principle  of  the  'Three  Rs'  -  to  Replace, 
Reduce and Refine the use of animals in EU legislation. The new Directive entered into force 
on  10  November  2010.  The  transposition  of  the  Directive  into  national  legislation  is  to  be 
completed by 10 November 2012 and the Directive will take full effect on 1 January 2013. 

Export and import of dangerous chemicals  

Regulation  (EC)  689/2008  of  the  European  Parliament  and  the  Council  of  17  June  2008 
concerning  the  export  and  import  of  dangerous  chemicals  implements  the  Rotterdam 
Convention on the Prior Informed Consent Procedure (PIC) for certain hazardous chemicals 
and pesticides in international trade. It establishes special rules for trade with third countries 
of  certain  chemicals  with  a  view  to  protecting  human  health  and  the  environment  from 
potential  harm  and contributing  to the  environmentally sound use of  such chemicals. By 10 
February  2011  around  150  substances  (pesticides  and  industrial  chemicals)  were  listed  in 
Annex  I  to  the  Regulation,  including  40  substances  that  are  subject  to  the  PIC  procedure 
under the Convention. 

 Biocides  

Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council  regarding    the  placing  of 
biocidal  products  on  the  market243  (the  Biocides  Directive)  concerns  the  authorisation  and 
placing  on  the  market  of  biocidal  products  in  Member  States,  the  mutual  recognition  of 
authorisations  within  the  Union  and  the  establishment  at  Union  level  of  a  list  of  active 
substances which may be used in biocidal products.  

As of 1 February 2011, 40 active substances were listed in Annex I and 1 active substance in 
Annex IA. In accordance with Article 16(1) of the Directive, Member States are allowed to 
apply national rules and practices during the implementation of the review programme. The 
first three product authorisations and 31 mutual recognitions were granted in accordance with 
the Biocides Directive in 2009 and 2010. 

8.7.1.2.  Report of work done in 2010 

This  sector  of  EU  environmental  law  is  characterised  by  substantial  new  developments; 
however, legal  enforcement action in these  fields does not constitute a significant workload 
for the Commission. 

 Chemicals 

REACH entered into force on 1 June 2007. This included the establishment of the European 
Chemicals  Agency  (ECHA)  and  the  preparation  of  IT-systems  to  hold  the  new  database. 

243  

OJ L 123, 24.4.1998, p. 1. 

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Registration of chemicals manufactured or imported in quantities of 1 tonne or more per year 
started  on  1  June  2008.  Between  1  June  and  1  December  2008  manufacturers  had  the 
possibility  to  pre-register  their  phase-in  substances.  Pre-registration,  as  its  name  suggests, 
precedes full registration and provides for extended deadlines. Depending on the volumes and 
the hazardous properties of substances, these extended deadlines are 2010, 2013 or 2018. In 
2008, ECHA received approximately 2.7 million pre-registration dossiers. If a company failed 
to  pre-register  by  1  December  2008  it  can  no  longer  place  its  phase-in  substances  on  the 
market until it has completed registration. The first registration deadline, 30 November 2010, 
marked an important milestone for the new EU chemicals policy. This deadline applied to the 
most  hazardous  substances  (e.g.  those  that  are  carcinogenic,  mutagenic  or  toxic  for 
reproduction)  manufactured  or  imported  in  quantities  of  1  tonne  or  more  per  year  per 
company,  substances  very  toxic  to  the  aquatic  environment  manufactured  or  imported  in 
quantities  of  100  tonnes  or  more  per  year  per  company  and  substances  manufactured  or 
imported above 1000 tonnes per year. 

24675 registration files for 4300 substances including nearly 3400 phase-in substances were 
submitted to ECHA by the November 2010 deadline. ECHA is proceeding with the checking 
of the files to ensure that all requirements have been met.  

Six court cases were brought up before the ECJ in 2010, all of them by individual companies 
against  ECHA  and  all  of  them  seeking  the  annulment  of  the  decision  to  include  certain 
substances in the candidate list. Some of the cases might be joined by the Court due to their 
similarities and the admissibility of some of the applications have been questioned by ECHA 
and the Commission. The Commission is intervening in five of these cases.  

Within  the  process  of  authorisation,  the  Commission  has  adopted  a  decision  to  add  6 
chemicals to the list of substances subject to authorisation from the so called Candidate List. 
Companies  that  want  to  continue  using  these  six  chemicals  have  to  submit  requests  for 
authorisation.  

The  Candidate  List  currently  consists  of  46  Substances  of  Very  High  Concern  (SVHC). 
Inclusion of substances in the Candidate List triggers several legal obligations, for example, 
producers or importers of articles have to notify ECHA if their article contains a substance on 
the Candidate List;  Suppliers  of articles  containing  these substances must provide sufficient 
information  to  allow  safe  use  by  their  customers  or,  upon  request,  to  consumers.  Similarly, 
suppliers of substances have to provide their customers with a safety data sheet. 

Member States have notified the Commission of national provisions for penalties applicable 
for REACH infringements. A Commission study finalised in 2009, on the setting of penalties 
for the infringement of REACH provisions in national laws identified a number of differences 
between Member States´ approach to adopting penalties which are effective, proportionate and 
dissuasive.  The  Commission  has,  therefore,  organised  a  workshop  for  Member  States  on 
penalties in order to discuss its findings. The results of the study, Member State's reports on the 
operation of REACH as well as work of the Forum for Exchange of Information on enforcement 
will provide the Commission with a broader picture as to the effectiveness of enforcement of the 
REACH Regulation across Member States and allow it to assess possible further steps. 

The Forum for Exchange of Information on Enforcement, composed of members nominated 
by Member States, was set up within ECHA. The Forum coordinates a network of Member 
State  authorities  responsible  for  the  enforcement  of  the  Regulation.  Its  main  tasks  include: 

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joint 
proposing,  coordinating  and  evaluating  harmonised  enforcement  projects  and 
inspections;  identifying  enforcement  strategies,  best  practice  in  enforcement  and  examining 
proposals for restrictions with a view to advising on enforceability. 

In 2009, the ECHA Forum developed inspection guidelines, in the form of minimum criteria 
to be applied as a common basis for the performance of REACH inspection activities within 
the MS. However, their provisions remain general and therefore it is useful to assess whether 
more  specific  and  binding  inspection  criteria  should  be  introduced  in  the  REACH  and  CLP 
Regulation.  At  the  end  of  2010,  the  Commission  launched  a  study  which  aims  to  assess 
whether and how the current enforcement requirements of REACH and CLP Regulations can 
potentially be reinforced. 

Member  States  were  obliged  to  notify  the  Commission  of  national  provisions  for  penalties 
applicable for CLP infringements by 20 June 2010. A number of Member States did not fulfil 
this obligation and the Commission has reminded Member States of this obligation during the 
Competent Authorities meetings of REACH and CLP. The Commission is currently considering 
launching infringement procedures against those Member Sates who have still not complied. 

In  2010,  the  Commission  started  the  review  of  the  scope  of  REACH  mandated  by  Article 
138(6), which calls on the Commission to assess by 1 June 2012 whether or not to amend the 
scope of REACH to avoid overlaps with other relevant provisions of EU law. On the basis of 
such  a  review,  the  Commission  may  if  appropriate,  present  a  legislative  proposal.  The 
Commission  is  being  assisted  by  a  contractor  in  the  development  of  this  work  and  has 
involved all its relevant services in the assessment of EU legislation. As part of the project, 
stakeholders  were  called  to  share  any  relevant  experiences  they  may  have  gathered  when 
facing 
through  a  dedicated  website 
www.reachscope.eu, which was operational from 10 March until 1 December 2010. 

implementing  REACH 

the  challenges  of 

One of the aims of the CLP regulation is to improve the protection of human health and the 
environment  by  providing  criteria  for  defining  when  a  substance  or  mixture  displays 
properties  that  lead  to  its  classification  as  hazardous.  The  CLP  regulation  applies  to 
manufacturers, importers, users or distributors of chemical substances or mixtures. They must 
classify,  label  and  package  any  substance  or  mixture,  regardless  of  its  annual  tonnage,  in 
accordance  with  the  Regulation.  By  3  January  2011,  industry  had  to  notify  ECHA  of  the 
classification  and  labelling  of  all  chemical  substances  that  are  hazardous  or  subject  to 
registration under the REACH regulation and placed on the EU market. ECHA received 3 114 
835 notifications of 107,067 substances.  

With regard to the CLP Regulation, two court cases challenged the classification of nickel and 
borates compounds listed in the 30th and 31st ATP of Directive 67/548/EEC and in the 1st ATP 
of CLP. The hearing took place on 20 January 2011.  

In  2010  twenty  non-communication  cases  were  registered  concerning  the  transposition  of 
Directive  2008/112/EC244  amending  a  number  of  Directives  in  order  to  adapt  them  to 
Regulation (EC) No 1272/2008  on classification, labelling and packaging of substances and 
mixtures. More than a half of them were closed during 2010.  

244 

OJ L 345, 23.12.2008, p. 68. 

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In 2010 amendments were made to Regulation EC No 850/2004 to implement within the EU, 
restrictions on the 9 substances, which were included within the framework of the Stockholm 
Convention on POPS in 2009.   

The  Commission  published  the  first  report  245on  the  application  of  Regulation  (EC)  No 
850/2004 on persistent organic pollutants in accordance with Article 12(6) of the Regulation. 
Despite several reminders some Member States had not fulfilled the reporting obligations. In 
the report, the Commission concluded that "Compliance with the reporting obligation is not 
satisfactory.  A  significant  number  of  Member  States  have  not  respected  their  reporting 
obligations. The quality of information provided must improve". 

In  2010,  the  Commission  finalised  a  study  on  mixture  toxicity  and  adopted  its  final  report 
which  aimed  to  provide  a  ‘state  of  the  art’  overview  of  the  science  and  methodologies  for 
assessing  the  hazardous  effects  arising  from  exposures  to  multiple  chemicals  from  different 
sources and pathways. The final report has been made publicly available on the Environment 
website and was open for consultations to the interested parties. The Commission organised a 
workshop and consultations with Member States on the subject. This work coincided with an 
initiative  taken  in  the  Council  in  December 2009  requesting  the  Commission  to  assess  how 
such effects arising from multiple exposures are covered in current legislation. 

Export and import of dangerous chemicals  

Two amendments of Regulation (EC) 689/2008 of the European Parliament and the Council 
of  17  June  2008  concerning  the  export  and  import  of  dangerous  chemicals  were  favourably 
received  by  the  regulatory  committee  in  which  the  Member  States  are  represented  and  are 
expected to be formally adopted and published in spring 2011. The amendments add further 
chemicals  to  the  list  of  chemicals  subject  to  certain  requirements  for  their  export  (Annex  I) 
and  also  to  the  list  of  chemicals  that  are  banned  for  export  (Annex  V).  The  Commission 
drafted  a  guidance  document  on  implementation  of  the  Regulation,  which  was  endorsed  by 
the Member States and will be published in February.  

 Biocides  

During  2008  the  Commission  followed  the  transposition  of  the  Commission  Directives 
amending Directive 98/8/EC concerning the placing of biocidal products on the market. The 
Commission has closed all of the open infringement cases. 

In  2010  four  non-communication  cases  were  registered  concerning  Commission  Directives 
2009/85/EC246,  2009/86/EC247,  2009/87/EC248,  2009/92/EC249,  2009/93/EC250 
and 
2009/99/EC251,  which  all  concern  the  inclusion  of  active  substances  in  Annex  I  to 
Directive 98/8/EC.  Furthermore,  three  non-communication  cases  were  registered  concerning 
Commission Directive 2009/94/EC252 amending Directive 98/8/EC to include boric acid as an 

245 
246 
247 
248 
249 
250 
251 
252 

COM(2010)514. 
OJ L 198, 30.7.2009, p. 28. 
OJ L 239, 6.9.2008, p. 9. 
OJ L 198, 30.7.2009, p. 35. 
OJ L 201, 1.8.2009, p. 43. 
OJ L 201, 1.8.2009, p. 46. 
OJ L 203, 5.8.2009, p. 62. 
OJ L 201, 1.8.2009, p. 50. 

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active  substance  in  Annex  I  thereto.  Furthermore,  two  non-communication  cases  were 
registered  concerning  each  of  Commission  Directives  2009/94/EC253,  2009/95/EC254  and 
2009/98/EC255. All of the cases were closed during 2010. 

The  Commission  adopted  Decision  2009/244/EC  concerning  the  placing  on  the  market  of  a 
carnation (Dianthus caryophyllus L., line 123.8.12) genetically modified for flower colour, for 
the purpose of import, retailing and ornamental uses (not for cultivation or food/feed uses). 

On  biocides,  as  set  out  in  the  implementation  report  following  Article  18  of  the  Directive 
published  in  2008,  the  current  progress  rate  of  the  review  programme  will  not  permit  its 
completion by 14 May 2010 as planned. This is due mainly to the fact that, before any review 
could start (the second phase), it was necessary to establish an inventory of active substances 
used in biocidal products placed on the European market of biocidal products. In light of these 
findings,  the  Commission  adopted  Directive  2009/107/EC  extending  the  deadline  for 
completion of the review programme until 14 May 2014256. 

The Commission presented its proposal for a revision of the Biocides Directive in 2009. The 
proposal  will  take  the  form  of  a  Biocides  Regulation  repealing  and  replacing  the  Biocides 
Directive. The main changes proposed by the Commission included an extension of the scope 
to articles treated with biocidal products, a possibility to have certain categories of products 
authorised at Union level, measures aimed at strengthening the mutual recognition, obligatory 
rules  on  data  sharing  of  tests  involving  vertebrate  animals  and  a  partially  harmonised  fee 
structure.  The  European  Parliament  voted  on  the  proposal  in  the  first  reading  in  September 
2010. The Council reached a political agreement on the file in December 2010. The second 
reading  will  start  in  the  second  half  of  2011.  The  proposed  Regulation  is  expected  to  be 
applicable as of 2013. 

Petitions  

During 2010, there was one petition handled on strychnine hydrochloride. 

8.7.2.  Evaluation based on the current situation 

 Chemicals 

The  REACH  Regulation  entered  into  force  on  1  June  2007.  Its  main  obligations  started 
applying  on  1  June  2008.  The  first  registration  deadline  was  an  important  milestone.  From 
now on the work of national enforcement authorities and Member States joined enforcement 
projects  will  become  even  more  important.    In  order  to  ensure  compliance,  Member  States 
should put in place effective monitoring and control measures. The Commission is concerned 
that  Member  States  may  not  be  able  to  make  sufficient  resources  available  to  ensure 
compliance by economic operators.  

Every five years Member States must submit a report to the Commission on the operation of 
the  Regulation  in  their  respective  territories,  including  sections  on  evaluation  and 

253 
254 
255 
256  

OJ L 201, 1.8.2009, p. 50. 
OJ L 201, 1.8.2009, p. 54. 
OJ L 203, 5.8.2009, p. 58. 
Directive 2009/107/EC of 16 September 2009 amending Directive 98/8/EC, OJ L262, 6.10.2009, p40 

EN 

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enforcement. The first reports were besubmitted in  June 2010. The Commission is currently 
assessing the Member States reports and has in addition launched a contract for the in depth 
analysis of MS reporting. The results of the Member States reports, together with results from 
the ECHA reporting on the operation of REACH, on the joint submission of information, on 
the  status  of  implementation  and  use  of  non-animal  test  methods,  the  results  of  several 
Commission studies related to enforcement of REACH  and  CLP  as  well  as  the  work  of  the 
Forum for Exchange of Information on enforcement will provide the Commission with a broader 
picture  as  to  the  effectiveness  of  enforcement  and  implementation  of  the  REACH  Regulation 
across the Member States and allow it to assess possible further steps. With regard to the POPs 
Regulation, a possible reason for the delay in submitting annual reports could be that they are 
considered low priority by Member States, as the reporting format only sets out four questions 
which remain the same every year. As for the three annual reports, the reasons could be linked 
to non-ratification of the Stockholm Convention on POPs and/or the Protocol to the regional 
UNECE Convention on Long-Range Transboundary Air Pollution (CLRTAP) on POPs.  

Biocides 

In the biocides area the Commission undertook  to  monitor  the  progress  made  in  the  second 
phase of the Review Programme for biocides regulated by Commission Regulation (EC) No 
1451/2007257. Serious delays and significant variations were found in the performance at all 
stages of the procedure between the Member States.  

The reasons for the delays are, for example, the technical complexity of the work, insufficient 
human resources and lack of experience with dossier preparation (by participants) and dossier 
evaluation  (by  Member  States).  However,  considerable  time  was  also  needed  to  develop 
appropriate  testing  methodologies  and  exposure  scenarios  or  for  defining  harmonised 
approaches for the evaluations. 

In reaction to the delays and variations in the performance, the Commission took a number of 
actions, for example prepared a note on the evaluation of multiple dossiers that should speed 
up  and  facilitate  the  evaluation  of  dossiers  from  several  applicants  by  the  competent 
authorities.  At  each  meeting  with  the  competent  authorities,  the  Commission  makes  an 
overview of late dossiers and agrees further steps with the relevant competent authorities (see 
also section on 'Planned action'). 

The  revised  PIC  Regulation  was  adopted  in  2008  and requires  the  Commission  to  regularly 
compile a report on the operation of the procedures, which shall include reports from Member 
States. The Commission foresees that this report will be compiled in the course of 2012. 

8.7.3.  Evaluation results 

8.7.3.1.  Priorities 

Chemicals 

257  

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market, OJ L 325, 11.12. 2007, p 3. 

EN 

223 

   EN 

 
 
                                                 
Effective  implementation  of  REACH  and  CLP  Regulations  is  the  main  priority  in  the 
chemicals sector. The Chemicals Agency is playing a key role in the effective implementation 
of  REACH.  It  will  coordinate,  over  a  period  of  11  years,  the  registration  of  some  30  000 
chemical substances in use today.  

Member  States  provided  their  first  reports  on  the  operation  of  REACH  in  June  2010  and 
ECHA will report by June 2011. On the basis of these reports, the Commission will prepare 
the first general report on the operation of REACH. 

The priorities for POPs will be, firstly, to transpose the agreements reached in 2009 under the 
UNECE  Protocol  into  the  POPs  regulation  and  secondly  to  develop  proposals  for  new 
additions to the Convention.  

Biocides 

The  first  applications  for  authorisations  and  mutual  recognitions  in  accordance  with  the 
Biocides  Directive  were  received  and  processed  in  2009/2010.  Estimations  showed  that  the 
number  of  applications  for  product  authorisation  and  mutual  recognition  will  exponentially 
increase in the future. In view of this, further action is needed to facilitate the implementation 
of  the  legal  and  practical  requirements  related  to  these  procedures.  The  Product 
Authorisations  &  Mutual  Recognition  Facilitation  Group,  an  informal  group  of  Member 
States'  authorities  set  up  in  2007  in  order  to  discuss  procedural,  regulatory  and  scientific 
issues  arising  during  the  course  of  product  authorisation  and  mutual  recognition,  intensified 
its work in 2010. Several guidance documents were prepared and agreed by the Group (e.g. 
frame formulations, letters of access, changes to authorisations).  

In  addition  the  speeding  up  of  the  evaluation  of  biocidal  active  substances  in  the  Review 
programme will be a main priority. 

As  concerns  the  PIC  Regulation,  it  is  planned  to  draft  a  proposal  for  an  amendment  that 
addresses changes resulting from Regulation (EC) 1272/2008 on classification, labelling and 
packaging  of  chemicals  and  to  finalise  the  guidance  documents  for  implementation  of  the 
Regulation. 

8.7.3.2.   Planned action (2011 and beyond) 

Chemicals 

The  Commission  will  continue  to  work  to  enhance  good  cooperation,  coordination  and 
exchange of information with Member States and the European Chemicals Agency regarding 
enforcement so that the system established by the REACH and CLP Regulations can operate 
effectively. The Commission will work closely with the Forum for Exchange of Information 
on Enforcement in this regard. 

Concerning  the  registration  process  there  are  two  further  registration  deadlines  in  2013  and 
2018 for chemicals produced or imported  in lower  volumes.  The  Commission will examine 
the lessons learned from the first registration phase to allow as smooth a process as possible 
for future registration deadlines. 

Most guidance documents necessary for industry preparedness for registration under REACH 
and notification to the Classification and Labelling inventory under the CLP Regulation have 

EN 

224 

   EN 

 
been adopted, with some necessary updates underway. The remaining staggered deadlines for 
registration are 2013 and 2018. Equally a lot of work will be developed in 2011 to ensure the 
proper functioning of the evaluation and authorisation titles in REACH for which ECHA and 
Member States are responsible.  

With  regard  to  authorisation,  following  a  recommendation  from  ECHA  in  December  2010, 
the Commission is taking steps to add a further 8 chemicals from the Candidate List to the list 
of substances subject to authorisation. The Candidate List currently consists of 46 Substances 
of  Very  High  Concern  (SVHC)  but  the  Commission  is  committed  to  working  together  with 
Member States towards a target of including an additional 90 SVHC on the Candidate List by 
2012 and to identify all relevant, currently known SVHCs in the Candidate List by 2020 

REACH calls for the Commission to carry out a review of the scope of the Regulation by June 
2012 to avoid overlaps with other relevant Community provisions and on the basis of this, a 
legislative proposal could be presented, if appropriate. The work to be undertaken has started 
and for this purpose the Commission has launched a study which will be further developed in  
2011  with  the  view  to  assessing  overlaps  and  gaps  between  REACH  and  other  community 
legislation  when  regulating  chemicals,  but  also  identifying  ways  of  increasing  synergies 
between all relevant pieces of legislation.   

In  2011  the  Commission  is  pursuing  the  study  which  aims  to  assess  whether  the  current 
enforcement  requirements  of  REACH  and  CLP  Regulations  could  potentially  be  reinforced 
and how. 

With regard to the POPs Regulation, the Commission will continue to stress to Member States 
the  importance  of  the  continuity  of  the  information  provided  by  them.  Furthermore  the 
Commission  intends  to  improve  the  reporting  format  with  the  aim  to  make  it  more  user-
friendly  and  less  time  consuming.  This  can  be  achieved  by  establishing  links  to  the  SEIS 
(Shared Environmental Information System) initiative. A SEIS Regulation is currently under 
preparation.  The  Commission  will  also  remind  Member  States  about  their  reporting 
obligations on the application of the POPs Regulation, followed by legal enforcement action 
where necessary. 

Export and import of dangerous chemicals  

The  Commission  will  present  to  the  Council  and  the  European  Parliament  a  proposal  for  a 
recast of Regulation (EC) 689/2008 concerning the export and import of dangerous chemicals 
which addresses changes stemming from the Treaty on the European Union and the Treaty on 
the  Functioning  of  the  European  Union.  The  proposal  will  also  align  that  Regulation  with 
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and 
mixtures  and  it  will  transfer  certain  administrative,  technical  and  scientific  tasks  to  the 
European Chemicals Agency. In addition the proposal seeks to clarify some technical issues. 

The  fifth  Conference  of  the  Parties  of  the  Rotterdam  Convention  will  be  held  in  June  2011 
and requires a thorough preparation by the Commission, which began in 2010 and is a priority 
in 2011. The administrative work as well as the software of the European Database on Export 
and Import of dangerous chemicals, which is the central tool for implementation of the PIC 
Regulation, will undergo major changes that need to be implemented smoothly. 

Biocides 

EN 

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With  regard  to  biocides,  the  Commission  will  continue  to  carefully  monitor  that  the 
obligations  of  the  Member  States  under  the  biocides  review  programme,  including  the 
delivery of competent authority reports, are adequately met and will take action where this is 
not  the  case.  During  the  meetings  of  the  competent  authorities  for  biocides,  which  are  held 
four  times  a  year,  the  Commission  asks  for  an  update  on  significantly  delayed  dossiers. 
Member States are invited to give their reasons in order to solve outstanding issues or collect 
expert views. 

In view of the acceleration in the product authorisation stage, the Commission in consultation 
with the Member States will focus on the smooth implementation of the process and ensure 
the operation of the Register for Biocidal Products to be in line with the requirements. 

8.7.4.  Sector summary 

The Chemicals and Biocides sector of EU environmental law is characterised by substantial 
new  developments.  In  the  chemicals  sector,  though  the  main  obligations  under  REACH 
started to apply from June 2008, the majority of registrations came in by December 2010. The 
Industry Classification and Labelling inventory will be established during 2011. The available 
information  on  implementation  is  currently  being  assessed.  Although  full  compliance  has 
been  achieved  concerning  introduction  of  penalties,  the  Commission  is  looking  at  the  way 
forward for a more harmonised approach in relation to these penalties.  

As  regards  biocides,  the  revision  of  the  current  legislative  framework  is  expected  to  bring 
important improvements to implementation. In addition, the review programme  for  biocides 
requires  close  monitoring  in  order  to  avoid  excessive  delays  and  the  start  of  the  product 
authorisation stage is a key challenge which will require attention in the forthcoming years. 

8.8. 

Governance  

8.8.1.  Current position 

8.8.1.1.  General introduction 

 Governance 

Public  access  to  environmental  information  has  always  been  considered  as  a  key  issue  to 
promote  greater  awareness  of  environmental  matters,  a  free  exchange  of  views  and  more 
effective  participation  by  the  public  in  environmental  decision-making.  The  EU  decided  as 
long  ago  as  1990  to  introduce  specific  legislation;  however,  new  impetus  was  given  by  the 
UN-ECE  Aarhus  Convention.  Directive  2003/4/EC258  expanded  the  access  granted  under  the 
previous legislation. The objectives of the Directive are: a) to guarantee the right of access to 
environmental information held by or for public authorities and to set out the basic terms and 
conditions  of  its  exercise;  and  b)  to  ensure  that,  as  a  matter  of  course,  environmental 
information  is  progressively  available  and  disseminated  to  the  public  using  in  particular 
computer  telecommunication  or  electronic  technology.  Both  'passive',  i.e.  upon  request,  and 
'active' dissemination of environmental information are covered by the Directive. Its scope is 

258 

Directive  2003/4/EC  of  the  European  Parliament  and  of  the  Council  of  28  January  2003  on  public 
access  to  environmental  information  and  repealing  Council  Directive  90/313/EEC,  OJ  L  41, 
14.2.2003.p. 26–32 

EN 

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broad  due  to  the  fact  that  'environmental  information'  and  'public  authority'  are  both  given 
very  wide  definitions.  The  latter  covers  not  only  national,  regional  and  local  authorities, 
including public advisory bodies, but also private non-governmental bodies providing public 
services  or  performing  public  administrative  functions  in  relation  to  the  environment.  The 
Directive  makes  provision  for  both  administrative  and  judicial  review.  Directive  2003/4/EC 
had to be transposed by 14 February 2005. 

Public  access  to  environmental  information  is  complemented  by  the  second  pillar  of  the 
Convention. This was implemented by Directive 2003/35/EC259 in respect of certain plans and 
programmes  relating  to  the  environment,  as  provided  for  in  Article  2.  The  scope  of  the 
instrument  is  further  extended  to  environmental  impact  assessment  (EIA)  and  integrated 
pollution  prevention  and  control  (IPPC).  The  main  objective  of  this  Directive  is  to  ensure 
effective public participation in decision-making linked to certain projects. This aim is further 
strengthened  by  its  integrated  access  to  information  and  access  to  justice  provisions.  This 
Directive had to be transposed by 25 June 2005. 

The  third  pillar  of  the  Aarhus  Convention  is  access  to  justice,  which  guarantees  the 
effectiveness  of  the  previous  two  pillars,  was  partially  implemented  by  the  previously 
mentioned two Directives and Directive 2004/35/EC and by Regulation 1367/2006260. 

Other activities pursued by the Commission to enhance access to justice can be summarised 
as compliance promotion, which ensures a dialogue with Member States on possible problems 
of  implementing  EU  law  at  national  level.  Amongst  others,  access  to  justice  constitutes  an 
integrated  element  of  the  Cooperation  with  Judges  programme  that  was  started  in  2008. 
Another  initiative  which  contributes  to  enhance  access  to  justice  is  the  e-Justice  portal 
launched  by  the  European  Commission,  where  environmental  justice  shall  be  gradually 
included.  

8.8.1.2.  Report of work done in 2010 

Governance 

Despite  some  delays,  all  the  Member  States  have  transposed  Directive  2003/4/EC.  The 
Commission contracted an external consultant to carry out studies dealing with the conformity 
of  national  implementing  legislation  with  the  requirements  of  the  Directive.  Further  to  the 
finalisation of these studies in 2008 and their examination, in 2009, letters were sent to most 
Member States inviting them to comment on the findings of the studies. 

Only few petitions submitted to the European Parliament raised problems of the application of 
Directive  2003/4/EC  in  the  Member  States.  On  the  basis  of  information  available  or 
supplementary documents supplied in the framework of the petitions, there was no evidence 
that public authorities applied the Directive incorrectly. 

259 

260 

Directive 2003/35/EC of 26 May 2003, OJ L 156, 25.06.2003, p. 17. Public participation and access to 
justice  concerning  Directives  85/337/EEC  and  96/61/EC  are  dealt  with  the  relevant  sections  of  this 
Report. 
See  Regulation  (EC)  No  1367/2006  of  the  European  Parliament  and  of  the  Council  of  6  September 
2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public 
Participation  in  Decision-making  and  Access  to  Justice  in  Environmental  Matters  to  Community 
institutions and bodies (OJ L 264, 25.9.2006, p. 13). 

EN 

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On  1.09.2010  a  hearing  took  place  before  the  Court  in  case  C-204/09,  reference  for  a 
preliminary ruling, Flachglas Torgau GmbH. Advocate-General's opinion and judgement have 
not  been  issued  yet.  The  Federal  Administrative  Court  of  Germany  asked  several  questions 
which concern interpretation of terms used in the Directive, i.e. bodies and institutions acting 
in a legislative capacity, public authority, confidentiality of proceedings. 

On  22.12.2010  the  Court  delivered  preliminary  ruling  in  case  C-524/09  Ville  de  Lyon 
following  the  French  Tribunal  Administrative  de  Paris  reference  on  the  applicability  of 
Directive  2003/4/EC  to  information  on  the  sale  of  emission  quota  and  the  scope  of 
"environmental  information".  The  Court  concluded  that  the  information  requested  comes 
under  the  specific  rules  governing  public  reporting  and  confidentiality  under  Directive 
2003/87/EC and Regulation 2216/2005. According to Regulation 2216/2005 that information 
is confidential and subject to specific rules on its access. 

On 16.12.2010 the Court made a judgement in case C-266/09 Stichting Natuur en Milieu. This 
concerns  preliminary  ruling  reference  from  the  Dutch  Administrative  College  (College  van 
beroep  voor  het  bedrijfsleven)  on  the  applicability  of  Directive  2003/4/EC  and  the  scope  of 
"environmental information". In agreement with the Advocate General, the Court concludes, 
first, that the Directive applies in the present case because the decision denying environmental 
information was taken after the transposition deadline of the Directive (while the request for 
environmental  information  was  made  before  that).  Second,  the  definition  of  environmental 
information  has  to  be  interpreted  broadly  and  therefore  includes  information  submitted  by 
operators in the application process for a permit under the Plant Protection Products Directive 
(91/414/EEC).  Third,  protection  of  commercial  information  is  limited  where  it  relates  to 
information on emissions into the environment or refusal to disclose is outweighed by public 
interest. 

Despite  some  delays,  all  the  Member  States  have  transposed  Article  2  of  the  Directive 
2003/35/EC.  By  25  June  2009  the  Commission  had  to  send  a  report  on  the  application  and 
effectiveness of the Directive to other institutions. National reports were not provided for by 
the Directive, however the Commission considered it important to have information from the 
Member  States.  The  requested  contributions  were  forwarded,  in  certain  cases,  with  an 
important delay, preventing from the elaboration of the report by the deadline. On the basis of 
the received information, it appears that the effective application of Article 2 in the Member 
States  was  limited,  notably  due  to  the  fact  that  in  most  cases  the  SEA  procedure  (see  the 
section on the SEA) was followed. There is no evidence that it was applied incorrectly. 

On  14  April  2010  the  Commission  adopted  a  report  on  the  application  and  effectiveness  of 
Directive  2003/35/EC261  compiled  pursuant  to  its  Article  5.  The  report  is  limited  to  an 
examination  of  Article  2  of  the  Directive  (public  participation  concerning  plans  and 
programmes),  due  to  the  fact  that  aspects  dealing  with  Article  3  of  the  Directive  (public 
participation and access to justice in EIA) were examined in a Commission Report of 23 July 
2009262  and  those  elements  relating  to  Article  4  of  the  Directive  (public  participation  and 
access  to  justice  under  IPPC)  will  be  dealt  with  in  the  report  to  be  compiled  pursuant  to 
Article 17(3) of Directive 2008/1/EC. 

261 
262 

 (COM(2010)143). 
(COM(2009)378). 

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In the interests of clarity, the recast of Directive 2008/1/EC of the European Parliament and of 
the  Council  of  15  January  2008  concerning  integrated  pollution prevention  and  control  took 
place  in  2010.263  Provisions  were  taken  over  from  the  previous  version  of  the  Directive, 
however the scope of public participation and access to justice has been broadened to cases of 
granting  or  updating  of  a  permit  for  an  installation  where  the  competent  authority  may,  in 
specific  cases,  set  less  strict  emission  limit  values  taking  into  account  aspects  of  cost 
efficiency.  

The  Seveso  II  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on 
control  of  major-accident  hazards  involving  dangerous  substances  was  adopted  by  the 
Commission.264  As  a  result  of  the  review  process,  on  21  December  2010  the  Commission 
adopted  a  proposal  for  a  new  Directive  that  would  repeal  and  replace  the  current  Seveso  I 
Directive by 1 June 2015. In order to make the broadest possible use of the Aarhus tools in EU 
law  access  to  information,  public  participation  and  access  to  justice  provisions  have  been 
included in the text.  

The  Cooperation  with  Judges  programme  continued  during  the  year  2010,  starting  with  a 
seminar in Paris on Nature, followed by a London seminar discussing the same topic and in 
September  a  Lithuanian  venue  which  all  had  the  integrated  element  of  access  to  justice  in 
environmental matters.    

The role of the Court of Justice of the European Union (ECJ) in interpreting access to justice 
provisions  is  outstanding  and  becoming  more  and  more  important  in  broadening  this  area.  
The Court delivered its first judgment on the topic in 2009 stating that Ireland has failed to 
transpose certain elements of Directive 2003/35, (case C-427/2007). By requiring the notion 
of  prohibitive  costs  in  judicial  environmental  cases  to  be  explicitly  transposed,  the  Court 
provided  a  better  guarantee  of  effective  access  to  justice  for  the  public  and  NGOs.  In  a 
preliminary ruling concerning the Swedish national rules (case C-263/08) the Court ruled on 
NGOs standing, stipulating that the national rule setting a requirement that only an association 
with  at  least  2 000  members  may  bring  an  appeal  against  a  decision  adopted  on  an 
environmental matter is against the provisions and the objective of wide access to justice set 
out in Directive 85/337/EEC.  

Ongoing cases before the Court of Justice of the European Union 

Since last year there are several new court cases based on the preliminary references before 
the ECJ all concerning access to justice and public participation. One is a Belgian case, the 
Belgian Council of State has referred several questions (in Joined Cases C-12/09 to 131/09, 
134/09  and  135/09)  on  the  interpretation  of  the  EIA  Directive  and  also  on  its  provisions  as 
modified by Directive 2003/35/EC, including its provisions on access to justice.  

Another  Belgian  case  is  brought  to  the  Court  by  the  Belgian  Constitutional  Court  under  C-
182/10.  The  reference  intends  to  receive  clarification  on  topics  such  as  the  application  of 

263 

264 

Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 November  2010  on 
industrial emissions (integrated pollution prevention and control) Text with EEA relevance  OJ L 334, 
17.12.2010, p. 17–119 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, 
SK, SL, FI, SV) . 
Seveso II Proposal for a Directive of the European Parliament and of the Council on control of major-
accident hazards involving dangerous substances was adopted by the Commission. /* COM/2010/0781 
final - COD 2010/0377 */. 

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article  1  (5)  of  the  EIA  Directive  and  its  relation  to  the  Aarhus  Convention  regarding  the 
applicability of legislative acts by virtue of which projects may be exempt from the scope of 
the Directive and possible links to access to justice. The Court requested clarification also on 
the  legal  status  of  the  Aarhus  Convention  Implementation  Guide.  A  further  issue  of 
interpretation was raised in relation to the requirement of EIA under Article 6(3) of Directive 
92/43/EEC  of  21  May  1992  on  the  conservation  of  natural  habitats  and  of  wild  fauna  and 
flora. 

In another case, a German administrative court of appeals has referred several questions (in 
Case  C-115/09)  concerning  the  interpretation  of  Article  3.7  of  Directive  2003/35/EC,  with 
respect to the admissibility of actions brought by environmental NGOs, even if there are no 
subjective rights affected, and the standard of review to be followed by national courts under 
that provision. The hearing of the latter was held in June 2010, and following this, Advocate 
General Sharpston has delivered her opinion in December 2010 indicating that NGOs need to 
be  given  wide  standing  in  order  to  meet  the  objective  of  wide  access  to  justice  set  by  the 
Directive. It should also be mentioned that there is a pending case on the same topic before 
the Aarhus Compliance Committee.   

Direct effect of the Aarhus Convention (AC) was also the subject of a preliminary reference. 
Regarding  Article  9  (3)  AC  the  Supreme  Court  of  the  Slovak  Republic  referred  several 
questions  to  the  ECJ  amongst  which  one  seeks  ECJ's  position  whether  it  is  possible  to 
recognise Article 9, and in particular Article 9(3) AC, which has become a part of EU law, as 
having the direct applicability or direct effect of EU law (Case C-240/09). Advocate General 
Sharpston has delivered her opinion in which she indicates that she does not find that there is 
direct  effect  of  the  provisions  referred  to.  However,  she  does  mention  that  even  though  not 
directly effective, Member States national courts have an obligation to take into account these 
provisions of the AC.  

In  Case  C-165/09  regarding  the  interpretation  of  provisions  of  the  IPPC  Directive  and 
Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on 
national  emission  ceilings  for  certain  atmospheric  pollutants  Opinion  of  Advocate  General 
Kokott has been released in December 2010. This also has an access to justice relevance, as 
she indicated that the individuals have the right to appeal before a national court by virtue of 
the IPPC access to justice provisions whenever the annual national emissions ceilings (based 
on Directive 2001/81) are endangered. 

In Case C-416/10 a reference for a preliminary ruling from Najvyšší súd Slovenskej republiky 
(NSSR)  was  sent  to  the  ECJ  to  answer  five  questions  relating  to  the  SK  system  of  public 
participation in EIA and IPPC procedures. The preliminary reference deals with the temporal 
effect of the EIA Directive, the role of national judges when applying EU law and also relates 
to  the  question  of  effective  access  to  justice  including  the  applicability  of  injunctive  relief 
even  though  there  is  no  explicit  provision  on  this  in  the  EIA  Directive  (as  modified  by 
Directive 2003/35/EC). 

Petitions  

During 2010, there was one petition handled on access to justice with regard to Ireland. 

Compliance promotion 

Several  studies  were  carried  out  during  the 

years  2008-2010  in  order  to  screen  the 

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implementation status of Member States of Directive 2003/35/EC on public participation.  

The Commission places a particular emphasis on implementing and monitoring the Member 
States' application of already adopted EU law, namely the Access to Information and Public 
Participation Directives' provisions on access to justice. On the basis of the above studies and 
judgements  the  Commission  has  started  exchanges  with  the  Member  States  in  order  to 
establish a clear picture on how they comply with the provisions of the Directive.  

8.8.2.  Evaluation based on the current situation 

Governance 

According  to  Directive  2003/4/EC,  no  later  than  14  August  2009  Member  States  had  to 
communicate  to  the  Commission  their  national  reports  on  the  experience  gained  in  its 
application to enable it to submit a report to other EU institutions. A Guidance Document for 
these reports was drawn up by the Commission, in co-operation with Member State experts, 
in 2007.  

During 2009, the Commission reminded Member States of the need to submit these reports. 
By  the  end  of  2009,  the  majority  of  the  Member  States  had responded to the  Commission's 
reminder,  but  it  proved  nonetheless  necessary  to  prepare  action  under  Article  258  of  the 
Treaty for those Member States who had failed to submit a report.  

Although the national reports had yet to be analysed at the end of the year, it appeared that, in 
general,  public  authorities  at  national  and  regional  level  have  applied  Directive  2003/4/EC 
correctly. However, given the Directive's wide scope, it was less clear whether, at local level, 
notably  in  small  municipalities  or  entities,  public  access  to  environmental  information  is 
always provided according to the relevant standards. 

In addition, requests for clarification to the Commission services show that public authorities 
need  to  make  greater  efforts  to  inform  the  public  adequately  of  their  rights  under  the 
Directive.  This  right  includes  the  right  to  make  an  administrative  or  judicial  challenge  at 
national level to a refusal by a public authority to provide requested information. In general, 
the Commission considers that these rights should be exhausted before the Commission itself 
examines  the  justification  for  an  individual  instance  of  refusal  of  access  to  information. 
Moreover,  it  appears  that  public  authorities  need  to  pay  further  attention  to  the  active 
dissemination of environmental information to the public, in particular, through the Internet.   

On the basis of information available and national contributions, there was no evidence that 
public participation concerning plans and programmes, provided for in Article 2 of Directive 
2003/35/EC was incorrectly applied by Member States. 

The implementation of public participation provisions related to EIA and IPPC is still under 
assessment by the Commission, further action shall be taken in light of the findings.  

The  Cooperation  with  Judges  programme  is  considered  to  be  a  useful  tool  in  raising 
awareness of access to justice requirements at EU level amongst judges. This can be regarded 
as  a  very  effective  way  of  fulfilling  the  requirements  of  the  Aarhus  Convention  on 
establishing a high level of access to justice and also ensuring the implementation of access to 

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justice  provisions  of  the  Treaty  of  Lisbon265.  Regarding  the  case-law  of  the  ECJ,  there  is  a 
growing number of cases on the most important issues related to access to justice (such as the 
admissibility  rules  of  the  public  in  review  procedures,  and  access  to  environmental 
information,  in  particular  on  the  definition  of  'environmental  information'  and  the  issue  of 
prohibitive  costs  that  can  be  regarded  as  barring  effective  access  to  justice)  which  have  an 
indisputable positive effect on better application of the Directive  and on access to justice. It 
can  be  seen  that  based  also  on  the  implementation  activity  of  the  Commission  there  is  a 
growing number of cases linked to access to justice.  

8.8.3.  Evaluation results 

8.8.3.1.  Priorities 

Governance 

The  priority  for  the  Commission  is  to  verify  the  conformity  of  national  legislation  with  the 
requirements  of  Directives  2003/4/EC  and  2003/35/EC  to  ensure  that  these  are  applied 
correctly in practice by public authorities at all levels. In 2011, the Commission will analyse 
Member State responses to the enquiries it sent and will ensure the necessary further follow-
up.  By  monitoring  Member  States'  implementation of existing provisions, drawing attention 
to possible non-compliance and engaging in interactive discussions the compliance promotion 
pursued by the Commission in access to justice issues is considered very effective.  

The  Cooperation  Programme  with  Judges  has  a  very  important  role  of  ensuring  the  high 
competence of Member States judges and a high level of awareness of the latest developments 
in EU law, not only as regards case-law, but also recent changes to the Treaties, international 
activity.  This  also  gives  the  possibility  of  national  training  centres  to  take  into  account  the 
material  developed  during  these  sessions.  Six  seminars  were  organized  in  the  first  phase  of 
implementation  of  the  programme:  four  seminars  dedicated  to  EU  nature  law  (in  Sofia, 
Bulgaria, May 2009; in Paris, France, February 2010 and in London, United Kingdom, March 
2010) and three seminars for EU waste law. 

More  than  100  judges  (judges  and  prosecutors,  from  courts  of  first  instance  to  Supreme 
Courts) from 20 Member States participated in these seminars. The content of the seminars, 
mixing front-teaching presentations with case-studies, proved to be very well adapted to the 
audience. It was considered as very useful, there was a high attendance rate with high quality 
expert debates amongst the different speakers and participants.  

The creation of a European e-Justice portal, of which the first release was launched on 16 July 
2010 is an important step in enhancing access to justice in Member States. The environmental 
access  to  justice  provisions  in  Member  States  are  envisaged  to  be  incorporated  into  the  site 
during  the  course  of  2011-2012,  which  shall  also  contribute  to  the  effectiveness  the 
procedures at Member States level. 

265 

The Charter of Fundamental Rights of the European Union confirms the right to an effective remedy for 
everyone whose rights and freedoms guaranteed by the law of the European Union are violated Article 
47(1).  OJ,  C  364  18.12.2000,  p.1  This  is  further  strengthened  by  Article  19(1)  of  the  Treaty  on 
European Union incorporating the principle of effective judicial protection, OJ C 306, 17.12.2007. 

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Identifying  shortcomings  in  implementation  and  compliance  promotion  is  a  key  aspect  of 
ensuring  a  higher  level  of  application  of  EU  law.  Given  the  constantly  evolving  nature  of 
national  legislation  it  is  in  some  cases  a  considerable  challenge  to  be  up  to  date  of  national 
legislation  in  force.  This  is  the  reason  the  different  stakeholder  events,  contact  with  civil 
society,  cooperation  with  judges  and  conferences  can  contribute  to  receive  up  to  date  and 
valid information on application of EU law. 

Thus,  it  is  a  key  priority  to  ensure  a  constant  exchange  of  information  with  different 
stakeholders on the application of EU law in national procedures and to ensure that effective 
legal protection is guaranteed in environmental procedures.     

8.8.3.2.  Planned action (2011 and beyond) 

Governance 

As  mentioned  above,  in  2011  the  Commission  will  ensure  an  appropriate  follow-up  to  the 
dialogue  it  initiated  with  Member  States  in  2010  in  order  to  address  transposition  of  the 
Aarhus-related  Directives  or  concrete  difficulties  encountered  by  public  authorities  in 
enforcement. 

Compliance promotion in access to justice issues is envisaged to continue beyond 2010. The 
on-going Cooperation with Judges Programme shall ensure a constant dialogue with national 
judges  on  access  to  justice.  The  topic  elaborated  and  presented  through  three  regional 
workshops will be EIA including provisions implementing the Aarhus Convention on public 
participation  and  access  to  justice.  Development  of  training  modules  in other  sectors  of  EU 
environmental law (impact assessment studies, water, industrial emissions) is foreseen.     

Cooperation  with  national  authorities  to  ensure  effective  implementation  is  crucial.  The 
Commission will liaise with counterparts in implementing EU law at Member States level.  

It  is  also  envisaged  to  start  preparation  for  the  inclusion  of  environmental  access  to  justice 
provisions in the e-Justice portal described above. 

As  it  was  presented  above,  the  ongoing  activity  of  ensuring  implementation  of  Aarhus 
provisions through compliance promotion, the Commission is exploring further the possibility 
to extend Aarhus provisions to other areas where projects and plans are involved in secondary 
EU law.  

8.8.4.  Sector summary 

Overall, Member States appear to apply the Directive on access to environmental information 
correctly, but the existing practice indicates that public authorities of all levels, in particular 
lower ones, need to make greater efforts to inform and respect the right of the public under the 
Directive. 

Full  transposition  of  Directives  2003/4/EC  and  2003/35/EC  in  the  Member  States  is  also  a 
priority for the Commission and in 2011 the Commission will pursue the exchanges opened 
with Member States in 2010.  

Based on the reports submitted by Member States, the Commission will also prepare a report 
on implementation of Directive 2003/4/EC. 

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A very important element of implementing the Aarhus Convention and secondary law is the 
developing case-law of the ECJ in the field. In view of the developing case-law of the ECJ, 
the Commission takes all the necessary measures to implement the findings in Member States. 

8.9. 

Environmental Liability 

8.9.1.  Current position 

8.9.1.1.  General introduction 

Directive  2004/35/EC  of  the  European  Parliament  and  of  the  Council  on  environmental 
the  prevention  and  remedying  of  environmental  damage 
liability  with  regard 
(Environmental  Liability  Directive)266  establishes  a  framework  for  environmental  liability 
based  on  the  "polluter  pays"  principle,  with  a  view  to  preventing  and  remedying 
environmental damage. 

to 

8.9.1.2.  Report of work done in 2010 

The  Environmental  Liability  Directive  (ELD)  was  to  be  transposed  by  30  April  2007. 
Transposition was slow and finally only completed by mid 2010 when the last Member State 
completed  its  transposing  legislation.  The  main  reasons  for  the  transposition  delays  were 
identified by the Commission as linked with (1) existing legal frameworks, particularly where 
Member States had already advanced liability rules on environmental issues, (2) challenging 
technical  requirements  of  the  directive,  such  as  the  need  for  economic  valuation  of 
environmental  damage,  different  remediation  types  and  techniques  and  damage  to  protected 
species and natural habitats, and (3) the framework character of the ELD which led to further 
delays as the broader range of options instigated relatively longer debates at national level. 

With  completion  of  transposition,  the  last  non-communication  cases  launched  by  the 
Commission in 2007 were closed in 2010. Currently, there is only one case open on the ELD, 
and this one is related to the non-conformity of the national transposition. The Commission 
has  assessed  and  is  further  assessing  the  transposition  as  well  as  the  implementation  of  the 
ELD  and  has  also  started  bilateral  meetings  with  the  Member  States  in  this  regard  with  the 
aim that both sides may address questions and potential problems in relation to transposition 
and implementation.  

Apart from the seven ECJ judgements of 2008 and 2009 as to non-communication, the only 
substantial  judgement  so  far  on  the  ELD  was  given  by  the  Court  on  9  March  2010  in  a 
combined  Italian  case  upon  a  request  for  a  preliminary  ruling  (C-378/08  combined  with  C-
379/08  and  C-380/08).  In  its  ruling  the  Court  decided  that  the  polluter-pays  principle  is 
directed at action at EU level  and can hence not be directly invoked by individuals without 
intermediate implementing legislation at EU level. The Court also decided that Member States 
have broad discretion in laying down national rules implementing the polluter-pays principle 
and  in  imposing  remedial  measures  on  the  operator  under  the  ELD  when  they  have  to 
establish a causal link between the activity and the environmental damage (for instance they 
may  apply  a  presumption  of  causality  which  has  to  be  based  on  plausible  evidence  such  as 
vicinity  between  activity  and  pollution  or  correlation  between  the  used  substances  and  the 
pollutants). The competent authority may also alter remediation measures which have already 

266 

OJ L 143, 30.4.2004, p. 56. 

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been partly or fully implemented if those are obviously ineffective and if certain conditions 
are  met  (operator  and  landowner  heard,  account  taken  of  remediation  criteria  in  the  ELD, 
grounds stated in the decision).      

After  the  Commission's  studies  of  2008  and  2009  and  extensive  consultations  with  national 
experts and relevant stakeholders, the Commission adopted on 12 October the report on the 
effectiveness  of  the  ELD  in  terms  of  environmental  remediation  and  the  availability  of 
financial security for the activities covered by the scope of strict liability of the ELD267. The 
ELD Report concludes that transposition of the Directive was slow due to the reasons outlined 
above,  and  that  this  lead  to  limited  implementation  and  experience  so  far  which  –  together 
with the very divergent application by Member States of implementation options offered by 
the  Directive  (e.g.  on  extension  of  the  scope  of  biodiversity  damage  or  on  the  optional 
incorporation  of  the  permit  and  state  of  the  art  defences)  -  impacted  negatively  on  the 
developments of financial security instruments and markets.  

Petitions  

During 2010, there were no petitions on this subject. 

8.9.2.  Evaluation based on the current situation 

The  abovementioned  ELD  Report  concluded  that  insufficient  availability  of  data  on  the 
effectiveness  of  the  Directive  in  terms  of  remediation  and  insufficient  developments  of 
financial security instruments did not allow the Commission to draw reliable conclusions as to 
the  core  question  whether  mandatory  financial  security  should  be  established  at  EU  level. 
Developments  in  those  Member  States  which  have  introduced  or  will  introduce  mandatory 
financial  security  at  national  level  (around  one  third  of  the  Member  States)  and  also 
developments  in  relation  with  large  scale  accidents  (the  Deepwater  Horizon  incident  in  the 
Gulf of Mexico, the red mud accident at Ajka in Hungary) will have to be further monitored in 
order to draw reliable conclusions.  

The  Report  has  however  identified  some  fields  and  measures  for  improving  the 
implementation  of  the  ELD:  promoting  information  exchange  and  communication  between 
key stakeholders, awareness raising of individual operators and financials security providers, 
development  of  interpretation  guidance  and  establishment  of  records  or  registries  of  ELD 
cases.  

Another, broader implementation report by the Commission will be due by April 2014, based 
on  Member  States  application  reports  due  by  2013.  Besides  several  other  questions,  that 
report  will  have  to  revisit  the  same  questions  on  effectiveness  and  financial  security  which 
had  to  be  left  unanswered  in  the  report  of  2010,  then  on  the  basis  of  the  evidence  gathered 
until 2013/2014.   

Apart  from  the  application  of  the  significance  criteria  (Annex  I  of  the  Directive)  and  the 
application  of  the  appropriate  measures  to  ensure  the  remedying  of  environmental  damage 

267 

Report  from  the  Commission  to  the  Council,  the  European  Parliament,  the  European  Economic  and 
Social Committee and the Committee of the Regions under Article 14(2) of Directive 2004/35/EC on 
the  environmental  liability  with  regard  to  the  prevention  and  remedying  of  environmental  damage, 
COM(2010) 581 final. 

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('primary',  'complementary'  and  'compensatory'  remediation  according  to  Annex  II  of  the 
Directive), the proper functioning of financial security instruments will be significant for the 
successful implementation of the ELD in the Member States in particular as regards effective 
remediation  of  environmental  damage.  Furthermore,  the  Commission  continued  to  provide 
support to the Member States through interpretation of open questions in expert meetings and 
in  particular  through  an  EU  supported  research  project  developing  a  tool-kit  on  the 
remediation methods. The results of the research programme REMEDE were made available 
in 2008268.  

8.9.3.  Evaluation results 

8.9.3.1.  Priorities 

All Member States completed the transposition of the ELD and the Commission presented its 
report  under  Article  14(2)  (COM(2010)  581  final).  Therefore,  the  last  horizontal  non-
communication  case  was  closed  in  2010.  The  next  priority  for  the  Commission  is  to  ensure 
that  the  Environmental  Liability  Directive  is  correctly  transposed  in  all  Member  States. 
Therefore  the  Commission  started  to  assess  the  conformity  of  the  domestic  legislation  with 
the  ELD  and  has  to  conclude  this  exercise  in  cooperation  with  Member  States  in  2011  and 
2012 and where necessary launch legal enforcement actions.  

8.9.3.2.  Planned action (2011 and beyond) 

The  Commission's  efforts  need  to  continue  to  ensure  that  the  ELD  is  correctly  transposed. 
Apart from continuing the examination of the conformity of the transposing legislation of the 
Member States and taking enforcement action as necessary, the Commission will continue to 
discuss  questions  of  interpretation  and  application  of  the  ELD  with  government  experts  in 
Commission organised meetings as well as in bilateral meetings. 

The  Commission  will  also  strive  to  draw  increasing  attention  to  the  areas  identified  in  the 
ELD Report which deserve more efforts in order to improve the implementation of the ELD 
(information  exchange,  awareness  raising,  interpretative  guidance,  ELD-cases  registries  by 
the Member States).  

8.9.4.  Sector summary 

Transposition  of  the  ELD  was  finally  completed  in  2010,  but  its  application  still  remains 
relatively limited. The Commission will have to promote the application and implementation 
of the ELD through measures identified in the ELD Report. It also works towards completing 
the conformity assessments and maintains dialogues with Member States on transposition and 
implementation.  Finally,  the  Commission  will  further  continue  monitoring  developments  at 
national level, in particular with regard to financial security instruments and markets. 

268 

Available  on  the  Internet  at  the  official  Website  of  Resource  Equivalency  Methods  for  Assessing 
Environmental Damage in the EU (REMEDE): <http://www.envliability.eu/> 

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9. 

INFORMATION SOCIETY AND MEDIA 

9.1. 

General Overview 

In  Information  society  and  media  the  regulatory  framework  for  electronic  communications 
continued to face a number of incorrect implementation issues, despite a decreasing number 
of open complaints and genuine efforts on the part of most Member States. Late transposition 
has generated non-communication cases in relation to the revised GSM Directive. 

One key challenge in some Member States remains the independence of national regulatory 
authorities  (NRA's),  which  is  a  prerequisite  for  ensuring  fair  and  effective  regulation  of  the 
sector.  Moreover,  the  Commission  had  to  intervene  against  some  Member  States  that  have 
imposed  undue  charges  on  operators.  Finally,  ensuring  the  effective  implementation  of 
consumer rights remained another key challenge for several Member States.  

Commission  guidance,  such  as  the  2010  Recommendation  on  Regulated  Access  to  Next 
Generation Access (NGA) networks, is intended to provide increased regulatory clarity to all 
market players, which is necessary to stimulate investment in fast and ultra-fast broadband.  

Finally,  in  the  run-up  to  the  May  2011  deadline  for  transposing  the  revised  regulatory 
framework  for  electronic  communications,  guidance  papers  have  been  provided  to  Member 
States, as well as bilateral assistance, on request. 

In  the  audiovisual  sector,  in  spite  of  preventive  work  with  a  view  to  ensuring  timely  and 
effective implementation of the Audiovisual Media Services Directive by the end of 2009, a 
sizeable  number  of  infringements  for  non-communication  of  transposition  measures  were 
launched in 2010.  

Regarding the Public Sector Information Directive, while a review is planned for 2012, a few 
Member States were still struggling with the correct implementation of the existing Directive, 
regarding for instance licensing and charging models that facilitate the availability and re-use 
of public information resources. 

9.2. 

Electronic communications 

9.2.1.  Current position 

9.2.1.1.  General introduction 

The EU regulatory framework for electronic communications came into force in 2002. Its 
five  Directives  are  transposed  into  the  national  law  of  all  27  Member  States269.  The 
Framework  Directive  outlines  the  general  principles,  objectives,  and  procedures.  The 
Authorisation  Directive  creates  a  regime  of  general  authorisations  for  providers  of 
communications services. The Access and Interconnection Directive sets out rules for a multi-
carrier  marketplace,  ensuring, 
to  networks  and  services  and 
in  particular,  access 
interoperability.  The  Universal  Service  Directive  guarantees  basic  rights  for  consumers  and 

269 

Directive  2002/21/EC  (Framework  Directive),  Directive  2002/20/EC  (Authorisation  Directive), 
Directive  2002/19/EC  (Access  Directive),  Directive  2002/22/EC  (Universal  Service  Directive)  and 
Directive  2002/58/EC  on  privacy  and  electronic  communications  (further  referred  to  as  the  ePrivacy 
Directive). 

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minimum levels of availability and affordability. The e-Privacy Directive covers protection of 
privacy and personal data communicated over public networks. 

Amendments  to  this  regulatory  framework,  included  in  the  Better  Regulation  Directive270 
and  the  Citizens’  Rights  Directive271  were  adopted  in  November  2009272  and  entered  into 
force  in  December  2009.  The  aim  of  this  telecoms  reform  is  to  consolidate  a  competitive 
internal  market  through  more  consistent  national  regulatory  approaches,  reinforce  consumer 
protection  and  users'  rights,  and  provide  for  more  effective  spectrum  management  and 
implementation. The new rules have to be transposed into national laws of all Member States 
by 25 May 2011. The new Regulation273 establishing the new European Telecoms Authority 
called  "Body  of  European  Regulators  for  Electronic  Communications  (BEREC)"  is  directly 
applicable. 

The  Roaming  Regulation274  was  introduced  in  2007  because  roaming  charges  were  at 
excessive levels and constituted a barrier to the Internal Market. In June 2009, the Regulation 
was extended for a further three years up to June 2012 and to include SMS and data roaming 
services (at wholesale level only) in addition to voice275. 

introduction  of  public  pan-European  cellular  digital 

The Directive amending the GSM Directive on the frequency bands to be reserved for the 
land-based  mobile 
coordinated 
communications in the Community276 came into force in November 2009. It provides for the 
introduction in the 900 MHz band of new wireless services, starting with UMTS services. The 
deadline for implementing the revised GSM Directive was 9 May 2010. 

270 

271 

272 
273 

274 

275 

276 

Directive 2009/140/EC of the European Parliament and of the Council of 25 November 2009 Directives 
2002/21/EC on a common regulatory framework for electronic communications networks and services, 
2002/19/EC on access to, and interconnection of, electronic communications networks and associated 
facilities, and 2002/20/EC on the authorisation of electronic communications networks and services. 
Directive 2009/136/EC of the European Parliament and of the Council of 25 November 2009 amending 
Directive  2002/22/EC  on  universal  service  and  users’  rights  relating  to  electronic  communications 
networks  and  services,  Directive  2002/58/EC  concerning  the  processing  of  personal  data  and  the 
protection  of  privacy  in  the  electronic  communications  sector  and  Regulation  (EC)  No  2006/2004  on 
cooperation between national authorities responsible for the enforcement of consumer protection laws 
OJ L 337, 18.12.2009, p. 37; OJ L 337, 18.12.2009, p. 11. 
Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 
establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office 
Regulation  (EC)  No  717/2007  of  the  European  Parliament  and  of  the  Council  of  27  June  2007  on 
roaming  on  public  mobile  telephone  networks  within  the  Community  and  amending  Directive 
2002/21/EC, OJ L 171, 29.6.2007, p. 32. 
Regulation (EC) No 544/2009 of the European Parliament and of the Council of 18 June 2009 
amending Regulation (EC) No 717/2007 on roaming on public mobile telephone networks within the 
Community and Directive 2002/21/EC on a common regulatory framework for electronic 
communications networks and services  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:167:0012:0023:EN:PDF 
OJ L 274, 20.10.2009, p. 25. 

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While  most  of  the  radio  spectrum  harmonisation  decisions  adopted  until  2009277  on  the 
basis of the Radio Spectrum Decision 626/2002/EC278 were implemented by the majority of 
Member States  for some Decisions this was not yet the case. In particular, the Commission 
services were monitoring whether and how Commission Decision 2009/766/EC of 16 October 
2009  on  the  harmonisation  of  the  900  MHz  and  1  800  MHz  frequency  bands  for  terrestrial 
systems  capable  of  providing  pan-European  electronic  communications  services  in  the 
Community had been implemented by Member States. 

On  the  basis  of  the  Decision  No 626/2008/EC  of  30  June  2008  of  the  European  Parliament 
and  of  the  Council  of  Decision  on  the  selection  and  authorisation  of  systems  providing 
mobile satellite services (MSS)279, the Commission adopted on 13 May 2009 a Decision No 
2009/449/EC selecting two operators of pan-European systems280. Implementation of the pan-
European MSS framework has now been taken-over by the Member States. The Commission 

277 

278 

279 
280 

EN 

Commission Decision 2005/928/EC of 20 December 2005 on the harmonisation of the 169,4-169,8125 
MHz frequency band in the Community (frequency band originally designated for the ERMES paging 
system); Commission Decision 2005/513/EC of 11 July 2005 on the harmonised use of radio spectrum 
in  the  5  GHz  frequency  band  for  implementation  of  Wireless  Access  Systems  including  Radio  Local 
Area  Networks  (WAS/RLANs);  Commission  Decision  2005/50/EC  of  17  January  2005  on  the 
harmonisation of the 24 GHz range radio spectrum band for the time-limited use by automotive short-
range radar equipment in the Community; Commission Decision 2004/545/EC of 26 July 2004 on the 
harmonisation  of  radio  spectrum  in  the  79  GHz  range  for  the  use  of  automotive  short-range  radar 
equipment  in  the  Community;  Commission  Decision  2006/771/EC  of  9  November  2006  on  the 
harmonisation  of  the  radio  spectrum  for  use  by  short-range  devices  (SRD);  Commission  Decision 
2006/804/EC  of  23  November  2006  on  harmonisation  of  the  radio  spectrum  for  radio  frequency 
identification (RFID) devices operating in the ultra high frequency (UHF) band; Commission Decision 
2007/90/EC  of  12  February  2007  amending  Decision  2005/513/EC  of  11  July  2005  on  5  GHz 
WAS/RLAN; Commission Decision 2007/98/EC of 14 February 2007 on the harmonised use of radio 
spectrum  in  the  2 GHz  frequency  bands for  the  implementation  of  systems  providing mobile  satellite 
services  (MSS);  Commission  Decision  2007/131/EC  of  21  February  2007  on  allowing  the  use  of  the 
radio  spectrum  for  equipment  using  ultra-wideband  technology  in  a  harmonised  manner  in  the 
Community (UWB); Commission Decision 2007/344/EC of 16 May 2007 on harmonised availability of 
information  regarding  spectrum  use  within  the  Community;  Commission  Decision  2008/294/EC  of  7 
April  2008  on  harmonised  conditions  of  spectrum  use  for  the  operation  of  mobile  communication 
services on aircraft (MCA services) in the Community; Commission Decision 2008/411/EC of 21 May 
2008 on the harmonisation of the 3400 - 3800 MHz frequency band for terrestrial systems capable of 
providing electronic communications services in the Community; Commission Decision 2008/432/EC 
of  23  May 2008  amending Decision 2006/771/EC on  harmonisation of  the radio spectrum  for use by 
short-range devices (SRD); Decision 2008/477/EC of 13 June 2008 on the harmonisation of the 2500-
2690  MHz  frequency  band  for  terrestrial  systems  capable  of  providing  electronic  communications 
services in the Community; Commission Decision 2008/671/EC of 5 August 2008 on the harmonised 
use  of  radio  spectrum  in  the  5875  -  5905  MHz  frequency  band  for  safety  related  applications  of 
Intelligent Transport Systems (ITS); Commission Decision 2008/673/EC of 13 August 2008 amending 
Decision  2005/928/EC  on  the  harmonisation  of  the  169,4-169,8125  MHz  frequency  band  in  the 
Community; Commission Decision 2009/343/EC of 21 April 2009 amending Decision 2007/131/EC on 
allowing the use of the radio spectrum for equipment using ultra-wideband technology in a harmonised 
manner  in  the  Community;  Commission  Decision  2009/381/EC  of  13  May  2009  amending  Decision 
2006/771/EC on harmonisation of the radio spectrum for use by short-range devices and Commission 
Decision  2009/766/EC  of  16  October  2009  on  the  harmonisation  of  the  900  MHz  and  1  800  MHz 
frequency bands for terrestrial systems capable of providing pan-European electronic communications 
services in the Community.  
Decision of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for 
radio spectrum policy in the European Community (Radio Spectrum Decision), OJ L 108, 24.4.2002, 
p.1. 
OJ L 172, 2.7.2008, p. 15. 
OJ L 149, 12.6.2009, p. 65. 

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services  closely  monitor  measures  taken  at  national  level,  notably  thanks  to  a  dedicated 
working  group  of  the  Communications  Committee  on  the  implementation  of  Decision 
2009/449/EC. 

9.2.1.2.  Report of work done in 2010 

the 

implementation  of 

Enforcing  effective 
for  electronic 
communications remained a priority in 2010. In line with the Commission Communication on 
better  monitoring  of  the  application  of  Community  law281,  the  Commission  services  have 
continued  to  avoid  the  need  for  recourse  to  infringement  proceedings  by  making  use  of 
bilateral  contacts  with  the  relevant  national  authorities,  including  via  the  EU  Pilot  system. 
the 
They  also  provided  general  guidance  on 
Communications Committee (COCOM) and the Radio Spectrum Committee (RSC). 

requirements  via 

implementation 

framework 

regulatory 

During 2010, in view of the implementation of the revised EU regulatory framework by May 
2011, the Commission presented to Member States in COCOM several guidance documents 
on  the  interpretation  of  specific  provisions,  such  as  provisions  on  independence,  universal 
service, network sharing, and privacy. In addition, the Commission continued to discuss with 
the Member States in COCOM the implementation of the European emergency number '112' 
and of the reserved '116' numbers for harmonised services of social value. 

In addition to non-communication cases and cases of non-compliance with judgments of the 
Court  of  Justice  in  the  area  of  electronic  communications,  infringement  priorities  in  2010 
continued to focus in particular on structural issues and consumer protection. 

Structural issues included in particular the functioning and the independence of the national 
regulatory  authorities.  As  regards  independence,  the  Commission  has  systematically 
monitored  the  requirement  for  independence  of  national  regulatory  authorities  (NRAs),  and 
has taken action when necessary. Firstly, clear rules regarding the formal establishment of the 
NRA  structures  should  ensure  the  independence  and  impartiality  of  the  NRA.  The  rules  for 
dismissal  of  NRA  management  are  fundamental  in  this  regard.  An  infringement  is  still 
pending in Slovenia in this respect, while a Slovakian case and a Romanian could be closed 
following  legislative  amendments.  Secondly,  Member  States  must  ensure  that  NRAs  are 
legally distinct from and functionally independent of electronic communications networks and 
services  providers  ('effective  structural  separation'),  not  least  when  Member  States  retain 
ownership or control of electronic communications undertakings. Concerns remained in this 
regard  in  some  Member  States  e.g.,  Romania,  Latvia,  and  Lithuania.  In  the  latter  case,  the 
Commission decide to refer Lithuania to the Court of Justice. 

Attention was also being paid to the full application of the Community consultation procedure 
involving national regulatory authorities and the Commission which aims to consolidate the 
internal  market  for  electronic  communications  (Article  7  procedure).  A  key  principle  of  the 
regulatory  framework  for  electronic  communications  is  that  undertakings  should  not  be 
subject  to  economic  ex  ante  regulation  unless  they  have  been  found  to  be  dominant  in  a 
relevant  market,  on  the  basis  of  a  thorough  market  analysis  by  their  national  regulatory 
authority  (NRA).  Two  infringement  cases  against  Germany  and  Poland  were  pending, 
concerning the absence of communication to the Commission of mobile termination rates and 

281 

COM(2002) 725, of 11 December 2002. 

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costing  methodology,  and  wholesale  broadband  access  rates  and  costing  methodology 
respectively. 

An increasing area of concern has been the imposition of specific telecom taxes on providers 
of electronic communications, in contradiction with the EU rules on administrative charges, 
under which charges can be levied on telecoms operators to cover only certain administrative 
and  regulatory  costs  (mainly  authorisations  and  regulatory  functions).  Reasoned  opinions 
were sent to France and Spain in this regard. 

A second priority  concerned the protection of consumer rights. Consumer protection goes 
hand in hand with the growth and diversification of electronic communication services and a 
growing  number  of  service  providers.  Infringement  cases  in  this  respect  included:  the 
functioning  of  the  European  emergency  number  112  (Italy);  the  possibility  to  keep  one's 
number when changing telecom operators, thereby allowing consumers to fully benefit from 
competition  (Bulgaria);  an  effective  mechanism  to  settle  disputes  between  consumers  and 
service  providers  that  offers  a  more  flexible,  cheaper,  and  less  formal  alternative  to  court 
proceedings (Luxembourg); respect for consumer privacy (United Kingdom, Italy). 

The general state of implementation of the regulatory framework, monitored in close contact 
with the national authorities and other stakeholders, is reflected inter alia in the Commission’s 
sector specific annual Progress Report addressed to the European Parliament, the Council, the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions282.  The 
Commission  continued  to  monitor  implementation  of  the  Roaming  Regulation,  which,  by 
means of its extensive six-monthly roaming data collection exercise, is providing a key input 
to  the  Commission's  monitoring  activities.  The  Commission  services  also  closely  monitor 
measures taken at national level to implement the initiative on mobile satellite services (MSS) 
following  the  selection  of  operators  by  the  Commission,  notably  thanks  to  a  dedicated 
working  group  of  the  Communications  Committee  on  the  implementation  of  Decision 
2009/449/EC. 

The  Commission  monitors  the  correct  application  of  the  provisions  contained  in  the  EU 
regulatory framework, also via contacts with stakeholders and complaints received from EU 
citizens.  The  online  web  tool  'EU  Pilot',  set  up  to  provide  quicker  and  better  solutions  to 
problems  arising  in  the  application  of  EU  laws,  has  been  increasingly  used  to  facilitate 
contacts with the participating Member States on the implementation of the EU rules relating 
to electronic communications.  

Management of infringements 

As  regards  infringement  proceedings,  during  2010,  the  Commission  opened  17  new  cases, 
including  seven  cases  for  non  communication  of  measures  transposing  the  revised  GSM 
Directive (concerning Spain, France, Italy, Cyprus, Hungary, Austria, and United Kingdom). 

Seven cases were taken to the second phase with a reasoned opinion being sent to the Member 
States concerned on the following issues: the independence of the NRA – effective structural 
separation  (Romania),  fixed  number  portability  (Bulgaria),  rules  on  alternative  dispute 
resolution  (Luxembourg),  the  notification  of  mobile  termination  rates  in  accordance  with 

282 

“Progress  Report  on  the  Single  European  Electronic  Communications  Market  -  2009  (15th  Progress 
Report)”, COM(2010)253 of 25 May 2010. The report covering 2010 is not yet available.  

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Article 7 of the Framework Directive (Germany), telecom wholesale price rules (Poland) and 
administrative charges (France, Spain). 

The Commission decided to refer two cases to the Court of Justice under Article 258 TFEU: 
one concerning the independence of the NRA in Lithuania, and one on the implementation of 
rules on confidentiality of electronic communications in the United Kingdom.  

At  the  same  time,  seven  cases  were  closed  following  progress  in  Member  States.  As  the 
definition  of  subscriber  was  amended  in  Polish  law  in  line  with  the  requirements  of  the 
Framework  Directive,  the  relevant  case  was  closed  by  the  Commission.  Following 
modifications  of  the  national  law,  the  Spanish  case  related  to  universal  service,  as  well  the 
Swedish  case  in  relation  to  dispute  resolution,  have  been  closed.  As  calls  to  the  European 
emergency  number  "112"  in  Italy  became  effectively  handled,  the  relevant  case  has  been 
closed as well. Other closed cases concerned the rules for dismissal of NRA management in 
Romania  and  Slovakia.  Both  cases  could  be  closed  following  modifications  of  the  national 
law. Finally, the case of non implementation of spectrum decisions concerning the 169 MHz 
frequency  band  in  Bulgaria  was  closed  following  clarifications  provided  on  the  use  of 
frequencies for security and defence purposes in line with the said Decisions. 

On the other hand, not all the Member States have complied with the regulatory framework 
following  infringement  proceedings,  and  in  2010  the  Court  of  Justice  ruled  on  three  cases 
[Poland  (C-545/08),  Belgium  (C-222/08)  and  Portugal  (C-154/09)].  The  Commission  was 
closely following whether the judgments of the Court of Justice were fully complied with. In 
particular, as Italy was not complying with the judgement concerning the availability of caller 
location information for 112 emergency number, it was decided to refer Italy to the Court of 
Justice under Article 260 TFEU which allows imposing financial sanctions on Member States 
that have not complied with a judgement of the Court of Justice. In view of the progress made 
by Italy to comply with the judgement, the Commission decided to suspend the application to 
the  Court  of  Justice.  At  the  same  time,  the  Commission  was  able  to  close  the  case  against 
Poland (with regard to a judgement C-492/07 delivered in 2009) as the issues were resolved. 

In  addition,  the  Commission  was  able  to  close  10  presumed  infringements  based  on 
complaints. At the end of 2010, there were only two complaints pending. These complaints 
concerned  the  notification  of  mobile  termination  rates  in  Poland  and  the  rules  on 
confidentiality in Ireland in view of an alleged limited scope of the provisions implementing 
Article 5 of the ePrivacy Directive. 

The  Commission  continues  to  frequently  issue  press  releases  on  the  opened  proceedings. 
These press releases are available on the implementation and enforcement website dedicated 
to Information Society and Media sector283 together with overview tables. 

In November 2010, the European Law Academy ERA on behalf of the Commission organised 
the  5th  seminar  for  national  judges  and  the  NRAs.  The  seminar  topics  have  been  further 
expanded.  In  2009,  the  new  package  amended  substantially  the  telecom  framework  and 
brought new challenges for all the players involved including national judges and regulators. 
Furthermore, a Digital Agenda for Europe, one of the key initiatives of the EU 2020 strategy, 
has  been  adopted  in  May  2010.  The  seminars  were  well  received  and  participants  indicated 
their  strong  interest  in  the  continuation  of  such  seminars,  as  such  seminars  contribute  to 

283 

http://ec.europa.eu./information_society/policy/ecomm/implementation_enforcement/index_en.htm 

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creating a network of qualified judges applying EC telecom rules in a consistent and efficient 
manner. 

Petitions 

Six petitions on the regulatory framework were registered in 2010. These petitions concerned 
mainly Germany and Italy and involved consumer protection issues e.g. the quality of service, 
telecom  prices  including  of  national  and  international  SMS  services,  as  well  as  ePrivacy 
issues. All were answered without opening an infringement proceeding. 

European Court of Justice 

Finally, the European Court of Justice issued several important judgments on substance in the 
electronic communication area in 2010, both following infringement proceedings and requests 
for  preliminary  ruling  under  Article  267  of  the  TFEU  Treaty.  These  covered  among  others 
universal  service  -  providing  special  rates  to  certain  categories  of  low-income  or 
disadvantaged customers (C-222/08 - Commission v Belgium, C-389/08 – Base and others), 
designation  of  universal  service  provider  (C-154/09  -  Commission  v  Portugal),  broadband 
retail  regulation  without  prior  market  analysis  (C-545/08  -  Commission  v  Poland),  out-of-
court dispute resolution (C-317/08 – C-320/08 - Alassini and others), prohibition of combined 
sales  (C-522/08  –  Telekomunikacja  Polska  S.A.)  or  number  portability  –  charges  to 
subscribers (C-99/09 – Polska Telefonia). 

Changes underway 

On 20 September 2010, the Commission adopted three initiatives which are part of the Digital 
Agenda for Europe284, one of the seven flagship initiatives of the Europe 2020 strategy for 
smart, sustainable and inclusive growth285. 

Firstly, the Commission adopted a Recommendation on Regulated Access to Next Generation 
Access  (NGA)  networks,  which  sets  out  a  common  regulatory  approach  for  access  to  new 
high-speed fibre networks that requires national telecoms regulators to ensure an appropriate 
balance between the needs to encourage investment and to safeguard competition286. This is 
intended  to  provide  increased  regulatory  clarity to  all  market  players,  which  is  necessary  to 
stimulate investment in fast and ultra-fast broadband. 

Secondly, the Commission made a proposal for a Decision of the European Parliament and of 
the  Council  to  establish  a  five  year  policy  programme  to  promote  efficient  radio  spectrum 
management and, in particular, ensure that sufficient spectrum is made available for wireless 
broadband287. Efficient and competitive use of spectrum in the EU is expected to also support 
innovation in other policy areas and sectors such as transport and the environment. 

Thirdly,  the  Commission  adopted  a  Broadband  Communication  that  sets  out  a  coherent 
framework for meeting the Digital Agenda's broadband targets and, in particular, outlines how 
best to encourage public and private investment in fast and ultra-fast broadband networks288. 

284 
285 
286 
287 
288 

COM (2010)245. 
COM (2010) 202.0 
2010/572/EU, OJ L 251, 25.9.2010. 
COM(2010) 471. 
COM (2010)472. 

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It calls on EU Member States to introduce operational broadband plans for high and ultra high 
speed  networks  with  concrete  implementing  measures,  it  provides  guidance  on  how  to  cut 
investment  costs  and  indicates  how  public  authorities  may  support  broadband  investment, 
including making better use EU funds. It also announces plans by the European Commission 
and the European Investment Bank to bring forward broadband finance instruments. 

In 2010, three spectrum harmonisation Decisions were adopted by the Commission: Decision 
2010/166/EU  of  19  March  2010  on  harmonised  conditions  of  use  of  radio  spectrum  for 
mobile  communication  services  on  board  vessels,  Decision  2010/368/EU  of  30  June  2010 
amending  Decision  2006/771/EC  on  harmonisation  of  the  radio  spectrum  for  use  by  short-
range devices and Decision 2010/267/EU of 6 May 2010 on harmonised technical conditions 
of  use  in  the  790-862  MHz  frequency  band  for  terrestrial  systems  capable  of  providing 
electronic communications services. In addition, the Commission adopted a Recommendation 
on  the  authorisation  of  systems  for  mobile  communication services  on  board  vessels  (MCV 
services)289. 

Volume of enquiries and priorities 

While  the  27  Member  States  have  completed  the  formal  transposition  of  the  regulatory 
framework  in 2007,  there were still 27 proceedings for incorrect implementation pending at 
the  end  of  2010.  The  Commission  was  however  able  to  close  10  presumed  infringements 
based on complaints leaving only two complaints pending at the end of 2010. 

In  the  light  of  complaints  and  issues  raised  by  market  players  and  national  regulatory 
authorities,  priorities  remained  the  same  as  in  the  previous  year:  the  functioning  of  the 
national  regulatory  authorities,  the  application  of  the  Community  consultation  (Article  7) 
procedure, and consumer rights, including privacy. In addition, increasing attention was paid 
to administrative charges unduly imposed on telecom operators. Compliance with judgments 
of the Court of Justice continued to be an issue. 

9.2.2.  Evaluation based on the current situation 

Overall, the implementation of the regulatory framework is working to bring competition to 
electronic  communications  markets,  to  the  benefit  of  consumers  in  terms  of  prices  and 
innovation. While examples of best practice are available across the range of regulatory and 
market  issues,  there  continues  to  be  considerable  scope  for  further  benefits  to  flow  from  a 
reinforced single market, strengthened competition and a reduction in inconsistent regulation. 

A number of non-conformity and incorrect application issues remains, which require attention 
and appropriate follow-up with a continued focus on the functioning of the structural issues 
and consumer rights.  

9.2.3.  Evaluation results: priorities and planned action (2011 and beyond) 

Specific  attention  will  be  paid  in  2011  to  the  transposition  of  the  revised  regulatory 
framework  for  electronic  communications,  due  by  25  May  2011.  The  swift  and  consistent 
implementation  of  the  revised  regulatory  framework  for  electronic  communications  is  an 
explicit priority of the Digital Agenda for Europe. 

289 

2010/167/EC. 

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Priorities for 2011 regarding correct implementation are expected to remain similar to those of 
the  reporting  year.  The  number  of  cases  is  expected  to  remain  about  the  same  as  in  the 
reporting year. 

In electronic communications, monitoring is expected to focus again on structural issues, such 
as the functioning and the independence of the national regulatory authorities. Independence 
of regulators is essential for the proper functioning of the electronic communications markets, 
and has been further strengthened in the revised framework. Attention will continue to be paid 
to  the  application  of  the  Community  consultation  procedure  involving  national  regulatory 
authorities and the Commission which aims to consolidate the internal market for electronic 
communications  (Article  7  procedure).  Attention  will  also  be  paid  to  undue  administrative 
charges imposed on providers of electronic communications. 

Another priority concerns the protection of consumer rights, including privacy. This issue is 
expected to remain a priority, not least as a result of the reinforcement of several consumer 
protection provisions in the revised regulatory framework. The Commission will continue to 
closely  monitor  the  implementation  of  the  Roaming  Regulation  which  has  ensured  that 
consumers  benefited  from  significant  cost  savings  using  mobile  phones  while  in  another 
Member State. Specific attention might also have to be devoted to the monitoring of spectrum 
refarming  processes  under  the  revised  GSM  Directive  and  to  the  full  implementation  in 
accordance with the Decision on mobile satellite systems. 

9.3. 

The Audiovisual and Media 

9.3.1.  Current position 

9.3.1.1.  General introduction 

The  main  instrument  is  the  Audiovisual  Media  Services  Directive290  (hereafter  the  “AVMS 
Directive”).  In  March  2010,  a  codified  version  of  Directive  89/552/EEC  and  its  subsequent 
amendments  were  adopted291.  It  repealed  all  previous  versions  and  renumbered  the 
Audiovisual  Media  Services  Directive  as  Directive  2010/13/EU.  Non-binding  measures 
include the Recommendation on Film Heritage292 and the Recommendation on the protection 
of minors and human dignity in audiovisual and information services293. 

9.3.1.2.  Report of work done in 2010 

The  activities  focused  mainly  on  the  monitoring  and  assessment  of  the  transposition  of  the 
Audiovisual Media Services Directive (Directive 2010/13/EU). In total, 25 infringement cases 
had  to  be  opened  for  non-communication  of  measures  transposing  the  AVMS  Directive  in 

290 

291 
292 

293 

Directive  89/552/EEC  of  the  European  Parliament  and  of  the  Council  of  3  October  1989  on  the 
coordination  of  certain  provisions  laid  down  by  law,  regulation  or  administrative  action  in  Member 
States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) 
as last amended by Directive 2007/65/EC of 11 December 2007, OJ L 332 of 18 December 2007. 
OJ L 95, 15.4.2010, p. 1–24. 
Recommendation of the European Parliament and of the Council of 16 November 2005 on film heritage 
and the competitiveness of related industrial activities, OJ L 323 of 9 December 2005, p. 57. 
Recommendation  of  the  European  Parliament  and  of  the  Council  of  20  December  2006  on  the 
protection of minors and human dignity and on the right of reply in relation to the competitiveness of 
the European audiovisual and on-line information services industry, OJ L 378 of 27 December 2006, p. 
72. 

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2010.  In  June,  reasoned  opinions  were  sent  to  12  Member  States  while  many  cases  were 
closed. 

As regards correct implementation, a great deal of attention was devoted to the monitoring of 
the implementation of provisions governing commercial communications. The monitoring of 
advertising  restrictions  carried  out  by  independent  experts  covered  not  only  quantitative 
restrictions, but also qualitative aspects of TV advertising, e.g. the rules on the protection of 
minors. It addressed bother advertising and other forms of commercial communications such 
as product placement. 

In  September  2010,  the  Commission  adopted  its  ninth  report  on  the  promotion  and 
distribution  of  European  works  and  independent  production294,  and  an  accompanying  staff 
working  document295.  In  July  2010,  the  Commission  adopted  the  Second  Report  on  the 
challenges  for  European  film  heritage  from  the  analogue  and  the  digital  era.  In  November 
2010, the Council adopted Council Conclusions on film heritage, including the challenges of 
the  digital  era  (17-18  November  2010).  A  study  on  challenges  of  the  digital  era  for  film 
heritage institutions was also launched. 

Preparatory  work  for  the  first  implementation  report  of  the  Audiovisual  Media  services 
Directive  was  also  carried  out.  In  June  2010,  a  study  on  the  levels  of  Media  Literacy  in 
Member States was launched. In October 2010, a questionnaire was sent to the Member States 
regarding the implementation of the Audiovisual Media Services Directive and stricter rules 
adopted. In addition, a workshop on codes of conduct governing advertising in food high in 
fat, salt and sugar took place. 

Changes underway 

Questions faced by all Member States in the process of transposition of the AVMS Directive 
continued to be clarified at two meetings of the Contact Committee set up under Article 29 of 
the Directive as well as at one meeting of the Working Group of EU Regulatory Authorities. 
In  2010,  priority  has  been  given  to  a  thorough  examination  of  national  implementing 
measures. 

The  AVMS  Directive  changed  the  number  and  order  of  subsidiary  jurisdiction  criteria  for 
satellite (re)transmissions. In 2010, the Contact Committee completed an exercise to identify 
those  audiovisual  media  services  which  would  change  jurisdiction  at  the  end  of  the 
transposition  period  as  a  consequence  of  that  reversal  of  criteria.  In  addition,  questions 
concerning the practical application of the reporting obligation on European and independent 
works were discussed both at the Contact Committee and Regulators meetings. Finally, a call 
for  tender  for  a  study  on  the  implementation  of  the  provisions  of  the  Audiovisual  Media 
Services  Directive  concerning  the  promotion  of  European  works  in  audiovisual  media 
services was launched. 

Volume of enquiries and priorities 

In  the  light  of  complaints  and  parliamentary  questions  received  so  far,  attention  focused  on 
the following areas: television advertising, protection of minors, prohibition of incitement to 

294 
295 

COM (2010)450. 
SEC(2010)995. 

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hatred,  and  freedom  of  expression.  In  addition,  the  issue  of  events  of  major  importance  for 
society,  with  the  cases  brought  before  the  Court  of  Justice  against  the  UK  and  Belgian 
measures, has been followed closely.  

The  number  of  complaints  on  alleged  pornographic  content  transmitted  during  daytime  and 
without encryption via satellite broadcasts decreased due to the cooperation procedure put in 
place  under  the  aegis  of  the  Commission  between  regulators  as  complaints  about  alleged 
pornographic content can be addressed directly to the regulator of the complainant's country 
for  appropriate  follow-up.  Other  issues  arose  concerning  cross  border  gambling  advertising 
and  the  concurrent  application  of  the  Audiovisual  Media  Service  Directive  and  of  the 
Authorisation Directive to digital terrestrial television services.  

9.3.2.  Evaluation based on the current situation 

The transposition of the revised AVMS Directive has been delayed in many Member States. It 
is  too  early,  therefore,  to  give  a  definitive  view  on  the  benefits  of  the  review.  At  the  same 
time, the number of complaints regarding pornographic content and alleged hate speech has 
decreased, in part thanks to cooperation between national regulators. 

9.3.3.  Evaluation results: priorities and planned action (2011 and beyond) 

In general, the number of cases of infringements and petitions is expected to stay at the same 
level as in previous years. The correct implementation of the AVMS Directive is expected to 
be  central.  A  first  implementation  report  of  the  Audiovisual  Media  services  Directive  is 
expected  to  be  adopted  by  the  end  of  2011.  Monitoring  of  audiovisual  commercial 
communication rules is expected to remain central. 

9.4. 

Public Sector Information 

9.4.1.  Current Position 

9.4.1.1.  General introduction 

Public  Sector  Information  (PSI)  is  the  single  largest  source  of  information  in  Europe  (e.g. 
maps  and  satellite  images,  legislation,  statistics  and  company  registers)  and  is  used  as  raw 
material for a variety of added-value products and services. Directive 2003/98 on the re-use 
of  public  sector  information  (PSI  Directive)  aims  at  enhancing  an  effective  cross-border 
reuse of PSI and to limit distortions of competition on the EU market. 

The  Directive  is  built  around  two  pillars  of  the  internal  market:  transparency  and  fair 
competition. It contains provisions on transparency of conditions and non-discrimination, on 
prohibition of cross-subsidies and exclusive arrangements, on procedures regarding handling 
of  re-use  requests,  on  upper  limits  for  charging,  as  well  as  on  practical  means  to  facilitate 
finding and using the material available for re-use. Ultimately, the Directive aims at a change 
of  culture  in  the  public  sector,  creating  a  favourable  environment  for  the  re-use  of  its 
information resources. 

The  Commission  applies  the  principles  of  the  PSI  Directive  also  to  its  own  documents 
through  a  Commission  re-use  policy.  Commission  Decision  2006/291/EC,  Euratom  goes 
beyond the Directive by applying charges based on (at most) marginal costs and by making all 
documents  re-usable.  Examples  are  EUROSTAT’s  statistical  data,  Commission  translation 

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memories, the EU law database EUR-Lex and studies. 

9.4.1.2.  Report of work done in 2010 

In  2010,  the  Commission  completed  the  evaluation  of  national  provisions  implementing  the 
PSI  Directive  and  took  appropriate  steps  against  some  Member  States,  who  have  not 
transposed the PSI Directive correctly. In June 2010, the Commission decided to refer Poland 
to  the  Court  of  Justice  of  the  EU.  In  September  2010,  the  Commission  closed  infringement 
cases against Italy and Sweden after these Member States adopted new legislation  correctly 
implementing the PSI Directive. 

The Commission also analysed several complaints concerning incorrect application of the PSI 
Directive.  In  particular,  the  complaints  against  Denmark  and  Latvia  have  been  successfully 
dealt  with  under  the  EU  Pilot  system.  The  exchange  of  views  with  national  authorities  has 
proved that there was no need to open infringements against the Member States concerned. 

In conformity with the Commission Communication on better monitoring of the application 
of  Community  law  (COM  (2002)725),  the  Commission  continued  to  pursue  various 
accompanying  measures  in  addition  to  formal  infringement  procedures.  It  has  been  closely 
monitoring the implementation process and providing technical assistance. 

In  particular,  in  June  2010  the  Commission  organised  and  chaired  its  annual  PSI  Group 
meeting  for  Member  State  experts  and  stakeholders  with  a  view  of  providing  assistance  in 
implementation and facilitating the exchange of good practices. In addition, the Commission 
continued its deployment actions by participating in seminars and workshops organised in the 
Member  States,  networking  across  Europe  and  co-funding  a  project  for  promoting  pan-
European PSI re-use (European PSI platform). The objective of these actions is to stimulate 
developments of a stronger and more transparent environment for the PSI re-use markets. 

In  2010,  the  Commission  also  carried  out  preparatory  work  for  the  2012  review  of  the 
Directive  as  foreseen  by  the  Commission's  Communication  on  the  application  of  the  PSI 
Directive  from  2009296.  The  Commission  analysed  the  current  situation  and  collected 
information  in  view  of  an  Impact  Assessment  and  possible  legislative  proposals.  The 
Commission also organised an on-line stakeholders' consultation.  

Moreover,  the  Commission  undertook  studies  on  PSI  re-use.  As  foreseen  by  the  2009 
Communication  on  the  application  of  the  PSI  Directive,  the  Commission  carried  out  a 
comprehensive  study  for  monitoring  the  most  important  PSI  markets  and  assessing  the 
existence of possible exclusive agreements concluded by public sector bodies. Nine Member 
States  were  surveyed.  The  research  has  yielded  a  very  few  leads  to  potential  exclusive 
agreements  in  the  Member  States  and  the  overall  results  of  the  study  are  reassuring  and 
positive.  

Finally, the Commission also published a report on Economic Indicators and Case Studies on 
the  PSI  pricing  models.  Moreover,  it  launched  calls  for  tenders  on  the  assessment  of  the 
different models of supply and charging for public sector information, as well as on revised 
PSI  market  value  for  Europe.  The  results  of  these  studies  are  expected  to  contribute  to  the 
review of the PSI Directive.  

296 

COM(2009)212. 

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9.4.2.  Evaluation based on the current situation 

Directive  2003/98  on  the  re-use  of  public  sector  information  is  a  first  ever  Directive  in  this 
area. A positive evolution and progress has taken place since the adoption of the Directive. At 
the time of the adoption of the PSI Directive, the issue of the re-use was barely known to the 
Member  States  and  to  other  stakeholders.  Seven  years  later,  the  PSI  Directive  is  a  well 
established  legal  instrument,  which  focuses  the  attention  of  governments,  public  sector 
holders  and  re-users.  The  online  stakeholders'  consultation  conducted  in  autumn  2010 
gathered  around  600  replies  showing  a  keen  interest  in  the  PSI  Directive  and  in  the  re-use 
matters.  

Yet, the full potential of the PSI Directive has no been unleashed. Barriers to re-use of public 
sector information still exist. The analysis of the current situation resulting from the state of 
implementation  and  application  of  the  PSI  Directive  in  the  Member  States  as  well  as  from 
various  consultations  and  studies  should  indicate  the  most  appropriate  means  for  the 
Commission to propose in its revision of the PSI Directive.  

9.4.3.  Evaluation results 

9.4.3.1.  Priorities 

The Digital Agenda for Europe lists the revision of the PSI Directive among its key actions. 
Accordingly,  the  Commission  will  focus  on  preparation  of  the  Impact  Assessment  for  the 
revision of the PSI Directive and will envisage possible legislative amendments. Besides, the 
Commission  will  continue  its  enforcement  action  as  well  as  the  relevant  deployment 
measures.  

9.4.3.2.  Planned action (2011 and beyond) 

In  2011,  the  Commission  will  focus  on  preparing  the  Impact  Assessment  with  a  view  of  a 
further revision of the PSI Directive, planned for 2012. Taking into account the progress made 
and the results of various studies, the Commission will consider, inter alia, the possibility of 
proposing legislative amendments to the PSI Directive. 

The Commission will also continue to monitor closely implementation and application of the 
PSI  Directive  in  the  Member  States.  It  will  continue  its  enforcement  action,  by  conducting 
ongoing infringement cases and launching new ones if appropriate.  

The Commission will keep on working on its deployment actions by facilitating the exchange 
of  good  practices  and  by  providing  technical  assistance  through  close  administrative 
cooperation with the Member States, the PSI expert group, as well as through other measures 
such as the European PSI platform.  

9.4.4.  Sector summary 

A  positive  evolution  and  progress  has  taken  place.  Governments  can  stimulate  content 
markets  by  making  public  sector  information  available  on  transparent,  effective  and  non-
discriminatory  terms.  This  is  an  important  source  of  potential  growth  of  innovative  online 
services. However, the full potential of PSI re-use has not yet been unleashed. The ongoing 
works within the Impact Assessment for the review of the PSI Directive will show whether 
legislative  amendments  to  the  PSI  Directive 

are necessary.  

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In  the  meantime,  the  Commission  will  continue  to  closely  monitor  implementation  and 
application of the PSI Directive by facilitating the exchange of good practices and awareness-
raising, and by launching infringement procedures where necessary. 

More information on the re-use of public sector information:  
http://ec.europa.eu/information_society/policy/psi/index_en.htm 

9.5. 

Electronic Signatures 

9.5.1.  Current Position 

9.5.1.1.  General introduction 

The  principal  instrument  is  Directive  1999/93/EC  on  a  community  framework  for 
electronic  signatures297.  The  implementing  measures  include  the  Commission  Decision  on 
the  minimum  criteria  for  the  designated  bodies298  and  the  Commission  Decision  on  the 
generally  recognised  standards  for  some  electronic  signatures  products299.  There  were  no 
infringement proceedings open. One complaint regarding the alleged discriminatory treatment 
of  electronic  signature  solution  providers  established  in  other  member  states  than  Germany 
could be closed 2010. 

9.5.1.2.  Report of work done in 2010 

Building on the Commission Action Plan on e-signatures and e-identification to facilitate the 
provision of cross-border public services in the Single Market300, whose main objective is to 
promote  the  implementation  of  mutually  recognised  and  interoperable  electronic  signatures 
and  e-authentication  solutions  in  Europe,  Decision  2009/767/EC  was  adopted  in  2009  and 
amended by Decision 2010/425/EU in July 2010. The Decision sets out measures facilitating 
the  use  of  procedures  by  electronic  means  through  the  ‘points  of  single  contact’  under 
Directive 2006/123/EC.  

It also created an obligation for Member States to establish and publish by 28 December 2009 
their  trusted  list  of  supervised/accredited  certification  service  providers  issuing  qualified 
certificates to the public301. 

At  the  beginning  of  2010,  the  Commission  has  mandated  the  European  standardisation 
organisations  to  rationalise  the  current  electronic  signatures  standardisation  framework, 
which was expected to start at the beginning of 2011.  

9.5.2.  Evaluation based on the current situation 

To  address  problems  of  mutual  recognition  and  cross-border  interoperability  of  electronic 
signature, standardisation work has been requested to the relevant European Standardisation 

297 
298 
299 
300 
301  

OJ L 13, 19.01.2000, p.12. 
OJ L 298, 16.11.2000, p.42. 
OJ L 45, 15.07.2003, p.45. 
COM(2008)798. 
See at: http://ec.europa.eu/information_society/policy/esignature/eu_legislation/trusted_lists 

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Organisation.  In  addition,  in  its  "Digital  Agenda  for  Europe"  communication302,  the 
Commission has  proposed  a  key  action  directed  at  the  creation  of a well functioning digital 
single  market  with  a  view  to  eliminate  the  current  barriers  to  the  use  of  e-signatures  across 
Europe.  Action  focuses  on  the  revision  of  the  e-Signatures  Directive  with  the  aim  to  adapt 
existing legislation to the new technological and legal challenges of the digital world and to 
remove electronic barriers created by the Member States with the adoption of different legal 
and technical solutions.  

9.5.3.  Evaluation results: priorities and planned action (2011 and beyond) 

In keeping with the above key action, the European Commission intended to launch a public 
consultation in early 2011 on how electronic signatures and electronic identification (eID) and 
authentication can help the development of the European Digital Single Market. The results of 
this consultation will feed into the Commission's review of the existing eSignature Directive. 

10. 

MARITIME AFFAIRS AND FISHERIES 

10.1.  General introduction 

With  the  Lisbon  Treaty,  fisheries  have  become  one  of  the  areas  of  shared  competence 
between  the  Union  and  the  Member  States.  However,  the  Treaty  attributes  exclusive 
competence the Union for the conservation of marine biological resources under the common 
fisheries  policy.  This  means  that  only  the  Union  can  legislate  in  this  latter  field  unless 
Member States have been explicitly empowered to do so by a legally binding Union act. The 
objectives  for  the  common  fisheries  policy  have  been  maintained  unchanged  in  the  new 
Treaty. 

The  main  body  of  secondary  legislation  enacted  in  the  field  of  fisheries  to  date,  i.e.  the 
conservation  regime  and  the  concomitant  control  framework,  remain  matters  of  exclusive 
Union competence. The full set of rules adopted under the Common Fisheries Policy can be 
found on the following website: http://ec.europa.eu/fisheries/index_en.htm. 

The  conservation  regime  in  its  current  version  is  governed  by  the  basic  Council  Regulation 
(EC)  No  2371/2002  on  the  conservation  and  sustainable  exploitation  of  fisheries  resources 
under  the  common  fisheries  policy303.  The  control,  inspection  and  enforcement  system  is 
circumscribed by the new Council Regulation (EC) No 1224/2009 establishing a Community 
control system for ensuring compliance with the rules of the common fisheries policy304. As 
for  external  fisheries,  Council  Regulation  (EC)  No  1005/2008  establishing  a  Community 
system to prevent, deter and eliminate illegal, unreported and unregulated fishing305 serves to 
ensure compliance with international conservation and management measures. 

302 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  A  Digital  Agenda  for  Europe, 
COM(2010)245, 19.5.2010. 

303 OJ L 358, 31.12.2002, p. 59. 
304 OJ L 343, 22.12.2009. 
305 OJ L 286, 29.10.2008, p. 1. 

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10.2.  Report of work done in 2010 

Most provisions of the new Control Regulation (EC) No 1224/2009 have become applicable 
from 1 January 2010. In this context, work concentrated on the elaboration of the necessary 
implementing  rules  throughout  the  entire  year  2010.  Priority  had  also  to  be  given  to  this 
process  since  some  of  the  provisions  of  the  said  Regulation  shall  not  apply  until  after  the 
corresponding implementing rules have entered into force. In the meantime, this process has 
resulted in the adoption of Commission Implementing Regulation (EU) No 404/2011306. 

Another  priority  consisted  of  a  sustained  and,  in  the  end,  successful  control  campaign  to 
protect the important bluefin tuna stocks in the Atlantic and the Mediterranean. The control 
campaign unfolded in most sensitive circumstances, namely the attempts to list bluefin tuna 
under  the  Convention  on  Trade  in  Endangered  Species  (CITES)  in  early  2010  and  the 
identification  of  the  Union  under  the  Trade  Measures  Recommendation  of  the  International 
Commission for the Conservation of Atlantic Tunas (ICCAT) for non-compliance with certain 
conservation and management measures established by that organisation. It served to secure 
compliance with the conservation measures for this fish stock and thus to attain the twofold 
objective of full respect of the catch quotas allocated to Member States and proper discharge 
of  the  Union's  international  obligations  vis-à-vis  ICCAT.  The  campaign  resulted  in  the 
Commission's deciding early closures of the purse seine fisheries of France and Greece307 and 
of  Spain308.  The  closure  now  forms  the  subject  matter  of  an  action  in  annulment,  which  an 
operator brought before the General Court309. 

Priority  was  also  given  to  the  control  of  cod  fisheries  in  the  Baltic  Sea  in  pursuance  of  the 
control  action  plan  undertaken  by  Poland  in  the  framework  of  Council  Regulation  (EC)  No 
338/2008 providing for the adaptation of cod fishing quotas to be allocated to Poland in the 
Baltic Sea from 2008 to 2011310. Action in this field has been addressed in the Report from 
the Commission to the Council on the implementation of the Polish National Action Plan in 
the framework of Council Regulation (EC) No 338/2008311. 

On 31 May 2010, transitional derogations to the minimum mesh size and minimum distance 
from  the  coast  for  the  use  of  fishing  gear  under  Council  Regulation  (EC)  No  1967/2006 
concerning management measures for the sustainable exploitation of fishery resources in the 
Mediterranean Sea312 lapsed. This led to a sustained effort to induce Member States to ensure 
full compliance with the requirements of the said Regulation by their vessels and operators. 

On 28 May 2010, the Commission adopted Regulation (EU) No 468/2010 establishing the EU 
list  of  vessels  engaged  in  illegal,  unreported  and  unregulated  fishing313.  This  Regulation 
(together with the underlying basic Regulation (EC) No 1005/2008) has been attacked by way 
of an action in annulment brought before the General Court314. 

306 OJ L 112, 30.04.2011, p. 1. 
307 See Commission Regulation (EU) No 498/2010, OJ L 142, 10.06.2010, p. 1. 
308 See Commission Regulation (EU) No 508/2011, OJ L 149, 15.06.2010, p. 7. 
309 Case T-367/10, Bluefin Tuna Hellas Maritime Company vs. Commission. 
310 OJ L 107, 17.04.2008, p. 1. 
311 SEC(2010) 434 final 16.08.2010. 
312 OJ L 36, 08.02.2007, p. 6. 
313 OJ L 131, 29.05.2010, p. 22. 
314 Case T-337/10, Seatech International and Others vs. Council and Commission. 

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By way of its Decision of 12 November 2010, the Commission initiated the conduct by Malta 
of  an  "administrative  inquiry"  into  irregularities  that  had  become  apparent  in  the  Maltese 
scheme for the control and enforcement of conservation and management measures pertaining 
to  bluefin  tuna  in  the  Mediterranean.  This  was  the  first  case  where  the  Commission  had 
recourse to the novel compliance tools under the new Control Regulation (EC) No 1224/2009. 

Furthermore, much work had to be devoted to the adaptations of the common fisheries policy 
to the novelties introduced by the Lisbon Treaty, e.g. the switch to co-decision as the ordinary 
legislative  procedure,  delegated  powers  and  implementing  powers  as  completely  novel 
decision-making procedures, the handling of pending legislative procedures which had to be 
continued under the new Treaty provisions, the issue  of implementation  ("transposition") of 
international  conservation  and  management  measures  established  by  Regional  Fisheries 
Management Organisations and the alignment of existing basic acts on delegated powers. 

Finally,  the  preparation  of  legislative  proposals  for  the  Reform  of  the  Common  Fisheries 
Policy entered its decisive phase in the second semester of 2010. 

In this context, work mainly concentrated on those cases where infringement proceedings had 
already  resulted  in  judgements  of  the  Court,  i.e.  the  driftnet  cases  against  France315  and 
Italy316  and  the  case  concerning  the  landing  and  marketing  of  undersized  fish  in  Spain317. 
Regular  contacts  with  Member  States  continued  and  inspection  missions  were  conducted 
throughout  the  year  2010  in  order  to  verify  whether  and  to  what  extent  the  Member  States 
concerned have complied with the respective judgments of the Court. 

Apart from that, the policy of formally bringing each detected instance of non-compliance to 
the Member States' attention was continued and led to a consistent use of the EU Pilot. 

10.3.  Evaluation based on the current situation 

Compliance  with  and  enforcement  of  applicable  rules  is  a  cornerstone  of  the  Common 
Fisheries Policy given that violations adversely affect the conservation and sustainable use of 
fisheries resources with possibly grave consequences in the longer term. Still, Member States' 
compliance records lack coherence. 

There  is  also  a  link  with  the  status  of  fish  stocks  and  the  endemic  overcapacity  of  the 
Community fishing fleet. Where fishing opportunities decrease, Member States should step up 
their control and enforcement efforts. 

The  new  Control  Regulation  (EC)  No  1224/2009  has  brought  into  focus  that  a  credible 
conservation policy presupposes strict compliance with and enforcement of applicable rules. 
The  new  control  system  has  introduced  manifold  novel  compliance  tools  vis-à-vis  both 
operators  (e.g.  a  point  system  for  serious  infringements)  as  well  as  Member  States  (e.g. 
administrative inquiries and action plans, strengthened conditionality of financial assistance, 
closure of fisheries and or deduction of catch quotas for failures to comply with the objectives 
of the common fisheries policy and emergency measures). 

315 Judgement of 05.03.2009 in Case C-556/07, Commission vs. France. 
316 Judgement of 29.10.2009 in Case C-249/08, Commission vs. Italy. 
317 Judgement of 22.12.2008 in Case C-189/07, Commission vs. Spain. 

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Those  new compliance tools will ensure that the Commission stays with its core  activity of 
controlling and verifying the implementation of the rules of the Common Fisheries Policy by 
Member  States.  They  strengthen  the  Commission's  capacity  to  intervene  proportionately  to 
the level of non-compliance and, when applied properly either in separate procedures or, as 
the case may be, synchronised with infringement proceedings, they allow for a well-measured 
co-operative and at the same time decisive approach towards compliance failures on the side 
of  Member  States.  It  is  expected  that  this  will  enhance  compliance  records  at  Union  level, 
bring  about  a  level  playing  field  in  this  area  and  result  in  a  genuine  compliance  culture 
eventually. 

It is also expected that this will tackle one other feature of compliance failures in the fields of 
fisheries,  namely  the  fact  that,  in  most  cases,  non-compliance  consists  of  administrative 
malpractice  on  the  side  of  Member  States.  The  new  compliance  tools  will  allow  handling 
general  and  ongoing  failures  such  that  infringement  proceedings  can  then  be  instituted  in 
those cases which can make a difference. 

10.4.  Evaluation results 

10.4.1.  Priorities 

The most tangible result was that a systematic approach to infringements could be upheld and 
that  priority-setting  and  anticipatory  planning  has  become  the  common  denominator  of  all 
control activities carried out by DG MARE in 2010. 

It was also decisive that the first case of recourse to the novel compliance tools under the new 
Control  Regulation  (EC)  No  1224/2009,  namely  the  administrative  inquiry  into  the  Maltese 
system  for  the  control  of  conservation  and  management  measures  pertaining  to  the  most 
sensitive bluefin tuna stock, was possible in 2010. 

Furthermore,  most  of  the  pre-contentious  cases  opened  in  2010  could  be  resolved  in  a 
satisfactory manner via the EU Pilot. 

10.4.2.  Planned action (for 2011 and beyond) 

Conceptual work on the synchronisation of the novel compliance tools under the new Control 
Regulation (EC) No 1224/2009 and infringement proceedings will be completed in 2011 with 
due regard to the first experiences that can be gained in the application of those novel tools. 

Ongoing  infringement  cases  will  be  handled  in  such  a  way  that  the  underlying  compliance 
failures by Member States can be removed or, if ever Member States persevered, can result in 
appropriate operational follow-up (mainly in those cases where the Common Fisheries Policy 
is particularly put at risk, e.g. illegal driftnetting). 

In the context of the reform of the Common Fisheries Policy, the Commission plans to present 
a proposal for a root-and-branch reform in the course of 2011, which will give priority to a 
long-term  perspective  and  which  will  re-emphasise  the  decisive  importance  of  compliance 
and of the rule of law as indispensable building blocks of the policy. 

10.5. 

Summary 

In  the  fields  of  fisheries,  the  finality  of  all  preventive  and  repressive  action  is  to  ensure  the 

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effectiveness  of  conservation  and  management  measures  adopted  under  the  Common 
Fisheries  Policy.  Yet,  Member  States  much  too  often  favour  short-term  solutions  when  it 
comes  to  compliance  with  and  the  enforcement  of  applicable  rules.  The  new  Control 
Regulation  (EC)  No  1224/2009  has  brought  into  focus  that  a  credible  conservation  policy 
presupposes strict compliance with and enforcement of applicable rules. 

The  Common  Fisheries  Policy  is  based  on  the  provisions  of  Article  3,  4  and  38  to  43  of 
TFEU. The full set of existing rules adopted under the Common Fisheries Policy can be found 
on the following website: http://ec.europa.eu/fisheries/index_en.htm . 

11. 

INTERNAL MARKET AND SERVICES 

11.1. 

Freedom to provide services and freedom of establishment (other than financial 
services) 

Current position 

General introduction 

The  relevant  legal  framework  for  this  sector  consists  of  Article  49  of  the  Treaty  on  the 
Functioning  of  the  European  Union  (TFEU)  on  the  freedom  of  establishment  as  well  as  of 
Article 56 of the TFEU on the freedom to provide services.  

This framework is complemented by a number of Internal Market Directives which develop 
these freedoms as regards specific service activities or specific legal aspect (Postal Services 
Directive318, the Directive on the legal protection of conditional access services319 and the E-
commerce Directive320 ). 

It  is  also  complemented  by  Directive  2006/123/CE  on  services  in  the  Internal  Market321,  a 
horizontal  instrument  adopted  in  December  2006  which  had  to  be  implemented  by  the 
Member  States  by  the  end  of  2009.  In  addition  to  the  two  Comitology  decisions  already 
adopted  in  2009322,  a  Comitology  decision  has  been  adopted  on  the  28th  of  July  2010 
regarding  the  establishment,  maintenance  and  publication  of  trusted  lists  of  certification 
service providers supervised/accredited by Member States.323 

318 

319 

320 

321 
322  

323  

Directive  2008/6/EC  of  the  European  Parliament  and  of  the  Council  of  20  February  2008  amending 
Directive 97/67/EC with regard to the full accomplishment of the internal market of Community postal 
services, OJ L 52, 27.2.2008. 
Directive 98/84/EC of the European Parliament and of the Council of 20 November 1998 on the legal 
protection of services based on, or consisting of, conditional access - OJ L 320, 28.11.1998, p. 54–57. 
Directive 2003/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal 
aspects  of  information  society  services,  in  particular  electronic  commerce,  in  the  Internal  Market 
(Directive on electronic commerce), OJ L 178 of 17.7.2000, p. 1. 
O.J. L 376/36 of 27.12.2006. 
One  on  the  use  of  the  Internal  Market  Information  System  ("IMI")  for  the  exchange  of  information 
between administrations as foreseen in the Services Directive (Commission Decision 2009/739/EC of  
2 October 2009, OJ L 263 of 7 October 2009) and another one on practical arrangements concerning the 
use of electronic procedures in the Points of Single Contact (Commission Decision 2009/767/EC of 16 
October 2009, OJ L 299 of 14 November2009). 
Commission Decision 2010/425/EU amending Decision 7009/767/EC, OJ L 199 of 31 July 2010. 

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Report of work done in 2010 

A. Management of legislation, including in committees and working groups 

The  Services  Directive  sets  out  a  comprehensive  modernisation  programme  for  national 
administrations and is more than just a piece of European legislation to be implemented into 
national  law.  Until  the  end  of  2010  Member  States  have  adopted  more  than  1.000 
implementing  laws,  some  of  which  were  "omnibus  laws"  containing  dozens  of  changes  to 
different pieces of legislation. At the same time, the Commission maintained its commitment 
from  2007  to  provide  assistance  and  guidance  to  Member  States  throughout  the  whole 
implementation process. As in 2009, bilateral meetings have been held with Member States as 
well as meetings of the “Expert Group on the implementation of the Services Directive” on 
specific  questions  of  the  implementation.  The  main  aim  of  those  meetings  was  to  ensure  a 
similar level of understanding by all Member States of the work required and the priorities for 
action. 

An important and major part of the work carried out in 2010 concerned the "mutual evaluation" 
process, an innovative and evidence-based exercise of "peer review" foreseen by the Services 
Directive.  By  putting  in  place  a  structured  dialogue  between  Member  States  it  has  created 
transparency as to the results of the implementation of the Services Directive and it has helped 
identify and promote good regulatory practices. Discussions have also helped to foster a habit 
of  dialogue.  Following  the  agreement  in  October  2009  of  the  High  Level  Group  of  the 
Competitiveness Council, the Commission and Member States on the methodology to use for 
what  was  to  be  a  major  exercise  involving  30  countries324  and  covering  close  to  35.000 
requirements, work started in 2010 with Member States meeting between January and March 
in "clusters"  of five countries each to  discuss the situation in those individual countries and 
prepare  further  discussions.  It  then  continued  between  March  and  October  with  "plenary 
meetings"  at  which  specific  requirements  and  the  main  services  sectors  covered  by  the 
Directive  were  examined325.  Interested  parties  were  called  upon  to  provide  their  views  in  a 
public consultation which was conducted between the end of June and mid September 2010. 

Taking the results of the process of "mutual evaluation" of the Services Directive as a starting 
point,  the  Commission  adopted  a  Communication326  setting  out  an  ambitious  work 
programme that should improve and further develop the Single Market for services. 327 

As  regards  the  Points  of  Single  Contact  (PSC),  a  so  called  "first  generation"  of  PSC's  is  in 
place  in  22  Member  States.  In  five  Member  States  (Greece,  Italy,  Romania,  Slovenia  and 
Slovakia) the electronic PSCs are not operational yet. Even if progress has been achieved with 

324 

325 

326  

327  

The  three  EFTA  countries  part  of  the  EEA  Agreement  -  Iceland,  Lichtenstein  and  Norway-  also 
participated. 
The  following  services  sectors  were  identified  by  Member  States  as  a  priority:  construction  and 
property related services, tourism and related services, food and beverage services, services of regulated 
professions,  wholesale  and  retail  services,  business  services  and  private  education  services.  The 
Services Directive Committee was informed on the results of the process at its meeting of 15 October 
2010. 
"Towards  a  better  functioning  Single  Market  for  services  –  building  on  the  results  of    the  mutual 
evaluation process of the Services Directive" - Communication from the Commission to the European 
Parliament,  the  Council,  the  European  Economic  and  Social  Committee  and  the  Committee  of  the 
Regions, COM (2011)20. 
See below section on "Evaluation based on current position". 

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regard to the online completion of procedures though the PSC, difficulties remain as to their 
cross  border  use.  Technical  solutions  for  the  identification  and  authentication  of  service 
providers, e-signatures and e-documents rely mostly on national means and their recognition 
and/or  validation  is  not  always  ensured.  In  order  to  facilitate  the  cross-border  use  of  e-
procedures, and in particular the use of e-signatures, the Commission has so far adopted two 
Decisions  (2009/767/EC  and  2010/425/EU).  The  first  Decision  had  in  particular  obliged 
Member States to establish so-called trusted lists (TLs) of their certification service providers 
(who  issue  qualified  certificates)  in  order  to  facilitate  verification  of  certificates  for  e-
signatures.  The  second  Decision  (2010/425/EU)  obliges  Member  States  to  provide  machine 
processable  forms  of  these  TLs  which  means  that  applications  can  be  created  to  automate 
their  use.  This  greatly  facilitates  the  cross-border  validation  of  e-signatures.  Given  that  the 
TLs can be used very widely, not limited to the use under the Services Directive, the impact 
of  the  Decision  has  been  widely  recognised  by  stakeholders,  including  commercial 
application  builders  who  have  already  put  in  place  some  commercial  services  based  on  the 
TLs.  The  Commission  has  created  a  central  list  of  Member  States'  TLs  which  further 
facilitates their use. 

A  number  of  Member  States  are  also  cooperating  in  the  framework  of  the  Competitiveness 
and  Innovation  Programme  (CIP)  Large  Scale  Pilot  "Simple  Procedures  Online  for  Cross-
border  Services"  (SPOCS)328.  16  Member  States  participate  in  SPOCS  directly  and  the  rest 
can  rely  on  the  results  of  SPOCS  when  they  so  wish.  SPOCS  should  lead  to  additional 
technical solutions for more user friendly PSCs329.  

Enhanced  PSCs,  as  fully  fledged  e-Government  centres  have  also  been  highlighted  as  a 
priority in the recently adopted "Digital Agenda for Europe"330. Beyond the legal obligations 
foreseen by the Services Directive, Member States are encouraged to make available via their 
PSCs  additional  services  that  are  vital  for  supporting/encouraging  their  use  and  that  are 
strongly  called  for  by  the  business  community  and  the  European  Parliament,  such  as 
procedures  relating  to  taxation  (registration  for  VAT  or  income  tax)  or  social  security 
registration.331  Another  prerequisite  to  stimulate  cross-border  trade  is  the  provision  of 
information  and  forms  in  other  EU  languages  through  the  PSCs.  11  Member  States  already 
provide  translations  to  varying  degrees  (mostly  in  English  and/or  the  language(s)  of 
neighbouring countries). Most other Member States have plans to provide translated content 
of their PSCs in the near future. 

328  

329  

330  
331  

CIP  pilots  are  financed  half  by  the  Commission  (DG  INFSO)  and  half  by  the  consortium  where  in 
addition to Member States, academia, and industry is present. The involvement of industry is essential 
to ensure the practical take up of solutions developed. 
SPOCS also enhances the PSCs with additional technical solutions for content syndication (to have the 
data on PSCs updated each time a change takes place for example at a relevant authority's webpage). It 
also foresees some assistance for businesses with mapping the documents that are required in Member 
States as some documents may exist in one Member State and not in another or they may have different 
names (like anti-maffia declarations which could be an extract of penal register in another one). 
"A Digital Agenda for Europe", COM(2010) 245 final/2. 
This  is  strongly  called  for  by  the  European  Parliament  in  its  recently  adopted  report  on  the 
See:  
implementation 
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A7-2011-
0012&language=EN  

(2010/2053(INI). 

Directive 

Services 

the 

of 

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Concerning  the  use  of  IMI,  the  "Internal  Market  Information  System"332,  the  network  of 
authorities  registered  in  IMI  for  the  purposes  of  administrative  cooperation  in  the  area  of 
services  is  consolidating.  End  of  2010  there  were  around  5200  authorities  which  had  been 
registered  in  the  system  across  the  Member  States  to  deal  with  information  exchanges  on 
service  providers.  The  number  of  registered  authorities  varies  widely  according  to  the 
Member  States  depending  on  their  size,  their  administrative  structure  and  their  choice  to 
organise their network of authorities in a more centralised or decentralised manner. In general, 
a solid structure for administrative cooperation appears to be in place in the large majority of 
Member States.  

Article  20(2)  of  the  Services  Directive  requires  Member  States  to  make  sure  that  service 
recipients,  in  particular  consumers,  are  not  made  subject  to  discriminatory  requirements 
imposed by service providers on grounds of their nationality or place of residence. In 2010 the 
Commission has continued its work in order to ensure that this non-discrimination obligation 
is correctly implemented by Member States and enforced by national authorities and courts. 
In  particular,  building  on  the  results  of  the  study  on  business  practices  liable  to  fall  under 
Article  20  carried  out  by  an  external  contractor  throughout  2009,  the  Commission  has 
discussed the first experiences with the application of national legislation implementing this 
provision  with  Member  States  and  consumer  assistance  bodies.  Based  on  this  work,  the 
Commission  intends  to  publish,  by  the  end  of  2011,  guidelines  to  Member  States  aiming  at 
facilitating the practical application of this provision. 

Concerning the assistance for recipients of services as foreseen in Article 21 of the Services 
Directive, a meeting of national bodies providing assistance to recipients of services, business 
as well as consumers, when they want to have access to services from another Member State 
was  held  on  1st  October  2010.  First  experiences  of  the  network  as  well  as  members' 
experiences in cases of discrimination on the basis of nationality/place of residence have been 
discussed. 

B. Management of Infringements 

In  order  to  ensure  that  work  is  speeded  up  in  the  Member  States  that  had  not  yet  finalised 
implementation  of  the  Services  Directive,  the  Commission  sent  in  June  2010  a  reasoned 
opinion  for  non-communication  of  the  national  transposition  measures  of  the  Services 
Directive to 12 Member States.333 

The control of the application of Articles 49 and 56 of TFEU remains an important task. 
Infringement proceedings in 2010 concerned the various areas of the Internal Market. 

As in previous years, a number of infringement procedures concerned health services: 

•  The  Commission  referred  Germany  to  the  Court  of  Justice334  over  its  rules  on 
reimbursement of cost of care services received in other Member States. The German 
rules  on  care  insurance  scheme  ("gesetzliche  Pflegeversicherung")  provide  that  care 
services  received  during  a  temporary  stay  in  another  Member  State  will  not  be 

332  

333  

334  

IMI  is  an  electronic  network  which  allows  for  direct  communication  and  exchange  of  information 
between  competent  authorities  in  different  Member  States  and  thus  facilitates  the  administrative 
cooperation required by the Services Directive. 
Austria, Belgium, Cyprus, France, Germany, Greece, Ireland, Luxemburg, Portugal, Romania, Slovenia 
and the United Kingdom – see IP/10/821. 
IP/10307. 

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reimbursed  to  the  same  level  as  care  services  received  within  Germany.  On  several 
occasions, 
to  receive 
the  Court  of  Justice  has  recognised  patients'  rights 
reimbursement  of  medical  expenses  incurred  in  other  Member  States  through  their 
health insurances. In the Commission's view, the same rule also applies in relation to 
care services received in other Member States. 
In another case concerning the reimbursement of medical expenses, Slovakia received 
a  reasoned  opinion335  as  under  Slovak  legislation,  patients  from  Slovakia  cannot  be 
certain that they will be reimbursed for medical treatment received in other Member 
States in line with the principle of the freedom to provide services.  

• 

•  Denmark  received  a  reasoned  opinion336  because  Danish  law  does  not  allow  the 
recognition  of  medical  prescriptions  issued  by  a  doctor  in  another  Member  State 
(except for Sweden and Finland). In the Commission's view, this is not justified by the 
public health reasons cited by the Danish authorities, especially given the fact that the 
medicines will be delivered on the basis of a medical prescription legally issued by a 
doctor in another Member State. Furthermore, Swedish and Finnish prescriptions have 
been recognised for some time without having produced the harmful effects claimed 
by the Danish authorities. 

The Court delivered four decisions C-211/08 of 15.06.2010, C-173/09 of 5.10.2010 
(preliminary ruling) C-512/08 of 5.10.2010 C-490/09 of 27.1.2011 relating to the issue of 
reimbursement of healthcare in another Member State, out of which three were actions for 
failure to fulfil obligations referred by the Commission. 

According  to  the  judgement  of  15June  2010,  patients  who  need  to  receive  unscheduled 
healthcare because of their state of health during a temporary stay in another country will be 
reimbursed the amount that is reimbursable under the legislation of the Member State where 
the treatment is received. This is in line with the European Health Insurance card provided for 
by  Regulation  1408/71  now  883/2004.  However,  in  certain  cases  the  reimbursed  amount  is 
lower than the amount which would have been reimbursed if the healthcare had been provided 
in  the  patient's  home  country.  The  Court  considered  that  the  restrictions  to  the  freedom  to 
provide hospital treatment services, tourist services or educational services (even in particular 
for the situation of elderly persons or of those suffering from chronic or pre-existing illness) 
alleged  by  the  Commission  were  too  uncertain  and  indirect.  The  Court  considered  that  the 
mechanisms  established  by  Regulation  1408/71  were  based  on  the  principle  of  overall 
compensation of risks and should be respected.  

In  its  preliminary  ruling  of  5th  October  2010,  the  Court  confirmed  its  case-law  regarding 
reimbursement of hospital care. The Court confirmed that Article 56 TFUE and Article 22 of 
Regulation  1408/71  could  apply  at  the  same  time.  Regarding  Article  56  TFUE,  the  Court 
considered that national legislation which excludes, in all cases, reimbursement in respect of 
hospital treatment given in another Member State without prior authorisation amounts to an 
unjustified  restriction  to  the  freedom  to  provide  services.  The  Court  clarified  that 
reimbursement  of  medical  costs  without  the  prior  authorisation  provided  for  by  Article  22 
(1)(c)(i) of Regulation 1408/71 can only be required within the limit of the cover provided by 
the sickness insurance scheme of the Member State of registration of the patient.  

In a judgement also delivered on 5th October 2010, the Court considered that an authorisation 
may  be  required  for  the  reimbursement  of  non  hospital  treatments  when  these  treatments 

335  
336  

IP/10/505. 
IP/10/505. 

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require  the  use  of  major  medical  equipment,  such  as  the  ones  exhaustively  listed  in  the 
national  legislation  at  issue,  which  are  especially  onerous  and  therefore  made  subject  of  a 
planning policy and subsidies in the Member State of affiliation and subsidised by it.  

Finally, in its judgement of 27th January 2010 , the Court declared that, by failing to provide a 
reimbursement  mechanism  regarding  costs  of  laboratory  analyses  and  tests  carried  out  in 
another Member State, Luxembourg has failed to fulfil its obligations under Article 56 TFEU. 
By contrast, the Court considered that the Commission failed to place before the Court all the 
information  needed  to  enable  the  Court  to  establish  that  the  dispensing  conditions  for 
laboratory analyses and tests were incompatible with Article 56 TFUE.  

Regarding  the  freedom  of  establishment,  the  Court  delivered  on  16  December  2010  a 
judgement  relating  to  restrictions  on  the  ownership  by  non-biologists  of  a  stake  in  a  firm 
operating biological analysis laboratories. Like in its judgments regarding "pharmacies", the 
Court  stated  that  such  restrictions  were  justified  by  the  protection  of  public  health,  were 
appropriate for securing attainment of this objective and did not go beyond what is necessary 
for  attaining  that  objective.  By  contrast,  the  Court  considered  that  by  prohibiting  biologists 
from  holding  shares  in  more  than  two  companies  formed  in  order  to  operate  jointly  one  or 
more biomedical analysis laboratories, the French Republic has failed to fulfil its obligations 
under Article 49 TFUE. 

In other areas, the Commission has sent a reasoned opinion to the Netherlands337, asking the 
Member  State  to  review  its  rules  on  the  posting  of  workers  who  do  not  (yet)  enjoy  free 
movement within the EU. Under Dutch rules, businesses must obtain work permits for certain 
staff members before they can be temporarily posted to the Netherlands to perform services. 
This applies to staff members from Bulgaria and Romania, as well as to staff members from 
non-EU  countries  who  live  and  work  legally  in  the  Member  State  of  their  employer.  The 
Commission considered that this work permit requirement constitutes a breach of the rules of 
the Treaty regarding the freedom to provide services.  

The  Commission  has  also  decided  to  take  action  against  Belgium  before  the  Court  of 
Justice338  for  failure  to  fulfil  its  European  obligations  by  requiring  self-employed  service 
providers  from  other  Member States  to  make  a  prior  declaration  before  being  able  to 
provide  temporary  services  in  Belgium  (so  called  'Limosa'  declaration).  The  fact  that  the 
Belgian  authorities  in  a  general  way  are  making  the  exercise  of  a  fundamental  freedom 
subject  to  a  prior  administrative  step  is  a  serious  restriction  on  the  freedom  to  provide 
services.  In  order  to  be  compatible  with  EU  law,  such  a  restriction  must  be  justified  and 
proportionate according to the consistent rulings of the Court. But the justifications cited by 
the Belgian authorities regarding self-employed workers have not convinced the Commission. 

The Commission has also decided to refer Belgium to the Court of Justice339 over its rules on 
temporary  employment  agencies.  According  to  EU  principles,  any  company  providing  a 
service  in  a  Member  State  (in  conformity  with  the  national  law  in  force)  has  the  right  to 
provide the same service without restrictions in all other Member States. However, Belgium 
imposed  a  number  of  requirements  on  temporary  employment  agencies  established  in  other 

337  
338  
339  

IP/10/304. 
IP/10/680. 
IP/10/307 

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Member States that wish to provide their services in Belgium.340 In particular, their scope was 
limited to activities related to human resources and they had to take on a specific legal form. 
In  the  Commission's  view,  these  requirements  were  disproportionate  and  had  the  effect  of 
limiting competition in this field. This situation was also likely to disadvantage employers and 
Belgian workers who used the services of these companies. 

In the area of patent agents, Portugal was referred to the Court while Austria received a letter 
of formal notice requesting full information on its execution of the Court's ruling of 11 June 
2009 (Case C-564/07). Despite its stated intention to change its rules in this area, Portugal still 
requires  any  patent  agent  established  in  a  Member  State  who  wishes  to  act  before  the 
Portuguese  trademarks  and  patent  office  as  a  temporary  service  provider  to  be  registered  in 
advance  with  and  be  accredited  by  the  Portuguese  authorities.  Furthermore,  registration  is 
subject  to  a  prior  check  on  professional  qualifications.  In  the  Commission's  view,  these 
requirements  breach  EU  rules  on  the  freedom  to  provide  services  and  the  recognition  of 
professional qualifications.  

A reasoned opinion was sent to Greece341 asking for an amendment of its legislation on the 
minimum prices that lawyers should charge for their services. The Commission considered 
that these national rules have the effect of restricting lawyers from other Member States from 
operating in Greece and limiting the range of legal services on offer to Greek citizens.  

The Court issued a ruling on 21 January 2010 in which it considered the bilateral agreement 
concluded  between  Germany  and  Poland  on  work  contracts  in  Germany  to  be  applied  in  a 
discriminatory  way.  Only  German  undertakings  could  call  on  Polish  subcontractors  for  the 
performance of work contracts in Germany. Undertakings established in other Member States 
that  were  considering  providing  services  in  Germany  could  not  benefit  from  the  agreement 
and  thus  could  not  call  on  Polish  subcontractors  to  provide  their  services.  The  Commission 
held  the  view  that  such  an  interpretation  neither  complied  with  EU  Treaty  rules  on  the 
freedom  to  provide  services  nor  with  the  rules  of  the  Treaty  of  Accession.  Following  the 
Court  ruling,  Germany  accepted  to  modify  the  interpretation  it  had  given  so  far  of  the 
provisions  of  the  said  agreement.  Consequently  the  Commission  closed  its  infringement 
proceedings against Germany.  

In  its  ruling  of  18  November  2010,  the  Court  confirmed  its  case  law  on  the  temporary 
provision  of  services  by  condemning  Portugal  for  its  legislation  relating  to  construction 
services which did not make any distinction between establishment and temporary provision 
of services. 

The Commission decided on 18 March 2010 to close infringement proceedings against France 
concerning restrictions on the establishment of retail stores which were incompatible with 
Article  49  TFEU,  following  the  adoption  of  a  new  legislation  in  2008  and  the  application 
measures in 2009.  

On establishment of pharmacies, the Court of Justice, on 1 June 2010, ruled in Joined Cases 
C-570/07  and  C-571/07  that  Article  49  TFEU,  in  principle,  does  not  preclude  national 
legislation that provides for a minimum distance between pharmacies of 250 metres and for a 
minimum number of 2800 inhabitants per pharmacy. Nevertheless, it considered that Article 

340  
341  

Certain of these restrictions have been lifted in 2010.
IP/10/498 

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49 TFEU precludes such national legislation in so far as the basic ‘2 800 inhabitants’ and ‘250 
metres’ rules prevent, in any geographical area which has special demographic features, the 
establishment  of  a  sufficient  number  of  pharmacies  to  ensure  adequate  pharmaceutical 
services.  It  left  it  to  the  national  court  to  ascertain  this.  Finally,  the  Court  ruled  that  the 
Asturias provisions that benefited those applicants for a pharmacy licence with experience in 
Asturias are incompatible with Article 49 TFEU. 

In  July  2010,  the  Commission  decided  to  refer  Greece  to  the  Court  of  Justice  regarding 
restrictions  on  the  establishment  of  petrol  stations.  The  Commission  challenged,  in 
particular,  the  incoherence  of  the  provisions  relating  to  the  location  of  new  petrol  stations' 
installations, the need to provide a fire safety study certified by a sworn expert registered in 
Greece  and  the  minimum  distances  between  petrol  stations.  The  referral  was  suspended  in 
September  2010  as  the  adoption  of  a  new  legislation  was  planned  for  November.  The  new 
Greek law was finally adopted on 7.12.2010. It is currently under examination. 

As  far  as  Concessions  are  concerned,  the  Commission  challenged  the  Italian  legislation 
concerning authorisations for the public domain (beaches), which granted a preference to the 
outgoing  holder  of  the  authorisation.  Following  the  letter  of  formal  notice,  the  Italian 
authorities  amended  the  law,  but  the  new  provisions  still  foresee  a  restriction,  notably  the 
automatic renewal of the authorisation. A complementary letter of formal notice was sent in 
May  2010.  In  their  reply,  the  Italian  authorities  notified  a  draft  law  abolishing  the 
abovementioned restriction.  

Concerning the question of restrictions on land acquisition, the European Commission sent 
on 28.6.2010 a reasoned opinion to Germany to ensure non-discriminatory treatment for EU 
citizens  with  regard  to  the  sales  of  land  by  municipalities,  as  a  number  of  them  have 
introduced for the sale of land a special system aimed at favouring residents. The Commission 
considers that these provisions of German municipalities do not comply with the principles of 
non-discrimination,  free  movement  of  EU  citizens,  free  movement  of  workers,  freedom  of 
establishment  and  free  movement  of  capital.  Germany  replied  to  the  reasoned  opinion  on 
28.10.2010. The reply is currently under examination. 

In the area of gambling services, the Commission services continued bilateral dialogue with 
Member  States  seeking  to  address  issues  raised  in  the  infringement  proceedings.  The 
Commission  decided  on  5  May342  and  24  November343  to  close  infringement  proceedings 
against  Italy  and  France  respectively  following  the  adoption  of  new  legislation  in  both 
Member States that allows for the cross border provision of on-line gambling services, with 
clear  rules  for  the  authorisation  and  the  granting  of  licences  to  domestic  and  European 
operators.  On  3  June  2010,  the  Court  of  Justice  ruled344  that  Article  56  TFEU  does  not 
preclude  legislation  that  gives  a  single  operator  exclusive  rights  to  offer  gambling  services 
and prohibits any other operator from doing the same in the relevant territory. The Court ruled 
that the principle of equal treatment and the consequent obligation of transparency applies to 
procedures for the granting or renewing of a gambling licence to a single operator, if it is not 
given  to  a  public  operator  whose  management  is  subject  to  direct  State  supervision  or  a 
private  operator  whose  activities  are  subject  to  strict  control  by  the  public  authorities.  The 

342  
343 
344  

IP/10/504. 
IP/10/159.7 
Case C-203/08, Sporting Exchange Ltd, trading as ‘Betfair’, v Minister van Justitie. 

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Court also ruled345 that national legislation, which seeks to curb addiction and combat fraud, 
can  be  regarded  as  limiting  betting  activities  in  a  consistent  and  systematic  manner  even 
where  the  holder(s)  of  an  exclusive  licence  may  introduce  new  games  and  advertise  their 
supply of gambling services. In so far as an implementing measure is necessary to ensure the 
effectiveness of that legislation and does not include any additional restriction over and above 
that  which  arises  from  the  legislation  itself,  national  courts  are  not  required  to  determine 
further,  in  each  case,  the  suitability  or  proportionality  of  the  measure  to  reach  the  stated 
objective. 
On  8  July  2010346  the  Court  of  Justice  ruled  that  Article  56  TFEU  does  not  preclude 
prohibitions  on  advertising  of  gambling  organised  for  the  purposes  of  profit  by  private 
operators in other Member States. However, a Member State subjecting gambling to a system 
of  exclusive  rights  cannot  make  promotion  of  gambling  organised  in  another  Member  State 
subject  to  stricter  penalties  than  the  promotion  of  gambling  operated  on  national  territory 
without a licence.  

In the first of three cases adopted on 8 September 2010347 the Court declared that, by reason 
of  the  primacy  of  directly-applicable  Union  law,  national  legislation  concerning  a  public 
monopoly for sports betting services which comprises restrictions that are incompatible with 
Articles 49 and 56 TFEU cannot continue to apply during a transitional period.  

In  the  second  case348  the  Court  ruled  that  national  authorities  that  seek  to  justify  a  public 
monopoly by an objective to combat gambling addiction and prevent incitement to squander 
money  do  not  necessarily  have  to  produce  a  study  establishing  the  proportionality  of  the 
measure which is prior to its adoption. Moreover, the choice to use a monopoly, in the context 
of  a  non-exclusive  legislative  framework,  may  satisfy  the  requirement  of  proportionality,  as 
regards  the  objective  of  a  high  level  of  consumer  protection,  if  there  is  a  legislative 
framework  for  the  establishment  of  the  monopoly  suitable  for  ensuring  it  will  be  able  to 
pursue  this  objective  in  a  consistent  and  systematic  manner.  The  fact  that  the  competent 
national  authorities  may  be  confronted  with  difficulties  in  ensuring  compliance  with  such  a 
monopoly, due to the online offer of gambling services by operators established outside that 
Member State, is not capable of affecting the potential conformity of such a monopoly with 
the Treaty. The national court may consider that such a monopoly is not suitable to achieve 
the objective for which it was established if it finds that (a) a monopoly is seeking, through 
advertising,  to  increase  participation  in  its  other  types  of  gambling  services  to  maximise  its 
revenue;  (b)  other  gambling  services  are  offered  by  licensed  private  operators;  and  (c)  the 
competent authorities are conducting or tolerating policies of expanding supply of gambling 
services not covered by the monopoly, with a higher potential risk of addiction, again with a 
view to maximising revenues. Finally, an operator having an authorisation to offer gambling 
services in its Member State of establishment, does not prevent another Member State, while 

345  

346  

347  
348  

Case C-258/08, Ladbrokes Betting & Gaming Ltd/Ladbrokes International Ltd v Stichting de Nationale 
Sporttotalisator. 
In  Joined  Cases  C-447/08  and  C-448/08,  criminal  proceedings  against  Otto  Sjöberg  (C-447/08)  and 
Anders Gerdin (C-448/08). 
Case C-409/06, Winner Wetten GmbH v Bürgermeisterin der Stadt Bergheim. 
Joined  Cases  C-316/07,  C-358/07 
to  C-360/07,  C-409/07  and  C-410/07,Markus  Stoß 
(C-316/07),Avalon  Service-Online-Dienste  GmbH  (C-409/07)  and  Olaf  Amadeus  Wilhelm  Happel 
(C-410/07)  v  Wetteraukreis  and  Kulpa  Automatenservice  Asperg  GmbH  (C-358/07),  SOBO  Sport  & 
Entertainment GmbH (C-359/07) and Andreas Kunert (C-360/07) v Land Baden-Württemberg. 

EN 

263 

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complying with the requirements of European Union law, from making such operator subject 
to an authorisation issued by its own authorities.  
In the third case349, the Court ruled that an operator holding an authorisation to offer online 
sports betting services only to persons located outside the territory of its seat of establishment 
and wishing to offer services to such persons does not cease to fall within the scope Article 56 
TFEU. The national court may legitimately be led to consider that a regional public gambling 
monopoly  is  not  suitable  to  achieve  the  objective  of  reducing  and  limiting  gambling 
opportunities in a consistent and systematic manner if that court at the same time establishes 
that: (a) other types of games of chance may be exploited by authorised private operators; and 
that  (b)  the  competent  authorities  pursue  policies  of  expanding  supply  of    games  of  chance 
falling  outside  the  said  monopoly  and  which    pose  a  higher  risk  of  addiction  than  those 
subject to the monopoly, in particular with a view to maximising revenue. A system of prior 
authorisation for the supply of certain gambling services, which derogates from the freedom 
to  provide  services,  may  satisfy  the  requirements  of  Article  56  TFEU  only  if  it  is  based  on 
objective  and  non-discriminatory  criteria  known  in  advance,  in  such  a  way  as  to  limit  the 
discretion  of  national  authorities  so  that  it  is  not  used  arbitrarily.  National  legislation 
prohibiting  the  provision  of  on-line  gambling  services  for  the  purposes  of  preventing  the 
squandering  of  money  on  gambling,  combating  gambling  addiction  and  protecting  young 
persons may be regarded as suitable for pursuing such legitimate objectives, even if the offer 
of such games remains authorised through more traditional channels. 

On  9  September,  the  Court  of  justice  ruled  that  Article  49  TFEU  must  be  interpreted  as 
precluding national legislation under which only operators whose seat is in the territory of that 
Member  State  may  offer  gambling  services  in  gambling  establishments.  Moreover,  the 
obligation  of  transparency  flowing  from  Articles  49  and  56  TFEU  precludes  the  grant  of 
concessions to operate gaming establishments without any competitive procedure350. 

Evaluation based on the current position 

In  2010,  the  work  continued  on  the  control  of  the  correct  implementation  of  the  Services 
Directive by Member States as well as on the carrying-out of the so called “mutual evaluation 
process”.  The  main  results  of  the  mutual  evaluation  process  were  presented  by  the 
Commission in a communication of 27 January 2011.351As regards the implementation of the 
Services  Directives  most  Member  States  have  informed  the  Commission  that  they  have 
completed  their  implementation  work.  However  some  Member  States  still  need  to  finalise 
their work. In particular in two Member States the adoption of the horizontal legislation has 
accumulated serious delays.  

Concerning  infringement  procedures,  the  Commission  focused  in  particular  on  those  areas 
which are not covered by the Services Directive. 

Evaluation results 

349 

350  
351  

Case  C-46/08,  Carmen  Media  Group  Ltd  v  Land  Schleswig-Holstein,  Innenminister  des  Landes 
Schleswig-Holstein. 
Case C-64/08, criminal proceedings against  Ernst Engelmann. 
"Towards  a  better  functioning  Single  Market  for  services  –  building  on  the  results  of    the  mutual 
evaluation process of the Services Directive" - Communication from the Commission to the European 
Parliament,  the  Council,  the  European  Economic  and  Social  Committee  and  the  Committee  of  the 
Regions, COM (2011)20. 

EN 

264 

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(a) Priorities 

The overall assessment of the "mutual evaluation" process is very positive. It has allowed the 
drawing  up  of  a  detailed  picture  of  the  state  of  an  important  part  of  the  Single  Market  for 
services. It has been the first time that Member States and the Commission have carried out 
together  a  thorough  assessment  of  national  rules  affecting  service  activities.  This  concerned 
rules at national, regional and local level as well as rules set by professional associations with 
regulatory  powers.  In  that  respect,  mutual  evaluation  has  had  an  unprecedented  "Single 
Market  effect"  within  Member  States  as  all  levels  of  national  administrations  were  called 
upon  to  critically  assess  their  own  rules  and  those  existing  in  other  Member  States  from  a 
Single  Market  perspective.  Finally,  this  process  has  also  proven  to  be  a  valuable  tool  to 
identify  remaining  obstacles  for  the  Single  Market  and  to  lay  the  basis  for  future  policy 
actions in the service sector. 

Concerning gambling services, the Directorate-General for Internal Market and Services held 
a Conference on 12 October 2010 jointly with the Belgian Presidency. It is expected that pro-
active  work  on  gambling  services  will  be  a  priority  in  2011  through  the  launch  of  a  public 
consultation on online gambling in the Internal Market. 

(b) Planned actions (2011 and beyond) 

Based  on  the  report  on  the  results  of  the  mutual  evaluation  process  and  as  set  out  in  the 
Communication  "Towards  a  better functioning Single  Market for services –  building  on the 
results  of  the  mutual  evaluation  process  of  the  Services  Directive"352,  the  Commission  will 
continue  and  step  up  work  with  Member  States  on  an  individual  basis  so  as  to  achieve  a 
complete  and  correct  transposition  and  implementation  of  the  Services  Directive  in  all 
Member  States.  A  series  of  bilateral  meetings  with  those  Member  States  where  there  are 
strong indications of incorrect or incomplete implementation of the Services Directive will be 
held.  

In parallel, a first economic assessment of the actual implementation of the Directive and of 
its impact on the functioning of the services markets will be carried out by the Commission in 
2011.  

The  Commission,  based  on  Member  States'  input  as  to  the  specific  sectors  that  should  be 
examined, will launch a so called "performance check" of the Single Market for services. 
The aim will be to assess the situation from the perspective of the users of the Single Market. 
The  performance  check  should  provide  an  assessment  of  how  different  pieces  of  EU 
legislation are applied and how they work on the ground. It should also allow the formulation 
of sector-specific conclusions on the functioning of the Single Market for services within one 
year in a report to the European Parliament and the Council and, where necessary, identify the 
need for other actions, including legislative intervention if required.  

Targeted  actions  aimed  at  tackling  remaining  regulatory  barriers  unjustifiably  hindering  the 
potential  of  the  Single  Market  for  services  will  also  be  undertaken.  There  will  be  an 
assessment of the issue of reserves of activity focussing in particular on areas where the link 
with the professional qualification required warrants further discussion. This should be done 
in view of the need to achieve more integrated services markets offering high quality services 

352  

idem. 

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as demanded by service recipients. Another assessment will be launched to better understand 
the manner in which restrictions on capital ownership and legal form affect certain services 
sectors  and  to  gather  evidence  on  the  economic  effects  of  these  rules.  In  addition  the 
difficulties for cross-border service providers resulting from insurance requirements will be 
examined  first  with  stakeholders,  including  the  insurance  industry,  with  a  view  to  finding 
practical  solutions.  On  the  basis  of  these  assessments  and  the  findings  of  the  "performance 
check" the Commission will decide by 2012 on possible specific initiatives. 

In order to ensure that the freedom to provide services clause in Article 16 of the Services 
Directive  is  applied  properly  and  consistently  in  all  Member  States,  the  Commission  will 
closely monitor its application and discuss its findings with all Member States. This process 
can  be  built  upon  the  Services  Directive  itself,  which  already  foresees  that  the  Commission 
reports on the functioning of this clause. The monitoring should, to a large extent, be based on 
the collection of information and views from Member States and stakeholders. In this respect 
the Commission will issue its first annual guidance on the application by Member States of 
the freedom to provide services clause and the evolution of cross-border service provision in 
the Single Market by the end of 2011.  

In 2011, the Commission will also work with Member States to consolidate the notification 
system in the Services Directive and to help providing guidance to national administrations as 
to  its  operation.  By  the  end  of  2012,  the  Commission  will  report  on  the  functioning  of  the 
system and the need for a targeted extension of its scope of application. 

And finally, in order to ensure that service providers, in particular SMEs, do not give up on 
testing markets across borders simply because it is made too difficult by  regulatory barriers 
and  in  order  to  enforce  their  rights  in  the  Single  Market,  the  Commission  will  assess  the 
effectiveness of means of redress available at national level to service providers for breach of 
their Single Market rights by national administrations and decide on next steps by the end of 
2012. 

As regards the "Points of Single Contact", the Commission will continue to cooperate with 
Member States in order to improve the practical functioning of the existing PSCs with the aim 
to  make  them  more  user-friendly  and  useful  for  entrepreneurs,  both  as  regards  the 
availability/presentation  of  information  and  the  availability  and  ease  of  the  completion  of 
procedures online both within a Member State and across borders. This work will be carried 
out through the so called "EUGO" network of national PSC experts (set up in 2010) to serve 
as  a  forum  for  the  exchange  of  good  practice,  benchmarking  of  PSCs  and  development  of 
common solutions at EU level. In 2011 the Commission will also carry out a large external 
benchmarking  study  to  assess  the  usability  of  the  PSCs  from  a  business  perspective  and  to 
identify  the  need  for  further  action.  The  results  of  this  study  will  be  presented  at  a  large 
conference, to take place in Brussels on 28 November 2011.  

Furthermore  the  Commission  will  continue  to  work  with  Member  States  to  further  enhance 
the cross-border use of e-procedures via PSCs. A new Decision is to be adopted that should 
improve  Member  States'  capacities  to  process  e-signatures  to  facilitate  the  verification  of 
documents  signed  electronically  by  public  authorities.  In  order  to  assist  Member  States  to 
implement  the  Decision,  open  source  software  for  the  creation/validation  of  common  e-
signature  formats  is  being  developed  by  an  outside  contractor  for  Member  States'  use  at 
national level. 

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SPOCS Pilot will continue and start testing in real life the technical solutions put in place.  

At  a  more  horizontal  level,  interoperability  of  electronic  tools,  such  as  electronic  signatures 
and  electronic  identification  is  to  be  enhanced  via  the  forthcoming  revision  of  the  "e-
signatures"  Directive353.  Such  interoperability  is  a  key  priority  in  the  context  of  the  "Single 
Market Act". 

Work will also continue in 2011, 

• 

• 

to monitor and improve the use of IMI for the administrative cooperation obligations 
under the Directive;  
to  support  the  network  of  assistance  to  recipients  of  services  and  all  other  measures 
contained  in  the  Directive  to  benefit  consumers  (e.g.  obligation  for  business  not  to 
discriminate  consumers  because  of  their  residence)  and  to  improve  the  quality  of 
services.  

Concerning infringement proceedings and enquiries, the Commission will continue to use EU 
Pilot according to set priorities or alternative problem solutions mechanisms such as SOLVIT. 
The efficient use of resources has to be taken in account, notably due to the vast variety of 
restrictions  concerning  the  Internal  Market.  As  in  previous  years,  the  enforcement  of  the 
Treaty  rules  on  the  freedom  to  provide  services  and  the  freedom  of  establishment  will 
continue to focus in particular on areas not covered by the Services Directive as well as on 
cases  of  clear  discriminations  or  cases  concerning  entire  categories  of  services  providers. 
Considering  the  emphasis  the  Commission  will  put  on  the  control  of  implementation  of  the 
Services  Directive,  infringement  proceedings  for  incorrect  implementation  of  this  Directive 
will be treated as priority. 

In the area of postal services and related logistics: 

Current position 

With  the  deadline  for  the  implementation  of  the  3rd  Postal  Directive  approaching,  the  main 
focus in 2010 was the continued provision of assistance to Member States in the run up to the 
complete implementation of the postal acquis.  

As  part  of  direct  assistance  to  Member  States,  numerous  bilateral  meetings  were  held  with 
ministries  and  national  regulatory  authorities;  these  meetings  took  place  with  all  Member 
States  that  are  in  the  first  group  to  implement  the  3rd  Postal  Directive  and  several  of  the 
second group. These meetings focused on delivering advice and guidance as well as providing 
preliminary evaluations of draft legislation under preparation by national authorities. In many 
instances, these meetings helped improve the quality of draft legislative texts. 

With a view to ensuring the proper implementation of the Postal Directive, a wide range of 
transposition issues was also taken forward in the framework of a series of Working Groups 
convened under the auspices of the Postal Directive Committee.  

353  

Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a EU 
framework for electronic signatures. 

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267 

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Building upon the recommendations of the sector study on the Role of Regulators in a More 
Competitive  Postal  Market354  and  following  the  activities  already  undertaken  in  2009,  the 
Commission established the European Regulators Group for postal services (ERGP)355. This 
expert  advisory  group  should  serve  as  a  body  for  reflection,  discussion  and  advice  to  the 
Commission in the postal services field.  

It  should  facilitate  consultation,  coordination  and  cooperation  between  the  independent 
national  regulatory  authorities  in  the  Member  States,  and  between  those  authorities  and  the 
Commission, with a view to consolidating the internal market for postal services and ensuring 
the consistent application in all Member States of the postal acquis. 

Evaluation based on the current position 

Two  sector  studies  were  delivered  and  presented  to  stakeholders  at  the  end  of  September 
2010.356  The  first  study  on  Main  developments  in  the  postal  sector  between  2008-2010, 
provided a clear overview of the developments and changes underway in the postal sector and 
assessed  the  impact  of  recent  market  and  regulatory  developments  on  postal  markets, 
especially  in  relation  to  the  provision  of  universal  service,  employment  in  the  postal  sector 
and the impact of the VAT exemption on markets. The second study presented the external 
aspects  of  the  EU  postal  acquis,  especially  in  relation  to  the  ongoing  trade  negotiations 
(multilateral and bilateral) and the acts of the Universal Postal Union.    

The  findings  of  sector  studies,  combined  with  complaints  from  stakeholders  focusing  on  an 
incorrect interpretation and uneven application of the postal acquis by some Member States, 
are  being  used  by  the  Commission  to  curtail  bad  market  practices  (e.g.  predatory/excessive 
pricing),  tackle  and  remove  regulatory  barriers  to  entry  (e.g.  excessive  and  burdensome 
licence  conditions,  access  to  the  postal  infrastructure)  and  ensure  the  timely  and  correct 
implementation of the postal acquis. 

Market  monitoring  is  being  enhanced  and  supported  also  through  the  provision  and 
publication  of  more  comprehensive  key  data  on  postal  markets  in  the  EU  (in  close  co-
operation with EUROSTAT). 

Evaluation results 

(1) 

Priorities  

Following  its  establishment  in  August  2010  and  adoption  of  the  Work  Programme  in 
December of the same year, the objectives of this Group are to ensure greater coherence in the 
operation of the postal regulatory model, exchanging best regulatory practices and "regulatory 
know  how",  notably  with  less  well  resourced  national  regulators,  and  contributing  to  the 
consolidation of the internal market for postal services. The priority for 2011 would therefore 
be  to  deliver  on  adopted  work  programme  and  to  develop  best  regulatory  practices  in 
identified areas, which should contribute to the attainment of common objectives.  

354  
355  

356  

Available at: http://ec.europa.eu/internal_market/post/doc/studies/2009-wik_regulators.pdf.  
Commission  Decision  of  10  August2010  establishing  the  European  Regulators  Group  for  Postal 
Services (ERGP), OJ C 217. 
Available  at:  http://ec.europa.eu/internal_market/post/doc/studies/2010-main-developments_en.pdf  and 
http://ec.europa.eu/internal_market/post/doc/studies/2010-wik-external-dimension_en.pdf.  

EN 

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Another  priority  would  be  the  assessment  of  the  transposition  measures  concerning  the  3rd 
postal  directive  (directive  2008/6/EC)  for  which  the  deadline  for  16  Member  States  has 
expired on 31 December 2010.  

(2) 

Planned action (2011 and beyond) 

The  European  Commission  and  the  Spanish  Presidency  co-hosted  a  High  Level  Conference 
on Postal Services in Valencia on 29-30 April 2010. The Conference provided a unique forum 
for  informal  discussion  on  the  prerequisites  for  successful  market  opening,  ensuring  greater 
competitiveness  across  the  postal  sector  and  overcoming  the  challenges  faced  by  regulatory 
bodies. Commission departments will follow up on the results of such conference and more in 
particular on the implementation of the postal reform which was recognised as the key issue. 

11.2.  Financial Services 

The financial services sector includes three major areas for which similar European policies 
apply: banking, insurance and securities. The objective of the EU secondary legislation is to 
facilitate the establishment and the cross-border provision of services for financial institutions 
on the basis of the home country control principle. In addition to these main areas, financial 
services legislation covers occupational pensions payments and retail financial services. 

11.2.1.   Banking 

Current position  

General introduction 

As  regards  infringement  proceedings  in  the  banking  sector,  the  Commission  mainly  dealt 
with non-communication cases. As regards the transposition of Directive 2007/44/EC which 
lays  down  the  procedures  and  criteria  for  the  prudential  assessment  of  acquisitions  and 
increase of holdings in the financial sector357, seven infringement cases against Greece, Spain, 
Italy, the Netherlands, Poland, Portugal and the United Kingdom due to non-communication 
of  the  national  transposition  measures  before  the  deadline  of  21  March  2009,  initiated  in 
2009, were still pending in 2010. Three cases were closed following to the notification of the 
implementing measures by the Member States concerned, while four cases – against Greece, 
Portugal,  Poland  and  the  Netherlands  –  were  referred  to  the  Court  of  Justice.  Out  of  these 
cases,  three  were  settled  in  Court  further  to  the  complete  implementation  of  the  directive, 
whereas  the  case  against  the  Netherlands  resulted  in  a  Court's  judgment  establishing  the 
failure of this country to transpose Directive 2007/44/EC in December 2010358. 

The  Commission  also  launched  infringement  proceedings  against  seventeen  Member  States 
for  non-communication  of  the  implementing  measures  of  Directive  2009/14/EC  which  has 

357  

358   

Directive 2007/44/EC of the European Parliament and of the Council of 5 September 2007 amending 
Council Directive 92/49/EEC and Directives 2002/83/EC, 2004/39/EC, 2005/68/EC and 2006/48/EC as 
regards  procedural  rules  and  evaluation  criteria  for  the  prudential  assessment  of  acquisitions  and 
increase of holdings in the financial sector (OJ L 247, 21.9.2007, p. 1–16). 
Judgment of the Court of 16 December 2010 in Case C-233/10, European Commission v Kingdom of 
The Netherlands. 

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amended the EU rules on deposit guarantee schemes359. 14 cases were already closed in 2009 
and the remaining three cases in 2010 (against Slovenia, Finland and Greece). 

In November 2010, 17 infringement proceedings were started against several Member States 
for failure to transpose Directive 2009/111/EC360. This Directive is part of the first package of 
changes to the Banking Directive 2006/48 (also known as "Capital Requirements Directive" 
or CRD) adopted in response to the financial crisis in order to strengthen prudential rules and 
supervision. The whole package of amendments had to be implemented in national law by the 
end of 2010. The other instruments of the package are two Commission Directives361 which 
have  made  technical  amendments  to  the  Annexes  of  the  CRD.  Parallel  infringement 
proceedings were also launched against the same 17 Member States for non-communication 
of the measures implementing these technical directives.  

Report of work done in 2010 

Further  changes  to  the  CRD  to  strengthen  rules  on  bank  capital  regarding  bank  trading 
activities  and  on  remuneration  policies  in  the  banking  sector  were  adopted  in  December 
2010362.   

A  Directive  improving  depositor  protection  was  proposed  in  July  2010  and  is  now  being 
negotiated363.  It  follows  Directive  2009/14/EC364,  which  only  dealt  with  selected  issues  to 
improve  depositor  confidence 
the  financial  crisis.  The  new  proposal  marks  a 
comprehensive  revision  and  notably  improves  consumer  protection  and  the  financing  of 
Deposit Guarantee Schemes. 

in 

In  August,  the  Commission  proposed  a  first  revision  of  the  Financial  Conglomerates 
Directive365,  aimed  at  enabling  supervisors  to  apply  group  related  provisions  in  banking, 
insurance  and  supplementary  conglomerates  rules  at  the  level  of  the  ultimate  parent 
undertaking, regardless of its legal statute. 

In preparation of future legislative proposals, the Commission launched a public consultation 
regarding the putting in place of an EU framework for crisis resolution in the banking sector 

359  

360  

361  

362  

363  
364  

365  

Directive  2009/14/EC  of  the  European  Parliament  and  of  the  Council  of  11  March  2009  amending 
Directive 94/19/EC  on  deposit-guarantee  schemes  as  regards  the  coverage  level  and  the  payout delay  
(OJ L 68, 13.3.2009, p. 3–7). 
Directive 2009/111/EC of the European Parliament and of the Council of 16 September 2009 amending 
Directives 2006/48/EC, 2006/49/EC and 2007/64/EC as regards banks affiliated to central institutions, 
certain own funds items, large exposures, supervisory arrangements, and crisis management. 
Commission Directive 2009/27/EC of 7 April 2009 amending certain Annexes to Directive 2006/49/EC 
of  the  European  Parliament  and  of  the  Council  as  regards  technical  provisions  concerning  risk 
management  (OJ  L  94,  8.4.2009)  and  Commission  Directive  2009/83/EC  of  27  July  2009  amending 
certain  Annexes  to  Directive  2006/48/EC  of  the  European  Parliament  and  of  the  Council  as  regards 
technical provisions concerning risk management (OJ L 196, 28.7.2009). 
Directive 2010/76/EU of the European Parliament and of the Council of 24 November 2010 amending 
Directives 2006/48/EC and 2006/49/EC as regards capital requirements for the trading book and for re-
securitisations, and the supervisory review of remuneration policies , OJ L329 of 14.12.2010.  
COM 2010/368 and 369. 
Directive 2009/14/EC of 11 March 2009 amending Directive 94/19/EC on deposit-guarantee schemes 
as regards the coverage level and the payout delay  (OJ L 68, 13.3.2009). 
COM(2010) 433 final. 

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and issued a communication on bank resolution funds. Consultations were also carried out in 
preparation of further proposed amendments to the CRD scheduled for 2011366.   

Evaluation results 

The  Commission's  strategy  to  encourage  early  and  consistent  transposition  in  this  area  is  to 
help  Member  States  through  the  'Capital  Requirements  Directive  Transposition  Group' 
(CRDTG). In 2010, the CRDTG has been busy providing clarifications, answering questions 
and  assisting  Member  States  in  the  transposition  of  new  legislation.  Currently  about  400 
answers are posted on its website367. 

(1) 

Priorities  

The main priorities in the banking area concern the preparation of legislative proposals aimed 
at  improving  regulation,  strengthening  supervision  and  developing  a  regime  for  dealing 
effectively with bank crisis. Co-operation with Member States will  continue to  ensure good 
preparation and coherent implementation of the law, through Committee and working group 
discussions, including further work of the CRDTG. 

(2) 

Planned action (2011 and beyond) 

The Commission will continue to monitor the implementation and application of the banking 
legislation across the EU.  

A further legislative proposal incorporating the new Basel III regulatory framework for banks 
in EU law is expected to be adopted by the Commission in July 2011. These proposals will 
significantly  strengthen  the  prudential  requirements  for  credit  institutions  and  investment 
firms and such the overall financial stability. The proposal will also include measures related 
to the Commission's efforts to create a single rule book for banking in the EU. In this regard, a 
regulation  appears  to  be  the  most  efficient  legal  instrument  to  achieve  such  objective. 
Therefore,  the  legislative  proposal  will  comprise  two  elements:  a  proposal  for  a  new 
regulation in banking and a proposal amending the CRD.  

A  more  comprehensive  review  of  the  Directive  on  Financial  Conglomerates  is  planned  in 
2011. The Commission will launch a consultation about a more fundamental revision of this 
Directive, following up developments at G20 level regarding the supplementary supervision 
of groups with material activities in financial markets beyond one regulated sector. 

Other  legislative  work  is  envisaged  in  2011  to  address  the  problem  -  surfaced  during  the 
financial crisis - of the absence of a coherent and comprehensive EU regime for dealing with 
cross-border bank crisis. The Commission intends to present a proposal for a new framework 
for bank recovery and resolution in September 2011.  

11.2.2.   Insurance and occupational pensions 

Current position 

366  
367  

The consultations are published at http://ec.europa.eu/internal_market/bank/regcapital/index_en.htm  
http://ec.europa.eu/internal_market/bank/regcapital/transposition_en.htm 

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In 2010, 5 files related to insurance and occupational pensions were opened in EU Pilot,1 in 
SOLVIT,.  11  infringement  cases  were  closed  and  one  was  referred  to  the  Court.  Bilateral 
contacts were held with the Member States either through package meetings, other (ad hoc) 
meetings or in the relevant sector committees. 

As  regards  the  non-communication  cases  launched  in  the  insurance  sector  with  regard  to 
Directive 2005/68/EC (the reinsurance Directive), the only case still under examination was 
closed in 2010.  

As regards motor insurance, the infringement case against the UK for non-communication of 
the  transposing  measures  of  Directive  2005/14/EC  (judgement  of  3.9.2009  in  Case  C-
2008/457) was closed in 2010. 

In 2010, the Court ruled that the Czech Republic had failed to transpose Directive 2003/41/EC 
on the institutions for occupational pension funds (Case C-343/08, judgement of 14 January 
2010).  The  procedure  under  Article  260  TFEU  was  launched  thereafter.  Several  other 
proceedings were launched concerning this Directive in 2010. 

In  2010,  the  Court  rendered  its  judgement  in  an  important  case  concerning  the  Belgian 
sickness  funds  ("mutualités/ziekenfondsen"),  which  offer  complementary  health  insurance 
without respecting the solvency rules of directives 73/239/EEC and 92/49/EEC (1st and 3rd 
non-life  insurance  Directives).  In  its  ruling  of  28  October  2010  (C-41/10),  the  Court  found 
that  Belgium  had  breached  those  Directives.  The  procedure  under  Article  260  TFEU  was 
launched thereafter. 

As regards petitions a total of 5 petitions were handled on insurance and pensions. They dealt 
inter alia with motor insurance, life assurance, non-life insurance (especially health insurance) 
and pension funds. About 168 queries of other nature concerned the insurance and pensions 
sector. 

The  key  change  and  challenge  ahead  is  the  proposal  for  a  directive  called  "Solvency  II" 
Directive  which  was  adopted  in  2009  and  is  to  be  transposed  by  late  2012.  The  Directive 
provides for a transposition period of about 3 years so that implementing measures needed to 
make  the  new  framework  completely  operational  are  adopted  beforehand.  Intensive  work 
intended  to  prepare  its  transposition  and  proper  application  continued  in  2010  and  will 
continue  through  2012.  It  is  furthermore  necessary  to  adapt  this  Directive  to  the  changes 
brought by the new regulatory architecture for financial services and notably the Regulation 
which  set  the  European  Insurance  and  Occupational  Pensions  Authority  (EIOPA)  in 
December 2010. A key year is the one of 2011, when the Commission tables the Omnibus 2 
Directive proposal, adapting Solvency II to the changes introduced by the EIOPA Regulation 
mentioned above, and the proposal of the Level 2 implementation measures. It is intended to 
modernise  the  evaluation  and  calculation  of  risks  and  therefore  will  provide  for  a  new, 
prospective, and economic and risk based approach putting much greater emphasis on sound 
risk management and robust internal controls by insurance undertakings. In addition Solvency 
II will also profoundly influence the way in which supervision is carried out by the competent 
supervisory authorities. It also contains a new approach as regards insurance groups. It is far 
too early to anticipate what will be the effects and consequences of the new Directive. 

Evaluation based on the current position 

Conformity  check  of  Directives  transposed 

remains  a  key  challenge.  In  the  insurance 

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sector,    comprehensive  and  updated  concordance  tables  allow  for  the  checking  of  the 
substantive conformity of the transposition. 

The implementation of the Directive on Reinsurance (2005/68/EEC) was due by 10.12.2007, 
but  not  all  Member  States  had  completed  their  transposition  process  by  that  date.  The 
checking of the completeness of the communication of the transposition of the said Directive 
has been completed. Focus has since shifted to a more in-depth and comprehensive look at the 
substance of the transposition measures. 

In the insurance sector, breache of EU law have generally a considerable impact in economic 
terms  and  in  terms  of  proper  functioning  of  the  relevant  market  both  for  undertakings  and 
final  users.  A  level  playing  field  is  particularly  affected  because  breaches  either  limit  the 
possibilities of competitors to stay on the market or allow national companies to offer services 
without fulfilling the obligations imposed by EU legislation. It also has consequences for the 
services and products that are offered to the consumers. 

The  number  of  complaints  and  infringement  cases  is  likely  to  increase  or  at  least  remain 
broadly stable in 2011-2012 mainly due to increasing awareness of citizens of their rights in 
all  27  Member  States.  The  economic/financial  crisis  may  have  repercussions  on  national 
measures  and  subsequently  on  complaints.  Priority  will  be  given  to  cases  of  non-
communication  of  transposition  measures,  non-respect  of  Court  judgments  and  cases  that 
show a breach of a fundamental freedom or principle of the TFEU or a breach of a Directive 
which is blatant. 

The main structural problems result from the complexity of the legislation adopted sometimes 
in  several  steps  according  to  the  Lamfalussy  process.  To  tackle  this  problem,  seminars 
explaining  the  legislation  have  already  been  organised  and  regular  contact  with  Member 
States is maintained via the relevant Committees and their working groups and also by using 
the  package  meetings  and  other  ad  hoc  meetings.  For  the  Solvency  II  proposed  Directive  a 
longer  transposition  period  (of  around  3  years)  is  planned  (with  the  so  called  "level  2" 
the  final 
measures  under 
implementation date). The same complexity creates problems in transposition which may also 
be  of  substance  (problems  of  interpretation,  for  instance,  or  of  misapplication,  either  in 
general or in specific individual cases). 

the  Lamfalussy  process  adopted  around  1  year  before 

Evaluation results 

(1) 

Priorities 

The main priority will be the ongoing work on the "level 2" measures as regards the Solvency 

II Directive. The checking of recently to be transposed Directives, notably Directive 

2005/68/EC on reinsurance, will be continued. 

To  ensure  timely  and  effective  problem  solving,  an  efficient  co-operation  with  the  Member 
states as well as an efficient management of infringement proceedings will be pursued. 

(2) 

Planned action (2011 and beyond) 

As  for  insurance  legislation,  preliminary  Guidance  on  the  transposition  of  Solvency  II  has 

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started in close co-operation with the Member States and will continue through to 2012. 

A detailed checking of the substance of the transposition of Directive 2005/68/EC by the 

Member States will be continued and completed by the Commission services. Failure to fully 
implement  these  Directives  prevents  the  creation  of  a  level  playing  field  and  could 
conceivably affect reinsurance undertakings and the reinsurance market in a negative way. 

The  package  meetings  (and  other  meetings)  with  Member  States,  as  well  as  the  use  of  EU 
Pilot, will be continued in order to tackle problems in this respect. 

11.2.3.   Securities 

Current position 

(1) 

General introduction 

'Securities markets' legislation includes the following (main) directives and regulations:  

a.  Directive  on  Markets  in  Financial  Instruments  2004/39/EC368  (MiFID)  and  its 
implementing  provisions  (Commission  Directive  2006/73/EC369  and  Commission 
Regulation  1287/2006370),  which  regulate  the  provision  of  investment  services  and 
activities  in  the  EU  and  for  the  trading  activity,  including  the  operation  of  regulated 
markets and multilateral trading facilities (MTF) and the rules applicable to systematic 
internalisers.  

b.  Investor  Compensation  Scheme  Directive  1997/9/EC371  (ICSD)  introducing  a 
compensation  for  investors  having  lost  their  assets  as  a  result  of  the  failure  of  an 
intermediary providing investment services.  

c.  Market  Abuse  Directive  2003/6/EC 

texts 
(Commission  Directive  2003/124/EC373,  Commission  Directive  2003/125/EC374, 

implementing 

its 

(MAD)372  and 

368

369   

370   

371   

372   

373   

374   

Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in 
financial  instruments  amending  Council  Directives  85/611/EEC  and  93/6/EEC  and  Directive 
2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC 
(OJ L 145, 30.4.2004, p. 1). 
Directive  2006/73/EC  of  10  August  2006  implementing  Directive  2004/39/EC  of  the  European 
Parliament  and  of  the  Council  as  regards  organisational  requirements  and  operating  conditions  for 
investment firms and defined terms for the purposes of that Directive (OJ L 241, 2.9.2006, p. 26). 
Regulation  (EC)  No  1287/2006  of  10  August  2006  implementing  Directive  2004/39/EC  of  the 
European  Parliament  and  of  the  Council  as  regards  record-keeping  obligations  for  investment  firms, 
transaction  reporting,  market  transparency,  admission  of  financial  instruments  to  trading,  and  defined 
terms for the purposes of that Directive (OJ L 241, 2.9.2006, p. 1–25). 
Directive  97/9/EC  of  the  European  Parliament  and  of  the  Council  of  3  March  1997  on  investor-
compensation schemes (OJ L 84, 26.3.1997, p. 22–31). 
Directive  2003/6/EC  of  the  European  Parliament  and  of  the  Council  of  28  January  2003  on  insider 
dealing and market manipulation (market abuse) (OJ L 96, 12.4.2003, p. 16–25). 
Directive  2003/124/EC  of  22  December  2003  implementing  Directive  2003/6/EC  of  the  European 
Parliament and of the Council as regards the definition and public disclosure of inside information and 
the definition of market manipulation (OJ L 339,  24.12.2003, p. 70–72). 
Directive  2003/125/EC  of  22  December  2003  implementing  Directive  2003/6/EC  of  the  European 
Parliament and of the Council as regards the fair presentation of investment recommendations and the 
disclosure of conflicts of interest (OJ L 339, 24.12.2003, p. 73–77). 

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Commission Regulation 2273/2003375, Commission Directive 2004/72/EC376), whose 
aim is to prevent and to fight against insider dealing and market manipulation.  

d.  Prospectus  Directive  2003/71/EC377  and  its  implementing  Regulation  809/2004378 
regulating the obligation to produce a prospectus and the content of the prospectus to 
be published when securities are offered to the public or admitted to trading in the EU.  
e.  Regulation  (EC)  No  1060/2009  of  the  European  Parliament  and  of  the  Council  on 

credit rating agencies 

(2) 

Report of work done in 2010 

Concerning the application of the acquis, in the area of securities markets, the Commission 
service  continued  with  the  quality  check  of  the  implementation  of  the  respective  acquis.  In 
this regards the following cases need to be mentioned: 

Markets  in  Financial  Instruments  Directive  (MiFID).  Concerning  Poland,  the  Polish 
authorities  notified  to  the  Commission  the  transposing  law  following  a  Court  judgement  in 
2009  (case  C-143/08),  therefore  the  Commission  services  closed  the  two  infringement 
proceedings opened for non communication and incorrect transposition of the MiFID and its 
implementing  Directive  2006/73/EC.  Thus,  all  non  communication  cases  against  Member 
States for MiFID and its implementing Directive 2006/73/EC have been closed.  

Furthermore, the Commission service investigated two cases of incorrect transposition of the 
MiFID  and  its  implementing  Directive.  The  case  against  Austria  was  closed  after  having 
received satisfying explanation by the Austrian authorities. The case against Hungary is still 
under examination. 

Moreover, the questions and answers database on MiFID (and meanwhile extended to other 
areas),  launched  by  the  Commission  in  2007,  continues  providing  all  stakeholders  with  the 
possibility to clarify interpretational issues concerning MiFID.   

Within  the  framework  of  the  MiFID  review,  the  Commission  service  organised  a  two-day 
public  hearing  which  was  held  in  Brussels  in  September  2010  and  launched  a  public 
consultation  on  8  December  2010  to  help  preparing  the  legislative  proposal  to  amend  the 
Directive by 2011.  

Investor  Compensation  Scheme  Directive  (ICSD).  On  12  July  2010  the  Commission 
adopted  a  proposal  to  amend  the  ICSD.379  The  review  of  the  ICSD  is  linked  to  evidence 

375   

376   

377  

378  

Regulation  (EC)  No  2273/2003  of  22  December  2003  implementing  Directive  2003/6/EC  of  the 
European  Parliament  and  of  the  Council  as  regards  exemptions  for  buy-back  programmes  and 
stabilisation of financial instruments (OJ L 336, 23.12.2003, p. 33–38). 
Directive 2004/72/EC of 29 April 2004 implementing Directive 2003/6/EC of the European Parliament 
and of the Council as regards accepted market practices, the definition of inside information in relation 
to  derivatives  on  commodities,  the  drawing  up  of  lists  of  insiders,  the  notification  of  managers' 
transactions and the notification of suspicious transactions (OJ L 162, 30.4.2004, p. 70–75). 
Directive  2003/71/EC  of  the  European  Parliament  and  of  the  Council  of  4  November  2003  on  the 
prospectus  to  be  published  when  securities  are  offered  to  the  public  or  admitted  to  trading  and 
amending Directive 2001/34/EC (OJ L 345, 31.12.2003, p. 64–89). 
Regulation (EC) No 809/2004 of 29 April 2004 implementing Directive 2003/71/EC of the European 
Parliament and of the Council as regards information contained in prospectuses as well as the format, 
incorporation  by  reference  and  publication  of  such  prospectuses  and  dissemination  of  advertisements 
(OJ L 149, 30.4.2004, p. 1–126). 

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received on problems in its practical  implementation, divergences in its national application 
and  to  reflect  changes  in  other  legislative  instruments,  such  as  MiFID  and  the  Deposit 
Guarantee Schemes Directive. The main elements of the review are the following: reinforce 
the  funding  requirements  of  the  schemes  and  introduce  a  borrowing  mechanism  between 
national  schemes  as  a  last  resort  tool;  reduce  the  considerable  payout  delays  before  the 
investor  receives  any  compensation,  requiring  provisional  payout  of  partial  compensation  if 
payout  delays  exceed  a  given  time  period;  further  specify  the  information  requirements  to 
clients; provide that investors have the right to be compensated by the scheme also in case of 
failure of a third party custodian resulting in the investment firm not being able to return the 
client's  assets;  extend  coverage  to  provide  for  compensation  to  UCITS  unit  holders  when 
there is a loss of assets due to the failure of the depositary of the UCITS scheme; increase the 
level of compensation to a fixed level of € 50 000; remove the requirement by which investors 
could  bear  a  proportion  of  up  to  10%  of  the  loss  within  the  compensation  limit.  Parallel 
reviews  are  also  being  conducted  on  other  compensation  schemes  (the  Deposit  Guarantee 
Scheme Directive and a possible insurance scheme).  

Market  Abuse  Directive  (MAD).  Two  infringement  proceedings,  one  against  Luxembourg 
and  one  against  the  United  Kingdom,  had  to  be  assessed.  Both  infringements  concerned 
provisions  on  the  powers  of  competent  administrative  authorities  and  administrative 
sanctions. Both Member States reacted by implementing a provision which tackles the issue 
sufficiently. Accordingly, both cases were closed in 2010. 

The Commission issued a public consultation between June and July 2010 on the review of 
the  MAD  to  receive  feedback  from  competent  authorities  and  market  participants  on  future 
legislative proposal to review the MAD.  

Short selling/CDS. The Commission adopted a proposal for a Regulation on short selling and 
credit-default swaps (CDS) in September 2010380. The proposal includes measures to increase 
transparency to regulators and the market about short selling positions in certain instruments; 
the  marking  or  flagging  of  short  orders  for  shares  executed  on  trading  venues;  measures  to 
reduce  settlement  and  other  risks  of  uncovered  or  naked  short  selling  and  powers  to 
competent  authorities  and  the  European  Markets  and  Securities  Authority  (ESMA)  to  take 
measures under exceptional circumstances. 

OTC  derivatives/central  counterparties/trade  repositories  (EMIR).  The  Commission 
adopted  a  proposal  for  a  Regulation  on  OTC  derivatives,  central  counterparties  and  trade 
repositories in September 2010381. The Regulation introduces a reporting obligation for OTC 
derivatives,  a  clearing  obligation  for  eligible  OTC  derivatives,  measures  to  reduce 
counterparty credit risk and operational risk for bilaterally cleared OTC derivatives, common 
rules  for  central  counterparties  (CCPs)  and  for  trade  repositories,  and  rules  on  the 
establishment of interoperability between CCPs. 

Prospectus Directive. The Commission service launched an infringement procedure against 
Poland  on  the  incorrect  transposition  of  the  prospectus  language  requirements.  Poland  has 

379  
380  
381  

COM(2010) 371 final. 
COM(2010) 482 final. 
COM(2010) 484 final 

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adapted  its  regulatory  framework  and  notified  it  to  the  Commission  services  which  are 
analysing it. 
Directive  2010/73/EU  amending  the  Prospectus  Directive  was  adopted  by  the  European 
Parliament and the Council on 24 November382. 

Credit  Rating  Agencies.  In  June  2010  the  Commission  adopted  a  proposal  to  amend  the 
Regulation  No  1060/2009  on  credit  rating  agencies  (CRA  Regulation)383  to  entrust  ESMA 
with exclusive supervisory powers over CRAs, for which a political agreement was reached 
by the European Parliament and the Council in December 2010. In addition, the Commission 
adopted  a  decision  on  the  recognition  of  the  legal  and  supervisory  framework  of  Japan  as 
equivalent to the requirements of the CRA Regulation.384 

The Commission services launched a public consultation in December 2010 on further issues 
linked to the use of credit ratings and the rating industry, such as the overreliance on ratings, 
the  high  concentration  in  the  rating  industry,  the  ratings  of  sovereign  debt,  the  conflicts  of 
interest linked to a specific bussines model and the civil liability of CRAs. 

Evaluation based on the current situation 

Secondary  legislation  is  in  permanent  development  in  the  financial  services  area,  although 
the main pillars have been already established following the Financial Services Action Plan 
launched in 1999.  

The acquis requires a continuous and close monitoring of national measures to ensure timely 
and  proper  transposition.  Further,  some  directives  require  the  Commission  to  report  on  a 
number  of  key  provisions  that  will  allow  to  better  evaluate  their  impact  and  to  determine 
possible problems that need to be addressed. In this area the permanent dialogue within  the 
various  sectoral  committees  and  the  newly  created  European  Supervisory  Authorities385 
contributes  to  avoid  deviations  by  Member  States  in  the  application  of  relevant  EU  law. 
Furthermore, convergence in the supervisory practices is also one of the key objectives in this 
area.  

Particular attention has been and continues to be devoted to  the observation and analysis of 
MiFID  on  securities  markets,  with  the  aim  of  assessing,  in  the  perspective  of  the  ongoing 
review, aspects such as investor protection, transparency, availability of data, fragmentation, 
and  regulatory  framework  applicable  to  different  venues.  The  Commission  services  have 
further followed closely, the phenomenon of high frequency trading, in the framework of the 
MiFID review. In addition, the G20 recommendations are taken into account in this review. 

As to the ICSD, the review of the Directive was needed in order to solve problems raised by 
several  complainants  to  the  Commission  concerning  the  application  of  the  directive  and  to 
keep it aligned with other changes in the acquis.   

382  

383 
384  
385  

Directive  2010/73/EU  amending  Directives  2003/71/EC  on  the  prospectus  to  be  published  when 
securities  are  offered  to  the  public  or  admitted  to  trading  and  2004/109/EC  on  the  harmonisation  of 
transparency  requirements  in  relation  to  information  about  issuers  whose  securities  are  admitted  to 
trading on a regulated market, OJ L327/1 of 11.12.2010. 
OJ L 302, 17.11.2009, p.1. 
OJ L 254, 29.9.2010, p. 46. 
EBA in the banking sector, EIOPA in the insurance sector and ESMA in the securities sector. 

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On  the  Prospectus  Directive,  no  particular  problems  were  identified  in  the  transposition 
check. However, some concerns were raised by plaintiffs regarding the way in which certain 
Member  States  implement  additional  requirements  outside  the  Prospectus  Directive.  CESR 
updated in 2010 the common positions by its Members in the application of the Directive and 
continued  to  operate  the  Q&A  database.  CESR  also  worked  on  a  mapping  exercise  leading 
into a peer review whose first results were presented in November 2010.386 While CESR finds 
Member  States  broadly  compliant  with  Prospectus  Directive,  the  mapping  showed  existing 
divergences in practices and in the day-to-day application. ESMA will continue this work and 
the Commission services will closely follow the exercise.  

Adopted  in  early  2003,  MAD  has  introduced  a  comprehensive  framework  to  tackle  insider 
dealing and market manipulation practices. However, since its adoption in 2003 the financial 
and  regulatory  landscape  has  changed  notably  through  the  financial  crisis  and  there  are  a 
number of areas where the Directive can be updated and improved. Furthermore, the necessity 
for  improvement  was  confirmed  lastly  through  two  infringement  procedures  concerning  the 
power of competent authorities and sanctions to be pronounced which were closed in 2010.  

Evaluation results 

(1) 

Priorities 

In  the  area  of  financial  services,  priority  will  be  given  to  the  review  of  MiFID,  MAD  and 
CRA  Regulation  and  to  the  negotiation  of  the  legislative  proposals  on  ICSD  and  on  short 
selling and CDS. 

(2) 

Planned action (2011 and beyond) 

The  MiFID  review  is  due  in  2011.  It  will  focus  on  issues  that  need  to  be  revised  and  on  a 
number of areas emerged from the first years of application in the EU. The review will tackle 
three  principal  issues:  (i)  ensure  the  directive  is  fully  up-to-date  concerning  the  latest 
technological  and  market  developments  in  the  interests  of  fair  competition  and  efficient 
markets;  (ii)  bring  into  effect  important  G20  commitments  in  the  field  of  derivatives  and 
commodity market transparency and oversight; (iii) repair specific shortcomings revealed by 
the financial crisis, whether in the field of investor protection or enforcement and supervision.  

The MAD review will aim at: (i) increasing the integrity of markets by widening the scope of 
the  legislation  to  capture  new  markets  (MTFs  and  other  organised  trading  facilities)  and 
instruments  (OTC);  (ii)  increasing  the  protection  of  investors  by  strengthening  the 
investigative and sanctioning powers of regulators; and (iii) clarifying certain key provisions 
and reducing administrative burdens where possible, especially for SMEs. 

The  review  of  the  CRA  Regulation  will  mainly  focus  on  reducing  the  reliance  on  credit 
ratings, improving the transparency on sovereign debt ratings,  increasing competition in  the 
credit  rating  business,  minimise  any  potential  conflict  of  interest  due  to  the  business  model 
and reinforce CRAs' civil liability. 

The Commission services will further continue to assist Member States via ESC and ESMA 
in providing advice and answering questions emerging from the implementation of the acquis.  

386  

See CESR's executive summary of the report, Ref. CESR/10-123. 

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11.2.4.   Asset management 

Current position 

(1) 

General introduction 

In the area of asset management the Commission focussed on legislative action on the basis of 
commitments made in 2009: 

1. The compromise text of the Directive on Alternative Investment Fund Managers (AIFMD) 
was approved by the European Parliament on 11 November. Its formal adoption and entry into 
force is expected to follow in early 2011. The AIFMD will then be transposed over a period of 2 
years, becoming fully operational by early 2013; 

2. Level 2 measures to the UCITS IV Directive were adopted on 1 July, in accordance with the 
set deadline, so that Member States could implement the whole UCITS IV package (Directive 
2009/65/EC and its implementing measures) by 30 June 2011. These comprise 4 acts: 

a)  Commission  Directive  2010/43/EU  on  organisational  requirements,  conduct  of  business 
rules, conflict of interests and content of the agreement between a management company and 
UCITS depositary; 
b)  Commission  Directive  2010/44/EU  on  fund  mergers,  master-feeder  structure  and 
notification procedures; 
c) Commission Regulation 583/2010 on key investor information; and 
d) Commission Regulation 584/2010 on notification and supervisory co-operation.  

The adoption of these measures completes the reform of the UCITS IV regulatory framework 
introduced by the UCITS IV Directive, ensuring the workability of the level I provisions.  

3. Two consultation papers were issued announcing legislative changes: 

a) on legislative steps for the Packaged Retail Investment Products initiative, and  

b)  on  the  UCITS  depositary  function  and  on  the  UCITS  managers’  remuneration.  This 
followed the commitment made by the Commission in its communication on 2 June 2010 
to publish proposals for appropriate legislative responses to issues revealed by the Madoff 
fraud and the Lehman Brothers default. 

(2) 

Report of work done in 2010 

In  the  asset  management  sector,  the  Commission  pursued  investigations  against  one  Member 
State. This procedure concerns the national rules designed to counter the negative effects of the 
financial crisis. These measures empower the national authorities to take decisions which will 
allow certain UCITS to breach the minimum common rules set out in the UCITS Directive.  

Concerning the UCITS IV package, during the second half of 2010, the Commission services 
provided  assistance  to  Member  States  in  their  transposition  efforts.  A  transposition  workshop 
was  organised  in  September  2010  to  kick-off  dialogue  with  Member  States  on  the  practical 
problems  authorities  are  facing  or  may  face  in  transposing  the  UCITS  IV  Package.  The 
workshop  showed  the  need  for  further  discussion.  This  took  place  through  the  transposition 
network  allowing  for  direct  contact  with  experts  involved  in  the  transposition  in  national 

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authorities. The dialogue will continue in 2011 (transposition deadline – 30 June 2011). 

2010 was marked by important actions affecting the asset management regulatory landscape: 

AIFMD 

In  2010  intensive  negotiations  of  AIFM  Directive,  based  on  the  Commission  proposal  of 
April  2009,  has  been  completed.  On  11  November  the  European  Parliament  approved  the 
compromise  text,  thereby  sealing  a  first  reading  agreement  with  the  Council.  Following  the 
adoption  of  the  AIFM  Directive  the  Commission  will  continue  its  work  on  implementing 
measures  required  to  give  effect  to  the  provisions  of  this  Directive  (over  90  implementing 
powers)  In November 2010 the Commission issued a mandate to CESR / ESMA to develop 
technical advice on these measures. 

Packaged Retail Investment Products (PRIPs) 

Following  the  April  2009  Commission  indicating  the  possible  ways  and  means  to  improve 
regulatory protection for retailed investors and a technical workshop which allowed to gather 
views of relevant stakeholders, the Commission published a consultation paper on legislative 
steps for the Packaged Retail Investment Products initiative. 

The consultation seeks feedback from stakeholders on the next steps to be taken in improving 
the European regulation of the retail investment market. The Commission committed in 2009 
to developing legislative proposals for raising standards of investor protection and improving 
the  consistency  of  existing  measures  across  the  different  sectors  making  up  the  retail 
investment market.  

Changes to UCITS IV Directive 

Results  of  the  public  consultation  of  July  2009  showed  the  need  to  revise  the  UCITS 
depositary  framework  in  order  to  strengthen  investor  protection.  In  the  context  of  AIFMD 
negotiations  the  Commission  also  committed  itself  to  introduce  targeted  changes  to  the 
depositary  provisions  in  the  UCITS  Directive.  These  changes  aim  at:  clarifying  the  UCITS 
depositary  functions  and  ensuring  consistency  between  the  legislation  applicable  to  the 
depositaries of UCITS and that applicable to the depositaries of AIF.  

The  financial  crisis  also  revealed  that  the  remuneration  and  incentive  schemes  commonly 
applied within financial institutions were themselves exacerbating the impact and scale of the 
crisis.  Remuneration  policies  contributed  to  short-termism  and  incentivised  excessive  risk 
taking,  thereby  increasing  levels  of  systemic  risk.  In  the  light  of  these  systemic  issues  and 
commitments that were made at the G20 level to address them, the EU is taking coordinated 
steps across all financial services sectors to introduce consistent requirements governing the 
remuneration policy. 

The purpose of the consultation paper published in December 2010 was to collect views and 
supporting evidence on the key options that are emerging in these two areas. The conclusions 
from this consultation will serve as a basis for the Commission to review the UCITS Directive 
in 2011. 

Evaluation based on the current situation 

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the 

limited  range  of  adopted,  crisis-related 

Verification launched in 2009, on the basis of Member States responses to the administrative 
letter,  showed 
legislative  measures  or 
administrative practice. Nevertheless, few questions still remain open, like the one concerning 
the possible scope of interpretation of the UCITS Directive by Member States in the context 
of  the  financial  crisis,  e.g.  introduction  of  side  pockets,  or  waivers  of  certain  UCITS 
obligations.  The  reflections  took  place  also  in  CESR  and  its  dialogue  with  the  Commission 
will continue in 2011.  

It  should  be  noted  that  concerns  related  to  the  depositary  liability  will  be  addressed  in  the 
legislative initiative resulting in the modification of UCITS rules on depositaries. 

Evaluation results 

Following  the  adoption  of  the  AIFM  Directive,  the  important  work  of  adopting  level  2 
measures  will  start  in  2011  for  completion  in  2012.  In  this  context,  particular  efforts  are 
needed from the Commission services to actively follow the work of ESMA on its technical 
advice. 

In  addition,  the  work  on  PRIPs  initiative  and  revision  of  depositary  rules  and  new 
requirements on remuneration policies within the UCITS Directive will enter in their decisive 
phases. Proposals are expected in the mid-2011. 

As the deadline for Member States to transpose the UCITS IV Directive and its implementing 
directives expires on 30 June 2011, the Commission services will be attentive to the need to 
ensure  that  a  maximum  number  of  timely  notifications  from  Member  States  are  submitted. 
Soon afterwards, the process of transposition check should be launched.  

Legislation 

1.  Council  Directive  85/611/EEC  of  20  December  1985  on  the  coordination  of  laws, 
regulations and administrative provisions relating to undertakings for collective investment in 
transferable  securities  (UCITS)  (OJ  L  375,  31.12.1985,  P.  3),  as  amended,  available  on  the 
following website: 

http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1985L0611:20080320:EN:HTML  

2. The recast of the 85/611/EEC Directive (Directive 2009/65/EC) is available on the website:  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:302:0032:01:EN:HTML  

3. Implementing measures to Directive 2009/65/EC are available on the website: 

-  Commission  Directive  2010/43/EU  of  1 July  2010  implementing  Directive 
2009/65/EC  of  the  European  Parliament  and  of  the  Council  as  regards 
organisational  requirements,  conflicts  of  interest,  conduct  of  business,  risk 
management  and  content  of  the  agreement  between  a  depositary  and  a 
management company Text with EEA relevance  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:176:0042:01:EN:HTML 

-  Commission  Directive  2010/44/EU  of  1 July  2010  implementing  Directive 
2009/65/EC  of  the  European  Parliament  and  of  the  Council  as  regards  certain 

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provisions  concerning  fund  mergers,  master-feeder  structures  and  notification 
procedure Text with EEA relevance 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:176:0028:01:EN:HTML 

-  Commission Regulation (EU) No 583/2010 of 1 July 2010 implementing Directive 
2009/65/EC of the European Parliament and of the Council as regards key investor 
information and conditions to be met when providing key investor information or 
the prospectus in a durable medium other than paper or by means of a website Text 
with EEA relevance 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:176:0001:01:EN:HTML  

-  Commission Regulation (EU) No 584/2010 of 1 July 2010 implementing Directive 
2009/65/EC  of  the  European  Parliament  and  of  the  Council  as  regards  the  form 
and  content  of  the  standard  notification  letter  and  UCITS  attestation,  the  use  of 
electronic  communication  between  competent  authorities  for  the  purpose  of 
notification,  and  procedures  for  on-the-spot  verifications  and  investigations  and 
the  exchange  of  information  between  competent  authorities  Text  with  EEA 
relevance  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:176:0016:01:EN:HTML 

11.2.5.   Payments and retail financial services 

Current position 

(1) 

General introduction 

A proposal for a Regulation establishing technical requirements for credit transfers and direct 
debits in euros and amending Regulation (EC) No 924/2009, COM(2010)775 (hereby referred 
as  "the  SEPA  migration  end-dates  Regulation")  was  adopted  by  the  Commission  and 
published in December 2010. 

In  order  to  ensure  a  timely  and  consistent  transposition  of  the  new  E-Money  Directive 
2009/110/EC ((hereby referred to as 'the EMD') by end April 2011, the Commission services 
have  continued  to  accompany  Member  States  in  their  transposition  process  through 
transposition  workshops,  bilateral  meetings  and  Q&A  facility  on  the  internet.  The 
transposition of the Payment Services Directive 2007/64/EC (hereby referred to as 'the PSD') 
has been accomplished, with the sole exception of one Member State.  

(2) 

Report of work done in 2010 

The preparatory work on the end-date Regulation proposal (impact assessment, inter-service 
consultation,  public  consultations  and  public  hearing  in  November)  as  well  as  the  actual 
drafting  of  a  highly  technical  legal  text  was  the  main  focus  of  the  Commission  services 
attention  in  the  area  of  payments.  The  proposal  was  adopted  by  the  Commission  on  16 
December  and  transmitted  to  other  EU  institutions  and  the  ECB.  The  main  objective  of  the 
proposal  is  to  accelerate  the  current  slow  rate  of  migration  to  pan-european  credit  transfers 
and  direct  debits  by  fixing  technical  requirements  which  must  be  respected  by  proposed 
migration  end-dates.  At  the  same  time  the  proposal  also  provides  clarity  on  the  business 

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model for pan-european direct debits and reassures consumers when using such products by 
providing various mandate checking options. 

An  EMD  Transposition  Group  (EMDTG),  which  has  been  set  up  a  year  before,  met  three 
times. The Group role was to address common transposition issues faced by Member States 
authorities  and  other  stakeholders  and  to  share  responses  with  all  interested  parties.  In  total 
the Group collected around 100 questions from Member States concerning 24 articles of the 
EMD  and  provided  written  observations  which  served  as  a  basis  for  reaching  a  common 
understanding.  The  web-based  question-and  answer  tool,  which  has  proved  its  effectiveness 
during the transposition of the PSD, has been also developed and used to answer individual 
questions on the EMD.  

An  ad  hoc  working  group  –  the  EMD  Passporting  Liaison  Group  –  composed  of 
representatives  of  a  number  of  competent  authorities  in  Member  States  responsible  for  the 
authorisation/supervision of e-money Directive Passport Notifications institutions has been set 
up and worked on the drafting of Guidelines on Electronic Money. These guidelines will be 
submitted  afterwards  to  the  Payments  Committee  for  information  and  discussion.  While  the 
use  of  the  Guidelines  is  voluntary,  all  competent  authorities  appointed  under  Directive 
2009/110/EC  will  be  strongly  encouraged  to  use  them  for  passport  notification  purposes. 
While the Commission services participated only as an observer in this working group, these 
Guidelines will be made available on the relevant area of the Commission’s website for easy 
stakeholder access and transparency. 

The Commission Communication Reaping the benefits of e-invoicing for Europe which was 
announced  in  the  Digital  Agenda  for  Europe  was  adopted  on  2  December  2010.  It  aims  at 
fostering the uptake of electronic invoicing within the EU. The Communication builds on the 
final  report  of  the  independent  Expert  Group  on  e-invoicing,  and  on  a  public  consultation 
following  this  report.  It  is  accompanied  by  a  Decision  which  establishes  a  European 
E-invoicing Forum to be set up by June 2011.  

The interpretative guideline  concerning application  of  Article  8  of  Regulation  924/2009  (on 
mandatory reachability for direct debits), which was much awaited by the payment industry, 
has  been  published  in  March.  Another  interpretative  note,  concerning  the  application  of 
Article 3 of the same Regulation in the case of ATM withdrawals has been also drafted and 
published in January 2011.  

In  the  field  of  payments,  the  number  of  petitions,  questions  and  complaints  remained 
relatively constant in comparison with previous years. Three petitions were received in 2010. 
The majority of the enquiries (around 200) concerned cross-border payment services and the 
application and interpretation of the two main legislative acts in this area – namely Regulation 
924/2009 and the PSD.  

Several infringement proceedings were launched during this period. Most of them concerned 
the late or non-transposition of the PSD. However, all of them, with the exception of the one 
involving Poland, were closed before summer following completion of transposition in all the 
Member States concerned. Poland was brought before the Court of Justice and the case is still 
pending, awaiting judgement. Another ongoing proceeding concerns Denmark and concerns 
discrimination  of  holders  of  payments  cards  issued  in  other  Member  States  in  breach  of 
Articles 56 and 63(2) TFEU. 

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In  the  area  of  retail  financial  services,  preparatory  work  (impact  assessments,  public 
consultations)  continued  on  two  legislative  proposals  concerning  responsible  lending  and 
borrowing and the access to basic bank accounts. 

Evaluation based on the current situation 

The work on EMD transposition seems to be well advanced in almost all Member States, 
though  no  notifications  of  transpositions  were  received  by  the  Commission  by  the  end  of 
2010. The deadline for implementation was 30 April 2011. The actions covered by the EMD 
Transposition Plan have been praised by most of the Member States as being very helpful for 
ensuring a quick and consistent implementation. Other stakeholders have also expressed their 
support. 

Late transposition of  the PSD by  Poland provokes legal uncertainty for both citizens and 
the  payment  industry.  In  addition,  it  undermines  the  SEPA  project  and,  in  particular,  the 
possibility of offering SEPA Direct Debit in, from and to that Member State. Moreover, while 
most of the provisions on disclosure requirements and the rights and obligations of payment 
service  providers  and  payment  service  users  could  be  invoked  directly  by  citizens  before 
national  courts,  this  is  not  the  case  for  provisions  regarding  a  positive  action  by  Member 
States (e.g., setting-up of registers, designation of competent authorities, etc.). So delay in the 
transposition  of  these  provisions  exposes  Poland  to  the  risk  of  actions  for  compensation  for 
losses related to the Member State's failure to implement the Directive in time. 

The  breach  of  Articles  56  and  63(2)  TFEU  by  Denmark  leads  to  the  situation  whereby 
holders  of  payment  cards  issued  in  other  Member  States  are  faced  with  disproportionate 
additional charges when using their cards in Denmark (including for internet transactions). On 
the other hand, holders of payment cards issued in Denmark are not subject to such charges. 
This constitutes a clear discrimination of customers from other Member States and, implicitly, 
could be treated as discrimination on the base of nationality, since holders of payment cards 
issued in Denmark are naturally, in the great majority of cases, Danish nationals.  

The  main  challenges  that  could  present  themselves  in  the  area  of  retail  financial  services 
include  a  possibility  that  consumers  and  businesses  will  not  be  motivated  to  seek  out  the 
benefits  of  the  Single  Market,  in  an  environment  of  increasing  national  focus  and  even 
protectionism.  This  could  lead  to  a  magnification  of  the  current  problems  of  access  to 
financial  services  for  non-residents.  Significant  efforts  will  have  to  be  made  if  citizens' 
confidence in the financial sector is to be restored. 

Evaluation results  

(1) 

Priorities 

Priorities in the field of payment services will be evolving in the course of 2011, with a focus 
on  the  adoption  of  the  proposal  for  a  Regulation  fixing  SEPA  migration  end-dates.  This 
legislation will mandate the migration euro credit transfers and direct debits to new common 
standards  and  rules,  thus  paving  the  way  to  establishing  a  true  Single  Market  for  euro 
payments in the EU. 

The  Commission  services  will  maintain  efforts  and  closely  follow-up  the  transposition 
process  (EMD)  and  support  Member  States'  work  with  the  aim  of  ensuring  consistent 
application of the existing acquis (Regulation 924/2009, PSD and EMD) in Member States. 

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More  priority  will  be  given  to  monitoring  the  correct  and  consistent  enforcement  of  the 
payment legal framework.  

Preparatory  steps  will  be  also  undertaken  in  view  of  the  foreseen  reviews  of  the  EMD,  the 
PSD and the Regulation 924/2009, scheduled for 2012. Particular regard will also be given to 
possible  measures  that  support  and  facilitate  operational  migration  to  pan-european  credit 
transfers and direct debits as set out in  the proposed SEPA  migration  end-dates  Regulation. 
For this purpose, tenders for studies on specific aspects of the PSD and Regulation 924/2009 
will be launched in the course of 2011. 

As for the activities carried out in the area of retail financial services, in the coming year, the 
Commission  will  bring  forward  proposals  to  promote  responsible  lending  and  borrowing  as 
well as to facilitate access to basic bank accounts. 

(2) 

Planned action (2011 and beyond) 

Independently  of  whether  the  negotiations  of  the  SEPA  migration  end-dates  Regulation  are 
completed  in  the  course  of  2011,  the  Commission  services  will  continue  to  closely  monitor 
the  progress  of  migration  to  pan-European  (SEPA)  credit  transfers  and  direct  debits  in  the 
Member  States  and  take  a  pro-active  approach  in  identifying  any  potential  barriers  to  that 
migration. 

Where  necessary  and  upon  request,  expert  group  or  bilateral  meetings  will  also  be  held  to 
support legislative efforts, to closely monitor the implementation process and to spread best 
practice among Member States. Finally, a template for a concordance table will be provided 
by the Commission services facilitating the task of Member States to illustrate the correlation 
between  the  EMD  provisions  and  the  transposition  measures  adopted  for  incorporation  into 
domestic law. 

Summary 

Based on the experience  of  the  transposition of the  PSD, we can conclude that a  pro-active 
transposition  approach  has  a  positive  impact  and  enhances  consistent  implementation  by 
Member  States.  Therefore,  a  similar  –  although  slightly  lighter  -  approach  has  been  applied 
for the implementation of the EMD. Legal and political pressure will be kept up on Member 
States  which  are  late  with  the  transposition  of  the  PSD  (Poland)  or  otherwise  infringe  EU 
payment services legislation and the TFEU (Denmark). 

Legislation: 

For  detailed  information  on  applicable  legislation  and  work  undertaken  in  the  area  of 
payments and retail financial services see the following web pages: 

http://ec.europa.eu/internal_market/payments/index_en.htm  

http://ec.europa.eu/internal_market/finservices-retail/index_en.htm 

11.3.   Free movement of capital (Articles 63 et seq. TFEU) 

Current position 

(1) 

General introduction 

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The relevant Treaty provisions governing the freedom of capital movements are enshrined in 
Articles 63 to 66 TFEU. In particular, Article 63 TFEU provides that "all restrictions on the 
movement of capital between Member States and between Member States and third countries 
shall be prohibited".  A list of transactions that are to be considered as capital movements can 
be found in Annex I of Directive 88/361/EEC.387 The legal framework governing this Treaty 
freedom can be found on the Europa website.388 

(2) 

Report of work done in 2010 

Work done in 2010 was again based on the priorities set in 2008, namely continuing the pro-
active  approach  by  way  of  monitoring,  concentrating  on  more  important  cases,  diversifying 
the  range  of  restrictions  to  the  free  movement  of  capital  which  are  being  dealt  with  and 
addressing these restrictions at an early stage. 

Since  the  last  report,  the  number  of  opened  formal  infringement  cases  has  considerably 
diminished389. The Commission services have engaged in a pro-active dialogue with Member 
States'  authorities  with  the  aim  of  exchanging  views  and,  as  facilitator,  to  closely  liaise  on 
topical matters and so avoid situations which could develop into infringements. EU Pilot also 
contributed  significantly  to  the  reduction  in  the  number  of  formal  infringement  proceedings 
for  those  Member  States  which  participated  in  this  system.  The  implementation  of  a  new 
registration  system  (CHAP  –“Complaints  Handling  –  Accueil  des  Plaignants  has  also 
facilitated the handling of complaints. 

Of  the  number  of  cases  that  were  open  during  the  reporting  period,  those  relating  to 
privatisation and special rights of the State in privatised companies form the majority (about 
60% of the total number of cases). 

The  other  types  of  cases  concerned  bilateral  investment  law,  real  estate  law,  and  financial 
services.  The  cases  related  to  several  specific  sectors,  the  most  common  being  the  energy 
sector  followed  by  real  estate,  telecoms,  financial  services  and  manufacturing.  The  energy 
sector  cases  concerned  measures  introduced  by  the  Member  States  to  secure  their  national 
interests (including protecting the security of supply) but which were potentially incompatible 
with the TFEU. 

On the free movement of capital, the Court of Justice outlawed the Portuguese Government's 
special rights allocated in connection with the State’s golden shares in Portugal Telecom390, 
thus  confirming  many  of  the  rules  established  in  its  earlier  jurisprudence  on  special  rights, 
namely: 

•  The free movement of capital includes both, 'direct' investments as well as 'portfolio' 
investments391,  and  national  measures  must  be  regarded  as  restrictions  to  Article  63 
TFEU if they are likely to prevent or limit the acquisition of shares in the undertakings 
concerned  or  to  deter  investors  of  other  Member  States  from  investing  in  their 
capital392. 

387  
388  
389  
390  
391  
392  

OJ No L178, 8.7.1988. 
http://ec.europa.eu/internal_market/capital/framework/index_en.htm  
This was in part due to a decline in Merger and Acquisition activity. 
Judgment in case C-171/08, Commission v Portugal, of 8/7/2010. 
Case C-171/08, §49, see also e.g. joined cases C-282+283/04, Commission v the Netherlands, §19. 
Case C-171/08, §50, see e.g. cases C-367/98, Commission v Portugal, §§45/46, C-483/99, Commission 
v France, §§40/41, C-463/00, Commission v Spain, §§61/62, C-174/04, Commission v Italy, §§30/31. 

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•  The Court further clarified what constitutes a measure attributable to the State within 
the scope of Article 63 TFEU, in particular by contrasting these measures to situations 
resulting from a normal application of company law393. 

•  The  Court  also  reiterated  that  golden  shares  granting  an  influence  which  is  not 
justified by the size of the State's shareholding are liable to discourage investors and 
thus  represents  a  restriction394.  And  it  further  found  that  Article  345  TFEU  does  not 
have the effect of exempting the Member States’ systems of property ownership from 
the fundamental rules of the Treaty and cannot, therefore, be relied on as justification 
for special rights395. 
It found again in a different sector that special rights are not comparable to the rules 
concerning  selling  arrangements  addressed  in  the  Keck  and  Mithouard  judgment,  as 
they  affect  the  position  of  a  person  acquiring  a  shareholding  as  such  and, 
consequently, affect access to the market396. 

• 

•  The  Court  also  held  that  an  interest  in  ensuring  the  conditions  of  competition  on  a 
particular market cannot constitute valid justification for restricting the free movement 
of capital397. 

•  And  it  pointed  out  that  whilst  ensuring  the  availability  of  the  telecommunications 
network in case of crisis, war or terrorism may constitute a ground of public security 
in  the  sense  of  Article  65(1)(b)  TFEU398,  such  requirements  must  be  interpreted 
strictly,  so  that  their  scope  cannot  be  determined  unilaterally  by  each  Member  State 
without  any  control  by  EU  institutions  and  they  may  be  relied  on  only  if  there  is  a 
genuine  and  sufficiently  serious  threat  to  a  fundamental  interest  of  society399.  The 
Court  again  highlighted  the  difficulty  for  Member  States  to  argue  a  connection 
between the holding or acquisition of shares and the safeguarding of public security400. 

On  11  November  2010  a  further  case  on  special  rights  in  Energias  de  Portugal  (EdP)  was 
decided. The ruling in this case, as that in July 2010, found that, by maintaining special rights 
for  the  State  and  other  public  bodies  in  the  company,  Portugal  had  failed  to  fulfil  its 
obligations  under  ECT  Article  56  (freedom  of  capital  movements  -  now  Article  63  TFEU). 
The  special  rights  involved  included  a  right  of  veto  for  a  number  of  important  company 
decisions (e.g. disposal of assets, recourse to significant financing, opening or closing places 
of business, amendments to the Articles of Association, etc.) as well as the right to appoint a 
director.  In  addition,  there  was/is  a  restriction  (which  does  not  apply  to  the  State)  on  the 
number  of  votes  which  could  be  cast  by  individual  shareholders  up  to  a  limit  of  5%  of  the 
share capital of EdP, regardless of the number of shares held.  

393  
394  
395  

396  

397  

398  

399  
400  

Case C-171/08, 54-56, confirming case C-112/05, Commission v Germany, §§45/46. 
Case C-171/08, §60, see, inter alia, case C-112/05, Commission v Germany, §50. 
Case C-171/08, §64 ("settled case law"), see e.g. cases C-463/00, Commission v Spain, §67, C-503/99, 
Commission v Belgium, §44, C- 483/99, Commission v France, §44. 
Case C-171/08, §§65-67, confirming case C-98/01, Commission v the United Kingdom (BAA), §§45-
47. 
Case C-171/08, §70, see cases C-174/04, Commission v Italy, §§36/37, C-274/06, Commission v Spain, 
§44. 
 Case C-171/08, §72 building on an analogy with energy supply in case C-274/06, Commission v Spain, 
§38; see also e.g. cases C-326/07, Commission v Italy, §69 and C-463/00, Commission v Spain, §71. 
Case C-171/08, §73, referring, inter alia, to case C-54/99, Église de scientology, §17. 
Case  C-171/08,  §74;  see  also  cases  C-326/07,  Commission  v  Italy,  §48,  C-207/07,  Commission  v 
Spain, §51. 

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Of special interest in the EdP ruling, was the Court's treatment of a claim from Portugal that it 
measures should only be examined under the right of establishment rather than the freedom 
of capital movements. Here Portugal relied on a ruling in a case against Italy (C-326/07 of 
16/5/2009).  In  the  EdP  ruling,  the  Court  rejects  Portugal's  arguments  in  some  considerable 
detail  (§§  39-44).  The  Court  refers  to  the  Italian  case  but  notes  (§  43):  "  43  National 
legislation not intended to apply only to those shareholdings which enable the holder to have 
a definite influence on a company’s decisions and to determine its activities but which applies 
irrespective of the size of the holding which the shareholder has in a company may fall within 
the  ambit  of  both  Article  43  EC  and  Article  56  EC  (C-326/07  Commission  v  Italy,  §  36)". 
From that, the Court, in this case, concludes the following (§44): "44 It must be stated that, in 
this action for failure to fulfil obligations, it is not inconceivable that the national provisions 
at  issue  affect  all  shareholders  and  potential  investors  and  not  only  those  shareholders 
capable of exerting a definite influence on the management and control of EdP. Consequently, 
the  contested  provisions  must  be  examined  in  the  light  of  both  Articles  56  EC  and  43  EC." 
Later on, in §56-57 of the ruling, the Court notes why the veto rights affect all shareholders. It 
treats controlling shareholders in §56. However, importantly in §57, which considers portfolio 
investment, it states: "57 Similarly, the right of veto at issue may have a deterrent effect on 
portfolio investment in EdP in so far as a possible refusal by the Portuguese State to approve 
and important decision, proposed by the organs of that company as being in the company's 
interest,  is  in  fact  liable  to  depress  the  value  of  that  company  and  thus  reduce  the 
attractiveness of an investment in such shares…." 

Evaluation based on the current position 

In 2010, eight infringement cases have been closed and two cases (restrictions on purchase of 
secondary  residences  in  Cyprus  and  restrictions  on  acquisition  of  agricultural  land  in  Tyrol 
(Austria)) have been opened. 

The  decisions  to  close  eight  cases  were  taken  following  satisfactory  amendment  or 
clarification of potentially discriminatory provisions in Member States. They were related to: 

•  special powers in certain strategic companies (Italy) 
•  an act conferring special powers in important national enterprises (Poland) 
•  privatisation agreements (two cases concerning Romania) 
• 
• 
• 
• 

investment restrictions for statutory pension funds (Slovakia) 
rental prices for apartments in restituted properties (Slovakia) 
limitation of voting rights of non-state shareholders (Greece) 
restrictions on acquisition of real estate in Tyrol (Austria). 

Two cases are pending before the Court of Justice: 

• 
• 

the special rights in a privatised company (GALP) in Portugal and; 
investment restrictions for pension funds in Poland. 

In  seven  other  cases,  following  Court  rulings,  the  Commission  services  are  following  the 
process  for  amending  the  discriminatory  provisions  and  achieving  compliance  with  Court 
rulings. Thus: 

•  C-112/05 Commission v Germany (Volkswagen); 
•  C-205/06 and C-249/06 Commission v Austria and Sweden (issues of EU rather than 
national competence with respect to third country Bilateral Investment Treaties); 

•  C-118/07 Commission v Finland (also a Bilateral Investment Treaty issue); 

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•  C-207/07 Commission v Spain (powers in an energy company), and; 
•  C-171/08 Commission v Portugal (Telecom) as well as C-543/08 Portugal (EdP). 

For  a  number  of  ongoing  cases,  Member  States  are  in  the  process  of  removing  provisions 
conflicting with the Treaty. The Commission services are closely following this process. 

On  the  BITs  outstanding  issues,  while  it  is  important  that  protection  is  maintained  for 
investors, it is all the more important that all investors be put in a position of legal certainty in 
compliance  with  EU  law.  The  Court  judgements  concerned  three  Member  States  who  must 
now remove the incompatibility found by the Court. However, many more Member States are 
likely to be in a similar situation (there are now, after recent accessions, around 300 other pre-
accession  BITs  which  were  not  subject  to  the  Court  rulings,  since  those  countries  were  not 
Member States at that stage, but which contain identical provisions).  

Evaluation results 

(1) 

Priorities 

During  the  period  under  review  two  procedures  were  engaged  in  respect  to  transitional 
provisions which had been granted to individual Member States.  
With  respect  to  Bulgaria  and  Romania  the  Accession  Treaty  laid  down  that  the  transitional 
period  granted  to  these  two  countries  with  respect  to  the  acquisition  of  agricultural  and 
forestry  land  would  be  reviewed.  The  review  was  carried  out  in  2010  and  the  Commission 
reported the results of its analysis to the Council on 14 December 2010401. 

In the context of the enlargement of May 2004, several new Member States were granted a 
transitional period of 7 years (until 1 May 2011)  for the acquisition of farming and forestry 
land402. There was an extreme possibility of a further extension of up to 3 years for certain of 
these new Member States. Poland was granted a transitional period of 12 years (until 1 May 
2016) without a possibility to extend it. In September 2010 Hungary requested an extension. 
By Decision of 20 December 2010403, in the light of the arguments presented by Hungary, the 
Commission  granted  an  extension.  In  December  2010  Latvia  also  requested  an  extension. 
Other countries with a transitional period might follow. 

(2) 

Planned action (2011 and beyond) 

As  regards  foreign  investment,  the  Commission  will,  where  necessary,  cooperate  actively 
with  Member  States  that  have  updated  or  are  in  the  process  of  updating  their  legislation  to 
cater for perfectly legitimate objectives as foreseen in EU law. 

Summary 

In  the  area  of  free  movement  of  capital  the  priorities  will  remain  enforcement  action  in 
important  sectors  (energy)  as  well  as  close  and  permanent  monitoring  activities  related  to 

401  

402  
403  

Report  from  the  Commission  to  the  Council  on  Review  of  the  transitional  measures  regarding 
theacquisition  of  agricultural  real  estate  foreseen  in  the  Accession  Treaty  2005;  COM(2010)734  of 
14/12/2010. 
The Czech Republic, Slovakia, Hungary, Estonia, Latvia, Lithuania. 
Decision 2010/792/EU of 20 December 2010. 

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strategic  foreign  investment  control  by  Member  States  and  to  the  unrolling  of  the  specific 
measures  taken  in  the  context  of  the  crisis.  Increased  activity  related  to  Member  States' 
bilateral  investment  treaties  which  involve  agreements  between  Member  States  will  also  be 
required. A resolution to this question by mutual agreement or infringement procedures will 
be required, so that this long running issue may start to be resolved in 2011.  

11.4.   Public procurement 

Current position 

(1) 

General introduction 

European  public  procurement  provisions  are  based  on  the  right  of  establishment  and  the 
freedom to provide services stemming from Articles 49 and 56 of the TFEU.  

The secondary legislation in this field is three folds: 

•  First,  there  are  two  Directives  on  the  coordination  of  procedures  for  the  award  of 
public  works,  supply  and  service  contracts,  Directives  2004/17/EC  and  2004/18/EC 
adopted  in  April  2004  replacing  the  previous  Directives  92/50/EEC,  93/36/EEC, 
93/37/EEC and 93/38/EEC. Directive 2004/18/EC concerns award procedures carried 
out  by  public  contracting  authorities  meeting  certain  value  thresholds.  Directive 
2004/17/EC  covers  contract  awards  by  entities  operating  in  specific  sectors  (water, 
energy, transport, postal services).  

•  Secondly,  there  are  two  Directives  concerning  the  legal  protection  of  bidders 
in  public  procurement  procedures,  Directives  89/665/EEC  and 
participating 
92/13/EEC. These Directives have been modified by Directive 2007/66/EC which has 
been  adopted  in  December  2007  and  had  to  be  implemented  by  Member  States  by 
December 2009. 

•  Thirdly, a special Directive for Defence and Sensitive Security procurement (Directive 
2009/81/EC404 of 13 July 2009) has been adopted in 2009. Member States have until 
August 2011 to transpose these new procurement rules into national law. 

(2) 

Report on the work done in 2010 

(a)  New  legislation  in  preparation or proposed and being adopted, impact assessments and 
implementation plans being developed in connection with new proposals, etc. 

Substantial  progress  has  been  made  in  2010  on  an  impact  assessment  on  a  Commission 
initiative  on  public  procurement  rules  for  service  concessions,  which  was  finalised  at  the 
beginning of 2011. 

Article  30  of  Directive  2004/17/EC  provides  that  the  Directive  does  not  apply  to  contracts 
that  are  awarded  for  the  pursuit  of  one  of  the  covered  activities  if,  in  the  Member  State  in 
which  it  is  performed,  the  activity  is  directly  exposed  to  competition  on  markets  to  which 
access  is  not  restricted.  In  other  words,  the  Directive  does  not  apply  if  there  has  been  a 
liberalisation resulting in such a level of competition that the discipline of the Directive is no 

404  

OJ L 216, 20.08.2009, p. 76. 

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290 

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longer  needed.  This  exemption  will  be  applicable  where  the  Commission  has  adopted  a 
formal Decision establishing that the conditions are met. 

In 2010, four requests for exemption were submitted to the Commission concerning electricity 
generation  and  sale  in  Italy,  exploration  for  and  extraction  of  oil  and  gas  in  Italy  and  in 
Denmark, except Greenland  and the Faroe Islands; exploration for  and extraction of coal in 
the Czech Republic. Commission Decision 2010/142/EU of 3 March 2010 exempting certain 
services in the postal sector in Austria405 ; Commission Decision 2010/292/EU of 29 March 
2010  exempting  exploration  for  and  exploitation  of  oil  and  gas  in  England,  Scotland  and 
Wales406 and Commission Decision 2010/403/EU of 14 July 2010 exempting the production 
and  wholesale  of  electricity  in  Italy’s  Macro-zone  North  and  the  retail  of  electricity  to  end 
customers connected to the medium, high and very high voltage grid in Italy407, were adopted 
in  2010.  Decisions  concerning  the  Italian,  Danish  and  Czech  requests  must  be  adopted, 
respectively, by 19.4.2011, 28.2.2011 and 23.5.2011 at the latest. 

(b)  Preventive  measures  being  taken  in  relation  to  recently  adopted  new  legislation, 
transposition  package  meetings,  development  of  guidelines,  initiation  of  networking  systems 
to manage the new legislation, etc. 

A transposition plan including a number of initiatives aiming to accompany Member States in 
the  transposition  process  was  elaborated  immediately  after  the  adoption  of  Directive 
2009/81/EC  on  defence  and  sensitive  security  procurement.  During  2010  six  workshops 
took  place  between  January  and  July  2010  with  national  experts  in  charge  of  preparing 
measures  to  be  taken  at  national  level  to  transpose  the  said  directive.  The  most  sensitive  or 
complex  issues,  both  from  implementation  and  legal  perspective,  were  debated.  The 
discussion  resulted  in  a  series  of  guidelines  –  essentially  intended  to  national  authorities  – 
published on the Commission website.408 The second half of the year has been dedicated to 
bilateral contacts with national authorities, where more detailed problems had to be analysed. 
Technical  assistance  will  continue  until  the  end  of  the  transposition  process  and  for  those 
Member States which would not succeed in respecting the deadline also at the end of 2011. 

Two  guides  on  social  procurement  and  procurement  of  social  services  of  general  interest 
have been updated in 2010 and were published in early 2011409. 

In  addition,  package  meetings  were  held  with  four  Member  States  (IT,  DE,  UK,  EL)  to 
discuss  the  most  pertinent  issues  of  the  application  of  procurement  law  in  the  respective 
Member State, which allowed to solve a considerable number of infringement cases as well as 
to  discuss  the  compliance  of  legislative  developments  in  Member  States  with  the  EU  legal 
framework. 

Finally, the Commission invested in bilateral processes with Member States like the work on 
structural reforms in the public procurement system in Greece in the framework of the crisis 
support measures and Memorandum of Understanding. 

405 
406 
407 
408  
409  

OJ L 056 , 06/03/2010, p. 8.  
OJ L 84 of 31.3.2010, p. 52. 
OJ L 186 of 20.7.2010, p. 44. 
http://ec.europa.eu/internal_market/publicprocurement/dpp_en.htm 
http://ec.europa.eu/internal_market/publicprocurement/other_aspects/index_en.htm#social  

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(c)  Main  actions  being  taken  to  control  the  correct  application  of  the  law  -  conformity 
assessments, reports on application of legislation, studies, etc. 

Conformity  of  the  national  transposition  measures  for  the  Remedies  Directive  (Directive 
2007/66/EC)) has been verified for the majority of Member States in 2010. 

An in-depth evaluation process has been launched in 2010 aimed at assessing the application 
and  effects  of  EU  public  procurement  rules  in  the  past,  and  several  studies  have  been 
committed on various aspects, the results of which are due in the first half of 2011. 

In  addition,  an  intense  cooperation  is  maintained  between  Commission  services  where  the 
proper application of EU public procurement rules plays an essential role for the achievement 
of specific sectoral objectives. Namely funding programs establish that full respect of public 
procurement  rules  is  a  condition  for  EU  financial  support  (regional  and  social  funds,  TEN 
programs). This cooperation takes place both prior and after the payment of funds. 

(d) Management of the acquis through committees and expert groups 

Exchange  with  the  Member  States  on  the  public  procurement  legal  framework  is  well 
established. The Commission regularly convenes Committees. First, the Advisory Committee 
on  Public  Contracts  (ACPC),  which  consists  of  the  representatives  of  Member  States 
authorities,  met  five  times  in  2010.  Specialised  working  groups  of  the  ACPC  also  met  in 
2010,  i.e.  the  Working  Group  on  E-Procurement  and  the  Economic  and  Statistical  Working 
Group  (two  meetings  each).  The  Commission  also  organises  meetings  of  the  Advisory 
Committee  on  the  opening  up  of  Public  Procurement  (CCO),  which  consists  of  public 
procurement and other technical experts. 

In the context of the described Committees, discussions included the following topics: 

- 

- 

- 

- 

- 

- 

- 

Evaluation  of  the  EU  acquis  in  public  procurement  and  reform  of  Directives 
2004/17/EC and 2004/18/EC 

A  Commission  initiative  concerning  European  rules  for  the  award  of  service 
concessions; 

The elaboration of a guidance document on the application of EU public procurement 
law to relations between contracting authorities; 

Electronic  dimension  of  public  procurement  (i.e.  PEPOL  project,  preparation  of  the 
Commission Green Paper on e-procurement; actions in favour of SMEs); 

Transposition  of  the  'Remedies'  Directive  2007/66/EC  (i.e.  national  time-schedules, 
problems  met)  and  actions  of  the  Commission  in  the  transposition  context  (bilateral 
meetings  with  Member  States  to  facilitate  the  transposition,  launch  of  infringement 
procedures after implementation deadline, etc); 

Transposition  of  the  "Defence"  Directive    2009/81/EC  of  13  July  2009  (i.e.  national 
time-schedules,  problems  met)  and  actions  of  the  Commission  in  the  transposition 
context (i.e. bilateral meetings with Member States, etc); 

Discussion on actions to be taken  by Member States to implement the European Code 

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of best practices facilitating access by SMEs to public procurement contracts; 

- 

- 

- 

National  recovery  plans  to  overcome  the  economic  crisis  and  phasing  out  of  such 
measures; 

Information on various negotiations with third countries which contribute to reinforce 
the role of the European public procurement legislation (i.e. GPA negotiations); 

Compilation  of  indicators  of  public  procurement  subject  to  the  EU  Directives, 
processing of national statistical reports, and statistical analysis of various aspects of 
total public expenditure (breakdown of total expenditure, analysis of above and below 
threshold expenditure). 

(e) Enquiries, problems and complaints management 

In  2010,  226  new  complaints  have  been  registered  by  the  Commission  in  the  public 
procurement field. Countries most concerned were Germany, Italy, Greece, UK and Bulgaria. 
Enquiries  and  complaints  in  the  field  of  public  procurement  have  been  increasingly  treated 
within  the  EU  Pilot  system  since  the  majority  of  Member  States  joined  the  system  in  the 
course  of  2010.  Public  procurement  files  accounted  for  50  %  of  the  EU  Pilot  files  in  the 
internal market and services area. 

(f) Petitions 

In  2010  the  sector  of  public  procurement  received  four  petitions  concerning  problems 
encountered in Spain, Italy and Romania. 

(g) Management of infringements 

In 2010, in 155 public procurement infringement files the Commission took relevant decisions 
to advance the files. Of these, 76 cases (49%) could be closed; 12 (approx. 7.5%) had to be 
referred to the Court. 

In  the  public  procurement  field,  20  non-communication  procedures  had  to  be  launched  in 
2010 concerning the Directive 2007/66/EC ("Remedies Directive"), which all could be closed 
except for one case due to compliance by the end of 2010. Two cases under Article 260 TFEU 
were opened and one brought before the Court. 

Evaluation based on the current position 

A comprehensive evaluation of the public procurement Directives 2004/17 and 2004/18 was 
set in motion in 2010. This essentially economic evaluation focuses on identifying the impact 
of the Directives, and assessing the effectiveness of the Directives in attaining their hoped-for 
objectives.  The  results  of  the  evaluation  –  published  in  June  2011410  –  will,  along  with 
stakeholder  responses  to  the  Commission  Green  Paper  on  the  modernisation  of  public 
procurement  policy411,  constitute  the  basis  for  proposing  relevant  adjustments  to  the 
Directives. Without prejudging the outcome of this in-depth evaluation project, the following 
indications can be made. 

410  
411  

http://ec.europa.eu/internal_market/publicprocurement/modernising_rules/evaluation/index_en.htm  
http://ec.europa.eu/internal_market/publicprocurement/modernising_rules/consultations/index_en.htm  

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Transposition of the EU acquis can be considered satisfactory by the end of 2010, although 
the  delays  in  the  transposition  of  the  Remedies  Directive  (see  reference  to  non-
communication cases above) deprived aggrieved bidders of the improved measures for redress 
against decisions of contracting authorities for the period of delay. 

As regards compliance of Member States with EU procurement rules, it has to be taken into 
account that more than 70.000 contracting authorities in the EU run procedures which have to 
respect EU rules on a daily basis. Any indicators such as the number of complaints have to be 
put into perspective against this background.  

2010 saw a continued high level of caseload of public procurement infringement complaints. 
The  increase  in  some  countries  may  be  explained  by  a  more  difficult  economic  situation, 
which  sharpens  competition  among  economic  operators  for  a  reduced  number  of  public 
contracts  in  an  environment  of  less  private  sector  opportunities.  However,  the  number  of 
infringement complaints and cases indicates that compliance levels should be improved in a 
number of Member States. The Impact Assessment on a Commission initiative on concessions 
revealed an important level of non-compliance with EU procurement principles in the area of 
service  concessions.  It  equally  has  to  be  recognised  that  the  Commission  regularly  detects 
cases of non-respect of EU public procurement rules in the context of the disbursement of the 
Union's structural and social funds. Every tender procedure disregarding the EU procurement 
rules puts their objectives – best value for money, equal and fair opportunities for European 
business and fight against corruption – at risk. 

Application of EU procurement rules lies exclusively with the Member States. The underlying 
reasons for cases of non-compliance at national level can include poor administrative capacity 
(contracting  authorities  subject  to  EU  procurement  rules  include  municipalities  and  other 
authorities  at  local  level),  complex  and  inefficient  administrative  procedures,  insufficient 
awareness in contracting authorities, problems of corruption and conflicts of interest, unclear 
transposition  in  national  rules  as  well  as  insufficient  deterrent  mechanisms  for  violations. 
While  responsibility  for  corrective  action  therefore  lies  mainly  with  Member  States,  the 
Commission  can  contribute  with  support  and  legislative  measures  to  remedy  existing 
weaknesses. 

Evaluation results 

In terms of legislative actions, work will focus on  

•  Adoption  of  a  proposal 

intended 

to  modernise  Directives  2004/17/EC  and 

2004/18/EC, including the development of a transposition plan at an early stage; 

•  Adoption  and  inter-institutional  negotiation  of  a  proposal  for  a  Directive  on  service 

concessions; 

•  Adoption  and  inter-institutional  negotiation  of  a  proposal  for  an  instrument 

transposing Member States' obligations under the GPA. 

In terms of support measures, efforts will primarily be devoted to 

•  Ensuring smooth transposition of Directive 2009/81/EC in all Member States until the 
transposition deadline (21 August 2011) and verification of the quality of the national 
transposition measures; 

•  Finalising the verification of the quality of the national transposition measures of the 

Remedies Directive 2007/66/EC; 

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•  Monitoring of the phasing out of national measures in the field of public procurement 
to  overcome  the  economic  crisis,  and  work  on  structural  reforms  in  Member  States 
mostly hit by the economic crisis. 

Concerning  infringement  cases,  in  addition  to  the  priority  categories  of  non-communication 
cases  and  Article  260  cases,  the  following  factors  will  determine  the  priority  treatment  of  a 
case:  high  contract  value  and  EU  funding,  problems  of  a  horizontal  nature  affecting  many 
procurements in a given Member State, cases raising important and/or new legal issues. 

Legislation: 

http://ec.europa.eu/internal_market/publicprocurement/legislation_en.htm 

11.5.  Professional qualifications 

Current position 

(1)  General introduction 

This sector deals with Member States' requirements for professional qualifications which lead 
to barriers to the free movement of qualified professionals in the Single market. To alleviate 
these  barriers,  Directive  2005/36/EC  of  the  European  Parliament  and  of  the  Council  on  the 
recognition  of  professional  qualifications412  implements  Articles  45,  49  and  56  of  the  FEU 
Treaty  for  all  regulated  professions.  Beneficiaries  are  all  EU  citizens  holding  a  professional 
qualification.  For  lawyers,  additional  specific  rules  have  been  laid  down  at  EU  level 
(Directive 77/249/EC on the free provision of services of lawyers413 and Directive 98/5/EC on 
the freedom of establishment of lawyers414). 

(2) 

Report of work done in 2010 

The  work  carried  out  in  2010  concentrated  on  the  launch  of  the  evaluation  and  on 
transposition,  implementation  and  accompanying  measures  to  Directive  2005/36/EC  with  a 
view to enabling citizens to make use of the new rights offered by the legislation (in particular 
the free provision of services and the mutual recognition under the so-called general system 
for cases which were previously only covered by the Treaty). The Commission also dealt with 
all  kinds  of  difficulties  reported  by  citizens  when  applying  for  recognition,  such  as  undue 
delays  in  decision  taking,  compensatory  measures  required  by  the  host  Member  State, 
negative decisions and requests for supplementary documentation, using all available means 
and in particular the network of national coordinators for Directive 2005/36/EC, EU Pilot and 
SOLVIT  according  to  the  nature  of  the  problem,  to  find  appropriate  and  EU  law  compliant 
solutions. 

(a) Management of the acquis through committees and expert groups 

The Commission held 7 meetings of its expert group composed of the national coordinators 
responsible for the application of Directive 2005/36/EC. The Group discussed the preparation 

412 
413 
414 

OJ L 255, 30.9.2005, p. 22. 
OJ L 78, 26.3.1977, p. 17. 
OJ L 77, 14.3.1998, p. 36. 

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of  the  evaluation  of  Directive  2035/36.  The  other  main  task  has  been  to  examine  the 
compliance with Directive 2005/36/EC of new diplomas in architecture notified by Member 
States  with  a  view  to  their  insertion  in  the  Annex  to  the  Directive,  granting  the  right  to 
automatic recognition to the holders of these diplomas. In total, 33 diplomas and 4 certificates 
were  examined.  This  work  has  allowed  the  achievement  of  a  good  level  of  mutual  trust 
between Member States avoiding subsequent problems of bad application. 

A  network  of  Contact  Points  for  Directive  2005/36/E,  whose  role  is  to  inform  and  assist 
citizens, met once. 

In  addition,  the  regulatory  committee  of  Directive  2005/36/EC  met  twice    and  voted  on  a 
Commission  regulation  amending  Annex  II  (to  upgrade  some  paramedical  diplomas)  and  V 
(to  add  medical  oncology  and  medical  genetics  to  the  list  specialities  to  be  recognized 
automatically)  to  the  Directive.  These  meetings  also  allowed  for  peer  pressure  to  accelerate 
the transposition of Directive 2005/36/EC for which some Member States were late. 

(b) Enquiries, problems and complaints management: 

Due to the large number of beneficiaries (all EU citizens holding a professional qualification 
and  who  wish  to  work  in  another  Member  State  even  temporarily),  a  large  number  of 
enquiries  is  received  by  the  Commission  which  do  not  necessarily  reveal  a  problem  of 
application  of  EU  law.  In  those  cases  the  Commission  refers  citizens  who  wish  to  enquire 
about  the  situation  in  Member  States  to  the  national  contact  points  under  Directive 
2005/36/EC  whose  task  it  is  to  give  all  information  about  regulated  professions  in  their 
territory but also about procedural steps to be taken. 

In the CHAP database approximately 88 inquiries and 82 complaints from citizens have been 
registered in 2010. As far as the complaints are concerned, roughly a half of these has already 
been closed.  

When enquiries reveal a potential problem of application of EU law in individual cases, the 
Commission mostly refers citizens to the SOLVIT network and/or inserts their cases into the 
system with the citizen's consent.  

Throughout 2010, 23 cases were introduced in EU Pilot for possible breaches of EU Law. 7 
cases have been solved and 4 cases led to the opening of the infringement procedure. 

(c) Management of infringements 

The volume of infringements concerning restrictions in breach of Articles 45, 49 and 56 of the 
TFEU and the directives on the mutual recognition of professional qualifications which were 
dealt  with,  remained  broadly  rather  stable  in  2010.  Approximately  31  decisions  (to  proceed 
with or to close a case) were taken by the Commission. 

the 

infringement  proceedings  opened  against  Member  States 

Concerning 
for  non-
communication  of  national  implementing  measures,  the  cases  referred  to  in  the  previous 
report concerning Directive 2006/100/EC and Directive 2005/36/EC have been closed further 
to compliance by Member States. 

The  infringements  cases  opened  against  Bulgaria,  the  Czech  Republic,  Hungary,  Latvia, 
Lithuania,  Malta,  Poland,  Romania,  Slovakia  and  Slovenia  because  of  the  nationality 

EN 

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condition  for  notaries  did  not  progress  in  2010.  This  is  due  to  the  fact  that  almost  all  the 
Member  States  concerned  intervened  to  support  the  Member  States  already  referred  to  the 
Court  of  Justice  (Germany,  Austria,  Belgium,  France,  Greece  and  Luxembourg).  In  these 
circumstances,  it  was  considered  necessary  to  examine  and  take  into  account  all  new 
arguments which might be brought forward by these Member States Estonia has abolished the 
condition of nationality but the Netherlands stopped the process of abolishing it waiting for 
the judgments of the Court. The Commission also referred Portugal to the Court on the same 
issue, because even though Portugal formally abolished the nationality condition previously in 
force for notaries, this condition thereafter appeared to still be applied. 

Concerning  the  measures  taken  by  Greece  to  comply  with  the  judgment  of  the  Court  of  21 
April  2005415  regarding  Greek  legislation  on  the  ownership,  opening  and  operation  of 
opticians' shops by companies, by judgment under Article 260 TFEU (ex-Article 228 EC) of 
4 June 2009 in Case C-568/07 Commission v. Greece, the Court held that by failing to take, 
by  the  date  on  which  the  time-limit  set  in  the  reasoned  opinion  issued  by  the  Commission 
expired, all the measures necessary to comply with the judgment of 21 April 2005 in Case C-
140/03  Commission  v  Greece,  Greece  had  failed  to  fulfil  its  obligations  under  Article  260 
TFEU (ex-Article 228(1) EC), and condemned Greece to pay a lump sum. This having been 
done, the case has been closed in January. 

In  addition,  under  Article  260  TFEU  (ex-article  228  EC),  the  Commission  sent  reasoned 
opinions  to  Greece  for  non-execution  of  the  judgments  of  the  Court  of  Justice  in  cases  C-
274/05  regarding  the  recognition  of  professional  qualifications  of  engineers  and  C-84/07 
regarding  the  recognition  of  professional  qualifications  of  opticians.  In  particular,  in  both 
cases, Greece still refused  to  recognise diplomas awarded  by competent authorities of other 
Member States under franchise agreements. Consequently, holders of such diplomas were still 
unable  to  practise  their  profession  in  Greece.  The  compliance  to  be  achieved  for  those  two 
judgments  has  been  included  in  the  Memorandum  of  Understanding  with  the  Greek 
government for financing assistance in 2010. 

(d) Petitions 

In  2010,  13  petitions  have  been  dealt  with.  These  petitions  in  essence  reflected  the  issues 
raised  in  enquiries  and  complaints  which  the  Commission  receives.  Most  cases  concern 
complex individual situations. 

(e)  Preventive  measures  being  taken  in  relation  to  recently  adopted  new  legislation-
transposition  package  meetings, 
conformity  assessment  of  national 
development  of  guidelines,  initiation  of  networking  systems  to  manage  the  new  legislation, 
etc. 

transposition, 

In  order  to  monitor  the  appropriate  and  smooth  application  of  this  Directive,  the  Code  of 
Good  Conduct  which  specifies  the  good  national  administrative  practices  competent 
authorities should follow when processing applications, adopted by the Group of Coordinators 
of Directive 2005/36/EC, has been published on the Europa website. 

To  enable  citizens  to  make  better  use  of  the  Directive,  a  document  with  frequently  asked 
question has been published on the Europa website along with the "User’s Guide". 

415  

Judgment of 21.04.2005, Case C-140/03 Commission v. Greece. 

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297 

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To  ensure  legal  certainty  for  professions  benefiting  from  automatic  recognition,  whose 
corresponding national titles are listed in Annex V to Directive 2005/36/EC, the Commission 
published twice416 the new titles and changes to existing titles notified by Member States on 
the  basis  of  Article  21  (7)  of  Directive  2005/36/EC.  These  publications  facilitate  free 
movement as they give the right to the holders of the qualifications concerned to benefit from 
automatic recognition. 

Evaluation based on the current position 

Directive 2005/36/EC had to be transposed by Member States by 20.10.2007. The 7 Member 
States which did not yet completely transpose it by the end of 2009 achieved it in 2010. For 
Directive  2006/100/EC  relating  to  accession  of  Bulgaria  and  Romania,  which  had  to  be 
transposed by 1.01.2007, the 3 Member States which had not completed transposition in 2009 
did it in 2010. However, and as indicated in the previous report, due to the fact that Directive 
2005/36/EC replaced 15 directives while maintaining their basic mechanisms of recognition, 
the non-transposition in due time by all Member States did not have a major negative impact 
on  free  movement  and  free  establishment.  In  the  large  majority  of  cases,  recognition  of 
qualifications still took place on the basis of the national implementing measures adopted on 
the basis of the now repealed directives. The Commission services published a report on the 
transposition  and  the  implementation  of  the  Directive  in  2010,  which  contains  a  first 
assessment of how the Directive has been transposed. 

A  second  scoreboard  was  published  in  April  2010  offering  an  overview  of  where  Member 
States  stand  in  implementing  Directive  2005/36/EC  into  national  law.  As  stressed  in  the 
previous  report,  the  main  challenge  related  to  this  directive  is  represented  by  the  enormous 
number  of  national  measures  needed  to  transpose  it.  By  the  end  of  2010,  around  1249 
measures had been notified to the Commission. 

The  IMI  system  plays  a  key  role  in  the  smooth  implementation  of  the  Directive.  It  allows 
competent authorities from the host and home Member States to exchange information linked 
with an application for recognition where doubts are raised in relation to the professional. The 
number of information exchanges increased by another 30 %. It was extended to 4 additional 
professions  (tour  guides,  psychologists,  engineers  and  social  workers)  in  October  2010, 
bringing the total number of professions covered to 35. 

Evaluation results 

(1) 

Priorities  

As indicated in the previous report, the following are being identified as key issues: the new 
regime for providing services for professions falling under the general system of recognition 
because  there  was  no  specific  regime  for  the  provision  of  services  for  all  the  professions 
falling  under  the  previous  Directives  89/48/EEC  and  92/51/EEC  on  the  general  system;  the 
subsidiary application of the general regime, which did not exist either (recognition then fell 
under the Treaty) as well as principle questions under the Treaty such as partial access to a 
given profession. 

416 

Communication  of  19  May  2010,  OJ  C  129  of  19.5.2009,  p.  1  and  Communication  of  14  December 
2010, OJ C 337, p. 10. 

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A  transposition  report  and  the  experience  reports  of  the  national  authorities  have  been 
published on our website. With professional organizations a meeting on the evaluation of the 
directive has been organized on 17 March and on 29 October.  

(2) 

Planned action (2011 and beyond) 

A  public  consultation  will  be  launched  in  2011.  This  consultation  will  aim  at  gathering 
stakeholders'  (in  particular  professionals  and  consumers)  views  on  a  modernisation  of  the 
Professional  Qualifications  Directive  (Directive  2005/36/EC),  in  particular  as  regards  a 
professional card. 

The final evaluation report and a Green Paper are foreseen for the autumn 2011 with a view to 
preparing a proposal for updating the Directive as announced in the Single Market Act. 

Summary 

Transposition  of  Directive  2005/36/EC  has  been  completed  in  all  Member  States.  The 
Commission therefore focussed on how Member States have implemented the Directive into 
their  national  regulations.  The  key  challenges for  the  Commission  have  been  first  to  ensure 
that  Member  States  accurately  transpose  the  Directive  and  second  to  evaluate  how  the 
Directive  works  and  whether  it  delivers  the  effects  compared  to  the  objective  of 
simplification. The evaluation could also take account of swiftly changing conditions, such as 
labour market, public health and others. 

11.6.  Company law, corporate governance and anti-money laundering 

Current position 

(1) 

General introduction 

Directives  in  the  fields  of  company  law  and  anti-money  laundering  aimed  at  ensuring  the 
stability and reputation of the financial sector (Anti-Money Laundering Directives, Directives 
2005/60/EC  and  2006/70/EC),  harmonizing  transparency  requirements  in  regulated  markets 
(Directives  2004/109/EC  and  2007/14/EC),  granting  a  transparent  framework  for  takeover 
bids  (Directive  2004/25/EC),  ensuring  shareholders'  rights  (Directive  2007/36/EC), 
strengthening  rules  on  remuneration  in  the  banking  sector  (Directive  2010/76/EC)  and 
facilitating  cross  border  mergers  as  well  as  easing  administrative  burden  of  companies  by 
modernising  and  simplifying  the  current  acquis  (Directives  2003/58/EC,  2005/56/EC, 
2006/68/EC, 2007/63/EC and 2009/109/EC). Taking into account the importance and impact 
of  this  acquis,  the  Commission  established  an  Action  Plan  in  2008  to  reduce  transposition 
deficit  and  complete  conformity  assessments  in  the  fields  of  company  law  and  anti-money 
laundering.  

(2) 

Report of work done in 2010 

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In  the  absence  of  communication  of  national  transposition  measures,  27  infringement  cases 
were  handled  in  2010417.  The  Commission  put  particular  emphasis  on  a  straightforward 
management of infringement cases and identified priorities such as to ensure compliance with 
judgements  of  the  European  Court  of  Justice.  Furthermore,  the  Commission  continued  to 
apply  a  number  of  complementary  measures  in  order  to  reduce  transposition  deficit.  It 
continued to publish scoreboards on state of play of transposition and package meetings were 
used  to  raise  the  issue  of  transposition.  The  Commission  also  kept  up  pressure  on  Member 
States through meetings of committees and national expert groups, in particular the Company 
Law  Experts'  Group  and  the  Committee  on  the  Prevention  of  Money  Laundering  by 
requesting delegations to justify their bad transposition record.  

The Court of Justice issued one Court ruling for a non-communication case in this sector in 
2010418. Furthermore, during 2010, the Commission dealt with seven infringement procedures 
based  on  Article  260  TFEU,  all  of  them  in  the  field  of  anti-money  laundering.  All  the 
procedures could be closed before the formal referral to the Court of Justice of the European 
Union. As infringement procedures based on Article 260 TFEU aim at ensuring compliance 
with Court rulings, these cases have been treated as a priority and followed-up closely by the 
Commission.  

The  infringement  procedures  for  non  communication  of  national  measures  for  Directive 
2007/36/EC  (the  transposition  deadline  was  3  August  2009)  were  also  followed  up  closely. 
Eight  cases  were  referred  to  the  Court  of  Justice.  By  the  end  of  2010,  five  cases  remained 
pending  before  the  Court.  The  Shareholder's  Rights  Directive  aims  at  introducing  minimum 
standards  to  ensure  that  shareholders  of  companies  whose  shares  are  traded  on  a  regulated 
market  have  a  timely  access  to  the  relevant  information  ahead  of  the  general  meeting  and 
simple means to vote at a distance. It also abolishes share blocking and introduces minimum 
standards for the rights to ask questions, put items on the general meeting agenda and table 
resolutions. Late transposition might jeopardize the objective to enable shareholders of listed 
companies throughout the European Union to exercise their rights and have their say.  

The  Action  Plan  elaborated  in  2008  also  included  the  monitoring  of  the  national  legislation 
implementing directives in the fields of company law and anti-money laundering. Conformity 
checks were therefore  given  all attention in 2010. The first phase of conformity  checks,  i.e. 
the  technical  conformity  assessments,  was  concluded  for  a  high  volume  of  national 
transposition  measures.  Taking  into  account  the  high  number  of  Directives  adopted  and 
transposed  in  the  previous  years,  the  absence  of  concordance  tables  and  the  fact  that  the 
assessment  of  long  and  comprehensive  national  instruments  (for  example  Civil  and 
Commercial  Codes)  have  significant  implications  in  terms  of  resources,  the  Commission 
outsourced  a  part  of  the  first  phase  of  conformity  checks  in  the  course  of  2009.  The  work 
related to seven different directives in the fields of company law and anti-money laundering419 
and  consisted  in  the  substantial  analysis  and  the  reporting  of  the  relevant  transposition 

417  

418  
419  

More than 140 procedures had been handled in 2009, out of which only 0.7% of the cases were non-
conformity cases in the fields of company law and anti-money laundering. In 2010, only 18.50% of the 
procedures handled were non-conformity cases.  
Decision of the Court of Justice of the European Union of 24 June 2010, in case C-2009/478.   
Directives  2004/109/EC  and  2007/14/EC 
(Transparency  Directives),  Directive  2003/58/EC 
(modification  to  the  1st  Company  Law  Directive),  Directive  2005/56/EC  (Cross-Border  Mergers 
Directive),  Directive  2007/36/EC  (Shareholders'  Rights  Directives)  and  Directives  2005/60/EC  and 
2006/70/EC (Anti-Money Laundering Directives).  

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measures420.  The  second  phase  of  the  conformity  checks  (i.e.  the  analysis  of  the  technical 
assessment  and,  when  required,  the  launching  of  formal  infringement  procedures  for  non 
conformity) will be carried out as from 2011.  

Although only one case for non compliance with the EU acquis was opened in 2010 (the case 
was  opened  ex  officio),  five  non  conformity  cases  were  examined  in  2010  in  the  fields  of 
company  law  and  anti-money  laundering.  All  of  them  were  at  an  early  stage  in  the  formal 
procedure. In parallel, contacts with national authorities were privileged to come to acceptable 
solutions. Although this approach will also be followed in 2011, the non conformity cases will 
be  pursued  in  the  absence  of  effective  action  with  a  view  to  putting  an  end  to  the  relevant 
infringements. 

As regards external submissions in the fields of company law and anti-money laundering the 
number of enquiries, petitions and complaints has increased; four petitions were received in 
2010. Two cases were registered in EU Pilot in 2010. Furthermore, fourteen complaints were 
registered in CHAP. 

One  new  Directive  which  deals  also  with  issues  related  to  company  law  (remuneration 
policies  in  the  banking  sector)  has  been  adopted  in  2010:  Directive  2010/76/EC  of  the 
European  Parliament  and  of  the  Council  of  24 November  2010  amending  Directives 
2006/48/EC and 2006/49/EC as regards capital requirements for the trading book and for re-
securitisations, and the supervisory review of remuneration policies.  

Evaluation based on the current position 

Through  the  rigorous  action  and  the  comprehensive  range  of  initiatives  taken  by  the 
Commission  in  accordance  with  its  Action  Plan,  positive  results  have  been  achieved.  The 
most  significant  success  in  2010  in  the  fields  of  company  law  and  anti-money  laundering 
were  the  completion  of  national  transposition  of  three  Directives421  and  the  conformity 
assessment of 57 national measures for seven directives.   

81% of the infringement cases for non communication recorded at the beginning of 2010 had 
been  closed  by  the  end  of  the  year  and  the  transposition  of  three  Directives  could  be 
completed.  Furthermore,  all  the  cases  in  relation  to  which  the  transposition  deadline  had 
expired before 2010 had been referred to the Court.  

Completing  the  transposition  of  the  Third  Anti-Money  Laundering  Directive  and  its 
implementing measures422 was essential since they aim at boosting the fight against financial 
crime as well as preventing damage to the stability and reputation of the financial sector and 
the single market. Moreover, delayed implementation could create difficulties for the banking 
sector in terms of costs related to the different rules in force in Member States. For its part, 
the  implementation  of  the  Directive  simplifying  the  rules  for  merger  or  division  of  public 
limited  liability  companies  as  regards  the  requirement  of  an  independent  expert’s  report423 
grants more flexibility to European companies. This had a particular importance in the context 
of the financial crisis.  

420  
421  
422  
423  

In the context of the outsourcing, 8,500 pages have been translated and analysed.  
Directive 2005/60/EC, Directive 2006/70/EC and Directive 2007/63/EC.  
Directives 2005/60/EC and 2007/60/EC.  
Directive 2007/63/EC.  

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The Commission drew up conclusions on the high effectiveness of the measures taken on the 
basis  of  the  Action  Plan  in  relation  to  the  completion  of  the  national  transposition  of 
Directives  in  the  fields  of  company  law  and  anti-money  laundering.  However,  a  number  of 
Member States proved to have still problems by being late with implementation. While in the 
fields  of  company  law,  Belgium,  France,  Greece,  Luxembourg,  Spain  and  Sweden424  had 
difficulties  to  transpose  on  time,  anti-money  laundering  rules  were  implemented  late  by 
Belgium, France, Ireland and Spain425. Although the Commission has kept and will keep up 
the  pressure  on  the  Member  States  which  are  late  with  transposition,  there  are  22  Member 
States which had no transposition deficit anymore at the end of 2010.  

The technical assessment of national transposition measures in the fields of company law and 
anti-money laundering was also a major success. The assessment included a reference to the 
relevant  articles  of  the  national  implementing  measures  in  the  light  of  the  corresponding 
articles of the concerned Directive (all in both the concerned Member State's official language 
and in English) and an indication of the technical assessment of conformity. 

Evaluation results 

(1) 

Priorities 

Priorities in the fields of company law and money laundering will not change substantially in 
2011.  The  Commission  will  endeavour  to  reduce  further  the  transposition  deficit,  keep  up 
pressure on Member States to ensure compliance with Court rulings, follow up closely non-
communication  cases  and  continue  with  the  conformity  checks  of  national  transposition 
measures. Two new transposition deadlines will expire in 2011. The transposition of Directive 
2010/76/EC426  is  due  for  1st  January  2011  for  issues  related  to  remuneration  policies  in  the 
banking  sector.  And  the  transposition  deadline  of  Directive  2009/109/EC427,  simplifying 
reporting  and  documentation  requirements  in  the  case  of  mergers  and  divisions,  is  30  June 
2011. A particular emphasis will be put on the four cases of late transposition of the Directive 
on Shareholders' Rights that were referred to the Court in June 2010428.  

(2) 

Planned action (2011 and beyond) 

424  

425  

426  

427  

428  

At  the  beginning  of  2010,  Belgium  and  Greece  were  late  with  the  transposition  of  the  Directive 
simplifying  the  3rd  and  the  6th  Company  Law  Directives  (2007/63/EC).  Both  Member  States  notified 
implementing  measures  in  2010.  The  score  of  the  transposition  of  the  Shareholders'  Rights  Directive 
(2007/36/EC)  improved  throughout  2010,  and  by  the  end  of  the  year,  only  five  out  of  the  14 
infringement cases existing at the beginning of the year remained open (Belgium, France, Luxembourg, 
Spain and Sweden).  
At  the  beginning  of  2010,  Belgium,  France,  Ireland  and  Spain  had  not  implemented  Anti-Money 
Laundering Directives (2005/60/EC and 2006/70/EC) and were pursued in the context of Article 260 of 
the TFEU. These four Member States transposed the directives in 2010 before the relevant cases were 
referred to the Court to ask for a penalty.  
Directive 2010/76/EC of the European Parliament and of the Council of 24 November 2010 amending 
Directives 2006/48/EC and 2006/49/EC as regards capital requirements for the trading book and for re-
securitisations, and the supervisory review of remuneration policies.  
Directive 2009/109/EC of the European Parliament and of the Council of 16 September 2009 amending 
Council  Directives  77/91/EEC,  78/855/EEC  and  82/891/EEC,  and  Directive  2005/56/EC  as  regards 
reporting and documentation requirements in the case of mergers and divisions.  
France notified measures transposing Directive 2007/36/EC at the beginning of 2011. 

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As  complementary  instruments  included  in  the  Action  Plan  had  successfully  reduced  the 
transposition  deficit  in  the  fields  of  company  law  and  anti-money  laundering,  they  will  be 
applied in the future. Concerning non-communication cases, Member States will be requested 
to provide detailed information on the state of play of transposition at relevant committee and 
experts' meetings. A scoreboard in the fields of company law and anti-money laundering will 
be published on a quarterly basis and as required, package meetings will be used as well. In 
the case of Directive 2007/36/EC, procedures under Article 260 TFEU would be accelerated 
as soon as the relevant Court Decisions will have been delivered.  

Remaining technical conformity assessments will be continued in the course of 2011. Given 
the high number of measures to be considered, the risk-based approach will be pursued. The 
second phase of the conformity checks (i.e. the analysis of the technical assessment and, when 
required, the launching of formal infringement procedures for non conformity) will be carried 
out as from 2011.  

Summary 

In the fields of company law and anti-money laundering, the focus remained on reducing the 
transposition  deficit,  on  ensuring  compliance  with  Court  rulings  and  on  assessing  the 
conformity  of  national  measures.  The  Action  Plan  established  in  2008  has  brought  very 
positive results. The actions and instruments identified in it will therefore be applied in 2011, 
too. In order to overcome the remaining difficulties related to conformity checks, risk-based 
assessments  will  be  continued.  Infringements  will  be  followed  up  strictly  against  Member 
States which are late with transposition. 

11.7.   Auditing – statutory audits 

Current position 

(1) 

Report of work done in 2010 

In  the  field  of  auditing,  in  2010  the  Commission  carried  on  its  work  on  the  correct 
implementation  of  the  Directive  2006/43/EC  on  statutory  audits  of  annual  accounts  and 
consolidated accounts of 17 May 2006429 ("the Directive"), which transposition was due on 29 
June 2008.  

In  2009,  six  Member  States  (Austria,  Estonia,  Ireland,  Italy,  Spain  and  Luxemburg)  were 
referred to the Court of Justice for non communication of the transposition measures for the 
Directive  2006/43/EC.  However,  all  theses  cases  were  closed  by  September  2010,  the 
Member States having communicated their national transposition measures.  

To  facilitate  the  establishment  of  auditor  public  oversight  bodies  in  Member  States,  as 
required by the Statutory Audit Directive, and to help the existing ones become operational, 
the  group  of  national  experts  "European  Group  of  Auditors'  Oversight  Bodies"  (EGAOB) 
continued its work on exchanging good practices on the establishment of those systems. Three 

429 

 OJ L 157, 9.6.2006, p.87. 

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EGAOB meetings – including one ad hoc EGAOB on the Green Paper on Audit Policy430 - 
were organized in 2010. 

Within  the  EGAOB,  the  sub-group  on  Cooperation  which  became  the  sub-group  on  Third 
Countries  held  three  meetings  in  2010.  At  these  meetings,  issues  related  to  the  equivalence 
assessment of third countries audit regulatory systems under Article 46 of the Directive, the 
adequacy assessment under Article 47 of the Directive, and the extension of the transitional 
regime for certain third countries were discussed.  

Another  sub-group  established  within  the  EGAOB,  the  sub-group  on  Inspections  held  four 
meetings  in  2010.  The  issues  discussed  at  the  meeting  of  this  sub-group  related  to,  among 
others,  the  inspections  procedures  among  the  Member  States,  inspections  of  network  firms, 
PCAOB joint inspections. 

Under the Directive, the Commission services may also adopt various implementing measures 
using the comitology procedure; whereby the Commission services are assisted by the Audit 
Regulatory  Committee  (AuRC)  composed  of  representative  of  the  Member  States.  In  2010, 
six AuRC meetings were held; issues discussed include the transposition of the Directive, the 
equivalence  and  adequacy  assessments,  the  cooperation  between  EU  public  oversight 
authorities. 

In  the  area  of  adequacy,  Article  47  of  this  Directive  requires  the  Commission  to  assess  the 
adequacy of the third country auditor oversight competent authorities that wish to cooperate 
with the Member States' auditor public oversight authorities on the exchange of audit working 
papers, in cooperation with the Member States. 

The  Commission  adopted  a  Decision  on  5  February  2010  recognising  the  adequacy  of  the 
auditor  oversight  system  of  the  competent  authorities  of  Canada,  Japan  and  Switzerland  431 
and another Decision on 1 September 2010 on the adequacy of the competent authorities of 
Australia and the United States of America432. These Decisions enable the exchanges of audit 
working papers between the EU Member State's oversight authorities and their counterparts in 
the above mentioned third countries.  

In  the  area  of  equivalence,  the  Commission  also  used  the  means  under  Article  46  of  the 
Directive  2006/43/EC  to  assess  the  equivalence  of  third  country  auditor  oversight,  external 
quality assurance, investigations and penalties systems. A draft Decision on the equivalence 
of  certain  third  country  public  oversight  systems  for  auditors  and  a  transitional  period  for 
audit activities of certain third country auditors in the European Union433 was submitted to the 
AuRC for its consideration in 2010. The draft Decision received a favourable vote from the 
AuRC at its meeting of 8 November 2010. This draft recognises the equivalence of the audit 
oversight systems in ten countries: Australia, Canada, China, Croatia, Japan, Singapore, South 
Africa,  South  Korea,  Switzerland,  and  the  United  States  of  America.  It  also  grants  a 
transitional  period  to  auditors  from  twenty  countries:  Abu  Dhabi,  Bermuda,  Brazil,  the 
Cayman  Islands,  The  Dubai  International  Financial  Centre,  Egypt,  Guernsey,  Hong  Kong, 
India, Indonesia, the  Isle of  Man, Israel, Jersey, Malaysia, Mauritius, New Zealand, Russia, 

430  
431  
432  
433  

COM (2010) 561 final. 
OJ L 35, 6.2.2010, p. 15. 
OJ L 240, 11.9.2010, p.6. 
OJ L 15, 20.1.2011, p. 12. 

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Taiwan,  Thailand  and  Turkey.  Following  the  adoption  of  this  Decision,  auditors  from  these 
third  countries  will  be  able  to  continue  their  audit  activities  in  the  European  Union  while 
further  assessments  are  carried  out.  After  the  exercise  of  the  European  Parliament's  right  of 
scrutiny which ended on 11 December 2010, the formal adoption of the draft Decision by the 
Commission and its publication in the Official Journal eventually took place in January 2011. 

(2) 

Changes underway in 2011 

The Commission published a Green Paper on audit policy on the 13th of October 2010 seeking 
views from stakeholders and the broader public on a broad range of issues related to statutory 
audit; the consultation closed on the 8th of December 2010, although responses continued to 
be filed after that date. In all, almost 700 responses were received. The objective of this Green 
Paper  was  to  initiate  a  debate  on  the  role  and  governance  of  auditor;  it  covered  issues 
encompassing the concentration of the audit market and its potential implications on financial 
stability, the need respond  to  the  specific needs  of  small  and  medium size  practitioners, the 
audit  of  SMEs  and  international  standards  on  auditing.  This  debate  would  continue  at  a 
Conference organised in February 2011. The conclusions of this debate may lead to a decision 
on the need to propose amendments to the current acquis in the area of audit. 

Furthermore,  the  European  Commission,  following  a  competitive  tendering  procedure, 
awarded  in  2010  a  contract  for  undertaking  an  external  study  on  the  effects  of  the 
implementation of the acquis on statutory audit of annual and consolidated accounts including 
the  consequences  on  the  audit  market.  The  study  will  also  provide  up  to  date  data  on  the 
European audit market. The results of this study should be available in autumn 2011. 

Evaluation based on current position 

The  transposition  deadline  for  the  Directive  2006/43/EC  was  29  June  2008.  Amongst  the 
remaining  six  Member  States  which  did  not  transpose  the  Directive  in  2009,  all  of  them 
finally implemented the Directive in 2010. 

The obligation for Member States to establish independent competent authorities to ensure a 
public oversight, external quality assurance, investigations and penalties of statutory auditors 
and  audit  firms  is  now  completed  in  twenty-six  Member  States  (most  of  these  authorities 
became  operational  in  2009).  As  of  end  2010,  only  one  Member  State  (Cyprus),  had  not 
established in practice an effective auditor public oversight body, even if it has adopted the 
relevant legislation to set up such an oversight body. On 6 April 2011, a reasoned opinion was 
sent  to  the  Cypriot  authorities  because  of  its  failure  to  set  up  a  public  oversight  system  for 
statutory  auditors  and  audit  firms  under  national  law  in  accordance  with  the  Directive 
2006/43.  Following  that,  the  Commission  services  received  information  that  an  effective 
oversight body was established in Cyprus and the case was thus closed. 

(1) 

Priorities 

The  main  priority  concerns  the  reshaping  of  the  audit  policy  at  European  level  through  the 
Green Paper, and the aftermath of its public consultation on the acquis in this domain.  

Another priority is ensuring that auditors' public oversight bodies pursuant to the Directive are 
operational  in  the  Member  States  and  cooperate  with  each  other  and  work  towards  the 
reinforcement of the supervision of audit firms at European level.  

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(2) 

Planned action (2011 and beyond) 

The transposition scoreboard will continue to be updated regularly and to be published on the 
Commission website. 

The  expert  group  "European  Group  of  Auditors'  Oversight  Bodies"  (EGAOB)  will  also 
continue its work on facilitating co-operation between public oversight bodies established by 
the Member States pursuant to Directive 2006/43/EC. 

11.8.  Accounting 

Current position  

(1) Report of work done in 2010 

In  the  field  of  accounting,  9  Directives  were  in  force  in  2010.  Two  of  them  had  not  yet,  in 
2010,  been  transposed  in  all  Member  States:  Directive  2006/46/EC,  which  transposition 
deadline expired on 5 September 2008 (the last transposition was completed in January 2011), 
and  Directive  2009/49/EC  which  transposition  deadline  expired  on  1  January  2011.  The 
Commission  services  control  the  application  of  the  relevant  EU  law  by  the  means  of 
infringement procedures and discussions in meetings with the Member States.  

transposing  measures.  Five 

The  majority  of  infringement  cases  and  the  petitions  received  stem  from  the  non-
communication/non-adoption  of  national 
infringements 
procedures  have  been  closed  in  2010.  The  Court  had  given  a  ruling  on  2  cases.  The 
Commission  services  have  been  encouraging  the  Member  States  to  complete  a  swift 
transposition. As regards transposition of Directive 2009/49, which transposition deadline was 
1  January  2011,  17  Member  States  notified  complete  transposition;  they  are  under 
examination by the services. For the 10 Member States which did not notify full transposition, 
several  reminders  have  been  sent  before  and  after  the  transposition  deadline  to  national 
authorities. 

(2) 

Changes underway 

The Commission services are working on a larger simplification and modernisation proposal 
to  review  the  4th  and  7th  Company  Law  Directives  which  is  expected  to  be  adopted  by  the 
Commission in 2011.  

Evaluation based on the current position  

At the beginning of 2010, the transposition deficit in the accounting field was rather low (6 
infringement procedures were open) and were all closed in the course of the year, except for 
one  which  was  closed  in  January  2011.  The  delay  in  transposition  was  not  due  to  political 
difficulties but rather to administrative delays in the Member States' legislative procedures. 

(1) 

Priorities 

The  main  priority  in  the  field  of  accounting  remains  to  ensure  the  timely  transposition  of 
adopted Directives. Furthermore, as mentioned above, the Services are working on a general 

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comprehensive overhaul of the accounting acquis (4th and 7th Company Law Directives). 

(2) 

Planned action (2011 and beyond) 

In the case of the Directive whose transposition deadline expired, the Commission Services 
are closely monitoring the transposition status by pursuing infringement cases. In the case of 
future  Directives,  the  Commission  services  will  continue  to  use  complementary  measures 
such  as  possible  transposition  workshops,  bilateral  meetings  and  discussions  within  the 
Accounting Regulatory Committee. 

As regards the planned overhaul of the 4th and 7th Company Law Directives, the Commission 
targeted 
services  are  pursuing  a  public  consultation,  meetings  with  stakeholders, 
questionnaires, an external study aimed at evaluation of the cost burden reduction potential of 
certain proposed simplification measures, in order to be able to present the amending proposal 
accompanied by a corresponding Impact Assessment. 

11.9.   Protection of rights 

Current position  

Patents 

On 30 June 2010, the European Commission proposed a Council Regulation on the translation 
arrangements for the EU patent434. The Commission's proposal was the subject of extensive 
discussions in the Council. Subsequently, the Presidency proposed a compromise based on the 
Commission's proposal with some extra elements addressing the concerns of several Member 
States.  Despite  strong  support  of  a  large  majority  of  Member  States  for  the  Presidency 
compromise, it was not possible to achieve unanimous agreement among the 27 EU Member 
States.  

Following the failure of the Council to agree on translation arrangements for the EU patent on 
the  basis  of  the  compromise  by  the  Presidency,  twelve  Member  States  sent  a  request  to  the 
Commission  to  propose  enhanced  cooperation  in  the  area  of  the  creation  of  unitary  patent 
protection. Furthermore, a number of other Member States were also favourable to enhanced 
cooperation and signalled their wish to participate. 

On  14  December,  the  Commission  adopted  a  proposal  for  a  Council  decision  authorising 
enhanced  cooperation  in  the  area  of  the  creation  of  unitary  patent  protection  indicating  the 
scope and objectives of enhanced cooperation. 

In  2010,  discussions  on  creation  of  a  unified  patent  litigation  system  have  been  suspended 
since the European Court of Justice was still considering a request for an opinion submitted 
by the Council435 regarding the compatibility with the EU Treaties of the draft Agreement to 
establish the European and EU Patents Court. 

Trademarks 

434  
435  

COM(2010) 350 final. 
Opinion 1/09. OJ C 220, 12.9.2009, p. 15–15. 

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The  process  of  comprehensive  evaluation  of  the  trade  mark  system  in  Europe  continued 
throughout  2010.  The  major,  but  not  the  only,  element  of  the  evaluation  is  a  study  on  the 
overall  functioning  of  the  European  trade  mark  system,  commissioned  to  the  Max  Planck 
Institute  on  16  October  2009,  which  will  serve  as  a  basis  for  the  revision  of  the  Council 
Regulation (EC) No 207/2009 on the Community trade mark and of the Directive 2008/95/EC 
approximating the laws of the Member States relating to trade marks. 

The Council adopted on 25 May 2010 conclusions on the future revision of the Trade Mark 
system  in  the  European  Union436.  The  Conclusions  identified  the  key  points  to  which  the 
Council would like to draw the Commission's attention in designing the future revision. The 
Conclusions  called  on  the  Commission  to  present  proposals  for  the  revision  of  the 
Community Trade Mark Regulation and the Trade Mark Directive.  

In  the  area  of  the  enforcement  of  intellectual  property  rights,  the  monitoring  of  the 
transposition  of  Directive  2004/48/EC  was  done.  The  Directive  had  to  be  implemented  by 
Member  States  by  29  April  2006.  All  Member  States  have  notified  their  national 
implementing  measures.  According  to  Article  18  of  the  Directive,  Member  States  were 
requested  to  submit  a  national  report  on  the  implementation  and  impact  of  the  Directive. 
Based of these reports, the Commission adopted in December 2010 a Communication on the 
Application  of  the  Directive.  This  Report  was  complemented  with  a  Staff  Working 
Document. 

The  Commission  continued  the  work  of  the  European  Observatory  for  Counterfeiting  and 
Piracy.  Subsequently,  the  Commission  organised  in  February  2010,  the  second  meeting  of 
private  stakeholders  and  in  June  the  first  Joint  Plenary  meeting  with  public  and  private 
sectors. In addition, the Commission in June organised, jointly with the European Parliament, 
the award ceremony for the competition addressed to schools. Finally, the Legal sub-group of 
the  Observatory  has  produced  three  different  reports  regarding  the  legal  framework  and  in 
particular comparative analysis and recommendations on the implementation of the Directive 
2004/48/EC.   

The  Commission  continued  also  the  work  of  the  stakeholders'  dialogue  on  the  sale  of 
counterfeit  goods  over  the  internet  and  on  the  similar  dialogue  for  the  illegal  down  loading 
and  illegal  up  loading.  The  objective  of  these  dialogues  is  to  foster  voluntary  inter-industry 
agreements between the relevant stakeholders; such agreements, given the quick development 
in the digital economy, often provide for quicker and more flexible solutions than legislation. 

A study on a possibility to establish an electronic exchange system on counterfeit goods has 
been concluded in November. 

Evaluation based on current position 

In  the  context  of  a  highly  political  area  and  due  to  the  complex  nature  of  the  Directive 
2004/48/EC, the main problem encountered by the Commission was the late transposition by 
some  Member  States.  This  has  impacted  directly  the  sending  of  national  reports  on  the 
implementation of the Directive. The monitoring was done through a constant dialogue with 
the Member States not having sent its report. The latest reports have been submitted only in 
October. Subsequently, the Commission has not been able, in its report, to engage in a critical 

436  

OJ C 140, 29.5.2010, p. 22–23. 

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economic  analysis  of  the  effects  that  this  Directive  may  have  had  on  innovation  and  the 
development of the information society. 

As far as the follow up of the European Counterfeiting and Piracy Observatory is concerned, 
in addition to the three working groups that have been set up and which meet on regular basis 
(one  working  group  on  statistics,  one  on  legal  framework  and  one  on  public  awareness),  a 
reflection has been launched on a possible future sustainable structure of the Observatory. 

As  far  as  the  stakeholders'  dialogues  are  concerned,  several  meetings  have  taken  place.  A 
drafting of a Memorandum of Understanding between participants has been almost completed 
for the stakeholders' dialogue on the sale of counterfeit goods over the internet. 

Concerning  trademarks,  the  Community  Trade  Mark  Regulation  and  the  Trade  Mark 
Directive  have  stood  well  the  test  of  delivering  an  efficient  and  effective  trade  mark 
registration  system.  However,  given  the  considerable  time  passed  since  their  adoption,  a 
revision process has been launched, in order to consider any necessary updates. 

As regards Patents, failure to reach an agreement on the translation issue and thus to break an 
impasse  over  a  single  EU  patent  prompt  some  Member  States  to  resort  to  enhanced 
cooperation under which at least nine EU countries can go ahead while others may join at any 
time at a later stage. 

(1) 

Priorities 

The priorities identified in the 2009 Annual Report were the same also for the year 2010. The 
monitoring  of  the  Directive  2004/48/EC  and  the  planning  for  the  enhancement  of 
administrative  cooperation  were  duly  performed.  Priorities  in  2010  included  also  the 
comprehensive  evaluation  of  the  European  trade  mark  system  the  creation  of  a  single  EU 
patent and the establishment of a unified patent litigation system in the EU. 

(2) 

Planned action (2011 and beyond) 

On  December  2010,  the  Commission  adopted  a  report  on  the  conformity  of  the  national 
measures with the provisions of the Directive 2004/48/EC. This report will be followed-up by 
a  public  consultation  and  a  deep  impact  assessment.  If  a  modification  of  Directive  appears 
necessary a proposal may be submitted by the end of 2011 or beginning 2012. Meetings with 
the Council on the Commission Communication will be organised during the year.   

Following  the  creation  of  the  European  Counterfeiting  and  Piracy  Observatory,  a  tender  on 
the  methodology  for  the  collection  of  statistics  is  expected  to  be  delivered  in  the  course  of 
next year. A proposal regarding its future structure and, in particular, its transfer to the Office 
for Harmonisation in the Internal Market (OHIM) is expected this year.  

As far the stakeholders' dialogue the Commission will keep working with the stakeholders on 
a possible adoption of the Memorandum of Understanding.  

In addition the Commission will follow-up the study on how to set up an information system 
for the rapid exchange of information on counterfeit goods.  

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Concerning  Trademarks,  in  March  2011,  the  final  report  of  the  study  on  the  overall 
functioning of the trade mark system was submitted to the Commission.  

The  Commission  will  come  up  with  proposals  for  revision  of  the  Community  Trade  Mark 
Regulation  (EC)  207/2009  and  the  Trade  Mark  Directive  2008/95/EC  in  the  1st  quarter  of 
2012. The objective is to modernise the trade mark system both at EU and national levels by 
making  it  more  effective,  efficient  and  consistent  as  a  whole,  including  enhancing  the 
complementarity  between  the  EU  and  national  systems  by  facilitating  cooperation  between 
the OHIM and national trade mark offices.  

As far as Patents are concerned, the creation of unitary patent protection is foreseen under the 
mechanism of enhanced cooperation. In March 2011, the Council authorised the launch of the 
enhanced  cooperation  among  25  Member  States  (Italy  and  Spain  do  not  take  part). 
Discussions in the Council and the European Parliament will continue throughout 2011 on the 
proposals  for  regulations  implementing  enhanced  cooperation  in  the  area  of  unitary  patent 
protection. Their adoption is envisaged in 2012. 

As regards the unified patents court, discussions were re-launched in the Council as the Court 
of Justice delivered its opinion on the compatibility of the draft agreement creating the unified 
patent  court  with  the  EU  Treaties  in  March  2011.  Discussions  on  the  way  forward  will 
continue  throughout  2011.  It  is  envisaged  that  the  draft  agreement  will  be  signed  by  the 
Member States in a diplomatic conference convened in 2012. 

12. 

REGIONAL POLICY 

12.1.  Current situation 

12.1.1.  General introduction 

According to Article 174 TFEU, European regional policy aims to reduce disparities between 
the levels of development of the various regions and the backwardness of the least favoured 
regions by actions supported by the Structural Funds437 (the European Regional Development 
Fund438,  ERDF,  and  the  European  Social  Fund439,  ESF)  and  the  Cohesion  Fund440  (CF). 
ERDF  and  CF  are  under  the  responsibility  of  the  Directorate  General  for  Regional  Policy, 
while  ESF  is  under  the  responsibility  of  the  Directorate  General  for  Employment,  Social 
Affairs  and  Equal  Opportunities.  These  Funds  are  managed  by  the  Commission  and  the 
Member States under shared management arrangements, as are similar programmes under the 

437 

438 

439 

440 

Council  Regulation  (EC)  No  1083/2006  of  11  July  2006  laying  down  general  provisions  on  the 
European Regional Development Fund, the European Social Fund and the Cohesion Fund and repealing 
Regulation (EC) No 1260/1999 (OJ L 210, 31.7.2006, p. 25). 
Regulation (EC) No 1080/2006 of the European Parliament and of the Council of 5 July 2006 laying 
down general provisions on the European Regional Development Fund and repealing Regulation (EC) 
No 1783/1999 (OJ L 210, 31.7.2006, p. 1). 
Regulation (EC) No 1081/2006 of the European Parliament and of the Council of 5 July 2006 laying 
down  general  provisions  on  the  European  Social  Fund  and  repealing  Regulation  (EC)  No  1784/1999 
(OJ L 210, 31.7.2006, p. 12). 
Regulation (EC) No 1084/2006 of the European Parliament and of the Council of 5 July 2006 laying 
down general provisions on the Cohesion Fund and repealing Regulation (EC) No 1164/94 (OJ L 210, 
31.7.2006, p. 79). 

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European Agricultural Fund for Rural Development441 and the fisheries sector442. In addition, 
Directorate General for Regional Policy is responsible for programmes under the Instrument 
for  Pre-Accession  Assistance  (IPA)443.  Rules  covering  the  programming  period  2007-2013 
were adopted in 2006. All 317 operational programmes financed by the ERDF and CF were 
negotiated in partnership and adopted by the Commission in 2007 or early 2008444. The new 
programmes of the Member States overlap with those of the period 2000-2006, for which the 
final  eligibility  date  for  expenditure  was  the  end  of  2008  or  30  June  2009.  Closure  is  now 
under way for the 2000-2006 programmes and projects.  

In  accordance  with  EU  law445,  assistance  under  the  Funds  is  provided  according  to  an 
approach  of  complementarity  and  partnership  between  the  Commission  and  the  Member 
States,  with  due  regard  to  their  respective  powers.  In  this  context,  implementation  on  the 
ground is the responsibility of the Member States, meaning in particular that the Commission 
is  normally  not  responsible  for  the  selection  of  individual  projects  (exceptions  being  the 
approval  of  CF  projects  for  the  2000-2006  period  and  of  major  projects  within  ERDF 
programmes), as this comes under the competence of the national authorities. 

To  be  eligible  for  co-financing  from  the  EU  budget,  projects  must  be  selected  and 
implemented  in  accordance  with  the  principles  laid  down  in  the  programming  documents 
adopted  by  the  Commission,  and  must  comply  with  the  specific  legislation  governing 
Cohesion Policy expenditure and generally applicable law (public procurement, state aid, the 
environment, etc.) and also with relevant national rules. The management and control system 
put  in  place  by  the  Member  States  seeks  to  ensure  the  regularity  of  all  expenditure  and  the 
Commission  supervises  its  effective  functioning.  When  the  rules  are  found  to  have  been 
breached,  making  expenditure  ineligible,  the  irregular  expenditure  has  to  be  excluded  by 
means of "financial corrections". If the Member States fail to correct irregular expenditure or 
to  remedy  deficiencies  in  the  management  and  control  system,  the  Commission  itself  may 
impose  financial  corrections  or  require  improvements  in  the  control  system.  In  the  event  of 
serious  deficiencies,  the  Commission  can  interrupt  or  suspend  its  interim  payments  to  a 
programme until the weaknesses are corrected. 

Most complaints tend to arise when an economic operator or member of the public considers 
that individual projects do not (fully) respect relevant EU and/or national rules and prefers to 
address  the  complaint  to  the  Commission  rather  than  to  his/her  national  authorities.  Such 
complaints can only be resolved with considerable support from the national authorities. Last 
year,  the  number  of  complaints  dealt  with  by  the  Directorate  General  for  Regional  Policy 
increased  significantly  (from  141  to  227).  Nevertheless,  they  do  not  normally  lead  to 
infringement procedures, but are resolved by application of the normal control and financial 
correction provisions specific to Cohesion Policy. 

441 

442 

443 

444 

445 

Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the 
European Agricultural Fund for Rural Development (OJ L 277, 21.10.2005, p. 1). 
Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund; (OJ L 223, 
15.8.2006, p. 1). 
Council Regulation (EC) No 1085/2006 of 17 July 2006 establishing an Instrument for Pre-Accession 
Assistance (IPA) (OJ L 210, 31.7.2006, p. 82). 
In  addition  17  programmes  under  IPA  were  adopted.  The  following  is  focussed  on  ERDF  and  CF 
programmes. 
Article 9 of Regulation (EC) No 1083/2006. 

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12.1.2.  Report of work done in 2010 

12.1.2.1. New legislation 

Simplification of existing legislation is in itself an additional means to promote a reduction in 
errors and irregularities while reducing administrative burdens.  

After a first wave of simplification in 2009, new regulations were adopted in 2010446 with a 
set  of  measures  amending  two  Council  Regulations  and  proposing  further  simplification  of 
the rules governing the financial management of the Structural Funds, in the context of efforts 
to  provide  more  support  in  face  of  the  international  financial  crisis  and  to  improve  the 
effectiveness of the delivery system of cohesion policy.  

A regulation was also adopted allowing the extension of financial support from the ERDF for 
housing  interventions  for  extremely  poor  and  marginalised  communities,  including  many 
Roma communities447. The aim is to promote the inclusion of Roma and other marginalised 
people by providing them with acceptable housing conditions.  

12.1.2.2. Preventive  measures  taken  (Comitology  and  cooperation  with  Member 

States) 

In  2010,  eight  documents  providing 
the 
implementation of operational programmes and to encourage good practice(s) were prepared 
by the Commission and then presented, discussed and finalised during  the  nine  meetings of 
the Committee for the Coordination of the Funds (COCOF)448. 

technical  guidance 

to  facilitate 

in  order 

12.1.2.3. Main actions being taken to control the correct application 

Financial corrections 

Financial  corrections  by  the  Member  States  themselves449  and  by  the  Commission450  are 
applied where expenditure for a project is irregular or where there are serious deficiencies in 

446 

447 

448 
449 

450 

Regulation  (EU)  No  539/2010  of  the  European  Parliament  and  of  the  Council  of  16  June  2010 
amending  Council  Regulation  (EC)  No  1083/2006  laying  down  general  provisions  on  the  European 
Regional  Development  Fund,  the  European  Social  Fund  and  the  Cohesion  Fund  as  regards 
simplification  of  certain  requirements  and  as  regards  certain  provisions  relating  to  financial 
management - (OJ L 158, 24.6.2010). 
Commission  Regulation  (EU)  No  832/2010  of  17  September  2010  amending  Regulation  (EC)  No 
1828/2006  setting out rules for  the  implementation of  Council  Regulation (EC) No  1083/2006  laying 
down general provisions on the European Regional Development Fund, the European Social Fund and 
the  Cohesion  Fund  and  of  Regulation  (EC)  No  1080/2006  of  the  European  Parliament  and  of  the 
Council on the European Regional Development Fund. (OJ L 248, 22.9.2010). 
Regulation  (EU)  No  437/2010  of  the  European  Parliament  and  of  the  Council  of  19  May  2010 
amending Regulation (EC) No 1080/2006 on the European Regional Development Fund as regards the 
eligibility of housing interventions in favour of marginalised communities (OJ L 132, 29.5.2010) 
Article 103 of Regulation (EC) No 1083/2006. 
Article  23  of  Regulation  (EEC)  No  4253/88  for  the  1994-1999  periods;  Article  39(1)  of  Regulation 
(EC)  No  1260/1999  for  the  2000-2006  period;  Article  98  of  Regulation  (EC)  No  1083/2006  for  the 
2007-2013 period. 
Article 24 of Regulation (EEC) No 4253/88 for the 1994-1999 period; Article 39(3) of Regulation (EC) 
No 1260/1999 for the 2000-2006 period; Articles 99 to 100 of Regulation (EC) No 1083/2006 for the 
2007-2013 period. 

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the management and control system of the operational programme (under the Member States' 
responsibility) which has put at risk the Union contribution paid to the programme. In 2010, 
total financial corrections carried out by the Member States (accepted at Commission request) 
and  by  the  Commission  (through  a  formal  Commission  decision),  following  Commission 
audit  work  (ERDF  and  CF;  periods  1994-1999  and  2000-2006)  amounted  to  approximately 
EUR 755 million. This amount is in addition to the EUR 288 million corrected in 2007, the 
EUR 1 billion corrected in 2008 and the 2 billion corrected in 2009, reaching thus a total of 
EUR 4, 1 billion in the years 2007-2010. The corrections reflect the completion of the follow-
up  of  previous  audit  work  and  an  acceleration  of  financial  correction  procedures  under  the 
"Action  plan  to  strengthen  the  Commission's  supervisory  role  under  shared  management  of 
structural actions"451 (hereinafter referred to as "Action Plan"). 

Compliance assessment 

In order to improve the management and control of the 317 programmes for the 2007-2013 
period,  the  Member  State  authorities  have  to  undertake  at  the  beginning  of  the  period  an 
assessment of the description of the national management and control system per programme 
accompanied,  by  an  independent  report  giving  an  opinion  on  their  compliance  with  the 
regulatory requirements to be  submitted before  the first interim payment can be made. This 
compliance assessment is a new element452 seeking to ensure that the set up of management 
and  control  systems  are  in  conformity  with  applicable  rules.  By  the  end  of  2010,  all 
compliance assessment reports (except one) regarding national systems had been received by 
the Commission, of which 313 (more than 98% of those received) were judged acceptable as 
of 31 December 2010. 

Audits 

In 2010, the Commission carried out 13 on-the-spot audit missions for the 2000-2006 period 
and 94 for the 2007-2013 period concerning ERDF and Cohesion Fund in 21 Member States 
(and some cross-border programmes). They focussed on the remaining risks in management 
and  control  systems,  the  review  of  bodies  responsible  for  the  closure  of  the  2000-2006 
programmes,  audits  of  operations  on  a  representative  sample  of  projects  for  the  2007-2013 
period and review of the work of the audit authorities for the 2007-2013 period. There were 
also  4  IPA/ISPA  audit  missions  in  Croatia,  Macedonia  and  Turkey.  Deficiencies  uncovered 
typically concerned organisational problems in the systems themselves or breaches in public 
procurement  or  eligibility  rules.  The  outcome  of  these  audits  may  take  the  form  of  action 
plans to improve performance, and possibly also suspension and interruptions of payments or 
the launch of financial corrections procedures, where necessary. 

12.1.2.4. Management of the acquis through committees and expert groups 

Beyond  the  development  of  guidelines  presented  to  the  COCOF  committee,  no  other 
committees  or  expert  group  meetings  linked  to  the  legality  of  the  expenditure  of  the  Funds 
have been organised. 

451 
452 

COM (2008)97 of 19 February 2008. 
Articles 71 and 72 of Regulation (EC) No 1083/2006. 

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313 

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12.1.2.5. Enquiries, problems and complaints management 

135 complaints have been registered. The complaints concerning Regional Policy did not lead 
to an infringement procedure in 2010. 

A first category of complaints concerns the selection process of individual projects under the 
different  programmes.  The  principal  motivation  for  complaints  was  the  rejection  of  the 
complainant's  application  for  financial  support.  As 
indicated  above,  under  shared 
management,  such  complaints  are  examined  by  the  competent  national  administrative  or 
judicial  authorities.  A  second  category  of  complaints  concerns  alleged  non-compliance  of 
individual projects with EU law, mostly relating to environmental law or public procurement 
law.  A  third  category  of  complaints  concerns  the  alleged  defects  in  selected  projects 
(examples include allegations that a particular infrastructure project is not in the right place 
(e.g. roads), does not work properly (water sewage treatment plants) or constitutes poor value 
for the European tax-payer's money. In such cases, there is generally no specific allegation of 
a breach of EU law. 

As  indicated  in  previous  reports,  concerning  the  new  Council  Regulation  on  a  European 
Grouping of Territorial Cooperation (EGTC)453, which entered into force on 1 August 2006, 
Member States have been required to adopt national rules to ensure the effective application 
of the Regulation and to inform the Commission of these rules. By the end of 2010, only two 
Member States had not completely adopted national rules due to their particular constitutional 
set-up.  These  results  were  achieved  through  political  dialogue  and  cooperation  with  the 
national authorities without recourse to infringement procedures. 

12.1.2.6. Petitions 

Directorate-General  for  Regional  Policy  has  treated  as  a  lead  service  11  petitions  involving 
projects  possibly  co-financed  by  the  Funds  and  has  been  associated  or  consulted  on  20 
petitions,  mostly  led  by  Directorate-General  for  Environment.  In  general,  petitions  concern 
the  misuse  of  EU  funding,  deterioration  of  environment  linked  to  the  construction  of 
infrastructure projects, or other alleged infringements of Union law. 

12.2.  Evaluation based on the current situation 

12.2.1.  Assessment of the current situation (satisfactory or problematic nature of the 

current situation) 

In  January  2005,  the  Commission  made  it  a  strategic  objective  to  strive  for  a  positive 
statement  of  assurance  (DAS)  from  the  European  Court  of  Auditors.  To  make  progress 
towards  this  goal,  it  introduced  an  Action  Plan  towards  an  Integrated  Internal  Control 
Framework454.  In  2008,  the  Commission  adopted  a  specific  Action  Plan455  to  strengthen  its 
supervisory role in the structural actions area, in order to address the European Parliament's 
concerns arising from the weaknesses identified by the Court of Auditors in its 2006 Annual 
Report. The structural actions Action Plan addressed both the causes and effects of the high 

453 

454 
455 

Regulation (EC) No 1082/2006 of the European Parliament and of the Council on a European Grouping 
of territorial cooperation (OJ L 210, 31.7.2006, p. 19). 
COM (2006) 9 and SEC (2006) 49. 
"Action Plan" (COM (2008)97 of 19 February 2008). 

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314 

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rate of error found by the European Court of Auditors in structural actions expenditure. The 
Commission's focus has been on increasing the effectiveness of the controls undertaken by the 
Member  States  and  of  its  own  supervisory  activity,  in  order  to  ensure  that  by  the  time  the 
2000-2006 programmes and projects are closed, most of the irregular expenditure is corrected 
and  the  residual  risk  of  error  is  as  low  as  possible.  For  the  2007-2013  period,  the 
Commission's  preventive  actions  aim  to  ensure  that  the  Member  States'  management  and 
control  systems  function  effectively  from  the  beginning  of  the  programme  implementation 
and that deficiencies are detected as early as possible. 

12.2.2.  Importance of the impact of the identified problems on the objectives of the 

acquis 

Achieving the aims of cohesion policy in reducing geographical disparities of the programmes 
depends on effective implementation and requires that projects are selected and implemented 
correctly. The planned actions set out below contribute to this overall priority. 

12.2.3.  Underlying reasons for problematic areas 

Under  shared  management  (see  following  section),  according  to  Article  317  of  the  Treaty, 
"the  Commission  shall  implement  the  budget  in  cooperation  with  the  Member  States,  in 
accordance with the provisions of the regulations  made pursuant  to Article 322, on its own 
responsibility (…), having regard to the principles of sound financial management. Member 
States  shall  cooperate  with  the  Commission  to  ensure  that  the  appropriations  are  used  in 
accordance  with  the  principles  of  sound  financial  management".  Consequently,  any  item  of 
expenditure co-funded from the Funds shall comply with the provisions of the Treaty and of 
acts adopted under  it456. Compliance with the acquis on matters as diverse as single market 
rules  (EU  Directives  on  public  procurement),  competition  (state  aid  rules),  environment, 
research,  transport  or  energy  poses  a  complex  task  for  Member  States  when  implementing 
operations on the ground together with a huge number of public or private final beneficiaries 
spending the contribution from the Funds. 

12.2.4.  Responsibility for the problems and their correction 

Under  shared  management,  the  Commission  is  responsible  for  the  execution  of  the  Union 
budget,  but  the  Member  States  are  responsible  for  the  implementation  of  the  individual 
projects.  Errors  and  irregularities  (which  in  practice  contain  very  few  cases  of  fraudulent 
behaviour) concerning the projects are matters outside the direct control of the Commission. 
Member States are responsible in the first instance to correct these errors (mainly by financial 
corrections  on  project  level).  The  Commission  seeks  to  ensure,  through  its  supervisory  role 
that the management and control systems set up by the Member States  are effective and, in 
cases  where  the  systems  are  dysfunctional  or  where  the  corrections  undertaken  by  Member 
States are not sufficient, applies financial corrections on programme or - in the case of CF for 
the 2000-2006 period – on project level. 

12.2.5.  Corrective action required (priority character, timing and scale) 

From  the  different  actions  carried  out  in  2010,  it  is  evident  that  the  respect  of  the  regional 
policy  acquis  requires  actions  of  a  different  nature:  corrective  (financial  corrections,  action 

456 

Article 9(5) of Regulation (EC) No 1083/2006. 

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315 

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plans, and infringement and complaints procedures), preventive (simplification of the acquis, 
compliance assessment, audits and controls, guidance notes, seminars) and informal/political 
(comitology, direct dialogue). 

The  implementation  of  the  Action  Plan  and  the  Joint  Audit  Strategy  of  the  Directorates-
General in charge of Cohesion Policy, which focus on measures to strengthen the supervision 
of the correct implementation of the programmes and projects, further simplification and the 
finalizing of the compliance assessment, have been key elements to reduce as far as possible 
errors linked to the closure of the 2000-2006 programmes and to avoid errors under the new 
programming exercise. 

12.3.  Evaluation results 

12.3.1.  Priorities 

As indicated in its "Annual Management Plan 2011" (21 December 2010) one of the specific 
objectives  identified457  is  to  seek  reasonable  assurance  that  the  management  and  control 
systems in the Member States and beneficiary countries comply with the requirements of the 
EU  regulations  and  are  functioning  effectively,  so  as  to  prevent  and  detect  errors  and 
irregularities  and  assure  the  legality  and  regularity  of  the  expenditure  declared  to  the 
Commission.  To  this  end,  the  Directorate  General  for  Regional  Policy  will  seek  to  ensure 
through its supervisory role that Member States and regions have established the appropriate 
structures for management and control and will advise on measures to tackle weaknesses in 
administrative  capacity  for  delivery,  as  well  as  provide  appropriate  support  for  setting  up  a 
sufficient stock of projects. 

12.3.2.  Planned action (2011 and beyond) 

12.3.2.1. New legislation in preparation 

The  informal  preparation  of  the  new  legislation  concerning  the  2014  to  2020  programming 
period has been intensified in 2010, but formal proposals will be sent to the legislator in 2011, 
including on the EGTC instrument. 

12.3.2.2. Preventive  measures  taken  (Comitology  and  cooperation  with  Member 

States) 

In  order  to  help  the  national  and  regional  authorities  with  implementation,  many    guidance 
notes  were  presented  in  the  years  2007  to  2010.  Two  are  planned  to  be  presented  to  the 
Committee for the Coordination of the Funds (COCOF) in 2011. Due to the amendments to 
the  legislation  adopted  in  2009  and  2010,  some  guidance  notes  will  have  to  be  revised 
accordingly. 

12.3.2.3. Main actions being taken to control the correct application 

Interruptions of payments 

As a preventive measure, in addition and as a possible first step to the suspension of payments 
decided by the Commission, Authorizing Officers by Delegation are empowered by Article 91 

457 

See section 5.2. 

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316 

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of  Regulation  (EC)  No  1083/2006)  to  interrupt  payment  deadlines  of  Structural  funds  and 
Cohesion fund applications for payments of the 2007/13 programming period if (a) in a report 
of a national or Community audit body there is evidence to suggest a significant deficiency in 
the functioning of the management and control systems or (b) he has to carry out additional 
verifications following information coming to his/her attention alerting that expenditure in a 
certified  statement  of  expenditure  is  linked  to  a  serious  irregularity  which  has  not  been 
corrected. These interruptions are valid for a maximum period of 6 months and lifted as soon 
as  the  remedy  measures  have  been  undertaken  by  the  national  authorities.  In  2010,  41 
applications for interim payments have been interrupted (corresponding to a total amount of 
EUR 2.155.582.086,26), most of which having been lifted, to date.  

Financial corrections 

The  current  estimate  of  potential  financial  corrections  likely  to  result  from  the  financial 
correction procedures underway at the end of 2010 is approximately EUR 459 million (it was 
600 million at the end 2009). Due to the audit work executed (see below section 1.3.2.3.3), 
financial  corrections  through  formal  Commission  decisions  are  necessary  only  in  cases  that 
recommendations  for  remedial  actions  for  deficiencies  identified  in  the  systems  or  detected 
irregularities have not been taken up by the Member States. 

Compliance assessment 

Concerning  the  2007-2013  period,  the  compliance  assessment  exercise  has  been  almost 
completed. 

Audits 

In  terms  of  audit  and  control  activities,  the  Directorate  General  for  Regional  Policy  will 
maintain  the  momentum  generated  by  the  Action  Plan  to  strengthen  the  Commission's 
supervisory role under shared management of structural actions and continue rigorous actions 
in  2011  under  its  multi-annual  audit  strategy.  Overall,  it  will  continue  to  seek  to  make 
progress  towards  a  positive  declaration  of  assurance  (DAS)  on  expenditure  under  Cohesion 
policy through preventive and corrective measures focused on the closure of the programmes 
for 2000-2006, and the start up and functioning of the programmes for the 2007-2013 period. 
Concerning the 2000-2006 period, the completion of financial corrections, the completion of 
the  follow-up  of  the  review  of  bodies  responsible  for  the  closure  of  the  2000-2006 
programmes  and  the  review  of  closure  declarations  has  been  the  main  priority  in  2010. 
Concerning the 2007-2013 period, audits will continue to be focused on the work of the audit 
authorities to obtain assurance on the reliability of their work and on the functioning of the 
management and control systems in the Member States.  

13. 

TAXATION AND CUSTOMS UNION  

13.1. 

Situation in the sector of CUSTOMS 

13.1.1.  Current position  

13.1.1.1. General introduction 

In continuation with previous years, the strategy was to put the emphasis on the prevention of 

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the  infringements,  fully  in  line  with  the  Communication458  on  a  strategic  review  of  better 
regulation  in  the  European  Union,  and  moreover  with  the  Communication459  on  a  better 
monitoring  of  the  application  of  EU  law,  the  attention  is  devoted  to  a  better  and  simplified 
legal  environment.  Due  to  its  responsibilities  in  the  area  of  the  EU  legislation,  the 
Commission continued its efforts aiming at enhancing the correct and uniform application of 
the customs EU legislation.  

Member States are fully committed to apply correctly EU customs rules, helped in this crucial 
task  by  a  close  cooperation  with  the  Commission.  The  key  element  of  this  process  is  the 
priority  given  to  preventive  approach  aimed  at  involving  all  parties  concerned.  To  enable  a 
comprehensible  approach,  the  multi-annual  programme  of  monitoring  the  compliance  of 
Customs  legislation  in  different  Member  States  has  been  satisfactorily  continued  and 
developed.  This  pro-active  strategy  follows  a  planning  process,  targeting  a  selection  of 
legislative sectors presenting, according to the risk criteria, actual or potential risk of incorrect 
or  non  uniform  application,  thus  damaging  main  interests  of  Trade  and  of  financial 
importance.  

13.1.1.2. Existing measures in force: see Annex IReport of work done in 2010 

In 2010 22 judgments related to customs were delivered, while 23 judgments were delivered 
in 2009.  

Most of the Court's judgments in this area concerned references for preliminary rulings.  

The  most  relevant  judgment  in  2010  was  C-386/08  Brita  GmbH  v  Hauptzollamt  Hamburg-
Hafen:  Brita,  a  German  company  wished  to  import  into  Germany  goods  supplied  by  Soda-
Club,  a  company  based  in  the  West  Bank  to  the  east  of  Jerusalem.  This  company  sought 
preferential  treatment  for  these  products  under  the  EC/MS-Israel  Association  Agreement 
while Germany suspected the products to have been produced in the occupied territories. 

The  judgment  ruled  that  the  assertion  made  by  the  Israeli  authorities  that  products 
manufactured  in  the  occupied  territories  qualify  for  the  preferential  treatment  granted  for 
Israeli goods is not binding upon the customs authorities of the territorial application of the 
Association agreement with Israel and the territory of the State of Israel, must be interpreted 
as meaning that products originating in the West Bank do not fall within the territorial scope 
of that agreement and therefore do not qualify for preferential treatment under the Association 
agreement  with  Israel.  Goods  which  originate  in  the  West  Bank  cannot  benefit  from 
preferential treatment unless origin certificates have been produced by Palestinian competent 
authorities.  

Regarding  parliamentary  questions,  nine  have  been  treated,  while  one  petition  has  been 
registered. 

As  regards  customs,  the  Commission  opened  no  own  investigations  regarding  presumed 
infringements, and three files on the basis of complaints.  

Besides, twenty three requests that constitute potential infringements have been received. 

458 
459 

COM(2006)689 of 14.11.2006. 
COM(2002)725 of 16.05.2003. 

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No  reasoned  opinion  (under  Article  258  TFEU)  has  been  sent.  Thus,  the  total  number  of 
infringement  cases  (three)  is  lower  than  in  2009  (four)  and  is  also  the  same  for  reasoned 
opinions (0 in 2009). 

During  2010,  two  infringement  cases  were  closed  after  the  Member  States  concerned 
modified their legislation to comply with EU Law. 

Most of enquiries and complaints in this area relate to the application of Customs legislation 
in general. No prioritisation was necessary to deal with the cases as regards clear and serious 
infringements of EU legislation. 

13.1.2.  Evaluation based on the current situation 

In the customs field, EU legislation is mainly adopted in the form of Regulations. The correct 
and uniform application of EU customs law is consequently a clear obligation for the Member 
States.  

The  policy  on  infringements  should  be  envisaged  in  a  larger  framework.  The  control  of  the 
correct  application  of  EU  legislation  should  be  seen  as  one  of  the  instruments  of  a  wider 
policy  of  the  harmonisation  of  Member  States  legislation  and  the  implementation  of  EU 
legislation (committees, working groups, soft law, comitology, proposing a modifying act). 

This is clear in the area of customs, where the main EU legislative instrument is the regulation 
and  where  a  correct  application  of  EU  law  and  a  common  application  of  EU  rules  are 
dependent on both clear and accurate legislation and strong cooperation between the Member 
States. The practical application of EU legislation to individual cases is particularly important, 
which  accounts  for  the  high  volume  of  requests  made  by  national  courts  to  the  ECJ  for 
preliminary rulings that become a major guarantee of the uniform application of the EU law. 

There has been no significant increase in the number of infringements over recent years. The 
overall  situation  in  the  area  of  customs  remains  stable  and  this  tendency  is  expected  to 
continue.  

Another way of improving the correct application of customs legislation is through increased 
use of informatics. Thus, in recent years, Customs authorities have developed and introduced 
the  extensive  application  of  electronic  instruments,  through  the  package  called  'E-Customs'. 
The introduction of this computerisation involves both a harmonisation and standardisation of 
data and procedures that should contribute to improved application.  

13.1.3.  Evaluation results 

13.1.3.1. Priorities 

As  far  as  Customs  are  concerned,  the  situation  has  not  clearly  changed  regarding 
infringements  but  the  number  of  references  to  the  Court  has  increased.  Consequently, 
priorities  set  for  2010  remain  unchanged  for  2011.  Considering  that,  on  the  one  hand,  the 
global  volume  of  infringements  and  complaints  remains  stable,  and  on  the  other  hand,  this 
trend  is  likely  to  be  stable  in  2011,  no  specific  action  regarding  prioritization  should  be 
envisaged.  

13.1.3.2. Planned action (2011 and beyond) 

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Taking  into  consideration  the  evaluation  of  the  current  situation,  a  specific  planning  is  not 
required.  Nonetheless,  it  should  be  noticed  that  a  decrease  of  volume  does  not  necessarily 
mean that the situation is fully satisfactory and that legislation is evenly and correctly applied. 
As in previous years, economic operators or citizens might face problems when they have to 
comply  with  measures  in  the  short  term,  but  they  do  not  always  report  to  Commission 
services. This is why a pro-active and horizontal approach has been preferred to continuing to 
target individual, isolated infringements approach. 

In  line  with  COM(2006)  689,  attention  has  been  put  on  helping  Member  States  to  ensure  
correct  and  uniform  application  of  EU  customs  legislation.  The  strategy  is  built  on  close 
cooperation with Member States oriented towards new tools enabling improved monitoring of 
the application of EU Customs law. Consequently multi-annual programme of monitoring the 
compliance  of  Customs  legislation  in  the  whole  EU  territory  has  been  introduced  and 
developed since 2008. 

13.1.4.  Sector summary 

During  the  year  2010  in  the  area  of  CUSTOMS,  the  volume  of  enquiries,  complaints  and 
references  for  preliminary  rulings  has  been  stable  compared  to  the  other  years.  Taking  in 
consideration  the  likeliness  of  this  tendency  to  continue,  there  is  no  need  for  any  specific 
urgent action to be launched.  

Like previously, the strategic emphasis targeted the prevention of the infringements in order 
to  act  ex  ante  instead  of  increasing  the  intervention  at  the  downstream  level,  through  the 
infringements process. 

Existing measures in force: see Annex I 

13.2. 

Situation in the sector of INDIRECT TAXATION 

13.2.1.  Current position 

13.2.1.1. General introduction  

Establishing  an  Internal  Market  supposes  the  application  of  legislation  on  indirect  taxation 
that neither distorts competition nor free movement of goods and services.  

Therefore  it is  necessary  to achieve harmonisation of legislation in  line with the changes in 
the  economy  by  means  of  proposals  for  new  directives  although  achieving  that  objective  is 
often compromised by the rule of unanimity.  

For  this  reason  a  coordinated  infringement  policy  is  necessary  to  ensure  the  proper 
functioning of the free market and to avoid distortions where there is no harmonisation.  

13.2.1.2. Existing  measures  in  force  (situation  on  31/12/2010):  see  Annex  IReport  of 

the work done in 2010  

a)  New  legislation  in  preparation  or  already  proposed  and  in  the  course  of  being  adopted, 
impact  assessments  and  implementation  plans  being  developed  in  connection  with  new 
proposals, etc. 

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Value added tax (VAT) 

Measures for a consistent response to carousel fraud in certain sectors 

In order to allow Member States to take rapid action against carousel fraud, the Commission 
adopted on 29 September 2009 a proposal for a Directive allowing the application of a reverse 
charge mechanism on the supply of five categories of particularly fraud sensitive goods and 
services, namely: computer chips, mobile phones, precious metals, perfumes and greenhouse 
gas emission allowances. 

The possibility for all Member States to opt for the application of reverse charging under the 
same  conditions  to  a  limited  list  of  goods  and  services  provides  Member  States  with  the 
necessary  tool  to  tackle  worrying  fraud  phenomena  in  a  flexible  manner  while  ensuring 
consistency in the response Member States give to carousel fraud and avoid fraud relocation. 
The  aim  was  also  to  provide  valuable  experience  for  evaluating  the  efficiency  of  such  a 
measure. 

On 16 March 2010 the Council adopted the part of this proposal relating to greenhouse gas 
emission allowances (Council Directive 2010/23/EU). 

The remaining part of the proposal is still on the table of the Council. 

Invoicing 

On 13 July 2010, the Council adopted a directive related to invoicing rules (Council Directive 
2010/45/EU).  The  aim  of  the  directive  is  to  simplify  VAT  invoicing  requirements,  and  in 
particular to facilitate the use of electronic invoicing by removing unnecessary conditions and, 
thereby, to create the conditions for equal treatment with paper invoicing. The directive also 
simplifies, modernises and harmonises other VAT invoicing rules. This measure will reduce 
burdens on business, support small and medium sized enterprises (SMEs) and help Member 
States to tackle fraud. While the Commission's initial proposal would also have led to a set of 
simplified  rules  on  invoicing,  the  Council  could  not  reach  agreement  on  the  removal  of  the 
many options available under the current rules.  

The directive is a key element of the EU commitment to reduce burdens on business by 25% 
by 2012.  

Improvement of the functioning of the cross-border refund directive 

The new VAT Refund Directive (Council Directive 2008/9/EC) replaced on 1 January 2010 a 
previous Directive from 1979 providing for a paper procedure by which taxpayers established 
within the EU had to send original invoices to all Member States in which they incurred VAT 
in order to receive a refund. The new Directive introduces an electronic system by which the 
taxable  person  submits  his  application  to  the  Member  State  of  refund  via  a  web  portal 
developed  by  the  Member  State  in  which  he  is  established.  Member  States  were  obliged  to 
make this web portal available on 1 January 2010. The deadline for submission of the refund 
application  in  the  Member  State  of  establishment  was  set  for  30  September  of  the  calendar 
year following the refund period.  

However, some Member States were late in launching their web portals (mid-May for the last 
one),  whilst  others  have  had  a  number  of  technical  problems,  both  leading  to  a  situation  in 

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which  taxable  persons  have  not  been  able  to  submit  their  refund  applications.  Additionally, 
divergences  in  the  technical  details  relating  to  Member  State  web  portals  led  to  several 
difficulties. 

Therefore  the  Commission  made  a  proposal  to  prolong  the  deadline  applicable  to  2009 
requests until 31 March 2011 as well as granting the Commission the necessary comitology 
powers  to  adopt  the  technical  measures  that  are  necessary  for  such  a  pan-European  refund 
scheme to function properly460. 

The  Council  adopted  on  14  October  2010  the  first  part  of  the  proposal  relating  to  the 
extension of the deadline (Council Directive 2010/66/EU). The second part relating to the use 
of comitology to adopt technical implementing measures is however still before the Council. 

VAT on postal services 

The  ECOFIN  Council  of  7  December  2010  discussed  the  way  forward  on  the  2003 
Commission  proposal  on  VAT  on  postal  services  and  acknowledged  that  it  will  not  be 
possible, at this stage, to make progress. 

In the absence of progress at this stage, the status quo, based on the current provisions of the 
VAT Directive and the case law from the Court of Justice will remain. 

VAT standard rate 

Following  the  Commission's  proposal  (COM(2010)  331)  of  24  June  2010,  the  Council 
adopted  on  7  December  2010  Directive  2010/88/EU  maintaining  the  current  minimum 
standard rate of VAT at 15% until 31 December 2015.  

Future of VAT 

On  1  December  2010,  the  Commission  adopted  a  Green  Paper  on  the  future  of  VAT 
(COM(2010) 695) - "Towards a simpler, more robust and efficient VAT system", by which it 
launched  a  wide  public  consultation  on  how  the  EU  VAT  system  can  be  strengthened  and 
improved, to the benefit of citizens, businesses and Member States. 

In  the  same  month  a  Communication  on  "Removing  cross-border  tax  obstacles  for  EU 
citizens"461 was also adopted. The Communication outlines the most serious tax problems that 
EU  citizens  face  in  cross-border  situations  (e.g.  double  taxation,  difficulties  in  claiming  tax 
refunds  or  obtaining  information  on  foreign  tax  rules)  and  announces  plans  for  solutions  in 
some areas such as e-Commerce. 

Recast – Council Regulation (EU) N° 904/2010 

In the context of the fight against VAT fraud, the Commission worked on its proposal for a 
Council Regulation on administrative cooperation and combating fraud in the field of Value 

460 

461 

Proposal  for  a  Council  Directive  amending  Directive  2008/9/EC  laying  down  detailed  rules  for  the 
refund of value added tax, provided for in Directive 2006/112/EC, to taxable persons not established in 
the Member State of refund but established in another Member State (COM(2010)381final). 
COM(2010)769 of 20 December 2010 

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Added Tax (Recast) (COM (2009) 427 final), a proposal that was adopted by the Commission 
18  August  2009.  The  aim  of  this  proposal  is  to  give  Member  States  the  means  to  combat 
cross-border  VAT  fraud  more  effectively  and  to  provide  for  a  legal  basis  for  Eurofisc.  The 
Council reached a political agreement on 8 June 2010. The proposal was formally adopted by 
the Council on 7 October 2010 (Council Regulation (EU) N° 904/2010). It was published in 
the  Official  Journal  of  EU  on  10  October  2010  and  the  major  part  will  enter  into  force  on 
1/1/2012.  

Mutual recovery assistance 

The  Council  adopted  Directive  2010/24/EU  concerning  mutual  recovery  assistance  on  16 
March  2010  (OJ  L  84  of  31.3.2010).  This  directive  is  based  on  Commission  proposal 
COM(2009)28  of  2  February  2009.  Member  States  have  to  transpose  this  Directive  by  31 
December 2011. 

Outermost regions 

The Commission adopted on 14 December a Report on the functioning of Council Decision 
2004/162/EC of 10 February 2004 concerning the dock dues tax arrangements in the French 
overseas departments and a proposal for a Council decision amending Decision 2004/162/EC 
as  regards  the  products  that  may  benefit  from  exemption  from  or  a  reduction  in  dock  dues. 
The proposal should be adopted during spring 2011 after the Parliament has given its opinion. 

Excise duties 

In  the  area  of  excise  duties,  Council  Directive  2010/12/EU  of  16  February  2010  amending 
Directives  92/79/EEC,  92/80/EEC  and  95/59/EC  on  the  structure  and  rates  of  excise  duty 
applied  on  manufactured  tobacco  and  Directive  2008/118/EC,  was  adopted.  This  new 
Directive has a two fold objective: 1) to achieve greater convergence between the tax levels 
and closer approximation of the retail prices of manufactured tobacco products applied in the 
Member States and by this means improve the functioning of the Internal Market; and 2) to 
ensure a higher level of health protection by increasing the level of taxation, and consequently 
the level of price of tobacco products, which in turn influences consumers to reduce tobacco 
consumption. 

b)  Preventive  measures  being  taken  in  relation  to  recently  adopted  new  legislation  – 
conformity  assessment  of  national 
transposition  package  meetings, 
development  of  guidelines,  initiation  of  networking  systems  to  manage  the  new  legislation, 
etc. 

transposition, 

Implementation of the "VAT Package" 

From  1  January  2010,  the  new  "VAT  Package",  i.e.  Directives  2008/8/EC  of  12  February 
2008  amending  Directive  2006/112/EC  as  regards  the  place  of  supply  of  services  and 
2008/9/EC of the same date laying down detailed rules for the refund of value added tax to 
taxable  persons  not  established  in  the  Member  State  of  refund  but  established  in  another 
Member  State,  entered  into  force  across  the  EU.  Those  directives  included  new  provisions 
which resulted in the payment of VAT for most business-to-business services in the country 
of the customer rather than in the country where the supplier is located, while for business-to-
consumer  services,  VAT  continued  to  be paid in the Member State in which the  supplier is 
established. On the same date, a new electronic procedure was put in place in order to allow 

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taxable persons to claim back the VAT they paid in another Member State. 

Implementing regulation 

In preparation for the entry into force of the new rules on supply of services and in order to 
further assure, at the EU level, the smooth and coordinated transition to the new system, the 
Commission  adopted  on  17  December  2009  a  proposal  on  implementing  measures  for  the 
VAT  Directive  2006/112/EC  (COM(2009)  672  final).  The  proposal  included  a  number  of 
measures related to the VAT Package, in particular with a view to prevent situations of double 
taxation that could arise as a result of diverging interpretations of the new rules. For example, 
there are guidelines for suppliers on establishing the location and tax status of the customer, 
as  this  will  determine  the  rate  of  VAT  that  must  be  paid.  Other  guidelines  focus  on  the 
provisions within the VAT Package which complement or provide exceptions to these general 
new rules. This proposal was based on work undertaken by the VAT Committee in 2009.  

The  proposal  has  been  extensively  discussed  in  2010  by  the  Council  (11  meetings  were 
organised).  The  preparation  of,  and  subsequent  discussions  on,  this  proposal  allowed  for 
further  clarification  of  numerous  concepts and rules adopted in Directive 2008/8/EC so that 
Member States could, if they so wished, take them into account in their national implementing 
measures. Political agreement was reached on 18 January 2011, allowing for the adoption of 
the Implementing Regulation early 2011. 

Refund directive 

As regards the new VAT Refund Directive, the Commission held a large number of meetings 
with  stakeholders  and  businesses  in  view  of  monitoring  the  concrete  implementation  of  the 
new scheme. In addition to the technical problems reported, it appeared that several Member 
States do not always apply correctly the provisions of the directive. 

Specifically,  these  cases  relate  to  restrictions  on  the  right  of  access  of  the  web  portal,  in 
particular  to  agents  who  are  not  established  in  the  same  Member  State  as  the  applicant;  the 
late  opening  of  web  portals  (or  more  recently  to  major  disruptions  in  the  functioning  of 
national systems); the absence of any confirmation by the Member State of establishment that 
a request has been submitted; the limitation of the number of invoices which can be claimed 
in one application; and the identification of VAT groups with multiple VAT numbers. 

Preventive measures have been taken through discussions in the relevant committee (SCAC). 

Studies in the field of VAT 

In  2010  the  Commission  launched  several  expert  studies  aimed  at  an  assessment  of  various 
fields of the current EU VAT system and proposals for further developments on: 

–  the  impact  of  different  medium-term  options  relating  to  import  VAT  collection  under 

centralised customs clearance; 

–  the  impact  of  the  current  VAT  rules  applied  to  the  public  sector  and  to  activities  in  the 
public  interest,  whose  aim  is  to  identify  options  for  legislative  actions  and  assess  their 
respective impact; 

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–  the feasibility of alternative methods for improving and simplifying the collection of VAT 

through means of modern technologies and/or financial intermediaries; 

–  supplies  on  board  means  of  transport  with  an  aim  to  identify  eventual  options  for  new 

legislative actions. 

Implementation of Regulation 904/2010 

The new provisions incorporated in recently adopted Regulation 904/2020 enter into force in 
2012.  Several  practical  details  need  to  be  further  developed  and  approved  by  the  Standing 
Committee  on  Administrative  Cooperation  (SCAC).For  this  purpose  several  project  groups 
will be set up early 2011 under the Fiscalis program. The outcome of these project groups and 
the decisions taken by SCAC will then need to be reflected in a Commission implementing 
Regulation amending and completing Regulation 1925/2004, that is planned to be adopted by 
the end of 2011. 

The specific provisions providing a legal base for Eurofisc entered into force already shortly 
after the publication of the 2010 Regulation in the Official Journal of EU. A first meeting of 
the  Eurofisc  Group  has  already  been  held,  where  the  rules  of  procedure  were  adopted,  the 
working fields were identified, the chairperson chosen and shortly after also the working field 
coordinators were elected. In the beginning of 2011 each working field will start its activities. 

Automated  access  by  competent  authorities  to  certain  types  of  information  will  enter  into 
force  only  by  1/1/2013  but,  as  this  will  require  changes  to  the  Member  State  IT  systems, 
preparatory works will also start early in 2011. 

c)  Main  actions  being  taken  to  control  the  correct  application  of  the  law  –  conformity 
assessments, reports on the application of legislation, studies, etc 

Value added tax (VAT) 

The  Commission  has  checked  the  correct  implementation  by  Member  States  of  the  Council 
Directive 2009/69/EC of 25 June 2009 regarding tax evasion linked to imports. This process 
has  not  yet  been  completed  as  not  all  Member  States  have  notified  their  transposition 
measures. 

a 

report 

Article  2  of  the  Council  Directive  2008/117/EC  of  16  December  2008  provides  that  the 
Commission  shall,  on  the  basis  of  information  provided  by  the  Member  States,  present, 
no later than30 June 2011, 
impact  of  Article 263(1)  of 
assessing 
Directive 2006/112/EC on Member States' ability to fight against VAT fraud connected with 
intra-EU supplies of goods and services as well as the usefulness of the options provided for 
in  Article 263(1a)  to (1c),  as  well  as,  depending  on  the  conclusions  of  the  report,  any 
appropriate proposals. Due to the fact that not all Member States have implemented the above 
mentioned Directive by 1/1/2010 and in order to have a complete picture of the impact of the 
new rules in all Member States, the Commission has decided to present the report by the end 
of 2011, rather than on 30 June 2011. 

the 

VAT Package 

As  the  VAT  Package  brought  about  a  fundamental  change  to  the  VAT  system,  after  31 
December 2009, with the new rules on the place of supply of services and the refund of VAT 

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to non-established EU VAT traders, it has been inevitable that a number of monitoring tools 
had to be implemented at an early stage by the Commission services. 

The Commission has checked thoroughly the transposition of national legislation of Member 
States to conform to the EU VAT Package rules –as a priority task identified in 2010 based on 
the Commission's risk-based approach to some monitoring actions. 

Those  monitoring  actions  were  initiated  in  2008-2009  (preparatory  stage  prior  to  the  entry 
into force of the new legislation) and continued in 2009-2010 (first monitoring stage). They 
included the following steps in the facilitation and control of this transposition:  

–  Organisation of Fiscalis seminars on the new place of supply and refund rules. 

–  Preparation  of  Working  Papers  and  chairing  discussions  with  national  delegations  on  the 

new place of supply and refund rules in the VAT Committee and the SCAC. 

–  Internal monitoring of the implementation of new measures in each Member State.  

–  Analysis of the notifications of national provisions to the Commission by Member States, 

followed by the Commission's analysis of Member States' measures. 

–  Analysis of the correctness of the transposition for each Member State, based on Member 
State  notifications  and  detailed  questionnaires  on  the  place  of  supply  and  refund  rules 
prepared  by  the  Commission  services  in  order  to  facilitate  the  check  to  be  conducted 
internally by the Commission staff. 

Excises 

Twice  a  year,  the  Commission  asks  Member  States  to  update  the  excise  duty  tables 
containing  detailed  information  on  the  rates  and  tax  reductions  or  exemptions  applied  by 
Member  States  on  excise  goods  subject  to  EU  legislation  (energy  products  and  electricity; 
alcohol  and  alcoholic  beverages;  manufactured  tobacco).  In  doing  so,  the  Commission 
controls the respect by Member States of the minimum levels of taxation and of the correct 
application of tax reductions or exemptions. 

d) Management of the acquis through committees and expert groups 

VAT Committee 

As  regards  management  of  the  EU  VAT  legislation,  the  VAT  Committee,  an  advisory 
committee set up by Article 398 of the VAT Directive 2006/112/EC of 28 November 2006, 
has competence to examine questions raised by the Commission or the representatives of the 
Member  States,  which  concern  the  application  of  EU  provisions  on  VAT.  At  least  twice  a 
year, the VAT Committee examines questions raised on the interpretation and application of 
the existing EU VAT legislation.  

The VAT Committee in 2010 had 2 meetings discussing issues arising from the new rules on 
the place of taxation of supplies of services. It resulted, amongst other, in common guidelines 
on the admission to events which could be included by the Council in the proposal for a recast 
of  implementing  measures  for  the  VAT  Directive  2006/112  (COM(2009)  672  final)  under 
discussion. 

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There were also discussions on the scope of the exemption applicable to the supply of postal 
services and the supply of goods incidental thereto, leading to the agreement of guidelines as 
a follow-up to the Court's judgement in the TNT-case (Case C-357/07 TNT Post UK Limited). 

Business Expert Group  

The Business Expert Group on the smooth functioning of VAT in the EU was set up in 2010. 
The Group had 3 meetings of one day each to discuss various topics concerning the EU VAT 
legislation with a view to strengthen and improve the EU VAT system.  

The  group  focuses  on  ways  in  which  the  relationship  between  tax  payers  and  tax 
administrations could result in a smoother functioning of the present VAT system. Day-to-day 
practical  problems  arising  from  managing  the  VAT  system  are  to  be  discussed,  as  well  as 
suggestions  for  possible  solutions.  The  aim  is  to  offer  a  platform  at  EU  level  where 
information  on  practical  bottlenecks  in  the  management  of  the  VAT  system  can  be  shared, 
discussed and solutions found in order to smoothen the functioning of the system and for the 
benefit of both the tax administrations and the business. 

Administrative cooperation in the field of VAT and the fight against VAT fraud 

As regards administrative cooperation in the field of VAT and the fight against VAT fraud, 
several expert groups, funded through the Fiscalis 2013 budget, discussed specific problems 
that  are  either  related  to  specific  fraud  problems  or  targeted  at  exchanging  best  practises  or 
enhancing  cross  border  administrative  cooperation.  These  groups  dealt  with  multilateral 
controls,  e-auditing,  internet  monitoring,  new  means  of  transport  (cars  and  yachts),  risk 
management and e-learning.  

In  2011  some  new  project  groups  will  be  set  up  under  Fiscalis  in  order  to  assist  the 
Commission  with  the  implementing  Regulation  for  Regulation  904/2010.  These  groups  will 
discuss forms, feedback, statement of best practises, statistics, etc. 

Eurofisc has also started its activities in 2010 and the different working fields will report to 
the Eurofisc Group that will annually report to SCAC. 

Through SCAC the Commission will continue to monitor the use Member States make of the 
tools on administrative cooperation and the fight against VAT fraud offered to Member States 
by this new legislation. 

Mutual recovery assistance 

Several  expert  project  groups,  funded  through  the  Fiscalis  2013  budget,  discussed  specific 
problems  to  prepare  the  implementation  of  the  new  Council  Directive  (dealing  with  the 
development of the request forms, the uniform recovery instruments, and the organisation of 
the new communication structure). 

Through the Recovery Committee, the Commission monitors the use Member States make of 
the tools on mutual tax recovery assistance. 

e) Enquiries, problems and complaints management 

Within  the  area  of  indirect  taxation,  the  prioritisation  criteria  were  fixed  in  line  with  the 

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2007 Communication of the Commission on 'A Europe of results'. The Commission continued 
with  its  efforts  to  ensure  alignment  of  Member  States'  indirect  tax  legislation  with  the 
requirements  of  primary  and  secondary  EU  law,  by  intensifying  its  infringement  actions 
following  the  adoption  of  new  Directives  and  by  pursuing  a  more  targeted  infringement 
approach in support of ongoing policy initiatives such as the Commission's initiative on tax 
policy  coordination.  Inter  alia  in  the  area  of  VAT  grouping,  the  Commission  issued  a 
Communication462 and has opened infringement procedures against Member States violating 
the  VAT  Directive.  Other  priorities  concerned  procedures  affecting  the  EU's  own  resources 
and  also  procedures  related  to  VAT  on  postal  services,  with  interpretation  of  the  VAT 
Directive  provided  by  the  Court  in  the  case  TNT  Post  UK  Limited.  Travel  agencies  and 
reduced VAT rates were likewise launched in this context. 

In  the  2007  Communication463,  the  Commission  decided  on  the  introduction  of  an 
arrangement  for  monthly  decision-taking  to  allow  for  the  quicker  progress  of  infringement 
cases which have to be referred to the Court. The results of this new decisional method were 
particularly  significant  within  this  domain  where  considerable  efforts  were  made  to  achieve 
this objective. A significant number of cases is currently awaiting a ruling from the Court of 
Justice. 

In the field of indirect taxation the Commission receives an increasing number of complaints. 
They are registered in CHAP (an internal registration system operating since 2009) and their 
treatment  is  tracked  in  each  step.  There  were  124  open  complaints  in  December  2010,  the 
processing  of  which  the  Commission  is  trying  to  accelerate  despite  the  complexity  of  the 
cases.  

The  year  2010  is  characterized  by  an  unusually  high  number  of  preliminary  questions  (52 
cases).  The  role  of  the  Commission,  to  suggest  an  interpretation  of  EU  law  to  the  Court,  is 
particularly important in this area as most of the judgments of the Court of Justice in this area 
are delivered on the basis of preliminary questions. 

The  Commission  also  continued  with  the  EU  Pilot  project  to  test  and  improve  working 
methods  between  Commission  services  and  Member  States  on  information  exchange  and 
problem solving.  

SOLVIT will also remain an important problem solving tool in cross-border cases involving 
Internal Market issues.  

f) Petitions 

Regarding  the  petitions  treated  in  the  area  of  indirect  taxation,  the  most  recurrent  issues 
reminded  in  the  area  of  taxation  of  cars.  It  should  be  noted  that  the  majority  of  petitions 
related to already open infringement cases by the Commission. 

g) Management of infringements 

462 
463 

COM(2009)325. 
COM(2007)502. 

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Within  the  area  of  indirect  taxation,  2010  was  another  year  with  a  considerable  number  of 
infringement cases closed after Member States brought their legislation into conformity with 
EU law during the different steps of the procedure.  

The following Court cases merit extra attention: 

In the joint cases Commission v. France464, Austria465 and Ireland466 the Court decided that by 
adopting and maintaining in force a system of minimum prices for the retail sale of cigarettes 
released for consumption and a prohibition on selling tobacco products ‘at a promotional price 
which is contrary to public health objectives’, the concerned Member States (France, Austria 
and Ireland) have failed to fulfill their obligations. 

In  the  judgment  in  the  case  Commission  v.  France467  the  Court  decided  that  France  in 
applying a reduced rate of value added tax to the supply of services by 'avocats', 'avocats' of 
the  Council  of  State  ('Conseil  d’État')  and  the  Court  of  Cassation  ('Cour  de  cassation'),  for 
which  they  are  paid  in  full  or  in  part  by  the  State  under  the  legal  aid  scheme,  violated 
provisions of EU law. 

In  the  judgment  in  the  case  Commission  v.  Poland468  the  Court  decided  that  Poland  by 
applying  a  reduced  value  added  tax  rate  to  supplies,  import  and  intra-EU  acquisition  of 
clothing  and  clothing  accessories  for  babies  and  of  children’s  footwear,  the  Republic  of 
Poland has failed to fulfill its obligations resulting from the VAT directive. 

Finally the judgment in the case Commission v. Austria469 the Court decided that by inclusion 
of  the  standard  fuel  consumption  tax  (SFCT),  which  essentially  consists  of  a  single 
registration tax, in the basis of assessment of the value added tax on the delivery of a motor 
vehicle Austria violated the EU law. 

13.2.2.  Evaluation based on the current situation  

It is important to recall again that unanimity is and will remain the rule for the adoption (and 
thus  the  adjustment  of  the  principles  as  of  1979  in  the  area  of  VAT)  of  the  texts  towards 
harmonization in the field of taxation. This situation makes harmonization through legislation 
more complex.  

The  overall  situation  in  the  area  of  indirect  taxation  is  changing  as  infringement  action  and 
references  to  the  Court  have  steadily  increased  in  recent  years  and  this  trend  is  likely  to 
continue.  The  key  challenges  will  be  to  achieve  correct  application  of  EU  law  within 
acceptable deadlines. This needs to be monitored continuously. 

Hence, infringement policy simplifies the situation for taxpayers by contributing significantly 
to more uniform application of EU rules in this area.  

464 
465 
466 
467 
468 
469 

Judgment of 4 March 2010, case C-197/08. 
Judgment of 4 March 2010, case C-198/08. 
Judgment of 4 March 2010, case C-221/08. 
Judgment of 17 June 2010, case C-492/08. 
Judgment of 28 October 2010, case C-49/09. 
Judgment of 22 November 2010, case C-433/09. 

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A  number  of  measures  have  already  been  taken  to  improve  the  situation  and  to  rationalize 
action. These include a more strategic approach to infringement action by focusing on specific 
priorities  and  adopting  a  more  horizontal  approach  to  similar  infringements  in  different 
Member States. In addition, a lot of emphasis is put on prevention by better co-ordinating the 
preparation of national legislation transposing EU legislation into national law.  

The Commission's approach can be illustrated by following examples: 

- In the field of postal services, three solutions adopted by the Member States were analysed 
(taxation,  exemption,  partial  taxation)  in  order  to  propose  a  solution  before  the  Court,  and 
then after the judgment in the TNT Post case the national legislation of all Member States was 
monitored. 

- In the field of VAT grouping, after a communication, all Member States not complying with 
the EU law were invited to change their legislation. In those cases where legislation was not 
changed,  a  referral  to  the  Court  is  envisaged.-  Regarding  travel  agencies,  infringement 
proceedings were suspended to give the Member States the possibility to adapt the text of the 
Directive.  After  three  successive  EU  presidencies  without  progress,  the  Commission 
announced  to  the  concerned  Member  States  that  the  cases  will  be  referred  to  the  Court  in 
order to prevent distortions of competition. 

The  new  system  of  complaints  registration  (CHAP)introduced  in  2009  to  simplify  the 
registration and treatment of complaints continued to be used and tested.  

Finally, it is welcomed that during 2010, 69 infringement cases have been closed because the 
Member States concerned brought their legislation into conformity with EU law without the 
need for any referral to the Court of Justice. These figures reveal clearly that the alignment of 
Member  State  legislation  with  EU  law  is  being  achieved  through  the  work  done  by  the 
Commission  and  Member  States  in  the  context  of  infringement  proceedings  following  the 
adoption of new directives. As stated in its 2007 Communication, the Commission has started 
to work with Member States to try to ensure quicker results without recourse to infringement 
proceedings always being necessary. 

13.2.3.  Evaluation results 

13.2.3.1. Priorities 

The  existing  pro-active  infringement  policy  and  prioritisation  of  specific  issues  has  been 
maintained and further developed as a strategy in order to persuade Member States to approve 
ongoing legislative proposals. Unfortunately, this policy has not always attained the goal (e.g. 
travel agencies and postal services). 

On the control of the implementation of Directives, the national implementing provisions were 
checked  systematically  by  the  Commission  services  in  charge.  In  this  regard,  correlation 
tables is recognised as a useful preventive tool for the Commission, national administrations 
and  stakeholders  as  they  ensure  transparency  and  facilitate  the  complex  work  related  to 
transposition of directives.  

A second priority concerns the EU own resources. Those resources within the area of indirect 
taxation  include  those  accruing  from  VAT  and  are  obtained  through  the  application  of  a 
uniform rate of tax to a tax base determined in a uniform manner and in accordance with EU 

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rules.  Cases  detected  through  own  investigation  with  a  possible  impact  on  own  resources 
continue to be initiated by the Commission. For example the Commission has initiated several 
procedures concerning the correct application of VAT exemptions according to Article 137 of 
the  VAT  Directive.  Their  purpose  is  to  ensure  the  equal  treatment  of  Member  States' 
contributions to EU own resources.  

Last  but  not  least,  in  the  field  of  car  taxation,  object  of  many  complaints  and  petitions,  the 
Commission, in accordance with is using Article 110 of the TFEU as interpreted by the Court 
of Justice, ensures that the Member States do not tax in a discriminatory way, at the time of 
registration, second-hand vehicles bought in the other Member States.  

Cases  of  registration  and  use  of  leasing  cars  and  company  cars  in  the  Member  State  of  the 
residence of an employee or manager other than Member State where the company is based 
constitute a new field of the control of application of EU law. 

For indirect taxation issues, Directorate-General for Taxation and Customs Union opened 80 
new  infringement  cases:  46  of  which  related  to  VAT,  22  related  to  excise  duties  and  12 
regarding  car,  energy  and  environmental  taxation.69  infringement  cases  were  closed  after 
Member States modified their legislation and therefore complied with EU Law; mostly after 
referral to the Court of Justice before compliance was achieved. 

The infringement policy of the Commission was reflected both in a considerable number of 
infringement  cases  and  a  considerable  number  of  observations  made  in  the  context  of 
references for preliminary rulings to the Court. The Court of Justice delivered 51 judgments 
related  to  indirect  taxation  (45  in  the  domain  of  VAT  and  6  regarding  other  indirect  tax 
issues), mostly judgments in consequence of a preliminary question in pursuance of which the 
Commission has given its interpretation. 

The volume of petitions in the different sectors falling within the competences of Directorate-
General for Taxation and Customs Union is relatively moderate and stable (33 new petitions 
have been introduced in 2010). 

Finally  the  number  references  for  preliminary  ruling  increased  significantly  (52  in  2010 
comparing with 36 in 2009)  

13.2.3.2.  

Planned action (2011 and beyond)  

One of the specific objectives planned for the mid-term is to create a simpler and transparent 
tax  environment  for  individuals,  SME's  and  other  businesses  in  cross-border  transactions 
through  the  control  of  the  application  of  EU  law,  modernisation,  better  coordination  and 
harmonisation of tax systems in the Internal Market.  

Since VAT has been identified as causing a high level of administrative burden for business, 
the Commission is seeking how to simplify and rationalise the VAT legislation.  

The Commission will focus in the field of indirect taxation on taxation of leasing and use of 
company  cars,  particular  aspects  of  VAT  grouping  and  follow  up  of  VAT-package-check 
results.  

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13.2.4.  Sector summary  

In the field of INDIRECT TAXATION, the number of enquiries, complaints and references 
for preliminary rulings in this year continued to increase. The Commission focused its efforts 
to  ensure  alignment  of  Member  States'  indirect  tax  legislation  with  the  requirements  of 
primary  and  secondary  EU  law,  by  pursuing  a  more  targeted  infringement  approach. 
Infringement  procedures  affecting  the  EU  own  resources  and  specific  infringement 
procedures related to VAT on postal services, VAT grouping, travel agents and reduced VAT 
rates were followed up. Despite the good figures for notification regarding the transposition of 
the existing secondary EU Law, the existing pro-active infringement policy and prioritisation 
of  specific  issues  should  be  maintained,  particularly  concerning  the  implementation  of  new 
legislation (e.g. VAT package). In 2010, 69 infringements proceedings have been closed after 
Member States modified their legislation in line with EU law, and 80 new infringement cases 
were opened.  

Existing measures in force: see Annex I 

13.3. 

Situation in the sector of DIRECT TAXATION 

13.3.1.   Current position  

13.3.1.1.  General Introduction 

There is very little harmonisation in the area of direct taxation. As a consequence, the relevant 
Treaty provisions constitute the main part of the legal framework.  

Existing measures in force: see Annex I.  

13.3.1.2. Report of work done in 2010 

a)  New  legislation  in  preparation  or  already  proposed  and  in  the  course  of  being  adopted, 
impact  assessments  and  implementation  plans  being  developed  in  connection  with  new 
proposals, etc. 

On  7  December  2010  political  agreement  was  reached  in  the  Council  on  the  proposal  for  a 
Council Directive on administrative cooperation in the field of taxation. It is based on a 
proposal  of  2009470  and  aims  to  create  a  legal  instrument  of  high  quality  enhancing 
administrative cooperation in the field of taxation in order to allow the smooth functioning of 
the  Internal  Market  by  providing  effective  means  to  combat  tax  evasion.  The  Directive 
ensures  that  the  EU  standards  for  the  exchange  of  information  on  request  are  aligned  on 
international  standards.  In  particular,  it  provides  that  Member  States  can  no  longer  rely  on 
bank secrecy to refuse the exchange of information.  

Several proposals for Directives were also on the agenda during 2010: 

•  In  the  interest  of  clarity  and  legal  certainty,  a  Proposal  for  a  Council  Directive  on  the 
common  system  of  taxation  applicable  in  the  case  of  parent  companies  and 
subsidiaries of different Member States was put on the table aiming at transforming the 

470 

(COM (2009)29). 

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332 

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planned  codification  of  Directive  90/435/EEC  into  a  recast  in  order  to  incorporate  the 
necessary amendment; 

•  Negotiations  are  ongoing  on  the  amendment  to  the  Savings  Taxation  Directive 
(2003/48/EC). Adoption by Council in 2011 would require substantial transposition work. 

Several public consultations were launched during 2010, which aim to gather information in 
areas of importance for the Internal Market and EU citizens, such as: 

•  Consultation on Taxation of cross border interest and royalty payments between associated 

companies; 

•  Consultation  on  possible  approaches  to  tackling  cross-border  inheritance  tax  obstacles 

within the EU; 

•  Consultation  on  Double  Tax  Conventions  and  the  Internal  Market:  factual  examples  of 

double taxation cases. 

Separately, the Council Resolution of 8 June 2010 on coordination of the Controlled Foreign 
Corporation (CFC) and thin capitalisation rules within the European Union (2010/C 156/01) 
addressed the question of how far the Member States are allowed to go in applying anti-abuse 
measures while preserving the fundamental freedoms as applied by the Court of Justice.  

b)  Main  actions  being  taken  to  control  the  correct  application  of  the  law  –  conformity 
assessments, reports on the application of legislation, studies, etc. 

In December 2010 the Commission launched an external study covering all 27 Member States 
aiming to identify the most common obstacles in the direct tax area that cross-border workers 
encounter when they decide to exercise their fundamental freedoms. The results of the study 
will be used as a basis for initiating infringement procedures.  

c) Management of the acquis through committees and experts groups 

The  Working  Group  for  Administrative  Cooperation  in  the  field  of  Direct  Taxes  (WG 
ACDT) examines matters concerning the application of the Directive on mutual assistance in 
direct tax matters and insurance premiums (Directive 77/799/EEC) and the application of the 
Directive  on  the  taxation  of  savings  income  in  the  form  of  interest  payments  (Directive 
2003/48/EC). Three meetings have been held in 2010. 

In  addition,  a  sub  group  of  the  WG  ACDT  devoted  to  the  design  and  IT  development  of 
common forms for exchange of information met four times in 2010.  

The eForms for exchange of information on request, spontaneous exchanges and for feedback 
have been released for entry into production at the end of 2010. 

d) Enquiries, problems and complaints management 

Considering that there is little secondary EU legislation in the area of direct taxation, almost 
all  of  the  enquiries  and  complaints  in  this  area  (a  sizable  volume  of  145  well-founded 
enquiries  and  complaints)  relate  to  the  application  of  the  fundamental  Treaty  freedoms  in 
respect  of  differential  treatment  of  domestic  and  cross-border  situations.  They  therefore  fall 
mainly  in  the  following  category  of  the  2007  Communication  'A  Europe  of  results'  – 

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"breaches of EU law, raising issues of principle or having particularly far-reaching negative 
impact for citizens, such as those concerning the application of Treaty principles (..)".  

As  in  previous  years,  the  main  focus  in  2010  were  infringement  actions  targeted  at  areas 
where the Commission sees scope for co-ordination of Member States' direct tax systems, as 
highlighted in the 2006 Communication on Co-ordinating Member States' direct tax systems 
in  the  Internal  Market.  Particular  emphasis  was  given  to  infringement  cases  in  respect  of 
taxation of dividend payments and dividend payments to pension funds. 

e) Petitions and parliamentary questions 

Most of the petitions in the direct tax area relate to possible infringements of Treaty freedoms 
and  instances  of  double  taxation  due  to  the  simultaneous  application  of  different  Member 
States' tax legislation. The volume of petitions in the direct tax area is relatively moderate (10 
petitions in 2010).  

In addition, the direct tax area has been of significant interest for the Honourable Members of 
the European Parliament as indicated by the significant number of parliamentary questions 
on the subject. 

f) Management of infringements 

In  the  wake  of  the  financial  crisis  and  the  need  for  Member  States'  to  preserve  and  expand 
their tax revenues, the external interest in the area of direct taxation remains substantial. The 
stable number of well-founded enquiries and complaints and the increased number of referrals 
for preliminary rulings from the Court are a clear indication of this trend. This trend is likely 
to increase and intensify over the coming years. 

In  the  area  of  direct  taxation,  the  Commission  opened  a  smaller  number  of  infringements 
than in 2009. This was partly due to more Member States joining EU Pilot and an increased 
use of this tool in order to find solutions compatible with EU law without the need to open a 
formal infringement procedure (32 such cases).  

A special emphasis has been given to those cases which reveal serious infringements of EU 
law  that  prevent  EU  citizens  and  enterprises  from  exercising  their  rights  to  establish 
themselves or invest in other Member States. Moreover, particular attention has been paid to 
those areas where the Commission sees scope for co-ordination of Member States' direct tax 
systems, as highlighted in the 2006 Communication on Co-ordinating Member States' direct 
tax systems  in the  Internal Market471  and the subsequent specific communications on cross-
border losses, exit taxes and anti-abuse rules. In addition, work on the priority areas of cross-
border  dividend  payments  and  cross-border  pensions  continued.  Finally,  two  new  priority 
areas are being addressed relating to inheritance tax and eliminating the direct tax obstacles 
encountered by cross-border workers. 

In  the  area  of  direct  taxation,  2010  was  once  again  a  year  with  a  considerable  number  of 
infringement files closed after Member States changed their legislation in order to conform to 
EU law as a direct result of the Commission initiating procedures under Article 258 TFEU. 
Namely, 68 infringement procedures were closed after the Member States concerned modified 
their legislation.  

471 

COM(2006)823 of 19.12.2006. 

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Likewise, the number of decisions by the Commission to refer Member States to the Court of 
Justice for incompatible direct tax legislation remained relatively stable (10 such decisions). 

In  2010  the  Court  of  Justice  delivered  15  judgments  related  to  direct  taxation.  Most  of  the 
Court's  judgments  in  this  area  (13)  concerned  references  for  preliminary  rulings.  The 
following cases were of particular relevance: 

In  SGI472  the  Court  held  that  Belgian  transfer  pricing  rules  applicable  only  to  cross-border 
situations are a restriction of the freedom of establishment. However they are justified by the 
need  to  prevent  abuse  and  safeguard  the  balanced  allocation  of  taxing  powers  between 
Member States. The Court concluded that the rules were, subject to verification to be carried 
out by the referring court, proportionate. 

In X-Holding473 the Court held that the Netherlands restricted the freedom of establishment by 
not  allowing  cross-border  group  taxation  for  foreign  subsidiaries.  However,  it  found  the 
restriction  justified  by  the  need  to  safeguard  the  balanced  allocation  of  taxing  powers,  even 
where the risk of double loss relief or tax avoidance was very limited. 

In  Gielen474  the  Court  ruled  that  the  Netherlands  infringed  the  freedom  of  establishment  by 
discriminating non-resident business operators by not taking into account the hours that they 
worked in their foreign business when calculating a deduction for self-employed persons and 
that the option for non-residents to be taxed as residents did not justify this discrimination. 

In  Commission  v.  Spain475  the  Court  ruled  that  Spain  infringed  the  freedom  of  capital 
movement  by  taxing  outbound  dividends  paid  to  companies  in  other  EU  Member  States, 
while  dividends  paid  to  Spanish  companies  were  exempt  from  any  taxation.  The  ruling 
confirms  the  legal  analysis  of  the  Commission's  Dividend  Taxation  Communication  of  19 
December 2003.  
In Commission v. Portugal476 (Case C-105/08), the Court rejected the action as it found that 
the Commission had not proven that the Portuguese tax legislation leads in certain situations 
to a higher taxation of non-resident financial institutions on the interest they receive on loans 
made to Portuguese borrowers.  

13.3.2.  Evaluation based on current situation 

The situation in the direct tax area continues to be challenging as the number of infringement 
actions stabilised while the number of references to the Court has increased in recent years. It 
remains to be seen whether this trend will continue.  

The  key  challenges  ahead  are  to  manage  the  high  level  of  activity  in  the  area  without  an 
increase  in  resources  while  achieving  equal  surveillance  and  uniform  application  across 
Member States of EU law in this largely non harmonised area. 

472 
473 
474 
475 
476 

Ruling of the Court of Justice in case C- 311/08, Société de Gestion Industrielle SGI of 21.01.2010. 
Ruling of the Court of Justice in case C-337/08, X Holding v. Staatssecr. van Fin. of 25.02.2010. 
Ruling of the Court of Justice in case C- 440/08, Gielen v. Staatssecr. van Fin of 18.03.2010. 
Ruling of the Court of Justice in case C-487/08, Commission v. Spain of 03.06.2010. 
Ruling of the Court of Justice in case C-105/08, Commission v. Portugal of 17.06.2010. 

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A number of measures have already been undertaken to improve the situation. This includes a 
more  strategic  approach  to  infringement  action  and  adopting  a  more  horizontal  approach  to 
similar infringements in different Member States. 

Moreover, the Commission is encouraging Member States to take a more pro-active approach 
to  removing  existing  tax  obstacles  by  examining  the  scope  for  co-ordination  of  Member 
States' direct tax systems. As outlined in the 2006 Communication on Co-ordinating Member 
States' direct tax systems in the Internal Market477, the aim of this initiative is to ensure that 
national  tax  systems  comply  with  EU  law  and  interact  coherently  with  each  other.  The 
initiative seeks to remove discrimination and double taxation for the benefit of individuals and 
business while preventing tax abuse and erosion of the tax base. Coordinated solutions could 
help to remove discrimination and further eliminate the tax obstacles to cross-border activity 
and thus help to reverse the trend of increased litigation by taxpayers in national courts and 
the ECJ.  

13.3.3.  Evaluation results 

13.3.3.1. Priorities 

As far as direct taxation is concerned, the priorities set for 2010 remain unchanged for 2011. 
Two new areas will also be addressed with priority: inheritance tax and eliminating the direct 
tax obstacles encountered by cross-border workers.  

13.3.3.2. Planned action (2011 and beyond) 

Given the evaluation of the current situation, continued and intensified infringement action is 
envisaged in the direct tax area.  

Common Consolidated Corporate Tax Base (CCCTB) 

In  2011,  adoption  by  the  Council  of  the  planned  legislative  proposal  for  a  Common 
Consolidated  Corporate  Tax  Base  (CCCTB)  would  require  substantial  implementation/ 
transposition  by  Member  States  and  conformity  assessment  by  the  Commission  possibly 
combined with expert group/ committee meetings to manage the application of the measure. 
Once adopted and implemented, CCCTB would reduce the scope for cross-border restrictions 
and thus result in a decrease in infringements in the corporate tax area.  

Amendment Savings Directive478  

The  Commission  on  13  November  2008  adopted  an  amending  proposal  to  the  Savings 
Taxation  Directive,  with  a  view  to  closing  existing  loopholes  and  better  preventing  tax 
evasion. The Commission proposal seeks to improve the Directive, so as to better ensure the 
taxation  of  interest  payments  which  are  channelled  through  intermediate  tax-exempted 
structures.  It  is  also  proposed  to  extend  the  scope  of  the  Directive  to  income  equivalent  to 
interest  obtained  through  investments  in  some  innovative  financial  products  as  well  as  in 
certain  life  insurance  products.  Adoption  by  the  Council  would  require  substantial 

477 
478 

COM(2006)823 of 19.12.2006. 
Directive 2003/48/EC on taxation of income from savings (OJ L 157 p 38 of 26.06.2003). 

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implementation by Member States and conformity assessment by the Commission combined 
with committee meetings to manage the correct application of the measure. 

Financial Transaction Tax 

On  7  September  2010,  the  Council  held  an  exchange  of  views  on  the  options  regarding 
financial  industry  contributions  in  the  wake  of  the  financial  crisis.  Discussions  covered  the 
coordination of levies on banks and other financial institutions and the possible introduction 
of a financial transaction tax.  

On 7 October 2010, the Commission set out its ideas for the future taxation of the financial 
sector.  Working  on  the  basis  that  the  financial  sector  needs  to  make  a  fair  contribution  to 
public  finances,  and  that  governments  urgently  need  new  sources  of  revenue  in  the  current 
economic climate, the Commission put forward a two pronged approach. At global level, the 
Commission supports the idea of a Financial Transactions Tax (FTT), which could help fund 
international challenges such as development or climate change. At EU level, the Commission 
recommends that a Financial Activities Tax (FAT) would be the preferable option. If carefully 
designed  and  implemented,  an  EU  FAT  could  generate  significant  revenues  and  help  to 
ensure  greater  stability  of  financial  markets,  without  posing  undue  risk 
to  EU 
competitiveness.  

The Commission has lunched an in-depth Impact Assessment to further examine the ideas it 
has set out in its Communication. The Impact Assessment is planned to be ready by summer 
2011. If appropriate, legislative proposals will follow before the end of the year. 

Inheritance taxes  

It appears that Member States' inheritance tax rules as applied in cross-border situations may 
hinder  EU  citizens  from  benefiting  fully  from  their  right  to  move  and  operate  freely  across 
borders within the Internal Market and create difficulties for the transfer of small businesses 
on the death of owners. First, such individuals may be exposed to tax discrimination. Second, 
there  is  the  risk  of  taxation  of  a  single  inheritance  by  several  Member  States  with  no 
comprehensive relief for the double taxation.  

The Commission has worked on several different fronts to obtain more evidence of the extent 
of any such cross-border inheritance tax problems within the EU and to find solutions to the 
problems  identified.  In  this  regard,  a  public  consultation  was  launched  in  2010  on  cross-
border  inheritance  tax  obstacles  within  the  EU  and  possible  approaches  to  tackling  these 
issues.  As  a  reference  document  to  this  consultation,  the  Commission  published  a  study  by 
external consultants on "inheritance taxes in EU Member States and possible mechanisms to 
resolve problems of  double inheritance  taxation  in  the  EU".  The Commission  has  also  been 
preparing an impact assessment, on the basis of which it will decide on the best solution and it 
aims to adopt an initiative along these lines in 2011.  

13.3.4.  Sector summary 

As  there  is  very  little  secondary  EU  legislation  in  the  area  of  DIRECT  TAXATION,  the 
main focus is on the application of the fundamental Treaty freedoms in respect of differential 
treatment of domestic and cross-border situations.  

The  number  of  well-founded  enquiries  and  complaints  remain  stable  while  the  referrals  for 
interest 
preliminary  rulings  from  the  Court  of  Justice 

increased, 

therefore 

have 

the 

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remains just as high as in previous years.  

In order to manage the workload in the direct taxation area, the Commission will continue to 
pursue  a  strategic  approach  to  infringement  action  by  focusing  on  specific  priorities  and  by 
looking more horizontally at similar infringements in different Member States. Moreover, as 
outlined in the 2006 Communication on Co-ordinating Member States' direct tax systems in 
the Internal Market, the Commission is encouraging Member States to be more pro-active in 
removing existing tax obstacles by examining the scope for co-ordination in this area. Such 
co-ordinated action can help to remove discrimination and promote compliance with EU law. 
The previous priorities established in this area remain unchanged for 2011. In addition, two 
new  areas  will  be  addressed  with  priority:  inheritance  tax  and  eliminating  the  direct  tax 
obstacles encountered by cross-border workers.  

14. 

EDUCATION AND CULTURE 

14.1.  Current position 

14.1.1.  General introduction 

14.1.1.1. Education and training 

The continuing challenge in the field of education and training is to ensure the application of 
the  principle  of  free  movement  for  students,  a  fundamental  objective  of  EU  action  in 
accordance with Article 165 TFEU. Students in the different types and levels of education and 
training  should  not  be  treated  less  favourably  because  they  have  exercised  their  mobility  to 
another country for all or a part of their studies. This problem is particularly manifest in the 
case of recognition of diplomas awarded in another country479. 

The  Commission  believes  that  learning  mobility  plays  a  key  role  both  in  the  personal  and 
skills development of the individual student and in promoting greater labour market flexibility 
after the studies. It is also an important component for creating a Europe of citizens, one of 
the key objectives of the Union. The obstacles to mobility should therefore be removed as far 
as  possible.  Despite  the  relative  lack  of  specific,  binding  provisions  in  EU  primary  and 
secondary  law  in  this  area,  the  Commission  took  action  to  protect  the  principle  of  free 
movement. The obstacles encountered relate mainly to the equality of tuition and registration 
fees, to some benefits directly related to student status, to the recognition of periods of study 
and  diplomas  acquired  in  other  Member  States  and  to  the  scholarships  and/or  student  loans 
offered. Infringement procedures begun in 2009 on areas such as discrimination in access to 
distance  learning  provided  from  a  Member  State  other  than  the  Member  State  of  residence 
and  discrimination  in  access  to  reduced  fares  for  students  on  public  transport,  have  been 
continued in 2010. 

The main Treaty articles and other legal provisions applicable are: 

479 

When  the  diploma  or  the  professional  qualifications  in  itself  would  be  sufficient  to  exercise  the 
profession  in  the  Member  State  of  origin,  the  terminology  used  is  "recognition  of  professional 
qualifications"; that is the responsibility of the Directorate General for Internal Market and recognition 
in  this  case  is  regulated  by  binding  provisions  (notably  Directive  2005/36/EC).  When  the  citizen  is 
mainly interested in the recognition of the diploma itself, especially for continuing studies, this is called 
academic recognition (TFEU, Article 165, par. 2, second indent).  

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•  Article  18  TFEU,  establishing  the  principle  of  prohibition  of  any  discrimination 

on grounds of nationality within the scope of application of the Treaty480.  

•  Article  20  TFEU,  establishing  citizenship  of  the  Union  and  ensuring  citizens  of 

the Union enjoy the rights conferred by the Treaty. 

•  Article 21 TFEU, which is the main provision on the right of every citizen of the 
Union  –  and  therefore  every  student  or  person  undergoing  a  training,  and  every 
teacher  as  well  –  to  move  and  reside  freely  within  the  territory  of  the  Member 
States. 

•  Articles 165 TFEU, related to education. In paragraph 2, the objectives of the EU 
institutions'  action  in  the  field  of  education  are  set  out.  Among  those  objectives 
are "encouraging mobility of students and teachers, by encouraging inter alia, the 
academic  recognition  of  diplomas  and  periods  of  study"  and  "encouraging  the 
development  of  distance  education".  Similar  provisions  are  contained  in  Article 
166, related to vocational training.  

•  Directive  2004/38/EC,  on  the  right  of  citizens  of  the  Union  and  their  family 
members to move and reside freely within the territory of the Member States. This 
Directive  contains  several  provisions  concerning  students  and  persons  under 
vocational training. Indeed, students are an important category of citizens moving 
between  Member  States  and  the  Directive  contains  key  provisions  related  to 
students  on,  for  example,  rights  of  residence  for  students  legally  enrolled  in 
education  or  vocational  training,  and  on  equal  treatment  of  EU  citizens  with 
specific rules on social assistance and maintenance grants. 

Directives  and  other  EU  legal  acts  containing  provisions  related  to  education  or  vocational 
training481  are  not  adopted  on  the  basis  of  Articles  165  and  166  TFEU,  because  the 
harmonisation  of  the  laws  and  regulations  of  the  Member  States  for  the  achievement  of  the 
objectives referred to in these Articles is excluded by the Treaty (see paragraph 4 of Articles 
165 and 166). EU action based on these articles may only encourage, support and supplement 
Member States' action, while fully respecting their responsibility for the content of teaching 
and vocational training and for the organisation of education and training systems.  

Nevertheless,  Article  165  paragraph  2,  taken  together  with  the  abovementioned  Articles  18, 
20  and  21  and  Directives,  provides  a  clear  structure  for  the  legal  framework  on  the  free 
movement of students. On that basis, a student who moves from his Member State of origin to 
another to carry out all or part of his/her studies, is protected not only against discrimination 
on grounds of nationality in the second Member State, but also against prejudicial treatment in 
his/her Member State of origin on grounds (directly or indirectly) related to the fact that s/he 

480 

481 

The  Court  of  Justice  has  held  that  the  field  of  education  is  among  those  included  in  the  scope  of  the 
Treaty  under  Article  12.  Inter  alia,  see  the  judgment  of  11  July  2002  in  the  case  C-224/98,  D'Hoop, 
grounds 29 to 32; judgment of 15 March 2005 in the case C-209/03, Bidar, operative part. Article 12 
(Article 18 TFEU) must be read in conjunction with the provisions of the Treaty on citizenship of the 
Union, i.e. articles 17 (Article 20 TFEU) and 18 (Article 21 TFEU). 
Another  example  is  Council  Directive  2000/78/EC  of  27  November  2000  establishing  a  general 
framework  for  equal  treatment  in  employment  and  occupation.  This  Directive,  which  lays  down  a 
general framework for combating discrimination on the grounds of religion or belief, disability, age or 
sexual orientation, may apply in some questions related to education and vocational training.Directive.  

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has studied abroad. This new standard finds its application, e.g., when a student asks his/her 
own  Member  State  to  recognize  a  diploma  acquired  in  another  Member  State  or  when  s/he 
asks  for  the  portability  of  a  grant  or  scholarship  in  order  to  continue  studying  in  another 
Member State482. 

In  that  light,  the  refusal  to  recognize  a  diploma  without  a  proper  justification  or  the 
application of disproportionately long or costly procedures could be interpreted as penalising 
a European citizen for having exercised his or her right to free movement and having followed 
studies in another Member State. Such practices could, therefore, also constitute violations of 
EU law.  

Finally, it is useful here to show the methodology used by the Commission in the exercise of 
its tasks for the classification of the issues pertaining to education and training. The categories 
are: 

(1) 

(2) 

(3) 

482 
483 

Access to educational institutions in a Member State for students from other Member 
States.  The  principle  of  non  discrimination  (18  CE)  is  the  main  rule  here.  Among 
seven  cases  handled  by  Directorate-General  for  Education  and  Culture  in  2010,  the 
cases against Austria and Belgium concerning access to their universities, principally 
for medical and related studies, by candidates from Germany and France respectively, 
remain suspended for five years (until 2012). The Commission is closely monitoring 
the  impact  of  the  conditions  imposed  by  those  Member  States,  requiring  them  to 
submit  to  the  Commission  statistical  data483  which  will  enable  a  judgement  to  be 
drawn  on  whether  the  measures  are  necessary  and  proportionate.  Moreover,  in  the 
preliminary case C-73/08, Bressol, related to the Belgian case of access to university 
(mainly  for  veterinary  studies)  the  Court  of  Justice  pronounced  its  judgment  on  13 
April 2010 and then ruled that Articles 18 and 21 TFEU preclude national legislation, 
such as that at issue in the main proceedings, which limits the number of students not 
regarded  as  resident  in  Belgium  who  may  enrol  for  the  first  time  in  medical  and 
paramedical  courses  at  higher  education  establishments,  unless  the  referring  court, 
having assessed all the relevant evidence submitted by the competent authorities, finds 
that  that  legislation  is  justified  in  the  light  of  the  objective  of  protection  of  public 
health. Therefore, in order to evaluate the impact of that judgment on the handling of 
the  Belgian  infringement  (and  perhaps  on  the  Austrian  infringement  as  well),  the 
Commission must wait for the judgment of the Constitutional Court of Belgium.  

The conditions for awarding grants, either to cover tuition and registration fees, or to 
cover  living  expenses.  This  issue  is  examined  both  in  connection  with  the  host 
country, where it concerns students from other Member States, and in relation to the 
country  of  departure,  which,  under  certain  conditions  (Case  C-11-06,  Morgan),  is 
obliged to award grants to students who decide to go to another country for all or part 
of their studies.  

Other  rights  of  students  in  the  host  country  during  their  studies,  in  order  to  ensure 
equal  treatment  with  domestic  students.  To  this  category  belongs  the  issue  of  of 
equality of treatment with national students in relation to transport fares. On this issue, 

Judgment of the Court of 23 October 2007 in the joint cases C-11/06 and C-12/06, Morgan and Bucher. 
A  second  annual  set  of  statistics  was  provided  by  Austria  in  December  2009  and  a  third  one  in 
November 2010. 

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the Commission in 2010 decided to refer to the Court of Justice the case against one 
Member  State  (Austria)  and  to  issue  a  reasoned  opinion  in  another  case  (the 
Netherlands).484.  

(4) 

The  academic  recognition  of  diplomas.  The  Commission  receives  a  lot  of 
correspondence  on  this  issue,  relating  particularly  to  excessive  delays  in  recognising 
diplomas  or  periods  of  study,  exceeding  a  reasonable  cost  for  such  recognition,  not 
permitting appeals against negative decisions or not presenting justifications for such 
decisions.  

Apart from the binding provisions of EU law in this sector, the role of "soft law", consisting 
principally  of  Recommendations  of  the  European  Parliament  and  of  the  Council,  is 
particularly  important  in  providing  a  framework  in  which  the  difficulties  encountered  by 
citizens can  be  resolved. In this context,  the European Qualifications  Framework, due  to be 
implemented by all Member States by 2012, is beginning to have an impact. Valuable results 
are  also  often  obtained  in  this  area  by  the  ENIC-NARIC  network  (European  Network  of 
Information Centres, National Academic Recognition Information Centres)485.  

14.1.1.2. Sport 

In the area of sport, it is established case-law of the Court of Justice that sport federations and 
regulations must respect the fundamental rights guaranteed by the Treaty, and in particular the 
principle  of  non-discrimination  on  grounds  of  nationality486.  The  same  case  law  has 
recognised that this principle does not apply to rules which have a purely sporting interest (i.e. 
rules  which  fall  into  the  definition  of  the  specific  nature  of  sport),  such  as  the  selection  of 
athletes for national teams. In this context, the principle of proportionality applies.  

The entry into force of the Lisbon Treaty introduced a new Article 165 TFEU extending the 
competence  of  the  European  Union  in  the  area  of  sport.  Following  a  combined  reading  of 
Articles  18,  21  and  165  TFEU,  the  Commission  considers  that  the  general  EU  principle  of 
prohibition of any discrimination on grounds of nationality applies to sport for all EU citizens 
who have used their right to free movement. As a consequence, sport activities as a whole fall 
into the scope of EU law, including therefore amateur as well as professional sport, while the 
latter also falls more specifically under the provisions related to internal market freedoms, in 
so far as the sport activities under consideration constitute an economic activity. 

Moreover, the Commission considers amateur sport to be a social advantage in the context of 
the  free  movement  of  workers.  According  to  Article  7(2)  of  Regulation  (EEC)  1612/68487, 

484 

485 
486 
487 

To the same category (student rights toward the country of destination) could be classified the issue of 
entry and residence permit for students. As for the movement of students between Member States, the 
issue was addressed initially by Directive 93/96/EC and recently by Directive 2004/38/EC. As for the 
movement  of students  between  a  EU  country  and  a  third country  to which  extends  the  application  of 
Union  programmes,  the  problems  are  often  resolved  by  the  provisions  governing  the  programme 
(mandatory or not). In cases of other third countries, the solutions are given either by the provisions of 
mutual agreements or by other instruments of the Union, which are the responsibility of the Directorate 
General for Justice, Liberty and Security.  
http://www.enic-naric.net/  
See the Court of Justice's cases C-36/74 Walrave; C-13/76 Donà; C-415/93 Bosman. 
Regulation  (EEC)  1612/68  of  the  Council  of  15  October  1968  on  freedom  of  movement  for  workers 
within the Community. 

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migrant  workers  have  to  be  treated  equally  with  nationals  of  the  host  country  concerning 
access  to  employment,  as  well  as  working  conditions  and  social  advantages.  The  Court  has 
held that these cover also non financial advantages, in particular those which would facilitate 
integration into the host Member State. 

Additionally, the Commission takes into account the recent ECJ case law488 which considers 
that  Union  citizenship  is  destined  to  be  the  fundamental  status  of  nationals  of  the  Member 
States.  In  that  regard,  the  Commission  considers  that  the  exercise  of  the  right  to  move  and 
reside freely in another Member State is enhanced if citizens of the EU are able to practice 
sport as amateurs on the same footing as its nationals. Consequently, in exercising that right in 
another  Member  State,  persons  are  in  principle  entitled,  pursuant  to  Article  18  TFUE,  to 
treatment no less favourable than that accorded to nationals of the host State. 

In  applying  Union  law  to  amateur  sport,  the  Commission  takes  into  account  the  specific 
characteristics of sport, as set out in Article 165 TFEU and in the Commission's White Paper 
on sport489.  

14.1.2.  Report of work done in 2010 

14.1.2.1. Education and training 

The  Commission  services  have  intensified  their  activity  in  this  area,  through  infringement 
cases,  replies  to  parliamentary  questions,  petitions  to  Parliament,  citizens'  inquiries  and 
complaints, and by the application of new tools (EU Pilot, CHAP) for the implementation of 
EU law.  

The  Commission  had  opened,  in  2009,  infringement  proceedings  under  Articles  18,  20,  21 
and 165 of the Treaty and Article 24 Directive 2004/38 about discrimination of students by 
the host country, regarding fares on public transport. On 2010, the procedures have reached 
the stage of reasoned opinion for one Member State (the Netherlands), and the referral to the 
Court  for  another  Member  State  (Austria).  The  Commission  believes  that  students  who 
perform some or all of their studies in a Member State should have access to public transport 
of that State under the same conditions as domestic students.  

The  Commission  had  also  opened  in  2009  infringement  proceedings  against  two  Member 
States  relating  to  fees  and  grants  for  distance  learning.  The  Commission  believes  that 
students, who study in a Member State other than the one where the university providing the 
distance learning is situated, should not pay higher tuition fees than students from that country 
nor receive a lower maintenance grant than if the university was situated in the Member State 
of  residence.  Significant  improvements  of  the  situation  in  one  of  the  Member  States 
concerned (UK), which meant compliance with EU law, enabled the Commission to close this 
case early in 2011, although the other one (Germany) remained open at the end of 2010. 

In an infringement file concerning tuition fees in higher education (Poland), compliance has 
been  achieved  following  approaches  from  the  Commission  services.  Therefore  the  file  has 
been closed. 

488 

489 

See Cases C-184/99 Grzelczyk, paragraphs 31 to 33; C-85/96, Martinez Sala, paragraph 63; C-158/07 
Förster, paragraphs 37 to 43. 
White paper on sport, 11 July 2007, COM (2007) 391 final. 

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In  response  to  a  petition  to  the  European  Parliament,  the  Commission  services  opened  an 
infringement file for possible discrimination in access to compulsory education based on the 
language  spoken  by  the  child  at  home.  Such  a  criterion  risks  constituting  indirect 
discrimination  based  on  nationality.  Clarification  of  the  situation  in  the  Member  State 
concerned (Belgium) enabled the Commission to close this case early in 2011.  

14.1.2.2. Sport 

The  Commission  received  a  significant  number  of  complaints  in  2010  relating  to 
discrimination  on  grounds  of  nationality,  concerning  access  to  competitions,  obstacles  to 
mobility and transfer or administrative fees. The Commission's concern is to ensure that rights 
to  free  movement  and  equal  treatment  are  respected,  taking  into  account  the  specific 
characteristics of sport. A study launched by the Commission addressing the specific issue of 
access to individual competitions has been published in December 2010 and the conclusions 
and recommendations contained therein help provide better guidance in this area.  

The  complaints  concerned  access  to  both  individual  and  collective  competitions  in  various 
sports  such  as  football,  handball,  basketball,  squash  or  shooting.  Infringement  proceedings 
started  in  2009  were  pursued  concerning  discrimination  on  grounds  of  nationality  in 
individual judo competitions (BE) and basketball regulations (Luxembourg). The former was 
closed in 2010 following modifications of national regulations that brought them in line with 
EU  law.  Two  requests  were  dealt  through  EU  PILOT  related  to  nationality  quota  in  squash 
and  restrictions  on  the  free  movement  of  young  football  players  between  clubs.  The 
Commission continued its dialogue with sport associations as foreseen in the White Paper on 
Sport. 

14.2.  Evaluation based on the current situation 

14.2.1.  Education and training 

The  observations  are  similar  to  those  of  the  previous  report.  The  level  of  compliance  of 
Member  States  with  the  acquis  can  be  considered  generally  satisfactory.  However,  the 
number of complaints and petitions of citizens, especially on the recognition of diplomas and 
periods of study, reveals that the obstacles to free movement are still widespread in practice. 
On 2010, in an issue of recognition of professional qualifications, in which the Commission 
decided  to  initiate  infringement  proceedings  (Greece),  some  problems  of  recognition  of 
academic qualifications were also the subject of the proceedings.  

Finally,  the  Commission  has  published  the  guidance  announced  in  a  previous  Report  on 
monitoring the application of EU law, for public authorities and stakeholders in the Member 
States, drawing out the key implications of the case law established by the Court thus far, on 
education and training. This guidance covers issues such as access to educational institutions, 
recognition  of  diplomas,  the  portability  of  grants,  and  other  rights  of  students  in  the  host 
country  or  in  the  country  of  origin.  It  should  help  to  establish  the  rights  of  students  to  free 
movement as a clear area of EU law, underpinning the trend already established by the Court. 
In doing so, it would contribute to the Union’s objective of achieving a substantial increase in 

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the level of mobility among students in higher education. This guidance has been published in 
the framework of the Commission initiative Youth on the Move490. 

14.2.2.  Sport 

In  the  area  of  amateur  sport,  sport  regulations  concerning  various  collective  and  individual 
sports, could reportedly contravene to EU law. The Union acquis concerning collective sports 
enables the Commission to act against discrimination on grounds of nationality and obstacles 
to free movement. The Staff Working Document on Sport and Free movement (January 2011) 
accompanying  the  Communication  on  Developing  the  European  Dimension  in  Sport 
(COM(2011)12)  should  provide  guidance  for  a  better  understanding  of  these  issues.  Other 
areas of sport challenging EU law and not yet covered by the Court's case law, such as access 
to individual competitions destined to select national athletes or award national titles, medals 
or records, need legal certainty. In that light, the study on equal treatment in individual sports 
competitions  launched  by  the  Commission  and  published  at  the  end  of  2010  provides  for  a 
better  guidance  in  this  area  and  a  better  definition  of  the  specific  characteristics  of  the 
concerned sports. 

14.3.  Evaluation results 

14.3.1.  Priorities 

14.3.1.1. Education and training 

The  priority  area  remains  the  mobility  of  students  within  the  European  Union,  where  the 
current obstacles prevent the Union from realising its full economic and social benefits. In this 
context,  the  academic  recognition  of  diplomas  is  probably  the  most  difficult  issue  to  deal 
with. 

14.3.1.2. Sport 

The  priorities  set  in  the  previous  Annual  Reports  are  unchanged.  The  Commission  will 
continue to ensure that rights to free movement and equal treatment are respected, taking into 
account the specific characteristics of sport. 

14.3.2.  Planned action (2011 and beyond) 

14.3.2.1. Education and training 

Noting that the area of education is a separate chapter of the Union's acquis, the Commission 
intends to support its implementation by:  

•  Opening formal proceedings in cases which, in the Commission’s view, represent 

clear infringements of EU law; 

•  Participation  in  significant  preliminary  references  to  the  Court,  when  matters 

relating to education and sport are involved; 

490 

http://ec.europa.eu/education/yom/wpguidance_en.pdf  

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•  The supervision of application of the abovementioned guidance to Member State 

administrations, students and other stakeholders. 

14.3.2.2. Sport 

The planned actions for 2011 are to: 

- Continue the enforcement of EU law, relying on the new provisions of Article 165 TFEU; 

- Continue dialogue with sport associations in a preventive perspective; 

- Continue to monitor closely the activities of the national and international governing bodies 
for sport; 

-  Provide  guidance  and  better  explain  the  existing  rules  to  Member  States  and  sport 
stakeholders so as to help them address possible legal difficulties stemming from actions or 
rules in the field of sport. 

15. 

HEALTH AND CONSUMERS 

15.1. 

Introduction 

The  mission  of  Directorate-General  Health  and  Consumers  is  to  improve  the  health,  safety 
and confidence  of European Citizens. Its policies and laws touch the daily lives  of  citizens. 
Consumers can be confident that their food is safe and that the safety of their food is protected 
by  strict  enforcement  of  controls.  Patients  can  rest  assured  that  a  high  protection  of  public 
health.  Citizens  benefit  from  action  at  EU  level  against  animal  and  plant  diseases  and  pests 
that  is  far  more  efficient  and  cost  effective  than  individual  efforts  of  Member  States. 
Consumers expect throughout the EU an equally high level of protection in consumer markets 
that  are  more  competitive,  open,  transparent  and  fair.  Directorate-General  Health  and 
Consumers  provides  European  Citizens  with  an  improved  regulatory  framework  that 
maintains its capacity to manage and communicate on risk, especially during times of crisis. 

To  accomplish  the  above  Treaty  powers  are  used  to  the  fullest  extent  possible  while 
overcoming  any  obstacles  in  the  application  of  acquis  in  this  domain.    Directorate-General 
Health and Consumers ensures that EU laws are fully and consistently enforced and seeks to 
engage  society  at  large  in  its  implementation  efforts.  Delivering  effective  policies  requires 
close cooperation with Member States so that lawmaking maximises benefits and minimizes 
burdens  to  society.  The  food,  consumer  and  health  policies  are  part  of  a  globalised  system 
where we should  take  every opportunity to show that as international partners we expect to 
trade in safe products. 

Member  States  are  key  partners  because  they  have  the  primary  responsibility  for  ensuring 
implementation  of  EU  law.  But  equally  better  cooperation  between  national  enforcement 
agencies  and  the  Commission  will  result  in  more  uniform  application  of  legislation  in  this 
area.  In  addition,  the  Commission  sought  during  the  course  of  2010  to  empower  citizens, 
consumers  and  patients  through  information  and  education  to  enable  them  to  support 
implementation efforts of Member States and the Commission. 

At  the  beginning  of  2010,  an  internal  reorganisation  of  competencies  took  place  between 

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Commission  departments.  Pharmaceuticals  (including  the  European  Medicine  Agency), 
medical devices and cosmetics policy areas were transferred from the domain of "Enterprise 
and  industry"  to  the  domain  of  "Health  and  Consumers",  and  policy  areas  of  genetically 
modified  organisms  (GMO)  and  of  sustainable  use  of  pesticides,  were  transferred  from  the 
domain  of  "Environment"  to  the  domain  of  "Health  and  Consumers",  while  policy  areas 
"Consumer  Contract"  and  "Marketing  law"  became  the  responsibility  of  Commission 
departments in the domain of "Justice". 

The  legislation  in  the  health  and  consumers  areas  is  often  technical  and  requires  some 
guidance to Member States for better implementation. For the implementation of this acquis 
prevention often works better than legal action. Although infringement proceedings remain an 
important  instrument,  prevention  of  an  infringement  is  often  a  more  optimal  use  of  the 
resources and nurtures better working relations with Member States. 

Although most of the acquis in this domain is stable, evaluation of the existing legislation is 
being continued to ensure that it meets its policy goals without creating unnecessary burden to 
business and national enforcers. 

15.2. 

Public health  

15.2.1.  Blood and tissues 

15.2.1.1. Current Position 

General Introduction 

The legislative framework for substances of human origin consists of: 

•  Directive  2002/98/EC  setting  standards  of  quality  and  safety  for  the  collection, 
testing,  processing,  storage  and  distribution  of  human  blood  and  blood 
components; 

•  Directive 2004/23/EC on setting standards of quality and safety for the donation, 
procurement, testing, processing, preservation, storage and distribution of human 
tissues and cells; and 

•  Directive  2010/53/EU  on  standards  of  quality  and  safety  of  human  organs 

intended for transplantation. 

The  legislative  framework  on  blood  and  blood  components  is  completed  by  the  following 
implementing  measures:  Commission  Directive  2004/33/EC  as  regards  certain  technical 
requirements for blood and blood components, Directive 2005/61/EC as regards traceability 
requirements  and  notification  of  serious  adverse  events  and  reactions  and  Directive 
2005/62/EC as regards EU standards and specifications relating to a quality system for blood 
establishments. 

With  regards  to  tissues  and  cells,  two  implementing  Directives  complete  the  legislative 
framework:  Directive  2006/17/EC  as  regards  technical  requirements  for  the  donation, 
procurement  and  testing  of  human  tissues  and  cells,  and  Directive  2006/86/EC  as  regards 
traceability requirements for the coding, processing, preservation, storage and distribution of 
human  tissues  and  cells.  Finally,  Commission  Decision  2010/453/EU  of  3  August  2010 

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establishes guidelines concerning the conditions of inspections and control measures, and on 
the training and qualification of officials, in the field of human tissues and cells. 

One of the main challenges of 2010 was the completion of the EU's efforts to ensure common 
quality  and  safety  standards  for  the  procurement,  transport,  characterisation,  transplantation 
and use of organs across the EU. The added value of this initiative was to reduce the risks to 
patients across Europe, maximise the benefits of transplantation for the EU citizens, increase 
trust in transplantation systems, facilitate exchanges of organs and finally ensure high quality 
transplantation  for  all  Europeans.  This  was  achieved  through  the  adoption  of  Directive 
2010/53/EU  of  the  European  Parliament  and  of  the  Council  on  7  July  2010  and  the 
Commission  Action  Plan  on  organ  donation  and 
that 
accompanies the Directive. 

transplantation  (2009-2015) 

15.2.1.2. Report of work done in 2010 

With respect to the blood Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC, 
the  Commission  continued  checking  whether  Member  States  have  transposed  them 
adequately into their national legislation on the basis of checklist tables which were sent out 
to the Member States in 2009. At the beginning of the year a number of Member States had 
not  yet  sent  to  the  Commission  their  responses.  During  the  meeting  with  the  competent 
authorities in April, the Commission asked those Member States that had not yet provided the 
relevant  information  to  do  so.  Consequently  a  number  of  Member  States  responded  to  the 
request,  whilst  the  Commission  continues  to  follow  up  the  situation  with  the  remaining 
Member  States  that  sent  either  no  information  at  all  or  sent  insufficient  information 
concerning their national legislation transposing the blood directives. 

As  regards  Directives  in  the  field  of  tissues  and  cells  the  transposition  rate  is  satisfactory. 
Only one infringement procedure is pending for incomplete transposition into national law of 
Directives 2004/23/EC, 2006/17/EC and 2006/86/EC with respect to reproductive cells, foetal 
tissues and cells, and adult and foetal stem cells. 

Following the completion of the notification of Member State's transposition, a questionnaire 
is  being  prepared  addressing  the  most  important  aspects  of  the  three  tissues  and  cells 
Directives  which  will  be  sent  to  the  Member  States  during  2011  for  completion.  With  this 
exercise the Commission aims to monitor the adequacy of the transposition measures into the 
national law of the Member States. 

In addition to the transposition checks, two reports on the implementation of the Directives on 
blood491 and on tissues and cells492 have been developed during 2009. Both were published in 
January  2010.  The  reports  show  that  the  implementation  of  both  Directives  is  satisfactory 
although further efforts are needed: 

1.  in 

the 

sector 
accreditation/designation/authorisation/licensing  process 

regarding 

blood 

the 

finalisation 

the 
of 
respect  of  each 

in 

491 

492 

COM(2010)0003 final. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0003:FIN:EN:PDF  
COM (2009) 0708 final. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0708:FIN:EN:PDF  

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individual blood establishment; the performance of inspections and the submission 
of the annual report on vigilance to the Commission; 

2.  in 

the 

and 

tissue 

sector 

the 
cell 
the 
respect  of  each 
accreditation/designation/authorisation/licensing  process 
individual  tissue  and  cell  establishment;  development  of  inspection  systems; 
monitoring  of  import/export  measures;  registry  of  tissue  establishments,  and 
fulfilment of different reporting requirements. 

finalisation 
in 

regarding 

of 

A common approach for setting up a vigilance and traceability system for tissues and cells at 
EU level is currently being developed. 

In  both  sectors  there  are  differences  concerning  how  Member  States  apply  the  principle  of 
voluntary  unpaid  donation.  These  issues  will  be  further  addressed  in  the  relevant  reports 
focusing on this principle which are being finalised and will be transmitted to the European 
Parliament and the Council in 2011. 

In 2010, the Commission adopted Decision 2010/453/EC establishing guidelines concerning 
the  conditions  of  inspections  and  control  measures,  and  on  the  training  and  qualification  of 
officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the 
European Parliament and of the Council. 

On  blood,  a  technical  amendment  to  Annex  V  to  Directive  2004/33/EC  with  regards  to 
maximum pH values for platelets concentrates at the end of the shelf life has been presented 
to and got a favourable opinion by the regulatory committee on blood and blood components. 
The draft directive is expected to be adopted in first semester of 2011. 

With regard to organs, the European Parliament and the Council adopted on 7 July 2010, in 
first  reading,  Directive  2010/53/EU  on  standards  of  quality  and  safety  of  human  organs 
intended for transplantation. 

Work for the preparation of the implementing measures and delegated acts in accordance with 
Directive 2010/53/EC has been initiated in 2010. 

In addition to Directive 2010/53/EU, the Action Plan on Organ Donation and Transplantation 
(2009-2015)  aims  at  1)  increasing  organ  availability,  2)  enhancing  the  efficiency  and 
accessibility  of  transplantation  systems  and  3)  improving  quality  and  safety,  through  the 
creation of several technical working groups and Projects funded by the Health Programme. 

Significant progress has been achieved in 2010 with regard to several priority actions of the 
Action plan. 

15.2.1.3. Evaluation, Priorities & Perspectives 

The  Commission  continues  to  ensure  that  legislation  on  organs,  blood,  tissues  and  cells  is 
fully and consistently implemented by competent authorities. Member States are called upon 
to take full responsibility for ensuring implementation of the EU legislation in this field and 
promote  cooperation  between  the  Commission  and  national  competent  authorities.  The 
Commission  holds  bi-annual  meetings  with  the  Competent  Authorities  for  Blood  and 
Tissues/Cells to exchange information, expertise and experience on the implementation of the 
Directives. The first Competent Authority meeting for Organs was held in September 2010. In 

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addition  implementation  of  the  organs  Directive  2010/53/EU  and  of  the  Action  Plan  (mid-
term and final review – 2012 and 2015 respectively) remain a priority. 

15.2.2.  Tobacco 

The  main  pieces  of  legislation  in  the  area  of  tobacco  control  are  Directive  2001/37/EC 
concerning  the  manufacture,  presentation  and  sale  of  tobacco  products  and  Directive 
2003/33/EC relating to the advertising and sponsorship of tobacco products. 

The two existing  Directives in the area of tobacco  control  are  well  implemented  in  Member 
States. 

Member States have, in general, wider advertising and sponsorship bans than the cross-border 
bans required by the Tobacco Advertising Directive (2003/33/EC). However, certain cases of 
tobacco  advertising  at  the  point  of  sale,  on  billboards,  in  airports  and  advertising  in  the 
context of on-line marketing occur. Advertising in the form of promotional campaigns outside 
the  EU  is  displayed  on  the  internet.  This  is  a  challenge  not  only  for  the  EU  but  requires  a 
global  solution.  Cross-border  internet  sales  of  cigarettes  continue  to  be  an  issue  which 
involves tax evasion and illegal tobacco advertising and promotion. 

As  regards  the  Tobacco  Products  Directive  (2001/37/EC),  the  second  report  on  its 
implementation493  identified  several  areas  which  should  be  improved.  In  a  resolution  from 
October 2007, the European  Parliament  called  on the Commission to present a proposal for 
amendments to the Tobacco Products Directive. 

Currently, an Impact Assessment is ongoing for a review of the legislation in order to update 
it in relation to scientific progress, market and international developments. The considerations 
include: extending the scope to cover e.g. novel forms of oral tobacco, herbal cigarettes and 
electronic  nicotine  delivery  systems;  regulating  all  non  combustible  (smokeless)  tobacco 
products in a consistent way; improving consumer information for example by making picture 
warnings  bigger  and  mandatory  and  by  making  packaging  more  neutral  (plain  packaging); 
dealing with the reporting, registration and regulation of ingredients; regulating the access to 
tobacco products in a way that does not induce people to smoking. 

Based on the outcome of the Impact Assessment, the Commission will work on the legislative 
text that is expected to be finalised by the end 2011. 

The Commission is also looking at the renewal of text warnings and corresponding pictures. 
This is done by Comitology procedure and does not require a change in the Directive. New 
warnings could be adopted towards the end of 2011. 

As regards the Council Recommendation on smoke-free environments494 the Commission will 
support and encourage its implementation by the Member States. A meeting of the National 
Focal Points on smoke free environments is planned for 2011. 

In  2010  the  fourth  Conference  of  the  Parties  of  the  Framework  Convention  on  Tobacco 
Control  (FCTC)  took  place.  The  EU  as  Party  to  the  FCTC  contributed  significantly  to  the 

493 
494 

COM(2007) 754 final. 
2009/C 296/02. 

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progress  in  international  tobacco  control  as  regards  the  protocol  on  illicit  trade  and  the 
guidelines  on  tobacco  product  regulation  and  disclosure;  on  education  and  communication; 
and on tobacco cessation. 

15.2.3.  Pharmaceuticals 

15.2.3.1. Current position 

Currently  the  level  of  harmonisation  in  the  pharmaceutical  is  very  well  advanced;  many 
aspects  concerning  safe,  effective  and  high-quality  medicinal  products  are  regulated  in  EU 
legislation.  In  this  regard  the  pharmaceutical  acquis  focuses  on  harmonised  authorisation 
requirements  for  human  and  veterinary  medicinal  products  by  establishing  common 
procedures and streamlining the scientific assessment. Additionally, surrounding aspects such 
as clinical trials, orphan medicines, paediatric medicines and advanced therapies are covered. 
Legislation is mainly based on the internal market competence of EU (Article 114 TFEU), but 
partly also on health competencies (Article 168 TFEU). 

In  general,  compliance  with  the  pharmaceutical  acquis  is  high.  One  reason  for  that  is  an 
established  and  sustained  dialogue  between  the  Commission,  the  Member  States  and  the 
competent  agencies  on  regulatory  matters  in  the  pharmaceutical  sector.  Working  parties 
dealing  with  the  general  interpretation  of  European  pharmaceutical  legislation,  such  as  the 
Pharmaceutical  Committee,  habitually  discuss  transposition  and  implementation  matters. 
Coordination  groups  in  the  human  and  in  the  veterinary  sector  are  in  place  to  examine 
questions in relation to marketing authorisations in two or more Member States. Additionally, 
the “Notice to applicants” group publishes guidance documents intended for stakeholders. If 
needed  chapters  of  the  guidelines  interpreting  requirements  for  applications  for  marketing 
authorisations are updated at regular intervals. These working parties are an important tool to 
find pro-active solutions outside or in parallel with infringement procedures under Article 258 
TFEU. 

Nevertheless,  these  instruments  cannot  totally  replace  the  formal  dialogue  with  Member 
States  within  the  framework  of  an  infringement  procedure.  Eleven  procedures  had  to  be 
opened  in  2010,  for  example  for  the  non-timely  transposition  of  Directive  2009/120/EC. 
However, by end of 2010, all but one was closed. 

Additionally, the Commission continues to receive complaints from stakeholders or initiates 
investigations on its own on certain aspects of implementation of pharmaceutical legislation. 
In 2010 an increase in the number of complaints was observed. In parallel, certain rulings of 
the  Court  of  Justice  contributed  valuable  clarifications  to  the  implementation  of  the 
pharmaceutical  acquis.  In  2010  the  Court  of  Justice  delivered  for  example  the  following 
judgments: 

•  In  cases  C-350/08  and  C-385/08  the  Court  clarified  based  on  infringement 
procedures initiated by the Commission accession related questions concerning 
the “phasing in” of national marketing authorisations granted prior to accession 
in  the  new  Member  States  in  order  to  guarantee  that  all  valid  marketing 
authorisations in the EU comply with the high standards of the acquis. 

•  In  case  C-62/09  the  Court  provided  guidance  as  to  the  borderline  between 
prohibited  promotion  for  medicinal  products  on  the  one  side  (covered  by 

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Directive  2001/83/EC)  and  financial  incentives  granted  by  public  health 
authorities  for  prescribing  named  generics  on  the  other  (not-covered  by 
Directive 2001/83/EC). 

As regards legislative developments, the adoption of parts of the pharmaceutical package and 
the  implementing  regulation  for  maximum  residue  limits  took  place  in  2010.  In  December 
2010  Regulation  (EU)  No  1235/2010  of  the  European  Parliament  and  of  the  Council  of  15 
December  2010  amending,  as  regards  pharmacovigilance  of  medicinal  products  for  human 
use Regulation (EC) No 726/2004 laying down Community procedures for the authorisation 
and  supervision  of  medicinal  products  for  human  and  veterinary  use  and  establishing  a 
European Medicines Agency as well as Directive 2010/84/EU of the European Parliament and 
of  the  Council  of  15  December  2010  amending,  as  regards  pharmacovigilance  Directive 
2001/83/EC  on  the  Community  code  relating  to  medicinal  products  for  human  use,  were 
published  in  the  Official  Journals.  These  new  rules  strengthen  pharmacovigilance  by 
establishing clear standards, while at the same time rationalising and simplifying obligations 
for all actors involved. 

Other parts of the “package” are being discussed within the co-decision procedure: 

•  Two  legislative  proposals  on  information  to  patients  involving  amendments  of 

Directive 2001/83/EC and Regulation (EC) No 726/2004; 

•  A legislative proposal on falsified medicines involving amendments of Directive 
2001/83/EC. A compromise agreement was reached between the three institutions 
at the end of 2010. 

Additionally,  the  Commission  published  several  guidance  documents  in  the  area  of  clinical 
trials and herbal medicines. 

Finally, some groundwork was done to consider the necessity for future policy action in the 
pharmaceutical sector. Public consultations on the functioning of the Clinical Trial Directive 
2001/20/EC and the review of the veterinary medicinal legislation were held. Moreover, the 
Commission  received  in  2010  the  final  report  on  the  evaluation  of  the  European  Medicines 
Agency. 

15.2.3.2. Evaluation based on the current situation 

The  pharmaceutical  sector  remains  a  highly  dynamic  sector,  which  is  subject  to  frequent 
change  because  of  innovation.  In  such  an  environment  questions  of  timely  and  correct 
implementation of EU law are crucial to achieve the public health goals of the acquis and to 
guarantee  a  level-playing  field  for  the  actors  involved.  In  this  respect  the  priorities  remain 
unchanged. 

The experience of the past years shows that in general the legal framework is well respected. 
Hence, implementation and compliance by Member States with the acquis can be considered 
satisfactory.  An  important  contributor  in  this  regard  are  the  various  working  groups, 
committees and networks which exists in the pharmaceutical sector and which provide useful 
forums for raising and discussing relevant questions. At the same time they may give impetus 
for tightening or clarifying the acquis, where necessary. 

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15.2.4.  Medical devices 

The role of medical devices in healthcare is essential. The diversity and innovativeness of this 
sector contribute significantly to enhanced quality and efficacy of healthcare. 

Covering  a  wide  range  of  products,  from  simple  bandages  to  the  most  sophisticated  life-
supporting  products,  the  medical  devices  sector  plays  a  crucial  role  in  the  diagnosis, 
prevention, monitoring, and treatment of diseases and the improvement of the quality of life 
of people suffering from disabilities. 

The  involvement  of  Directorate-General  Health  and  Consumers  concerns  mainly  the 
regulatory  framework  for  market  access,  international  trade  relations  and  regulatory 
convergence,  all  aiming  to  ensure  the  highest  level  of  patient  safety  while  promoting  the 
innovation and the competitiveness of this sector. 

Rules relating to the safety and performance of medical devices were harmonised in the EU 
with Council Directive 90/385/EEC relating to active implantable medical devices, Directive 
93/42/EEC concerning medical devices and Directive 98/79/EC on in vitro diagnostic medical 
devices. 

15.2.4.1. Report of work done in 2010 

European databank for medical devices  

Patient's  safety  will  increase  in  Europe  as  a  direct  result  of  the  development  of  the  new 
European databank for medical devices called 'Eudamed'. 

A Commission Decision adopted on 19 April 2010 obliges EU Member States, as from May 
2011, to enter and share data on medical devices in this secure web-based databank. 

Essential  data  for  safety,  such  as  certificates  (including  those  which  are  withdrawn  or 
suspended)  and  incident  reports  will  be  rapidly  accessible  to  the  Authorities  in  charge  of 
market surveillance and therefore risks for patients will be reduced. 

Reprocessing of single use medical devices, a complex issue 

The current EU law (the Medical Devices Directive) distinguishes between reusable medical 
devices and medical devices intended for single use: 

•  Some medical devices, such as many of the surgical instruments, are intended by 
their  manufacturers  to  be  reused.  In  this  case,  the  legislation  sets  specific 
requirements that the manufacturer must fulfil in order to allow safe reuse. 

•  Other medical devices, such as syringes, needles and catheters, are intended to be 
used once only for a single patient. Such devices are defined as single-use medical 
devices. 

The issue of the reprocessing of single use medical devices, such as catheters, was discussed 
in the context of the last revision of the medical devices Directives, especially at the request 
of the European Parliament, but it was not possible to solve such a complex issue during this 
negotiation. 

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To ensure a follow up of these discussions, the Parliament asked the Commission to prepare a 
report on this issue and to put forward appropriate measures. 

The reprocessing practice of single-use medical devices is not regulated at European level and 
the  situation  diverges  in  the  Member  States,  with  the  consequence  that  patients  are  treated 
with  reprocessed  single-use  medical  devices  in  some  Member  States  -  without  knowing  it  - 
when it is not the case in some other Member States. 

On  the  basis  of  a  scientific  opinion  of  the  Scientific  Committee  on  Emerging  and  Newly 
Health  Risks  (SCENIHR),  the  Commission  adopted  on  27  August  2010  a  report  which 
examines public health, ethical, liability, economic and environmental considerations. In the 
light of the findings of this report, the Commission will assess which measures are to be put 
forward as part of the forthcoming review of the medical devices Directives to ensure a high 
level of protection for patients. 

Improved  control  and  safety  for  the  future  in  vitro  diagnostic  medical  devices  for 
variant Creutzfeldt–Jakob disease (vCJD) 

In vitro diagnostic medical devices for vCJD are not yet on the EU market. 

However, to pave the way for such tests and ensure an appropriate regulatory framework, two 
Comitology measures have been prepared which are planned to be adopted in 2011: 

The  first  measure  will  submit  vCJD  blood  screening,  diagnostic  and  confirmation  assays  to 
the control of notified bodies (instead of a manufacturer's control only) before such tests can 
be placed on the market; 

The  second  measure  will  establish  performance  criteria  for  vCJD  blood  screening  assays. 
Performance criteria will be established for the two other categories of vCJD tests as soon as 
science will have sufficiently evolved. 

Possibility to provide instructions for use on electronic way for medical devices 

Work  has  progressed  well  on  the  preparation  of  another  Comitology  measure  which  will 
allow  that,  for  certain  categories  of  devices,  the  instructions  for  use  may  be  provided  in 
electronic rather than paper form. In order to ensure at least an equivalent protection of patient 
safety  the  modalities  of  delivering  such  electronic  instructions  need  to  be  specified.  The 
measure is expected to be adopted during 2011. 

Improved governance for GMDN (Global Medical Device Nomenclature) Agency 

Work was ongoing to improve the governance of the GMDN Agency, to find a new funding 
mechanism  and  to  achieve  international  acceptance  of  the  GMDN  nomenclature.  Use  of  a 
single nomenclature for medical devices will greatly facilitate communication on devices. A 
representative  of  Directorate-General  Health  and  Consumers  holds  the  Chair  of  the  Policy 
Advisory  Group  to  the  Agency.  Work  is  ongoing  on  the  translation  of  GMDN  into  20  EU 
languages. 

Screening of the national law transposing Directive 2007/47/EC 

The  screening  of  national  legislation  transposing  Directive  2007/47/EC,  started  in  2008  and 

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was  completed  in  2010.  Several  deficiencies  of  the  national  law  of  Member  States  were 
identified  and  discussed  with  the  respective  Member  State.  The  screening  also  helped  to 
identify issues in which the Member States are ahead of EU law. These issues are examined in 
order  to  enhance  better  understanding  of  the  regulatory  landscape  in  a  view  of  the  next 
revision of medical devices directives. 

Screening of standards 

The screening  of standards providing presumption of  conformity  with legal requirements of 
directives  prevented  some  of  these  standards  to  deviate  from  the  directives  on  medical 
devices. The screening led to several informal interventions and the first Commission driven 
formal objection against several standards. 

Support for and supervision of Member States authorities 

Mostly  in  a  supportive  role,  but  also  partly  in  a  supervisory  role,  the  Commission  followed 
the  application  of  the  medical  devices  directives  by  the  Member  States.  Numerous 
interpretative  questions  have  been  clarified  together  with  the  authorities.  Some  of  these 
interpretative  questions  were  dealt  with  in  guidance  documents.  The  Commission  services 
offered  advice  to  authorities  in  individual  cases,  mainly  in  the  field  of  market  surveillance, 
and co-ordinated Member States' actions with regard to incidents (so-called vigilance cases). 
The screening of Member States' designations of Notified Bodies led to numerous restrictions 
of  the  scope  of  designations.  Cases  of  insufficient  performance  of  Notified  Bodies  were 
investigated. 

International regulatory cooperation  

1. At bilateral level, the main issues to mention are the following:  

•  USA: in the context of a confidentiality arrangement, sharing of information took 
place  on  the  revision  of  both  legislations  (for  example,  on  the  rules  on  in  vitro 
diagnostic  medical  devices  –  IVD).  On  specific  products,  the  exchange  focused 
primarily  on  the  adoption  of  corrective  actions  to  improve  the  safety  and 
performance  of  infusion  pumps  and  to  avoid  the  recurrence  of  serious  vigilance 
cases. 

•  China:  the  following  major  events  took  place  in  2010:  China  International 
Medical  Device  Forum  in  September  in  Beijing,  High  Level  Forum  on 
Standardization with SFDA, Regulatory dialogue on Medical devices in October 
in Beijing. 

•  India: a workshop took place in June 2010, in view of regulatory developments, 

in order to provide EU expertise. 

•  Turkey:  several  legal  obligations  were  clarified  in  order  to  ensure  the  free 

movement of medical devices within the Custom Union. 

Following  the  development  of  several  WHO's  programs  in  the  field  of  medical  devices, 
direct  contacts  have  been  established  with  this  organisation  in  order  to  enhance  bilateral 
exchange of information. 

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2. At multilateral level, the main results are the following: 

•  In  the  context  of  GHTF  (Global  Harmonization  Task  Force),  a  first  discussion 
took place on a strategy for the future of GHTF and the EU will have to define its 
position in this context. 

•  On  a  more  technical  side,  the  work  has  progressed  in  the  study  groups  through 
guidance on clinical evidence for IVD and on labelling and essential requirements 
for IVD and MD. Such guidance will be useful in the context of the recast of the 
medical devices Directives. 

•  An international ad hoc working group, chaired by a Commission representative, 
has  prepared  a  draft  guidance  document  on  a  commonly  agreed  traceability 
system, based on a unique device identifier (UDI). This paper was published for 
public consultation in November 2010. Comments were received until April 2011 
and  are  being  analysed.  This  work  is  reflected  at  European  level:  this  issue  was 
discussed under the Spanish Presidency in a Competent Authorities meeting, and 
a small working group chaired by Directorate-General Health and Consumers held 
its first meeting in June, composed of representatives of some Member States, to 
which will be added representatives of industry, hospitals and patients. The aim of 
this  group  of  volunteers  is  to  provide  concrete  answers  in  view  of  an  impact 
assessment  of  the  implementation  of  a  UDI  mechanism  at  the  European  level, 
which  will  improve  market  surveillance  and  contribute  to  fighting  against 
counterfeiting. 

the  Members  of 

•  An  international  regulators  ad  hoc  Task  Force  on  combination  products, 
the  GHTF  for  medical  devices  and  of 
composed  of 
representatives  of  ICH  (International  Conference  on  Harmonization)  for  the 
pharmaceutical  products  explored  the  possible  way  forward  in  converging  the 
regulatory  frameworks  of  combination  products  internationally  and  produced  a 
draft report on the preliminary scoping of objectives, issues and process. 

15.2.4.2. Evaluation, Priorities & Perspectives 

Experience  indicates  that  the  current  system  does  not  always  offer  a  uniform  level  of 
protection  of  public  health  in  the  EU.  New  and  emerging  technologies  have  challenged  the 
current  framework,  highlighting  gaps  and  pointing  to  a  certain  scarcity  of  expertise.  In 
addition,  in  recognition  that  the  medical  devices  market  is  a  global  one,  to  keep  European 
industry  competitive,  the  EU  regime  needs  to  further  converge  on  the  'global  model'.  And 
finally,  the  legal  system  has  been  criticised  as  being  too  fragmented  and  difficult  to  follow 
and fraught with national variation. 

The  Commission  is  considering  a  revision  of  the  legal  framework  for  Medical  Devices  in 
order  to  improve  and  strengthen  this  framework  and  to  meet  the  growing  expectations  of 
European citizens since the last technical revision brought about by Directive 2007/47/EC. 

The initiative to undertake a systemic revision of the three medical devices directives took off 
with  a  public  consultation  in  2008.  In  2010  it  was  complemented  by  an  additional  public 
consultation concerning specific aspects related to in vitro diagnostic medical devices (IVD).  

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The  drivers  for  the  proposed  revision  are  the  simplification  programme  2005,  the  "revised 
New Approach", legal gaps regarding products falling outside any specific EU legislation and 
weaknesses of the current directives (lack of coordination and unequal level of enforcement). 

The initiative to "recast" the three medical devices directives shall contribute to a high level of 
safety  for  the  patient  and  user,  delivering  a  transparent  system  whereby  citizens  can  be 
confident in the safety of medical devices. Its objective is also to ensure a simple and easily-
understandable regulatory environment for medical devices to ensure the efficient functioning 
of the Internal Market. 

A  lot  of  contacts  have  also  taken  place  with  the  stakeholders,  the  work  on  the  impact 
assessment  has  begun  and  the  roadmap  was  finalized  in  October  2010.  A  high  level 
conference will be organised in March 2011 on research and innovation in the field of medical 
devices and the revision of the regulatory framework. 

At  the  same  time,  the  implementation  of  the  current  medical  devices  directives  will  be 
ongoing  in  2011  to  support  their  effective  and  coherent  application  throughout  the  EU,  in 
particular as regards: 

•  the maintenance of IT tools for the database Eudamed;  

•  the  coordination  of  the  treatment  of  vigilance  cases  and  market  surveillances 

activities;  

•  the  elaboration  of  new  and  the  revision  of  existing  guidance  documents 
combined  medical 

particular 

field 

the 

of 

in 

(MEDDEVs), 
devices/pharmaceuticals;  

in 

•  the supervision of the designation of Notified Bodies by the Member States. 

15.3.  Consumers  

There are now some 500 million consumers in Europe and their expenditure represents over 
half of the EU’s gross domestic product (GDP). Consumers are essential to economic growth 
and job creation in a large market of products and services. 

The Commission's Consumer Policy supports the aims laid out in Articles 169 and 114 TFEU, 
which promote the interests, health and safety of European consumers. It is designed to ensure 
that  the  internal  market  is  open,  fair  and  transparent  and  products  sold  are  safe,  allowing 
consumers to exercise real choices, whilst excluding rogue traders. 

With  so  many  new  products  and  brands  and  increasingly  sophisticated  financial  services, 
European consumers are having a hard time getting their bearings. They are not comfortable 
with the idea of buying something in another Member State: only one out of five people have 
done so over the past twelve months. Yet, the EU single market offers many possibilities for 
competition and for buying at a lower price. 

15.3.1.  Report of work done in 2010  

Consumer credit  

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Directive  2008/48/EC  of  23  April  2008  on  credit  agreements  for  consumers  had  to  be 
implemented by Member States on 11 June 2010. By the end of 2010, 23 Member States have 
already notified their implementing measures, although some of them have done it partially. 
Four Member States have not yet notified any implementing measure. 

The Commission sent a Reasoned Opinion for non-communication on 24 November 2010 to 
Spain,  Luxemburg,  the  Netherlands,  Poland  and  Sweden.  Sweden  notified  its  implementing 
measure  on  22  December  2010.  Moreover,  a  Reasoned  Opinion  has  also  been  issued  on  24 
November  2010  against  Belgium  and  France  for  partial  transposition.  In  addition,  the 
Commission  launched  on  24  November  2010  infringement  procedures  for  incorrect 
transposition against Belgium, UK and Romania. 

EU-Sweeps  

In  2010  the  fourth  EU  "Sweep"  was  carried  out,  involving  systematic  and  simultaneous 
checks  in  different  Member  States  to  investigate  potential  breaches  of  consumer  protection 
rules  in  the  tickets  for  cultural  and  sporting  events  sector.  This  Sweep  looked  into  414 
websites, of which 60% were flagged for further investigation in the enforcement phase. The 
exercise was carried out by all the EU Member States, as well as by Norway and Iceland. The 
most  common  breaches  detected  in  the  2010  Sweep  were  related  to  missing,  incomplete  or 
misleading  information  about  the  price  (e.g.  hidden  taxes  or  handling  charges),  74%  of  the 
problems;  unfair  terms  and  conditions  (e.g.  ticket  delivery  was  not  guaranteed  on  time  or  a 
refund  was  excluded  in  the  event  of  cancellation),  73%  of  the  problems;  and  missing, 
incomplete or misleading information about the trader (e.g. missing geographical address and 
e-mail or falsely presenting himself as authorised by the promoter), 48% of the problems. The 
results of the enforcement phase are planned to be presented during the second half of 2011. 

The  final  report  on  the  follow-up  of  the  2009  Sweep  related  to  websites  selling  electronic 
goods was published in 2010. In 2009 the Sweep on electronic goods looked at 369 websites 
of  which  55%  were  flagged  for  further  investigation.  At  the  end  of  the  enforcement  phase, 
84% of the websites flagged were compliant with EU laws. 

Consumer empowerment  

Through  the  European  Consumer  Consultative  Group  (ECCG),  the  Commission  pursued  its 
dialogue with consumer organisations  and  consulted them on initiatives having an effect on 
consumers.  ECCG  members  also  shared  their  views  regarding  the  application  of  EU 
legislation. Following the revision of the Commission Decision setting up the ECCG495 aimed 
at further improving the efficiency and representativeness of the group; the group has met 4 
times under its new composition. 

The European Consumer Centres Network (ECC-Net)  

In  2010,  the  European  Consumer  Centres  Network  (ECC-Net)  handled  over  71000  contacts 
with consumers who turned to them for advice about their rights or for help with problems in 
the course of cross-border shopping. 

495 

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The  work  of  the  centres  shows  that,  in  2010,  as  it  was  already  the  case  in  2009,  European 
consumers’  biggest  problems  were  related  to  transport,  recreation  and  culture  and 
accommodation services. 

The ECCs also helped consumers to reach agreements on complaints with traders using out-
of-court dispute resolution mechanisms. 

In  addition,  the  ECCs  have  carried  out  joint  projects  analysing  consumer  complaints  and 
concerns  on  key  issues  such  as  Alternative  Dispute  resolution  mechanisms  in  Europe  and  a 
pan European survey on ski resorts. 

The  ECCs  participated  actively  in  the  European  Consumer  Summit  2010  in  the  workshop 
dedicated  to  car  hire  that  looked  at  problem  areas  in  existing  practices  and  tried  to  raise 
standards for consumers in the car hire sector. 

Education and training activities  

In  2010,  an  information  campaign  raising  awareness  of  EU-wide  consumer  rights  was 
launched in Bulgaria. The campaign contributes to the better enforcement of consumer law by 
informing consumers about specific rights they have at home and in other EU countries, and 
by increasing awareness of associations and institutions that provide further information and 
advice,  such  as  consumer  associations,  government  institutions  and  European  Consumer 
Centres. 

In  2010  the  Commission  carried  out  a  series  of  training  courses  designed  to  help  build  the 
capacity of European consumer organisations, aiming at providing a better understanding of 
the consumer acquis and thereby preventing infringements. The Commission also distributed 
3.275.500 copies of the Europa Diary containing consumer education materials to over 21.000 
EU schools and developed its consumer education website: www.dolceta.eu. 

Consumer Protection Cooperation (CPC)  

The  CPC  Network  was  established  by  the  Consumer  Protection  Cooperation  (CPC) 
Regulation496 in  December  2006  to stop intra-Union infringements of  EU consumer laws in 
cross-border situations. It links some 250 enforcement authorities in Member States to form 
an EU-wide enforcement network. 

In 2010 the Network recorded a total of 222 new mutual assistance requests497 (compared to 
319 the year before) which include 37 alerts concerning suspected or confirmed intra-Union 
infringements (compared to 43 in 2009). As every year since the Network started operating, a 
joint  market  surveillance  and  enforcement  exercise  was  carried  out  in  the  form  of  an  EU-
sweep (for more details see above under "EU sweeps"). Other  joint activities that started in 
2010  include  a  project  on  strengthening  the  Network's  internet  enforcement  capacities  by 
establishing  new  means  of  sharing  best  practice  and  that  takes  forward  some  of  the  work 
carried out in the context of a first common CPC activity in 2007. The latter had established 
among other things a common methodology for the EU-sweeps ("sweepers' manual"). 

496 

497 

Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on 
cooperation between national authorities responsible for the enforcement of consumer protection laws, 
OJ L 364 dates 9.12.2004. 
Data extracted from the IT-tool used by the Network as of 30 November 2010. 

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A second project focuses on the visibility of the Network's activities and will seek to develop 
a common (internal and external) communication strategy for the Network. Both projects will 
continue in 2011. The Commission pursued its efforts to address, in close partnership with the 
Member  States,  the  shortcomings  in  the  Network's  operations  as  described  in  the  first 
Commission  biennial  assessment  of  the  application  of  Regulation  (EC)  No  2006/2004498. 
Building  on  the  work  already  initiated  in  2009,  operating  guidelines  were  endorsed  by  the 
CPC committee in June 2010 and a number of initiatives were taken to enhance the IT-tool 
used  by  the  Network.  Finally,  as  some  issues  required  adjusting  partially  some  of  the 
cooperation  rules  applied  by  the  Network,  an  amendment  to  the  rules  implementing  the 
Regulation  was  discussed  with  the  Member  States  and  is  planned  to  be  adopted  by  the 
Commission  in  2011.  Training  on  the  IT-tool  continued  with  the  assistance  of  the  Trainers 
Network established in 2009. 

Drawing  from  the  experience  learnt  in  2009,  the  Commission  organised  two  workshops  on 
subjects of relevance to the CPC-Network: the outcome of the workshops on applicable law 
and sanctions were taken forward in a follow-up discussion end of 2010 and a workshop on 
consumer  issues  in  the  area  of  financial  services  prepared  the  ground  for  future  Network 
activities in 2011. 

Product safety 

In 2010 the Commission presented the key elements and envisaged actions of the consultation 
on  the  revision  of  the  General  Product  Safety  Directive.  Streamlined  procedures  to  get 
European standards of safe products and alignment with other market surveillance rules are in 
the core of the intended improvements. As the stakeholder consultation confirmed, consumer 
confidence  and  level  playing  field  for  business  indeed  require  that  the  product  safety 
framework  and  its  enforcement  are  modern  and  effective  and  that  benchmarks  are  fully 
shared. 

Commission Decision 2010/9/EU on the safety requirements for bath rings, bathing aids 
and bath tubs and stands for babies and young children 

On  6  January  2010  the  Commission  adopted  Decision  2010/9/EU499  setting  the  safety 
requirements  for  products  used  to  assist  parents  and  caregivers  to  bath  their  babies.  The 
Decision,  based  on  Article  4  (1)  of  Directive  2001/95/EC,  lays  down  the  essential 
requirements  to  ensure  that  bath  rings,  bathing  aids  and  bath  tubs  are  safe.  There  are  no 
European safety standards for these products which if not used adequately expose the babies 
to drowning. Also, requirements are needed to eliminate additional risks such as entrapment 
and injuries. Standardisation work follows to make this decision effective. 

Commission Decision 2010/11/EU on the safety requirements for child-resistant locks for 
window and balcony doors 

On  7  January  2010,  the  Commission  adopted  Decision2010/11/EU500  setting  the  safety 
requirements  for  child-resistant  locks  for  windows  and  balcony  doors.  This  Decision, 
based  on  Article  4(1)  of  Directive  2001/95/EC  lays  down  the  requirements  that  European 

498 
499 
500 

COM (2009) 336 final. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:003:0023:0029:EN:PDF 
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standards  will  have  to  meet  to  ensure  that  these  locks  are  safe.  Accidental  falls  of  children 
from windows and balconies are a leading cause of death or permanent damages to children 
below the age of 5 in Europe. There are no European standards for these products. The safety 
requirements will ensure that the locks cannot be disengaged by children, resist wear and tear 
and  weather  conditions  and  are  moreover  provided  with  the  necessary  instructions  to  be 
installed by consumers. Standardisation work follows to make this decision effective. 

Commission Decision 2010/376/EU on the safety requirements for some products in the 
sleeping environment of babies and young children  

On  2  July  2010  the  Commission  adopted  Decision  2010/376/EU501  setting  safety 
requirements for 5 products commonly used in the sleep environment of babies and young 
children. The products concerned are cot mattresses, cot bumpers, sleeping bags for babies, 
suspended  baby  beds,  duvets  for  babies.  The  Decision,  based  on  Article  4  (1)  of  Directive 
2001/95, lays down the requirements that European standards will have to meet to ensure that 
these products are safe. At the moment there are no safety standards for these products, which 
can  pose  serious  risks  to  babies  and  young  children,  such  as  entrapment,  suffocation, 
strangulation and injuries. Standardisation work follows to make this decision effective. 

Commission  Decision  2010/153/EU  prolonging  the  ban  of  dimethyl  fumarate  in  all 
consumer products 

The  Commission  adopted  Decision  2010/153/EU  on  11  March  2010  on  the  basis  of  Article 
13(4)  of  the  General  Product  Safety  Directive  (GPSD).  The  Decision  concerns  dimethyl 
fumarate  (DMF),  a  biocide  preventing  moulds  which  is  strongly  sensitising  and  can  cause 
severe  skin  reactions.  The  Decision  requires  Member  States  to  ensure  that  all  consumer 
products containing DMF are withdrawn from the market and recalled from consumers. Since 
the Decision can only be valid for one year at a time, it will be prolonged for further periods 
until a permanent measure is put in place in EU legislation. Such a measure is currently under 
preparation under REACH. 

Commission Decision 2010/157/EU on child-resistant lighters  

On 12 March 2010, the Commission adopted Decision 2010/157/EU, extending for the fourth 
time – until 11 May 2011 – Decision 2006/502/EC requiring Member States to take measures 
to ensure that only lighters which are child-resistant are placed on the market and to prohibit 
the  placing  on  the  market  of  so-called  novelty  lighters.  Upon  a  mandate  from  the 
Commission,  CEN  is  currently  revising  the  relevant  standard  (EN  13869:2002  ‘Lighters  — 
Child-resistance for lighters — Safety requirements and test methods’).  

RAPEX system  

RAPEX is the EU Rapid Information System for dangerous non-food products which operates 
under the General Product Safety Directive and the Regulation No  765/2008 setting out the 
requirements for accreditation and market surveillance relating to the marketing of products 
and  repealing  Regulation  (EEC)  No  339/93  (hereinafter  the  'Regulation  765/2008').  The 
Member States, EFTA/EEA countries and the Commission use RAPEX to rapidly exchange 

501 

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information about dangerous non-food products found on and consequently withdrawn from 
the European market. 

RAPEX operations improved again in 2010, when in total 2 244 notifications were exchanged 
through  the  system  by  participating  countries  and  the  Commission.  This  constitutes  an 
increase of 13% compared to 2009. Half of the countries participating in the system further 
enhanced their activities and submitted more notifications on dangerous products than in the 
previous years. As RAPEX notifications sent by the Member States in 2010 were of the better 
quality,  the  number  of  notifications  distributed  for  information  purpose  decreased  by  14% 
compared  to  2009  (243  notifications  distributed  in  2010  compared  to  283  notifications  in 
2009). 

Clothing  and  textiles,  toys,  motor  vehicles,  electrical  appliances  and  childcare  articles  were 
still among the most often notified products through the system. These categories of products 
accounted for almost 80% of all products notified in 2010. It should be noted that since 2009, 
there has been a significant increase in the number of RAPEX notifications on clothing and 
textiles  (in  2009:  395  notifications,  23%  of  the  total  and  in  2010:  625  notifications,  32%) 
which results mainly from the enhanced market surveillance activities undertaken by national 
authorities following, in particular, the launch of the joint market surveillance action on cords 
and  drawstrings  in  children's  clothing  and  the  adoption  of  the  Commission  Decision 
2009/251/EC  banning  dimethyl  fumarate  in  all  consumer  products.  This  proves  that  risk-
focused  EU-level  measures  and  joint  prioritisation  of  certain  types  of  products  in  the 
surveillance actions taken by Member States result in well spent resources in terms of finding 
dangerous products that could be harmful to consumers. 

The  number  of  notifications  with  an  unidentified  country  of  origin  increased  slightly 
compared with 2009 (from 7% in 2009 to 10% in 2010). It should, however, be stressed that it 
is one of the big improvements of the system, as in 2004 23% of notifications contained no 
information  about  the  country  of  origin.  This  is  an  indicator  that  the  market  surveillance 
authorities in Europe are increasingly aware of the importance of (a) taking the incriminated 
product off the shelves in their country but also (b) of the importance of traceability data for 
authorities  in  other  countries  and  ultimately  in  the  country  of  origin  of  the  product.  The 
number of dangerous products of Chinese and European origin notified through RAPEX was 
maintained at the level of respectively 58% and 17% of all notifications (i.e. 1 134 and 338 
notifications). These results are similar to previous year's results. 

Extension of the scope of RAPEX  

On 1 January 2010, following the entry into force of the Regulation 765/2008, the scope of 
the  RAPEX  system  was  extended.  As  of  that  day,  RAPEX  applies  to  both  consumer  and 
professional products which pose serious risks to various public interests, such as health and 
safety of consumers, environment, energy efficiency, public security, etc. 

Risk Assessment Application  

Following Decision 2010/15/EU laying down the new guidelines for the management of the 
EU  Rapid  Information  System  ‘RAPEX’  established  under  Article  12  and  the  notification 
procedure  established  under  Article  11  of  Directive  2001/95/EC,  improved  risk  assessment 
method started to be applied. In December 2010,  the  Commission  made  available  an  online 
system  called  "Risk  Assessment  Guidelines  application".  The  application  was  established  to 

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simplify  the  preparation  of  risk  assessments  according  to  the  new  RAPEX  Guidelines.  The 
application makes it possible to easily estimate and document the risk of consumer products, 
while giving the risk assessor the necessary freedom to make the appropriate assumptions as 
described in the Guidelines. 

Joint Actions on market surveillance activities  

To  support  the  Member  States  in  their  cross-border  activities,  in  2010  the  Commission 
awarded  a  financial  contribution  of  EUR  1.4  million  to  a  single  joint  market  surveillance 
action, covering 4 different product groups including; children's fancy dresses, laser pointers, 
ladders  and  high  visibility  clothing.  To  further  strengthen  cooperation  between  the  Member 
States  on  consumer  product  safety,  the  Commission  will  continue  joint  actions  in  2011  and 
will financially contribute to the best proposals suggested by Member States. 

International cooperation  

The  Commission  further  strengthened  collaboration  with  its  international  partners  in  the 
product safety area. The main aim is to share information about emerging product safety risks, 
provide  updates  on  legislative  and  normative  developments  and  prevent  dangerous  products 
from  finding  their  way  onto  the  EU  market.  More  particularly,  in  October  2010, 
Commissioner  Dalli  participated  in  the  EU-US-China  Trilateral  Summit  on  Product  Safety, 
which  took  place  in  Shanghai,  China.  The  meeting  agreed  a  joint  statement  on  points  of 
consensus  regarding  international  product  safety  cooperation  and  committed  to  develop 
specific  actions  to  further  their  implementation.  Negotiations  with  the  United  States  for  an 
agreement on cooperation and information exchange in the area of consumer product safety 
and consumer protection cooperation made progress but will continue in 2011. 

In  2010  the  collaboration  with  the  People's  Republic  of  China's  General  Administration  for 
Quality  Supervision,  Inspection  and  Quarantine  (AQSIQ)  continued  and  the  Commission 
continued to make available on the Internet the analyses of the quarterly follow-up reports to 
the RAPEX notifications sent to China. 

COSMETICS  

Cosmetic products are important consumer products with an essential role in everyone's life: 
apart  from  "traditional"  cosmetic  products,  such  as  make-up  and  perfumes,  it  also  includes 
products for personal hygiene, for example tooth-care products, shampoos and soaps. 

Today's  cosmetic  market  is  driven  by  innovation  including  new  colour  pallets,  treatments 
targeted  to  specific  skin  types  and  unique  formulas  concentrating  on  different  needs.  Most 
cosmetics products have a lifespan of less than five years and manufacturers reformulate 25% 
of their products every year. They need to improve products constantly in order to stay ahead 
in a highly competitive market where more choice and ever greater efficacy are expected by 
the consumer. 

The European cosmetics industry is a world leader and dominant cosmetics exporter, a highly 
innovative  sector  and  a  significant  employer  in  Europe.  The  EU's  involvement  concerns 
mainly  the  regulatory  framework  for  market  access,  international  trade  relations  and 
regulatory  convergence,  all  aiming  to  ensure  the  highest  level  of  consumer  safety  while 
promoting the innovation and the competitiveness of this sector. 

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Technical adaptations to the current Cosmetics Directive  

Until 2013 the work continues under the current Cosmetics Directive and following opinions 
of the Scientific Committee on Consumer Safety (SCCS), two technical adaptation directives 
were adopted in 2010 (one of them is important for the safety of hair-dyes) while two other 
are in preparation (one of them concerning zinc oxide used as UV filter in sunscreens). 

A technical adaptation on tooth whitening products was submitted to the Member States for a 
vote,  but  did  not  receive  an  opinion.  The  file  should  be  transmitted  to  the  Council,  and 
discussions are ongoing to try to get Member States on board. 

Animal testing  

The Commission has to prepare annual reports on this issue, explaining the evolution of the 
situation (number of animals used, validation of alternative methods, international situation). 
The 2008 Report was adopted in September 2010. 

In  2011  the  Commission  will  inform  the  European  Parliament  and  the  Council  if  the 
alternative methods will not be developed and validated before 2013 for three complex end-
points: repeated-dose toxicity, reproductive toxicity and toxicokinetics. 

In order to establish the perspectives for the availability of alternative methods for these three 
end-points, the Commission has set up a working group of independent experts proposed by 
different stakeholders. This group has elaborated a draft technical report which was available 
for  public  consultation  until  October  2010  and  is  now  being  finalized.  The  results  so  far 
clearly indicate that - while important progress has been made – full replacement of animal 
tests will not be possible by 2013 and for some end-points it is not likely to become a reality 
in the coming 10 years. 

In parallel to this technical exercise, an impact assessment will be carried out on the basis of 
the hypothesis that alternative methods are not available. Options to be analysed in order to 
define  the  Commission's  position  include  keeping  the  2013  deadline,  a  further  extension  of 
the  deadline  and  considering  other  mechanisms.  A  targeted  stakeholder  consultation  was 
launched in December 2010. 

International regulatory cooperation  

At bilateral level, the main results are the following: 

•  a  first  meeting  took  place  in  June  with  Indonesia  with  the  aim  to  convince  this 
country  to  adopt  the  Asean  cosmetics  Directive,  based  on  the  model  of  the  EU 
legislation. Indonesia agreed to start implementing the requirements of the Asean 
cosmetics Directive as from 2011 and expressed the wish to further increase the 
regulatory cooperation with the EU; 

•  an Asean Cosmetic meeting took place in June during which Unit B2 presented 
the new cosmetics Regulation to the Asean countries in view of an increased EU-
Asean cooperation in the area of convergence of cosmetics regulations; 

•  a Consumer Thematic Day took place in Shanghai in October, and the EU-China 
Cosmetics Safety Assessment  Seminar and the regulatory dialogue on cosmetics 

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at the same period in Beijing; 

•  attention  has  been  drawn  by  industry  on  important  difficulties  encountered  to 
export  cosmetic  products  to  China.  After  signalling  the  problem  in  writing, 
bilateral  meetings  were  convened  in  the  autumn  with  the  Chinese  Authorities  in 
charge of the registration of new cosmetics in order to speed up the resolution of 
the backlog of imported cosmetics which could not be put on the Chinese market. 

At multilateral level, Directorate-General Health and Consumers took the chair in July 2010 
of ICCR (International Cooperation on Cosmetics Regulation), for which five teleconferences 
were  held  with  regulators  from  US,  Canada  and  Japan,  as  well  as  a  face-to-face  meeting  in 
Toronto in July 2010. This led to significant progress towards regulatory convergence and, in 
particular,  to  the  joint  support  by  the  ICCR  jurisdictions  of  a  document  on  criteria  for  the 
identification of nanomaterials in cosmetics. 

15.3.2.  Evaluation, Priorities & Perspectives 

On 13 March 2007 the Commission adopted a Consumer Policy Strategy for 2007-2013. The 
strategy  sets  out  the  challenges,  role,  priorities  and  actions  of  EU  consumer  policy  for  this 
period.  The  overall  objectives  of  the  Strategy  are  to  empower  consumers,  to  enhance  their 
welfare  and  to  protect  them  effectively.  The  Commission's  vision  is  to  achieve  by  2013  a 
single, simple set of rules for the benefit of consumers and retailers alike. 

Given the progress achieved on the review and development of the consumer acquis, effective 
enforcement  will  play  an  important  role.  This  will  include,  from  the  Commission's  point  of 
view, continued efforts in accompanying the transposition process in the Member States and 
supervising the transposition and application of directives by the Member States. 

As part of a larger exercise to monitor how well the internal market functions for consumers, 
Commission  services  and  the  Member  States  developed  in  2009  a  framework  for  regular 
collection of enforcement indicators to measure the effectiveness of enforcement at national 
level. National policies and institutions related to enforcement play a key role in making the 
Internal Market function for consumers: free circulation of safe products and the protection of 
consumers  from  rogue  traders  depend  on  the  effectiveness  of  enforcement  and  market 
surveillance  in  all  Member  States.  An  expert  group  composed  of  members  of  the  CPC 
(Consumer  Protection  Cooperation)  and  GPSD  (General  Product  Safety  Directive) 
committees identified the most appropriate indicators, taking account of differences between 
national enforcement systems. 

The  Commission  carried  out  in  2010  a  mid-term  evaluation  of  the  2007-2013  Consumer 
Policy  Strategy  and  of  the  2007-2013  Programme  of  Community  Action  (as  well  as  an  ex-
post  evaluation  of  the  Programme  of  Community  Action  2004-2006).  The  results  of  this 
evaluation  will  feed  into  the  preparation  in  2011  of  the  next  (post  2013)  Consumer  Policy 
Strategy and Programme of Community Action. The new Strategy and Programme will also 
integrate  the  results  of  separate  evaluations  which  will  be  conducted  in  2011  on  consumer 
education tools. 

The  Commission  plans  to  open  a  period  of  joint  reflection  with  the  Member  States  on  the 
future role of ECC-Net. In parallel, an evaluation of the Network is foreseen five years after 
the merger of the two previous networks into ECC-Net. This evaluation started in 2010. 

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One of the key initiatives is the implementation of the new Cosmetics Regulation. Main issues 
are the Cosmetics Products Notification Portal, a centralized notification database which will 
be managed by the Commission, guidelines on the cosmetics product safety report, guidelines 
on common criteria in order to use specific claims, "cosmetovigilance", CMR substances and 
nanotechnologies. Other key issues will be the availability of alternative methods to animals 
and the EU Chair of ICCR until July 2011 when the ICCR-5 meeting takes place in Europe. 

15.3.3.  Summary of the Consumer activities' field 

The challenge in this sector in the near future is to increase EU-wide consumer confidence in 
the  Internal  Market  through  clearer,  simplified  and  harmonised  rules  that  are  uniformly 
enforced  by  national  authorities.  Another  challenge  is  to  further  engage  consumers  in 
enforcement  efforts  because  the  Commission  cannot  deliver  effective  application  of  EU 
consumer law alone, without the Member States and consumers themselves playing their full 
role.  To  do  so  the  Commission  will  seek  increased  transparency  of  enforcement  action  and 
output to ensure that Member States' role is not only crucial in ensuring proper transposition 
of Directives but also in effectively deploying the resources and mechanisms needed to ensure 
compliance. 

15.4. 

Food safety and animal health and welfare 

15.4.1.  General Introduction 

For consumers, safety is the most important ingredient of their food. Consumer confidence is 
an essential outcome of a successful food policy and is therefore a primary goal of EU action 
in this area. The central goal of the Commission's food safety policy is to ensure a high level 
of protection of human health and consumers' interests in relation to food, taking into account 
diversity,  including  traditional  products,  whilst  ensuring  the  effective  functioning  of  the 
internal market. 

The  Commission's  guiding  principle  is  to  apply  an  integrated  approach  from  farm  to  table 
covering  all  sectors  of  the  food  chain,  including  feed  production,  primary  production,  food 
processing,  storage,  transport  and  retail  sale.  The  credibility  and  legitimacy  of  the 
Commission's actions depend on how effectively  the food safety policy is implemented and 
results delivered. Greater transparency at all levels of food safety policy is the thread running 
through  the  Commission's  integrated  approach  and  will  contribute  fundamentally  to 
enhancing consumer confidence in Europe's food safety policy. 

Legislation applicable to the various components of the food chain includes, in addition to the 
food and feed law, rules applicable to animal and plant health and to the welfare of animals. 
There  have  been  enormous  developments  in  the  past  decades,  both  in  the  methods  of  food 
production and processing, and the controls required to ensure that acceptable safety standards 
are  being  met.  Legislation  will  be  reviewed  and  amended  as  necessary  in  order  to  make  it 
more  coherent,  comprehensive  and  up-to-date.  Enforcement  of  this  legislation  at  all  levels 
will  be  promoted.  Member  States  are  key  partners  in  ensuring  adequate  and  uniform 
application of Europe's food safety legislation. 

15.4.1.1. Report of work done in 2010 

Work is ongoing on the modernisation and simplification of the legislation applicable to food 
and  feed  safety,  animal  and  plant  health,  and  animal  welfare.  The  aim  is  to  achieve  better 

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enforceability of existing rules, whilst providing for a state of the art legislative framework. 

Both  the  Animal  Health  Strategy502  and  the  recently  launched  work  towards  a  Plant  Health 
Strategy503  include  the  objective  of  providing  the  EU  with  a  more  coherent  and  directly 
enforceable set of rules in these areas in order to replace a vast amount of Directives adopted 
in the course of the last decades (the food safety acquis is one of the largest, numbering more 
than 500 Directives). 

In  more  general  terms,  the  Commission  through  an  internal  reorganisation  in  2009  has 
integrated  the  issue  of  enforcement  throughout  the  EU  food  safety  policy  area.  This  has 
mainly  resulted  in  a  systematic  analysis  of  all  issues  related  to  implementation  of  EU 
legislation and emerging from in-house information, including the more than 200 inspection 
reports  produced  yearly  by  the  Food  and  Veterinary  Office  (FVO)  of  the  Commission,  or 
from  information  received  from  Member  States  or  stakeholders.  For  each  of  them  an 
appropriate action is decided upon in cooperation with the responsible Units and a continuous 
follow-up is ensured until the issue has been resolved. 

The  issues  related  to  transposition  highlighted  in  the  previous  report  have  been  specifically 
followed-up during 2009 and 2010, and all of them have now been closed due to the fact that 
transposition has taken place. 

FVO inspections 

At EU level, valuable information regarding the application of EU legislation along the food 
chain is provided by the inspection activities of the Commission's FVO. Information collected 
by the FVO during recent years was carefully screened during the course of 2009 to provide 
an  overview  of  potential  shortcomings  in  relation  to  transposition  problems  of  some 
Directives or inadequate application of legislation throughout the food chain. 

The Commission services are in contact with the Member States concerned to address these 
issues  through  an  array  of  approaches.  The  FVO  continues  to  screen  Directives  with  the 
purpose  of  identifying  any  significant  transposition  problems.  In  a  similar  vein,  the 
Commission services are considering the most efficient and effective enforcement action with 
respect to issues other than transposition that have been identified by the FVO. 

The  Court  delivered  in  the  framework  of  three  infringement  proceedings  judgments 
condemning Greece to have failed to correctly apply EU law: 

•  The  FVO  missions  have  highlighted  since  1998  fundamental  systemic 
shortcomings in the performance of the Greek authorities’ official controls in the 
area  of  food  safety,  animal  health  and  animal  welfare.  These  shortcomings  are 
mainly  attributable  to  the  shortage  of  human  resources  in  the  Greek  veterinary 
services.  Because  of  these  shortages  both  in  central  administration  as  well  as  in 
the decentralised authorities, there was a failure to carry out the official controls in 

502 

503 

Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  European 
Economic and social committee and the Committee of the Regions on a new Animal Health Strategy 
for the European Union (2007-2013) where “Prevention is better than cure”. COM(2007) 539 final. 
The  Council  called  on  the  Commission  to  evaluate  the  current  plant  health  acquis  and  to  consider 
possible modifications to it, and subsequently present a proposal for a Community plant health strategy. 
The Commission has launched the evaluation, and is preparing a study. 

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an  effective  and  substantial  way.  The  Court  concluded  that  the  results  of  the 
efforts  made  by 
these  problems  were 
unsatisfactory504. 

the  Greek  authorities 

to  solve 

•  FVO missions provided evidence of systemic deficiencies in the management of 
animal by-products. The Court concluded that Greece failed to correctly apply key 
provisions of Regulation (EC) No 1774/2002 laying down health rules concerning 
animal by-products not intended for human consumption505. 

•  Also  on  the  basis  of  evidence  gathered  during  FVO  inspections,  the  Court  of 
Justice condemned Greece for failure to apply in a satisfactory way EU legislation 
relating to the protection of animals during transport and in slaughterhouses506. 

All three cases show the need to give priority to initiatives that aim at engaging fully Member 
States'  enforcement  actors  in  discussions  and  actions  to  address  the  optimal  use  of  finite 
enforcement resources. 

15.4.2.  Enforcement of the rules applicable to the food chain 

15.4.2.1. Current Situation 

Sustained attention to and coordination of enforcement action remains a priority in all areas 
related to food and feed safety, plant health and animal welfare. 

Consideration will continue the strengthening of cooperation on enforcement matters with and 
among  Member  States'  competent  authorities  and  to  a  more  transparent  use  and  efficient 
handling of the vast amount of enforcement related data which is available to the Commission 
and to Member States. 

Information contained in several reports from the FVO audits carried out in 2010 indicate that 
in  some  Member  States  the  recent  economic  crisis  might  have  had  an  impact  on  the 
availability  of  resources  allocated  for  official  controls  to  verify  compliance  with  the  food 
chain acquis (food and feed law, animal and plant health and animal welfare rules). Lack of 
resources  is  not  a  valid  justification  for  non  compliance  with  EU  rules,  and  cases  where 
insufficient controls result in a violation of EU law will be dealt with accordingly. 

The  finite  nature  (and  sometimes  the  scarcity) of  control  resources  is  however  a  fact  which 
deserves  attention.  The  Commission  has  therefore  started  a  review  of  the  rules  on  the 
financing  of  official  controls,  as  set  out  in  Regulation  (EC)  No.  882/2004,  with  a  view  to 
improving  the  mechanisms  with  the  intention  to  ensure  appropriate  resourcing  of  control 
activities  at  national  level  and  ultimately  to  promote  a  more  efficient  use  of  available 
resources. 

Legislative changes underway 

504 
505 
506 

Judgment of the Court of Justice of 23.4.2009 in case C-331/07. 
Judgment of the Court of Justice of 17.12.2009 in case C-248/08. 
Judgment of the Court of Justice of 10.9.2009 in case C-416/07. 

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The impact assessment on the mentioned review on the legislation on the financing of official 
controls  has  started  and  it  is  planned  to  be  finalised  during  early  2012.  It  will  include 
extensive consultation with the Member States and other stakeholders in order to assess the 
advantages and disadvantages of the different options available for change. The related data 
will be acquired in the course of the consultation or, where needed, through specific surveys. 
A proposal for change, if required, can therefore be expected in 2012 (further details can be 
found at the following web address:  

http://europa.eu/food/food/controls/inspection_fees/index_en.htm). 

The review of the specific rules laid down in Council Directive 96/23/EC will be continued in 
order  to  fully  integrate  the  related  provisions within  the  framework  of  Regulation  (EC)  No. 
882/2004 to provide Competent Authorities, operators and exporting countries with a simpler 
and more transparent framework for controls on residues of veterinary medicines. 

15.4.3.  GMO Food and Feed 

15.4.3.1. Current position 

Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically 
modified  (GM)  food  and  feed  sets  out  a  comprehensive  set  of  rules  governing  the 
authorisation  process  for  GM  food  and  feed,  while  ensuring  a  high  level  of  protection  of 
human and animal health, of the environment and of consumers. 

The Regulation provides for a single EU procedure for the authorisation of all food and feed 
containing, consisting or produced from a genetically modified organism. This authorisation, 
valid  throughout  the  EU,  is  granted  subject  to  a  single  risk  assessment  process  under  the 
responsibility  of  the  European  Food  and  Safety  Authority  (EFSA)  and  a  single  risk 
management  process  involving  the  Commission  and  the  Member  States  through    the 
examination procedure. 

Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release 
into  the  environment  of  genetically  modified organisms  (GMOs)  outlines  the  principles  for, 
and  regulates,  experimental  releases  and  the  placing  on  the  market  of  GMOs  in  the  EU  for 
uses  other  than  food  and  feed.  The  Directive  provides  for  a  notification  procedure  for  the 
placing  on  the  market  according  to  which  the  applicant  notifies  the  Member  State  where  it 
wishes to cultivate. The Member State in question conducts an assessment report and decides 
whether to grant consent or not to the applicant in consultation with the other Member States 
and the Commission. Once the consent for placing on the market is granted the product may 
be used throughout the EU. 

The  Regulation  provides  for  a  single  authorisation  procedure,  “one  door  -  one  key”,  for  all 
food and feed containing GMOs. The operator can submit his application in accordance with 
this  Regulation  or  else  he  can  split  this  application  and  have  it  dealt  with  under  this 
Regulation  and  under  Directive  2001/18/EC  on  the  deliberate  release  of  GMOs  into  the 
environment. 

15.4.3.2. Report of work done in 2010 

In  line  with  its  obligations  deriving  from  Regulation  (EC)  No  1829/2003  and  Directive 
2001/18/EC, the Commission implemented the EU legislation on GM food and feed mainly in 

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the two following areas: 

Authorisations were granted to those GM food and feed complying with all the conditions set 
out in the basic legislation: 

•  On  02  March  2010  the  Commission  adopted  Decision  2010/141/EU  authorising 
the placing on the market of products containing, consisting of, or produced from 
genetically  modified  maize  MON863xNK603  (MON-ØØ863-5xMON-ØØ6Ø3-
6); 

•  On 03 October 2010 the Commission adopted Decision 2010/140/EU authorising 
the placing on the market of products containing, consisting of, or produced from 
genetically modified maize MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-
6); 

•  On  02  March  2010  the  Commission  adopted  Decision  2010/139/EU  authorising 
the placing on the market of products containing, consisting of, or produced from 
genetically modified maize MON863xMON810xNK603 (MON-ØØ863-5xMON-
ØØ81Ø-6xMON- ØØ6Ø3-6); 

•  On  02  March  2010  the  Commission  adopted  Decision  2010/136/EU  authorising 
the placing on the market of feed produced from the genetically modified potato 
EH92-  527-1  (BPS-25271-9)  and  the  adventitious  or  technically  unavoidable 
presence of the potato in food and other feed products; 

•  On 28 July 2010 the Commission adopted Decision 2010/432/EU authorising the 
placing  on  the  market  of  products  containing,  consisting  of,  or  produced  from 
genetically modified maize 1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7); 

•  On 28 July 2010 the Commission adopted Decision 2010/428/EU authorising the 
placing  on  the  market  of  products  containing,  consisting  of,  or  produced  from 
genetically  modified  maize 
(DAS-59122-7xDAS-
Ø15Ø7xMON-ØØ6Ø3-6); 

59122x1507xNK603 

•  On 28 July 2010 the Commission adopted Decision 2010/429/EU authorising the 
placing  on  the  market  of  products  containing,  consisting  of,  or  produced  from 
genetically  modified  maize  MON  88017  x  MON  810  (MON-88Ø17-3  x  MON-
ØØ81Ø-6); 

•  On 28 July 2010 the Commission adopted Decision 2010/420/EU authorising the 
placing  on  the  market  of  products  containing,  consisting  of,  or  produced  from 
genetically modified maize MON89034xNK603 (MON-89Ø34-3xMON-ØØ6Ø3-
6); 

•  On 28 July 2010 the Commission adopted Decision 2010/426/EU authorising the 
placing  on  the  market  of  products  containing,  consisting  of,  or  produced  from 
genetically modified maize Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9). 

Authorisations  were  granted  to  the  following  GM  for  cultivation  complying  with  all  the 
conditions set out in the basic legislation: 

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•  On 2 March 2010 the Commission adopted Decision 2010/135/EU authorising the 
placing on the market of a potato product (Solanum tuberosum L. line EH92-527-
1)  genetically  modified  for  enhanced  content  of  the  amylopectin  component  of 
starch. 

•  The  Commission  monitored  the  situation  as  regards  the  risk  of  non-authorised 
GM food and feed in products imported from third countries being placed on the 
EU  market.  This  was  in  particular  the  case  concerning  emergency  measures 
regarding the presence of the unauthorised genetically modified organism Bt 63 in 
rice  products  coming  from  China  and  regarding  the  non-authorised  genetically 
modified  organism  LL  RICE  601  in  rice  products  originating  from  the  United 
States  for  which  an  emergency  withdrawal  measure  was  adopted.  In  addition,  a 
protocol  of  sampling  and  testing  on  linseed  has  been  agreed  with  the  Canadian 
authorities in order to prevent the import of the non authorised linseed FP 967 and 
its functioning has been audited by FVO inspections to Canada. 

15.4.3.3. Evaluation based on the current situation 

The  Commission  launched  in  June  2009  two  evaluations  in  parallel,  one  on  genetically 
modified food and feed and one on the cultivation of GMOs, with a view to assess to what 
extent the EU legislative framework and its objectives in this sector are still in line with the 
needs of EU society. 

The  primary  objective  of  these  evaluations  is  to  assess  the  implementation  of  the  major 
aspects of the legislative framework and to present possible policy options. 

Both evaluations have been concluded in 2010 and the results will be assessed in 2011. 

15.4.3.4. Priorities and planned action 

Priorities 

On 13 July 2010 the Commission proposed to confer to Member States the freedom to allow, 
restrict  or  ban  the  cultivation  of  GMOs  on  part  or  all  of  their  territory.  While  keeping 
unchanged the EU's science-based GM authorisation system, the proposed package consists of 
a  Communication,  a  new  Recommendation  on  the  co-existence  of  GM  crops  with 
conventional  and/or  organic  crops,  and  a  draft  Regulation  proposing  a  change  to  the  GMO 
legislation.  The  new  Recommendation  on  co-existence  allows  more  flexibility  to  Member 
States  taking  into  account  their  local,  regional  and  national  conditions  when  adopting  co-
existence measures. The proposed regulation amends Directive 2001/18/EC to allow Member 
States to restrict or prohibit the cultivation of GMOs in their territory. 

The  priority  for  2011  is  to  obtain  the  endorsement  by  the  European  Parliament  and  the 
Council of the draft Regulation. 

Additionally,  the  Commission  drafted  and  presented  to  the  Member  States,  with  a  view  for 
adoption  in  2011,  a  Commission  proposal  for  a  Regulation  which  would  harmonise  the 
methods of sampling and analysis for the official control of feed as regards presence of GMOs 
for which an authorisation procedure is pending ("Low Level Presence" proposal – LLP). 

Another  priority  is  the  adoption  of  the  report  on  socio-economic  implications  of  the 

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cultivation of GMOs. The report will be transmitted to Council and Parliament in 2011. 

Planned action 

The Commission will continue to decide on applications for authorisations of GMOs for food 
and feed and cultivation and with the implementation of the current legislative framework. 

The guidelines on GM food and feed have reached an advanced stage and will be presented 
for adoption to the Member States representatives in 2011. 

Discussion  with  the  Member  States  on  the  updated  guidance  on  the  Environmental  Risk 
Assessment  (ERA)  of  GMOs,  as  published  by  EFSA  on  12  November,  will  take  place  in 
2011, in order to allow the Member States to take greater ownership of the scientific content 
and data requirements in this regard. 

15.4.3.5. Summary 

As an overview, in 2010, some key authorisation decisions have been treated as expeditiously 
as  allowed  by  procedures.  A  draft  text  on  LLP  has  been  completed  and  presented  to  the 
Member States whilst the cultivation package as adopted by the Commission and presented to 
both the European Parliament and Council is currently under discussion. The evaluation of the 
legislation has been completed and the results will be assessed in 2011. The ERA guidelines 
will be discussed with the Member States in 2011 whereas the guidelines for GM food and 
feed  will  be  presented  for  adoption  in  2011.  Finally,  the  report  on  socio-economic 
implications of the cultivation of GMOs will be transmitted to Council and Parliament at the 
beginning of 2011. 

Food hygiene 

15.4.3.6. Rapid Alert System for Feed and Food 

The Rapid Alert System established by Regulation (EC) No 178/2002 (Article 50) is a tool for 
exchange of information between competent authorities on consignments of food and feed in 
cases where a risk to human health has been identified and measures have been taken, such as 
withholding, recalling, seizure or rejection of the products concerned. This quick exchange of 
information allows all Member States to verify immediately whether they are also affected by 
the problem. Whenever the product is already on the market and should not be consumed, the 
Member States' authorities are then in a position to take all urgent measures, including giving 
direct information to the public, if necessary. 

A  Commission  Regulation  implementing  Article  50  of  Regulation  (EC)  No  178/2002  is 
scheduled for adoption in 2011. These measures concern in particular the specific conditions 
and procedures applicable to the transmission of notifications and supplementary information. 
This  Regulation  was  discussed  with  the  Member  States  and  the  stakeholders  before  its 
adoption. 

15.4.3.7. Food hygiene legislation 

The  EU  Food  "Hygiene  package"  is  composed  of  three  Regulations  consolidating,  updating 
and simplifying the EU legislation on food hygiene: 

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•  Regulation (EC) No 852/2004 of the European Parliament and of the Council on 

the hygiene of foodstuffs; 

•  Regulation  (EC)  No  853/2004  of  the  European  Parliament  and  of  the  Council 

laying down specific hygiene rules for food of animal origin; and 

•  Regulation  (EC)  No  854/2004  of  the  European  Parliament  and  of  the  Council 
laying down specific rules for the organisation of official controls on products of 
animal origin intended for human consumption. 

Those  rules  are  based  on  the  principles  of  a  risk-based  approach  to  a  comprehensive  and 
integrated food chain and the separation of responsibilities of food business operators and the 
competent authorities. Food business operators are primarily responsible for the (food) safety 
of their products. 

•  Flexibility:  the  new  rules  incorporated  the  principle  of  flexibility  that  enables 
inter alia the continued use of traditional methods of production, processing and 
distribution  of  food.  In  2010,  a  Commission  Staff  Working  Document  on  the 
Understanding  of  certain  provisions  on  flexibility  provided  in  the  Hygiene 
Package  was  presented  to  give  guidance  to  the  food  business  operators  and 
another  one  to  provide  guidance  to  the  competent  authorities  of  the  Member 
States.  The  aim  is  to  better  explain  the  possibilities  for  flexibility  so  they  are 
correctly used. 

•  Composite  products:  A  Regulation 

laying  down  requirements  for 

the 
certification  for  imports  into  and  transit  through  the  EU  of  certain  composite 
products  has  been  adopted  in  2010.  Regulation  (EC)  No  853/2004  provides  that 
food  business  operators  importing  food  containing  both  products  of  plant  origin 
and  processed  products  of  animal  origin  (composite  products)  are  to  ensure  that 
the  processed  products  of  animal  origin  contained  in  such  food  satisfy  certain 
public health requirements laid down therein. In addition, food business operators 
must  be  able  to  demonstrate  that  they  have  done  so,  for  example  through 
appropriate  documentation  or  certification.  The  application  of  such  measures 
would  have  presented  practical  difficulties  in  certain  cases.  Commission 
Regulation  (EC)  No  2076/2005  therefore  provided  a  transitional  measure 
derogating  from  that  obligation.  This  transitional  period  was  prolonged  until  31 
December 2013 by Regulation (EC) No 1162/2009. 

•  Mechanically  Separated  Meat  (MSM):  In  accordance  with  Article  9  of 
Regulation  (EC)  No  999/2001,  the  Commission  is  required  to  present  a 
communication  to  the  European  Parliament  and  the  Council  on  the  future 
necessity  and  use  of  MSM  in  the  EU,  including  the  information  policy  towards 
consumers.  On  2  December  2010,  the  Commission  adopted  a  Communication 
presenting an overview of the specific hygiene and labelling requirements in the 
EU legislation and their implementation, an overview of the production and use of 
MSM, information concerning the future necessity of production and use of MSM 
and  the  perception  of  consumers  concerning  the  use  of  MSM  and  the  preferred 
information policy from the side of consumers. 

•  Review of meat inspection: In the Council Conclusions on the Hygiene report of 

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20  November  2009,  the  Commission  has  been  requested  to  reflect  on  a  new 
approach  to  meat  inspection  taking  into  account  trends  of  hazards  over  the  last 
decades. The Commission organised on 18 May 2010 a first Round Table on meat 
inspection  with  all  relevant  parties  (Member  States  Authorities,  stakeholders, 
EFSA, international organisations (Codex) and representatives of third countries) 
to  review  the  effectiveness  of  current  sanitary  inspection  in  slaughterhouses. 
Sessions  were  included  on  current  provisions  on  meat  inspection,  the  risk-based 
approach and the international context. A second conference focussed on pig meat 
inspection was organised on 25 October 2010. 

•  Derogations  granted  to  Romania  and  Bulgaria:  In  order  to  give  certain 
establishments  in  Romania  and  Bulgaria  enough  time  to  adapt  to  the  EU  legal 
framework,  the  Commission  granted  them  derogation  from  certain  structural 
requirements  of  Regulations  (EC)  Nos  852/2004  and  853/2004.  Commission 
Decision 2010/89/EU lays down transitional measures concerning the application 
of  certain  structural  requirements  of  to  establishments  for  meat,  egg  products, 
fishery products and cold stores in Romania. Commission Decision 2009/861/EC, 
amended in 2010 by Commission Decision 2010/653/EU grants a derogation from 
Regulation  (EC)  No  853/2004  to  allow  the  processing  of  compliant  and  non-
compliant  milk  with  or  without  separate  production  lines.  As  long  as  these 
establishments  are  covered  by  transitional  measures,  products  originating  from 
them may only be placed on the domestic market. 

•  Biotoxins: The mouse bioassay is the official reference method for the detection 
of  certain  marine  biotoxins.  In  July  2006  the  Commission  requested  EFSA  to 
provide  a  scientific  opinion  to  assess  the  current  EU  limits  and  methods  of 
analysis with regard to human health for various marine biotoxins as established 
in EU legislation, including new emerging toxins. The last opinion was published 
on  24  July  2009.  EFSA  noted  that  this  bioassay  has  shortcomings  and  is  not 
considered an appropriate tool for control purposes because of the high variability 
in results, the insufficient detection capability and the limited specificity. Recently 
developed  alternatives  to  the  biological  methods  for  the  determination  of  the 
marine  biotoxins  have  successfully  been  tested  in  pre-validation  studies. 
Consequently,  Regulation  (EC)  No  15/2011  was  adopted  and  establishes  that  a 
technique such as liquid chromatography (LC) mass spectrometry (MS) should be 
applied as the reference method for the detection of lipophilic toxins and used as 
matter of routine, both for the purposes of official controls at any stage of the food 
chain and own-checks by food business operators. 

Following the report from the Commission to the Council and the European Parliament on the 
experience  gained  from  the  application  of  the  hygiene  Regulations,  adopted  in  2009,  the 
Commission will draft a proposal amending these Regulations. This will concern the review 
of meat inspection and revision of certain articles. The procedure will start in 2011 with the 
aim to achieve a result by 1 January 2014. 

15.4.3.8. Better training for Safer Food 

Regulation  (EC)  No  882/2004  provides  the  legal  base  for  the  initiative  "Better  Training  for 
Safer Food (BTSF)". It aims at training official safety control staff in the Member States and 
third countries on food, veterinary and plant health issues. This initiative keeps control staff 

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up  to  date  with  EU  rules  and  guarantee  uniform  and  efficient  controls.  This  helps  ensure 
respect for EU legislation and contribute to providing safer food and feed. 

In  2010,  120  events  gathering  6000  people  took  place  in  the  Member  States  and  in  third 
countries. 

In the Member States, the programme covered the following subjects: 

•  HACCP 

•  Animal By Products 

•  Food Hygiene and Control 

•  Animal Health Controls (Aquaculture) 

•  Animal Health Controls (bees and Exotic zoo animals) 

•  Plant Health Control 

•  BIPs Seaport/roads/rail 

•  Zoonoses and microbiological criteria 

•  Animal Welfare 

•  Plant Protection Products 

•  Feed law  

•  Food Contact Materials 

•  TSE  

•  Import controls of food of non-animal origin 

The third country programme concerned: 

•  RASFF/TRACES 

•  Avian Influenza 

•  EU food import standards 

•  GMO Analysis 

•  Food testing on SPS issues 

•  BTSF Africa 

In  2011,  130  events  will  be  organised  for  approximately  6300  participants.  The  2010 

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programmes will continue on: 

•  HACCP 

•  Animal By Products 

•  Food Hygiene and Control (3 modules) 

•  Animal Health Controls (Aquaculture) 

•  Animal Health Controls (bees/exotic zoo animals) 

•  Plant Health Control (2 modules) 

•  Feed Law 

•  Animal Welfare  

•  Plant Protection Products 

•  Veterinary/food safety controls in BIPs 

•  Prevention, control, eradication of TSE 

•  Microbiological criteria/zoonoses 

•  Controls on feed/food of non-animal origin 

New programmes will be launched on: 

•  Quality schemes (organic farming/geographical indications) 

•  TRACES 

•  Audit systems/internal auditing 

•  FVO Pool of EU inspectors 

15.4.4.  Transmissible spongiform encephalopathies  

Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of 
certain  transmissible  spongiform  encephalopathies.  The  success  of  the  EU's  efforts  in 
combating Transmissible Spongiform Encephalopathies (TSEs), such as Bovine Spongiform 
Encephalopathy (BSE) in cattle or scrapie in sheep and goats, allows the EU to contemplate 
changes in some of its rules. On 16 July 2010, the Commission adopted a Communication to 
the European Parliament and the Council, which outlines areas where future possible changes 
to  EU  TSE-related  measures  could  be  made.  The  document  "The  TSE  Road  Map  2  –  A 
strategy paper on Transmissible Spongiform Encephalopathies for 2010-2015" underlines that 
any amendment should maintain the EU's high level of protection of human and animal health 
and of food safety and should be backed up by solid science. The Road Map is a reflection 
paper that opens up dialogue on the issue. 

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15.4.5.  Food additives 

15.4.5.1. Current position 

General introduction presenting the legislation 

Council  Directive  89/107/EEC  on  the  approximation  of  the  laws  of  the  Member  States 
concerning  food  additives  authorised  for  use  in  foodstuffs  intended  for  human  consumption 
has been repealed by Regulation (EC) No 1333/2008 on food additives which applies since 20 
January 2010. 

The  new  regulation  required  a  review  of  all  current  additives  authorisations  for  their 
compliance  with  their  general  conditions  of  use  by  20  January  2011  and  transfer  of  these 
provisions in the Annex of this Regulation. Until that transfer was completed, the Annexes to 
Directives 94/35/EC, 94/36/EC and 95/2/EC continued to apply. In addition, powers to adopt 
implementing  measures  were  conferred  to  the  Commission  to  amend  the  annexes  to 
Directives  94/35/EC,  94/36/EC  and  95/2/EC  until  the  establishment  of  the  EU  list  of  food 
additives in the Annex of Regulation (EC) No 1333/2008. 

Regulation (EC) No 1333/2008 required furthermore the adoption of a programme for the re-
evaluation of food additives by 20 January 2010 and a regulation adopting specifications of 
the authorised food additives. It requires the establishment of new lists of food additives used 
in food additives, enzymes and nutrients (Annex III, parts 2, 3 and 5). 

Regulation (EC) No 1331/2008 established as well that a common authorisation procedure for 
food additives, food enzymes and food flavourings should be adopted by end 2010. 

Report of work done in 2010 

In 2010 the Commission adopted: 

•  Commission  Regulation  (EU)  No  257/2010  of  25  March  2010  setting  up  a 
programme  for  the  re-evaluation  of  approved  food  additives  in  accordance  with 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council on 
food additives. 

•  Commission Directive 2010/69/EU of 22 October 2010 amending the Annexes to 
European Parliament and Council Directive 95/2/EC on food additives other than 
colours and sweeteners. 

•  Commission  Directive  2010/37/EU  of  17  June  2010  amending  Directive 

2008/60/EC laying down specific purity criteria on sweeteners (neotame). 

•  Commission  Directive  2010/67/EU  of  20  October  2010  amending  Directive 
2008/84/EC  laying  down  specific  purity  criteria  on  food  additives  other  than 
colours and sweeteners. 

15.4.5.2. Evaluation based on the current situation 

In the framework of the regulatory procedure with scrutiny, the European Parliament adopted 
a  resolution  against  the  food  additives  which  required  a  re-submission  addressing  the 

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concerns of the resolution. This delayed however the adoption of all other parts of the text. In 
future, closer and earlier contacts with European Parliament and more specific drafts are to be 
prepared. 

The  adoption  of  an  implementing  measure  for  Regulation  (EC)  No  1331/2008  is  slightly 
delayed.  A  Commission  proposal  will  be  ready  for  vote  at  the  Standing  Committee  on  the 
Food Chain and Animal Health in 2011. 

The Commission Regulations establishing the Union lists of food additives and the regulation 
adopting specifications of the authorised food additives are in a final stage of preparation. The 
procedure for their adoption will be launched in 2011. 

15.4.5.3. Priorities and planned action 

Priorities 

The adoption of following acts is prioritised: 

Commission  Regulation 

1. 
implementing  Regulation  (EC)  No  1331/2008 
establishing a common authorisation procedure for food additives, food enzymes and 
food flavourings. 

2. 
Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 
of  the  European  Parliament  and  of  the  Council  on  food  additives  by  establishing  a 
Union list of food additives. 

Commission  Regulation  amending  Annex  III 

to  Regulation  (EC)  No 
3. 
1333/2008  of  the  European  Parliament  and  of  the  Council  on  food  additives  by 
establishing. a Union list of food additives approved for use in food additives, food 
enzymes, food flavourings and nutrients. 

Commission  Regulation  laying  down  specifications  of  the  approved  food 

4. 
additives. 

Commission Directive amending Directive 2008/128/EC laying down specific 

5. 
purity criteria concerning colours for use in foodstuffs (lycopene). 

Commission  Regulations  amending  the  Annexes  to  Regulation  (EC)  No 

6. 
1333/2008 of the European Parliament and of the Council on food additives. 

Planned actions 

Actions  1,  2,  3,  4  and  5  are  in  a  final  stage  and  will  be  presented  for  vote  at  the  Standing 
Committee during 2011, except for action 5, which is expected to be adopted in January 2011.  

The Commission Regulations amending the Annexes to Regulation (EC) No 1333/2008, will 
be  presented  for  vote  at  the  Standing  Committee  during  the  second  half  of  2011  following 
consultation with Member State experts and stakeholders, and the Union list of food additives 
needs to be established first. 

15.4.5.4. Summary of food additives 

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The  application  of  the  EU  law  in  the  area  of  food  additives  is  ongoing  as  planned.  The 
adoption of the Commission regulations establishing the Union lists of food additives during 
the  first  half  2011  will  receive  highest  priority.  The  Commission  Regulation  on  an 
implementing measure for Regulation (EC) No 1331/2008 will allow an efficient management 
of the Union lists. Amendments to these lists will be necessary to take into account possible 
safety concern raised in the opinions of EFSA and to allow authorisations of new additives. 

15.4.6.  Food enzymes 

15.4.6.1. Current Situation 

General introduction presenting the legislation 

The new Regulation (EC) No 1332/2008 on food enzymes harmonises for the first time the 
use of food enzymes, both as food additives and processing aids. 

This  Regulation  has  already  entered  into  force,  with  the  exception  of  Article  4  which  shall 
apply from the date of application of the Union list. 

The Union list of food enzymes shall be drawn up on the basis of applications made pursuant 
to the requirements of Article 17 of the above Regulation. The deadline for submitting such 
applications  from  interested  parties  is  24  months  after  the  date  of  applications  of  the 
implementing measures to be laid down in accordance with Article 9(1) of Regulation (EC) 
No 1331/2008. 

The Commission shall establish a Register of all food enzymes to be considered for inclusion 
in the Union list in respect of which an application complying with the validity criteria laid 
down  in  the  implementing  measure  has  been  submitted  following  the  requirements  of 
Regulation on food enzymes. 

The establishment of the Union list will take place in a single step procedure after the EFSA 
has  expressed  opinions  on  all  products  for  which  sufficient  information  has  been  submitted 
during the 24-month period. This is, however, a lengthy process which will take several years. 

Report of work done in 2010 

When drafting Regulation on implementing measure which concerns the content, drafting and 
presentation of the applications to update the Union lists on food additives, food enzymes and 
flavourings,  the  arrangements  for  checking  the  validity  of  applications  and  the  type  of 
information  that  must  be  included  in  the  opinion  of  the  EFSA,  a  number  of  meetings  have 
taken place with Member States experts and with stakeholders. EFSA was also consulted. The 
Commission is currently finalising this implementing measure which should be adopted in the 
first half of 2011. 

As far as food enzymes are concerned, a couple of trial dossiers were submitted in April and 
July  2010  by  the  Association  of  Manufacturers  and  Formulators  of  Enzyme  Products 
(AMFEP)  to  the  Panel  on  food  contact  materials,  enzymes,  flavourings  and  processing  aids 
(CEF Panel) to be tested under the published guidelines. This is a simulated evaluation to give 
indications to EFSA about the type of dossiers that they will get and info to applicants on how 
to  prepare  the  application,  notably  concerning  grouping  of  dossiers.  As  a  result  of  this 
exercise, which has taken place in December 2010, EFSA will update its guidelines with more 

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practical advice. 

15.4.6.2. Evaluation based on the current situation 

It is not yet possible to fully appreciate the enforcement of Regulation (EC) No 1332/2008. 
However, significant improvements are expected (in particular by food businesses) from the 
simplification of the legislative framework. 

15.4.6.3. Priorities and planned action 

Priorities 

The Regulation on implementing measure was planned to be adopted in the first half of 2011 
and  a  number  of  applications  were  expected  to  be  submitted  from  interested  parties  to  the 
Commission.  A  data  base  for  food  enzymes  will  be  established  in  order  to  handle  these 
applications. This database will be used for establishing a Register of all food enzymes which 
will be made available to the public. This Register will be established in 2012. 

Planned action 

The Commission is responsible for verifying whether an application falls within the scope of 
the  enzyme  Regulation  and  whether  an  application  is  valid.  Once  the  application  is  valid  it 
will be submitted to EFSA for its risk assessment. 

Meetings  with  Member  States,  stakeholders  and  EFSA  are  also  foreseen  during  2011  to 
follow the requirements of this set of legislation. 

15.4.6.4. Summary 

Although there is a new Regulation on food enzymes which harmonises for the first time the 
use of food enzymes it is not yet possible to fully appreciate the enforcement of this provision.  

An important number of dossiers are expected to be submitted in the two-year initial period of 
submission which will start at the date of application of the implementing measures. A couple 
of trial dossiers have been tested by the CEF panel and a new database will be established. 

15.4.7.  Food flavourings 

15.4.7.1. Current position 

General introduction presenting the legislation 

The general framework for food flavourings in the EU was established by Council Directive 
88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating 
to flavourings for use in foodstuffs and to source materials for their production. This Directive 
lays down general requirements for safe use of flavourings in food and provides definitions 
for  different  types  of  flavourings.  It  also  establishes  maximum  levels  for  certain  substances 
that are naturally present in flavourings and in food ingredients with flavouring properties, but 
which may raise concern for human health. 

Commission  Directive  91/71/EEC  of  16  January  1991  completing  Council  Directive 

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88/388/EEC sets out labelling rules on flavourings. 

It  was  necessary  to  update  these  Directives  in  the  light  of  technical  and  scientific 
developments.  Therefore,  the  Commission  proposed  on  28  July  2006  a  new  Regulation  on 
flavourings and certain food ingredients with flavouring properties. 

The  new  Regulation  (EC)  No  1334/2008  on  flavourings  and  certain  food  ingredients  with 
flavouring properties for use in and on foods was adopted on 16 December 2008. It repealed 
Council  Directive  88/388/EEC  and  Commission  Directive  91/71/EEC  as  from  20  January 
2011. 

Similar to the previous legislation, the Regulation lays down general requirements for safe use 
of flavourings and provides definitions for different types of flavourings. The Regulation sets 
out  flavourings  and  source  materials  for  which  an  evaluation  and  approval  is  required.  The 
Regulation  prohibits  the  addition  of  certain  substances  as  such  to  food  and  lays  down 
maximum levels for certain substances, which are naturally present in flavourings and in food 
ingredients with flavourings properties, but which may raise concern for human health. The 
Regulation also sets out the rules for labelling of flavourings from business to business and 
for sale to the final consumers. It also describes the specific requirements for use of the term 
"natural". 

Currently,  Regulation  (EC)  No  2232/96  sets  out  the  basic  rules  for  the  use  of  flavouring 
substances in or on foodstuffs and lays down a procedure for the establishment of an EU list 
of flavouring substances. The Regulation will become obsolete after the establishment of the 
EU  list  provided  for  in  Regulation  (EC)  No  1334/2008,  when  only  those  flavouring 
substances listed will be allowed to be added to foods. 

The  European  Parliament  and  the  Council  Regulation  (EC)  No  2065/2003  on  smoke 
flavourings used or intended for use in or on foods establishes an EU procedure for the safety 
assessment  and  the  authorisation  of  smoke  flavourings  in  order  to  ensure  a  high  level  of 
protection  of  human  health  and  protection  of  consumers'  interests,  as  well  as  to  ensure  fair 
trade practices. 

In addition, a separate Regulation (EC) No 1331/2008 establishes an effective, expedient and 
transparent  common  authorisation  procedure  for  food  additives,  food  enzymes  and  food 
flavourings. 

Report of work done in 2010 

Several working group meetings were organised with the governmental experts on flavourings 
to discuss the EU list on flavouring substances (around 2600 substances). The list will form 
part of the Regulation (EC) No1334/2008 and was scheduled to be adopted in the by the end 
of  the  year.  However,  the  evaluations  of  flavouring  substances  by  EFSA  is  still  on-going, 
therefore, no list could be adopted yet. 

The EU list on smoke flavourings was discussed twice in the Standing Committee on Food 
Chain  and  Animal  health,  in  several  working  group  meetings  of  governmental  experts  on 
flavourings and with the stakeholders in the working group if the Advisory Group on the Food 
Chain,  Animal  and  Plant  Health.  However,  no  conclusion  on  the  authorised  substances  was 
reached so far. 

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15.4.7.2. Evaluation results based on the current situation 

The  use  of  flavourings  continues  to  be  regulated  by  general  requirements  laid  down  in  the 
framework  measures.  The  use  of  flavourings  substances  is  not  yet  harmonised  in  the  EU. 
Those smoke flavouring primary products for which a valid application was submitted by 30 
June 2005 in accordance with Regulation (EC) No 2065/2003 and for which applications have 
not been withdrawn, continue to be traded in and used. 

15.4.7.3. Priorities and planned action 

Priorities 

Priority for 2011 is to adopt the EU list of flavourings substances and the EU list on smoke 
flavouring primary products. 

Planned action 

Although  the  evaluations  of  flavourings  substance  are  on-going,  the  work  on  the  EU  list  of 
flavouring substances will continue and the intention is to establish the list in the first half of 
2011. 

The EU list of smoke flavouring primary products was expected to be established in the first 
half of 2011 as EFSA was reviewing new scientific data in 2011 related to already evaluated 
smoke flavourings. 

15.4.7.4. Summary by sector 

The  new  framework  Regulation  applies  from  20  January  2011.  New  rules,  for  example  on 
categorising flavourings, on the labelling and on the maximum levels for certain substances, 
which are naturally present in flavourings and in food ingredients with flavourings properties, 
will  apply.  Work  is  on-going  to  harmonise  the  use  of  flavouring  substances  and  smoke 
flavouring primary products in the EU.  

15.4.8.  Residues of veterinary medicinal products 

15.4.8.1. Current position 

General introduction presenting the legislation 

During their lifetime animals may have to be treated with medicines for prevention or cure of 
diseases.  In  food  producing  animals  such  as  cattle,  pigs,  poultry  and  fish  this  may  lead  to 
residues  of  the  substances  used  for  the  treatment  in  the  food  products  derived  from  these 
animals (e.g. meat, milk, eggs). The residues should not however be harmful to the consumer. 

EU legislation requires that the toxicity of potential residues is evaluated before the use of a 
medicinal  substance  in  food  producing  animals  is  authorised.  If  considered  necessary, 
maximum  residue  limits  (MRLs)  are  established  and  in  some  cases  the  use  of  the  relevant 
substance is prohibited. The evaluation procedure is laid out in Regulation (EC) No 470/2009 
of  6  May  2009.  This  Regulation  also  sets  out  procedures  to  establish  and  review  reference 
points for action (RPAs) to be used in case residues of non authorised substances are detected. 
Such  RPAs  are  currently  established  by  Commission  Decision  2005/34/EC.  Finally,  due  to 

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the  health  risks  for  consumers,  the  use  of  certain  groups  of  veterinary  medicinal  products 
(such  as  substances  having  a  hormonal  or  thyrostatic  action  and  beta-agonists)  in 
stockfarming is banned by Directive 96/22/EC. 

To  guarantee  a  high  level  of  consumer  protection,  an  EU-wide  monitoring  of  certain 
substances and residues is implemented by the Member States. Provisions on frequencies and 
level  of  sampling,  groups  of  substances  to  be  controlled  for  each  food  commodity,  drafting 
and approval of annual national residue monitoring plans (NRCPs) are laid down in Directive 
96/23/EC  and  Commission  Decision  97/747/EC.  The  principal  objective  of  Directive 
96/23/EC  is  to  detect  illegal  use  of  substances  in  animal  production  and  the  misuse  of 
authorised  veterinary  medicinal  products  and  to  ensure  the  implementation  of  appropriate 
actions to minimise recurrence of all such residues in food of animal origin. Detailed rules for 
official sampling procedures and official treatment of samples until they reach the laboratory 
responsible  for  analysis  are  laid  down  in  Commission  Decision  98/179/EC.  Laboratory 
accreditation  and  validation  of  methods  used  is  established  in  Commission  Decision 
2002/657/EC. 

Residue monitoring requirements for third countries wishing to export food of animal origin 
to the EU are outlined in Directive 96/23/EC: such third countries must submit a plan setting 
out  the  guarantees  which  it  offers  as  regards  the  monitoring  of  the  groups  of  residues  and 
substances. The guarantees must have an effect at least equivalent to those provided for in the 
Directive for Member States. 

Report of work done in 2010 

The  annual  approval  of  the  NRCPs  of  the  Member  States  and  third  countries  assures  a 
uniform  basis  for  residue  monitoring  in  the  EU  and  provides  for  the  necessary  guarantees 
regarding residues of veterinary medicinal products in food of animal origin, both produced in 
the  EU  and  imported  from  third  countries.  The  drafting  of  the  annual  report  on  the  residue 
monitoring  exercise  of  the  previous  year,  based  on  more  than  750.000  analytical  results, 
consolidates the efforts regarding residue monitoring within the EU. Finally, the shortcomings 
detected during the FVO missions carried out both in Member States and third countries are 
closely monitored. 

Several topics related to residue monitoring were discussed during working group meetings: 
accreditation  of  laboratories  and  validation  of  methods,  interpretation  of  results,  control 
measure to apply in case of non compliance. The future steps in residue monitoring, including 
control  measures,  reduction  of  administrative  burden,  new  implementing  measures  were 
presented to the Member States. 

15.4.8.2. Evaluation based on the current situation 

The current legal framework related to residues of veterinary medicinal products seems to be 
achieving its goals through correct enforcement. No complaints have been received regarding 
the bad application of the relevant legislation by the Member States. 

15.4.8.3. Priorities and planned action 

Priorities 

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The administrative procedure laid down in Directive 96/23/EC in relation to the approval of 
the NRCPs is rather heavy and the outcome offers little flexibility to adapt the NRCPs, once 
approved,  in  a  risk  based  manner  to  changes  in  risk  profile.  Reporting  on  monitoring  is 
limited  to  compliance/non-compliance  and  follow-up  measures  on  non-compliant  samples. 
Data  concerning  residues  below  MRLs  available  at  Member  State  level  are  not  available  at 
EU  level,  reducing  information  related  to  the  percentage  of  animals  treated  and  consumer 
exposure. 

Since Regulation (EC) No 470/2009 now offers the necessary legal basis, priorities regarding 
control  measures  will  relate  to  residues  following  cascade  use  (use  in  non  target  species, 
defined in Directive 2001/82/EC) and residues of non authorised substances. Regarding this 
last  issue,  it  is  important  to  clarify  how  the  existing  RPAs  under  Commission  Decision 
2005/34/EC relate to the provisions in Regulation (EC) No 470/2009. 

Planned action 

The  general  objectives  of  the  review  of  Directive  96/23/EC  are  the  optimisation  and 
simplification of the overall legislative framework, the consistency with Regulation (EC) No 
882/2004  allowing  for  the  introduction  of  risks  assessment  criteria  and  an  increased 
flexibility.  This  review  will  be  continued  starting  with  the  impact  assessment  with  the 
involvement of Member States and other stakeholders. 

On  the  establishment  and  review  of  RPAs,  a  mandate  will  be  sent  to  EFSA  to  request  and 
opinion on scientific methods and methodological principles to be taken into account in this 
context. Following discussion with the Member States, the Opinion will be used as a basis for 
the  implementing  measures.  The  next  step  will  include  the  transfer  (including  possible 
review) of the existing RPAs to this new implementing measure. In parallel, the actions to be 
taken in case of repeated confirmed presence below RPA and the MRLs to be considered for 
control  purposes  for  foodstuffs  derived  from  animals  which  have  been  treated  under  the 
cascade system will be discussed at working group level. 

15.4.8.4. Summary by sector 

The legislative framework on monitoring of residues of veterinary medicinal products in food 
of animal origin is effective but the administrative burden is high, both for the Commission 
and the Member States. 

Possibilities for implementing measures laid down in Regulation 470/2009 relating to control 
issues will be fully explored in the near future. 

15.4.9.  Contaminants in food 

15.4.9.1. Current position 

General introduction presenting the legislation 

The EU harmonisation of legislation on contaminants in food fulfils two essential objectives: 
the protection of public health and the removal of internal barriers to trade. 

Council  Regulation  (EEC)  No  315/93  of  8  February  1993,  laying  down  community 
procedures  for  contaminants  in  food,  constitutes  the  framework  for  the  EU  action  on 

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contaminants. 

The Regulation provides that: 

•  Food  containing  a  contaminant  in  an  amount  which  is  unacceptable  from  the 

public health viewpoint shall not be placed on the market; 

•  Contaminant  levels  shall  be  kept  as  low  as  can  reasonably  be  achieved  by 

following good practices at all stages of the production chain; 

•  In order to protect public health, maximum levels for specific contaminants shall 

be established where necessary (by comitology); and  

•  The  consultation  of  EFSA  for  all  provisions  which  may  have  an  effect  upon 

public health is mandatory. 

Based on this framework Regulation, maximum levels for the following specific contaminants 
in  foodstuffs  have  been  established  by  Commission  Regulation  (EC)  No  1881/2006  of  19 
December  2006;  such  as  nitrate,  aflatoxins,  ochratoxin  A,  fusarium-toxins,  and  patulin 
(mycotoxins);  lead,  cadmium,  mercury  (heavy  metals);  dioxins  and  PCBs;  3-MCPD; 
inorganic tin; benzo(a)pyrene (as marker substance for the group of PAH). 

In  addition,  several  Regulations  have  been  adopted  containing  provisions  as  regards  the 
sampling and methods of analysis to be used for official control of the compliance with the 
maximum  levels  established  on  contaminants,  in  order  to  ensure  a  harmonised  enforcement 
approach: 

•  Commission  Regulation (EC) No  1882/2006  of  19  December  2006  laying  down 
methods of sampling and analysis for the official control of the levels of nitrates 
in certain foodstuffs; 

•  Commission  Regulation (EC) No  1883/2006  of  19  December  2006  laying  down 
methods of sampling and analysis for the official control of the levels of dioxins 
and dioxin-like PCBs in certain foodstuffs; 

•  Commission  Regulation  (EC)  No  401/2006  of  23  February  2006  laying  down 
methods  of  sampling  and  analysis  for  the  official  control  of  the  levels  of 
mycotoxins in foodstuffs; 

•  Commission  Regulation  (EC)  No  333/2007  of  28  March  2007  laying  down 
methods  of  sampling  and  analysis  for  the  official  control  of  the  levels  of  lead, 
cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. 

Following safeguard measures as regards mineral oil, melamine and aflatoxins are in place: 

•  Commission  Regulation  (EC)  No  1135/2009  of  25  November  2009  imposing 
special  conditions  governing  the  import  of  products  originating  in  or  consigned 
from China, and repealing Commission Decision 2008/798/EC. 

•  Commission  Regulation  (EC)  No  1151/2009  of  27  November  2009  imposing 
special  conditions  governing  the  import  of  sunflower  oil  originating  in  or 

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consigned from Ukraine due to contamination risks by mineral oil and repealing 
Decision 2008/433/EC. 

•  Commission  Regulation  (EC)  No  1152/2009  of  27  November  2009  imposing 
special  conditions  governing  the  import  of  certain  foodstuffs  from  certain  third 
countries  due  to  contamination  risk  by  aflatoxins  and  repealing  Decision 
2006/504/EC. 

Report of work done in 2010 

The  provisions  on  maximum  levels  and  sampling  for  aflatoxins  in  food  were  updated, 
including the  alignment of EU legislation with Codex decisions as regards maximum levels 
and  sampling  for  aflatoxins  in  almonds,  hazelnuts  and  pistachios  (Commission  Regulation 
(EU)  No  165/2010  of  26  February  2010  amending  Regulation  (EC)  No  1881/2006  setting 
maximum levels for certain contaminants in foodstuffs as regards aflatoxins and Commission 
Regulation (EU) No 178/2010 of 2 March 2010 amending Regulation (EC) No 401/2006 as 
regards  groundnuts  (peanuts),  other  oilseeds,  tree  nuts,  apricot  kernels,  liquorice  and 
vegetable oil). 

Taking  into  account  the  outcome  of  EFSA  scientific  opinion  on  ochratoxin  A  in  food,  new 
provisions  on  maximum  levels  for  ochratoxin  A  in  spices  and  liquorice  were  adopted 
(Commission Regulation (EU) No 105/2010 of 5 February 2010 amending Regulation (EC) 
No  1881/2006  setting  maximum  levels  for  certain  contaminants  in  foodstuffs  as  regards 
ochratoxin A). 

An amendment of Regulation (EC) No. 1881/2006 containing clarifications and updates of the 
existing provisions (e.g. with regard to the portion to be analysed for cadmium in crabs), was 
finalised  in  2010.  Adoption  and  entry  into  force  is  foreseen  for  2011.  Additionally,  an 
Information  Note  containing  guidance  for  national  authorities  to  issue  consumer  advice  on 
cadmium  in  crabs,  was  prepared  and  will  be  put  on  the  Directorate-General  Health  and 
Consumers' webpage when the Regulation enters into force. 

Following  the  outcome  of  the  FVO  inspection  mission  in  October  2009,  Commission 
Regulation (EU) 258/2010 of 25 March 2010 imposing special conditions on the imports of 
guar  gum  originating  in  or  consigned  from  India  due  to  contamination  risks  by 
pentachlorophenol and dioxins, and repealing Decision 2008/352/EC, was adopted. 

Two  recommendations  on  acrylamide  were  finalised  in  2010.  The  first,  a  recommendation 
extending  the  existing  monitoring  programme,  was  adopted  early  2010.  The  second,  a 
recommendation  for  Member  States  to  carry  out  further  investigations  on  acrylamide,  was 
finalised at the end of 2010, and adoption was planned for 2011. 

Data  is  being  collected  on  a  number  of  other  contaminants,  such  as  brominated  flame 
retardants 
furan,  ethylcarbamate, 
perfluorooctane sulfonates/acids (PFOS/A). 

(polybrominated  diphenyl  ethers 

(PBDE’s)  etc), 

15.4.9.2. Evaluation based on the current situation 

Much  attention  is  paid  to  the  effective  and  uniform  enforcement  of  the  legislation  on 
contaminants and of related safeguard measures. Consideration is given to enforcement issues 
from  the  very  first  stages  of  the  discussions  on  new  measures,  in  order  to  ensure  optimal 

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uniform enforcement across the EU. 

Enforcement issues are discussed in the Standing Committee on the Food Chain and Animal 
Health  and  in  relevant  expert  groups  thereof.  These  discussions  result  in  some  cases  in 
guidance documents for the control of the legislation, publicly available and published on the 
Directorate-General Health and Consumers' web pages: 

•  Guidance document for competent authorities for the control of compliance with 

EU legislation on aflatoxins507 (available in all EU languages); 

•  Guidelines  for  the  enforcement  of  provisions  on  dioxins  in  the  event  of  non-

compliance with the maximum levels for dioxins in food508; 

•  Guidance on sampling of whole fishes of different size and/or weight509; 

•  Report  on  the  relationship  between  analytical  results,  measurement  uncertainty, 
recovery  factors  and  the  provisions  of  EU  food  and  feed  legislation,  with 
particular reference to the contaminants legislation510. 

15.4.9.3. Priorities and planned action 

Initiatives  for  possible  changes  to  the  contaminant  legislation  include  the  development  of 
proposals to limit the presence in food of other contaminants (T-2 toxin, HT-2 toxin, arsenic 
and  PCBs)  and  to  review  some  existing  provisions  (heavy  metals,  polycyclic  aromatic 
hydrocarbons  (PAHs)  and  dioxins).  Alongside  the  review  of  maximum  levels  for  PAHs, 
Regulation (EC) No 333/2007 laying down methods of sampling and analysis for the official 
control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene 
in foodstuffs, will be amended to reflect the changes in legislation. 

In  the  contaminants  area  new  and  emerging  risks  are  difficult  to  predict,  but  require 
continuous attention to protect public health. 

15.4.9.4. Summary by sector 

Existing maximum levels for contaminants are continuously reviewed and updated in the light 
of new scientific evidence and technological progress. New maximum levels are established 
where  this  is  necessary  to  protect  public  health.  Furthermore,  much  attention  is  paid  to  the 
effective and uniform enforcement of the legislation on contaminants and of related safeguard 
measures. 

507 
508 
509 

510 

http://ec.europa.eu/food/food/chemicalsafety/contaminants/aflatoxin_guidance0309_en.pdf 
http://ec.europa.eu/food/food/chemicalsafety/contaminants/guidelines-july_2004_en.pdf 
http://ec.europa.eu/food/food/chemicalsafety/contaminants/guidance-sampling%20-whole-fish-
with%20exemples-dec2006.pdf 
http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf 

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15.4.10. Plant Protection Products – Pesticide Residues 

15.4.10.1. 

Current position 

The  legislation  in  this  area  regulates  the  placing  on  the  market  and  use  of  plant  protection 
products (Directive 91/414/EEC and Regulation (EC) No 1107/2009), the sustainable use of 
pesticides  (Directive  2009/128/EC)  and  the  maximum  residue  levels  (MRLs)  of  pesticides 
that can be found in or on food and feed (Regulation (EC) No 396/2005). 

The evaluation, marketing and use of plant protection products in the EU are regulated under 
Council Directive 91/414/EEC. This Directive lays out a comprehensive risk assessment and 
authorisation procedure for active substances and products containing these substances. Each 
active  substance  has  to  be  proven  safe  in  terms  of  human  health,  including  residues  in  the 
food chain, animal health and the environment, in order to be allowed to be marketed. It is the 
responsibility of industry to provide the data showing that a substance can be used safely with 
respect to human health and the environment. 

The  rules  for  the  placing  on  the  market  and  use  of  plant  protection  products  provide  that 
persons or companies wishing to secure the inclusion of active substances in the positive list 
of  Annex  I  of  Directive  91/414/EEC,  submit  by  a  certain  date  a  dossier  meeting  the 
requirements  of  the  Directive  in  order  to  demonstrate  that  it  may  be  expected  that  plant 
protection  products  containing  those  active  substances  are  sufficiently  safe  for  human  or 
animal health or for the environment. 

In  2010  the  Commission's  activity  in  this  area  was  mainly  focussed  on  active  substances 
previously not included in Annex I of Directive 91/414/EEC and for which a new dossier was 
re-submitted.  18  Commission  proposals  were  finalised  in  2010.  This  work  will  continue  in 
2011,  when  some  60  active  substances  will  have  to  be  evaluated  by  the  Commission.  In 
addition, several other decisions were taken for 1) the approval or renewal of the approval for 
12  active  substances;  2)  the  amendment  of  the  conditions  for  approval  of  15  substances, 
including new provisions to protect honeybees for certain insecticides; 3) the establishment of 
a work programme in view of the future renewal of 31 active substances. 

In  2010  the  Commission  started  working  on  the  implementation  of  Regulation  (EC)  No 
1107/2009 concerning the placing of plant protection products on the market. This Regulation 
will enter into force in June 2011 and will repeal  Council Directive 91/414/EEC.  The work 
carried  out  in  2010  was  mainly  devoted  to  the  creation  of  the  conditions  for  the  correct 
implementation of the authorisation system in 3 zones (zonal system) and to the transfer of the 
existing data requirements under Directive 91/414/EEC into Regulation (EC) No 1107/2009. 

As regards Regulation (EC) No 396/2005, in 2010 the Commission adopted 5 Regulations to 
set  several  new  maximum  residue  levels  (MRLs),  following  the  EFSA  evaluation  of  new 
MRLs applications by manufacturers, as well as third countries. The Commission finalised 4 
other proposals for Regulations expected to be published in the first half of 2011, including a 
proposal to reduce the MRLs of 13 pesticides no longer approved in the EU. In addition, the 
Commission  also  adopted  a  Regulation  to  amend  the  list  of  commodities  to  which  MRLs 
apply  (Reg.  (EU)  No  600/2010),  and  a  Regulation  on  a  coordinated  multi-annual  control 
programme of the EU on pesticide residues (Reg. (EU) 915/2010). 

15.4.10.2. 

Evaluation based on the current situation  

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Although this policy area is characterised by complex technical issues, the enforcement of the 
legislation seems to be adequate.  

As regards the new Regulation on the placing on the market of plant protection products and 
the  Directive  on  the  sustainable  use  of  pesticides,  it  will  not  be  possible  to  appreciate  the 
situation comprehensively until the legislation is fully applicable and implementing measures 
have been in force for some time. 

The  implementation  of  Regulation  (EC)  No  396/2005,  which  since  September  2008 
harmonises the setting of MRLs in the EU, resulted in significant improvements (in particular 
for  food  business  operators)  due  the  simplification  of  the  regulatory  system  and  to  the 
removal of national MRLs. However, this area needs to be further improved, with particular 
regard  to  the  time  needed  from  the  submission  of  an  application  from  a  third  party  to  the 
publication  of  the  MRLs  in  the  EU  Official  Journal.  Furthermore,  the  provisions  of  this 
Regulation  need  also  to  be  aligned  to  the  timelines  and  procedures  of  Regulation  (EC)  No 
1107/2009. 

Commission Decisions not to include active substances in the positive list of active substances 
that may be used in plant protection products (Annex I of Directive 91/414/EEC) are regularly 
challenged before the Court. As in 2009, the General Court and the Court of Justice continued 
in 2010 to dismiss such applications511. In addition, one case was withdrawn from the Court. 
Those  judgments  confirm  the  correct  application  by  the  Commission  of  EU  law  when 
assessing and deciding on active substances. 

15.4.10.3. 

Priorities and planned action 

In 2011 the Commission's activity will be aimed mainly at the implementation of Regulation 
(EC) No 1107/2009 and of Directive 2009/128/EC. This will include, among other things, the 
adoption  of  new  data  requirements  for  the  dossiers  to  be  submitted  by  industry  on  active 
substances  and  plant  protection  products  and  the  adoption  of  several  implementing 
Regulations, required by 14 June 2011. By 14 December 2011 the Commission will present a 
report to the European Parliament and to the Council on the establishment of a European fund 
on minor uses. 

In parallel, the activity under Directive 91/414/EEC will continue, with a special focus on the 
dossiers  submitted  by  several  manufacturers  under  Regulation  (EC)  No  33/2008.  This 
Regulation  lays  down  rules  concerning  the  re-submission  of  dossiers  regarding  substances 
previously  not  included  in  the  positive  list  of  Directive  91/414/EEC  (Annex  I).  About  60 
dossiers are expected to be finalised in 2011. 

The work in the area of pesticides residues will increase in 2011, due to the need to review 
existing MRLs for a) substances approved before 1 September 2008 and b) substances both 
approved and not approved after 1 September 2008. This MRLs review programme is based 
on the provisions of Article 12 of Reg. (EC) No 396/2005 and is expected to involve about 80 
active substances per year. In parallel, the normal MRL setting process will also continue, as 
required by Reg. (EC) No 396/2005. 

511 

Cases  C-77/99  Gowan  Comercio  v;  Commission,  C-517/08P  Makhteshim-Agan  Holding  v. 
Commission. 

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15.4.10.4. 

Summary by sector 

Placing on the market of plant protection products  

Activity in 2010 was mainly devoted to 1) the decision for active substances previously not 
approved and for which new dossiers were resubmitted and 2) the preparation of a number of 
implementing measures for Reg. (EC) No 1107/2009. In 2011 the Commission will continue 
the  work  started  in  2010  both  for  resubmitted  substances  and  for  the  implementation  of  the 
new  Regulation  (EC)  No  1107/2009  and  also  of  Directive  2009/128/EC.  Important 
achievements are expected to take place in both directions, as the Commission should finalise 
the decision-making for around 60 substances and ensure the smooth implementation of the 
new legislation. This will involve the adoption of several implementing Regulations in 2011, 
the  update  of  the  data  requirements  for  the  dossiers  and  the  submission  of  a  report  on  a 
European fund on minor uses. 

Pesticide residues 

The Commission's activity in 2010 focused mainly on the setting of new MRLs for about 100 
MRLs  applications.  The  Commission  has  also  worked  to  reduce  the  MRLs  for  13  old 
pesticides and to adapt the list of commodities by including several new crops. In 2011 more 
work is expected in this area, due to the need to review existing MRLs for several substances 
according to Article 12 of Reg. (EC) No 396/2005. 

15.4.11. Extraction Solvents 

15.4.11.1. 

Current position 

General introduction presenting the legislation 

Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 applies 
to  extraction  solvents  used  or  intended  for  use  in  the  production  of  foodstuffs  or  food 
ingredients. 

This  Directive  establishes  the  list  the  above  mentioned  extraction  solvents  as  well  as 
maximum residual amounts, where appropriate. 

Report of work done in 2010 

The European Food Safety Authority evaluated the safety of dimethyl ether as an extraction 
solvent to remove fat from animal protein raw materials. On the basis of the proposed uses, it 
was considered appropriate to permit the use of this extraction solvent. 

The  conditions  of  use  for  methanol  and  propane-2-ol  were  too  strict  for  the  production  of 
flavourings. Specific conditions for this use were therefore needed. The proposed conditions 
of use for the production of flavourings should be introduced in Part III of the annex to the 
Directive. 

For the above mentioned reasons the following act was adopted: 

•  Commission  Directive  2010/59/EU  of  26  August  2010  amending  Directive 
2009/32/EC of the European Parliament and of the Council on the approximation 

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of the laws of the Member States on extraction solvents used in the production of 
foodstuffs and food ingredients. 

15.4.12. Food Labelling 

15.4.12.1. 

Current position 

General Introduction 

EU legislation on food labelling includes general provisions on the labelling of foodstuffs to 
be  delivered  to  the  consumer,  as  laid  down  in  Directive  2000/13/EC  of  the  European 
Parliament and of the Council on the approximation of the laws of the Member States relating 
to the labelling, presentation and advertising of foodstuffs. This Directive sets out harmonised 
rules to enable European consumers to get comprehensive information on the content and the 
composition  of  food  products.  Nutrition  labelling  on  foods  is  regulated  by  Directive 
90/496/EEC. At the moment, under EU legislation, nutrition labelling is optional, although it 
becomes compulsory when a nutrition or health claim is made in the labelling, presentation or 
advertising of a foodstuff or when vitamins or minerals are voluntarily added to foods. 

Report of work done in 2010 

EU legislation on food labelling is currently under revision. The Commission adopted, on 30 
January 2008, a proposal for a Regulation of the European Parliament and of the Council on 
the  provision  of  food  information  to  consumers.  This  proposal  combines  Directive 
2000/13/EC with Council Directive 90/496/EEC on nutrition labelling for foodstuffs into one 
instrument. In addition, the proposal is in line with the simplification process in the context of 
Better Regulation as it simplifies the structure of the horizontal food labelling legislation in 
Directive  2000/13/EC,  by  recasting  and  replacing  provisions  already  in  place  under  this 
Directive. 

In  2010  there  was  progress  in  the  negotiations  between  the  European  Parliament  and  the 
Council. The European Parliament adopted on 16 June 2010 its first reading position on the 
Commission's  proposal.  The  Employment,  Social  Policy,  Health  and  Consumer  Affairs 
Council  of  7  December  2010  reached  a  political  agreement  on  the  Council  position  on  the 
Commission's proposal. 

The  labelling  acquis  is  managed  through  the  Standing  Committee  on  the  Food  Chain  and 
Animal Health (SCFCAH). The Committee plays a key role in exchange of views between the 
Member States and the Commission regarding the application of the labelling provisions and 
the  increasing  number  of  draft  measures  notified  by  the  Member  States  (on  the  basis  of 
Article 19 of Directive 2000/13/EC). In 2010, the Commission dealt with the assessment of 
the following notified draft national measures: 

Italy: draft measure providing, inter alia, for additional warnings for the labelling of 

• 
certain herbal extracts (completion of the assessment carried out in 2009). 

• 
France: draft measure laying down the conditions and labelling requirements for the 
use of virgin linseed oil for human consumption (completion of the assessment carried out in 
2009). 

• 

Spain:  draft  Decree  laying  down  that  labelling  or  documentation  of  all  the  meat 

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intended  for  human  consumption  which  is  obtained  from  animals  slaughtered  according  to 
religious  rites  shall  indicate  the  following  wording  “obtained  through  the  stunning  special 
exemption”. 

Germany:  Second  Order  amending  the  Order  on  fruit  juice  and  other  regulations 

• 
under food law providing for the mandatory health warnings on energy drinks. 

Belgium: draft measure requiring inter alia compulsory warning to be provided on the 

• 
labelling of a number of plants. 

Spain: draft Royal  Decree providing inter alia for  mandatory labelling requirements 

• 
for candied fruit as well as for 'dragées' or 'confits' made of dried fruit. 

• 
Latvia:  draft  Regulation  requiring  inter  alia  mandatory  labelling  requirements  for 
dairy  products,  composite  dairy  products  or  preparations  of  dairy  products  to  which  other 
foodstuffs or ingredients, whatever piece-like or not, and flavouring have been added; as well 
as  labelling  requirements  for  cheese  and  other  specific  dairy  products  and  preparations  of 
dairy products. 

Of  the  draft  measures  above,  only  the  Spanish  draft  Decree  concerning  candied  fruit  and 
'dragées' or 'confits' made of dried fruit was accepted by the Commission. The assessment of 
the Belgian draft measure is still ongoing. 

15.4.12.2. 

Evaluation based on the current situation 

During 2010 discussions on the Commission's proposal for a Regulation on the provision of 
food information to consumers continued with the European Parliament and the Council. The 
controversial discussions demonstrated the difficulties in striking a balance between the need 
to  streamline  and  simplify  food  labelling  and  the  need  to  help  consumers  to  make  well 
informed  choices.  The  main  political  issues  were:  the  presentation  of  nutrition  information; 
the  inclusion  of  origin  labelling  and  whether  it  should  be  mandatory  for  all  or  certain 
categories  of  foods;  the  application  of  the  general  labelling  requirements  to  alcoholic 
beverages; the responsibilities of food business operators; and the inclusion of specific criteria 
to  improve  legibility  of  information.  The  developments  in  the  European  Parliament  and 
Council  during  the  first  reading  endorsed  the  approach  of  the  Commission  proposal  to 
strengthen  nutrition  labelling  as  a  channel  for  information  to  consumers  to  support  their 
ability to choose a balanced diet. 

Concerning national legislation in the area of food labelling for specific foods, the increasing 
number of notifications should be noted. 

15.4.12.3. 

Priorities and planned action 

The  priority  in  the  general  and  nutrition  labelling  sector  remains  the  overhaul  of  existing 
legislation in order to optimise this regulatory area. This involves work towards adoption of 
the  proposal  for  the  Regulation  on  the  provision  of  food  information  to  consumers  by  the 
European Parliament and the Council. 

Following  the  adoption  of  the  proposed  Regulation  it  will  be  necessary  to  take  forward 
appropriate implementing measures. 

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In  parallel,  work  will  continue  on  developing  guidance  for  technical  issues  on  nutrition 
labelling. This comprises guidance on acceptable tolerances between nutrition labelling values 
and values found by controlling authorities, and guidance on methods of analysis on fibre. 

The assessment of draft national measures on additional mandatory labelling requirements for 
specific foods will continue depending on the notifications of such measures by the Member 
States. 

15.4.12.4. 

Sector summary 

EU  food  labelling  legislation  is  regulated  by  Directive  2000/13/EC.  This  Directive  sets  the 
compulsory information that has to be provided to the final consumer, such as the name of the 
product,  the  list  of  ingredients,  the  use-by  date  and  any  special  conditions  of  use.  Nutrition 
labelling  rules  are  laid  down  in  Council  Directive  90/496/EEC.  This  Directive  provides 
harmonised  rules  on  the  basic  nutrition  labelling  provided  on  a  voluntary  basis  or,  when 
necessary, a mandatory basis. In order to modernise and improve EU food labelling rules, the 
Commission  adopted  on  30  January  2008  a  proposal  for  a  Regulation  of  the  European 
Parliament  and  of  the  Council  on  the  provision  of  food  information  to  consumers,  which  is 
currently under discussion in the European Parliament and the Council. The priority areas are 
the adoption of the final Regulation in the coming year, to continue work on technical issues 
of  nutrition  labelling  and  to  assess  Member  State  notifications  of  draft  national  legislative 
measures concerning food labelling. 

15.4.13. Nutrition and Health Claims 

15.4.13.1. 

Current position 

General introduction 

Regulation  (EC)  No  1924/2006  of  the  European  Parliament  and  of  the  Council,  has  been 
applicable since 1 July 2007, and lays down harmonised rules for the use of health or nutrition 
claims  (such  as  “low  fat”,  “high  fibre”  and  “helps  lower  cholesterol”)  on  foodstuffs.  The 
Regulation aims at ensuring that any claim made on a food label in the EU is clear, accurate 
and substantiated and will thus enable consumers to make informed and meaningful choices 
when it comes to food and drinks. This should contribute to a higher level of human health 
protection,  as  it  ties  in  with  the  Commissions  campaign  for  healthier  lifestyle  choices  by 
allowing  citizens  to  know  exactly  what  they  are  consuming.  The  Regulation  also  strives  to 
ensure  fair  competition  and  to  promote  and  protect  innovation  in  the  area  of  food.  Only 
products offering genuine health or nutritional benefits will be allowed to refer to that on their 
labels. 

Among  the  principles  laid  down  in  the  Regulation,  nutrient  profiles  were  foreseen  to  be 
established by January 2009. Nutrient profiles have to determine whether foods are eligible to 
bear claims on the basis of their nutrient composition and will be based primarily on the levels 
of  nutrients  for  which  excessive  intakes  in  the  overall  diet  are  not  recommended  (e.g.  fat, 
saturated fat, salt and sugars). 

The Regulation has two routes for authorising health claims; either via adoption of the EU list 
of  permitted  health  claims  based  on  national  lists  (the  so-called  article  13  list  of  functional 
claims)  or  via  authorisation  procedures  based  on  applications  directly  from  food  business 

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operators. 

Regarding  nutrition  claims,  the  Regulation  included  in  its  Annex  a  list  of  such  authorised 
claims. 

Report of work done in 2010 

In 2010, further development of the nutrient profiles system and analysis of its impact were 
performed following EFSA's advice in 2008. The Commission services have put forward draft 
measures taking into account the opinion of EFSA, Member States, and stakeholders. These 
draft measures raised considerable public interest, showing that longer discussion was needed, 
thus delaying the Commission Decision on this matter. 

Concerning nutrition claims, an amendment adding 5 new nutrition claims was adopted in the 
beginning of 2010. The new nutrition claims are related to the content in fatty acids such as 
omega-3 fatty acids, and conditions for the use of such claim guarantee a minimum content of 
these fatty acids in foods bearing these claims. 

The Commission authorised and rejected the first health claims under the Regulation. In total, 
since 2009, 13 were authorised and 52 were rejected of those based on applications directly 
from  food  business  operators.  Such  health  claims  refer  to  the  reduction  of  disease  risk,  to 
children's development and health of children, or newly scientific evidence and/or include a 
request for protection of proprietary data. 

Concerning  the  EU  list  of  permitted  health  claims  based  on  national  lists  further  work  was 
done to consolidate the unexpected high number (44.000) of health claims from the Member 
States. Examination of the national lists showed that Member States had applied the relevant 
criteria  differently  when  preparing  the  lists  and  in  certain  cases  not  applied  them  at  all. 
Consequently, consolidating the national lists into a single list including the claims for which 
the  Authority  should  give  scientific  advice,  required  further  discussions  with  the  Member 
States,  stretching  throughout  2009/2010.  The  list  submitted  to  EFSA  was  finalised  with  the 
submission  of  an  addendum  in  March  2010.  The  consolidated  list  contains  more  than  4600 
health claims. 

Meetings  with  Member  States'  experts  have  been  held  on  a  monthly  basis  to  facilitate 
discussions  on  the  application  of  the  Regulation  and  to  prepare  the  votes  in  the  Standing 
Committee on the authorisation of health and nutrition claims. Guidance documents aimed at 
the  food  business  operators  and  enforcement  authorities  are  being  developed.  The  guidance 
strives to ensure that only valid applications are submitted to EFSA and that authorised claims 
are used in compliance with the Regulation. 

15.4.13.2. 

Evaluation based on the current situation 

Though key implementation measures, such as the nutrient profiles, still need to be adopted, 
the application of the new Regulation is already showing signs of its effects. The decisions on 
permitted  and  not  permitted  claims  in  2010,  though  limited  in  numbers,  resulted  in  strong 
messages  passed  onto  the  market  for  the  benefit  of  the  European  consumer  and  fair 
competition on the market. 

The  new  rules  on  nutrition  claims  on  fatty  acids  such  as  "Source  of  Omega-3  fatty  acids" 
ensure that consumers will have significant contributions of these fatty acids when choosing 

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foods  bearing  such  claims.  Few  Member  States  had  rules  for  the  use  of  these  claims  and 
therefore  the  introduction  of  harmonised  rules  is  an  improvement  of  consumer  information 
that could help consumers to make healthier choices. 

15.4.13.3. 

Priorities and planned actions 

Priorities 

The  priority  remains  to  ensure  a  smooth  implementation  of  the  Regulation,  meeting  the 
objectives of that legislation in terms of both protecting consumers and harmonizing the use 
of nutrition and health claims within the EU. The work in this area will focus on the adoption 
of measures establishing nutrient profiles and of the EU list of permitted claims. 

Planned action 

Nutrient  profiles  have  to  be  set  up  in  accordance  with  the  basic  Regulation,  as  they  are 
necessary  to  complete  the  implementing  rules  and  allow  an  efficient  functioning  of  that 
legislative framework. 

Concerning  the  list  of  permitted  Article  13  health  claims,  on  27  September  2010  the 
Commission  announced  its  intention  to  adopt  it  in  two  steps:  one  for  all  claims  other  than 
those  on  botanical  ingredients,  and  a  subsequent  consideration  of  claims  on  botanicals.  The 
Commission  and  the  Member  States  received  from  EFSA  3  series  of  opinions  providing 
advice on 1944 health claims in the consolidated list. 2 more series of opinions are expected 
by June 2011. The adoption of the EU list of permitted health claims is expected for end of 
2011  or  the  beginning  of  2012.  EFSA  advice  on  the  assessed  health  claims  is  being 
scrutinized and discussed with the Member States and stakeholders with a view to prepare the 
list. 

15.4.13.4. 

Sector summary 

Implementing  Regulation  (EC)  N°  1924/2006  on  nutrition  and  health  claims  made  on  food 
was a major task in 2009 and 2010. Substantial preparatory work has been completed for the 
establishment  of  specific  nutrient  profiles,  and  further  development  of  the  nutrient  profiles 
system  and  analysis  of  its  impact  were  performed.  Five  additional  nutrition  claims  were 
proposed and received a favourable opinion from the Regulatory Committee, and have been 
included in the list at the beginning of 2010. Regarding health claims based on applications 
directly  from  food  business  operators,  13  were  authorised  and  52  were  rejected  by  the 
Commission on the basis of the scientific opinions published by EFSA. 

Concerning the EU List of permitted health claims based on national lists further work was 
done to consolidate the unexpected high number (44.000) of health claims submitted by the 
Member  States.  EFSA  evaluated  a  very  substantial  number  of  such  claims  included  in  the 
consolidated list. 

15.4.14. Dietetic foods 

15.4.14.1. 

Current position 

General introduction 

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Directive 2009/39/EC on foodstuffs intended for particular nutritional uses (recast of Council 
Directive  89/398/EEC,  hereafter  referred  to  as  the  Framework  Directive)  establishes 
requirements on product composition and appropriate consumer information for foods that are 
suitable to fulfil the particular nutritional requirements of certain groups of the population. 

Foods for particular nutritional uses, or dietetic foods, are defined as foodstuffs which owing 
to their composition or manufacturing process, are clearly distinguishable from foodstuffs for 
normal consumption, which are suitable for their claimed nutritional purposes and which are 
marketed in such a way as to indicate such suitability. The labelling of these products must 
include the particular elements of the qualitative and quantitative composition or the special 
manufacturing process which gives its particular nutritional characteristics. 

For  a  number  of  these  groups  specific  legislation  has  already  been  adopted.  There  are 
Commission Directives on foods for infants and young children, foods for weight reduction, 
medical  foods  and  gluten-free  foods.  There  are  two  groups  of  foods  covered  by  the 
Framework  Directive  and  mentioned  in  its  Annex  for  which  no  specific  rules  have  been 
elaborated so far: food products for people with diabetes and foods for sports people. 

Products  that  do  not  belong  to  the  abovementioned  categories  are  required  to  undergo  a 
notification procedure in the Member States, with a view to facilitating the official monitoring 
and the placing on the market of innovative products. 

Report of work done in 2010 

The Framework Directive on dietetic foods is now more than 30 years old and a number of 
issues have arisen in relation to its scope and implementation. Many relate to the continued 
evolution of EU food legislation. Of particular importance is the adoption of the Directive on 
food  supplements,  the  Regulation  on  the  addition  of  vitamins  and  minerals  and  of  certain 
other substances to foods and the Regulation on nutrition and health claims made on foods. 
Following  the  developments  in  the  food  market  over  the  last  decade  and  due  to  the  broad 
definition mentioned above, many 'normal' foods now claim particular nutritional benefits due 
to their composition.  

These elements render the revision of this legislation necessary. 

An impact assessment to support the revision of the legislation on dietetic foods was therefore 
undertaken in 2009 and submitted to the Impact Assessment Board which issued a favourable 
opinion on 20 December 2010. 

15.4.14.2. 

Evaluation based on the current situation 

It  is  clear  from  surveys,  reports  and  comments  from  stakeholders  and  national  competent 
authorities that recently adopted food legislation overlaps to a large extent with some of the 
underlying  principles  of  the  dietetic  food  framework  legislation.  Consequently,  the 
application  of  each  piece  of  legislation  to  dietetic  foods  might  be  unclear  for  businesses  or 
Member  States.  Discussions  have  highlighted  difficulties  in  particular  with  regard  to  the 
interpretation of the definition of dietetic foods. 

There  is  also  a  need  to  consider  the  legislation  on  dietetic  foods  in  relation  to  the  more 
"strategic goals" of ensuring a better and simplified legal framework to facilitate innovation. 
The impact assessment on the revision of the Framework Directive on dietetic foods therefore 

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also  considers  the  need  to  simplify  the  legislative  framework  for  businesses  and  Competent 
Authorities  and  to  reduce  administrative  burdens.  Particular  attention  is  given  on  small 
businesses  to  ensure  that  any  change  made  to  the  legislation  is  easily  communicated  and 
simple to implement. 

15.4.14.3. 

Priorities and planned actions  

Priorities 

The main priority is to continue on the ongoing work related to the revision of the legislation 
on foods for particular nutritional uses, otherwise called dietetic foods. 

Three key objectives must be achieved through the revision: 1) ensure appropriate consumer 
information, 2) ensure the free movement of goods within the internal market and with third 
countries, and 3) minimise burdens on food business operators and ensure suitable flexibility 
and clarity for small businesses. 

The  Commission  services  will  now  start  the  work  on  the  draft  proposal  on  the  basis  of  the 
preferred option identified in the Impact Assessment. 

Planned action 

The adoption of a proposal by the Commission is scheduled for 2011. 

15.4.14.4. 

Sector summary 

The need to optimise the existing legal framework on dietetic foods to take into account the 
more recent developments in food legislation (food supplements, fortified foods, claims) and 
to clarify their interactions with the dietetic food legislation is considered under the revision 
of  the  framework  Directive  on  dietetic  foods.  On  the  basis  of  the  impact  assessment,  the 
Commission has assessed all the potential impacts that various options for the revision could 
have on the management of dietetic foods. The adoption of a proposal by the Commission is 
foreseen for 2011.  

Food  Supplements  and  addition  of  vitamins  and  minerals  and  of  certain  other 
substances to foods 

15.4.14.5. 

Current position 

General introduction 

Directive  2002/46/EC  of  the  European  Parliament  and  of  the  Council  on  food  supplements 
partially harmonises the rules applicable to the placing of food supplements on the market. 

The  scope  of  the  Directive  covers  all  food  supplements.  However,  only  the  specific  rules 
applicable to the use of vitamins and minerals in the manufacture of food supplements are laid 
down  in  the  Directive.  In  accordance  with  Article  4(8)  of  the  Directive,  the  Commission 
adopted  on  5  December  2008  a  Report512  on  the  use  of  substances  other  than  vitamins  and 
minerals in food supplements which concludes that the existing EU legal instruments already 

512 

COM(2008)824. 

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constitute a sufficient legislative framework for regulating this area and does not consider it 
opportune to lay down specific rules for substances other than vitamins or minerals for use in 
foodstuffs.  Therefore,  the  use  of  substances  other  than  vitamins  or  minerals  in  the 
manufacture  of  food  supplements  continues  to  be  subject  to  the  rules  in  force  in  national 
legislation. 

Regulation  (EC)  No  1925/2006  of  the  European  Parliament  and  of  the  Council,  which  is 
applicable  as  of  1  July  2007,  harmonises  the  provisions  laid  down  in  Member  States  that 
relate to the addition to foodstuffs of vitamins and minerals and of certain other substances, 
such  as  amino  acids,  essential  fatty  acids,  fibre,  various  plants  and  herbal  extracts.  The 
objective of this Regulation is to ensure the effective functioning of the internal market whilst 
providing a high level of consumer protection. 

Report of work done in 2010 

In  2010,  the  Commission  requested  the  EFSA  to  evaluate  the  safety  of  other  vitamin  and 
mineral substances for use in foods based on dossiers submitted by food business operators. 
The Commission followed the assessment work carried out by EFSA. 

15.4.14.6. 

Evaluation based on the current situation 

In order to complete the harmonization in that sector, the two acts mentioned above foresee 
that maximum amounts should be set up for use of the vitamins and minerals listed in their 
Annexes in foods and in food supplements. 

An  impact  assessment  report  to  analyse  the  economic,  social  and  environmental  impacts  of 
the options for the setting of maximum amounts is being finalized. 

15.4.14.7. 

Priorities and planned actions  

Priorities 

In the area of food supplements and of fortified foods, the priority remains the completion of 
the harmonization for the use of vitamins and minerals. 

Planned actions 

Future activities in the field of food supplements and of fortified foods relate to the adoption 
of  implementing  measures  which  include,  inter  alia,  the  setting  of  maximum  amounts  of 
vitamins and minerals and the updating of the positive list of substances in the Annexes to the 
Directive. 

The lists of vitamins and minerals and their forms that may be added to foods including food 
supplements will be updated. 

15.4.14.8. 

Sector summary 

Directive 2002/46/EC and Regulation (EC) No 1925/2006 of the European Parliament and of 
the  Council  respectively  harmonise  partially  the  rules  applicable  to  the  placing  of  food 
supplements  on  the  market  and  the  addition  of  vitamins  and  minerals  and  of  certain  other 
substances to foodstuffs. 

EN 

397 

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The completion of the harmonization should take place in the near future with the setting up 
of maximum amounts for the use of the substances concerned. 

15.4.15. Novel foods 

15.4.15.1. 

Current position 

General introduction 

Novel foods are foods and food ingredients that have not been used for human consumption to 
a  significant  degree  within  the  EU  before  15  May  1997.  Regulation  (EC)  No  258/97  of  the 
European Parliament and of the Council lays out detailed rules for the authorisation of novel 
foods and novel food ingredients. 

Companies that want to place a novel food on the EU market need to submit their application 
in  accordance  with  Commission  Recommendation  97/618/EC  which  concerns  the  scientific 
information and the safety assessment report required. 

The  Commission  adopted  on  14  January  2008  a  proposal  for  a  Regulation  of  the  European 
Parliament and the Council on novel foods, based on Article 114 TFEU, which would revise 
and replace the existing legislation. 

Report of work done in 2010 

A total of 6 novel foodstuffs (puree and concentrate from Morinda citrifolia; Ferric Sodium 
EDTA, Ferrous Ammonium Phosphate by a Commission Decision and Sucromalt, Guar gum 
and  Magnolia  bark  extract  pursuant  to  their  initial  assessment  carried  by  a  Member  State 
which did not receive objections) were authorised for marketing in the EU. The authorisation 
of bee venom as novel food ingredient was refused following the initial assessment. Around 
50 novel food products that were substantially equivalent to existing foods or food ingredients 
were notified according to the simplified procedure in 2010. 

15.4.15.2. 

Evaluation based on the current situation 

The current legislation lays down a decentralized procedure leading to a long (3-5 years) and 
costly process which may prevent companies, in particular SMEs, from innovating in the food 
sector. The Commission's proposal addressed these points, in particular through a centralised 
evaluation and authorisation procedure and to provide for better conditions for innovation in 
the food sector. 

The European Parliament adopted its opinion in second reading on the novel food proposal on 
7 July 2010 and reconfirmed most of the amendments adopted at first reading. Following the 
rejection of these amendments by the Council, the conciliation procedure has been launched. 

The inter-institutional debate has remained focused on the issues of animal cloning for food 
production and to a lesser extent on nanotechnology in food. 

On  cloning,  the  Commission  adopted  on  19  October  2010  a  report  to  the  Council  and  the 
European Parliament on all aspects of animal cloning for food production. 

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The  report,  based  on  the  EFSA  opinion513  and  statements514,  clearly  establishes  that  food 
derived  from  clones  and  their  offspring  does  not  differ  from  conventional  food  as  regards 
food safety. However animal welfare concerns, linked to the use of the technique, have been 
identified in the case of clones. 

To  address  the  animal  welfare  issues  of  cloned  animals,  the  report  concludes  that  the 
Commission  intends  to  propose  legislation  to  suspend  for  5  years  the  use  of  the  cloning 
technique  in  the  EU  for  food  production  purposes  and  traceability  of  their  reproductive 
material. 

More  specifically,  the  report  proposes  a)  a  temporary  suspension  of  the  use  of  the  cloning 
technique  for  the  reproduction  of  all  food  producing  animals;  b)  a  temporary  suspension  of 
the use of these animals for food production; c) a temporary suspension of the marketing of 
food from these animals; and d) the establishment of the traceability of imports of semen and 
embryos to allow farmers and industry to set up data banks of offspring in the EU. 

On nanotechnologies,  the draft  definition of "engineered nanomaterials" has been  supported 
by  the  European  Parliament,  the  Council  and  the  stakeholders.  A  provision  has  also  been 
introduced  in  the  Novel  Food  Regulation  allowing  for  its  adaptation  to  the  scientific 
developments at EU or international levels. It was agreed that all food ingredients containing 
such nanomaterials would need a pre-market authorisation. 

As regards the labelling of food containing nanomaterials, the Commission is in favour of the 
introduction of a mandatory labelling requirement  for all such foodstuffs to ensure a proper 
consumer information through the food information proposal. 

15.4.15.3. 

Evaluation based on the current situation results 

Priorities 

Taking  into  account  the  objectives  of  the  Commission's  proposal  of  improving  the 
authorisation procedure of novel foods, and of providing for better conditions for innovation 
in the food sector, the priority is to reach agreement in conciliation on the proposal. 

Planned actions 

Compromise solutions on the main negotiation issues should be found without delay, during 
the conciliation phase. The Commission will provide all the necessary support to facilitate a 
final  agreement.  The  Commission  also  intends  to  perform  an  impact  assessment  and  to 
prepare a legislative proposal on cloning as foreseen in its report. 

15.4.15.4. 

Sector summary 

The current legislation on novel foods does not allow for an efficient authorization procedure 
and  for  stimulating  innovation  in  the  food  sector.  The  proposal  currently  under  conciliation 
procedure  aims  at  adapting  the  legislative  framework  in  these  respects.  In  that  context 

513 
514 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902019540.htm 
http://www.efsa.europa.eu/cs/BlobServer/Statm_of_Efsa/sc_statementej_RN319_en.pdf?ssbinary=true  

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discussions gave rise to a debate on the issues of the safety implications and ethical concerns 
of the use of cloning and nanotechnologies in the food sector. 

15.4.16. Food contact materials 

15.4.16.1. 

Current Situation 

Presentation of the legislation 

Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials 
and articles intended to come into contact with food (FCM) sets out the basic requirements for 
a  harmonised  European  market  on  food  contact  materials,  while  ensuring  a  high  level  of 
protection  of  human  health.  This  legal  act  empowers  the  Commission  to  set  material 
particular rules in specific legislation. 

Specific  legislation  exists  for  ceramics,  regenerated  cellulose  film,  plastic  food  contact 
materials and recycled plastics, and active and intelligent materials. 

Report of work done in 2010 

In order to facilitate the application of current rules on plastics intended to come into contact 
with food a draft Commission Regulation on plastic materials and articles intended to come 
into contact with food was endorsed by the Standing Committee on 10 September 2010. The 
proposal  draws  together  fourteen  Directives  covering  basic  rules  for  plastic  materials  and 
removes obsolete and contradictory rules and outdated analytical methods. It updates the list 
of  authorised  substances  in  accordance  with  the  scientific  assessment  by  the  EFSA,  and  of 
food simulants and testing regime according to scientific knowledge. The draft Commission 
Regulation also clarifies the approach for the authorisation of nanomaterials. All explanatory 
parts will be compiled in a separate guidance document. The new proposal, which is expected 
to be adopted in 2011, will speed up the authorisation of new substances and simplify rules on 
migration test, therefore it will definitely ensure a better application of current EU law in the 
field. 

Following the continuous high number of non-compliant plastic kitchenware originating from 
China  notified  through  the  Rapid  Alert  System  on  Feed  and  Food  (RASFF)  during  the  last 
years,  a  draft  Commission  Regulation  laying  down  specific  conditions  and  detailed 
procedures  for  the  import  of  polyamide  and  melamine  plastic  kitchenware  originating  in  or 
consigned from People's Republic of China and Hong Kong Special Administrative Region, 
China, was endorsed by the Standing Committee on 25 November 2010. 

Following the EFSA Scientific Opinion on Bisphenol A (BPA)515 adopted on 23 September 
2010, and the notification of national bans by Denmark and France as set out in Article 18 of 
Regulation  (EC)  No  1935/2004,  a  draft  Commission  Directive  amending  Directive 
2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles 
was  endorsed  by  the  Standing  Committee  on  25  November.  The  measure  is  based  on  the 
precautionary  principle  referred  to  in  Article  7  of  Regulation  (EC)  No  178/2002  of  the 
European  Parliament  and  of  the  Council  of  28  January  2002  laying  down  the  general 
principles and requirements of food law, establishing the EFSA and laying down procedures 

515 

http://www.efsa.europa.eu/en/scdocs/scdoc/1829.htm  

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in matters of food safety516, which allows EU to provisionally adopt measures on the basis of 
available pertinent information, pending an additional assessment of risk and a review of the 
measure within a reasonable period of time. 

15.4.16.2. 

Evaluation based on current situation 

Harmonisation  of  legislation  for  plastic  food  contact  materials  started  in  1980  and  led  to 
fourteen  Directives.  The  draft  Commission  Regulation  on  plastic  materials  and  articles 
intended to come into contact with food to be adopted in 2011 will simplify the application of 
the legal provisions for plastic materials. 

While the harmonisation of legislation on plastic food contact materials at EU level is nearly 
complete,  only  the  basic  principles  are  set  out  for  other  materials  such  as  paper  and  board, 
printing  inks,  adhesives.  The  lack  of  harmonised  measures  at  EU  level  creates  problems  in 
particular  where  Member  States  do  not  have  legislation  in  place  and  specific  rules  for 
compliance  with  general  safety  requirements  for  food  contact  materials  remains  unclear. 
Member  States  would  welcome  the  development  of  EU  measures  for  certain  materials.  A 
system tackling not-yet harmonised materials should be developed. This system will have to 
avoid  overregulation  of  the  sector  and  at  the  same  time  should  be  efficient  and  be  able  to 
ensure that the safety of citizens is guaranteed. 

Taking  into  account  the  recent  EFSA  Opinions  on  lead517  and  cadmium518,  the  Council 
Directive on the approximation of the laws of the Member States relating to ceramic articles 
intended to come into contact with foodstuffs519 needs to be revised. 

15.4.16.3. 

Priorities and planned actions 

Priorities 

First priorities are the adoption of the draft Commission Regulation on plastic materials and 
articles  intended  to  come  into  contact  with  food  and  of  the  draft  Commission  Directive 
amending  Directive  2002/72/EC  as  regards  the  restriction  of  use  of  Bisphenol  A  in  plastic 
infant feeding bottles in 2011. 

Once the draft Commission Regulation on plastic materials and articles intended to come into 
contact  with  food  is  adopted,  which  will  repeal  Directive  2002/72/EC,  it  will  be  amended 
accordingly  to  reflect  the  restrictions  concerning  Bisphenol  A  proposed  in  the  draft 
Commission  Directive  amending  Directive  2002/72/EC  as  regards  the  restriction  of  use  of 
Bisphenol A in plastic infant feeding bottles. 

The draft Commission Regulation laying down specific conditions and detailed procedures for 
the import of polyamide and melamine plastic kitchenware originating in or consigned from 
People's Republic of China and Hong Kong Special Administrative Region, China, is planned 
to be adopted in the first half of2011. 

Planned actions 

516 
517 
518 
519 

OJ L 31, 1.2.2002, p. 1. 
http://www.efsa.europa.eu/en/scdocs/scdoc/1570.htm 
http://www.efsa.europa.eu/en/scdocs/scdoc/980.htm 
OJ L 277, 20.10.1984, p. 12. 

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A roadmap for setting out the policy regarding not yet harmonised materials (Paper and board, 
glass,  wood,  cork,  metals  and  alloys,  textiles,  adhesives,  ion-exchange  resins,  printing  inks, 
silicones, varnishes and coatings and waxes) will be drafted in 2011. 

The  Council  Directive  on  the  approximation  of  the  laws  of  the  Member  State  relating  to 
ceramic articles intended to come into contact with foodstuffs (84/500/EEC) will be updated 
during 2011 to take into account opinions by EFSA on lead and cadmium. 

Adoption of regulation(s) updating the list of authorised substances to be used in plastic food 
contact materials following the adoption of opinions by EFSA. 

15.4.16.4. 

Summary by sector 

The legislation on food contact materials will gain in clarification once the draft Commission 
Regulation on plastic materials and articles intended to come into contact with food developed 
in  2010  is  adopted.  The  update  of  the  legislation  on  ceramics  following  the  recent  EFSA 
opinions on lead and cadmium will adjust the legislation to current scientific knowledge. The 
preparation of the roadmap for the setting out the policy on not-yet harmonised materials will 
avoid possible problems that Member States may face due to lack of specific requirements for 
these materials at national level. 

The implementation of the draft Commission Regulation laying down specific conditions and 
detailed procedures for the import of polyamide and melamine plastic kitchenware originating 
in  or  consigned  from  People's  Republic  of  China  and  Hong  Kong  Special  Administrative 
Region,  China,  will  reinforce  the  controls  of  imported  plastic  products  and  therefore  the 
enforcement of the EU legislation. 

15.4.17. Plant Health 

15.4.17.1. 

Current position 

General introduction presenting the legislation 

The  plant  health  legislation  provides  the  framework  for  the  protection  of  the  EU  territory 
against  the  introduction  of  organisms  that  are  harmful  to  plants  and  not  yet  present  or,  if 
locally present, not widespread and under official control. Therefore, all plants and some plant 
products  are  subject  to  phytosanitary  requirements  at  import;  a  restricted  number  of  plant 
species  require  phytosanitary  guarantees  for  internal  movements  within  the  EU.  This 
preventative  approach  avoids  expensive  curative  action  afterwards  or  loss  of  agricultural 
production or environmental damage. 

Report of work done in 2010 

The Commission's strategy in the plant health field continued on the lines initiated in 2009, 
i.e.  focussing  on  a  correct  implementation  of  existing  legislation,  while  developing  a  new 
plant health law. 

The  correct  implementation  of  the  current  acquis  was  ensured  by  a  stricter  enforcement  of 
existing legislation, a revision of some emergency measures and an appropriate budget for co-
financing  eradication  actions  in  Member  States.  Stricter  enforcement  and  strengthening  of 
existing legislation was put in place for several emergency measures against the introduction 

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or  spread  of  harmful  organisms.  This  was  the  case  with  a  strict  follow-up  of  the 
implementation  of  existing  measures  against 
the  spread  of  pine  wood  nematode 
Bursaphelenchus xylophilus in conifers in Portugal, as well as for a new isolated outbreak on 
the  Spanish  side  of  the  Portugal/Spain  frontier.  The  emergency  measures  to  prevent  the 
introduction of the Chinese longhorn beetle and the measures to contain the further spread of 
the red palm weevil – Rhynchophorus ferrugineus which threatens most palms species in the 
Mediterranean  areas  were  updated.  For  Western  corn  rootworm  -  Diabrotica  virgifera 
virgifera  in  maize,  an  impact  assessment  was  elaborated  to  underpin  the  development  of  a 
new EU control strategy, as this pest is now widespread in certain areas within the EU. 

The  existing  phytosanitary  policy  for  the  import  of  potatoes  from  Egypt  was  prolonged  for 
one  year.  Phytosanitary  restrictions  for  the  import  of  Japanese  and  Korean  bonsai, 
Argentinean and Chilean strawberry plants and oak logs from the USA were renewed for a ten 
year  period.  The  recognition  of  zones  in  the  EU  with  an  extra  protection  against  certain 
harmful organisms was screened and updated where necessary. 

Upon request of Germany, Spain, France, Italy, Cyprus and Portugal, and in order to ensure a 
better and harmonised protection against the spread of new pests and diseases in the territory 
of  the  Union,  the  EU  co-financed  the  national  eradication  campaigns  against  harmful 
organisms for a total amount of EUR 7,3 million. The campaigns concerned actions against 
longhorn  beetles  (Anoplophora  chinensis  and  A.  glabripennis),  red  palm  weevil 
(Rhynchophorus  ferrugineus),  Western  corn  rootworm  (Diabrotica  virgifera  virgifera), 
round-headed apple tree borer (Saperda candida) and pine wood nematode (Bursaphelenchus 
xylophilus). 

In  parallel,  the  initiative  to  develop  a  new  common  plant  health  strategy  has  been  further 
elaborated.  The  existing  regime  aims  to  protect  the  EU  territory  against  introduction  and 
spread of regulated organisms which are harmful to plants. It lays down specific requirements 
for imports of all plants and some plant products into the EU and for internal movement of a 
limited  number  of  plants  within  the  EU.  During  2010,  an  overall  evaluation  of  the  current 
plant  health  regime  was  finalised  with  the  input  of  an  external  contractor.  The  evaluation 
results  and  recommendations  were  presented  to  the  Member  States  and  stakeholders  during 
two conferences and comments have been collected. Terms of reference were developed for 
an extra study in preparation of an impact assessment for new policy options, and the study 
was contracted out. 

15.4.17.2. 

Evaluation based on the current situation 

The monitoring of the implementation and updates of the current plant health acquis needs to 
continue  to  offer  a  harmonised  protection  of  the  EU  territory  against  harmful  organisms. 
However,  due  to  several  important  changes  since  the  first  EU  plant  health  legislation  was 
adopted in 1977, including globalisation of trade, accession of new Member States,  and the 
environmental expectations of society, a global revision of the plant health strategy is needed. 

15.4.17.3. 

Priorities and planned action 

Priorities 

The completion of the new plant health strategy with a better focus on prevention is the major 
priority.  The  revisions  of  the  emergency  measures  against  pine  wood  nematode  and  against 

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Western corn rootworm have to be accomplished in order to reflect better the situation in situ. 

Planned action 

The  results  of  the  2010  evaluation  study  and  the  additional  2011  impact  assessment  study, 
will  allow  the  Commission  to  develop  a  proposal  for  a  new  plant  health  law.  This  process 
includes extensive input from Member States and stakeholders. 

As far as the EU control strategy against the spread of Western Corn Rootworm is concerned, 
an impact assessment has been launched and will allow the review of the existing emergency 
measures in 2011. 

15.4.17.4. 

Summary by sector 

Regular  updates  of  existing  phytosanitary  emergency  measures,  prolongation  of  temporary 
import conditions  for specific  plant material,  revision of protected zones and verification of 
correct implementation of EU acquis was continued in 2010 to keep the existing plant health 
legislation operational. In parallel, all preparatory work has been initiated in 2010 to allow the 
development of a proposal for a new plant health law in 2011. 

15.4.18. Plant reproductive material – Plant Variety Rights – Plant Genetic Resources 

15.4.18.1. 

Current position 

General introduction presenting the legislation  

The sector of plant reproductive material consists of the three work areas: 

•  legislation on marketing of seed and plant propagating material 

•  legislation on plant variety rights and  

•  international initiatives on plant genetic resources. 

The legislation on the marketing of seed and plant propagating material consists of 12 basic 
Council Directives. The two pillars of the legislation concern (1) the registration of new plant 
varieties  and  (2)  the  inspection  (e.g.  certification)  of  seed  and  propagating  material  for 
marketing of such varieties. Detailed requirements, depending on the type of plant species, are 
set for the registration of new varieties and quality inspection of lots prior to marketing. 

The EU plant variety rights regime was created by Council Regulation (EC) No 2100/94. On 
the  basis  of  a  single  application  to  the  Community  Plant  Variety  Office  based  in  Angers 
(France),  a  breeder  may  be  granted  an  EU-wide  intellectual  property  right  for  his/her  new 
variety. 

The  objectives  of  the  International  Treaty  on  Plant  Genetic  Resources  for  Food  and 
Agriculture are the conservation and sustainable use of plant genetic resources for food and 
agriculture  and  the  fair  and  equitable  sharing  of  the  benefits  arising  out  of  their  use.  The 
Commission  on  Genetic Resources for  Food and Agriculture  is an intergovernmental forum 
for negotiations and discussions by Governments on matters related to biodiversity for food 
and agriculture. 

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Report of work done in 2010 

Seed and plant propagating material 

In the sector of seeds and plant propagating material, the current legislation was kept updated 
and further developed. However, an increasing part of the work concentrated on the review of 
the  legislation.  A  specific  working  group  'on  seeds  and  propagating  material'  for  the 
stakeholders of the sector hold a number of meetings to discuss the legislative work. 

The common catalogues on varieties of agricultural and vegetable plant species were updated 
12 times and both had a consolidated edition published. Altogether over 1800 new varieties of 
agricultural  plant  species  and  1000  vegetable  varieties  were  included  in  the  catalogues.  The 
Community  list  of  Forest  Reproductive  Material  was  also  regularly  updated  and  a  new 
common  catalogue  for  vine  propagating  material  was  created.  In  2010,  the  Member  States 
made 20 requests for less stringent requirements on minimum germination under Regulation 
(EC) 217/2006 and accepted by the Commission. In August 2010, the Commission adopted 
Directive  2010/60/EU  providing  for  certain  derogations  for  marketing  of  fodder  plant  seed 
mixtures  intended  for  use  in  the  preservation  of  the  natural  environment.  Concerning  the 
review of the legislation, an external study to collect necessary data for the impact assessment 
was carried out. The impact assessment was elaborated and Member States and stakeholders 
were extensively consulted. 

Plant Variety Rights 

In  2010  the  number  of  applications  for  plant  variety  rights  increased  compared  with  2009. 
Currently, more than 17 500 varieties of plants are protected under the EU system. As the EU 
plant variety rights regime dates back to more than 15 years, Directorate-General Health and 
Consumers launched an external evaluation, which started in May 2010. 

Genetic Resources 

Some  preparatory  meetings  for  the  upcoming  meeting  of  the  contracting  parties  of  the 
International Treaty in 2011 were organised. 

15.4.18.2. 

Evaluation based on the current situation 

The impact assessment on the review of the seeds and plant propagating material legislation is 
ongoing  and  a  public  consultation  is  foreseen  for  the  beginning  of  2011.  Several  working 
group meetings with the Member States to prepare new legislation have been held and legal 
drafting  is  under  way.  Notwithstanding  the  work  done  on  the  review  of  the  legislation, 
different actions have been undertaken to ensure the updating and adaptation to current needs 
as well as the administrative procedure of the seeds and plant propagating material legislation. 
This was carried out in a timely manner. The new rules on the preservation seed mixture were 
adopted  as  planned.  Following  the  adoption  of  Council  Directive  2008/90/EC  on  the 
marketing  of  fruit  plant  propagating  material  and  fruit  plants  intended  for  fruit  production 
(recast), work is under way to update and develop the implementing rules. 

15.4.18.3. 

Priorities and planned action 

Priorities 

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The priority of the sector is to finalise the necessary impact assessment and the development 
of  a  legal  proposal  for  the  review  of  the  legislation  on  marketing  of  seeds  and  plant 
propagating  material.  Another  priority  of  the  sector  is  to  finalise  the  evaluation  of  plant 
variety rights legislation and to prepare a conference to present and discuss the results and the 
future  of  the  plant  variety  rights  regime.  There  is  a  legal  obligation  to  adopt  all  requested 
implementing  measures  for  fruit  plants  before  30  September  2012  when  the  basic  Directive 
enters into force. 

Planned action 

Concerning  the  review  of  the  legislation,  the  aim  is  to  finalise  the  necessary  impact 
assessment in 2011 and to prepare a proposal for the new legislative framework in 2011. The 
revision  will  be  aligned  with  other  ongoing  revisions,  like  the  revision  of  the  plant  health 
legislation  and  Regulation  (EC)  No  882/2004  on  official  controls,  foreseen  for  2012. 
Therefore  it  is  likely  that  some  additional  information  gathering  for  the  impact  assessments 
will need to be carried out in 2011. Depending on the outcome of the evaluation results of the 
PVR regime a recast of the current legislation could be foreseen. The results of the evaluation 
will be discussed with the stakeholders in course of 2011, including through the organisation 
of a conference. The fruit implementing measures are foreseen to be adopted in 2011. 

15.4.18.4. 

Summary by sector 

Two  Commission  Directives  and  9  Decisions  were  adopted  in  2010.  The  work  on  impact 
assessment work on the review of the seeds and plant propagating material legislation and on 
the  implementing  measures  for  the  fruits  plants  are  both  ongoing.  A  new  major  project  on 
evaluating the legislation on plant variety rights started. In addition, important pre-legislative 
work for the seeds and plant propagating material review and on issues related to plant variety 
rights legislation was carried out. 

15.4.19. Animal Health – including non food-borne zoonotic diseases 

15.4.19.1. 

Current position 

General introduction 

Animal health is an important factor for a functioning agriculture and internal market and the 
safe supply of food. It has been part of the EU acquis from the very beginning of the EU and 
legislation in force dates back to the 1960s. Animal health legislation has been adapted over 
the  years,  in  order  to  accommodate  new  diseases  such  as  BSE  or  changes  in  the  spread  of 
existing  diseases  such  as  avian  influenza  or  bluetongue.  Outbreaks  of  e.g.  classical  swine 
fever and foot and mouth disease have triggered adoption of specific legislation. 

The  result  is  a  body  of  law  of  over  60  acts  (mostly  Directives)  laying  down  horizontal  and 
vertical  principles  for  intra-EU  trade,  imports  of  animals  and  their  products,  health  and 
movement controls (veterinary checks), the notification of diseases and financial support. 

Formal complaint cases in this area are few. Most refer to isolated cases of alleged incorrect 
implementation at local level which usually cannot be solved by the EU institutions but have 
to be dealt with in national courts. 

Nevertheless, requests for interpretation and the difficulties arising from the complexities and 

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inconsistencies  have  shown  that  this  framework  does  not  fully  comply  with  more  modern 
requirements  for  simplicity,  transparency  and  flexibility.  Thus  in  2007  the  Commission 
presented  its  plans  to  improve  the  situation  through  a  New  Animal  Health  Strategy520.  This 
triggered  a  broad  consultation  involving  stakeholders,  trade  partners  and  institutions.  As  a 
result, a Communication on an Animal Health Action Plan521 was published in 2008, listing 
all the actions considered necessary up to 2013 for a new approach to animal health. The most 
important action is the preparation of a proposal on a new animal health law. 

Against  this  background  the  challenge  to  address  acute  animal  health  concerns  effectively 
remains.  Animal  health  is  under  consistent  threat  from  outbreaks  within  the  EU,  in 
neighbouring  countries  or  on  the  territory  of  trade  partners.  Diseases  such  as  classical  or 
African  swine  fever  and  foot  and  mouth  disease,  which  cause  heavy  economic  losses,  are 
constantly  at  EU  gates.  Modified  agricultural  practices  increase  the  importance  of  fish 
diseases  and  tuberculoses.  Changes  in  the  environment,  especially  in  the  climate,  foster  the 
spread of bluetongue. 

Report of work done in 2010 

In  2010  the  Commission  pursued  the  actions  to  implement  the  Animal  Health  Action  Plan 
mentioned above. 

Serious disease outbreaks can have devastating impacts on farmers, society and the economy, 
and the new strategy is based on the principle that “prevention is better than cure” and thus 
puts greater focus on precautionary measures, disease surveillance, controls and research. The 
aim is to reduce the incidence of animal disease and minimise the impact of outbreaks when 
they do occur. 

One part of this approach is the review of the existing animal health legislation while creating 
an  overarching  EU  Animal  Health  Law.  It  will  in  particular  provide  the  principle  rules  for 
some  fundamental  issues,  such  as  responsibilities  of  animal  keepers,  business  operators, 
competent  veterinary  authorities,  as  well  as  concerning  disease  prevention  and  protection 
from biological threats (biosecurity). It will clarify the links between animal health policy and 
other  relevant  EU  policies  and  thus  ensure  coherence.  The  new  law  will  embrace  the 
principles of Smart Legislation by providing flexibility to adapt to new circumstances and to 
take account of new developments in science, relevant technology and animal husbandry. 

The best possible implementation and enforcement of the new rules will be assisted by careful 
alignment of those with the applicable general rules on official controls for the animal health 
area as laid down by Regulation (EC) No 882/2004, by amending that Regulation and creating 
further detailed control rules as necessary. 

Preparatory  work  continued  in  2010  for  a  proposal  and  impact  assessment  of  this  law.  The 
above key issues have been discussed on several  occasions and in  various fora (such as  the 
Working  Group  of  the  Chief  Veterinary  Officers  and  the  Animal  Health  Advisory 
Committee).  A  web-based  public  consultation  was  open  from  the  beginning  of  the  year  to 
mid-March to collect data on foreseen implementation and administrative costs and burdens. 

520 
521 

COM(2007)539final. 
COM(2008)545final. 

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The intra-EU movement of pet and companion animals (such as dogs and cats) is of practical 
importance  to  citizens.  The  relevant  Regulation522  was  amended  in  2010  to,  finally,  fully 
harmonise the regime in the whole EU, after a limited (1,5 year) prolongation of the special 
regime to facilitate transition. During the negotiations the Commission declared its intention 
to  align  the  whole  Regulation  (and  not  only  the  amended  Articles)  to  the  provisions  of 
Articles 290 and 291 of the TFEU (new comitology) and handled the matter with urgency. It 
was  also  identified  that  less  than  optimal  legal clarity,  readability  and  "user-friendliness"  of 
the Regulation compromises its uniform implementation and compliance across the EU. 

New  rules  are  applicable  as  from  1  January  2010  in  the  area  of  electronic  identification  of 
ovine and caprine animals. The Commission addressed this issue in several fora, informed all 
concerned  about  the  details,  and  regularly  required  reports  from  Member  States  on  their 
efforts to correctly implement these rules. Assistance to Member States included a high level 
conference on traceability, partially dedicated to this subject and even field visits to Member 
States (e.g. UK) where implementation proved to be challenging. 

Preparatory  work  has  been  ongoing  on  the  area  of  bovine  identification  for  a  proposal  to 
amend  the  relevant  Regulation523.  This  Regulation  has  been  identified  in  the  past  as 
burdensome by the High Level Group on Administrative Burden. The planned changes intend 
to  facilitate  the  use  of  modern  electronic  identification  technology  in  the  sector,  lessen 
administrative burden for holding registers, passports and beef labelling while adhering to the 
objectives of the Regulation. They also intend to align the Regulation to the Articles 290 and 
291 of the TFEU. This will facilitate future implementation and compliance. 

The  provisions  of  Council  Decision  79/542/EEC  regulating  certain  aspects  of  the  import  of 
specific live animals and fresh red meat into the EU were recast in a Commission Regulation 
and  the  Decision  was  repealed.  This  was  due  to  fundamental  changes  in  the  regulatory 
framework  on  this  area  but  also  to  provide  increased  clarity  and  transparency.  New  model 
import  certificates  incorporating  public  health  provisions  were  laid  down.  These  integrated 
models  assist  all  concerned  stakeholders  to  comply  with  the  rules  and  enable  authorities  to 
check  compliance  more  easily.  An  ample  transitional  period  was  provided  for  smooth 
changeover from the old to the new regime. 

Directive 2008/73/EC has a deadline of 1 January 2010 for transposition and implementation. 
Member  States  were  reminded,  and  possible  problems  were  discussed  in  the  Standing 
Committee on the Food Chain and Animal Health. Most Member States have transposed and 
implemented its provisions, but 2 infringements for non-communication of national measures 
are ongoing against Austria and Portugal. 

In 2010 the first ever series of trainings for official veterinarians on rules in the area of bee 
health and bee keeping as well as for exotic zoo animals started and will continue into 2011. 

The control of the spread of bluetongue continued to be successful. However the evaluation of 
the  current  legal  environment  based  on  direct  experience  with  an  ongoing  vaccination 
campaign indicated that although it is effective, it is less than optimal. The rules are complex, 
often  difficult  to  apply  for  local  farmers,  traders,  local  and  national  veterinary  services  and 
other stakeholders and more restrictive than they could be. 

522 
523 

Regulation (EC) No 998/2003. 
Regulation (EC) No 1760/2000. 

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Because  of  this,  a  specific  reflection  on  bluetongue  continued  in  2010  and  led  to  a  new 
Commission  proposal  to  change  the  Directive.  The  key  elements  of  this  proposal  (and  a 
subsequent amendment to the implementing rules) relate to the facilitation of preventive use 
of  modern, 
increased  simplification, 
proportionality and sustainability. 

inactivated  vaccines  with 

less  restriction  for 

In  2010  simplification  and  streamlining  of  the  animal  health  implementing  rules  for  the 
movements (including imports) of semen, ova, and embryos of the equine, ovine and caprine 
species and ova and embryos of the porcine species took place. It comprised an amendment to 
the relevant Annex to Directive 92/65/EEC and was followed up by a complete recast of the 
eight  relevant  Commission  Decisions  into  three  new  Commission  Decisions.  The  whole 
exercise created better alignment of the substantial rules to international standards, new model 
certificates  as  well  as  the  management  of  lists  of  establishments  from  which  such  products 
can originate. 

Successful  disease  control  relies  not  only  on  an  adequate  legal  framework  but  also  on  its 
implementation.  In  2010,  Member  States  again  have  responded  to  outbreaks  in  a  swift  and 
successful  manner.  None  of  the  outbreaks  had  an  impact  on  public  health  or  led  to  major 
economic losses. The framework to adopt rapid safeguard measures was kept updated, as well 
as  constant  re-evaluation  of  the  situation,  the  legal  requirements  and  best  possible 
implementation, mostly with the experts from the Member States in the Standing Committee 
on the Food Chain and Animal Health. 

15.4.19.2. 

Evaluation based on the current situation 

Considering the above, the animal health framework for handling various disease generally is 
adequate and effective. It can however be improved by smarter and more efficient solutions. 
Hence the area is currently in a phase of reform with the purpose to identify opportunities of 
further enhancing efficiency and to reduce unnecessary burdens. 

15.4.19.3. 

Evaluation based on the current situation results 

Priorities 

The combat of disease outbreaks is the first priority dictated by the circumstances. The second 
priority remains the further development of the Animal Health Strategy as a long term goal. 

Planned action 

In 2011 work will continue on the creation of the Animal Health Law with the view that the 
final  proposal  could  be  adopted  in  early  2012.  The  proposal  to  amend  Regulation  (EC)  No 
1760/2000 is expected to be finalised in the first part of 2011. Preparatory work will continue 
throughout 2011 on the important area of how the EU finances certain animal health measures 
(whether emergency measures or planned and systematic eradication of diseases). This should 
result  in  late  2012  in  an  impact  assessment  and  proposal  for  the  review  of  Decision 
2009/470/EC,  the  financial  instrument  for  EU  veterinary  expenditure.  On  the  area  of  pet 
animals,  developments  in  2010  both  in  the  European  Parliament  and  Council  necessitate  a 
recast of the whole Regulation. 

15.4.19.4. 

Summary of Sector 

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This sector faces major overhaul. The goal is to consolidate a long term and largely successful 
and  profound  collaboration  into  a  more  modern  system  by  integrating  tried  and  tested 
methods  within  an  improved  framework.  The  challenge  to  swiftly  and  effectively  react  to 
epidemics will remain. 

15.4.20. Zootechnics 

15.4.20.1. 

Current position 

Zootechnical  legislation  is  closely  linked  with  the  Animal  Health  acquis  as  it  establishes 
minimum genetic criteria to ensure free trade in breeding animals and their genetic material 
(semen, embryos). The current system of EU zootechnical legislation was established in the 
1980s by the Council in order to remove barriers to trade. The result is a body of law of over 
30  pieces  of  legislation  (6  basic  Directives  and  their  implementing  acts)  laying  down 
principles  on  the  registration  of  breeding  animals  in  herd  books  and  the  work  of  breeding 
organisations. 

Report of work done in 2010 

A series of consultations has taken place with stakeholders and Member States. Advice was 
given to the Member States on the implementation of the legislation. 

15.4.20.2. 

Evaluation based on the current situation 

The  present  system  generally  works  well.  But  the  provisions  of  the  basic  zootechnical 
legislation granting implementing or delegating powers to the Commission are not consistent 
with the requirements of Articles 290 and 291 of the TFEU. In addition the relevant Council 
texts are scattered across 11 similar but in certain details different acts. A similar pattern can 
be  seen  at  Commission  level.  This  compromises  the  coherence,  full  implementation, 
accessibility and legal clarity of this acquis. This can also cause unjustified obstacles to EU 
trade  and  threaten  the  uniform  application  of  EU  law.  A  significant  volume  of  complaints 
suggest that both Member States and economic operators are finding it difficult to apply this 
legislation in practice. 

Hence it has been recognised that there is scope to clarify and simplify the legislation as well 
adapt  it  to  the  TFEU.  In  addition  complaint  cases  have  identified  several  problems  in  the 
current framework which need to be handled, such as: 

•  It  does  not  specifically  address  cross-border  activities  of  approved  breeding 
organisations,  while  these  organisations  increasingly  serve  breeders  in  several 
Member States and breeding programmes are carried out at international level. 

•  Due to lack of clarity of the legislation there are disparities in the application and 
the  implementation  of  zootechnical  legislation.  This  can  cause  unjustified 
obstacles to EU trade and threaten the uniform application of EU law. 

15.4.20.3. 

Evaluation based on the current situation results 

Priorities 

The  first  priority  is  to  recast  the  legislation  as  soon  as  possible  into  one  single  piece  of 

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legislation.  The  second  priority  is  to  support  Member  States  in  the  implementation  of  the 
current legislation. 

Planned action for 2011 and beyond 

Recast of the legislation and its adaptation to the TFEU is planned for the first half of 2011. 

15.4.21. Animal by-products 

15.4.21.1. 

Current Situation 

General introduction 

Animal by-products not intended for human consumption include slaughterhouse waste, fallen 
stock  and  dairy  products  going  to  animal  feed,  as  well  as  a  variety  of  other  products  for 
different applications. The health rules for those animal by-products are currently laid down 
in Regulation (EC) No 1774/2002 and a number of implementing measures. The Regulation 
relies on a risk-based categorisation of animal by-products, which determines the options for 
their use and obligations for their disposal. Experience with the application of the Regulation 
since  2003  revealed  that  the  interaction  with  other  EU  legislation,  its  risk-benefit  ratio,  and 
the proportionality of the prescribed measures in particular as regards their use for technical 
applications, posed problems and needed to be reviewed. Therefore, based on a Commission 
proposal, the European Parliament and the Council adopted Regulation (EC) No 1069/2009, 
which replaces Regulation (EC) No 1774/2002 as from 4 March 2011. 

Report of work done in 2010 

Regulation (EC) No 1069/2009 only establishes the general principles for animal by-products 
and  leaves  its  implementation  to  Commission  measures.  Therefore  the  Commission  carried 
out  wide  consultations  with  stakeholders  in  2010.  Based  on  those  consultations,  a  draft 
implementing  Regulation  was  submitted  to the  Standing  Committee  on  the  Food  Chain  and 
Animal Health and received a favourable opinion. It is foreseen to be adopted and published 
in good time for the application of Regulation (EC) No 1069/2009. 

The  training  of  officials  and  some  stakeholders  on  the  new  principles  has  already  started 
under the "Better Training for Safer Food" initiative, with 4 trainings done in 2010. 

15.4.21.2. 

Evaluation based on the current situation 

The  new  implementing  rules  for  Regulation  (EC)  No  1069/2009  replace  the  technical 
standards set out in the 11 Annexes to Regulation (EC) No 1774/2002, as well as in more than 
10  separate  Commission  measures  by  a  single,  more  coherent  legal  act.  They  specify  the 
obligations  of  commercial  operators  handling  animal  by-products  and  of  the  control 
authorities  of  Member  States  and  they  lay  down  specific  requirements  for  the  hygienic 
handling, processing, tracing and placing on the market of such by-products. The new rules 
determine under which conditions certain animal by-products (which were until now excluded 
from any use), may be used, under appropriate health conditions. Thus, the new implementing 
rules  contribute  to  further  simplification  of  the  EU  law  and  a  further  reduction  in 
administrative burden for business operators. 

15.4.21.3. 

Evaluation based on the current situation results 

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Planned Action 

The Commission will ensure that the new implementing rules continue to be updated in the 
light  of  progress  in  science  and  technology,  particularly  as  regards  new  processes  for  the 
treatment of animal by-products, which are subject to a risk assessment by the European Food 
Safety Authority. In addition, in the course of 2011, further "Better Training for Safer Food" 
training courses will be organised in order to contribute to a smooth transition to the new legal 
framework. 

Summary of Sector 

Significant  achievements  were  made  in  2010.  The  challenge  now  is  to  further  assist  the 
players in the sector (both the authorities of the Member States and the economic operators) to 
learn,  understand,  correctly  implement  and  enforce  the  new  rules  and  obtain  the  maximum 
benefit. 

15.4.22. Feed 

15.4.22.1. 

Current position 

General introduction presenting the legislation 

The  relevant  Treaty  provisions  for  legislation  in  the  Feed  sector  are  Article  43  and  Article 
168(4)(b) of the TFEU. 

As regards the feed marketing and feed labelling sector, new Regulation (EC) No 767/2009 of 
the  European  Parliament  and  of  the  Council  of  13  July  2009  applies  since  the  1  September 
2010. It lays down rules on the placing on the market and use of feed for both food-producing 
and  non-food  producing  animals  within  the  EU,  including  requirements  for  labelling, 
packaging  and  presentation.  Feed  materials  and  compound  feed  are  both  covered  by  this 
Regulation. 

Council  Directive  90/167/EEC  still  applies  to  medicated  feed,  but  new  legislation  is  in 
preparation (see below). 

As  regards  the  feed  additives  sector,  Regulation  (EC)  No  1831/2003  of  the  European 
Parliament and of the  Council  provides for the rules on the authorisation for placing on the 
market and use, including labelling, of these products. Detailed rules for the preparation and 
presentation of applications for authorisation are laid down in Commission Regulation (EC) 
No  429/2008,  while  the  Community  Reference  Laboratory  (CRL)'s  duties  and  tasks  are  set 
out in Commission Regulation (EC) No 378/2005. 

Undesirable substances in feed are governed by Council and European Parliament Directive 
2002/32/EC. 

Report of work done in 2010 

Feed marketing and labelling 

Regulation  (EC)  No  767/2009  on  the  placing  on  the  market  and  use  of  feed  entered  into 
application  on  1  September  2010.  It  constitutes  an  essential  piece  of  legislation  to  ensure  a 

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high level of feed safety and thus of public health, but also to provide adequate information 
for users and consumers and to strengthen the effective functioning of the Internal Market. 

In  2010  the  management  tools  for  the  harmonised  implementation  of  the  new  regime  were 
established, including the following actions: 

•  After the adoption of the Catalogue of feed materials, collaboration with the feed 
business sectors enabled the development of an updated and modernised version 
of  this  key  tool.  The  coverage  of  the  feed  materials  listed  in  the  draft  new 
Catalogue,  which  has  already  been  endorsed  by  the  Standing  Committee,  is 
significantly increased and the information about their properties is improved. 

•  Guidelines clarifying the borderlines between different types of feed were defined. 

•  The list of prohibited materials in feed was updated. 

•  Transitional measures for the application of the new labelling rules were adopted 

to facilitate compliance of feed operators to the new legislation. 

•  The permitted tolerances for the compositional labelling of feed were adapted to 

scientific and technological developments. 

•  The list of dietetic feed was updated further to operators' requests. 

Medicated feed 

Council Directive 90/167/EEC on medicated feed is outdated and not consistent with current 
legislation on both feed and veterinary medicinal products. Preparatory work for recasting and 
modernising  the  legislation  for  this  specific  type  of  products  was  carried  out  in  2010, 
including: 

•  the  finalisation  of  an  external  study  on  the  evaluation  of  the  EU  legislative 

framework in the field of medicated feed; 

•  exchanges  within  the  Standing  Committee  on  the  situation  within  the  Member 

States; 

•  the launch  of  the  impact assessment  in advance of the drafting of the legislative 

proposal. 

Feed additives 

In  2010,  nearly  30  Regulations  concerning  additives  authorisations  were  adopted  by  the 
Commission  after  completion  of  a  procedure  involving  EFSA,  the  CRL  and  the  Member 
States, and applicants' requests of confidentiality of the data submitted have been processed 
by the Commission. 

The preparatory work for the re-evaluation of current additives authorisations, as provided for 
in  Regulation  (EC)  No  1831/2003,  continued  in  view  of  the  large  amount  of  applications 
received  by  the  deadline  of  8  November  2010.  This  important  challenge  was  successfully 
taken  up  with  the  reception  and  management  by  the  Commission  of  several  hundred 

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applications  covering  all  essential  existing  feed  additives.  This  allows  the  continuity  of 
relevant authorisations and therefore supports good animal health and welfare within the EU. 

A Regulation clarifying the "non-additive" status of a series of products was adopted by the 
Commission, in order to bring clarity to operators regarding "borderline" products. 

As regards the labelling of feed additives and premixtures, clarification and simplification of 
the rules laid down in Regulation (EC) No 1831/2003 were achieved with the entry into force 
on 1 September 2010 of amending provisions contained in Regulation (EC) No 767/2009. 

Undesirable substances in feed 

In  2010,  maximum  levels  of  certain  contaminants  in  feed  were  reviewed  in  the  context  of 
Directive  2002/32/EC,  taking  account  of  EFSA  risk  assessments.  In  addition,  work  and 
discussion with the Member States and stakeholders continued as regards the acceptability of 
detoxification  processes  and  as  regards  the  consolidation  of  the  annexes  to  Directive 
2002/32/EC. 

Regular  discussion  took  place  with  the  Member  States  and  stakeholders  concerning  feed 
contamination cases reported through the RASFF. 

Committee and expert groups 

The management of the above mentioned feed sectors is subject to close co-operation with the 
Member States through regular (generally monthly) meetings of the Standing Committee on 
the Food Chain and Animal Health, section on Animal Nutrition, and punctual expert groups 
meetings where appropriate. 

International issues 

In  2010,  the  Commission  continued  its  participation  to  the  work  of  task  forces  in  OIE, 
CODEX and FAO in the feed sector. 

15.4.22.2. 

Evaluation based on the current situation 

The  adoption  in  2010  of  key  implementing  measures  of  Regulation  (EC)  No  767/2009 
concerning the marketing and labelling of feed ensured the effective and uniform application 
of the new regime from 1 September 2010. In particular, clarification of the status of certain 
"borderline" products and modernisation of the Catalogue of feed materials bring more legal 
certainty to feed operators in the EU. 

EU legislation on medicated feed is obsolete and not in line with current legislation on feed, in 
particular  the  Feed  Hygiene  Regulation,  but  also  with  legislation  on  veterinary  medicines. 
This makes the preparation of new legislation in this sector a priority action, as provided for 
in the Commission Work Programme 

In  the  field  of  undesirable  substances  in  animal  feed,  the  setting  of  maximum  levels  of 
contaminants  is  decided  through  successive  amendments  to  the  Annex  to  Directive 
2002/32/EC. This complicates the legibility of such measures. It is necessary to integrate and 
re-structure  all  amendments  into  a  new  tool.  In  addition,  the  analysis  and  management  of 
RASFF notifications may result in amendments to the existing legislation where needed. 

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Planned action 

As  regards  the  feed  marketing  and  labelling  sector,  it  is  intended  to  adopt  further 
implementing  measures  in  order  to  ensure  the  optimal  application  of  Regulation  (EC)  No 
767/2009. 

For the medicated feed sector, a full impact assessment will be carried out in 2011, taking into 
account the preparatory work already carried out, in order to present by 2012, as provided for 
in the Commission Work Programme, a Commission proposal recasting and modernising the 
legislation in this field. This initiative will be in a package with the revision of the Directive 
on veterinary medicinal products. 

The  main  challenge  in  the  feed  additives  area  will  be  the  optimal  implementation  of  the 
review  exercise  of  all  current  authorisations,  in  collaboration  with  EFSA  and  the  EU 
Reference  Laboratory.  This  will  result  in  a  thorough  "cleaning"  of  the  Register  of  feed 
additives  with  the  withdrawal  of  additives  which  were  not  subject  to  any  re-evaluation 
applications.  In  addition,  requests  for  the  authorisation  of  feed  additives  submitted  to  the 
Commission  will  continue  to  be  processed  within  the  time-limits  prescribed  by  Regulation 
(EC) No 1831/2003. It is also envisaged to study the possibility of a revision of the labelling 
rules, including concerning claims, laid down in Regulation (EC) No 1831/2003. 

As far as undesirable substances in feed are concerned, in addition to the continuous review 
of  maximum  levels  in  the  framework  of  Directive  2002/32/EC,  it  is  envisaged  to  take 
measures  concerning  the  presence  of  pharmaceuticals  in  feed  for  non-target  animals  and  to 
adopt measures on acceptability criteria for detoxification/decontamination processes in feed. 
Work concerning the consolidation of the annexes of Directive 2002/32/EC will continue in 
2011. 

More generally, adaptation of the feed legislation will be needed in order to comply with the 
provisions of the Lisbon Treaty concerning delegated and implementing acts. 

15.4.22.3. 

Summary by sector 

In summary, the following actions are to be considered as main priorities for 2011 and beyond 
in the feed sector: 

•  management of a full impact assessment and preparation of new legislation in the 

field of medicated feed; 

•  adoption  of  further  implementing  measures  of  Regulation  (EC)  No  767/2009  on 

the placing on the market and use of feed; 

•  implementation  of 
authorisations. 

the  re-evaluation  exercise  of  current  feed  additives 

15.4.23. Import controls on live animals and food from animal origin 

15.4.23.1. 

Current position 

General introduction presenting the legislation 

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Live animals and products of animal origin (such as meat, eggs and fish) and animal products 
not intended for human consumption (such as semen and embryos) are considered to represent 
a high risk because they can be vectors for the transmission of diseases not only to humans, 
but also to livestock. Apart from the threats to human health, the threats to animal health are 
particularly  worrying  due  to  the  detrimental  effects  of  the  spread  of  disease  on  European 
livestock production. 

Live animals and animal products can only enter the EU through approved border inspection 
posts (BIPs) under strictly harmonised import conditions. These require that such imports are 
sourced  from  approved  third  countries,  from  approved  or  registered  establishments  and  that 
the  veterinary  certificates  accompanying  the  consignments  are  signed  by  the  competent 
authority of the exporting country providing detailed information as to the public and animal 
health status of the products and their conformity with the EU’s import requirements. In the 
event  of  a  serious  animal  disease  outbreak  in  a  third  country,  import  restrictions  may  be 
established to prevent the introduction of the disease in the EU. 

Upon  arrival,  BIP  staff  carries  out  mandatory  controls  including  documentary,  identity  and 
physical  checks  to  verify  that  the  goods  conform  to  their  description  and  meet  EU  import 
conditions.  Physical  checks  are  always  required  in  the  case  of  live  animals,  however  such 
checks  may  be  reduced  for  animal  products  when  they  meet  harmonised  import  conditions 
and  when  veterinary  agreements  -  proving  that  the  third  country  can  offer  the  same  or 
equivalent levels of safety to those of the EU - are in place. Targeted analytical checks may 
form part of the physical check. 

Once  a  consignment  has  satisfactorily  undergone  these  checks  a  Common  Veterinary  Entry 
Document (CVED) is issued allowing the goods to be released for free circulation. There is 
close co-operation between veterinary and customs authorities, who do not permit the release 
of animals or animal products unless and until a CVED has been issued. 

Report of work done in 2010 

A roadmap of the review of the legislative framework of the import controls on live animals 
and products of animal origin was developed in the context of the review of the Official Food 
and Feed Controls Regulation (EC No 882/2004) on official controls on food and feed safety, 
animal  health  and  animal  welfare.  This  Regulation  will  serve  as  the  basic  act  for  the  new 
legislation on live animals and products of animal origin that will be developed. 

In 2010, two Commission decisions were adopted to amend the list of border inspection posts 
approved in accordance with Directives 91/496/EEC and 97/78/EC: 

•  Commission  Decision  2010/277/EU  of  12  May  2010  amending  Decision 
2009/821/EC as regards the lists of border inspection posts and veterinary units in 
Traces; 

•  Commission  Decision  2010/617/EU  of  14  October  2010  amending  Decision 
2009/821/EC as regards the lists of border inspection posts and veterinary units in 
Traces. 

In  the  last  quarter  of  2010,  a  report  was  prepared  to  the  Council  and  the  Parliament  on  the 
effectiveness and consistency of sanitary and phytosanitary controls on imports of food, feed, 

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animals and plants. 

Directorate-General Health and Consumers also contributed to a Commission Project Group 
aimed at developing technical specifications for establishing national Single Windows linking 
national electronic customs clearance systems with the CVED in TRACES. The establishment 
of the Single Windows will reduce administrative burden and deepen the cooperation between 
customs and veterinary services involved in import controls. 

The programme Better Training for Safer Food (BTSF) has a specific training module for the 
staff of BIPs to facilitate a harmonised approach to imports by BIPs. Several training courses 
for this module took place in 2010. 

15.4.23.2. 

Evaluation based on the current situation 

The  General  Food  Law  and  the  Official  Food  and  Feed  Controls  Regulation  (EC  No 
882/2004) will continue to provide the general framework for the control of foodstuffs and of 
other products of relevance for the food chain, while a number of new and innovative steps 
will  be  taken  to  consider  how  the  current  system  can  evolve  towards  a  more  efficient 
mechanism for the handling of coordinated import controls at EU borders. 

The review of its provisions will consolidate this integrated approach by looking at the rules 
currently applicable to veterinary controls on import of live animals and products of animal 
origin currently laid down in Council Directives 91/496/EEC and 97/78/EC respectively. 

Changes to the Official Food and Feed Controls Regulation are planned as part of the wider 
initiative to recast and simplify EU legislation - in the areas of food and feed safety, animal 
health, animal welfare and plant health – initiated in 2004. The aim is to ensure an integrated 
approach to official controls in all areas related to the food chain. 

15.4.23.3. 

Priorities and planned action 

15.4.23.4. 

Priorities 

The priorities are to: 

•  Introduce  mechanisms  to  better  link  the  level  of  controls  to  the  level  of  the 
associated risks to better target resources and increase the efficiency of controls; 

•  Optimise the legislation to ensure that policy goals are met; 

•  Simplify and clarify the legislation; 

•  Take into consideration the burdens to business and enforcers; 

•  Introduce new technologies into the legislation; 

•  Clarify and streamline the interaction with other EU legislation regarding import 

controls, in particular customs legislation. 

Planned action 

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In operational terms, this will require the improvement of current tools, such as the TRACES 
database, and the possible development of new ones, to allow risk management decisions on 
imported goods to fully take into account the risk profile of a given consignment considering 
its associated hazard and origin. This will be supported by data mining and handling functions 
to provide for more harmonisation of import controls across EU borders, and a consistent and 
transparent  process  to  determine  border  controls.  The  use  of  electronic  databases  including 
electronic  certification  should  be  promoted  to  reduce  administrative  burden  and  to  enhance 
co-operation between different authorities involved in import controls. 

15.4.23.5. 

Summary 

The review and update of the legislative rules governing import controls on live animals and 
products  of  animal  origin  will  bring  about  a  more  holistic  approach,  which  will  serve  to 
reinforce  the  efficiency  of  the  EU’s  import  control  regime,  ensure  an  optimal  allocation  of 
resources and make it easier to promote and defend the EU’s regulatory model. In addition, 
the  legislation  will  also  address  the  many  challenges  posed  by  emerging  technologies,  new 
diseases and globalisation. 

Relations with International Organisations 

In  2010  Directorate-General  Health  and  Consumers  continued  its  participation  to  plenary 
sessions and preparatory meetings of the Codex Alimentarius Commission (CAC) and of the 
World  Trade  Organisation/Sanitary  and  Phytosanitary  Committee.  The  accession  of  the  EU 
and  its  representation  by  the  Commission  are  clearly  defined  in  Council  Decision 
2003/822/EC. 

15.4.24. Animal welfare 

15.4.24.1. 

Current Situation 

General introduction 

Animals are keys to food supply and human nutrition. Animal welfare concerns have grown 
in  the  society  and  there  is  a  growing  insistence  on  high  animal  welfare  standards.  As  the 
world's largest trader (exports plus imports), Europe leads in promoting high levels of animal 
welfare.  TFEU  recognises  that  animal  are  sentient  beings  and  animal  welfare  requirements 
must be taken into account when drafting and implementing EU policies. 

Animal welfare in holdings/on the farm 

Council  Directive  98/58/EC  on  the  protection  of  animals  kept  for  farming  purposes  sets 
general  rules  for  the  protection  of  animals  of  all  species  kept  for  the  production  of  food, 
textiles or for other farming purposes. It defines general principles and minimum standards on 
appropriate  feeding,  comfort  and  prevention  of  unnecessary  suffering.  More  specific  rules 
apply to species raised in intensive systems such as laying hens, broilers, calves and pigs. 

Animal welfare during transport 

Council Regulation (EC) No 1/2005 on the protection of animals during transport and related 
operations intends to reduce the stress and harm that animals can experience when moved. It 
sets general principles and introduces standards for vehicles and equipment, and requirements 

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for those dealing with animals when being transported. 

Animal welfare at the time of killing 

Every  year  nearly  360  million  pigs,  sheep,  goats  and  cattle,  several  billion  poultry  and  25 
million  fur  animals  are  slaughtered  in  the  EU  for  production  purposes.  The  control  of 
contagious diseases may require the killing of thousands to millions of animals. 

Directive 93/119/EC on the protection of animals at the time of slaughter or killing laid down 
minimum  requirements  applicable  to  the  killing  of  animals  for  production  purposes  within 
and outside slaughterhouses. From 1 January 2013, it will be replaced by Council Regulation 
(EC) No 1099/2009. 

Ban on cat and dog fur 

Regulation (EC) No 1523/2007 of 11 December 2007 bans the placing on the market and the 
import to, or export from, the EU of cat and dog fur, and products containing such fur. The 
ban applies since 31 December 2008. 

Complaints: 

3.  The number of complaints on animal welfare remains relatively high, partly because 
in  recent  years  the  general  public,  together  with  Civil  Society,  have  become  more 
aware of issues related to animal welfare standards. The Commission is often placed 
in a position of resolving difficult judgement calls involving: 

•  The  fact  that  a  number  of  welfare  requirements  are  in  conflict  with  some  economic 

interests; 

•  The fact that animal welfare science is a relatively new area and consequently stakeholders 

are not aware of the benefits of respecting some provisions of the EU legislation. 

Different levels of priority are given to animal welfare in Member States due to the following 
factors: 

•  The  need  for  compromise  on  minimum  standards  which  lead  to  complaints  against 

Member States applying stricter rules; 

•  Animal welfare does not receive the same level of prioritisation in the political agenda of 

each Member State. 

In 2010, most of the complaints were either related to the conditions of transport of animals or 
to the conditions under which pigs are kept. 

Report of work done in 2010 

Strategic initiatives 

During 2010, the Commission mandated an external consultant to carry out an evaluation of 
the  EU  policy  on  animal  welfare.  The  outcomes  of  the  study  were  made  available  in 
December 2010. 

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Several communication actions were organised aiming at improving the level of knowledge of 
inspectors  in  Member  States  within  the  framework  of  "Better  Training  for  Safer  Food",  or 
facilitating  the  exchange  of  best  practices  between  stakeholders  in  order  to  improve 
enforcement. In addition, the Commission carried out specific actions to raise the awareness 
of the general public on animal welfare. The first international conference on animal welfare 
education was organised in Brussels on 1 and 2 October 2010. 

Animal welfare in holdings/on the farm 

Following the results of the EU funded research project Welfare Quality, the Commission is 
working on the possibility to integrate animal based welfare indicators into future legislation 
on  farm  animals.  To  this  effect,  the  Commission  mandated  the  EFSA  to  assess  the  welfare 
indicators currently available in dairy cows and see how these could be used to address EFSA 
recommendations  on  the  welfare  of  dairy  cows.  The  Commission  intends  to  extend  this 
approach to other farm species (pigs, beef cattle, calves, broilers, laying hens) in the next two 
years. 

The proper implementation of Directive 1999/74/EC on the protection of laying hens in order 
to avoid possible internal market distortions is a priority for the Commission which is closely 
following the actions taken so far by Member States to phase out battery cages by 1 January 
2012. During 2010, the Commission monitored closely the situation through FVO visits and 
Member States reports. Regular discussions within the framework of the Standing Committee 
on the Food Chain and Animal Health and meetings of Chief Veterinary Officers took place 
in order to collect and review the data on the state of play of the implementation. In particular, 
the Commission requested Member States to provide updated data and national plans for the 
proper implementation of Council Directive 1999/74/EC. 

The  Commission  continues  to  work  to  obtain  a  better  implementation  of  Directive 
2009/120/EC  on  the  protection  of  pigs.  To  this  effect,  the  Commission  organised  a  second 
workshop on the welfare of pigs in Parma on 11 November 2010. The aim is to exchange on 
best  farming  practices  pig  welfare  between  Member  States  and  main  stakeholders.  In 
particular,  it  represents  a  constructive  approach  to  address  some  of  the  difficulties  met  by 
Member States to fully implement EU requirements on the welfare of pigs such as avoidance 
of routine tail docking and providing adequate enrichment material.  Furthermore, the  future 
implementation of group housing of sows and gilts in all pig holdings by 1 January 2013 was 
discussed. 

Directive 2007/43/EC on the protection of broilers applies since 30 June 2010. In July 2010, 
EFSA published scientific opinions on the impact of genetic selection of broilers and on the 
welfare  of  grand-parents  and  parents  of  broilers.  The  Commission  will  use  EFSA  scientific 
opinions to prepare the report to the European Parliament and the Council on the welfare of 
broilers required by the Directive. 

Animal welfare during transport 

The  number  of  complaints  and  numerous  requests  for  specific  amendments  reveal  that 
Council Regulation (EC) No 1/2005 on the transport of animals is not properly enforced. As 
foreseen  this  Regulation,  the  Commission  is  preparing  a  report  on  the  welfare  of  animals 
being transported in the EU. 

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The  report  will  take  into  account  scientific  evidence  on  the  welfare  needs  of  animals  as 
presented  in  the  recent  scientific  opinion  produced  by  the  EFSA.  The  Commission  plans  to 
adopt  the  report  in  September  2011.  In  the  light  of  the  conclusions  of  the  report  and  the 
outcome  of  the  following  discussions  with  the  Council  and  the  European  Parliament,  the 
Commission will decide on which actions are necessary to ensure proper implementation of 
the current legislation, and it will analyse if changes to the legislation are needed. 

Meanwhile,  the  Commission  is  taking  concrete  actions  to  ensure  a  better  and  more 
harmonised  enforcement  of  Regulation  (EC)  No  1/2005.  The  Commission  organised  in 
December 2010 a meeting with the contact points in charge of transport of the Member States 
in order to exchange practical experience on controls on the transport of live animals. 

The Commission launched a call for proposals for a preparatory action of EUR 4 million on 
high  quality  control  posts,  which  was  successfully  awarded  in  2010.  The  action  will  be 
performed  in  2011-2012  and  will  include  the  renovation  of  12  control  posts  as  well  as  the 
development  of  a  certification  scheme.  It  will  include  training  and  communication  to 
stakeholders. 

Animal welfare at the time of killing 

Following  complaints,  the  Commission  launched  a  survey  on  the  way  Member  States 
competent authorities granted the derogation from stunning in the case of ritual slaughter. The 
results of the survey have been analysed and will be communicated to the Member States in 
2011 for improving the situation.  

FVO Inspections Findings 

Laying hens 

The FVO carried audits in 25 Member States between 2008 and 2010 in order to assess the 
situation in the laying hen sector regarding in particular the state of preparedness of Member 
States to implement the ban on battery cages from 1 January 2012. As mentioned earlier, the 
situation  is  quite  variable  between  Member  States:  some  are  already  implementing  the  ban, 
others  took  actions  and  will  ready  by  1  January  2012  and  others  are  late  in  putting  the 
necessary measures in place to implement the ban on battery cages by the legal deadline. 

In the pig sector there is a general lack of enforcement of long standing requirements such as 
provision  of  enrichment  materials  and  avoidance  of  routine  tail-docking.  The  state  of 
preparedness  for  Member  States  to  implement  group  housing  of  sows  and  gilts  in  all  pig 
holdings by 1 January 2013 is quite variable and will need to be closely monitored over the 
next two years. 

Concerning the transport of animals, the  requirements  of vehicles for long journeys and the 
control of journey times are in general not sufficiently applied. The conditions of transport of 
horses for slaughter are still a problematic issue. 

Although on farm emergency slaughter has been implemented in a number of Member States, 
the  issue  of  the  transport  of  injured  cows  to  slaughterhouses  continues  to  be  a  significant 
problem in others. 

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15.4.24.2. 

Evaluation based on the current situation 

Animal  welfare  remains  an  issue  attracting  public  attention  given  that  ordinary  citizens  are 
keenly interested in how livestock is raised and whether the required animal welfare standards 
are  being  respected.  Member  States  are  key  in  ensuring  implementation  of  animal  welfare 
legislation. The Member States' role is not only crucial in ensuring transposition of Directives 
in this area but also in effectively deploying the resources and mechanisms needed to ensure 
compliance with the EU's animal welfare requirements. 

Some  resources  are  devoted  to  dealing  with  situations  for  which  the  Commission  lacks 
powers to regulate. Stray dogs and cats, for instance, do not fall under the scope of the Treaty 
but  yet  the  Commission  devotes  considerable  resources  in  replying  to  citizens  complaining 
about cruelty towards pet animals. 

The different relevance and political weight that animal welfare has amongst Member States 
makes  it  difficult  to  set  rules  that  satisfy  agriculture,  animal  welfare  organisations  and 
consumers at the same time. 

The evaluation performed in 2010 identified several areas for improvement, and in particular 
enforcement,  research,  communication,  education  and  international  issues.  The  Commission 
will work in 2011 to present a second EU strategy for the protection and welfare of animals 
2011-2015, which will set up the main policy objectives for the forthcoming years on animal 
welfare. 

Priorities 

Enforcement difficulties have been identified as one of the key problems to be addressed in 
the  future  strategy  for  animal  welfare.  Different  possibilities  will  be  explored  in  the 
framework of the future strategy to tackle the issue. 

It  will  remain  important  to  react  swiftly  and  adequately  to  the  concerns  of  interested 
stakeholders.  The  FVO  will  continue  to  put  an  emphasis  on  establishing  data  on  the 
compliance  of  Member  States  with  EU  rules  on  animal  welfare  in  order  to  detect 
shortcomings but also in order to understand more precisely why certain Member States have 
difficulties to comply with welfare rules. 

The  Commission  will  continue  to  raise  awareness  on  animal  welfare  by  developing  further 
already  existing  tools  such  as  "Farmland"  and  developing  new  education  tools  targeted 
towards  children,  and  by  pursuing  its  active  participation  in  the  "Better  Training  for  Safer 
Food" programme. 

Planned Actions 

In 2011, the Commission will prepare the second EU strategy for animal welfare 2011-2015. 
This document will laid down the specific objectives and actions needed for the forthcoming 
years  on  animal  welfare  at  EU  level.  Several  reflections  are  ongoing  and  in  particular  the 
Commission will consider the suggestion of the European Parliament to propose a general EU 
framework  law.  Such  a  law  could  be  the  occasion  to  introduce  new  principles  in  particular 
animal based indicators as developed by the Welfare Quality Project, an EU research based 
project on animal welfare. 

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A number of actions which have been initiated in the previous years will be maintained and 
expanded. 

Concerning farm animals, the Commission will continue to work for a better implementation 
of  the  current  EU  legislation.  Priorities  will  be  given  to  help  Member  States  to  be  ready  to 
implement  the  ban  on  battery  cages  by  1  January  2012,  and  to  the  proper  enforcement  of 
certain requirements of the Directive on the protection of pigs. The Commission will work to 
facilitate the future implementation of group housing of sows by 1 January 2013. 

Concerning  broilers,  the  Commission  will  launch  an  evaluation  study  in  order  to  prepare  a 
report  to  the  European  Parliament  and  to  the  Council  concerning  the  influence  of  genetic 
parameters  on  identified  deficiencies  resulting  in  poor  welfare  of  chickens  and  the  state  of 
play of the Directive. 

Concerning the transport of animals, the Commission will work on a report to the European 
Parliament and to the Council on the impact of Regulation (EC) No 1/2005 on the protection 
of  animals  during  transport,  using  the  EFSA  scientific  opinion  which  updates  the  scientific 
information available on the welfare of animals during transport as well as the results of the 
study  on  transport  which  was  launched  in  2010.  The  Commission  report  is  planned  for 
adoption in September 2011. 

The implementation of the ban on cat and dog fur within the EU will be assessed on the basis 
of  questionnaires  sent  to  the  Member  States,  in  a  report  which  the  Commission  intends  to 
submit to the European Parliament and to the Council by December 2011. 

15.4.24.3. 

Summary of Sector 

The  challenge  in  this  sector  is  to  reply  to  the  growing  concerns  of  European  citizens'  on 
animal welfare both in the EU and internationally, and to balance the expectations of animal 
welfare  organisations  with  the  requirements  of  a  competitive  agriculture,  while  seeking  to 
simplify legislation and reduce administrative burden. 

15.5.  Overall evaluation 

15.5.1.  Better application of the health and consumer acquis is everyone's concern 

The  Commission  seeks  to  use  the  full  extent  of  its  Treaty  powers  in  these  policy  areas  that 
have  such  a  direct  impact  on  citizens,  consumers  and  economic  operators.  To  do  so 
Directorate-General  Health  and  Consumers  endeavours  to  engage  society  at  large  so  that 
everyone  reaps  the  benefits  of  the  acquis  in  this  area.  But  the  Commission  cannot  alone 
deliver better application of this acquis without the cooperation of the Council, the European 
Parliament and Member States. Member States are primarily responsible for implementation 
and  the  Commission  works  to  build  partnerships  and  bridges  of  cooperation  to  ensure  that 
legislation becomes reality on the ground. 

Cooperation  between  Commission  services  and  national  enforcers  and  experts  is  essential, 
starting  from  the  design  phase  of  any  new  legislation.  Evaluations  carried  out  by  the 
Commission  assess  systematically  the  actual  application  of  the  relevant  EU  legislation  and 
will contribute to the preparation of subsequent impact assessments, which measure the real 
impact of intended changes on the daily lives of citizens and on other stakeholders. 

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The Commission is mindful that this area of legislation is often technical, complicated and not 
easy  to  understand  by  enforcers,  economic  operators  and  ordinary  citizens.  Every  effort  is 
being made to promote a regulatory environment that is modern, simple and proportionate but 
that does not weaken the necessary health protection afforded by the policies in this area. 

This area is very close to many concerns that citizens have about Europe. The Commission 
will  seek  to  increase  transparency  on  actions  being  taken  by  Member  States'  enforcement 
actors to ensure compliance. At the same time the Commission will seek to empower citizens, 
consumers  and  patients  through  information  to  enable  them  to  support  implementation 
practices and outcomes in Member States. 

15.5.2. Prevention 

The  Commission  continued  in  2010  to  issue  or  to  update  implementation  guidelines  on  the 
correct  application  of  its  policy  areas.  In  the  public  health  policy  area,  the  Commission,  by 
adopting  Decision  2010/453/EC,  established  guidelines  concerning  the  conditions  of 
inspections and control measures, training and qualification of officials in the field of human 
tissues  and  cells  provided  for  in  Directive  2004/23/EC.  In  the  consumer  policy  area  the 
Commission, by adopting Decision 2010/15/EU, revised the RAPEX guidelines. This revision 
was necessary because of the significant increase in the number of notifications through the 
RAPEX network that has be followed up in the Member States and of the need to increase the 
traceability of dangerous products notified via the system. 

In  addition  the  Commission  organised  workshops  to  assist  the  Member  States  with  the 
implementation  of  Directives  which  they  are  in  the  process  of  transposing  (for  example  the 
implementation  of  the  Organs  Directive  2010/53/EU)  or  with  national  authorities  and 
stakeholders to promote an exchange of information and best practices between industry and 
veterinary  experts  from  Member  States  (for  example  on  how  to  minimise  animal  suffering 
during pig tail docking). 

For  the  implementation  and  consistent  application  of  Directive  91/414/EEC  concerning  the 
placing  of  plant  protection  products  on  the  market,  the  Commission  continued  to  develop 
further guidelines. Currently 47 guidelines documents are available to the public. 

In  2006  the  Commission  launched  a  training  programme  entitled  "Better  Training  for  Safer 
Food". This is an EU training strategy for food and feed law, animal health and welfare rules 
and plant health rules. Training is designed for Member State's and third country's competent 
authority's staff involved in official control activities. It aims to keep them up-to-date with EU 
law in the areas specified above and to ensure more uniform and efficient controls across the 
EU and on imports to the EU. Better Training for Safer Food comprises training programmes 
on  subjects  where  needs  for  improved  application  of  EU  law  have  been  identified.  The 
number of programmes and the number of people trained have increased each year since the 
initiative's  launch.  Further  new  training  actions  are  to  be  launched  in  2011.  These  include 
training  on  new  subjects  such  as  Audit  systems/Internal  auditing,  TRACES524  and  quality 
schemes. 

524 

TACES:  TRAde  Control  and  Expert  System  (a  trans-European  network  for  veterinary  health  which 
notifies, certifies and monitors imports, exports and trade in animals and animal products). 

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Another type of prevention is provided for in Directive 98/34/EC laying down a procedure for 
the provision of information in the field of technical standards and regulations. This Directive 
obliges  Member  States  to  notify  to  the  Commission,  before  they  are  adopted,  draft  acts 
containing  technical  standards  and  regulations.  During  2010  the  Commission  services 
responsible for health and consumers examined around 220 notifications of draft legislation. 

The rapid alert system for food and feed (RASFF) is an effective tool to exchange information 
about  national  measures  taken  responding  to  serious  risks  detected  in  relation  to  food  or 
feed525. This is a concrete and visible result of a successful European integrated approach to 
ensure food safety. It helps Member States to act more rapidly and in a coordinated manner in 
response to a health threat caused by food or feed. Its effectiveness is ensured by keeping its 
structure simple: it consists essentially of clearly identified contact points in the Commission 
and at national level, and exchanging information in a clear and structured way by means of 
templates.  The  Commission  together  with  Member  States  continues  to  work  hard  in  further 
shaping this essential tool that contributes to high food safety standards in the EU, preventing 
dangerous food or feed from reaching the consumer and allowing swift action to be taken to 
remove  such  products  from  the  market.  In  2010  a  total  of  3358  original  notifications  were 
transmitted  through  the  RASFF;  of  which  592  were  classified  as  alert,  1188  as  information 
and 1578 as border rejections. 

The EU rapid information system RAPEX (for dangerous non-food consumer products found 
and  consequently  withdrawn  from  the  market)  is  a  similar  tool.  In  2010,  2244  notifications 
were  exchanged  through  the  system.  Following  the  entry  into  force  of  Regulation  (EC)  No 
765/2008 the scope of the system was extended.  

Discussions  with  Member  States  in  expert  groups  or  with  stakeholders  in,  for  example, 
workshops,  often  identify  areas  of  difficulty  in  fully  appreciating  the  nature  of  specific 
legislative  instruments.  The  Commission  services  often  provide  detailed  interpretations  of 
specific provisions in order to achieve broad but uniform understanding of specific provisions. 

15.5.3. Regular review of legislation 

The health and consumer legislation is regularly reviewed after careful evaluation of impacts 
as well as continuous and fruitful dialogue with citizens, consumers and other stakeholders in 
order to: 

•  optimise the legislation for ensuring that policy goals are met; 

•  enhance the effectiveness of the legal framework; 

•  simplify and clarify the legislation; 

•  take into consideration the burdens to business and enforcers; 

•  to introduce new technologies into the legislation; 

525 

The legal basis of RASFF is Article 50 of Regulation (EC) No 178/2002 of the European Parliament 
and of the Council laying down the general principles and requirements of food law, establishing the 
European  Food  Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety,  OJ  L  31, 
1.2.2002, p. 1. 

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•  clarify the interaction with other EU legislation. 

In 2010, as a result of that work, the adoption of Regulation (EU) No 1235/2010 amending, as 
regards  pharmacovigilance  of  medicinal  products  for  human  use,  Regulation  (EC) 
No 726/2004  laying  down  Community  procedures  for  the  authorisation  and  supervision  of 
medicinal  products  for  human  and  veterinary  use  and  establishing  a  European  Medicines 
Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products as well 
regards 
as  Directive  and 
pharmacovigilance,  Directive  2001/83/EC  on  the  Community  code  relating  to  medicinal 
products for human use, finalised the revision of several key pieces of legislation. 

the  adoption  of  Directive  2010/84/EU  amending  as 

Evaluations  of  existing  legislation  have  been  carried  out  and  will  be  the  basis  of  impact 
assessments in 2011 for future major legislative revisions (e.g. in the plant health legislation 
and the plant seed legislation). Further evaluations have been launched (inter alia on the plant 
variety rights legislation). 

15.5.4. Audits, Inspections and market surveillance 

Another aspect of prevention is the ability of the Commission services to see for themselves 
the realities of enforcement on the ground. 

Enforcement of the food safety legislation would be weak if the FVO was not able to examine 
whether Member States and third countries from which food is imported, properly apply food 
and feed safety controls. 

Each year the FVO develops an audit and inspection programme identifying priority areas and 
countries. It carries out around 250 audits and inspections, including both general and specific 
audits, annually. Following each, a report is issued which sets the actions needed to improve 
compliance. The large majority of weaknesses in control systems identified by the FVO are 
addressed  through  specific  action  plans  drawn  up  by  national  authorities  in  response  to  its 
recommendations. 

In recent years, the FVO has developed overall country profiles for each Member State and 
for the EU's main trading partners. These profiles bring together and summarise the results of 
general and specific audits and inspections over time and across all relevant sectors. They can 
thus  help  to  identify  systemic  weaknesses  in  the  overall  design  and  application  of  national 
control systems. As these results are progressively refined and validated, remedial action can 
be  proposed  that  address  the  underlying  causes  that  are  common  to  a  number  of  specific 
sectors,  for  example,  the  absence  of  a  system  of  documentary  records  of  controls  or  the 
absence of an effective system of sanctions for non-compliance. 

The FVO regularly carries out general follow-up missions in order to monitor the action taken 
by  Member  States  to  address  the  concerns  identified  by  FVO  in  its  recommendations. 
Directorate-General Health and Consumers has reorganised its structure in order to enhance 
the enforcement in the food safety area (including animal health and welfare and plant health). 
An enforcement Unit ensures a coordinated and sustained approach to all enforcement issues 
through  improved  decision  making.  Its  task  is  supported  by  a  recently  developed  internal 
database  which  enables  to  coordinate  progress  towards  the  resolution  of  particular 
enforcement issues that, on the basis of risk analyses, need to be followed up. 

In  the  consumer  policy  area  the  Commission  for  the  fourth  time  carried  out  a  market 

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surveillance exercise in the form of a sweep on sites selling tickets for cultural and sporting 
events. Such sweeps allow the Commission to identify the existing incompliant conditions on 
websites  and  through  contacts  with  the  involved  companies  to  obtain  corrections  on  the 
websites. 

Conclusion 

The above shows the Commission's determination to fully implement its acquis in the policy 
areas of consumers, food safety and public health and to up-date its regulatory framework, if 
necessary.  Consumers  can  be  confident  that  the  safety  of  their  food  is  protected  by  strict 
enforcement  of  controls.  Trade  can  take  place  under  conditions  of  uniform  and  high  safety 
levels,  which  allow  markets  to  focus  on  price,  quality  and  consumer  preferences.  The 
Commission remains ready to manage any emergencies or other unforeseen circumstances in 
this area having always in mind the welfare, well-being and protection of European citizens. 

16. 

HOME AFFAIRS 

16.1. 

Immigration and integration 

16.1.1.  Current position: General introduction 

EU legislation in the field of immigration and integration currently consists of nine directives.  

Regarding legal migration, four sets of measures have been adopted: 

•  a first set of measures adopted in 2003: the Family Reunification Directive 2003/86526 and 

the Long-term Residents Directive 2003/109527; 

•  Directive  2004/81  on  the  residence  permit  issued  to  third-country  nationals  who  are 
victims  of  trafficking  in  human  beings  or  who  have  been  the  subject  of  an  action  to 
facilitate illegal immigration, who cooperate with the competent authorities528; 

•  the Students Directive 2004/114529 and the Researchers Directive 2005/71530; and 

•  the Highly qualified Workers Directive 2009/50531 (‘EU Blue Card’). 

Three directives concern irregular immigration: 

526 

527 

528 
529 

530 

531 

Council  Directive  2003/86  of  22  September  2003  on  the  right  to  family  reunification,  OJ  L  251, 
3.10.2003, p. 12. 
Council Directive 2003/109/EC of 25 November 2003 concerning the status of third-country nationals 
who are long-term residents, OJ L 16, 23.1.2004, p. 44. 
OJ L 261, 6.8.2004, p. 19. 
Council Directive 2004/114/EC of 13 December 2004 on the conditions of admission of third-country 
nationals for the purposes of studies, pupil exchange, unremunerated training or voluntary service, OJ L 
375, 23.12.2004, p. 12. 
Council Directive 2005/71/EC of 12 October 2005 on a specific procedure for admitting third-country 
nationals for the purposes of scientific research, OJ L 289, 3.11.2005, p. 15. 
Council Directive 2009/50/EC of 25 May 2009 on the conditions of entry and residence of third-country 
nationals for the purposes of highly qualified employment, OJ L 155, 18.6.2009, p. 17. 

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•  the Carriers Liability Directive 2001/51532 and Directive 2002/90533 defining facilitation of 

unauthorised entry, transit and residence; and 

•  the Employer Sanctions Directive 2009/52534, which aims to reduce illegal immigration by 
prohibiting the employment of illegal staying migrant workers and providing for sanctions 
against employers who infringe the prohibition. 

The EU’s comprehensive migration policy continues to be developed, so efforts in this area 
are as much about developing new legislation as ensuring the correct application of existing 
legislation.  Regarding  labour  migration,  in  its  2005  Policy  Plan  on  Legal  Migration535,  the 
Commission  announced  its  intention  to  present  proposals  for  a  general  framework  directive 
and directives for specific categories of paid workers.  

The  first  such  directive  —  the  EU  Blue  Card  —  was  adopted  in  2009,  and  discussions 
continued  in  the  European  Parliament  and  Council  on  the  proposed  ‘Single  Permit’ 
Directive536.  The  Commission  presented  proposals  for  Directives  on  seasonal  workers  and 
intra-corporate  transferees  in  July  2010,  and  discussions  in  the  European  Parliament  and 
Council are ongoing.  

16.1.2.  Current position: Report on work done in 2010 

In  line  with  the  Stockholm  Programme's  call  on  the  Commission  to  evaluate  and,  where 
necessary, to review the Family Reunification Directive, taking into account the importance 
of integration measures537, the Commission intends to carry out a wider consultation — in the 
form of a Green Paper — on the future of the family reunification regime.  

In  2010,  the  Commission  presented  a  Report  on  the  Victims  of  Trafficking  Directive 
(2004/81)538.  It  found  that  the  number  of  residence  permits  issued  on  the  basis  of  this 
Directive was significantly lower than the number of victims identified. This proved that the 
potential of this Directive is being underused.  

As  regards  presumed  infringements  disclosed  by  complaints,  the  case  in  the  Netherlands 
concerning the high level of fees charged to those applying for long-term residents’ permits is 
still pending before the Court of Justice. In another infringement  case,  concerning the  same 
point, but against Cyprus, the results of the ECJ judgment will be applied accordingly.  

The Commission continued the infringement procedure against Austria regarding rules under 
which  third-country  national  students  are  permitted  to  work  in  that  Member  State.  The 

532 

533 

534 

535 
536 

537 
538 

Council  Directive  2001/51  of  28  June  2001  supplementing  the  provisions  of  Article  26  of  the 
Convention implementing the Schengen Agreement of 14 June 1985, OJ L 187, 10.7.2001, p. 45. 
Council Directive 2002/90 of 28 November 2002 defining the facilitation of unauthorised entry, transit 
and residence, OJ L 328, 5.12.2002, p. 17. 
Directive  2009/52/EC  of  the  European  Parliament  and  of  the  Council  of  18  June  2009  providing  for 
minimum  standards  on  sanctions  and  measures  against  employers  of  illegally  staying  third-country 
nationals, OJ L 168, 30.6.2009, p. 24. 
COM(2005) 669 final. 
Proposal for a Council Directive on a single application procedure for a single permit for third-country 
nationals to reside and work in the territory of a Member State and on a common set of rights for third-
country workers legally residing in a Member State, COM (2007) 638 final of 23.10.2007. 
Presidency Conclusions, document EUCO 6/09. The Programme itself is in document 17024/09. 
COM(2010) 493 final. 

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Commission  considers  that  the  Students  Directive  2004/114  requires  that  third-country 
national students be allowed to work under less restrictive conditions.  

Regarding  the  management  of  the  existing  acquis,  a  meeting  of  the  contact  committee  on 
legal migration directives in December 2010 provided the opportunity for a useful exchange 
of  views  between  the  Commission  and  national  experts  involved  in  their  application.  A 
meeting  of  national  contact  points  appointed  under  the  Long-term  Residents  Directive 
2003/109  was  also  held.  Alongside  discussions  in  the  contact  committee,  the  European 
Migration  Network539  (EMN)  continued  to  be  a  means  for  Member  States  (and  the 
Commission)  to  address  ad  hoc  queries  to  obtain  a  quick  overview  on  how  other  Member 
States  transpose  specific  provisions  of  the  directives.  The  Committee  on  Immigration  and 
Asylum (CIA) provided a forum for the Commission to give up-dated information to Member 
States on the legal acquis, as well as allowing Member States to comment on factual aspects 
of their transposition in the context of the Commission's reports. 

Work  continued  on  the  external  transposition  studies  for  the  Students  Directive  and  the 
updated study on the Long-term Residents Directive, commissioned with a view to preparing 
implementation reports on the directives. In cooperation with Commission department in the 
area  of  Research,  the  contract  for  an  external  study  on  the  Researchers  Directive  was 
launched. The final study is due in August 2011. These three studies will form the basis of the 
Commission’s reports on the application of the directives in question.  

Regarding the transposition of new legislation, Member States have to transpose the EU Blue 
Card  into  national  law  by  June  2011,  and  the  Employer  Sanctions  Directives  by  July  2011. 
Meetings of the contact committees were held in late 2009 and in 2010 (two meetings for the 
EU  Blue  Card,  three  meetings  for  Employers’  Sanctions),  enabling  a  useful  exchange  of 
views between the Commission and national experts involved in the national transposition of 
the directives. 

Legislative  discussions  in  the  Council  and  European  Parliament  continued  on  the  ‘Single 
Permit’  Directive  for  labour  migration.  This  will  provide  for  a  single  permit  (residence  and 
work)  and  basic  socio-economic  rights  for  migrant  workers.  Negotiations  also  started  on 
proposals adopted in July 2010 on seasonal workers and intra-corporate transferees. 

16.1.3.  Evaluation based on the current situation 

Bearing  in  mind  that  it  took  until  2009  to  fully  transpose  directives  dating  from  2005  and 
earlier  EU-wide,  there  is  a  pressing  need  for  Member  States  to  reinforce  their  efforts  to 
complete  transposition  of  the  most  recent  directives  in  this  field,  the  EU  Blue  Card  and 
Employer Sanctions, by the mid-2011 deadline. By end of 2010, only one Member State had 
communicated its full transposition measures for these to the Commission.  

The  Commission  has  continued  to  pursue  the  most  important  presumed  infringements 
disclosed by complaints, and it will go on doing so.  

Legislative  activity  (preparing  new  proposals  as  well  as  legislative  discussions  themselves) 
continued to be important in this sector. The Lisbon Treaty has introduced co-decision in the 

539 

Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network, OJ L 131, 
21.5.2008, p. 7. 

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area of legal immigration, thus giving an enhanced role to the European Parliament. This has 
given impetus to legislative discussions on the general framework directive for a single permit 
and rights.  

16.1.4.  Evaluation results: Priorities 

The main priorities are: 

1. 

2. 

3. 

4. 

Ensuring the correct application of existing legal migration directives;  

Ensuring  the  correct  and  timely  transposition  of  the  Blue  Card  and  Employers’ 
Sanctions Directives; 

Preparing Commission reports on the application of existing directives; 

Ensuring  appropriate  follow-up  to  the  Report  on  the  Victims  of  Trafficking 
Directive. 

16.1.5.  Evaluation results: Planned action (2011 and beyond) 

As  regards  priorities  1  and  2,  the  Commission  will  examine  Member  States’  transposition 
measures  for  the  Blue  Card  and  Employer  Sanctions  Directives,  and  will  take  action  as 
appropriate for non-transposition and incorrect transposition of the Directives. In addition it 
will actively follow up complaints about the application of the other legal migration directives 
in Member States. 

As  regards  priority  3,  the  Commission  will  in  2011  present  reports  on  the  Long-term 
Residents, Students and Researchers Directives. On the basis of these, the Commission will 
decide what further action is needed. 

As  regards  priority  4,  the  Commission  will  examine  all  cases  of  problems  in  applying  this 
directive. This may involve contacting Member States and/or launching procedural steps for 
non-compliance, where appropriate, in accordance with Article 258 TFEU. In its report on the 
Victims  of  Trafficking  Directive,  the  Commission  also  announced  that  it  may  consider  the 
need for amendments.  

Other activity will include: 

–  Contributions to the Commission’s intervention before the Court of Justice with regard to 
requests by national courts for preliminary rulings on the interpretation of EU legislation in 
the area of legal migration; 

–  Continued  discussions  in  the  "contact  committees",  allowing  Member  States  an  open 
forum in which to discuss questions or problems they have identified in their transposition 
of the Directives. 

16.1.6.  Summary 

The Commission will prepare reports on the Students, Researchers and Long-term Residents 
Directives.  Given  the  ongoing  development  of  the  EU’s  comprehensive  migration  policy,  it 
will also give attention to the legislative process to ensure coherence with directives already 

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adopted.  Ensuring  the  correct  transposition  of  the  two  Directives  adopted  in  2009  will  be  a 
priority. 

16.2.  Asylum 

16.2.1.  Current position: General introduction 

Following  the  entry  into  force  of  the  Treaty  of  Lisbon,  asylum  policy  is  now  regulated  by 
Article  78  TFEU.  The  asylum  acquis  is  essentially  composed  of  four  directives  (Reception 
Conditions540, Qualification541, Asylum Procedures542 and Temporary Protection543) and three 
regulations (Dublin544, Eurodac545 and European Asylum Support Office546). The directive on 
the status of third-country nationals who are long-term residents547 is also relevant for asylum 
policy.  Amendments  to  all  these  legal  instruments  (except  the  European  Asylum  Support 
Office Regulation) are currently being negotiated by the co-legislators. 

Regarding asylum policy, the main development in 2010 was the continuation of negotiations 
on legal instruments for the second phase of the Common European Asylum System (CEAS). 
Negotiations gathered pace, especially during the second semester, as the Belgian Presidency 
had  made  asylum  one  of  its  priorities.  Significant  progress  was  made  on  some  legal 
instruments,  e.g.  with  the  formal  adoption  of  the  instruments  aiming  at  the  creation  of  the 
European Asylum Support Office (EASO) and a compromise reached between the European 
Parliament  and  the  Council  on  the  extension  of  the  legal  system  for  third-country  nationals 
with  long-term  resident  status  to  include  persons  with  international  protection  (modification 
of  Directive  20003/109/EC).  Concerning  the  Qualification  Directive,  in  the  course  of  2010, 
the  Presidencies  proposed  several  compromise  amendments  and  an  important  number  of 
reservations  was  lifted.  Progress  was  also  made  on  the  'Joint  EU  Resettlement  Programme'. 
Discussions were however difficult on some instruments, in particular with limited progress 
on  the  Asylum  Procedures  Directive,  the  Reception  Conditions  Directive  and  the  Dublin 
Regulation. As far as the EURODAC Regulation is concerned, the Commission aims with a 
new  proposal  at  allowing  for  a  rapid  agreement  by  the  co-legislators,  and  thereby  facilitate 

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06.02.2003 Council Directive 2003/9/EC of 27 January 2003 laying down minimum standards for the 
reception of asylum seekers; OJ L 031, 06.02.2003 p. 18 – 25. 
30.09.2004 Council Directive 2004/83/EC of 29 April 2004 on minimum standards for the qualification 
and status of third country nationals or stateless persons as refugees or as persons who otherwise need 
international protection and the content of the protection granted; OJ L 304, 30.09.2004 p. 12 – 23. 
13.12.2005 Council Directive 2005/85/EC of 1 December 2005 on minimum standards on procedures in 
Member States for granting and withdrawing refugee status OJ L 326, 13.12.2005, p. 13. 
20.07.2001 Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary 
protection in the event of a mass influx of displaced persons and on measures promoting a balance of 
efforts between Member States in receiving such persons and bearing the consequences thereof; OJ L 
212, 07.08.2001, p. 12 – 23. 
25.02.2003  Council  Regulation  (EC)  No  343/2003  of  18  February  2003  establishing  the  criteria  and 
mechanisms for determining the Member State responsible for examining an asylum application lodged 
in one of the Member States by a third-country national; OJ L 50, 06.02.2003, p. 1 – 10. 
15.12.2000 Council Regulation (EC) No 2725/2000 of 11 December 2000 concerning the establishment 
of 'Eurodac' for the comparison of fingerprints for the effective application of the Dublin Convention; 
OJ L 316, 15.12.2000, p. 1 – 10. 
29.05.2010  Regulation  (EU)  no  439/2010  of  the  European  Parliament  and  of  the  Council  of  19  May 
2010 establishing a European Asylum Support Office; OJ L 132, 29.05.2010, p. 11- 28. 
23.1.204 Council Directive 2003/109/EC of 25 November 2003 concerning the status of third-country 
nationals who are long-term residents Official Journal L 16, 23.1.2004, p. 44–53. 

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progress  on  the  whole  asylum  package  as  well  as  the  timely  set  up  of  the  IT  Agency  (that 
should also be responsible for the management of EURODAC).  

As  far  as  the  EASO  is  concerned  the  co-legislators  formally  approved  the  creation  of  the 
EASO and Member States decided that its seat would be in Valletta, Malta. Since then, the 
Commission  has  been  actively  working  with  a  view  to  preparing  the  start  of  EASO's 
operations, and it should be fully operational by 19 June 2011.  

16.2.2.  Current position: Report on work done in 2010 

The Commission decided in June 2010 to refer Belgium to the Court of Justice for failure to 
communicate  measures  fully  transposing  the  Asylum  Procedures  Directive  further  to 
infringement  proceeding  initiated  in  2008.  In  September  2010,  the  Commission  received 
notification of full transposition, so the infringement proceeding was closed. 

In June 2010, the  Commission  decided to  refer Ireland  to the  Court of Justice for failure to 
communicate measures fully transposing the Asylum Procedures Directive. Ireland delivered 
its Defence to the Court of Justice on 25 November 2010. It indicated that it intended to adopt 
measures transposing the provisions of the Asylum Procedures Directive in the near future. 

In March 2010, the Commission proposed closing three cases of non-communication against 
Sweden,  Spain  and  Cyprus,  further  to  notifications  of  full  transposition  of  the  Asylum 
Procedures  Directive;  and  to  close  two  cases  of  non-communication  against  Sweden  and 
Spain concerning the Qualification Directive. 

The  Commission  has  taken  steps  to  review  reported  deficiencies  in  the  asylum  system  in 
Greece. The reports raised concerns as to whether the Greek asylum system is in compliance 
with the minimum standards prescribed by EU law, particularly those set out in the Asylum 
Procedures Directive, the Qualification Directive and the Reception Conditions Directive. In 
November  2009,  the  Commission  sent  Greece  a  letter  of  formal  notice  followed  by  a 
supplementary letter of formal notice in June 2010.  

An  Action  Plan  has  been  drawn  up  and  submitted  to  the  Commission  in  August  2010.  The 
Commission,  Member  States,  the  European  Asylum  Support  Office,  UNHCR  and  other 
European  Partners  have  signalled  their  commitment  to  assist  Greece  in  this  process  (by 
financial and other means). In December 2010, Member States experts visited Greece under 
Commission  financing,  to  provide  advice  in  the  areas  of  backlog  management,  training  and 
screening/registration of asylum applications. The expert reports drafted in collaboration with 
UNHCR have become the basis for planning future supporting measures. The provision of EU 
assistance  to  Greece  will  continue  in  2011,  with  the  support  of  the  Commission  and  EASO 
and in close cooperation with UNHCR.  

16.2.3.  Evaluation based on the current situation 

In line with ambitions the Council articulated in the Hague Programme adopted in 2004, and 
the  Stockholm  Programme  agreed  in  December  2009,  as  well  as  in  the  Commission’s  own 
2008  Policy  Plan  on  Asylum,  the  scope  of  the  asylum  acquis  needs  to  be  extended  and 
enhanced to ensure successful completion of the Common European Asylum System (CEAS).  

More specifically, EU asylum legislation should guarantee: 

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–  higher levels of protection generally; 

–  a more level playing field for persons seeking asylum in different Member States; 

–  more efficient treatment of asylum applications; 

–  better coordination of external aspects of asylum policy; 

–  more  solidarity  between  Member  States  in  sharing  the  burdens  associated  with  receiving 

asylum seekers. 

Moreover,  the  Commission  is  particularly  concerned  by  the  fact  that  rates  of  recognition  of 
asylum  seekers  as  qualifying  for  protection  still  vary  very  considerably  among  Member 
States, despite common minimum standards and a significant degree of harmonisation via the 
current  acquis,.  This  can  be  attributed  to  a  number  of  causes,  including  insufficiently  far-
reaching  legislative  harmonisation,  variation  in  the  manner  in  which  current  legislation  is 
applied in practice, and variation in the nature of information on the situation in countries-of-
origin on which asylum decisions are taken. 

In view of these shortcomings, the Commission intends to continue to pursue a ‘twin-track’ 
approach.  This  will  consist  of  working  to  extend  and  improve  the  EU  acquis,  as  well  as 
consolidating it by: 

(a) taking infringement actions against Member States for non-transposition and/or incorrect 
application of the acquis, and  

(b)  enhancing  practical  cooperation  activities,  particularly  by  ensuring  that  the  European 
Asylum Support Office is placed on a sound footing. 

16.2.4.  Evaluation results: Priorities and planned action (2011 and beyond) 

To date, the Commission has given priority to creating and further developing EU legislation 
in the asylum field, and to facilitating practical cooperation among Member State authorities. 

The  Commission  intends  to  pursue  the  following  priorities  regarding  development, 
application and monitoring of EU law in the coming years: 

–  Further  development  of  EU  legislation,  notably  as  regards  the  amendment  of  existing 

legislative instruments and the possible adoption of new ones; 

–  Pursuit of practical cooperation efforts to improve the practical implementation/application 
of the acquis in Member States, particularly as regards ensuring an effective transition to 
setting up the EASO; 

–  Monitoring and evaluating the implementation of EU legislation; 

–  Contribution to the Commission’s intervention before the Court of  Justice with regard to 
requests by national courts for preliminary rulings on the interpretation of EU legislation, 
and follow-up of individual complaints about compliance with EU legislation in Member 
States. 

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16.2.5.  Summary 

EU law in the asylum field is still being developed. Some shortcomings have been identified 
in the scope and impact of the existing acquis and in the manner in which it is applied. The 
priority in the short to medium term should be to extend and improve the legislation. At the 
same time, practical cooperation among Member States needs to be intensified with a view to 
ensuring  more  consistency  in  their  application  of  the  acquis,  particularly  by  ensuring  the 
successful  establishment  of  a  European  Asylum  Support  Office.  The  Commission  will 
continue to monitor and evaluate implementation of the law, to intervene before the Court of 
Justice with regard to requests by national courts for preliminary rulings on interpretation of 
the law, and to follow up complaints against Member States for incorrect application of the 
acquis. 

16.3.  European visa policy 

16.3.1.  Current situation: Report on work done in 2010  

In  July  2009,  the  European  Parliament  and  Council  adopted  a  Regulation  establishing  a 
Community Code on Visas548, applicable since 5 April 2010. The Visa Code recasts the legal 
framework  for  the  common  visa  policy  and  enhances  transparency,  equal  treatment  of 
applicants  and  legal  certainty,  and  it  harmonises  procedures  for  issuing  short-stay  visas.  It 
includes  inter  alia  provisions  on  mandatory  motivation  of  visa  refusal  and  right  to  appeal 
(applicable  as  from  5  April  2011),  harmonised  deadlines  for  the  visa  handling  process, 
enforcement  of  local  Schengen  cooperation  and  development  of  consular  representation  at 
local level. 

In  line  with  Article  51  of  the  Visa  Code,  the  Commission  elaborated  two  Commission 
decisions providing operational instructions on the practical application of the Visa Code, i.e. 
the Commission Decision of 19 March 2010 establishing the Handbook for the processing of 
visa applications and the modification of issued visas549 and the Commission Decision of 11 
June 2010 establishing the Handbook for the organisation of visa sections and local Schengen 
cooperation550. 

16.3.2.  Evaluation based on the current situation 

As  the  Visa  Code  has  only  recently  become  applicable,  efforts  were  focused  mainly  on 
ascertaining together with Member States that the new provisions were correctly interpreted, 
through discussions in the Visa Working Party and the Visa Committee. It was not considered 
opportune to open infringement proceedings, since no flagrant systematic practice infringing 
the Visa Code had been observed. 

Under  the  Visa  Code,  Member  States  are  required  to  try  to  harmonise  their  practices  in  the 
framework of local Schengen cooperation in each third country.  

In 2010, the Commission continued to receive complaints from individuals that EU law had 
been incorrectly implemented in the field of visas. After examination, it appeared that, when 

548 

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550 

Regulation  (EC)  No  810/2009  of  the  European  Parliament  and  of  the  Council  of  13  July  2009 
establishing a Community Code on Visas. 
C(2010) 1620 final. 
C(2010) 3667 final. 

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well founded, these complaints reflected some weaknesses in the current Visa acquis. These 
will  be  resolved  thanks  to  implementation  of  the  Visa  Code  and  sustained  efforts  in  the 
framework of local Schengen cooperation. 

16.3.3.  Evaluation results: Priorities and planned action (2011 and beyond) 

In light of important changes that intervened on 5 April 2010 and those due on 5 April 2011, 
the  Commission  considers  that  ensuring  timely,  correct  and  efficient  implementation  of  the 
new legislative framework by all Member States is a priority. The Commission will undertake 
systematic  screening  of  Member  States’  implementation  of  the  Visa  Code's  provisions, 
particularly those with a significant impact on visa applicants.  

Due  to  the  importance  of  visa  policy  in  EU  external  relations,  as  well  as  the  impact  of  an 
efficient  visa  policy  on  combating  irregular  migration,  the  Commission  closely  monitors 
implementation of the Visa Code. Existing fora such as the Visa Working Group in Council 
or  the  Visa  Committee  will  continue  to  play  an  important  role  in  identifying  issues  of 
common interest and solving them in an appropriate way.  

At  local  level,  the  involvement  of  EU  delegations  in  local  Schengen  cooperation  should 
increase,  and  they  should  play  a  stronger  role  in  ensuring  that  the  common  visa  policy  is 
implemented correctly and in a harmonised way by all Member States’ consulates. 

16.4.  Document Security (European passport and residence permits) 

16.4.1.  Current situation: Report on work done in 2010 

Regarding  infringement  procedures  on  residence  permits,  the  case  against  Italy  was 
withdrawn from the Court in September 2010 as Italy had started to issue residence permits in 
conformity with Regulation (EC) No 1030/2002.  

Regarding  non-conformity  with  Regulation  (EC)  No  2252/2004  on  passports,  reasoned 
opinions  were  sent  to  Bulgaria  and  Cyprus  in  March  2010.  Following  confirmation  that 
biometric  passports  were  being  issued,  the  case  against  Bulgaria  was  closed  in  September 
2010 and the case against Cyprus is expected to be closed in early 2011. Belgium was sent a 
letter of formal notice for non-conformity with Regulation (EC) No 2252/2004 on passports 
as regards the implementation of the second biometric identifier (fingerprints). 

16.4.2.  Evaluation results: Priorities and planned action (2011 and beyond) 

The main priorities are: 

(1) 

(2) 

(3) 

Ensuring  correct  implementation  of  Regulation  2252/2004.  The  vast  majority  of 
Member  States  have  now  correctly  implemented  the  Regulation.  However,  further 
measures are needed in terms of infringement policy and to carry out the conformity 
testing of specimens notified by Member States. 

Ensuring  correct  implementation  of  Regulation  1030/2002  on  residence  permits 
(incorporating facial image); deadline: May 2011.  

Facilitating Member States' implementation of the complex Public Key Infrastructure 
(required to protect personal data stored on documents) for both residence permits and 

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passports. 

In 2011,  conformity testing of 2nd generation  biometric  passports (with a chip storing facial 
image and fingerprints) will be carried out by the Joint Research Centre, and the Commission 
will decide on any subsequent infringement procedures as appropriate.  

16.5.  Border management and return policy 

16.5.1.  Current position: General introduction 

In  the  field  of  border  management  and  return  policy,  the  Commission  mainly  carried  out 
monitoring of the application of EU law. This resulted in the follow-up of one infringement 
proceeding  launched  in  2008,  and  several  consultations  between  the  Commission  and  some 
Member States via EU Pilot. Moreover, the Commission handled multiple consultations with 
Member  States  on  the  compatibility  of  draft  bilateral  agreements  with  third  countries  in  the 
framework of the Local Border Traffic Regulation. Strategic priority was given to preparing 
the ground for timely, correct transposition of the European Parliament and Council Directive 
2008/115/EC on common standards and procedures in Member States for returning illegally 
staying third-country nationals (the ‘Return Directive’). 

16.5.2.  Current position: Report on work done in 2010 

The  Commission  has  received  and  followed  up  several  complaints  from  individuals  and 
written questions from Members of European Parliament related to the incorrect application 
of  EU  law  in  the  field  of  border  management,  particularly  of  the  Schengen  Borders  Code. 
Most  of  these  concern  non-compliance  with  provisions  related  to  the  abolition  of  internal 
border  controls  at  land  and  air  borders  and  to  the  removal  of  obstacles  to  traffic  at  road 
crossing points at internal borders between Member States.  

Furthermore, the Commission drafted a proposal to amend the Schengen Borders Code as a 
result of experience since its entry into force. Adoption is expected in early 2011.  

Within the framework of the Local Border Traffic (LBT) Regulation, multiple consultations 
took  place  between  the  Commission  and  a  number  of  Member  States  on  the  compatibility 
between bilateral draft agreements with third countries and the LBT Regulation. There were 
exchanges  of  information  and  informal  advice,  and  experts'  meetings,  as  well  as  formal 
exchanges of correspondence.  

Regarding  implementation  of  Council  Directive  2004/82/EC  on  the  obligation  of  carriers  to 
communicate  passenger  data,  the  evaluation  of  transposition  measures  communicated  by 
Member States has been completed by closing the non-communication case against Poland. 

Regarding  return  policy,  action  focused  on  cases  of  non-communication  of  transposition  of 
Directive  2001/40/EC  on  mutual  recognition  of  decisions  on  the  expulsion  of  third  country 
nationals closing one remaining case against Malta and Directive 2003/110/EC on assistance 
in cases of transit for the purposes of removal by air closing the case against Spain. 

To  facilitate  the  correct,  consistent  transposition  of  the  Return  Directive,  Commission 
Services  convened  three  meetings  of  a  Contact  Group  in  2010.  This  group  provides  an 
informal forum for exchanging views between Member States and the Commission on how to 
meet  requirements  set  out  in  the  directive.  The  Commission  also  organised  two  workshops, 

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bringing  together  Member  States  and  key  stakeholders  in  the  return  process,  namely 
international  and  non-governmental  organisations  which  have  concrete  practical  experience 
on selected issues. They focused on how best to apply specific provisions in the directive. The 
topics discussed were the requirement to provide alternatives to detention, and the return of 
unaccompanied minors. 

The deadline for transposing all provisions of the directive into national law (except for those 
relating to free legal aid) expired on 24 December 2010. The deadline for provisions relating 
to free legal aid will expire on 24 December 2011. All Member States, with the exception of 
the United Kingdom and Ireland, are bound by the Return Directive. By the end of 2010, only 
six Member States had notified measures that they consider constitute full transposition of the 
directive: the Czech Republic, Estonia, Greece, Spain, Portugal and Slovakia. A further four 
Member States had notified measures which they consider as constituting partial transposition 
by  the  same  date:  Belgium,  Latvia,  Lithuania  and  Sweden.  The  Commission  will  examine 
these notifications in the course of 2011. 

According  to  the  doctrine  of  direct  effect  developed  by  the  European  Court  of  Justice, 
provisions  of  a  directive  which  confer  rights  on  individuals  and  which are  sufficiently  clear 
and unconditional become directly effective from the end of the time limit for implementing 
the  directive.  Many  of  the  provisions  of  the  Return  Directive  fulfil  these  requirements  and 
therefore  have  to  be  directly  applied  by  national  administrative  and  judicial  authorities  in 
Member States, even if they have not yet transposed the directive. 

16.5.3.  Evaluation based on the current situation 

The  correct  application  of  EU  legislation  in  the  field  of  border  management,  particularly  in 
the absence of internal border controls, has a substantial impact on the area without internal 
borders  in  which  the  free  movement  of  persons  has  to  be  ensured.  Alleged  internal  border 
checks at land borders and at airports were again reported during 2010. The Commission is 
closely  monitoring  the  situation  regarding  internal  border  zones.  It  is  also  following 
developments regarding the dismantling of remaining traffic obstacles at road crossing-points 
at internal borders.  

In  October  2010,  the  Commission  adopted  a  report  to  the  European  Parliament  and  the 
Council on the application of Title III (Internal borders) of the Schengen Borders Code551. In 
the report, the Commission paid particular attention to the practical application of Article 21 
of  the  Schengen  Borders  Code  (police  checks  within  the  territory,  particularly  in  internal 
border  zones),  to  difficulties  related  to  the  removal  of  obstacles  to  traffic  at  road  crossing-
points at internal borders, and to difficulties arising from the reintroduction of border controls 
at internal borders.  

In  November  2010,  the  Commission  adopted  a  proposal  for  a  Regulation  of  the  European 
Parliament and of the Council on setting up an evaluation mechanism to verify application of 
the  Schengen  acquis552.  The  proposal  is  currently  under  discussion  in  the  Council  and 
European  Parliament.  It  organises  in  more  detail  the  Commission's  power  to  carry  out 
unannounced  on-site  visits  to  verify  the  absence  of  controls  at  internal  borders.  The 

551 
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COM(2010) 554 final. 
COM(2010) 624 final. 

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Commission  is  of  the  opinion  that  such  visits  would  make  a  significant  contribution  to  the 
correct application of EU law as regards the abolition of internal border controls.  

In  the  field  of  return,  the  Commission  continued  its  successful  experience  of  organising  a 
Contact  Group  (or  Contact  Committee)  in  2010.  This  facilitates  the  correct  and  consistent 
transposition  of  the  Return  Directive.  Since  the  directive  was  adopted  at  the  end  of  2008, 
Commission services have convened six such meetings, including three in 2010. The Contact 
Group,  and  related  Workshops  on  specific  return-related  topics,  are  highly  appreciated  by 
Member  States.  They  have  contributed  to  better  transposition  of  the  directive  and  to  better 
general  understanding  of  its  provisions.  The  Group  will  therefore  continue  meeting  during 
2011, though the transposition deadline expired in December 2010. It is expected that these 
meetings  will  go  on  facilitating  correct  application  of  the  directive  at  national  level  in  the 
coming years and will facilitate transposition where this has not yet taken place.  

16.5.4.  Evaluation results: Priorities 

In 2010, priority was given to following up complaints received from citizens and questions 
from  Members  of  European  Parliament  regarding  checks  carried  out  on  persons  in  internal 
border zones and at  airports,  and  to  remaining  obstacles to traffic at road crossing points at 
internal  borders.  The  Commission  regularly  addressed  Member  State  national  authorities  to 
obtain  explanations,  particularly  on  alleged  checks  on  persons  within  internal  border  zones, 
and  it  sought  information  on  remaining  traffic  obstacles,  concerning  their  progressive 
removal.  

In the field of return, strategic priority was given to preparing the ground for timely, correct 
transposition of the Return Directive 2008/115/EC. Several complaints related to return issues 
were received, but no concrete follow-up could be given, as the transposition period for the 
directive had not yet expired. 

16.5.5.  Evaluation results: Planned action (2011 and beyond) 

As  one  of  its  fundamental  objectives,  the  Commission  will  continue  to  closely  monitor  the 
correct  application  of  EU  legislation  on  dismantling  internal  border  controls  and  remaining 
traffic  obstacles.  The  Commission’s  proposal  on  the  Schengen  evaluation  mechanism  could 
undoubtedly  contribute  to  accomplishing  this.  Priority  will  thus  be  given  to  following  up 
complaints received from individuals and questions from Members of European Parliament. 
The Commission will continue to seek explanations from relevant Member States regarding 
alleged  border  checks  and  remaining  traffic  obstacles  at  internal  borders.  The  Commission 
will  take  all  measures  necessary,  including  the  launching  of  infringement  procedures,  to 
ensure the correct application of EU law. 

Moreover,  the  Commission  will  continue  to  have  consultations  with  Member  States  and  to 
analyse  the  compatibility  of  draft  local  border  traffic  agreements  with  EU  law.  The 
Commission  submitted  a  second  report  on  the  implementation  and  functioning  of  the  local 
border  traffic  regime  to  the  European  Parliament  and  Council  and  this  was  adopted  on  9 
February 2011. 

During 2011, strategic priority will be given to  examining  national measures notified to the 
Commission for transposition of the Return Directive 2008/115/EC. The Commission will be 
assisted in this task by an external contractor with relevant expertise in the national laws of 
be launched against Member States which 
Member States. Infringement proceedings will 

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have not communicated transposition measures. The Commission will, moreover, continue to 
convene the Contact Group during 2011, to facilitate the correct application of the directive at 
national level, and to facilitate the transposition of the Return Directive 2008/115/EC where 
this has not yet been done. Once the transposition deadline has expired, the Commission will 
become more active regarding complaints and petitions from stakeholders (NGOs, etc) calling 
for action to be taken against Member States which have allegedly incorrectly transposed the 
directive, or which are allegedly not applying or incorrectly applying aspects of it. This could 
result in infringement proceedings against some Member States. Depending on the number of 
complaints received, there will be a need to set priorities.  

16.6. 

Security 

16.6.1.  Data Retention Directive 

Current position: General introduction 

On  15  September  2007,  Member  States  should  have  brought  into  force legal  instruments  to 
comply with the Data Retention Directive 2006/24/EC. In all, 18 Member States553 invoked 
the clause of Article  15(3) that allowed them to postpone application of the directive to the 
retention of communications data relating to internet access, internet telephony and internet e-
mail until 15 March 2009.  

Current position: Report on work done in 2010 

In  2010,  the  Commission  continued  non-communication  cases  against  four  Member  States: 
against  Greece  and  Ireland,  condemned  by  the  European  Court  of  Justice  on  26  November 
2009  (cases  C-211/09  and  C-202/09  respectively),  against  Sweden,  condemned  in  February 
2010 in case C-185/09, and against Austria, condemned in July 2010 in Case C-189/09. 

In May 2010, the Commission sent Greece a letter of formal notice pursuant to Article 260 
TFEU. A similar letter was sent to Sweden in June 2010. 

The Commission closed an infringement case against Luxembourg after receiving its national 
transposition measures.  

Evaluation based on the current situation 

The evaluation report that the Commission intended to submit to the Council and Parliament 
further  to Article 14 of  the  directive, due on 15 September 2010, was postponed  until  early 
2011 to take on board further data and analysis. The state of notifications will also be included 
in that evaluation. 

Evaluation results: Priorities and planned action (2011 and beyond) 

The  Commission  will  proceed  with  pending  infringement  cases  and  open  new  ones  against 
Member  States  where  the  applicable  law  was  annulled  because  of  rulings  of  Constitutional 
Courts, unless the Member States concerned enact new legislation. 

553 

The  Netherlands,  Austria,  Estonia,  United  Kingdom,  Cyprus,  Greece,  Luxemburg,  Slovenia,  Sweden, 
Lithuania,  Latvia,  Czech  Republic,  Belgium,  Poland,  Finland,  Germany  and  upon  accession  Bulgaria 
and Romania. 

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16.6.2.  European Programme for Critical Infrastructure Protection 

Current position: General introduction 

The  Directive  2008/114/EC  on  the  Identification  and  Designation  of  European  Critical 
Infrastructures  and  the  Assessment  of  the  Need  to  Improve  their  Protection  was  adopted  in 
December 2008 and entered into force in January 2009.  

Its objectives are: 

–  To establish a procedure to identify European Critical Infrastructures (ECIs); 

–  To establish a procedure to designate infrastructures as European Critical Infrastructures; 

–  To devise a common approach to assess whether it is necessary to improve the protection 

of such infrastructures. 

Current position — Report on work done in 2010 

The  deadline  for  implementing  Directive  2008/114/EC  is  January  2011,  and  most  Member 
States  are  working  on  identifying  potential  ECIs  in  the  energy  and  transport  sectors. 
Generally,  work  on  identification  is  being  carried  out  at  national  level  by  working  groups 
bringing  together  the  relevant  national  ministries  or  agencies,  as  well  as  associations  of 
operators.  

By the end of 2010, 14 Member States had notified measures that they consider constitute full 
transposition of the directive. A further two Member States had notified measures which they 
consider as constituting partial transposition by the same date. The Commission will examine 
these  notifications  in  the  course  of  2011  and  take  the  necessary  actions  also  in  respect  of 
Member States which will not notify measures by the deadline. 

The  Commission  continued  to  offer  its  support  to  the  process  of  identification  of  potential 
ECIs. Two workshops have taken place at the Joint Research Centre in Ispra, with a view to 
exchanging  practices  and  information  on  the  implementation  procedure  in  Member  States. 
Both workshops also provided an opportunity to discuss the general framework for reviewing 
the directive, and both Member States and Commission made preliminary contributions on the 
structure and content of the process leading to the review.  

Evaluation based on the current situation 

The situation and volume of work in 2010 was stable and focused on exchanging information 
and good practices on the identification and designation of ECI experience in Member States. 

Evaluation results: Priorities and planned action (2011 and beyond) 

The  review  of  Council  Directive  2008/114/EC  will  begin  in  January  2012,  i.e.  three  years 
after  its  entry  into  force.  For  a  smooth  review  process,  mutual  trust  and  a  sound  basis  for 
discussion  between  Member  States,  the  Commission  and  the  European  Parliament  must  be 
established  as  early  as  possible.  This  is  particularly  important,  as  the  legal  basis  of  the 
directive changed with the entry into force of the Lisbon Treaty.  

The  voluntary  ‘implementation’  workshops  and  the  CIP  contact  point  meetings  will  remain 

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the  backbone  of  the  review process  throughout  2011  and  beyond.  If  needed,  extra  meetings 
could be added, or side-events dedicated to preparing the review. In addition, the Commission 
will procure a separate study to inform the review process.  

The  Commission  will  deliver  summary  reports  providing  results  from  these  workshops. 
Shortly before the start of the review process (January 2012), the Commission, supported by 
Member  States,  will  put  forward  a  general  report  summarising  preparatory  activities.  This 
report will be the starting point for political discussions at Council level.  

Moreover,  a  general  discussion  on  the  European  Programme  for  Critical  Infrastructure 
Protection will start in 2011. 

16.6.3.  Directive on preventing and combating trafficking  in  human  beings, and protecting 

victims, replacing Framework Decision 2002/629/JHA 

Current position: General introduction 

In March 2010, the European Commission tabled a proposal for a new directive on trafficking 
in human beings, aimed at further approximating legislation and penalties, ensuring successful 
prosecution, better protection of victims and assistance to them, and prevention of trafficking. 
In December 2010, political agreement was reached on a final text. 

The objectives of the directive are: 

–  To approximate substantive criminal law; 

–  To bring robust provisions on victims’ rights in criminal procedures and on assistance; 

–  To facilitate prosecution of offenders, including extraterritorial jurisdiction; 

–  To step up preventive measures to discourage the demand that fosters trafficking. 

16.6.4.  Third pillar instruments  

Current position: Report on work done in 2010 

Monitoring  in  the  context  of  ex-third  pillar  instruments  was  mainly  done  on  the  basis  of 
implementation reports. These had to be produced following specific provisions in articles in 
the legal instrument itself.  

In  the  case  of  the  Council  Framework  Decision  2008/919/JHA  of  28  November  2008, 
amending  Framework  Decision  2002/475/JHA  on  combating  terrorism,  Article  3  requested 
Member States to take the measures necessary to comply with the Framework Decision by 9 
December  2010.  During  2010,  the  Commission  assisted  Member  States  by  organising  two 
expert meetings on the transposition of the Framework Decision, on 19 April and 28 June.  

The  Commission  is  currently  preparing  an  update  of  the  first  implementation  report  on  the 
application of Framework Decision 2003/568/JHA of 22 July 2003 on combating corruption 
in the private sector. The report will be issued in mid-2011. 

Also  being  prepared  is  an  implementation  report  on  Decision  2007/845/JHA,  concerning 
of the Member States in the field of tracing 
cooperation  between  Asset  Recovery  Offices 

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and identification of proceeds of crime, or other property related to crime. 

The  Council  Framework  Decision  2008/841/JHA  of  24  October  2008  on  the  fight  against 
organised  crime  required  Member  States  to  take  measures  necessary  to  comply  with  its 
provisions before 11 May 2010 and to communicate the text of transposing legislation to the 
General Secretariat of the Council and to the Commission. 

The Swedish Framework Decision (Council Framework Decision 2006/960/JHA) concerning 
simplification  of  the exchange  of information  and criminal  intelligence across the European 
Union  required  the  Commission  to  submit  an  evaluation  report  to  the  Council  before  18 
December  2010.  Just  four  months  after  the  implementation  deadline  had  expired,  the 
Commission organised a conference that sought to review implementation of this instrument. 
The outcome of that conference, including detailed replies to the Commission’s questionnaire, 
fed into a second conference on implementation, also organised in 2010.  

Evaluation based on the current situation 

Regarding the Council Framework Decision 2008/919/JHA of 28 November 2008 amending 
Framework Decision 2002/475/JHA on combating terrorism, only three Member States fully 
complied  with  their  obligations  and  informed  the  Commission  in  time  about  provisions  to 
transpose the Framework Decision. The Commission has sent a reminder to the other Member 
States concerned. The deadline set for submitting notifications is 4 March 2011. 

Evaluation results: Priorities and planned action (2011 and beyond) 

In accordance with Article 3(2) of the Framework Decision 2008/919/JHA and on the basis of 
information  received  from  Member  States,  the  Commission  will  prepare  a  report  to  assess 
whether  Member  States  have  taken  the  measures  necessary  to  comply  with  the  Framework 
Decision.  

The  second  report  on  implementation  of  Framework  Decision  2003/568  on  combating 
corruption in the private sector and the report on implementation of Decision 2007/845/JHA 
concerning cooperation between Asset Recovery Offices of the Member States in the field of 
tracing  and  identification  of  proceeds  of  crime,  or  other  property  related  to,  crime,  are 
scheduled for 2011.  

Regarding Council Framework Decision 2008/841/JHA on the fight against organised crime, 
on  the  basis  of  a  Council  report  based  on  information  provided  by  Member  States  and  a 
written  report  transmitted  by  the  Commission,  the  Council  will,  before  11  November  2012, 
assess the extent to which Member States have complied with the Framework Decision. 

17. 

JUSTICE 

17.1. 

Free movement of persons 

17.1.1.  Current Position 

17.1.1.1. Introduction 

Free movement is a core right of EU citizens and their family members. It is one of the most 

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cherished  rights  by  EU  citizens.  Citizenship  of  the  Union  confers  on  every  EU  citizen  a 
primary  and  individual  right  to  move  and  reside  freely  in  the  EU.  It  should  therefore  be 
strictly enforced. 

Article 21(1) TFEU stipulates that every citizen of the Union shall have the right to move and 
reside  freely  within  the  territory  of  the  Member  States,  subject  to  the  limitations  and 
conditions laid down in the Treaties and by the measures adopted to give them effect. These 
limitations  and  conditions  are  to  be  found  in  Directive  2004/38/EC554  which  codified  the 
existing legislation and case-law in the area of free movement, streamlined the procedures, cut 
the red tape and simplified the legal text in the interest of reader-friendliness and clarity. 

17.1.1.2. Report of work done in 2010  

Building on the 2008 report555 on the application of Directive 2004/38/EC which concluded 
that the transposition of the Directive in Member States was not satisfactory and identified a 
large  number  of  shortcomings  and  following  the  2009  guidelines556  for  better  transposition 
and application of Directive 2004/38/EC which provided guidance to Member States on how 
to apply Directive  2004/38/EC correctly, in 2010 the Commission focused  on enforcing the 
EU rules on free movement.  

In accordance with the priorities established by the previous Annual Report on the Control of 
Application  of  Community  law,  the  Commission  held  bilateral  meetings  with  almost  all 
Member States to discuss the issues of implementation of Directive 2004/38/EC identified as 
problematic. By the end of 2010, the Commission met the authorities of 22 Member States557, 
thus largely complying with its commitments.  

A  group  of  Member  States’  experts  on  the  practical  application  of  Directive  2004/38/EC 
established in 2009 met three times in 2010 to discuss issues related to the correct application 
of  EU  law  in  the  area  of  free  movement,  particularly  on  fighting  abuses  and  frauds.  The 
exchange  of  views,  know-how  and  best  practices  are  contributing  towards  improved 
implementation of EU law and the case-law of the  Court of Justice of the European Union. 
The group continues to meet on a regular basis. 

In 2010, the Commission continued to deal with a large number of enquiries and complaints 
in the area of free movement of persons; 781 enquiries and complaints were received.There 
were also 44 written EP questions and 31 petitions in this area. 

The Commission made an extensive use of informal dispute-settlement mechanisms, such as 
SOLVIT.  According  to  the  2010  report  on  development  and  performance  of  the  SOLVIT 

554 

555 
556 
557 

Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of 
citizens  of  the  Union  and  their  family  members  to  move  and  reside  freely  within  the  territory  of  the 
Member States (OJ L 158 of 30 April 2004, p. 77). 
COM(2008)840 final. 
COM(2009)313 final. 
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Ireland, Spain, France, Italy, Latvia, Hungary, 
Malta,  Austria,  Poland,  Portugal,  Romania,  Slovak  Republic,  Slovenia,  The  Netherlands,  Finland, 
Sweden, United Kingdom. 

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network558,  in  2010  SOLVIT  centres  closed  306  cases  concerning  residence  rights,  which 
amounted  to  23%  of the total of all SOLVIT cases, managing to solve 91% of them. There 
was a decrease in cases in comparison to 2009 (549 cases handled and closed) because one 
Member  State  has  reduced  the  delays  in  handling  applications  for  residence  cards  for  EU 
citizens' family members, in response to the high number of problems flagged, among others 
by SOLVIT. Progress has also been made with regard to other cases under Article 258 TFEU, 
where priority was given to older cases. 

Concerning  cases  raising  issues  of  principle  or  having  particularly  far  reaching  negative 
impact for citizens, the United Kingdom informed the Commission in October 2010 that it has 
abolished  delays  in  handling  applications  for  residence  cards  for  EU  citizens'  family 
members.  A  simplified  guide  on  EU  law  for  EU  citizens  on  freedom  of  movement  was 
updated, published and widely distributed in 2010 in all EU languages. 

17.1.2.  Evaluation based on the current situation 

The analysis and the work done by the Commission in 2010 showed that the situation in the 
area of free movement of persons requires further improvement.  

In October 2010, the Commission adopted the EU citizenship report 2010 "Dismantling the 
obstacle  to  EU  citizens'  rights"559,  which  gives  a  comprehensive  overview  of  the  obstacles 
citizens  still  face  and  makes  proposals  on  how  they  can  best  be  removed.  The  report 
underlines  the  fact  that  the  right  to  free  movement  is  hindered  by  divergent  and  incorrect 
application  of  EU  law  and  by  cumbersome  administrative  procedures.  To  facilitate  free 
movement  of  EU  citizens  and  their  third-country  family  members,  the  Commission  will 
enforce EU rules strictly, including on non-discrimination, by promoting good practices and 
increased  awareness  of  EU  rules  on  the  ground  and  by  stepping  up  the  dissemination  of 
information to EU citizens about their free movement rights. 

Alike, the 2008 report on the application of Directive 2004/38/EC concluded that the overall 
transposition  of  the  Directive  was  rather  disappointing.  The  situation  improved  gradually  in 
2010.  The  2009  guidelines  and  the  exchange  of  views  and  information  with  the  Member 
States  during  the  bilateral  meetings  held  in  2010  provided  them  further  guidance  on  what 
legislative  amendments  are  needed  in  their  national  legislation  and  on  how  to  apply  the 
Directive  2004/38/EC  correctly,  with  the  objective  of  dismantling  the  obstacles  to  free 
movement of EU citizens and of making the EU an area of security, freedom and justice. To 
address  the  unsatisfactory  implementation,  the  Commission  continued  working  in  2010  at 
technical level with the Member States within the group of experts. The work of the group in 
2010 focused on the sensitive areas of fighting frauds and abuses, but also on how to improve 
information about residence rights.  

Many  EU  citizens  have  complained  about  Member  States  not  implementing  correctly  their 
national law transposing EU law in the area of free movement of EU citizens. The complaints 
concern  various  problematic  areas  in  the  field  of  free  movement  and  residence  rights.  An 
important  issue  addressed  by  the  Commission  in  2010  related  to  the  delays  in  handling 
residence applications of EU citizens and their family members in the United Kingdom. Some 

558 
559 

Report under finalisation. 
COM(2010) 603 final 

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350 individual complaints were received by the Commission on this issue since October 2008 
alleging that the authorities of that Member State were failing to meet the deadlines imposed 
by national and EU law. Following contacts with the Member State, a comprehensive solution 
was  implemented  and  in  October  2010  the  Commission  was  informed  that  the  backlog  has 
been cleared and that measures were taken to avoid such backlogs in future. The Commission 
will continue to closely monitor the situation.  

This  particular  issue  underlines  the  crucial  role  Member  States  play  in  the  practical 
implementation  of  EU  law  and  that  correct  transposition  must  be  accompanied  by  robust 
measures  enabling  national  authorities  to  effectively  apply  the  law.  This  is  even  more 
important  in  the  areas  of  direct  concern  to  large  groups  of  EU  citizens,  such  as  residence 
applications.  

In 2010 first positive results could be visible, since a significant number of Member States, 
following the bilateral meetings and exchanges with the Commission, modified their law or 
announced amendments including a precise calendar to ensure full transposition of Directive 
2004/38/EC thoroughly discussed. Improvement of transposition will remain a priority for the 
Commission in 2011.  

17.1.3.  Evaluation results 

17.1.3.1. Priorities 

In  2011  the  Commission  will  pursue  the  infringement  cases  related  to  the  incorrect 
transposition  of  Directive  2004/38/EC.  It  will  also  address  the  infringement  proceeding 
raising issues of principle or having particularly far reaching negative impact for citizens. 

17.1.3.2. Planned action (2011 and beyond) 

As from 2011 the Commission will step up its efforts to ensure that the Directive is correctly 
transposed  and  implemented  across  the  EU,  using  fully  its  powers  under  the  Treaty  and 
launching infringement proceedings, when necessary. 

The  Commission  will  continue  working  at  technical  level  with  the  Member  States  in  the 
group of experts. 

The Commission will continue to inform EU citizens about their rights under the Directive. 
An updated simplified guide on EU law for EU citizens on freedom of movement, which was 
launched  in  2010,  will  continue  to  be  widely  distributed.  The  Commission  will  encourage 
Member  States  to  launch  awareness-raising  campaigns  to  inform  EU  citizens  of  their  rights 
under Article 34 of the Directive. 

17.1.4.  Summary 

The Commission attaches great importance to the concrete fulfilment of the fundamental and 
personal  right  of  EU  citizens  and  their  family  members  to  move  and  reside  freely.  The 
transposition  and  implementation  of  the  Directive  in  Member  States  need  to  be  further 
completed. The Commission has been stepping up its efforts to ensure full enforcement and 

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will continue to work closely together with Member States to solve more problematic issues 
of free movement and share best practices. Together with intensified information to citizens 
this should bring real improvements in the daily life of EU citizens and their family members. 

17.2.  Citizenship 

17.2.1.  Current position 

17.2.1.1. Introduction 

Article  22  of  the  Treaty  on  the  Functioning  of  the  European  Union  grants  the  right  to  EU 
citizens to vote and to stand as candidates in municipal and European elections in the Member 
State where they reside, without holding  the nationality of  that State. These rights were put 
into  effect  by  Directive  1993/109/EC560  as  regards  European  Parliament  elections  and 
Directive 1994/80/EC561 as regards  municipal elections. Directive  1994/80  was modified by 
Directive 1996/30/EC and Directive 2006/106/EC in view of consecutive enlargements of the 
Union. 

17.2.1.2. Report of work done in 2010 

In October 2010, the Commission adopted the Report on the implementation of EU law in the 
2009  European  elections562.  The  report  concludes  that  on  the  whole,  the  legal  conditions 
allowing EU citizens to exercise their right to vote and to stand as candidates in their Member 
State of residence are fulfilled. As for the few issues of transposition of Directive 93/109/EC 
and  of  the  Act  of  1976  that  were  identified  in  the  report,  a  number  of  EU  Pilot  (pre-
infringement) cases have been opened during 2010.  

In particular, six cases were opened concerning the transposition of Directive 93/109/EC, one 
case  concerning  the  implementation  of  the  Act  of  1976  on  the  election  of  Members  of  the 
European Parliament and five cases concerning the right of EU citizens to become members 
or to found a political party in the Member State where they reside. 

The Commission has also dealt with 97 enquiries and complaints on citizenship and electoral 
rights of the EU citizens: 55 on citizenship and 42 on electoral rights. In 2010, there were 14 
written  EP  questions  and  5  petitions  in  this  area.  This  shows  the  increasing  awareness  and 
interest of EU citizens concerning their electoral rights.  

560 

561 

562 

Council Directive 93/109/EC of 6 December 1993 laying down detailed arrangements for the exercise 
of the right to vote and stand as a candidate in elections to the European Parliament for citizens of the 
Union residing in a Member State of which they are not nationals. 
Council Directive 94/80/EC of 19 December 1994 laying down detailed arrangements for the exercise 
of the right to vote and to stand as a candidate in municipal elections by citizens of the Union residing 
in a Member State of which they are not nationals. 
Report  on  the  election  of  Members  of  the  European  Parliament  (1976  Act  as  amended  by 
Decision2002/772/EC,  Euratom)  and  on  the  participation  of  European  Union  citizens  in  elections  for 
theEuropean Parliament in the Member State of residence (Directive 93/109/EC); COM(2010)605 

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17.2.2.  Evaluation based on the current situation  

Essentially,  all  Member  States  transposed  the  Union  legislation  in  electoral  matters.  No 
infringement proceedings were open as of 31 December 2010. The situation in the field of the 
electoral rights of EU citizens can be considered broadly satisfactory. 

However,  as  a  result  of  a  compatibility  study  concluded  in  February  2009,  EU  Pilot  (pre-
infringement)  cases  were  opened  in  2010.  The  replies  of  the  Member  States  are  currently 
under examination.  

As far as the right of EU citizens to vote and stand as candidates in the municipal elections in 
the  Member  State  of  residence  is  concerned,  a  Commission  Report  assessing  the 
implementation of Directive 93/109/EC is planned for 2011.  

17.2.3.  Evaluation results 

17.2.3.1. Priorities:  

In 2011, the Commission will continue the work to ensure conformity of national legislations 
of  Member  States  with  Directive  93/109/EC  (participation  of  EU  citizens  in  European 
elections) and Directive 94/80/EC (participation of EU citizens in municipal elections) and to 
ensure  conformity  across  the  EU  member  States  with  the  1976  Act  on  the  elections  of  the 
representatives of the European Parliament. 

17.2.3.2. Planned action (2011 and beyond) 

As  from  2011,  the  Commission  will  step  up  its  efforts  to  ensure  that  the  instruments  in 
electoral  matters  are  correctly  transposed  and  implemented.  The  Commission  will  continue 
working  at  technical  level  with  the  Member  States  in  the  group  of  experts  and  launch 
infringement proceedings when necessary. 

A  report  on  the  implementation  of  Directive  94/80/EC  (participation  of  EU  citizens  in 
municipal elections) is planned for 2011.  

On the basis of a study on possible developments of the EU law on electoral rights, concluded 
in  2010,  and  in  the  light  of  the  2010  report  on  European  elections,  the  Commission  is 
considering options to better achieve the objectives of Directive 93/109/EC. The objective is 
to  improve  the  efficiency  of  the  administrative  proceedings  to  facilitate  participation  of 
candidates  in  the  elections,  as  well  as  to  improve  the  information  exchange  mechanism  for 
preventing double voting.  

A proposal to amend the Directive, presented by the Commission in 2006563, is currently with 
the Council and negotiations are suspended. Any new step for improvements has to take into 
account the outcome of the electoral reform ongoing in the European Parliament which may 
have a direct effect on the Directive. 

563 

COM(2006)791Proposal for a Council Directive amending Directive 93/109. 

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17.2.4.  Summary 

Electoral rights of the EU citizens accompany their right to free movement and are part of the 
rights attached to the Citizenship of the Union: EU law in the electoral field grants the right to 
the EU citizens to participate in municipal and European elections in the Member State where 
they  reside  without  holding  the  nationality  of  that  State.  Detailed  arrangements  for  the 
exercise  of  these  rights  are  to  be  found  in  Directive  94/80/EC  with  regard  to  municipal 
elections and in Directive 93/109/EC with regard to European elections. The Act of 1976 on 
the election of representatives of  the  European Parliament  as  amended by Council Decision 
2002/772/EC, lays down common principles for the Member States in the organisation of the 
European elections. 

Transposition  of  Union  law  in  electoral  matters  can  generally  be  considered  satisfactory. 
However,  EU  Pilot  (pre-infringement)  cases  were  opened  in  2010  addressing  a  number  of 
issues.  These  issues  concern  inter  alia  details  of  the  arrangements  in  the  organisation  of 
elections,  such  as  the  procedure  for  registering  voters  or  candidates  on  the  electoral  rolls. 
They also concern the possibility of founding or participate in a political party for those EU 
citizens residing in another EU Member State who want to stand as candidates in municipal 
and European elections. 

The Commission should continue to focus on checking and ensuring correct transposition and 
implementation of Directives 93/109/EC and 94/80/EC and of the Act of 1976, as amended by 
Council  Decision  2002/772.  This  will  need  close  work  at  technical  level  with  the  Member 
States and use of infringement proceedings, where necessary. 

The  Commission  shall  report  on  the  implementation  of  Directive  94/80/EC  on  municipal 
elections in its Report planned for 2011. The Commission will also pursue preparatory work 
to consider how to go forward with the modification of Directive 93/109. 

17.3. 

Fundamental rights 

17.3.1.  Current Position 

17.3.1.1. Introduction  

With the entry into force of the Lisbon Treaty the Charter is now legally binding on the EU's 
institutions  and  on  Member  States  when  they  are  implementing  EU  law.  The  foreseen 
accession  of  the  EU  to  the  European  Convention  of  Human  Rights  will  complement  the 
strong protection of fundamental rights that already exists in the Union's legal order through 
the  EU's  own  Charter  of  Fundamental  Rights  and  the  case  law  on  fundamental  rights 
developed over time by the Court of Justice.  

The  important  number  of  letters  received  by  the  Commission  reveals  a  strong  interest  and 
expectation  from  citizens  on  fundamental  rights.  It  also  reveals  that  more  information  is 
needed  to  explain  that  the  Commission  has  no  general  powers  to  intervene  in  cases  of 
violations  of  fundamental  rights  and  that  it  can  do  so  only  if  an  issue  of  Union  law  is 
involved. 

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The Commission shall ensure that when implementing EU legislation, Member States strictly 
respect fundamental rights and that cases involving fundamental rights should be treated as a 
matter of priority. This obligation will become even more essential when the EU will gain full 
membership to the European Convention of Human Rights.  

17.3.1.2. Report of work done in 2010 

The Commission has published on 19  October  2010 a Communication setting the "Strategy 
for  the  effective  implementation  of  the  Charter  of  Fundamental  Rights  by  the  European 
Union"564. The objective of the Charter Strategy is to make the fundamental rights as effective 
as possible. The respect of the rights enshrined in the Charter must be upheld throughout the 
entire  legislative  process.  The  Commission  reinforced  the  evaluation  of  the  impact  on 
fundamental rights of its legislative proposals by establishing a "Fundamental Rights Check-
List" to check systematically the compliance of the proposals with the Charter.  

The 2010 Report on the Application of the EU Charter of Fundamental Rights, to be adopted 
in 2011, will show that all Commission departments in 2010 received more than 4000 letters 
from  the  general  public  on  fundamental  rights  issues.  Approximately  one  third  concerned 
situations  where  the  Charter  could  apply,  while  the  rest  did  not  involve  Union  law  and  fell 
outside the powers of the Commission to control the application of Union law. Approximately 
half  of  petitions  and  questions  from  the  European  Parliament  concerned  cases  where  the 
Charter could apply and the rest were related to issues outside of EU competence. 

The  EU  Treaty  (Article  6  paragraph  2  TEU)  requires  the  EU  to  become  a  member  of  the 
European  Convention  on  Human  Rights.  The  Commission  has  thus  recommended  on  17 
March 2010 to the Council to open accession negotiations with the Council of Europe. On the 
basis  of  a  mandate  agreed  by  the  Council,  the Commission launched accession negotiations 
on  7  July  2010.  The  EU's  accession  to  the  European  Convention  of  Human  Rights  will 
complement  the  strong  protection  of  fundamental  rights  that  already  exists  in  the  Union's 
legal order through the EU's own Charter of Fundamental Rights and the fundamental rights 
developed over time by the Court of Justice.  

17.3.2.  Evaluation based on the current situation 

The  2010  Charter  Strategy  pointed  out  that  for  the  rights  enshrined  in  the  Charter  to  be 
effective the public needs to be well informed about these rights and how to enforce them in 
practice when they are violated. Citizens should know where they can turn for assistance in 
cases  of  violations  of  fundamental  rights.  The  Commission  will  promote  awareness  raising 
and will explain in particular what it can and cannot do.  

17.3.3.  Evaluation results 

The Charter Strategy announced the presentation of an Annual Report on the Application of 
the EU Charter of the Fundamental Rights, as an essential tool in implementing the rights and 

564 

Communication  from  the  Commission  of  19  October  2010  on  the  Strategy  for  the  effective 
implementation of the Charter of Fundamental Rights by the EU, COM/2010/0573 final, available at: 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0573:FIN:EN:PDF  

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freedoms of the Charter. These annual reports will track the progress being made and also the 
new  concerns  that  are  arising.  The  Annual  Report  will  be  the  track  record  on  the 
implementation of all the provisions of the Charter. 

17.3.4.  Summary 

The  Charter  needs  to  be  put  into  practice  whenever  EU  law  applies,  so  that  people  can 
effectively enjoy their  fundamental  rights. That is why the Commission, in  2010, adopted a 
Strategy on the effective implementation of the Charter. The Charter Strategy pointed out the 
need to inform the public about fundamental rights and how to enforce them in practice when 
they are violated.  

17.4. 

Protection of personal data 

17.4.1.  Current position  

17.4.1.1. Introduction 

Personal  data  is  collected  and  used  in  many  aspects  of  everyday  life.  The  protection  of 
personal data is a fundamental right, which requires that individuals must be protected with 
regard to the processing of personal data. Personal data should be able to flow freely from one 
Member State to another. In order to remove the obstacles to the free movement of such data 
without diminishing the protection of personal data at the level of the EU, Directive 95/46/EC 
(the data protection Directive) was developed to harmonise national provisions in this field. 

In 2010, the Commission continued the monitoring of the correct application of the Directive 
95/46/EC on data protection, the main piece of legislation in this area.  

As concerns the protection of personal data processed in the framework of police and judicial 
cooperation  in  criminal  matters,  the  Commission  started  monitoring  the  implementation  of 
Framework Decision 2008/977/JHA at the end of 2010. Member States were obliged to have 
taken the necessary measures and to have informed the Commission by 27 November 2010.  

17.4.1.2. 

Report of the work done in 2010 

The year 2010 has been marked by the ongoing works in the context of the reform of the data 
protection framework. Two stakeholder conferences were organised in June/July 2010 which 
were  based  on  a  list  of  questions  prepared  by  the  Commission.  The  contributions  provided 
valuable  insight  on  issues  covered  by  Directive  95/46/EC  which  need  to  be  revised.  In 
November  2010,  the  Commission  presented  a  comprehensive  approach  on  personal  data 
protection in the EU. 

In parallel, works started on an impact assessment on a new legal framework, replacing and 
amending the legal instruments currently in force in the area of data protection. 

The  Commission  has  received  87  letters  (information/documents  requests  and  complaints) 
from citizens, 55 parliamentary questions and 3 petitions in 2010. 

In 2010, the Commission was also dealing with 13 infringement cases in the data protection 
field.  The  number  of  cases  referring  to  the  incorrect  application  of  the  data  protection 

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directive was higher than the non-conformity cases.  

The conclusions of the European Court of Justice in an infringement case against Germany on 
the  lack  of  independence  of  the  data  protection  authority  of  9.3.2010  (C-518/07)  were 
essential and allowed the Commission to advance a similar case against Austria, bringing the 
matter before the Court of Justice at the end of 2010. As the data protection authorities have 
the  crucial  task  of  protecting  the  fundamental  right  to  data  protection,  the  Commission  will 
continue  to  investigate  the  correct  application  of  the  provision  contained  in  Article  28  of 
Directive 95/46/EC referring to the independence of data protection authorities. 

The Commission advanced a case against the UK for concerns in relation to the transposition 
of Directive 95/46/EC and its application by UK courts. The Commission has worked with the 
UK authorities to resolve a number of issues, but several remained, notably limitations of the 
Information Commissioner's Office's powers or the possibility of courts in the UK to refuse 
the  right  to  have  personal  data  rectified  or  erased.  Therefore  the  Commission  adopted  a 
reasoned opinion against the UK.  

17.4.2.  Evaluation based on the current situation  

The situation and volume of work in 2010 was stable regarding the infringement cases. The 
number  of  letters  and  enquiries  has  decreased  while  the  number  of  parliamentary  questions 
increased. 

In terms of implementation of the Directive, the increased level of harmonisation that might 
have provided a solution has not been obtained. The improvement, which was hoped for and 
which could have resolved the difficulties identified during the first and the second review of 
the implementation of the Directive was neither achieved by the guidance of case law and of 
the  opinions  of  the  Article  29  Working  Party  nor  through  the  Commission's  infringement 
policy. Additionally developments such as the impact of new technologies and globalisation, 
divergent approaches in national law, application and enforcement, created uncertainties and 
contributed to administrative burden.  

No new infringement cases have been opened in 2010. 

17.4.3.  Evaluation results 

17.4.3.1. 

Priorities 

The priority during 2010 was to advance with the elaboration of a new legal framework for 
data protection. The Commission has succeeded to identify/analyse a number of issues to be 
covered by the new instrument. 

The  Commission  has  also  made  significant  progress  in  the  handling  of  infringement  cases 
which have been pending for a number of years. 

17.4.3.2. 

Planned action (2011 and beyond) 

The primary objective for 2011 will be the adoption of the new legislative framework for data 

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protection. 

The  Commission  will  also  present  a  report  on  the  implementation  of  Framework  Decision 
2008/977/JHA which will be based on the information received from the Member States. A 
stakeholder conference was held scheduled on 2 February 2011.  Member  States  were given 
the  possibility  to  discuss  problems  they  encountered  in  the  implementation  process  and  to 
highlight issues they consider important in view of the currently ongoing review of the data 
protection framework. 

The implementation of the ruling of the European Court on the lack of independence of the 
data protection authority in Germany was closely monitored. A letter of formal notice under 
Article 260(2) TFEU was notified to Germany on 7 April 2011 as Germany had not complied 
with the Court's ruling. 

17.4.4.  Summary 

Work towards the reform of the current legislative data protection framework was the major 
objective in 2010. The adoption of the reform package is due in 2011.  

Until  the  adoption  of  the  new  legislation,  the  Commission  will  continue  to  monitor  the 
application of Directive 95/46/EC. 

17.5. 

Judicial cooperation in civil matters 

17.5.1.  Current position  

17.5.1.1. 

Introduction 

Judicial cooperation in civil matters aims to contribute to the creation of a genuine European 
area  of  justice  based  on  mutual  recognition  and  trust.  In  particular,  it  aims  to  promote  the 
elimination  of  obstacles  to  the  good  functioning  of  cross-border  civil  proceedings  in  the 
Member States and thus improve the daily life of citizens and businesses mainly by fostering 
access to justice. In this context, a considerable number of instruments have been adopted in 
the  area  of  civil,  commercial  and  family  law  establishing  European  rules  on  jurisdiction, 
applicable  law,  recognition  and  enforcement  of  judgements  for  cross-border  civil  justice 
cases.  

17.5.1.2. Report of the work done in 2010 

•  New legislation  

On 24 March 2010, the Commission adopted a package of proposals to respond to a request 
by  a  group  of  Member  States  to  establish  enhanced  cooperation  in  the  area  of  the  law 
applicable to divorce and legal separation565. The enhanced cooperation package consists of 
two  parts:  first,  a  Council  Decision  that  authorises  enhanced  cooperation  for  14 Member 

565 

Proposal  for  a  Council  Decision  No  …/2010/EU  authorising  enhanced  cooperation  in  the  area  of  the 
law  applicable  to  divorce  and  legal  separation,  COM(2010)  104  final/2  and  Proposal  for  a  Council 
Regulation (EU) implementing enhanced cooperation in the area of the law applicable to divorce and 
legal separation, COM(2010)105 final/2. 

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States  and,  second,  a  Council  Regulation  containing  the  actual  measures  applying  in 
participating Member States.  

On  12 July 2010,  the  Council  of  the  European  Union,  with  the  consent  of  the  European 
Parliament, authorised 14 Member States to go ahead with the first enhanced cooperation in 
the history of the European Union and implement rules enabling international couples to agree 
on which law would apply to their divorce or legal separation566. The proposal will increase 
flexibility and autonomy by giving spouses a possibility to choose the law which will apply to 
their divorce. The new Regulation567 entered into force on 30 December 2010 and will apply 
as from 21 June 2012. 

Proposed legislation  

Following the 2009 Report evaluating the application of Regulation 44/2001 (Brussels I) and 
the Green Paper identifying ways to improve its functioning, a Proposal for the amendment to 
Regulation (EC) n°44/2001 (Brussels I) was adopted on 14 December 2010568.  

Preparatory legislative work  

The  Impact  assessment  on  Proposals  for  a  Regulation  on  matrimonial  property  rights  and 
property  rights  of  registered  partnerships  was  finalised  with  the  view  to  propose  two 
Regulations to cover questions on jurisdiction, applicable law recognition and enforcement of 
judgements of international couples' property rights.  

A Green Paper on the free circulation of documents within the European Union was adopted 
on 14 December 2010. In this paper, the Commission asks questions on how to improve the 
free circulation of public documents, such as diplomas, proof of nationality, property deeds. 
The Green Paper is open for consultation until April 2011.  

As  to  the  evaluation  exercises,  evaluation  studies  on  the  Legal  Aid  Directive  and  the  EEO 
Regulation as well as the assignment of claims under the Rome I Regulation were launched in 
2010. 

External Competence 

During 2010 negotiations concerning the proposal for a Council Decision on the signature and 
conclusion  of  the  Convention  on  the  International  Recovery  of  Child  Support  and  Other 
Forms of Family Maintenance continued at the Council; the negotiations are now progressing 
towards a definitive agreement which could be reached in the course of 2011. 

The first two Commission's decisions based on Regulations No 662/2009 and 664/2009 were 
adopted and three Commission Decisions with Denmark were signed569. 

566 

567  

568  
569 

Council Decision 2010/405/EU of 12 July 2010 authorising enhanced cooperation in the area of the law 
applicable to divorce and legal separation, OJ L 189, 22.7.2010, p. 12. 
Council Regulation N 1259/2010/EU of 20 December 2010 implementing enhanced cooperation in the 
area of the law applicable to divorce and legal separation, OJ L 343, 3.12.2010, p. 10. 
COM (2010) 748 final. 
Commission  Decision  authorising  Denmark  to  ratify  the  1995  Unidroit  Convention  on  Stolen  or 
Illegally Exported Cultural Objects – Commission Decision of 22.4.2010 authorising Denmark to ratify 

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international  organisations  (as  HCCH,  Council  of  Europe, 
Cooperation  with  other 
UNIDROIT,  UNCITRAL,  CIEC)  has  been  further  carried  out  with  participation  in  the 
relevant meetings and follow-up of the Conventions in the area of civil judicial cooperation. 

Monitoring  of  enlargement  issues  and  contacts  with  European  Neighbour  Policy  countries 
continued on a regular basis.  

The  international  negotiations  related  to  the  Space  Protocol  to  the  Cape  Town  Convention 
progressed. 

European Judicial Network in civil and commercial matters (EJN) 

In  2010,  the  European  Judicial  Network  in  civil  and  commercial  matters  prepared  the  entry 
into  force  of  its  amending  decision  (Decision  568/2009/EC),  especially  with  respect  to  the 
association  of  the  legal  professions  to  the  network,  new  tasks  for  the  contact  points  and 
various projects aimed at increasing the level of awareness of the Network with the judicial 
authorities, citizens and companies. 

In  2010,  five  contact  points  meetings  have  been  organised  which  were  dealing,  amongst 
others,  with  the  following  topics:  parental  responsibility,  the  European  order  for  payment 
procedure, the European Small Claims Procedure, the service of documents, legal aid and the 
migration of the EJN website to the European e-Justice portal. 

A citizens' guide to cross-border civil litigation in the European Union has been published in 
2010 on the portal of the EJN.  

17.5.2.  Evaluation based on the current situation  

In  2010,  the  Commission  continued  to  monitor  the  correct  application  of  the  civil  justice 
acquis. The Commission answered 91 complaints. The number of infringement cases pending 
decreased from 14 to 4. The remaining ones will be dealt with in the forthcoming period.  

The  Commission  is  also  contributing  to  the  correct  interpretation  of  acquis  through 
observations to the preliminary questions to the Court of Justice. With the entering into force 
of  the  Lisbon  Treaty,  which  allows  also  first  instance  courts  to  ask  the  Court  of  Justice  for 
preliminary rulings, their number has increased considerably in the area of civil justice.  

In  the  area  of  family  law,  the  new  urgent  preliminary  ruling  procedure  (PPU)  is  available 
since 1 March 2008 and has also increased the number of cases. The new procedure enables 
the  Court  of  Justice  to  deal  much  more  quickly  with  issues  relating  to  the  area  of  freedom, 
security and justice. Such an issue may arise, for example, in proceedings concerning parental 
responsibility if the jurisdiction under EU law of the national court hearing the case depends 
on the answer to the question referred for a preliminary ruling. 

In  2010,  Commission  observations  were  made  in  20  cases  in  civil  justice,  4  of  them  being 
"PPU" procedures doubling in number compared to 2009.  

the Protocol to amend the Convention on Third Party Liability in the Field of Nuclear Energy of 29 July 
1960, as amended by the Additional Protocol of 28 January 1964 and by the Protocol of 16 November 
1982 – Commission Decision of 22.4.2010 authorising Denmark to ratify the International Convention 
on Civil Liability for Bunker Oil Pollution Damage, 2001 (the Bunkers Convention). 

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The Commission gave opinions on 14 preliminary questions which concerned the application 
of  the  Regulation  (EC)  44/2001  (Brussels  I),  the  most  important  one  being  the  Pammer  – 
Alpenhof ruling. 

In the Cases C-585/08 and C-144/09 Pammer – Alpenhof, the Court of Justice explained the 
rules  of  jurisdiction  in  European  Union  law  that  are  applicable  to  consumer  contracts,  in 
relation  to  services  offered  on  the  internet.  Mere  use  of  a  website  by  the  trader  does  not  in 
itself trigger  application of the rules of  jurisdiction for the protection  of  consumers in other 
Member States. 

In the family law area, 4 of the Preliminary ruling cases were ‘PPU’ procedures relating to the 
interpretation of Regulation (EC) No 2201/2003 (the 'Brussels II a Regulation’).  

In  the  Case  C-211/10  PPU  the  Court  of  Justice  ruled  that  the  enforcement  of  a  certified 
judgment which required the return of the child could not be refused either on account of a 
judgment  delivered  subsequently  by  a  court  of  the  Member  State  of  enforcement  or  on 
account of a change of circumstances after its delivery. In Case C-400/10 PPU, the Court of 
Justice stated that the removal of a child by a parent to another Member State was wrongful 
only  if  it  was  in  breach  of  custody  rights  granted  by  national  law.  Furthermore,  the  Court 
ruled that national legislation under which the acquisition of rights of custody by a father who 
was not married to the mother of the child was dependent on his obtaining a court judgment 
was not in breach of the right to respect for private and family life protected by the Charter of 
Fundamental  Rights  of  the  EU.  The  Court  of  Justice’s  judgment  in  Case  C-491/10  PPU 
clarifies that the court with jurisdiction in the Member State of enforcement cannot oppose the 
enforcement of a certified judgment, ordering the return of a child who has been wrongfully 
removed, on the ground that the court of the Member State of origin which handed down that 
judgment  may  have  infringed  Article  42  of  Regulation  (EC)  No 2201/2003  interpreted  in 
accordance with Article 24 of the Charter of Fundamental Rights of the European Union. In 
Case C-497/10 PPU the Court of Justice was given the opportunity to interpret the concept of 
‘habitual residence’ for the purposes of the provisions of Regulation (EC) No 2201/2003 that 
make reference to a child’s habitual residence in a Member State.  

Awareness raising activities 

The  Commission  published  a  citizens'  guide  to  cross-border  civil  litigation  in  the  European 
Union in all languages. The European Union has a system of laws in place designed to help 
individuals and businesses with cross-border litigations. The Guide aims to explain these laws 
and  the  principles  behind  these  European  procedures  and  how  citizens  can  choose  whether 
they want to use them. The "Compendium of Community Legislation on Judicial Cooperation 
in  civil  and  commercial  matters"  was  published  in  all  languages  and  distributed  in  the  27 
Member States. 

In  October  2010,  at  the  same  time  as  the  European  Day  of  Civil  Justice,  the  Commission 
published a Eurobarometer survey in civil justice. 

17.5.3.  Evaluation results 

17.5.3.1. Planned action (2011 and beyond) 

A  wide  range  of  activities  has  been  launched  in  order  to  improve  the  conditions  for  cross-
border  trade  and  consumer  rights,  such  as  the  revision  of  the  Brussels  I  regulation  and  the 

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legislative  proposal  on  attachment  of  bank  accounts  which  will  contribute  to  reducing  costs 
for  businesses  in  line  with  the  objectives  of  the  flagship  initiative  Industrial  policy  for  the 
globalisation  era.  Together  with  the  foreseen  legislation  on  European  contract  law,  these 
activities strongly aim at improving consumer confidence in cross-border trade and increase 
business activities in cross-border trade. 

The  proposals  on  matrimonial  property  rights  and  property  rights  of  registered  partnerships 
are planned to be adopted in 2011. Both Regulations will include provisions on jurisdiction 
rules, applicable law rules, and recognition and enforcement rules. As regards applicable law, 
the  proposed  Regulations  will  in  particular  provide  for  objective  criteria,  allowing 
determining  the  law  applicable  to  the  assets  of  the  couples  and  should  also  explore  the 
spouses' possibilities of choosing, to a certain extent, the law applicable to their assets. The 
proposals  will  also  deal  with  the  question  of  jurisdiction.  Its  provisions  will  have  to  be 
consistent with existing or future rules, relating to divorce proceedings and successions. 

17.5.4.  Summary 

With  the  aim  of  facilitating  the  life  of  individuals  and  businesses  involved  in  cross-border 
litigation, a wide range of activities has taken place in the area of judicial cooperation in civil 
matters during 2010. The European Union adopted new legislation on the question of the law 
applicable to divorce and legal separation using for the first time in its history the enhanced 
cooperation procedure. Intense preparatory legislative work has been carried out by means of 
impact assessment studies, evaluation reports and Green Paper consultations. A proposal for 
revising existing legislation has been put forward to improve and facilitate the circulation of 
judgments  across  the  European  Union.  Particular  attention  has  been  given  to  the  correct 
implementation and application of the civil justice acquis. The role of the European Judicial 
Network  in  civil  and  commercial  matters  has  been  reinforced.  Numerous  preliminary 
questions to the Court of Justice of the European Union gave the Commission the opportunity 
to  contribute  to  the  interpretation  of  civil  justice  instruments.  With  regard  to  the  Union's 
external  competence,  cooperation  with  international  organisations  and  negotiations  on 
questions  of  private  international  law  were  carried  out.  Last  but  not  least,  various  activities 
took  place  aiming  at  measuring  and  raising  public  awareness  across  the  EU  of  civil  justice 
instruments and procedures.  

17.6.  Consumer and marketing law 

17.6.1.  Current position  

17.6.1.1. Introduction 

There are more than 500 million consumers in Europe and their expenditure represents over 
half of the EU’s gross domestic product (GDP). Consumers are essential to economic growth 
and job creation in a large market of products and services. 

Directorate-General Justice's responsibility for  consumer  and  marketing  law  is  embedded  in 
the  Commission's  Consumer  Policy  Strategy  as  well  as  in  the  implementation  of  the 
Stockholm Programme, the aim of which is to create an area of freedom, security and justice 
for Europe's citizens. The objective in consumer and contract law is to maintain and develop 
an  effective  legislative  framework  which  promotes  the  economic  interests  of  European 
consumers  and  ensures  an  open,  fair  and  transparent  internal  market.  This  will  allow 
the  required  protection,  while  providing  a 
consumers  to  exercise  real  choice,  give  them 

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level playing field and predictable rules for businesses and excluding rogue traders, thereby 
helping consumers and businesses take full advantage of the market’s potential. 

Directorate-General  for  Justice  is  in  charge  of  eight  directives  in  the  area  of  consumer  and 
marketing law. In 2010 it was active in both monitoring the transposition and application of 
these directives as well as the modernisation of the acquis.  

17.6.1.2. Report of the work done in 2010 

•  Review of the Package Travel Directive 

In the framework of the potential revision of the Package Travel Directive (90/314/ EEC), a 
public  consultation  was  open  until  7  February  2010.  It  mainly  focused  on  possible  ways  of 
solving  problems  with  the  current  rules.  It  also  aimed  to  quantify  the  impacts  of  various 
possible legislative options. At the same time a public consultation on air passenger rights was 
initiated.  It  touched  on  a  related  topic,  namely  the  possible  introduction  of  passenger 
protection in the event of airline bankruptcy (There is currently no insolvency protection for 
standalone  air  tickets,  i.e.  for  flights  which  are  not  included  in  a  travel  package).  In  April 
2010,  the  Commission  held  a  stakeholders'  workshop  to  discuss  different  policy  options.  In 
the second half of 2010, the Commission worked on the impact assessment for the revision of 
the  Directive  taking  account  the  parallel  impact  assessment  on  passenger  protection  in  the 
event of airline insolvency. 

•  Negotiations on the proposal for a new directive on consumer rights 

The  co-decision  legislative  process  in  relation  to  the  proposal  for  a  new  Directive  on 
consumer rights has now come to a successful conclusion. The proposal, which was adopted 
by  the  Commission  in  2008,  intended  to  bring  together  and  update  the  Distance  Selling 
Directive 97/7/EC, the Doorstep Selling Directive 85/577/EEC, the Consumer Sale of Goods 
Directive 99/44/EC and the Unfair Contract Terms Directive 93/13/EEC, thereby reducing the 
legal  fragmentation  in  the  internal  market.  Intense  negotiations  on  the  proposal  under  the 
Belgian presidency led to the adoption of a general approach by the Council on 24 January 
2011. The general approach focuses on distance and off-premises contracts and foresaw, with 
the exception of three opening clauses, to fully harmonise the information requirements, the 
right of withdrawal and the provisions on delivery and passing of risk. Directives 99/44/EC 
and 93/13/EEC would remain unchanged. The European Parliament adopted the agreed text in 
plenary on 23 June 2011. Formal adoption of the new Directive by the Council is expected in 
October 2011. 

•  Transposition, application and interpretation of the existing directives  

Directive 2005/29/EC on Unfair Commercial Practices 

The national laws transposing Directive 2005/29/EC have been in force in all Member States 
since the beginning of 2010. However, the transposition of the Directive continues to pose a 
number of challenges considering the important legal impact of full harmonisation in a broad 
area which was characterised by considerable differences in national rules and policies.  

In  order  to  ensure  an  adequate  implementation  of  the  Directive  in  the  Member  States,  the 
Commission  continued  its  transposition  checks  and  discussions  with  Member  States  and 
transposition problems. In this connection, 
stakeholders  with 

a  view 

solving 

to 

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the  Commission  intervened  in  various  cases  referred  to  the  Court  of  Justice  for  preliminary 
rulings,  such  as  C-540/08  Mediaprint  and  C-122/10  Ving  Sverige  (judgement  issued  on  12 
May 2011). In the Mediaprint case, the Court had to examine the compatibility of an Austrian 
provision  banning  the  sale  of  newspapers  combined  with  the  possibility  to  take  part  in  a 
competition  (i.e.  sales  of  newspapers  with  so-called  "bonuses"),  and  stated  that  "[…]  the 
Directive must be interpreted as precluding a national provision, such as that at issue in the 
main  proceedings,  which  lays  down  a  general  prohibition  on  sales  with  bonuses  and  is  not 
only designed to protect consumers but also pursues other objectives". 

In  2010  the  Commission  started  the  preparation  of  the  report  on  the  application  of  the 
Directive (as provided for by Article 18 of the Directive) and launched a call for tender for a 
study  to  assess  the  application  of  the  Directive  in  the  fields  of  financial  services  and 
immovable property. In the report the Commission will address various issues including the 
effects of full harmonisation in areas such as sales promotions. 

To promote a common understanding and to develop a uniform application of the Directive, 
the  Commission  worked  on  the  development  of  a  legal  (online)  database  for  the  Directive. 
The  database  will  make  available  to  the  public  information  on  the  transposition  and 
implementation measures in the Member States, relevant decisions of the European Court of 
Justice,  the  leading  national  jurisprudence  and  administrative  practice,  relevant  legal 
literature,  guidelines  from  national  authorities,  codes  of  conduct  etc.  This  database  was 
launched at a conference in July and will be publicly available as from July 2011. 

Other consumer protection directives  

In  2010  the  Commission  continued  infringement  proceedings  resulting  from  systematic 
checks on the quality of transposition of certain consumer protection directives. In addition, 
its services dealt with a number of complaints identifying potential implementation problems. 
The Commission also replied to numerous parliamentary questions and correspondence from 
citizens. 

In  particular,  the  Commission  closed  all  infringement  proceedings  based  on  the  inadequate 
transposition  of  Directive  93/13/EEC  on  unfair  terms  in  consumer  contracts  which  were 
opened in 2008. In 2010 the two remaining cases were closed since the CZ and SK changed 
their legislation following a reasoned opinion570.  

Three out of the nine infringement cases opened in 2009571 in relation to deficiencies in the 
transposition of Directive 99/44/EC on the sale of consumer goods and associated guarantees 
were  closed  after  a  letter  of  formal  notice.  In  six  cases  the  Commission  issued  reasoned 
opinions  in  2010.  Two  of  these  cases  were  closed  following  legislative  changes  in  the 
Member  States  concerned572.  In  the  four  remaining  cases573  the  Member  States  concerned 
have announced legislative changes. 

In relation to Directive 90/314/EEC on package travel, PL, following the Commission's letter 
of  formal  notice,  amended  its  national  rules  transposing  Article  7  of  the  Directive.  This 

570 
571 
572 
573 

Commission's press release IP/09/1451.  
Commission's press release IP/09/1032. 
Luxembourg and Greece. 
Czech Republic, Estonia, Poland and Slovenia.  

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provision  obliges  Member  States  to  ensure  that  consumers  are  guaranteed  a  refund  of  the 
money paid over and repatriation in case of the organiser's insolvency.  

Finally, there were a number of new requests for preliminary rulings under Article 267 TFEU 
in relation to different consumer protection directives as well as rulings on questions that had 
previously been submitted to the Court of Justice. Some of these cases are mentioned below. 

In Case C-215/08 E. Friz the Court ruled that Directive 85/577/EEC does apply to contracts 
concerning a consumer's entry in a closed-end real property fund established in the form of a 
partnership even though the principal purpose of joining is not to become a member of that 
partnership,  but  is  a  means  of  capital  investment.  If  the  consumer  exercises  his  right  of 
withdrawal from such partnership, Article 5 (2) of Directive 85/577/EEC does not preclude a 
national law according to which the consumer's claim against that partnership is calculated on 
the basis of the value of his interest at the date of his withdrawal from this membership; the 
consumer  may  thus  get  back  less  than  the  value  of  his  capital  contribution  or  have  to 
participate in the losses of that fund.  

In Case C-511/08 Heinrich Heine on a preliminary request from a German court concerning 
Directive  97/7/EC  on  distance  contracts,  the  Court  found  that  the  provisions  of  Directive 
97/7/EC  on  the  legal  consequences  of  the  withdrawal  clearly  have  as  their  purpose  not  to 
discourage  consumers  from  exercising  this  right.  Therefore,  the  directive  precludes  national 
legislation which, in the context of a distance contract, allows the supplier to charge the costs 
of delivering the goods to the consumer after the latter has exercised his right of withdrawal. 

In  Case  C-484/08,  Caja  de  Ahorros  y  Monte  de  Piedad  de  Madrid,  the  Court  of  Justice 
confirmed  that,  given  its  minimum  harmonisation  character,  Directive  93/13/EEC  on  unfair 
terms in consumer contracts does not preclude national legislation which authorises a judicial 
review  as  to  the  unfairness  of  contractual  terms  which  relate  to  the  definition  of  the  main 
subject-matter of the contract or to the adequacy of the price and remuneration, even in the 
case where those terms are drafted in plain, intelligible language574. 

In Case C-137/08 VB Pénzügyi Lízing the Court of Justice further developed its case law on 
Article 6(1)575 of Directive 93/13/EEC on unfair terms in consumer contracts. Following on 
from  previous  judgments  in  relation  to  this  provision576  the  Court  concluded  that  national 
courts  must  investigate  of  their  own  motion  whether  a  term  conferring  exclusive  territorial 
jurisdiction in a contract concluded between a seller or supplier and a consumer, which is the 
subject of a dispute before it, falls within the scope of Directive 93/13 and, if it does, assess of 
its own motion whether such a term is unfair577.  

574 
575 

576 
577 

See point 1 of the operative part of the Court's judgment of 3 June 2010. 
Article 6 (1) reads: "Member States shall lay down that unfair terms used in a contract concluded with a 
consumer by a seller or supplier shall, as provided for under their national law, not be binding on the 
consumer  and  that  the  contract  shall  continue  to  bind  the  parties  upon  those  terms  if  it  is  capable  of 
continuing in existence without the unfair terms." 
E.g. Cases C-243/08 Pannon GSM, and C-40/08 Asturcom Telecomunicaciones. 
See point 3 of the operative part of the Court's judgment of 9 November 2010. 

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In  Case  C-76/10578  Pohotovosť  s.r.a.  the  Court  of  Justice  established,  in  line  with  existing 
case law579, that also in connection with the assessment of execution requests for arbitration 
awards which were granted in the absence of the consumer and have become final, national 
courts are obliged to examine, of their own motion, whether a sanction (e.g. a penalty) which 
was applied in the arbitration award is disproportionate, where they have available to them the 
necessary legal and factual elements and in so far as, under national rules of procedure, such 
an  assessment  can  be  carried  out  in  similar  actions  of  a  domestic  nature.  The  Court  also 
concluded that the lack of indication of the annual percentage rate of charge required under 
the consumer credit legislation may be a decisive factor when determining whether the cost of 
the  credit  is  expressed  in  plain  intelligible  language  in  the  sense  of  Article  4  of  Directive 
93/13580.  

In  the  joined  cases  C-585/08  and  C-144/09  Pammer  &  Alpenhof,  concerning  Directive 
90/314/EEC  on  package  travel,  the  Court  confirmed  that  a  voyage  by  freighter  (which 
included accommodation) could be considered to be a "package travel" under the Directive.  

17.6.2.  Evaluation based on the current situation  

The  acquis  in  consumer  and  contract  law  has  been  transposed  by  all  Member  States.  The 
quality  of  the  transposition  of  several  directives  has  improved  or  is  about  to  improve  in 
specific Member States due, in particular, to infringement proceedings. Several questions on 
the interpretation of particular provisions have been clarified through rulings by the Court of 
Justice.  Specific  implementation  problems,  may,  however,  still  be  discovered  through  new 
complaints and requests for preliminary rulings.  

Continued efforts will be necessary in particular in relation to the assessment of the quality of 
transposition of Directive 2005/29/EC on Unfair Commercial Practices.  

Since the time-limit for the transposition of Directive 2008/122/EC on timeshare will run out 
in  February  2011,  the  monitoring  of  the  transposition  of  this  Directive  will  be  made  in  the 
next period.  

17.6.3.  Evaluation results 

17.6.3.1. Priorities 

The revision of the Package Travel Directive (90/314/EEC) will be a priority in 2011. 

In  addition,  the  assessment  of  the  implementation  of  Directive  2005/29/EC  on  unfair 
commercial practices and the preparation of the Report on the application of the Directive will 
receive particular attention. The same applies to the announced communication on the review 
of Directive 2006/114/EC on misleading and comparative advertising. 

578 

579 
580 

Order of the Court of Justice of 16 November 2010, in particular point 54 and point 1 of the operative 
part. This case is also relevant from the point of view of the consumer credit legislation, which is in the 
remit of DG SANCO. 
See in particular C-40/08 Asturcom Telecomunicaciones. 
See, in particular, paragraphs 71 and 72, as well as point 3 of the operative part. 

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The monitoring of the timely transposition of Directive 2008/122/EC on timeshare, and, at a 
later  stage,  of  the  quality  of  the  national  transposition  measures  will  also  constitute  an 
important objective for the Commission's services.  

17.6.3.2. Planned action (2011 and beyond) 

Several  initiatives  in  the  field  of  consumer  and  marketing  law  are  included  in  the 
Commission's  action  plan  for  the  implementation  of  the  Stockholm  Programme  for  the 
creation of an area of freedom security and justice for European Citizens in the period 2010-
2014.  Moreover,  the  Commission  plans  to  issue  a  Consumer  Agenda  in  the  first  quarter  of 
2012.  The  Consumer  Agenda  will  build  on  the  results  achieved  by  the  Commission's 
Consumer  Policy  Strategy  for  2007-2013  and  will  bring  together  a  number  of  initiatives  in 
different areas which aim at improving the situation for Europe's consumers. It will contribute 
to  fighting  a  number  of  obstacles  to  EU  economic  growth  and  improve  the  protection  of 
consumers. Compared to the current Strategy, it will focus on the empowerment of consumers 
throughout the consumption life-cycle in a constantly changing environment. For example, it 
will  address  the  challenges  consumers  face  because  of  the  increased  importance  of  digital 
products and the online environment, increased complexity of decision making (information 
overload,  more  responsibility  shifted  to  consumers),  the  need  to  move  towards  more 
sustainable  patterns  of  consumption,  population  ageing  and  social  inclusion/vulnerable 
consumers. 

The actions planned in the coming years aim to improve the legislative framework, achieve 
transparency  of  the  applicable  rules  and  to  ensure  effective  implementation  in  the  Member 
States.  

They  include  the  revision  of  the  Package  Travel  Directive  (90/314/EEC),  a  Communication 
followed by a possible legislative proposal to bring existing EU consumer acquis in line with 
developments  in  the  digital  environment,  as  well  as  different  activities  in  relation  to  the 
Directive on Unfair Commercial Practices (2005/29/EC). The latter actions involve increased 
transparency  through  the  launch  of  the  legal  online  database,  the  examination  of  the 
transposition  in  the  Member  States  as  well  as  the  possible  review  of  the  Directive  in 
connection  with  the  report  on  the  application  of  the  Directive.  This  report  as  well  as  the 
the  Misleading  and  Comparative  Advertising  Directive 
planned  communication  on 
(2006/114/EC) may lead to new legislative proposals. 

The Commission will also have to decide whether and how the existing public database on the 
national rules transposing eight consumer protection directives and their application is to be 
continued beyond 2011. 

Effective  implementation  by  the  Member  States  will  remain  a  very  important  aspect. 
Therefore the Commission will supervise the transposition of recent directives (e.g. Directive 
2008/122/EC  on  timeshare  and  the  new  Consumer  Rights  Directive  once  it  has  been 
implemented)  and  respond  to  complaints  and,  where  appropriate,  initiate  infringement 
proceedings. 

17.6.4.  Summary 

The combined action of Commission and Member States in 2010 has led to a high degree of 
conformity  with  the  acquis  in  the  area  of  consumer  and  marketing  law.  There  are  however 
one  of  the  challenges  is  to  create  a  more 
important  challenges  ahead.  In  the  near  future 

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coherent  framework  for  cross-border  shopping  through  clearer,  simplified  and  harmonised 
rules  that  are  uniformly  enforced  by  national  authorities,  to  increase  EU-wide  consumer 
confidence and enable consumers and businesses to fully benefit from the potential offered by 
the internal market. The implementation of the new Consumer Rights Directive will constitute 
one  step  towards  this  goal,  but  further  action  will  be  needed.  This  will  require  continued 
efforts  by  all  players  and,  in  particular,  the  Member  States,  whose  role  is  to  transpose  and 
enforce Union law. Consumers and their organisations may help also by signalling problems 
in the implementation of particular rules.  

17.7. 

Judicial cooperation in criminal matters 

17.7.1.  Current position  

17.7.1.1. Introduction 

With  the  entry  into  force  of  the  Lisbon  Treaty  and  the  abolition  of  the  pillars  structure,  the 
implementation  of  Framework  Decisions  in  the  field  of  judicial  cooperation  in  criminal 
matters is expected to become less problematic in future. There is widespread recognition that 
implementation of third pillar instruments has been very poor. In the former third pillar, the 
Commission  did  not  have  enforcement  powers  and  therefore  could  not  start  infringement 
procedures  against  Member  States  who  did  not  implement  Framework  Decisions  (or  who 
implemented them belatedly or incorrectly).  

17.7.1.2. Report of the work done in 2010 

There  are  currently  12  mutual  recognition  instruments  in  criminal  law,  out  of  which  five 
ought to have been implemented before or by 2010. 

Out  of  the  12  instruments,  only  the  European  Arrest  Warrant  instrument  has  been 
implemented satisfactorily and on time. Framework Decision 2002/584/JHA on the European 
Arrest  Warrant  has  been  transposed  by  all  Member  States.  Since  the  Framework  Decision 
came into operation, in general the time taken to execute a warrant is provisionally estimated 
to have fallen from more than nine months to five weeks. This does not include frequent cases 
where the person consents to surrender, for which the average time taken is two weeks.  

Implementation of the other instruments has not been satisfactory. In particular 4 instruments 
have been merely partially implemented so far: 

•  Council Framework Decision 2001/220/JHA of 15 March 2001 on the standing of victims 
in criminal proceedings has been poorly implemented. Although the scope of this Member 
States'  initiative  covering  most  of  the  rights  of  victims  of  all  types  of  crimes  is  still 
relevant, European societies have evolved and there is growing awareness and a changing 
judicial culture to better address the rights and needs of victims of crime. This legislation 
has not been effective in meeting the desired outcome of addressing the needs of victims 
and achieving minimum standards across the EU. No Member State can claim to have fully 
implemented  the  instrument.  The  ineffectiveness  of  this  legislation  is  also  due  to 
ambiguous  drafting,  lack  of  concrete  obligations  and  lack  of  infringement  possibilities 
under  the  former  3d  pillar.  In  2010,  the  Commission's  services  have  carried  out  three 
expert  meetings,  a  public  consultation  and  an  external  impact  assessment  study,  which 
confirmed these findings and helped to elaborate options for EU legislation. 

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•  Council Framework Decision 2005/214/JHA of 24 February 2005 on the application of the 
principle  of  mutual  recognition  to  financial  penalties581  has  been  implemented  in  22 
Member  States,  while  implementation  (or  notification)  from  5  Member  States  is  still 
missing. Besides delays in its transposition, the quality of implementation leaves much to 
be  desired.  While  some  of  the  most  important  issues  such  as  the  abolition  of  dual 
criminality and the recognition of decisions without further formality are properly reflected 
in the implementing provisions, the grounds for refusal have been implemented mostly as 
obligatory  grounds  and  additional  grounds  have  been  added  in  contravention  of  the 
Framework Decision. Little information is still available on its practical application. 

•  Council  Framework  Decision  2003/577/JHA  of  22  July  2003  on  the  execution  in  the 
European  Union  of  orders  freezing  property  or  evidence582  has  been  implemented  by  23 
Member  States.  Little  information  is  still  available  on  the  practical  application  of  the 
legislation. Feedback from practitioners seems to indicate that the certificate to request the 
execution  of  freezing  orders  is  rather  difficult  to  complete  and  does  not  contain  all  the 
necessary fields. Therefore, judicial authorities tend to prefer recourse to the mutual legal 
assistance forms.  

•  Council  Framework  Decision  2006/783/JHA  of  October  2006  applies  the  principle  of 
mutual recognition to confiscation orders issued by a court competent in criminal matters 
for the purpose of facilitating enforcement of such confiscation orders in a Member State 
other than the one in which the confiscation order was issued. The implementation report 
adopted  by  COM  in  August  2010  (delay  resulted  from  the  low  number  of  notifications 
received  by  the  deadline  set  by  the  FD:  only  two  notifications  were  received  on  time) 
showed  that  the  degree  of  implementation  of  FD  is  clearly  not  satisfactory.  Thirteen 
Member States implemented the FD and notified it the Commission (at least informally) by 
the end of February 2010, fifteen months after the deadline set by the Framework Decision. 
The  national  implementing  provisions  received  from  the  thirteen  Member  States  are 
generally  satisfactory  and  can  be  considered  to  be  in  line  with  the  Framework  Decision, 
especially  regarding  the  most  important  issues  such  as  the  abolition  of  dual  criminality 
checks  and  the  recognition  of  decisions  without  further  formality.  Unfortunately,  the 
analysis  of  grounds  for  refusal  of  recognition  shows  that  almost  all  Member  States 
included  in  their  national  legislation  several  additional  grounds,  in  contravention  of  the 
Framework  Decision.  At  present,  notifications  on  the  implementation  of  the  Framework 
Decision have been received from 17 Member States. 

Since  the  rules  currently  in  force  do  not  allow  the  Commission  to  initiate  infringements 
proceedings  in  respect  of  legislation  adopted  before  1  December  2009  (for  a  transitional 
period of five years from the entry into force of the Lisbon Treaty), DG Justice had decided to 
launch an array of initiatives designed to improve the implementation record in this area, in 
particular  by  providing  Member  States  with  guidance  and  help  during  the  implementation 
stage.  These  initiatives  have  included:  a  series  of  workshops  with  national  legislators  and 
practitioners on the three Framework Decisions mentioned above, preparation of handbooks 
for practitioners; streamlined contact with national authorities responsible for implementation; 
participation of Commission officials in national training for judges and prosecutors. 

581 

582 

Council Framework Decision 2005/214/JHA of 24 February 2005 on the application of the principle of 
mutual recognition to financial penalties, OJ L 76/16 of 22.3.2005. 
Council Framework Decision 2003/577/JHA of 22 July 2003 on the execution in the European Union of 
orders freezing property or evidence, OJ L 196 of 2.8.2003, p. 45. 

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17.7.2.  Evaluation based on the current situation  

Workshops  carried  out  in  2010  contributed  to  creating  a  new  forum  for  discussion  and 
exchange  of  information  on  the  practical  application  of  the  Framework  Decision  and 
prompted implementation by a number of Member States. Workshops have been instrumental 
in increasing compliance with the Framework Decision and in streamlining contact between 
national authorities and the Commission, which in turn lead to better quality of implementing 
legislation.  They  have  also  allowed  demonstrating  an  increasing  cross-border  use  between 
certain Member States.  

However, the degree of implementation of the three instruments above is still not satisfying. 

17.7.3.  Evaluation results 

17.7.3.1. Priorities 

The number of legislative proposals to be adopted in 2011 or already on the table imposes a 
prioritisation of the work. On that basis, the main priorities for 2011: 

•  Recast the Framework Decisions on the standing of victims in criminal proceedings in the 
framework of a broader package of legislative and non legislative measures to improve the 
situation of victims of crime; 

•  Recast the Framework Decisions on mutual recognition of confiscation orders and freezing 

orders; 

•  Monitoring  the  correct  implementation  of  the  Framework  Decisions  on  probation  orders 

and custodial sentences (see below); 

•  Monitoring  of  the  conformity  of  national  measures  transposing  Directive  2004/80 

(compensation for victims of intentional crime). 

17.7.3.2. Planned action (2011 and beyond) 

Conclusions from the workshops and other meetings on the instruments led to the decision on 
recasting the Framework Decisions mentioned above in the framework of the 2011 Working 
Programme  in  view  of  achieving  better  quality  legislation  as  well  as  improving  effective 
measures in the fight of the cross-border criminality. Legislative proposals on all instruments 
will be adopted in 2011. 

At  the  same  time  the  Commission's  implementation  strategy  will  be  continued  concerning 
other  instruments.  In  an  attempt  to  prevent  problems  stemming  from  implementation  at  an 
earlier stage, Implementation Workshops with national legislators and practitioners this year 
will concern Framework Decisions 2008/947/JHA on probation measures and 2008/909/JHA 
on custodial sentences (transfer of prisoners), for which the implementation periods are still 
running  until  December  2011.  Streamlined  contacts  with  Member  States  may  include 
implementation  "package  meetings",  where  all  the  different  services  involved  in  the 
implementation work could benefit from the expertise of the Commission services.  

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The  legislative  and  non  legislative  package  on  victims'  rights  to  be  adopted  in  2011  will 
include  concrete  measures  to  improve  the  implementation  of  the  new  legislation  such  as 
elaborating handbooks, exchange of best practices and training  of  officials which will be in 
contact with victims. 

Regarding  Directive  2004/80/EC  on  compensation  for  victims  of  violent  intentional  crime, 
and although infringement procedures were already launched against two Member States for 
lack  of  communication  of  national  transposing  measures  (Greece)  and  for  non  transposition 
(Italy),  there  is  increasing  evidence,  largely  based  on  NGOs  and  citizens'  letters, 
parliamentary  requests  and  petitions,  that  these  two  Member  States  might  still  not  be 
compliant with the current Directive. The implementation of the Directive is currently under 
exam by the Commission which will shortly take action under the EU pilot scheme. 

The  Commission  will  also  present  a  report  on  the  application  of  Framework  Decision 
2002/584/JHA on the European Arrest Warrant. 

17.7.4.  Summary 

The EU has only been legislating in this area for around 10 years. The expertise of Member 
States’  national  legislators  is  therefore  still  limited.  In  order  to  reduce  this  gap,  the 
Commission  has  undertaken  a  number  of  initiatives  to  improve  the  situation,  including: 
implementation workshops on a regional basis, on top of the regular expert meetings which 
take  place 
in  Brussels;  streamlined  contacts  between  national  administrations  and 
Commission  services,  possibly  coupled  by  meetings  in  the  capitals;  dissemination  of 
implementation handbooks. 

Since  the  entry  into  force  of  the  Lisbon  Treaty,  the  Commission  can  exercise  enforcement 
powers,  straight  away  as  concerns  newly  adopted  legislation  and  subject  to  a  period  of  five 
years  as  concerns  Framework  Decisions  adopted  before  1  December  2009.  Until  then,  the 
Commission  will  continue  to  monitor  the  correct  application  of  criminal  justice  instruments 
by other means. 

17.8.  Antidiscrimination and gender equality 

17.8.1.  Current position 

17.8.1.1. Introduction 

The legislative acquis in the field of gender equality and anti-discrimination is composed of 
11  Directives,  based  mainly  on  the  specific  Treaty  provisions:  Article  157  TFEU  (former 
Article  141  TEC)  for  gender  equality  and  Article  19  TFEU  (former  Article  13  TEC)  for 
antidiscrimination.  

The  number  of  infringement  proceedings  concerning  this  field  used  to  be  high  due  to  a 
combination  of  non-conformity  and  non-communication  cases.  The  majority  of  these  cases 
were  non-conformity  cases  opened  in  the  period  2005-2007  following  conformity  check  of 
recently transposed directives. During the period 2008-2010 the number of infringements has 
steadily  decreased  following  amendments  to  national  laws  in  the  Member  States  which 
brought the national legislation in line with the EU acquis: more than 100 cases at the end of 

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2008, 74 at the end of 2009 and 45 at the end of 2010. By the end of 2010, the last remaining 
non-communication  cases  were  expected  to  be  closed  in  early  2011  following  adoption  of 
national transposing laws. 

17.8.1.2. Report of work done in 2010 

New legislation adopted 

•  Directive 2010/18/EU of 8 March 2010 implementing the revised Framework Agreement 
on  parental  leave  concluded  by  BUSINESSEUROPE,  UEAPME,  CEEP  and  ETUC  and 
repealing Directive 96/34/EC, 

•  Directive 2010/41/EU of 7 July 2010 on the application of the principle of equal treatment 
between men and women engaged in an activity in a self-employed capacity and repealing 
Directive 86/613/EEC. 

Directive  2010/18/EU  implements  the  revised  framework  agreement  on  parental  leave 
concluded by the social partners at European level. The Directive extends workers' rights to 
parental  leave  from  three  to  four  months  for  each  parent.  The  Directive  will  allow  working 
parents  to  better  balance  family  and  work.  To  encourage  a  more  equal  take-up  of  leave  by 
both parents, at least one of the four months shall be provided on a non-transferable basis. The 
transposition deadline for the Directive is 8 March 2012.  

Directive 2010/41/EU strengthens social protection of self-employed workers with a view to 
removing  disincentives  to  female  entrepreneurship  and  improves  the  social  protection  of 
"assisting"  spouses  who  often  work  in  the  self-employed  sector  without  enjoying  the 
corresponding rights. The Directive grants for the first time at EU level a maternity allowance 
to self-employed workers. Self-employed workers are also granted a leave period of at least 
14  weeks  should  they  choose  to  take  it. The  Directive  marks  an  important  step  forward  in 
terms of increasing social protection and providing equal economic and social rights for self-
employed men and women, and their partners. The transposition deadline for the Directive is 
5 August 2012. 

There  are  Member  States  which  have  already  notified  transposing  measures  for  both 
directives, therefore well in advance of the transposition deadlines in 2012. 

New legislation in preparation 

In  the  area  of  gender  equality  and  anti-discrimination,  two  2008  legislative  proposals 
remained under discussion in 2010:  

•  a proposal for a Directive implementing the principle of equal treatment between persons 
irrespective of religion or belief, disability, age or sexual orientation outside employment, 

•  a proposal for a Directive amending Directive 92/85/EEC on the introduction of measures 
to  encourage  improvements  in  the  safety  and  health  at  work  of  pregnant  workers  and 
workers who have recently given birth or are breastfeeding. 

Concerning  the  proposal  for  a  Directive  implementing  the  principle  of  equal  treatment 
between persons irrespective of religion or belief, disability, age or sexual orientation outside 
employment  the  Council  negotiations  continued  at  technical  level  in  2010.  However,  no 

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significant progress has been registered in the Council.  

Council  discussions  on  the  proposal  for  a  Directive  amending  Directive  92/85/EEC  also 
continued  in  2010.  The  European  Parliament  commissioned  a  cost  –  benefit  study  of  the 
amendments  and  in  its  first  reading  position  in  October  2010  proposed  considerable 
amendments  to  the  proposal.  These  amendments  raised  concerns  in  a  number  of  Member 
States as regards the cost of the Directive and remained under analysis until the end of 2010.  

Monitoring of infringements 

All  Member  States  have  transposed  Directives  2000/43/EC,  2000/78/EC  and  2002/73/EC. 
One  procedure  for  non-communication  of  national  measures  to  transpose  Directive 
2004/113/EC and two procedures for Directive 2006/54/EC remained still open at the end of 
2010.  However,  in  one  of  the  proceedings  concerning  Directive  2006/54/EC  Member  State 
had already notified national transposition and in the two other proceedings the national law 
had  been  adopted  and  the  cases  were  pending  the  entry  into  force  of  the  national  laws  on 
1.1.2011. 

To  monitor  the  application  of  the  EU  legislation  in  the  area  of  gender  equality  and  anti-
discrimination the Commission took the following action in 2010: 

•  With  regard  to  ensuring  the  conformity  with  Article  157  TFUE,  the  Commission  was 
analysing  the  new  legislative  package  adopted  by  one  Member  State  (FR)  whilst  the 
Article 260 TFEU proceedings against IT and EL could be closed in November 2010 since 
the gender differences in pensionable age were corrected in both Member States.  

•  Concerning Directive 2000/43/EC, the Commission closed five cases (SE, LV, SI, CZ and 

DE) ; seven other cases for incorrect transposition remained open at the end of 2010,. 

•  Concerning Directive 2000/78/EC, the Commission closed six cases (CZ, HU, LV, LT, SE 
and DE); eight other cases for incorrect transposition remained open at the end of 2010.  

•  Concerning  transposition  of  Directive  2006/54/EC  five  non-communication  proceedings 
(BE, EE, IT, LU and UK) were closed whilst proceedings against two Member States (AT, 
PL) remained technically open until the end of the year; in the meantime AT had already 
notified the national transposing law.  

•  Concerning  transposition  of  Directive  2004/113/EC  the  non-communication  proceedings 
against UK were closed, whilst proceedings against PL remained open until the end of the 
year.  

•  Concerning  Directive  2002/73/EC,  six  cases  (DE,  LT,  LV,  SI,  IT  and  IE)  for  incorrect 
transposition were closed, the Commission being satisfied with the amendments introduced 
or the explanations given. Thirteen proceedings remained open, but a number of these were 
heading for a solution following legislative amendments at national level. 

Contribution to preliminary rulings: 

The  Commission's  services  also  contributed  to  a  number  of  preliminary  rulings  received  by 
the  Court  of  Justice  under  Article  267  TFEU  (ex  Article  234  TEC)  in  connection  to  the 
application  of  the  gender  equality  and  anti-discrimination  acquis.  The  cases  below  worth 

EN 

467 

   EN 

 
particular attention: 

In Case C-149/10, Chatzi, the Court was asked whether a mother who gives birth to twins is 
entitled to two periods of parental leave, one period for each child, or whether she is entitle to 
only one period of parental leave corresponding to the birth. Indeed, children have the right to 
protection and care as is necessary for their well-being. In its ruling, the Court considered that 
the right to protection and care of the child does not mean however that children have to be 
acknowledged as having an individual right to see their parents obtain parental leave.  

Case  C-555/07,  Kücükdeveci:  In  Germany,  the  notice  periods  which  an  employer  must 
comply  with  in  the  case  of  dismissal  increase  progressively  according  to  the  length  of  the 
employment relationship. Periods of employment completed by an employee before reaching 
the age of 25 were not taken into account for calculating the notice period. The Court found 
that  the  German  rules  on  dismissal  were  discriminatory  as  they  contain  a  difference  of 
treatment based on age which cannot be justified. 

In Case C-45/09, Rosenbladt, the Court was asked whether a collective agreement providing 
that the working relationship automatically terminates when the employee has reached the age 
of 65 is in accordance with Article 2 (1) prohibiting the discrimination on ground of age and 
6(1)583  of  Directive  2000/78.  The  Court  replied  that  Article  6  of  the  Directive  does  not 
preclude such national provisions, to the extent that such provisions are objectively justified 
by a legitimate aim related to employment policy (social policy objective). 

In  addition,  the  Commission's  services  handled  an  important  number  of  complaints  coming 
from citizens. The Commission also replied to numerous parliamentary questions and requests 
for information from citizens. 

17.8.2.  Evaluation based on the current situation 

The monitoring of the transposition of the two antidiscrimination directives adopted in 2000 
and of the gender equality directive adopted in 2002 gave initially rise to a high number of 
infringement  cases,  but  many  of  these  could  be  closed  in  2010.  This  led  to  a  considerable 
decrease in the number of infringement proceedings, but the work still needs to be continued 
in 2011. In 2010 work was underway to check the conformity of legislation  in BG and RO 
with the existing acquis.  

The number of infringement cases can be expected to decrease further although the work on 
conformity  checks  of  Directive  2004/113/EC  and  Directive  2006/54/EC  is  likely  to  lead  to 
opening of new proceedings in 2011. 

The  work  done  in  2010  led  to  significant  progresses  towards  conformity  with  the  EU 
legislation in the in the area of anti-discrimination and gender equality. It can be assessed that 
the full transposition of the legal acquis was almost achieved by the end of 2010. Whilst three 
proceedings for non communication of national measures to transpose the two most recently 
adopted  Directives  (2004/113/EC  and  2006/54/EC)  remained  open  at  the  end  of  2010,  the 

583 

Article  6(1)  reads:  "Notwithstanding  Article  2(2),  Member  States  may  provide  that  differences  of 
treatment on grounds of age shall not constitute discrimination, if, within the context of national law, 
they  are  objectively  and  reasonably  justified  by  a  legitimate  aim,  including  legitimate  employment 
policy,  labour  market  and  vocational  training  objectives,  and  if  the  means  of  achieving  that  aim  are 
appropriate and necessary". 

EN 

468 

   EN 

 
                                                 
national laws had been adopted and the proceedings were expected to be ready for closure in 
early 2011. 

The only two proceedings under Article 260 TFEU (IT and EL) were successfully closed in 
November 2010 following compliance by the Member States with the Court rulings. Dealing 
with these cases had been one of the priorities set for 2010.  

17.8.3.  Evaluation results 

17.8.3.1. Priorities 

The main priorities for 2011 will be: 

•  Monitoring  of  the  conformity  of  national  measures  transposing  Directives  2004/113/EC 
and  2006/54/EC,  since  full  transposition  of  these  two  directives  was  foreseen  by  the 
beginning of 2011. 

•  Continuing the negotiations on the two legislative proposals on the table. 

•  Dealing with the pending infringement cases as quickly as possible. 

17.8.3.2. Planned action (2011 and beyond) 

In  the  area  of  gender  equality  and  anti-discrimination,  the  negotiation  of  the  two 
legislative  proposals  from  2008  currently  on  the  table  remains  a  priority.  The 
Commission  will  have  to  continue  its  efforts  to  facilitate  the  adoption  of  these 
proposals.  

On  infringements  the  efforts  will  concentrate  on  advancing  with  the  existing  infringement 
cases as quickly as possible. After analysing the replies from Member States, the Commission 
will either refer them to the Court or close them.  

Since full transposition of Directives 2004/113/EC and  2006/54/EC  will be achieved by the 
beginning of 2011, the new priority will be to monitor the conformity of national transposition 
measures with the two Directives. This may lead to opening of new infringement proceedings 
in the future.  

In  2012  the  transposition  deadline  of  Directives  2010/18/EU  and  2010/41/EU  will  expire, 
which  will  gradually  set  as  a  new  priority  towards  2012  and  beyond  monitoring  the 
transposition of these two directives.  

17.8.4.  Summary 

The Commission will continue to use all the available means to monitor the application of EU 
law in the field and to deal with the workload resulting from this monitoring work. This will 
include the use of a number of different tools such as CHAP and EU Pilot, but also external 
expertise and information from Equality Bodies and Networks of Independent Legal Experts.  

National  Equality  Bodies  will  continue  to  contribute  to  a  reduction  in  the  number  of 
complaints concerning this area of EU law, in the areas in which they are competent (so far 
gender and race). 

EN 

469 

   EN 

 
18. 

TRADE 

Trade  policy  is  governed  by  Article  207  of  the  Treaty  on  the  Functioning  of  the  European 
Union.  The  bulk  of  the  Union  legislation  in  this  field  takes  the  form  of  regulations,  for 
example, the basic anti-dumping and countervailing duty regulations, the Generalised System 
of  Preferences  Regulation,  the  Trade  Barriers  Regulation  and  the  Import  and  Export 
Regulations.584  There  are  only  two  directives.  These  directives  are  Council  Directive 
98/29/EC  of  7  May  1998  on  harmonisation  of  the  main  provisions  concerning  export credit 
insurance  for  transactions  with  medium  and  long-term  cover  and  Council  Directive 
84/568/EEC  of  27  November  1984  concerning  the  reciprocal  obligations  of  export  credit 
insurance organizations of the Member States acting on behalf of the State or with its support, 
or of public departments acting in place of such organizations, in the case of joint guarantees 
for  a  contract  involving  one  or  more  subcontracts  in  one  or  more  Member  States  of  the 
European  Communities.  There  were  no  infringements  cases  open  during  2010  concerning 
these directives.  

It is not expected that there will be any significant work required on the transposition of these 
directives in 2011. 

19. 

ENLARGEMENT 

19.1.  Current  position  –  Most  important  legal  instruments  and  related  work  and 

reporting on 2010 

(1) 

General introduction 

Enlargement  policy  is  based  on  Article  49  of  the  EU  Treaty.  Association  agreements  with 
candidate  or  potential  candidate  countries  may  contain  certain  rights  and  obligations  which 
are directly applicable under EU law. Violation of such provisions by a Member State could 
therefore be subject to infringement proceedings. 
This  is  in  particular  the  case  for  the  1963  EEC-Turkey  Association  Agreement,  its  1970 
Additional  Protocol  and  related  Association  Council  Decisions,  particularly  Decision  1/80. 
The  Stabilisation  and  Association  Agreements  with  the  former  Yugoslav  Republic  of 
Macedonia  (2004),  Croatia  (2005),  Albania  (2009)  and  Montenegro  (2010)  and  the  Interim 
Agreements  on  Trade  and  Trade-related  issues  with  Bosnia  and  Herzegovina  (2008)  Serbia 
(2010) fall into the same category of EU law, partly liable for trial in the European Court of 
Justice as far as implementation or application by Member States is concerned.  

(2) 

Report of work done in 2010 

584 

Council Regulation (EC) No 384/96 of 22 December 1995 on protection against dumped imports from 
countries not members of the European Community as amended; Council Regulation (EC) No 2026/97 
of  6  October  1997  on  protection  against  subsidized  imports  from  countries  not  members  of  the 
European Community as amended; Council Regulation (EC) No 732/2008 of 22 July 2008 applying a 
scheme of generalised tariff preferences for the period from 1 January 2009 to 31 December 2011 as 
amended;  Council  Regulation  (EC)  No  3286/94  of  22  December  1994  laying  down  Community 
procedures  in  the  field  of  the  common  commercial  policy  in  order  to  ensure  the  exercise  of  the 
Community's rights under international trade rules, in particular those established under the auspices of 
the World Trade Organization as amended; Council Regulation (EC) No 260/2009 of 26 February 2009 
on  the  common  rules  for  imports  and  Council  Regulation  (EEC)  No  2603/69  of  the  Council  of  20 
December 1969 establishing common rules for exports. 

EN 

470 

   EN 

 
                                                 
The  Commission  has  received  correspondence  and  complaints  from  citizens  related  to  legal 
acts  and  agreements  in  the  field  of  enlargement.  However,  they  mainly  concerned  alleged 
violations  of  obligations  by  the  third  country  or  other  matters  not  directly  related  to  the 
application of EU law by Member States.  

The Court has issued four judgements in 2010 on the interpretation of standstill clauses under 
the  EEC-Turkey  Association  Agreement  referred  by  national  jurisdictions  for  preliminary 
ruling. Moreover, the Court has ruled in April 2010 that the Dutch legislation and practice to 
charge  Turkish  workers  higher  fees  for  issuing  or  prolonging  their  residence  permits  than 
those required for EU nationals in a comparable situation was contrary to EU law. 

In  2010,  the  Commission  received  more  complaints  and  inquiries  related  to  the  application 
and  interpretation  of  certain  provisions,  including  standstill  clauses,  of  the  EEC/Turkey 
Association  Agreement,  which  are  being  examined  in  cooperation  with  the  governments 
concerned.  Following  comprehensive  explanations  by  the  government,  the  Commission 
continued to thoroughly assess possible infringements in several other cases, which concern 
alleged  breaches  of  the  standstill  clauses  set  out  in  the  1970  Additional  Protocol  and  the 
Association Council Decision No1/80. 

19.2.  Evaluation based on the current situation 

All  complaints  received  on  the  application  of  EU  law  by  a  Member  State  concern  the 
application of the EEC/Turkey Association Agreement. Taking into account the references to 
preliminary rulings pending at the Court, this confirms that the application and interpretation 
of this Association Agreement is still subject to a variety of legal interpretations with regard 
to  residence  and  work  of  Turkish  citizens  in  Member  States.  In  addition,  the  number  of 
judicial  decisions  interpreting  the  scope  of  application  of  the  EEC-Turkey  Association  Law 
has triggered an increasing number of complaints in this field.  

Other  Stabilisation  and  Association  Agreements  with  Western  Balkan  countries  which  have 
entered into force are, so far, not subject to any infringement case. 

The  number  of  complaints  has  slightly  increased  but  does  not  yet  require  additional 
prioritisation.  

19.3.  Evaluation results 

There  is  only  one  priority  in  the  area  of  enlargement  and  that  is  the  application  of  the 
EEC/Turkey  Association  Agreement.  This  priority  remains  unchanged  given  the  limited 
number of cases. 

19.4. 

Summary 

Infringement  procedures  in  the  area  of  enlargement  are  rare  in  comparison  to  other  policy 
areas.  All  pending  cases  at  the  Court  and  the  Commission  concern  the  alleged  violation  of 
directly  applicable  provisions,  particularly  standstill  clauses,  under  the  EEC/Turkey 
Association Agreement.  

20. 

EUROSTAT 

20.1.  General introduction 

Ensuring the quality of statistical information is both an operational and a legal requirement 

EN 

471 

   EN 

 
 
 
 
 
insofar as European statistics production must respect the principles set out in Article 338 of 
the  TFEU  and  in  Regulation  (EC)  No  223/2009  of  the  European  Parliament  and  of  the 
Council  of  11 March  2009  on  European  statistics585,  and  in  the  various  sectoral  legislative 
instruments586. 

Moreover,  in  accordance  with  Decision  1578/2007/EC  on  the  Community  statistical 
programme  2008  to  2012587,  compliance  monitoring  of  European  legislation  in  the  field  of 
statistics  is  a  specific  objective  of  strategic  importance  for  the  medium  to  long-term 
development of European statistics: 

"The  quality  of  Community  statistics  comprises  the  fundamental  requirement  of  compliance 
with  the  principles  of  the  Treaty  and  the  secondary  legislation.  Therefore,  a  vigorous  and 
systematic monitoring of the application of the legislation is a priority. A global and coherent 
compliance  strategy  structured  around  the  principles  of  a  realistic  legislative  policy,  the 
obligation of Member States to apply systematically the statistical legislation and a coherent 
and systematic monitoring of compliance, will be followed. Close contacts with the competent 
national authorities throughout all of the phases is part of the compliance process". 

20.2.  Report of work done in 2010 

Since  2006,  about  the  Commission  monitors  the  state  of  play  of  legislation  in  the  field  of 
statistics  and  recommend  possible  follow-up  actions.  In  addition,  the  ESS  Committee 
(European Statistical System Committee) has been regularly informed of the actions carried 
out by the Commission in the field of compliance monitoring.  

As for the previous years, the non-compliance with the transmission deadlines remained the 
principal  problem  in  2010.  However,  and  even  if  a  large  part  of  the  statistical  legislation  is 
affected by this transmission problem, constant work and frequent operational contacts allow 
a regular improvement of the respect of legislation.  

Furthermore, it appears also that the evaluation of quality remains a difficult exercise, even at 
operational level. However, Regulation (EC) No 223/2009 establishes a new framework  for 
quality (article 12) with a list of specific criteria which should be used for the assessment of 
quality.  Those  criteria  should  be  systematically  included  in  all  new  statistical  legislation 
through a standard article. 

The  improvement  of  the  overall  situation  can  generally  be  confirmed.  Member  States  in 
default are making serious efforts to fully comply when they are challenged at suitable level. 
In most cases, Member States react positively to reminders. In several cases, a solution to the 
difficulties could be found thanks to reciprocal collaboration with the National Institutes. This 
collaborative  approach  has  been  applied  also  in  the  only  ongoing  infringement  procedure 
concerning  statistics  (against  Greece),  where  close  contacts  with  Greek  authorities  have 
ensured progress in relation to the grievances contained in the letter of formal notice.  

585 
586 

587 

OJ L 87, 31.3.2009, p. 164. 
As  an  indication,  the  legal  corpus  in  the  field  of  statistics  comprises  around  300  acts  of  secondary 
legislation, of which about one third are basic acts, i.e. acts of the Council and/or of the EP. 
Decision  1578/2007/EC  of  the  European  Parliament  and  the  Council  of  11  December  2007  on  the 
Community statistical programme 2008 to 2012 - Point 3.2 of Annex I – (OJ L 344, 28.12.2007, p. 15). 

EN 

472 

   EN 

 
                                                 
It  is  important  to  notice  that  in  order  to  ensure  a  complete  follow  up  of compliance  with 
European  statistical  legislation,  there  are  also  parallel  systems  in  place  which  serve  the 
purpose of ensuring fulfilment of the complex methodological rules discussed with Member 
States at different sectoral statistical Committees and expert Working Groups. 

21. 

HUMAN RESOURCES AND SECURITY 

21.1.  Current  position  –  Most  important  legal  instruments  and  related  work  and 

reporting on 2010 

21.1.1.  General introduction 

In the field of human resources, the Commission seeks to guarantee that European Union law is 
correctly  applied  to  EU  staff  by  ensuring  that  Member  States  adopt  legislation  and 
implementing  provisions  in  compliance  with  1)  the  Protocol  on  Privileges  and  Immunities  of 
the  European  Union  as  well  as  with  2)  the  Regulations  and  Rules  applicable  to  officials  and 
other servants of the EU. 

In particular, the following legal texts are applicable: 

- Council Regulation (EEC, Euratom, ECSC) No 259/68 of 29 February 1968 and amendments 
thereto, 

- The Protocol  on  the Privileges and  Immunities of EU (PPI), annexed to the Treaty on the 
European Union of 2010, 

-  Other  agreements  between  the  European  Commission  and  Member  States  regarding  the 
functioning of the Institutions' services. 

21.1.2.  Report of work done in 2010 

In  2010,  the  Commission  pursued  infringements  by  proceeding  directly  against  national  rules 
providing for the imposition of taxes on EU Institutions based in Brussels, in violation of the 
provisions providing for a tax exemption under Article 3 of the PPI.  

The  Commission  has  continued  to  make  additional  arrangements  for  the  transfer  of  pension 
rights for officials and other servants of the European Union who had either originally worked 
and acquired pension rights in Member States (transfer in) or who leave the Institutions (transfer 
out).  This  ongoing  process  has  been  quite  successful  and  some  of  the  competent  national 
authorities have already fulfilled their obligations in this regard. In other cases, the Commission 
services continue to insist with the national authorities to arrange for this right provided in the 
Staff Regulation ('SR') to be correctly implemented.  

The  Commission  monitored  the  coverage  of  staff  by  the  sickness'  insurance  scheme  in  all 
Members States in line with the rules provided by the SR. In this framework, actions were taken 
to ensure that there was no discrimination linked with the status of non-resident in a Member 
State.  

In  2010,  the  Court  of  Justice  declared  not  to  have  jurisdiction  to  rule  on  the  action  of  the 
European  Commission  seeking  a  judgment  to  confirm  that  Belgium  should  comply  with  its 

EN 

473 

   EN 

 
undertaking, to subsidise the cost of equipment for European Schools (Case C-132/09).  

21.2.  Evaluation based on the current situation 

As regards the transfer of pension rights and taking into account the direct applicability of the 
SR,  some  Member  States  have  failed  to  adopt  the  necessary  internal  rules  allowing  these 
transfers even several years after having joined the EU. As regards new Member States, some 
are  still  working  on  basic  legislation,  while  others  on  implementing  regulations.  However,  it 
should  be  stressed  that  even  if  the  implementing  regulations  are  in  place,  their  practical 
application is not always guaranteed. 

In this area, the Commission continues to seek pro-active solutions outside or in parallel with 
the infringement procedure provided under Article 258 of the Treaty on the functioning of the 
European Union. Contacts are regularly organised between the institution's administration and 
the competent authorities of the Member States in order to anticipate and resolve matters, as far 
as possible, which could otherwise lead to such proceedings.  

The tax laws applied by Member States both to the European Institutions and staff are carefully 
examined and checked for possible infringements of Articles 3 and 12 of the PPI. Complaints 
relating to national taxation in violation of the PPI are sometimes lodged by current or former 
staff  of  European  Institutions.  Taking  into  account  the  obligation  of  EU  to  assist  its  staff 
members and their families in proceeding against any attack to them by reason of their position 
or duties, the Commission grants legal assistance for ensuring that the benefits provided by the 
PPI  are  respected  in  all  Member  States.  Only  in  few  cases,  when  national  procedures  do  not 
allow for the conflict to be settled in a satisfactory manner, the Commission would consider it 
necessary to launch infringement procedures against Member States. 

21.3.  Evaluation results  

21.3.1.  Priorities 

The priorities in the human resources field remain the same as those which were identified in 
previous years. Implementation of national rules for permitting a correct application of the SR 
and the other rules applicable to officials and other servants of the Union is one of the major 
issues in this sector. 

On the basis of statutory rules, the Commission's services continue to assess whether assistance, 
in the form of legal support, against presumed infringements of Article 12 of PPI in the field of 
taxation has to be granted to current or former staff. 

21.3.2.  Planned action 

In this context, the collaboration with Member States has proven to be of great assistance for 
solving conflicts and ensuring the correct application of the Union legislation.  

Nevertheless,  despite  the  efforts  of  the  Human  Resources  Services  in  helping  national 
authorities  to  fulfil  their  obligations  within  a  reasonable  timeframe,  the  Commission  will  not 
refrain  from  proceeding  with  infringement  procedures  under  Article  258  of  the  Treaty  where 
required.  

EN 

474 

   EN 

 
22. 

BUDGET 

22.1.  Current situation 

22.1.1.  General introduction 

 The  main  three  own  resources  financing  the  EU  budget  are:  traditional  own  resources,  the 
VAT-based own resource and the balancing resource based on Member States' gross national 
income (GNI). The own resources system is at present under review. 
In particular, the following legal texts are applicable: 

• 

• 

• 

• 

Articles  311  and  322(2)  of  the  Treaty  on  the  Functioning  of  the  European 
Union,  
Council  Decision  2007/436/EC,  Euratom  on  the  system  of  the  Communities' 
own resources, 
Council  Regulation  (EC,  Euratom)  No  1150/2000  implementing  the  above 
decision, 
Council  Regulation  (EEC,  Euratom)  No  1553/89  on  the  definitive  uniform 
arrangements  for  the  collection  of  own  resources  accruing  from  value  added 
tax. 

Additional  budgetary  revenue  is  secured  under  Articles  3  and  4  of  the  Protocol  on  the 
Privileges and Immunities of the EU (PPI), annexed to the above Treaty as Protocol n° 7. 

The main rules for budget execution are contained in Council Regulation (EC, Euratom) No 
1605/2002  of  25  June  2002  on  the  Financial  Regulation applicable to the general budget of 
the  European  Communities  as  last  amended  by  Regulation  (EC,  Euratom)  No 1081/2010  of 
24 November 2010. 

22.1.2.  Report of work done in 2010  

In 2010, the Commission detected 278 anomalies in the area of traditional own resources (of 
which  120  in  the  course  of  on-the-spot  inspections)  and  set  52  reservations  in  the  area  of 
VAT/GNI (= 52 VAT+ 0 GNI). Correspondingly, 649 accounting actions for traditional own 
resources and 183 for VAT/GNI were generated for potential corrective payments (principal 
amounts and belated interest) by Member States. Most of the newly detected anomalies could 
be solved at an initial stage in bilateral discussions with Member States, including senior level 
management meetings, or in the Advisory Committee on Own Resources. 

Regarding infringements, in 2010 the follow-up to the Court judgments of 15 December 2009 
and 4 March 2010 concerning duty-free imports of military and dual use goods made by seven 
Member States continued. Three other 2010 Court judgments (C-423/08 of 17 June 2010, C-
442/08 of 1 July 2010 and C-334/08 of 8 July 2010) in favour of the Commission in the field 
of Own Resources as well as two pending Court cases were followed up, amongst which the 
priority  case  against  Germany  relating  to  the  refusal  of  the  German  authorities  to  cooperate 
with  the  European  Court  of  Auditors  with  regard  to  the  administrative  VAT  cooperation  of 
Member  States  under  Council  Regulation  (EC)  No  1798/2003.  Six  infringement  cases  were 
closed in 2010, of which five related to earlier Court decisions in favour of the Commission.  

22.2.  Evaluation 

The Commission's work on infringements and the important clarifications provided by Court 
decisions  in  recent  years  in  the  area  of  own  resources  have  allowed  to  keep  the  number  of 
conflicts and differences of interpretation between the Commission and the Member States at 

EN 

475 

   EN 

 
 
 
a  low  level.  Problems  were  encountered  with  the  availability  of  supporting  documentation. 
This  issue  should  be  addressed  in  the  revision  of  the  regulation  for  the  next  financing 
framework period. 

22.3.  Evaluation results 

(1) 

Priorities 

The priorities set up in the 2009 Annual Report were maintained in 2010. In setting priorities 
in  the  field  of  infringements,  the  Commission  has  to  take  account  of  the  system  of  own 
resources  which  provides  for  solidarity  and  joint  financing  of  the  EU  budget.  Accordingly, 
where a Member State does not establish own resources or omits the recovery of established 
amounts, the financial charge of the other Member States increases. In view of assuring equal 
treatment of Member States a strict monitoring by the Commission services and, if necessary, 
infringement  proceedings,  are  essential.  The  Commission  takes  legal  action  whenever  a 
satisfactory solution cannot be found in bilateral contacts and discussions with Member States 
in  the  Advisory  Committee  for  Own  Resources.  Priorities  are  assigned  based  on  the 
seriousness of infringements and their impact on the budget. 

(2) 

Planned action 

The  Lisbon  Treaty  introduced  new  financial  provisions  (Article  310  et  seq.  TFEU)  in  the 
system of own resources and the Budget Review addresses the 'Reform of EU financing'. There 
is  therefore  an  opportunity  to  reinforce  the  sincere  cooperation  between  the  Union  and  the 
Member  States  as  prescribed  by  Article  4  (3)  of  the  Treaty  on  the  EU.  In  budgetary 
infringement  cases  where  the  Court  of  Justice  examines  to  which  extent  Member  States  are 
obliged  to  make  available  Own  Resources,  Member  States  should  keep  all  necessary 
documentation  enabling  a  swift  follow-up  of  the  Court's  decisions.  Article  3  of  Council 
Regulation  n°  1150/2000  already  contains  a  general  obligation  for  Member  States  to  keep 
supporting documents concerning the establishment and making available of own resources. 
Recent  experience  with  the  follow-up  of  Court  decisions  suggests  that  this  obligation  may 
need to be reinforced in case of infringements. 

22.4. 

Summary  

In general, Member States contribute timely and correctly to the EU budget and comply with 
the budgetary legislation, which ensures a stable and smooth financing of the EU budget. In 
this light, keeping the existing priorities as mentioned above is appropriate. 

23. 

ANNEX  I  -  LIST  OF  MEASURES  IN  FORCE  AND  OTHER  RELEVANT  INSTRUMENTS 
REFERRED TO IN THE TEXT OF THE DOCUMENT 

I. 

ENTERPRISE AND INDUSTRY 

I.1. 

REACH 

•  REACH and its implementing legislation are available through the following link: 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/index_en.htm 

EN 

476 

   EN 

 
 
 
 
•  REACH and its links to previous legislation on restriction is available here:  

http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/archives/market-
restrictions/index_en.htm 

I.2 Classification, labelling and packaging: 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-
chemicals/index_en.htm 

I.3 Pyrotechnic Articles and Explosives 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-
chemicals/index_en.htm 

I.4 Drug precursors 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-
chemicals/index_en.htm 

I.5 Detergents 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-
chemicals/index_en.htm 

I.6 Fertilisers 

http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-
chemicals/index_en.htm 

I.7 Textiles/clothing, footwear and wood 

http://ec.europa.eu/enterprise/sectors/textiles/single-market/textiles-names-
legislation/index_en.htm 

I.8 Non-harmonised area 

Treaty provisions: 

EN 

477 

   EN 

 
 
 
 
 
 
 
 
http://ec.europa.eu/enterprise/policies/single-market-
goods/files/treaties/tfeu_en.pdf#page=15 

Regulation Mutual recognition regulation: 

http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0021:0029:en:P
DF 

Guide to the application of Treaty provisions governing the free movement of goods: 

http://ec.europa.eu/enterprise/policies/single-market-
goods/files/goods/docs/art34-36/new_guide_en.pdf 

II. 

EMPLOYMENT, SOCIAL AFFAIRS AND INCLUSION 

List of measures in force 

II.1. 

Free movement of workers and coordination of social security schemes 

II.1.1.  Free movement of workers 

Art. 45 TFEU  

Regulation (EEC) No 1612/68 of the Council of 15 October 1968 on freedom of movement 
for workers within the Community. A codification of this regulation is under way.  

Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the 
right of citizens of the Union and their family members to move and reside freely within the 
territory of the Member States. 

II.1.2 

Social Security  

•  Article 48 TFUE 
•  Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application 
of social security schemes to employed persons, self-employed persons and to the 
members of their families moving within the Community.  

•  Regulation (EC) No 859/2003 of the Council of 14 May 2003 extending the 

provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to 
nationals of third countries who are not already covered by those provisions solely 
on the ground of their nationality. 

•  Regulation (EC) No 883/2004 of the European Parliament and of the Council of 

29 April 2004 on the coordination of social security schemes. 

•  Regulation (EC) No 987/2009 of the European Parliament and of the Council of 

EN 

478 

   EN 

 
 
 
 
 
16 September 2009 laying down the procedure for implementing Regulation (EC) 
No 883/2004 on the coordination of social security systems. 

•  Regulation (EC) No 988/2009 of the European Parliament and of the Council of 
16 September 2009 amending Regulation (EC) No 883/2004 on the coordination 
of social security systems, and determining the content of its Annexes. 

Recently adopted measures due to enter into force in the sector of the coordination of social 
security systems 

•  Regulation (EC) No 1231/2010 of the Council extending the provisions of 

Regulation (EC) No 883/2004 and of Regulation (EC) No 987/2009 to nationals 
of third countries who are not already covered by those provisions solely on the 
ground of their nationality. 

EN 

479 

   EN 

 
II.2. 

Labour Law 

II.2.1.  Working conditions 
•  Directive 96/71/EC588 of the European Parliament and of the Council of 16 December 
1996 concerning the posting of workers in the framework of the provision of services 

•  Council Directive 97/81/EC589 of 15 December 1997 concerning the Framework 

Agreement on part-time work concluded by UNICE, CEEP and the ETUC - Annex : 
Framework agreement on part-time work; 

•  Council Directive 98/23/EC590 of 7 April 1998 on the extension of Directive 97/81/EC 
on the framework agreement on part-time work concluded by UNICE, CEEP and the 
ETUC to the United Kingdom of Great Britain and Northern Ireland; 

•  Council Directive 1999/70/EC591 of 28 June 1999 concerning the framework agreement 

on fixed-term work concluded by ETUC, UNICE and CEEP; 

•  Council Directive 1999/63/EC592 of 21 June 1999 concerning the Agreement on the 
organisation of working time of seafarers concluded by the European Community 
Shipowners Association (ECSA) and the Federation of Transport Workers' Unions in the 
European Union (FST); 

•  Council Directive 2000/79/EC593 of 27 November 2000 concerning the European 

Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation 
concluded by the Association of European Airlines (AEA), the European Transport 
Workers' Federation (ETF), the European Cockpit Association (ECA), the European 
Regions Airline Association (ERA) and the International Air Carrier Association (IACA); 
•  Directive 2003/88/EC594 of the European Parliament and of the Council of 4 November 

2003 concerning certain aspects of the organisation of working time; 

•  Council Directive 2005/47/EC595 of 18 July 2005 on the Agreement between the 
Community of European Railways (CER) and the European Transport Workers’ 
Federation (ETF) on certain aspects of the working conditions of mobile workers engaged 
in interoperable cross-border services in the railway sector; 

•  Directive 2008/104/EC596 of European Parliament and of the Council of 19 November 

2008 on temporary agency work. 

•  Council Directive 2009/13/EC implementing the Agreement concluded by the European 
Community Shipowners' Associations (ECSA) and the European Transport Workers' 
Federation (ETF) on the Maritime Labour Convention, 2006 and amending Directive 
1999/63/EC 

II.2.2. 

Information and consultation of workers 

•  Council  Directive  94/45/EC597  of  22  September  1994  on  the  establishment  of  a 
European  Works  Council  or  a  procedure  in  Community-scale  undertakings  and 

588 
589 
590 
591 
592 
593 
594 
595 
596 
597 

OJ L 18, 21.1.1997, p. 1–6 
OJ L 14, 20.1.1998, p. 9–14 
OJ L 131, 5.5.1998, p. 10–10 
OJ L 244, 16.9.1999, p. 64–64 
OJ L 167, 2.7.1999, p. 33–37 
OJ L 302, 1.12.2000, p. 57–60 
OJ L 299, 18.11.2003, p. 9–19 
OJ L 195, 27.7.2005, p. 15–17 
OJ L 327, 5.12.2008, p. 9-14 
OJ L 254, 30.9.1994, p. 64–72 

EN 

480 

   EN 

 
                                                 
Community-scale groups of undertakings for the purposes of informing and consulting 
employees; 

•  Council Directive 97/74/EC598 of 15 December 1997 extending, to the United Kingdom 
of  Great  Britain  and  Northern  Ireland,  Directive  94/45/EC  on  the  establishment  of  a 
European  Works  Council  or  a  procedure  in  Community-scale  undertakings  and 
Community-scale groups of undertakings for the purposes of informing and consulting 
employees 

•  Council Directive  2006/109/EC599 of 20 November  2006 adapting  Directive 94/45/EC 
on the establishment of a European Works Council or a procedure in Community-scale 
undertakings  and  Community-scale  groups  of  undertakings  for  the  purposes  of 
informing  and  consulting  employees,  by  reason  of  the  accession  of  Bulgaria  and 
Romania; 

•  Council  Directive  2001/86/EC600  of  8  October  2001  supplementing  the  Statute  for  a 

European company with regard to the involvement of employees; 

•  Council  Directive  2003/72/EC601  of  22  July  2003  supplementing  the  Statute  for  a 

European Cooperative Society with regard to the involvement of employees; 

•  Directive  2002/14/EC602  of  the  European  Parliament  and  of  the  Council  of  11  March 
2002 establishing a  general framework for informing and consulting employees in the 
European Community - Joint declaration of the European Parliament, the Council and 
the Commission on employee representation; 

•  Directive  2009/38/EC  on  the  establishment  of  a  European  Works  Council  or  a 
in  Community-scale  undertakings  and  Community-scale  groups  of 

procedure 
undertakings for the purposes of informing and consulting employees (Recast). 

II.2.3.  Protection of workers 

•  Council  Directive  91/383/EEC603  of  25  June  1991  supplementing  the  measures  to 
encourage  improvements  in  the  safety  and  health  at  work  of  workers  with  a  fixed- 
duration employment relationship or a temporary employment relationship; 

•  Council  Directive  91/533/EEC604  of  14  October  1991  on  an  employer's  obligation  to 
inform  employees  of  the  conditions  applicable  to  the  contract  or  employment 
relationship; 

•  Council  Directive  94/33/EC605  of  22  June  1994  on  the  protection  of  young  people  at 

work; 

•  Council Directive 98/59/EC606 of 20 July 1998 on the approximation of the laws of the 

Member States relating to collective redundancies; 

•  Directive 2008/94/EC607 of the European Parliament and of the Council of 22 October 
2008  on  the  protection  of  employees  in  the  event  of  the  insolvency  of  their  employer 
(codified version); 

598 
599 
600 
601 
602 
603 
604 
605 
606 
607 

OJ L 365, 31.12.1994, p. 46–51 
OJ L 363, 20.12.2006, p. 416–417 
OJ L 294, 10.11.2001, p. 22–32 
OJ L 207, 18.8.2003, p. 25–36 
OJ L 80, 23.3.2002, p. 29–34 
OJ L 206, 29.7.1991, p. 19–21 
OJ L 288, 18.10.1991, p. 32–35 
OJ L 216, 20.8.1994, p. 12–20 
OJ L 225, 12.8.1998, p. 16–21 
OJ L 283, 28.10.2008, p. 36-42 

EN 

481 

   EN 

 
                                                 
•  Council Directive 2001/23/EC608 of 12 March 2001 on the approximation of the laws of 
the  Member  States  relating  to  the  safeguarding  of  employees'  rights  in  the  event  of 
transfers of undertakings, businesses or parts of undertakings or businesses; 

II.3. 

Health and safety at work 

•  Directive 89/391/EEC609 of 12 June 1989 on the introduction of measures to encourage 

improvements in the safety and health of workers at work; 

•  Council Directive 89/654/EEC610 of 30 November 1989 concerning the minimum safety 
and health requirements for the workplace (first individual directive within the meaning 
of Article 16(1) of Directive 89/391/EEC); 

•  Directive  2009/104/EC611  of  the  European  Parliament  and  of  the  Council  of  16 
September 2009 concerning the minimum safety and health requirements for the use of 
work equipment by workers at work (second individual Directive within the meaning of 
Article  16(1)  of  Directive  89/391/EEC  –  Codification  of  Directive  89/655/EEC,  as 
amended by Directives 95/63/EC and 2001/45/EC); 

•  Council  Directive  89/656/EEC612  of  30  November  1989  on  the  minimum  health  and 
safety  requirements  for  the  use  by  workers  of  personal  protective  equipment  at  the 
workplace  (third  individual  directive  within  the  meaning  of  Article  16(1)  of  Directive 
89/391/EEC);  

•  Council  Directive  90/269/EEC613  of  29  May  1990  on  the  minimum  health  and  safety 
requirements for the manual handling of loads where there is a risk particularly of back 
injury  to  workers  (fourth  individual  directive  within  the  meaning  of  Article  16(1)  of 
Directive 89/391/EEC);  

•  Council  Directive  90/270/EEC614  of  29  May  1990  on  the  minimum  safety  and  health 
requirements for work with display screen equipment (fifth individual directive within 
the meaning of Article 16(1) of Directive 89/391/EEC);  

•  Directive  2004/37/EC615  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004 on the protection of workers from the risks related to exposure to carcinogens or 
mutagens  at  work  (sixth  individual  directive  within  the  meaning  of  Article  16(1)  of 
Directive 89/391/EEC - Codification of Directive 90/394/EEC); 

•  Directive  2000/54/EC616  of  the  European  Parliament  and  of  the  Council  of  18 
September  2000  on  the  protection  of  workers  from  risks  related  to  exposure  to 
biological  agents  at  work  (seventh  individual  directive  within  the  meaning  of  Article 
16(1) of Directive 89/391/EEC) - Codification of Directive 90/679/EEC);  

•  Council  Directive  92/57/EEC617  of  24  June  1992  on  the  implementation  of  minimum 
safety  and  health  requirements  at  temporary  or  mobile  construction  sites  (eight 
individual directive within the meaning of Article 16(1) of Directive 89/391/EEC);  

608 
609 
610 
611 
612 
613 
614 
615 
616 
617 

OJ L 82, 22.3.2001, p. 16–20 
OJ L 183, 29.6.1989, p. 1 
OJ L 393, 30.12.1989, p. 1 
OJ L 260, 3.10.2009, p. 5 
OJ L 393, 30.12.1989, p. 18 
OJ L 156, 21.6.1990, p. 9 
OJ L 156,21.6.1990, p. 14 
OJ L 229, 29.6.2004, p. 23 
OJ L 262, 17.10.2000, p. 21 
OJ L 245, 26.8.1992, p. 6 

EN 

482 

   EN 

 
                                                 
•  Council Directive 92/58/EEC618 of 24 June 1992 on the minimum requirements for the 
provision  of  safety  and/or  health  signs  at  work  (ninth  individual  Directive  within  the 
meaning of Article 16(1) of Directive 89/391/EEC);  

•  Council  Directive  92/91/EEC619  of  3  November  1992  concerning  the  minimum 
requirements for improving the safety and health protection of workers in the mineral-
extracting industries through drilling (eleventh individual directive within the meaning 
of Article 16(1) of Directive 89/391/EEC );  

•  Council  Directive  92/104/EEC620  of  3  December  1992  on  the  minimum  requirements 
for  improving  the  safety  and  health  protection  of  workers  in  surface  and  underground 
mineral-extracting industries (twelfth individual directive within the meaning of Article 
16(1) of Directive 89/391/EEC);  

•  Council Directive 93/103/EC621 of 23 November 1993 concerning the minimum safety 
and  health  requirements  for  work  on  board  fishing  vessels  (thirteenth  individual 
directive within the meaning of Article 16(1) of Directive 89/391/EEC);  

•  Council Directive 98/24/EC622 of 7 April 1998 on the protection of the health and safety 
of  workers  from  the  risks  related  to  chemical  agents  at  work  (fourteenth  individual 
directive within the meaning of Article 16(1) of Directive 89/391/EEC); 

•  Commission Directives establishing indicative exposure limit values: 
•  Commission Directive 91/322/EEC623 of 29 May 1991 on establishing indicative limit 
values  by  implementing  Council  Directive  80/1107/EEC  on  the  protection  of  workers 
from the risks related to exposure to chemical, physical and biological agents at work 
•  Commission  Directive  2000/39/EC624  of  8  June  2000  establishing  a  first  list  of 
indicative  occupational  exposure  limit  values  in  implementation  of  Council  Directive 
98/24/E on the protection of the health and safety of workers from the risks related to 
chemical agents at work 

•  Commission  Directive  2006/15/EC625 of 7 February 2006 establishing a second list of 
indicative  occupational  exposure  limit  values  in  implementation  of  Council  Directive 
98/24/EC and amending Directives 91/322/EEC and 2000/39/EC 

•  Commission Directive 2009/161/EU626 of 17 December 2009 establishing a third list of 
indicative  occupational  exposure  limit  values  in  implementation  of  Council  Directive 
98/24/EC and amending Commission Directive 2000/39/EC 

•  Directive 1999/92/EC627 of the European Parliament and of the Council of 16 December 
1999  on  minimum  requirements  for  improving  the  safety  and  health  protection  of 
workers  potentially  at  risk  from  explosive  atmospheres  (fifteenth  individual  directive 
within the meaning of Article 16(1) of Directive 89/391/EEC) 

•  Directive 2002/44/EC628 of the European Parliament and of the Council of 25 June 2002 
on  the  minimum  health  and  safety  requirements  regarding  the  exposure  of  workers  to 

618 
619 
620 
621 
622 
623 
624 
625 
626 
627 
628 

OJ L 245, 26.8.1992, p. 23 
OJ L 348, 28.11.1992, p. 9 
OJ L 404, 31.12.1992, p. 10 
OJ L 307, 13.12.1993, p. 1 
OJ L131, 5.5. 1998, p. 11 
OJ L177, 5.7. 1991, p. 22 
OJ L 142, 16.6.2000, p. 47 
OJ L 38, 9.2.2006, p. 36 
OJ L 338 of 19.12.2009, p. 87 
OJ L 23, 28.1.2000, p. 57 
OJ L 177, 6.7.2002, p. 13 

EN 

483 

   EN 

 
                                                 
the  risk  arising  from  physical  agents  (vibration)  (sixteenth  individual  directive  within 
the meaning of Article 16(1) of Directive 89/391/EEC); 

•  Directive 2003/10/EC629 of the European Parliament and of the Council of 6 February 
2003 on the minimum health and safety requirements regarding the exposure of workers 
to the risk arising from physical agents (noise) (seventeenth individual directive within 
the meaning of Article 16(1) of Directive 89/391/EEC); 

•  Directive  2004/40/EC630  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004 on the minimum health and safety requirements regarding the exposure of workers 
to  the  risks  arising  from  physical  agents  (electromagnetic  fields)  (18th  individual 
Directive within the meaning of Article 16(1) of Directive 89/391/EEC); as amended by 
Directive 2008/46/EC631 

•  Directive 2006/25/EC632 of the European Parliament and of the Council of 5 April 2006 
on  the  minimum  health  and  safety  requirements  regarding  the  exposure  of  workers  to 
risks arising from physical agents (artificial optical radiation) (19th individual Directive 
within the meaning of Article 16(1) of Directive 89/391/EEC); 

•  Council  Directive  2010/32/EU633  of  10 May  2010  implementing  the  Framework 
Agreement  on  prevention  from  sharp  injuries  in  the  hospital  and  healthcare  sector 
concluded by HOSPEEM and EPSU; 

•  Council  Directive  92/29/EEC634  of  31  March  1992  on  the  minimum  safety  and  health 

requirements for improved medical treatment on board vessels; 

•  Directive 2009/148/EC of the European Parliament and of the Council of 30 November 
2009  on  the  protection  of  workers  from  the  risks  related  to  exposure  to  asbestos  at 
work635 

•  Directive 2007/30/EC636 of the European Parliament and of the Council of 20 June 2007 
amending  Council  Directive  89/391/EEC,  its  individual  Directives  and  Council 
Directives  83/477/EEC,  91/383/EEC,  92/29/EEC  and  94/33/EC  with  a  view  to 
simplifying and rationalising the reports on practical implementation. 

III   ENERGY 

III.1. 

Legislation in force 

Primary law 

•  Article 194 TFEU: the insertion of a specific legal basis for energy in the Treaty on the 
Functioning  of  the  European  Union  has  strengthened  EU  energy  policy.  This  Article 
consolidates and clarifies the competences of the EU in the field of energy. The use of Art. 
194 TFEU is without prejudice to the application of other provisions of the Treaty. 

•  Article 192 TFEU: environmental measures which affect the energy mix. 
•  Article 122 TFEU: short term measures necessary to react to an actual crisis. 
•  Articles 170 and 171 TFEU: trans-European networks 
•  Article 113 TFEU: energy taxation 

629 
630 
631 
632 
633 
634 
635 
636 

OJ L 42, 15.2.2003, p. 38 
OJ L 184, 24.5.2004, p. 1 
OJ L 114, 26.4.2008, p. 88 
OJ L 114, 27.4.2006, p. 38 
OJ L 134, 1.6.2010, p. 66 
OJ L 113, 30.4.1992, p. 19 
OJ L 330, 16.12.2009, p. 28 
OJ L 165, 27.6.2007, p. 21 

EN 

484 

   EN 

 
                                                 
•  Articles 258 and 260 TFEU: so-called "infringement procedures". 

Secondary Law 

•  The texts of current Community legislation on energy are available in section 12 of the 

EUR-Lex database 

http://eur-lex.europa.eu/en/legis/20100301/chap12.htm 

Euratom 

Primary Law: Euratom Treaty  

A number of provisions of the Treaties vest the Commission with specific powers: 

–  Article 33 Euratom Treaty: Verification of conformity of draft legislation in the field of 
radiation  protection  and  education  and 
issue 
recommendations). 

(the  Commission  may 

training 

–  Article 37 Euratom Treaty:  Assessment of national plans for the release of radioactive 
waste into the environment, before approval by the national authorities (the Commission shall 
deliver an opinion). 

–  Article 38 Euratom Treaty: In cases of urgency, the Commission shall issue a directive 
requiring the Member State concerned to take, within a period laid down by the Commission, 
all  necessary  measures  to  prevent  infringement  of  the  basic  standards  and  to  ensure 
compliance  with  regulations.  Article  38  of  the  Euratom  Treaty  institutes  also  a  special 
derogative procedure from the general infringement procedure, allowing the Commission or 
any  Member  State  concerned  to  bring  the  matter  before  the  Court  of  Justice  if  the  State  in 
question fails to comply with the Commission directive within the period laid down therein. 

–  Articles  41/43  Euratom  Treaty:  This  notification  procedure  on  nuclear  investments 
requires that any new investment related to nuclear activities has to be communicated to the 
Commission which shall, in return, send its views to the Member State concerned. 

–  Article 77 Euratom Treaty:  The Commission shall satisfy itself that, in the territories of 
member  states,  (a)  ores,  source  materials  and  special  fissile  materials  are  not  diverted  from 
their  intended  uses  as  declared  by  the  users;  (b)  the  provisions  relating  to  supply  and  any 
particular  safeguarding  obligations  assumed  by  the  Community  under  an  agreement 
concluded with a third state or an international organisation are complied with. 

–  Article  78  Euratom  Treaty:    Operators  shall  declare  to  the  Commission  the  basic 
technical  characteristics  of  the  installations,  to  the  extent  that  knowledge  of  these 
characteristics is necessary for the attainment of the objectives set out in Article 77. 

–  Article 81 Euratom Treaty:  The Commission's nuclear inspectors (Commission's staff!) 
shall at all times have access to all places and data and to all persons who, by reason of their 
occupation,  deal  with  materials,  equipment  or  installations  subject  to  the  safeguards.  If  the 
carrying out of an inspection is opposed, it can be carried out compulsorily (after decision of 

EN 

485 

   EN 

 
 
 
the  president  of  the  Court  of  Justice;  or,  even,  after  Commission's  written  order,  if  there  is 
danger in delay). 

–  Article  82  Euratom  Treaty:  In  case  of  infringement  to  the  safeguards  provisions 
established by its safeguards inspectors, the Commission may issue a directive calling upon 
the  Member  State  concerned  to  take,  by  a  time  limit  set  by  the  Commission,  all  measures 
necessary  to  bring  such  infringement  to  an  end.  Possible  direct  referral  of  the  matter  to  the 
Court  of  Justice,  if  the  Member  State  in  question  does  not  comply  with  the  Commission 
directive  in  the  timeframe  set  up  therein,  in  derogation  from  the  general  infringement 
procedure. 

–  Article  83  Euratom  Treaty:  In  the  event  of  an  infringement  on  the  part  of  persons  or 
undertakings  of  the  obligations  on  nuclear  safeguards,  the  Commission  may  impose  the 
following sanctions, in order of severity : (a) a warning ; (b) the withdrawal of special benefits 
such as financial or technical assistance ; (c) the placing of the undertaking for a period not 
exceeding four months under the administration of a person or board appointed by common 
accord of the Commission and the state having jurisdiction over the undertaking; (d) total or 
partial withdrawal of source materials or special fissile materials. 

–  Article 103 Euratom Treaty: assessment of draft international agreements in the fields of 
the Euratom Treaty (the Commission may issue comments on the drafts) 

–  Articles 141 and 143 Euratom Treaty have been repealed as of 30/11/2009; Articles 258 
and 260 TFEU now apply. 

–  Article  145  Euratom  Treaty:  if  the  Commission  considers  that  a  person  or  undertaking 
has committed an infringement of this Treaty (other than to the safeguards provisions), it shall 
call  upon  the  member  state  having  jurisdiction  over  that  person  or  undertaking  to  cause 
sanctions to be imposed in respect of the infringement in accordance with its national law. If 
the state concerned does not comply with such a request within the period laid down by the 
Commission,  the  latter  may  bring  an  action  before  the  Court  of  Justice  to  have  the 
infringement of which the person or undertaking is accused established. 

Secondary law 

•  The Community acquis related to Title II, Chapter 3, can be consulted in section 15 of the 
EUR-Lex database, the Community acquis (heading 15.10.20.10 "Nuclear Safety and 
Radioactive Waste"). 

http://eur-lex.europa.eu/en/legis/20100301/chap15102010.htm 

•  A comprehensive list of acquis and case-law related to the Euratom Treaty can be 
consulted in the annexes to the Commission staff working paper (SEC (2007) 347) 
accompanying the Communication on the 50 years of the Euratom Treaty (COM(2007) 
124 final) at  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52007SC0347:EN:NOT 

III.2. 

Legislation adopted in 2010 

EN 

486 

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General 

•  Council  Regulation  n°  617/2010  of  24  June  2010  concerning  the  notification  to  the 
Commission  of  investment  projects  in  energy  infrastructure  within  the  EU  &  repealing 
Regulation (EC) n° 736/96 (OJ L 180, 15.7.2010, p. 7). 

•  Commission  Regulation  n°833/2010  of  21  September  2010  implementing  Council 
Regulation  n°617/2010  concerning  the  notification  to  the  Commission  of  investment 
projects in energy infrastructure within the European Union (OJ L 248, 22.9.2010, p. 36). 

Internal electricity and gas market 

•  Commission  Decision  of  10  November  2010  amending  Chapter  3  of  Annex  1  to 
Regulation  (EC)  No  715/2009  of  the  European  Parliament  and  of  the  Council  on 
conditions  for  access  to  the  natural  gas  transmission  networks  (OJ  L  293,  11.11.2010,  p. 
67). 

•  Commission  Regulation  (EU)  No  774/2010  of  2  September  2010  on  laying  down 
guidelines  relating  to  inter-transmission  system  operator  compensation  and  a  common 
regulatory approach to transmission charging (OJ L 233, 3.9.2010, p. 1) 

•  Commission  Regulation  (EU)  No  838/2010  of  23  September  2010  on  laying  down 
guidelines  relating  to  inter-transmission  system  operator  compensation  and  a  common 
regulatory approach to transmission charging (OJ L 250, 24.9.2010, p. 5) 

Security of supply - gas 

•  Regulation  (EU)  No  994/2010  of  the  European  Parliament  and  of  the  Council  of  20 
October  2010  concerning  measures  to  safeguard  security  of  gas  supply  and  repealing 
Directive 2004/67/EC (OJ L 295, 12.11.2010, p. 1) 

Energy Performance of Buildings 

•  Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on 

the energy performance of building (recast) (OJ L 153, 18.6.2010, p. 13) 

Energy efficiency of products 

•  Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on 
the indication by labelling and standard product information of the consumption of energy 
and other resources by energy-related products (OJ L 153, 18.6.2010, p; 1) 

•  Commission  Delegated  Regulation 

(EU)  No 1059/2010  of  28 September  2010 
supplementing Directive 2010/30/EU of the European Parliament and of the Council with 
regard to energy labelling of household dishwashers (OJ L 314, 30.11.2010, p. 1) 

•  Commission  Delegated  Regulation 

(EU)  No 1061/2010  of  28 September  2010 
supplementing Directive 2010/30/EU of the European Parliament and of the Council with 
regard to energy labelling of household washing machines (OJ L 314, 30.11.2010, p. 47) 

•  Commission  Delegated  Regulation 

(EU)  No 1062/2010  of  28 September  2010 

EN 

487 

   EN 

 
supplementing Directive 2010/30/EU of the European Parliament and of the Council with 
regard to energy labelling of televisions (OJ L 314, 30.11.2010, p. 64) 

•  Commission  Delegated  Regulation 

(EU)  No 1060/2010  of  28 September  2010 
supplementing Directive 2010/30/EU of the European Parliament and of the Council with 
regard to energy labelling of household refrigerating appliance (OJ L 314, 30.11.2010, p. 
17) 

•  Commission  Regulation  (EU)  1016/2010  of  10  November  2010  implementing  Directive 
2009/125/EC  of  the  European  Parliament  and  of  the  Council  with  regard  to  ecodesign 
requirements for household dishwashers (OJ L 293, 11.11.2010, p. 31) 

•  Commission  Regulation  (EU)  1015/2010  of  10  November  2010  implementing  Directive 
2009/125/EC  of  the  European  Parliament  and  of  the  Council  with  regard  to  ecodesign 
requirements for household washing machines (OJ L 293, 11.11.2010, p. 21) 

•  Commission  Regulation  (EU)  No  347/2010  of  21  April  2010  amending  Commission 
Regulation (EC) No 245/2009 as regards the ecodesign requirements for fluorescent lamps 
without  integrated  ballast,  for  high  intensity  discharge  lamps,  and  for  ballasts  and 
luminaires able to operate such lamps (OJ L 104, 24.4.2010, p. 20) 

Euratom 

•  Revised Commission recommendation on the application of Art. 37 of the Euratom Treaty 

was adopted in October 2010 (210/635/Euratom, OJ L 279, 23.10.2010, p. 36-67) 

•  Regulation (Euratom) No 647/2010 of the Council of 13 July 2010 on financial assistance 
of the Union with respect to the decommissioning of Units 1 to 4 of the Kozloduy Nuclear 
Power Plant in Bulgaria (Kozloduy Programme) (OJ L 189, 22.7.2010, p. 9). 

•  Commission  Decision  C(2010)6885  on  the  procedures  related  to  the  programming  and 
monitoring  of  the  measures  and  financial  assistance  under  the  Bohunice,  Ignalina  and 
Kozloduy  programmes  for  the  period  2007  to  2013  was  adopted  on  8  October  2010  and 
repealed Commission Decision C(2007)5538. 

•  Commission  Decision  C(2010)6971  on 

financing  of  additional  Community 
contributions  to  the  Nuclear  Decommissioning  Assistance  Programmes  for  Bohunice, 
Ignalina and Kozloduy in 2010 was adopted on 12 October 2010. 

the 

III.3.  New measures proposed or in preparation in 2010 

Internal electricity and gas market 

•  Proposal for a Regulation of the European Parliament and of the Council on energy market 

integrity and transparency (COM(2010(726) final). 

Euratom 

•  Proposal for a Council Directive on the management of spent fuel and radioactive waste 

(COM(2010)618, 3.11.2010). 

EN 

488 

   EN 

 
•  Proposal  of  Revision  and  recast  of  the  Basic  Safety  Standards:  The  revision  of  the 
Basic  Safety  Standards  is  also  the  opportunity  for  the  consolidation  of  existing  radiation 
protection  legislation  involving  four  other  Directives  and  incorporating  one  Commission 
Recommendation. The draft text of the Directive is complete and the drafting of the Impact 
Assessment  Report  is  in  an  advanced  stage.  The  Article  31  Group  of  Experts  gave  its 
opinion in February 2010.  

•  Negotiating mandate for a Euratom-Australia cooperation agreement: The proposal of 
a  Council  Decision  on  the  new  mandate  to  renegotiate  the  Euratom-Australia  agreement, 
due  to  expire  in  2012.  The  Council  adopted  the  negotiating  mandate  for  a  revised 
agreement  on  12  July  2010.  The  text  of  the  agreement  will  be  submitted  to  Council  for 
approval during the 1st quarter of 2011. 

•  Negotiating mandate for a Euratom-South Africa cooperation agreement was adopted 

by the Council on 25 October 2010. 

IV  

MOBILITY and TRANSPORT 

Current Legislation: 

Single Sky and Modernisation of air traffic control 

Air safety (Legal basis: Article 100(2) (ex-Article 80 par.2) 

Newest legislation 

•  Regulation  (EU)  No  996/2010  of  the  European  Parliament  and  of  the  Council  of  20 
October  2010  on  the  investigation  and  prevention  of  accidents  and  incidents  in  civil 
aviation repealing Directive 94/56/EC (OJ 12.11.2010)  

Infrastructures and airports 

Newest legislation: 

•  Regulation (EU) No 255/2010 of 25 March 2010 laying down common rules on air traffic 

flow management. 

•  Regulation (EC) No 545/2009 of the European Parliament and of the Council of 18 June 
2009 amending Regulation (EEC) No 95/93 on common rules for the allocation of slots at 
Community airports. 

•  Directive 2009/12/EC of the European Parliament and of the Council of 11 March 2009 on 

airport charges. 

Aviation security 

•  Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 
2008 on common rules in the field of civil aviation security and repealing Regulation (EC) 

EN 

489 

   EN 

 
No 2320/2002, as amended; 

•  Commission  Regulation  (EC)  No  272/2009  of  2  April  2009  supplementing  the  common 
basic standards on civil aviation security laid down in  the  Annex to Regulation (EC) No 
300/2008 of the European Parliament and the Council, as amended; 

•  Commission Regulation (EU) No 1254/2009 of 18 December 2009 setting criteria to allow 
Member States to derogate from the common basic standards on civil aviation security and 
to adopt alternative security measures; 

•  Commission  Regulation  (EU)  No  18/2010  of  8  January  2010  amending  Regulation  (EC) 
No  300/2008  of  the  European  Parliament  and  of  the  Council  as  far  as  specifications  for 
national quality control programmes in the field of civil aviation security is concerned; 

•  Commission Regulation (EU) No 72/2010 of 26 January 2010 laying down procedures for 

conducting Commission inspections in the field of civil aviation security; 

•  Commission  Regulation  (EU)  No  185/2010  of  4  March  2010  laying  down  detailed 
measures  for  the  implementation  of  the  common  basic  standards  on  aviation  security,  as 
amended; 

•  Commission  Decision  C(2010)/774  of  13  April  2010  laying  down  detailed  measures  for 

the implementation of the common basic standards on aviation, as amended. 

V. 

TAXATION and CUSTOMS UNION  

V.1  

Situation in the sector of CUSTOMS 

The following webpage contains a list of legal measures in the customs area adopted since 
2003: 

http://ec.europa.eu/taxation_customs/common/legislation/legislation/customs/index_en.htm 

•  Relevant Treaty provisions: 

Art 18; 

Art 23-27 TCE; 

Art 95 (approximation of laws); 

Art 133; 

Art 135. 

•  Relevant secondary EU law acts: 

•  Council  Regulation  (EEC)  No  2913/92  (Council  Regulation  (EEC)  No  2913/92 

establishing the EU Customs Code) 

•  Commission  Regulation  (EEC)  No  2454/93  (provisions  for  the  implementation  of 

Council Regulation (EEC) No 2913/92 establishing the EU Customs Code); 

EN 

490 

   EN 

 
•  The Common Customs Tariff (Combined Nomenclature and tariff measures): Council 
Regulation  (EEC)  No  2658/87  on  the  tariff  and  statistical  nomenclature  and  the  duty 
relief legislation (Council Regulation (EEC) No 918/83 of 28 March 1983 setting up a 
EU system of relief from customs duty); 

•  Regulation (EC) No 1889/2005 of the European Parliament and of the Council; 
•  International agreements in customs matters or the customs provisions of international 

agreements; 

•  Specific  legislation  on  customs  control  (counterfeit,  drug  precursors,  cultural  goods, 

cash control) in particular : 

•  Council Regulation (EC) No 1383/2003; 
•  Council Regulation (EC) No 111/2005; 
•  Council Regulation (EEC) No 3911/92.  

V.2  

INDIRECT TAXATION  

The following webpage contains a list of legal measures in the tax area adopted since 2003: 

http://ec.europa.eu/taxation_customs/common/legislation/legislation/taxation/index_en.htm 

Existing measures in force (situation on 31/12/2010) 

Relevant Treaty (TFEU) provisions:  

Mainly: 

Art 110;  

Additional: 

Art 45 

Art 49 

Art 56 

Art 63 

Art 113 

Relevant secondary EU law acts  

Directive 2010/88/EU 

Directive 2010/66/EU 

Directive 2010/45/EU 

Directive 2010/23/EU 

EN 

491 

   EN 

 
 
 
Directive 2010/12/EU 

Directive 2009/162/EU 

Directive 2009/132/EC 

Directive 2009/69/EC 

Directive 2009/55/EC 

Directive 2009/47/EC 

Directive 2008/118/EC 

Directive 2008/117/EC 

Directive 2008/55/EC 

Directive 2008/9/EC 

Directive 2008/8/EC 

Directive 2007/75/EC 

Directive 2007/74/EC 

Directive 2006/138/EC 

Directive 2006/112/EC 

Directive 2006/98/EC 

Directive 2006/79/EC 

Directive 2003/96/EEC 

Directive 2002/10/EC 

Directive 95/60/EC 

Directive 95/59/EC 

Directive 92/84/EEC 

Directive 92/83/EEC 

Directive 92/80/EEC 

Directive 92/79/EEC 

Directive 91/680/EEC 

EN 

492 

   EN 

 
Directive 86/560/EEC 

Directive 86/247/EEC 

Directive 83/648/EEC 

Directive 83/182/EEC 

Directive 78/1032/EEC 

Directive 72/230/EEC 

Directive 69/463/EEC 

Directive 68/297/EEC 

Council Regulation (EU) N° 904/2010 

Commission Regulation (EC) 1174/2009 

Council Regulation (EU) N° 37/2009 

Council Regulation (EU) N° 143/2008 

Commission Regulation (EC) No 1179/2008 

Council Regulation (EC) 1777/2005 

Commission Regulation (EU) N° 1925/2004 

Council Regulation (EU) N° 1798/2003 

V.3 

DIRECT TAXATION 

The following webpage contains a list of legal measures in the tax area adopted since 2003: 

http://ec.europa.eu/taxation_customs/common/legislation/legislation/taxation/index_en.htm 

Existing measures in force (situation on 31/12/2010)  

•  Relevant Treaty (TFEU) provisions:  

Art 21;  

Art 45 (to 48);  

Art 49 (to 54);  

Art 56 (to 62);  

Art 63 (to 66); 

EN 

493 

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Art 115;  

•  Relevant secondary EU law acts:  

Directive 77/799/EEC (+2 amending directives);  

Directive 90/434/EEC (+1 amending directive);  

Directive 90/435/EEC (+1 amending directive);  

Directive 2003/48/EC; 

Directive 2003/49/EC (+1 amending directive);  

Directive 2008/7/EC; 

Directive 2008/55/EC; 

Directive 2009/133/EC. 

VI 

EDUCATION AND CULTURE 

A full list of relevant provisions, which also includes non-binding provisions, can be found at: 

•  http://eur-lex.europa.eu/en/legis/20100101/chap1630.htm for education and training 
•  http://eur-lex.europa.eu/en/legis/20100101/chap1640.htm for culture 
•  http://ec.europa.eu/sport/white-paper/doc/wp_on_sport_en.pdf for sport 

A  guide  to  the  rights  of  mobile  students  in  the  European  Union  –  a  European  Commission 
staff working document, mentioned above: 

•  http://ec.europa.eu/education/yom/wpguidance_en.pdf  
•   

VII 

HEALTH AND CONSUMERS 

Main Measures in Force 31/12/2010 

VII.1 

Public Health 

Relevant EU Treaty provisions: 

Art 114 TFEU 

Art 168(4) TFEU 

Relevant secondary European Union law acts: 

•  Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the 
approximation of the laws, regulations and administrative provisions of the Member States 

EN 

494 

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concerning the manufacture, presentation and sale of tobacco products 

•  Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003 
setting  standards  of  quality  and  safety  for  the  collection,  testing,  processing,  storage  and 
distribution of human blood and blood components and amending Directive 2001/83/EC 

•  Directive  2003/33/EC  of  the  European  Parliament  and  of  the  Council  of  26  May  2003  on 
the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member 
States relating to the advertising and sponsorship of tobacco products 

•  Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on 
setting  standards of  quality  and safety for the donation, procurement, testing, processing, 
preservation, storage and distribution of human tissues and cells 

•  Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC 
of  the  European  Parliament  and  of  the  Council  as  regards  certain  technical  requirements 
for blood and blood components 

•  Commission  Directive  2005/61/EC  of  30  September  2005  implementing  Directive 
2002/98/EC  of  the  European  Parliament  and  of  the  Council  as  regards  traceability 
requirements and notification of serious adverse reactions and events 

•  Commission  Directive  2005/62/EC  of  30  September  2005  implementing  Directive 
2002/98/EC  of  the  European  Parliament  and  of  the  Council  as  regards  Community 
standards and specifications relating to a quality system for blood establishments 

•  Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC 
of  the  European  Parliament  and  of  the  Council  as  regards  certain  technical  requirements 
for the donation, procurement and testing of human tissues and cells 

•  Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC 
of  the  European  Parliament  and  of  the  Council  as  regards  traceability  requirements, 
notification of serious adverse reactions and events and certain technical requirements for 
the coding, processing, preservation, storage and distribution of human tissues and cells 

•  Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 
1998  setting  up  a  network  for  the  epidemiological  surveillance  and  control  of 
communicable diseases in the Community 

•  Commission Decision 2003/534/EC of 17 July 2003 amending Decision No 2119/98/EC of 
the  European  Parliament  and  of  the  Council  and  Decision  2000/96/EC  as  regards 
communicable  diseases  listed  in  those  decisions  and  amending  Decision  2002/253/EC  as 
regards the case definitions for communicable diseases 

•  Commission  Decision  2007/875/EC  of  18  December  2007  amending  Decision  No 
2119/98/EC  of  the  European  Parliament  and  of  the  Council  and  Decision  2000/96/EC  as 
regards communicable diseases listed in those decisions 

•  Commission Decision 2000/96/EC of 22 December 1999 on the communicable diseases to 
be  progressively  covered  by  the  Community  network  under  Decision  No  2119/98/EC  of 

EN 

495 

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the European Parliament and of the Council 

•  Commission  Decision  2003/542/EC  of  17  July  2003  amending  Decision  2000/96/EC  as 

regards the operation of dedicated surveillance networks 

•  Commission  Decision  2009/312/EC  of  2  April  2009  amending  Decision  2000/96/EC  as 

regards dedicated surveillance networks for communicable diseases, 

•  Commission  Decision  2009/539/EC  of  10  July  2009  amending  Decision  2000/96/EC  on 
communicable  diseases  to  be  progressively  covered  by  the  Community  network  under 
Decision No 2119/98/EC of the European Parliament and of the Council 

•  Commission  Decision  2000/57/EC  of  22  December  1999  on  the  early  warning  and 
response system for the prevention and control of communicable diseases under Decision 
No 2119/98/EC of the European Parliament and of the Council. 

•  Commission  Decision  2008/351/EC  of  28  April  2008  amending  Decision  2000/57/EC  as 
regards  events  to  be  reported  within  the  early  warning  and  response  system  for  the 
prevention and control of communicable diseases 

•  Commission  Decision  2009/547/EC  of  10  July  2009  amending  Decision  2000/57/EC  on 
early  warning  and  response  system  for  the  prevention  and  control  of  communicable 
diseases under Decision No 2119/98/EC of the European Parliament and of the Council 

•  Commission  Decision  2002/253/EC  of  19  March  2002  laying  down  case  definitions  for 
reporting  communicable  diseases  to  the  Community  network  under  Decision  No 
2119/98/EC of the European Parliament and of the Council 

•  Commission  Decision  2008/426/EC  of  28  April  2008  amending  Decision  2002/253/EC 
laying  down  case  definitions  for  reporting  communicable  diseases  to  the  Community 
network under Decision No 2119/98/EC of the European Parliament and of the Council 

•  Commission  Decision  2009/363/EC  of  30  April  2009  amending  Decision  2002/253/EC 
laying  down  case  definitions  for  reporting  communicable  diseases  to  the  Community 
network under Decision No 2119/98/EC of the European Parliament and of the Council 

•  Commission  Decision  2009/540/EC  of  10  July  2009  amending  Decision  2002/253/EC  as 

regards case definitions for reporting Influenza A(H1N1) to the Community network  

•  Regulation  (EC)  No  1882/2003  of  the  European  Parliament  and  of  the  Council  of  29 
September  2003  adapting  to  Council  Decision  1999/468/EC  the  provisions  relating  to 
committees which assist the Commission in the exercise of its implementing powers laid 
down in instruments subject to the procedure referred to in Article 251 of the EC Treaty 

•  Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 

2004 establishing a European Centre for Disease Prevention and Control 

•  Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 
2009 adapting a number of instruments subject to the procedure referred to in Article 251 
of  the  Treaty  to  Council  Decision  1999/468/EC  with  regard  to  the  regulatory  procedure 

EN 

496 

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with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four 

•  Directive  2010/53/EU  of  the  European  Parliament  and  of  the  Council  on  standards  of 

quality and safety of human organs intended for transplantation 

•  Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning 
the conditions of inspections and control measures, and on the training and qualification of 
officials, in the field of human tissues and cells  provided  for in Directive  2004/23/EC of 
the European Parliament and of the Council 

Pharmaceutical Legislation Medicinal Products for Human Use: 

http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm 

Pharmaceutical legislation Medicinal Products for Veterinary Use: 

http://ec.europa.eu/health/documents/eudralex/vol-5/index_en.htm 

Medical Devices Legislation 

http://ec.europa.eu/consumers/sectors/medical-devices/documents/index_en.htm 

VII.2  Consumers 

Relevant EU Treaty provisions: 

Art 169 TFEU 

Relevant secondary European Union law acts: 

•  Council  Directive  87/357/EEC  of  25  June  1987  on  the  approximation  of  the  laws  of  the 
Member States concerning products which, appearing to be other than they are, endanger 
the health or safety of consumers 

•  Council Directive 90/88/EEC of 22 February 1990 amending Directive 87/102/EEC for the 
approximation of the laws, regulations and administrative provisions of the Member States 
concerning consumer credit 

•  Directive  98/7/EC  of  the  European  Parliament  and  of  the  Council  of  16  February  1998 
amending  Directive  87/102/EEC  for  the  approximation  of  the  laws,  regulations  and 
administrative provisions of the Member States concerning consumer credit 

•  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 

on general product safety  

•  Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 

EN 

497 

   EN 

 
 
 
 
concerning  the  distance  marketing  of  consumer  financial  services  and  amending  Council 
Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC 

•  Regulation  (EC)  No  2006/2004  of  the  European  Parliament  and  of  the  Council  of  27 
October 2004 on cooperation between national authorities responsible for the enforcement 
of consumer protection laws (the Regulation on consumer protection cooperation) 

•  Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on 

credit agreements for consumers and repealing Council Directive 87/102/EEC 

•  Commission  Decision  2006/502/EC  of  11  May  2006  requiring  Member  States  to  take 
measures to ensure that only lighters which are child-resistant are placed on the market and 
to prohibit the placing on the market of novelty lighters  

•  Commission  Decision  2008/322/EC  of  18  April  2008  prolonging  the  validity  of  Decision 
2006/502/EC requiring Member States to take measures to ensure that only lighters which 
are  child-resistant  are  placed  on  the  market  and  to  prohibit  the  placing  on  the  market  of 
novelty lighters 

•  Regulation  (EC)  No  765/2008  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008 setting out the requirements for accreditation and market surveillance relating to the 
marketing of products and repealing Regulation (EEC) No 339/93 

•  Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on 

injunctions for the protection of consumers' interests (Codified version) 

•  Commission Decision 2009/251/EC of 17 March 2009 requiring Member States to ensure 
that products containing the biocide dimethylfumarate are not placed or made available on 
the market 

•  Commission Decision 2009/298/EC of 26 March 2009 prolonging the validity of Decision 
2006/502/EC requiring Member States to take measures to ensure that only lighters which 
are  child-resistant  are  placed  on  the  market  and  to  prohibit  the  placing  on  the  market  of 
novelty lighters 

•  Commission Decision 2009/490/EC of 23 June 2009 on the safety requirements to be met 
by European standards for personal music players pursuant to Directive 2001/95/EC of the 
European Parliament and of the Council 

•  Commission  Decision  2009/705/EC  of  14  September  2009  setting  up  a  European 

Consumer Consultative Group 

•  Commission Decision 2010/9/EU of 6 January 2010 on the safety requirements to be met 
by European standards for bath rings, bathing aids and bath tubs and stands for infants and 
young  children  pursuant  to  Directive  2001/95/EC  of  the  European  Parliament  and  of  the 
Council 

•  Commission Decision 2010/11/EU of 7 January 2010 on the safety requirements to be met 
by European standards for consumer-mounted childproof locking devices for windows and 
balcony  doors  pursuant  to  Directive  2001/95/EC  of  the  European  Parliament  and  of  the 

EN 

498 

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Council 

•  Commission  Decision  2010/15/EU  of  16  December  2009  laying  down  guidelines  for  the 
management  of  the  Community  Rapid  Information  System  RAPEX  established  under 
Article  12  and  of  the  notification  procedure  established  under  Article  11  of  Directive 
2001/95/EC (the General Product Safety Directive) 

•  Commission Decision 2010/153/EU of 11 March 2010 prolonging the validity of Decision 
2009/251/EC  requiring  Member  States  to  ensure  that  products  containing  the  biocide 
dimethylfumarate are not placed or made available on the market 

•  Commission Decision 2010/157/EU of 12 March 2010 prolonging the validity of Decision 
2006/502/EC requiring Member States to take measures to ensure that only lighters which 
are  child-resistant  are  placed  on  the  market  and  to  prohibit  the  placing  on  the  market  of 
novelty lighters 

•  Commission Decision 2010/376/EU of 2 July 2010 on the safety requirements to be met by 
European  standards  for  certain  products  in the  sleep  environment  of  children  pursuant  to 
Directive 2001/95/EC of the European Parliament and of the Council 

Cosmetics Legislation: 

http://ec.europa.eu/consumers/sectors/cosmetics/regulatory-framework/index_en.htm#h2-
legislation 

VII.3 

Food Safety 

GMO  

Relevant EU Treaty provisions: 

•  34 and 36 of TFEU (Quantitative restrictions-Free movement of goods and grounds for 

exceptions) 

•  114 TFEU (Approximation of Laws) 

•  168 TFEU (Protection of Health) 

Relevant secondary European Union law acts: 

•  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on 
the  deliberate  release  into  the  environment  of  genetically  modified  organisms  and 
repealing Council Directive 90/220/EEC 

•  Commission  Decision  2009/770/EC  of  13  October  2009  establishing  standard  reporting 
formats for presenting the monitoring results of the deliberate release into the environment 
of  genetically  modified  organisms,  as  or  in  products,  for  the  purpose  of  placing  on  the 
market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council 

•  Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the 

contained  use  of  genetically  modified 

micro-organisms (Recast)  

EN 

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   EN 

 
•  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 

2003 on transboundary movements of genetically modified organisms  

•  (Cartagena Protocol) 

•  Commission Decision repealing Decision 2006/601/EC on emergency measures regarding 
the  non-authorised  genetically  modified  organism  LL  RICE  601  in  rice  products  New 
measures already proposed and due to be adopted 

The authorisation Decisions: 

•  Commission  Decision  2010/141/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
MON863xNK603 (MON-ØØ863-5xMON-ØØ6Ø3-6); 

•  Commission  Decision  2010/140/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
MON863xMON810 (MON-ØØ863-5xMON-ØØ81Ø-6); 

•  Commission  Decision  2010/139/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
MON863xMON810xNK603  (MON-ØØ863-5xMON-ØØ81Ø-6xMON-  ØØ6Ø3-
6); 

•  Commission Decision 2010/136/EU authorising the placing on the market of feed 
produced  from the  genetically  modified potato EH92- 527-1 (BPS-25271-9) and 
the  adventitious  or  technically  unavoidable  presence  of  the  potato  in  food  and 
other feed products; 

•  Commission  Decision  2010/432/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
1507x59122 (DAS-Ø15Ø7-1xDAS-59122-7); 

•  Commission  Decision  2010/428/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7xMON-ØØ6Ø3-6); 

•  Commission  Decision  2010/429/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
MON 88017 x MON 810 (MON-88Ø17-3 x MON-ØØ81Ø-6); 

•  Commission  Decision  2010/420/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
MON89034xNK603 (MON-89Ø34-3xMON-ØØ6Ø3-6); 

•  Commission  Decision  2010/426/EU  authorising  the  placing  on  the  market  of 
products containing, consisting of, or produced from genetically modified maize 
Bt11xGA21 (SYN-BTØ11-1xMON-ØØØ21-9). 

•  Commission  Decision  2010/135/EU  authorising  the  placing  on  the  market  of  a 

EN 

500 

   EN 

 
potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for 
enhanced content of the amylopectin component of starch. 

FOOD HYGIENE 

Relevant EU Treaty provisions: 

Art 43 TFEU 

Art 114 TFEU 

Art 168 TFEU 

Relevant secondary European Union law acts: 

•  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing the European Food Safety Authority and laying down procedures in matters of 
food safety 

•  Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004 on official controls performed to ensure the verification of compliance with feed and 
food law, animal health and animal welfare rules 

•  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) 
No 882/2004 of the European Parliament and of the Council as regards the increased level 
of official controls on imports of certain feed and food of non-animal origin and amending 
Decision 2006/504/EC 

•  Council  Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor  certain  substances 
and  residues  thereof  in  live  animals  and  animal  products  and  repealing  Directives 
85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC 

•  Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of 
sampling  provided  for  by  Council  Directive  96/23/EC  for  the  monitoring  of  certain 
substances and residues thereof in certain animal products 

•  Commission  Decision  98/179/EC  of  23  February  1998  laying  down  detailed  rules  on 
official  sampling  for  the  monitoring  of  certain  substances  and  residues  thereof  in  live 
animals and animal products 

•  Commission  Decision  2002/657/EC  of  12  August  2002  implementing  Council  Directive 
96/23/EC  concerning  the  performance  of  analytical  methods  and  the  interpretation  of 
results 

•  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 

2004 on the hygiene of foodstuffs 

•  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 

EN 

501 

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2004 laying down specific hygiene rules for food of animal origin 

•  Regulation  (EC)  No  854/2004  of  the  European  Parliament  and  of  the  Council  of  29  April 
2004  laying  down  specific  rules  for  the  organisation  of  official  controls  on  products  of 
animal origin intended for human consumption 

•  Commission  Regulation  (EC)  No  2073/2005  of  15  November  2005  on  microbiological 

criteria for foodstuffs 

•  Commission  Regulation  (EC)  No  2074/2005  of  5  December  2005  laying  down 
implementing  measures  for  certain  products  under  Regulation  (EC)  No  853/2004  of  the 
European Parliament and of the Council and for the organisation of official controls under 
Regulation  (EC)  No  854/2004  of  the  European  Parliament  and  of  the  Council  and 
Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating 
from  Regulation  (EC)  No  852/2004  of  the  European  Parliament  and  of  the  Council  and 
amending Regulations (EC) No 853/2004 and (EC) No 854/2004 

•  Commission  Regulation  (EC)  No  2075/2005  of  5  December  2005  laying  down  specific 

rules on official controls for Trichinella in meat  

•  Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional 
arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 
and  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  and  amending 
Regulations (EC) No 853/2004 and (EC) No 854/2004 

•  Commission  Regulation  (EC)  No  1162/2009  of  30  November  2009  laying  down 
transitional measures for the implementation of Regulations (EC) No 853/2004, (EC) No 
854/2004 and (EC) No 882/2004 of the European Parliament and of the Council 

•  Commission Decision 2009/861/EC of 30 November 2009 on transitional measures under 
Regulation (EC) No 853/2004 of the European Parliament and of the Council as regard the 
processing  of  non-compliant  raw  milk  in  certain  milk  processing  establishments  in 
Bulgaria 

•  Commission Decision 2010/89/EU of 9 February 2010 on transitional measures concerning 
the  application  of  certain  structural  requirements  of  Regulations  (EC)  No  852/2004  and 
(EC) No 853/2004 of the European Parliament and of the Council to certain establishments 
for meat, fishery products and egg products and cold stores in Romania 

•  Commission  Decision  2010/653/EU  of  21  October  2010  amending  Annex  II  to  Decision 
2009/861/EC  on  transitional  measures  under  Regulation  (EC)  No  853/2004  of  the 
European  Parliament  and  of  the  Council  as  regards  the  processing  of  non-compliant  raw 
milk in certain milk processing establishments in Bulgaria 

•  Commission Regulation (EU) No 15/2011 of 10 January 2011 amending Regulation (EC) 
No 2074/2005 as regards recognised testing methods for detecting marine biotoxins in live 
bivalve molluscs 

Food Hygiene Overview: 

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   EN 

 
http://ec.europa.eu/food/food/biosafety/hygienelegislation/index_en.htm. 

Food Hygiene Guidance documents: 

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guide_en.htm. 

FOOD  

•  Directive 2000/13/EC of the European Parliament and of the Council on the approximation 
of the laws of the Member States relating to the labelling, presentation and advertising of 
foodstuffs 

•  Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs 

•  Regulation  (EC)  No  1924/2006  of  the  European  Parliament  and  of  the  Council  of  20 

December 2006 on nutrition and health claims made on foods 

•  Directive  2009/39/EC  of  the  European  Parliament  and  of  the  Council  of  6  May  2009  on 

foodstuffs intended for particular nutritional uses 

•  Regulation  (EC)  No  1331/2008  of  the  European  Parliament  and  of  the  Council  of  16 
December  2008  establishing  a  common  authorisation  procedure  for  food  additives,  food 
enzymes and food flavourings. 

•  Regulation  (EC)  No  1333/2008  of  the  European  Parliament  and  of  the  Council  of  16 

December 2008 on food additives. 

•  Regulation  (EC)  No  1332/2008  of  the  European  Parliament  and  of  the  Council  of  16 
December  2008  on  food  enzymes  and  amending  Council  Directive  83/417/EEC,  Council 
Regulation  (EC)  No  1493/1999,  Directive  2000/13/EC,  Council  Directive  2001/112/EC 
and Regulation (EC) No 258/97. 

•  Commission Directive 2009/163/EU of 22 December 2009 amending Directive 94/35/EC 
of  the  European  Parliament  and  of  the  Council  on  sweeteners  for  use  in  foodstuffs  with 
regard to neotame. 

•  Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for 
the  re-evaluation  of  approved  food  additives  in  accordance  with  Regulation  (EC)  No 
1333/2008 of the European Parliament and of the Council on food additives. 

•  Commission  Directive  2010/37/EU  of  17  June  2010  amending  Directive  2008/60/EC 

laying down specific purity criteria on sweeteners. 

•  Commission  Directive  2010/69/EU  of  22  October  2010  amending  the  Annexes  to 
European Parliament and Council Directive 95/2/EC on food additives other than colours 
and sweeteners. 

EN 

503 

   EN 

 
 
 
•  Commission  Directive  2010/67/EU  of  20  October  2010  amending  Directive  2008/84/EC 
laying down specific purity criteria on food additives other than colours and sweeteners. 

•  Commission  Directive  2008/128/EC  of  22  December  2008  laying  down  specific  purity 

criteria concerning colours for use in foodstuffs. 

•  Council  Directive  88/388/EEC  of  22  June  1988  on  the  approximation  of  the  laws  of  the 
Member States relating to flavourings for use in foodstuffs and to source materials for their 
production. 

•  Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, 
of  an  inventory  of  the  source  materials  and  substances  used  in  the  preparation  of 
flavourings. 

•  Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 
1996 laying down a Community procedure for flavouring substances used or intended for 
use in or on foodstuffs. 

•  Regulation  (EC)  N°  2065/2003  of  the  European  Parliament  and  of  the  Council  of  10 

November on smoke flavourings used or intended for use in or on foods. 

•  Regulation  (EC)  No  1334/2008  of  the  European  Parliament  and  of  the  Council  of  16 
December 2008 on flavourings and certain food ingredients with flavouring properties for 
use  in  and  on  foods  and  amending  Council  Regulation  (EEC)  No  1601/91,  Regulations 
(EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC. 

•  Council  Regulation  (EEC)  No  315/93  of  8  February  1993  laying  down  Community 

procedures for contaminants in food. 

•  Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 
on  the  approximation  of  the  laws  of  the  Member  States  concerning  foods  and  food 
ingredients treated with ionising radiation. 

•  Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 
on  the  establishment  of  a  Community  list  of  foods  and  food  ingredients  treated  with 
ionising radiation. 

•  Commission  Regulation  (EC)  No  1881/2006  of  19  December  2006  setting  maximum 

levels for certain contaminants in foodstuffs. 

•  Commission Regulation (EU) No 105/2010 of 5 February 2010 amending Regulation (EC) 
No  1881/2006  setting  maximum  levels  for  certain  contaminants  in  foodstuffs  as  regards 
ochratoxin A.  

•  Commission  Regulation  (EU)  No  165/2010  of  26  February  2010  amending  Regulation 
(EC)  No  1881/2006  setting  maximum  levels  for  certain  contaminants  in  foodstuffs  as 
regards aflatoxins. 

•  Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods 
of  sampling  and  analysis  for  the  official  control  of  the  levels  of  nitrates  in  certain 

EN 

504 

   EN 

 
foodstuffs. 

•  Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods 
of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs 
in certain foodstuffs. 

•  Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods 
of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. 

•  Commission  Regulation  (EU)  No  178/2010  of  2  March  2010  amending  Regulation  (EC) 
No  401/2006  as  regards  groundnuts  (peanuts),  other  oilseeds,  tree  nuts,  apricot  kernels, 
liquorice and vegetable oil. 

•  Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of 
sampling  and  analysis  for  the  official  control  of  the  levels  of  lead,  cadmium,  mercury, 
inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. 

•  Commission  Regulation  (EC)  No  1151/2009  of  27  November  2009  imposing  special 
conditions governing the import of sunflower oil originating in or consigned from Ukraine 
due to contamination risks by mineral oil and repealing Decision 2008/433/EC. 

•  Commission  Regulation  (EC)  No  1152/2009  of  27  November  2009  imposing  special 
conditions  governing  the  import  of  certain  foodstuffs  from  certain  third  countries  due  to 
contamination risk by aflatoxins and repealing Decision 2006/504/EC. 

•  Commission  Regulation  (EC)  No  1135/2009  of  25  November  2009  imposing  special 
conditions  governing  the  import  of  certain  products  originating  in  or  consigned  from 
China, and repealing Commission Decision 2008/798/EC. 

•  Commission Regulation (EU) 258/2010 of 25 March 2010 imposing special conditions on 
the imports of guar gum originating in or consigned from India due to contamination risks 
by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC. 

•  Commission proposal for a Regulation of the European Parliament and of the Council on 

the provision of food information to consumers (COM 2008(40) final). 

•  Council  Directive  96/22/EC  of  29  April  1996  concerning  the  prohibition  on  the  use  in 
stockfarming  of  certain  substances  having  a  hormonal  or  thyrostatic  action  and  of  beta-
agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC. 

•  Regulation  (EC)  No  470/2009  of  the  European  Parliament  and  of  the  Council  of  6  May 
2009  laying  down  Community  procedures  for  the  establishment  of  residue  limits  of 
pharmacologically  active  substances  in  foodstuffs  of  animal  origin,  repealing  Council 
Regulation  (EEC)  No  2377/90  and  amending  Directive  2001/82/EC  of  the  European 
Parliament  and  of  the  Council  and  Regulation  (EC)  No  726/2004  of  the  European 
Parliament and of the Council. 

•  Council  Directive  91/414/EEC  of  15  July  1991  concerning  the  placing  of  plant  protection 

products on the market 

EN 

505 

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•  Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21 
October  2009  concerning  the  placing  of  plant  protection  products  on  the  market  and 
repealing Council Directives 79/117/EEC and 91/414/EEC 

•  Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 
establishing a framework for Community action to achieve the sustainable use of pesticides 

•  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 
2005 on maximum residue levels of pesticides in or on food and feed of plant and animal 
origin and amending Council Directive 91/414/EEC 

•  Commission Regulation (EC) No 1097/2009 of 16 November 2009 amending Annex II to 
Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the  Council  as  regards 
maximum 
fenarimol, 
methamidophos, methomyl, omethoate, oxydemeton-methyl, procymidone, thiodicarb and 
vinclozolin in or on certain products 

for  dimethoate, 

fenamiphos, 

ethephon, 

residue 

levels 

•  Commission Regulation (EU) No 915/2010 of 12 October 2010 concerning a coordinated 
multiannual  control  programme  of  the  Union  for  2011,  2012  and  2013  to  ensure 
compliance  with  maximum  levels  of  and  to  assess  the  consumer  exposure  to  pesticide 
residues in and on food of plant and animal origin 

•  Commission Directive 2010/59/EU of 26 August 2010 amending Directive 2009/32/EC of 
the  European  Parliament  and  of  the  Council  on  the  approximation  of  the  laws  of  the 
Member  States  on  extraction  solvents  used  in  the  production  of  foodstuffs  and  food 
ingredients 

•  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on 

the approximation of the laws of the Member States relating to food supplements 

•  Regulation  (EC)  No  1925/2006  of  the  European  Parliament  and  of  the  Council  of  20 
December 2006 on the addition of vitamins and minerals and of certain other substances to 
foods 

•  Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the 
Member States relating to ceramic articles intended to come into contact with foodstuffs 

•  Commission  Directive  2002/72/EC  of  6  August  2002  relating  to  plastic  materials  and 

articles intended to come into contact with foodstuffs 

•  Regulation  (EC)  No  1935/2004  of  the  European  Parliament  and  of  the  Council  of  27 
October  2004  on  materials  and  articles  intended  to  come  into  contact  with  food  and 
repealing Directives 80/590/EEC and 89/109/EEC 

•  Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on 

the exploitation and marketing of natural mineral waters 

•  Commission  Directive  2003/40/EC  of  16  May  2003  establishing  the  list,  concentration 
limits  and  labeling  requirements  for  the  constituents  of  natural  mineral  waters  and  the 
conditions  for  using  ozone-enriched  air  for  the  treatment  of  natural  mineral  waters  and 

EN 

506 

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spring waters 

•  Commission Regulation (EU) No 115/2010 of 9 February 2010 laying down the conditions 
for  use  of  activated  alumina  for  the  removal  of  fluoride  from  natural  mineral  waters  and 
spring waters 

Directorate General for Health and Consumers' Website: 

http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/index_en.htm 

Nutrition profiles and health claims 

The  basic  act  as  well  as  all  related  legislation  and  measures  adopted  may  be  found  at  the 
following address. 

http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm 

The legislation on dietetic foods is based on Article 114 of the TFEU and can be found on the 
following web link: 

http://ec.europa.eu/food/food/labellingnutrition/nutritional/index_en.htm. 

The legislation on food supplements and on the addition of vitamins and minerals and of 
certain other substances to foodstuffs is based on Article 114 of the TFEU and can be found 
on the following web links:  

http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm 

http://ec.europa.eu/food/food/labellingnutrition/vitamins/index_en.htm 

The information related to novel foods can be found at the following address: 

http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm 

Labelling of foodstuffs: 

• 

General food labelling, legislation and decisions on draft national measures notified 
by Member States: 

http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/index_en.htm 

EN 

507 

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Nutrition Labelling: 

http://ec.europa.eu/food/food/labellingnutrition/nutritionlabel/index_en.htm 

• 

Information  on  the  Commission  proposal  for  a  Regulation  of  the  European 
Parliament and of the Council on the provision of food information to consumers: 

http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/proposed_legislation_en.htm 

PLANT HEALTH 

•  Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures  against  the 
introduction  into  the  Community  of  organisms  harmful  to  plants  or  plant  products  and 
against their spread within the Community 

•  Commission  Regulation  (EC)  No  1756/2004  of  11  October  2004  specifying  the  detailed 
conditions for the evidence required and the criteria for the type and level of the reduction 
of the plant health checks of certain plants, plant products or other objects listed in Part B 
of Annex V to Council Directive 2000/29/EC 

•  Commission Directive 2004/103/EC of 7 October 2004 on identity and plant health checks 
of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 
2000/29/EC,  which  may  be  carried  out  at  a  place  other  than  the  point  of  entry  into  the 
Community or at a place close by and specifying the conditions related to these checks 

•  Council Directive 69/464/EEC of 8 December 1969 on control of Potato Wart Disease 

•  Council Directive 74/647/EEC of 9 December 1974 on control of carnation leaf-rollers 

•  Council Directive 93/85/EC of 4 October 1993 on control of Potato Ring Rot 

•  Council  Directive  98/57/EC  of  20  July  1998  on  the  control  of  Ralstonia  solanacearum 

(Smith) Yabuuchi et al. 

•  Council Directive 2006/91/EC of 7 November 2006 on control of San José Scale 

•  Council Directive 2007/33/EC of 11 June 2007 on the control of potato cyst nematodes and 

repealing Directive 69/465/EEC (from 01/06/2010) 

•  Commission Directive 92/70/EEC of 30 July 1992 laying down detailed rules for surveys to 

be carried out for purposes of the recognition of protected zones in the Community 

•  Commission  Directive  93/51/EEC  of  24  June  1993  establishing  rules  for  movements  of 
certain plants, plant products or other objects through a protected zone, and for movements 
of  such  plants,  plant  products  or  other  objects  originating  in  and  moving  within  such  a 
protected zone 

•  Commission  Regulation  (EC)  No  690/2008  of  4  July  2008  recognising  protected  zones 

EN 

508 

   EN 

 
 
exposed to particular plant health risks in the Community 

•  Commission  Directive  92/90/EEC  of  3  November  1992  establishing  obligations  to  which 
producers  and  importers  of  plants,  plant  products  or  other  objects  are  subject  and 
establishing details for their registration 

•  Commission  Directive  92/105/EEC  of  3  December  1992  establishing  a  degree  of 
standardization  for  plant  passports  to  be  used  for  the  movement  of  certain  plants,  plant 
products or other objects within the Community, and establishing the detailed procedures 
related to the issuing of such plant passports and the conditions and detailed procedures for 
their replacement 

•  Commission  Directive  93/50/EEC  of  24  June  1993  specifying  certain  plants  not  listed  in 
Annex  V,  part  A  to  Council  Directive  77/93/EEC,  the  producers  of  which,  or  the 
warehouses, dispatching centres in the production zones of such plants, shall be listed in an 
official register 

•  Commission  Directive  94/3/EC  of  21  January  1994  establishing  a  procedure  for  the 
notification  of  interception  of  a  consignment  or  a  harmful  organism  from  third  countries 
and presenting an imminent phytosanitary danger 

•  Commission Directive 98/22/EC of 15 April 1998 laying down the minimum conditions for 
carrying out plant health checks in the Community, at inspection posts other than those at 
the  place  of  destination,  of  plants,  plant  products  or  other  objects  coming  from  third 
countries 

•  Commission Directive 2008/61/EC of 17 June 2008 establishing the conditions under which 
certain harmful organisms, plants, plant products and other objects listed in Annexes I to V 
to Council Directive 2000/29/EC may be introduced into or moved within the Community 
or certain protected zones thereof, for trial or scientific purposes and for work on varietal 
selections 

SEEDS – PLANT VARIETY 

•  Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed  

•  Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed  

•  Council  Directive  68/193/EEC  of  9  April  1968  on  the  marketing  of  material  for  the 

vegetative propagation of the vine 

•  Council  Directive  2008/72/EC  of  15  July  2008  on  the  marketing  of  vegetable  propagating 

and planting material, other than seed 

•  Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating 

material and fruit plants intended for fruit production 

•  Council  Directive  2008/90/EC  of  29  September  2008  on  the  marketing  of  fruit  plant 

propagating material and fruit plants intended for fruit production 

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•  Council  Directive  98/56/EC  of  20  July  1998  on  the  marketing  of  propagating  material  of 

ornamental plants 

•  Council  Directive  1999/105/EC  of  22  December  1999  on  the  marketing  of  forest 

reproductive material 

•  Council  Directive  2002/53/EC  of  13  June  2002  on  the  common  catalogue  of  varieties  of 

agricultural plant species 

•  Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed 

•  Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed 

•  Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes  

•  Council  Directive  2002/57/EC  of  13  June  2002  on  the  marketing  of  seed  of  oil  and  fibre 

plants 

•  Commission Decision 80/512/EEC of 2 May 1980 authorizing the Kingdom of Denmark, the 
Federal  Republic  of  Germany,  the  Grand  Duchy  of  Luxembourg,  the  Kingdom  of  the 
Netherlands  and  the  United  Kingdom  not  to  apply  the  conditions  laid  down  in  Council 
Directive 66/401/EEC on the marketing of fodder plant seed, as regards the weight of the 
sample for determination of seed of Cuscuta 

•  Commission Decision 85/370/EEC of 8 July 1985 authorizing the Netherlands to assess the 
satisfaction  of  the  varietal  purity  standards  laid  down  in  Annex  II  to  Council  Directive 
66/401/EEC for seed of apomictic uniclonal varieties of Poa pratensis, also on the basis of 
the results of seed and seedling testing 

•  Commission  Decision  2004/371/EC  of  20  April  2004  on  conditions  for  the  placing  on  the 

market of seed mixtures intended for use as fodder plants 

•  Commission Directive 2008/124/EC of 18 December 2008 limiting the marketing of seed of 
certain species of fodder plants and oil and fibre plants to seed which has been officially 
certified as ‘basic seed’ or ‘certified seed’ 

•  Commission  Decision  80/755/EEC  of  17  July  1980  authorizing  the  indelible  printing  of 

prescribed information on packages of cereal seed 

•  Commission Directive 2004/29/EC of 4 March 2004 on determining the characteristics and 

minimum conditions for inspecting vine varieties 

•  Commission  Directive  93/61/EEC  of  2  July  1993  setting  out  the  schedules  indicating  the 
conditions  to  be  met  by  vegetable  propagating  and  planting  material,  other  than  seed 
pursuant to Council Directive 92/33/EEC 

•  Commission  Directive  93/62/EEC  of  5  July  1993  setting  out  the  implementing  measures 
concerning  the  supervision  and  monitoring  of  suppliers  and  establishments  pursuant  to 
Council  Directive  92/33/EEC  on  the  marketing  of  vegetable  propagating  and  planting 
material, other than seed 

EN 

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   EN 

 
•  Commission  Directive  93/48/EEC  of  23  June  1993  setting  out  the  schedule  indicating  the 
conditions to be met by fruit plant propagating material and fruit plants intended for fruit 
production, pursuant to Council Directive 92/34/EEC 

•  Commission  Directive  93/64/EEC  of  5  July  1993  setting  out  the  implementing  measures 
concerning  the  supervision  and  monitoring  of  suppliers  and  establishments  pursuant  to 
Council Directive 92/34/EEC on the marketing of fruit plant propagating material and fruit 
plants intended for fruit production 

•  Commission  Directive  93/79/EEC  of  21  September  1993  setting  out  additional 
implementing provisions for lists of varieties of fruit plant propagating material and fruit 
plants, as kept by suppliers under Council Directive 92/34/EEC 

•  Commission  Directive  93/49/EEC  of  23  June  1993  setting  out  the  schedule  indicating  the 
conditions  to  be  met  by  ornamental  plant  propagating  material  and  ornamental  plants 
pursuant to Council Directive 91/682/EEC 

•  Commission Directive 1999/66/EC of 28 June 1999 setting out requirements as to the label 

or other document made out by the supplier pursuant to Council Directive 98/56/EC 

•  Commission Directive 1999/68/EC of 28 June 1999 setting out additional provisions for lists 
of varieties of ornamental plants as kept by suppliers under Council Directive 98/56/EC 

•  Commission Regulation (EC) No 1597/2002 of 6 September 2002 laying down detailed rules 
for the application of Council Directive 1999/105/EC as regards the format of national lists 
of the basic material of forest reproductive material 

•  Commission Regulation (EC) No 1598/2002 of 6 September 2002 laying down detailed rules 
for  the  application  of  Council  Directive  1999/105/EC  as  regards  the  provision  of  mutual 
administrative assistance by official bodies 

•  Commission Regulation (EC) No 1602/2002 of 9 September 2002 laying down detailed rules 
for  the  application  of  Council  Directive  1999/105/EC  as  regards  the  authorisation  of  a 
Member  State  to  prohibit  the  marketing  of  specified  forest  reproductive  material  to  the 
end-user 

•  Commission Regulation (EC) No 2301/2002 of 20 December 2002 laying down detailed rules 
for  the  application  of  Council  Directive  1999/105/EC  as  regards  the  definition  of  small 
quantities of seed 

•  Commission Regulation (EC) No 69/2004 of 15 January 2004 authorising derogations from 
certain provisions of Council Directive 1999/105/EC in respect of the marketing of forest 
reproductive material derived from certain basic material 

•  Commission  Decision  2004/678/EC  of  29  September  2004  authorising  Member  States  to 
permit  temporarily  the  marketing  of  seed  of  the  species  Cedrus  libani,  Pinus  brutia  and 
planting stock produced from this seed not satisfying the requirements of Council Directive 
1999/105/EC 

•  Commission Decision 2005/853/EC of 30 November 2005 authorising France to prohibit the 

EN 

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marketing to the end user, with a view to seeding or planting in certain regions of France, 
of  reproductive  material  of  Pinus  pinaster  Ait.  of  Iberian  Peninsula  origin,  which  is 
unsuitable for use in such territories under Council Directive 1999/105/EC 

•  Commission  Decision  2005/871/EC  of  6  December  2005  releasing  Denmark  and  Slovenia 
from  certain  obligations  for  marketing  of  forest  reproductive  material  under  Council 
Directive 1999/105/EC 

•  Commission  Decision  2006/665/EC  of  3  October  2006  temporarily  authorising  Spain  to 
approve for marketing seed of the species Pinus radiata and planting stock produced from 
this seed imported from New Zealand which does not satisfy the requirements of Council 
Directive 1999/105/EC in respect of identification and labelling 

•  Commission  Decision  2007/527/EC  of  25  July  2007  authorising  Bulgaria  and  Romania  to 
derogate  from  Council  Directive  1999/105/EC  on  the  marketing  of  forest  reproductive 
material with regard to the stocks accumulated from 1 January 2003 to 31 December 2006 

•  Council  Decision  2008/971/EC  of  16  December  2008  on  the  equivalence  of  forest 

reproductive material produced in third countries 

•  Commission  Decision  2008/989/EC  of  23  December  2008  authorising  Member  States,  in 
accordance  with  Council  Directive  1999/105/EC,  to  take  decisions  on  the  equivalence  of 
the  guarantees  afforded  by  forest  reproductive material  to  be  imported  from  certain  third 
countries 

•  Commission Directive 89/14/EEC of 15 December 1988 determining the groups of varieties 
of  spinach  beet  and  beetroot  referred  to  crop  isolation  conditions  of  Annex  I  to  Council 
Directive 70/458/EEC on the marketing of vegetable seed 

•  Commission Directive 2003/91/EC of 6 October 2003 setting out implementing measures for 
the purposes of Article 7 of Council Directive 2002/55/EC as regards the characteristics to 
be covered as a minimum by the examination and the minimum conditions for examining 
certain varieties of vegetable species 

•  Commission  Directive  93/17/EEC  of  30  March  1993  determining  Community  grades  of 
basic  seed  potatoes,  together  with  the  conditions  and  designations  applicable  to  such 
grades 

•  Commission  Decision  2004/3/EC  of  19  December  2003  authorising,  in  respect  of  the 
marketing  of  seed  potatoes  in  all  or  part  of  the  territory  of  certain  Member  States,  more 
stringent  measures  against  certain  diseases  than  are  provided  for  in  Annexes  I  and  II  to 
Council Directive 2002/56/EC 

•  Commission  Decision  97/125/EC  of  24  January  1997  authorizing  the  indelible  printing  of 
prescribed information on packages of seed of oil and fibre plants and amending Decision 
87/309/EEC  authorizing  the  indelible  printing  of  prescribed  information  on  packages  of 
certain fodder plant species 

•  Commission Directive 2003/90/EC of 6 October 2003 setting out implementing measures 
for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics 

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to  be  covered  as  a  minimum  by  the  examination  and  the  minimum  conditions  for 
examining certain varieties of agricultural plant species 

•  Commission  Decision 2004/266/EC of 17 March 2004 authorising the indelible printing of 

prescribed information on packages of seed of fodder plants 

•  Commission Directive 2008/124/EC of 18 December 2008 limiting the marketing of seed of 
certain species of fodder plants and oil and fibre plants to seed which has been officially 
certified as ‘basic seed’ or ‘certified seed’ 

•  Commission  Directive  2008/62/EC  of  20  June  2008  providing  for  certain  derogations  for 
acceptance of agricultural landraces and varieties which are naturally adapted to the local 
and regional conditions and threatened by genetic  erosion  and  for  marketing  of  seed  and 
seed potatoes of those landraces and varieties 

•  Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights 

•  Commission  Directive  2009/145/EC  of  26  November  2009  providing  for  certain 
derogations,  for  acceptance  of  vegetable  landraces  and  varieties  which  have  been 
traditionally  grown  in  particular  localities  and  regions  and  are  threatened  by  genetic 
erosion and of vegetable varieties with no intrinsic value for commercial crop production 
but developed for growing under particular conditions and for marketing of seed of those 
landraces and varieties 

•  Commission  Directive  2010/60/EU  of  30  August  2010  providing  for  certain  derogations 
for  marketing  of  fodder  plant  seed  mixtures  intended  for  use  in  the  preservation  of  the 
natural environment 

ANIMAL HEALTH 

•  Council  Decision  79/542/EEC  of  21  December  1976  drawing  up  a  list  of  third  countries 
from which the Member States authorize imports of bovine animals, swine and fresh meat 

•  Council  Directive  2008/73/EC  of  15  July  2008  simplifying  procedures  of  listing  and 
publishing information in the veterinary and zootechnical fields and amending Directives 
64/432/EEC,  77/504/EEC,  88/407/EEC,  88/661/EEC,  89/361/EEC,  89/556/EEC, 
90/426/EEC,  90/427/EEC,  90/428/EEC,  90/429/EEC,  90/539/EEC,  91/68/EEC, 
91/496/EEC,  92/35/EEC,  92/65/EEC,  92/66/EEC,  92/119/EEC,  94/28/EC,  2000/75/EC, 
Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC 

•  Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field 

•  Council  Directive  90/425/EEC  of  26  June  1990  concerning  veterinary  and  zootechnical 
checks  applicable  in  intra-Community  trade  in  certain  live  animals  and  products  with  a 
view to the completion of the internal market 

•  Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-

Community trade with a view to the completion of the internal market 

•  Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal 

EN 

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products 

•  Council  Directive  2002/99/EC  of  16  December  2002  laying  down  the  animal  health  rules 
governing the production, processing, distribution and introduction of products of animal 
origin for human consumption 

•  Council  Directive  89/608/EEC  of  21  November  1989  on  mutual  assistance  between  the 
administrative authorities of the Member States and cooperation between the latter and the 
Commission to ensure the correct application of legislation on veterinary and zootechnical 
matters 

•  Council  Directive  91/496/EEC  of  15  July  1991  laying  down  the  principles  governing  the 
organization of veterinary checks on animals entering the Community from third countries 
and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 

•  Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the 
organisation of veterinary checks on products entering the Community from third countries 

•  Regulation  (EC)  No  1760/2000  of  the  European  Parliament  and  of  the  Council  of  17  July 
2000  establishing  a  system  for  the  identification  and  registration  of  bovine  animals  and 
regarding  the  labelling  of  beef  and  beef  products  and repealing  Council  Regulation  (EC) 
No 820/97 

•  Council  Directive  64/432/EEC  of  26  June  1964  on  animal  health  problems  affecting  intra-

Community trade in bovine animals and swine 

•  Council Directive 2008/71/EC of 15 July 2008 on the identification and registration of pigs 

•  Council  Regulation  (EC)  No  21/2004  of  17  December  2003  establishing  a  system  for  the 
identification and registration of ovine and caprine animals and amending Regulation (EC) 
No 1782/2003 and Directives 92/102/EEC and 64/432/EEC 

•  Council  Directive  90/427/EEC  of  26  June  1990  on  the  zootechnical  and  genealogical 

conditions governing intra-Community trade in equidae 

•  Council  Directive  2003/85/EC  of  29  September  2003  on  Community  measures  for  the 
control  of  foot-and-mouth  disease  repealing  Directive  85/511/EEC  and  Decisions 
89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC 

•  Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control 

of classical swine fever 

•  Council  Directive  2002/60/EC  of  27  June  2002  laying  down  specific  provisions  for  the 
control  of  African  swine  fever  and  amending  Directive  92/119/EEC  as  regards  Teschen 
disease and African swine fever 

•  Council  Directive  92/35/EEC  of  29  April  1992  laying  down  control  rules  and  measures  to 

combat African horse sickness 

•  Council  Directive  2005/94/EC  of  20  December  2005  on  Community  measures  for  the 

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control of avian influenza and repealing Directive 92/40/EEC 

•  Council  Directive  92/66/EEC  of  14  July  1992  introducing  Community  measures  for  the 

control of Newcastle disease 

•  Council  Directive  2006/88/EC  of  24  October  2006  on  animal  health  requirements  for 
aquaculture  animals  and  products  thereof,  and  on  the  prevention  and  control  of  certain 
diseases in aquatic animals 

•  Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the 

control and eradication of bluetongue 

•  Regulation  (EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council  of  22  May 
2001 laying down rules for the prevention, control and eradication of certain transmissible 
spongiform encephalopathies 

•  Regulation (EC) No 220/2009 of the European Parliament and of the Council of 11 March 
2009  amending  Regulation  (EC)  No  999/2001  laying  down  rules  for  the  prevention, 
control  and  eradication  of  certain  transmissible  spongiform  encephalopathies,  as  regards 
the implementing powers conferred on the Commission 

•  Commission Regulation (EC) No 103/2009 of 3 February 2009 amending Annexes VII and 
IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying 
down rules for the prevention, control and eradication of certain transmissible spongiform 
encephalopathies 

•  Commission  Regulation  (EC)  No  162/2009  of  26  February  2009  amending  Annexes  III 
and  X  to  Regulation  (EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council 
laying  down  rules  for  the  prevention,  control  and  eradication  of  certain  transmissible 
spongiform encephalopathies 

•  Commission  Regulation  (EC)  No  163/2009  of  26  February  2009  amending  Annex  IV  to 
Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down 
rules  for  the  prevention,  control  and  eradication  of  certain  transmissible  spongiform 
encephalopathies 

•  Commission  Decision  2009/719/EC  of  28  September  2009  authorising  certain  Member 

States to revise their annual BSE monitoring programmes 

•  Directive  2003/99/EC  of  the  European  Parliament  and  of  the  Council  of  17  November 
2003  on  the  monitoring  of  zoonoses  and  zoonotic  agents,  amending  Council  Decision 
90/424/EEC and repealing Council Directive 92/117/EEC 

•  Regulation  (EC)  No  2160/2003  of  the  European  Parliament  and  of  the  Council  of  17 
November  2003  on  the  control  of  salmonella  and  other  specified  food-borne  zoonotic 
agents 

•  Zoonoses and Antimicrobial Resistance (AMR): 

Zoonoses:  http://ec.europa.eu/food/food/biosafety/salmonella/index_en.htm 

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AMR:  http://ec.europa.eu/food/food/biosafety/public_consultation_AMR_en.htm 

•  Council  Directive  92/119/EEC  of  17  December  1992  introducing  general  Community 
measures for the control of certain animal diseases and specific measures relating to swine 
vesicular disease 

•  Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases 

within the Community 

•  Council  Directive  91/68/EEC  of  28  January  1991  on  animal  health  conditions  governing 

intra-Community trade in ovine and caprine animals 

•  Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing 
intra-Community  trade  in  and  importation  from  third  countries  of  embryos  of  domestic 
animals of the bovine species 

•  Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements 
applicable  to  intra-Community  trade  in  and  imports  of  deep-frozen  semen  of  domestic 
animals of the bovine species 

•  Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements 
applicable to intra- Community trade in and imports of semen of domestic animals of the 
porcine species 

•  Council  Directive  92/65/EEC  of  13  July  1992  laying  down  animal  health  requirements 
governing trade in and imports into the Community of animals, semen, ova and embryos 
not subject to animal health requirements laid down in specific Community rules referred 
to in Annex A (I) to Directive 90/425/EEC 

•  Regulation  (EC)  No  998/2003  of  the  European  Parliament  and  of  the  Council  of  26  May 
2003 on the animal health requirements applicable to the non-commercial movement of pet 
animals and amending Council Directive 92/65/EEC 

•  Council  Directive  96/22/EC  of  29  April  1996  concerning  the  prohibition  on  the  use  in 
stockfarming  of  certain  substances  having  a  hormonal  or  thyrostatic  action  and  of  ß-
agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC 

•  Council  Directive  2004/68/EC  of  26  April  2004  laying  down  animal  health  rules  for  the 
importation  into  and  transit  through  the  Community  of  certain  live  ungulate  animals, 
amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC 

•  Directive  2004/41/EC  of  the  European  Parliament  and  of  the  Council  of  21  April  2004 
repealing  certain  Directives  concerning  food  hygiene  and  health  conditions  for  the 
production  and  placing  on  the  market  of  certain  products  of  animal  origin  intended  for 
human  consumption  and  amending  Council  Directives  89/662/EEC  and  92/118/EEC  and 
Council Decision 95/408/EC 

•  Council  Directive  2009/157/EC  of  30  November  2009  on  pure-bred  breeding  animals  of 

the bovine species 

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•  Council  Directive  88/661/EEC  of  19  December  1988  on  the  zootechnical  standards 

applicable to breeding animals of the porcine species 

•  Council  Directive  89/361/EEC  of  30  May  1989  concerning  pure-bred  breeding  sheep  and 

goats 

•  Council  Directive  90/428/EEC  of  26  June  1990  on  trade  in  equidae  intended  for 

competitions and laying down the conditions for participation therein 

•  Council  Directive  91/174/EEC  of  25  March  1991  laying  down  zootechnical  and  pedigree 
requirements for the marketing of pure-bred animals and amending Directives 77/504/EEC 
and 90/425/EEC 

•  Council  Directive  94/28/EC  of  23  June  1994  laying  down  the  principles  relating  to  the 
zootechnical  and  genealogical  conditions  applicable  to  imports  from  third  countries  of 
animals, their semen, ova and embryos, and amending Directive 77/504/EEC on pure-bred 
breeding animals of the bovine species 

•  Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public 
health  requirements  governing  trade  in  and  imports  into  the  Community  of  products  not 
subject  to  the  said  requirements  laid  down  in  specific  Community  rules  referred  to  in 
Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC 

•  Regulation  (EC)  No  1774/2002  of  the  European  Parliament  and  of  the  Council  of  3 
October  2002  laying  down  health  rules  concerning  animal  by-products  not  intended  for 
human consumption 

•  Regulation  (EC)  No  1069/2009  of  the  European  Parliament  and  of  the  Council  of  21 
October 2009 laying down health rules as regards animal by-products and derived products 
not  intended  for  human  consumption  and  repealing  Regulation  (EC)  No  1774/2002 
(Animal by-products Regulation) 

•  Council  Directive  2009/156/EC  of  30  November  2009  on  animal  health  conditions 

governing the movement and importation from third countries of equidae 

FEED 

Relevant EU Treaty provisions: 

Articles 43 and 168(4)(b) TFEU  

Relevant secondary European Union law acts: 

•  Commission  Directive  81/680/EEC  of  30  July  1981  amending  Directives  71/250/EEC, 
71/393/EEC,  72/199/EEC,  73/46/EEC,  74/203/EEC,  75/84/EEC,  76/372/EEC  and 
78/633/EEC  establishing  Community  methods  of  analysis  for  the  official  control  of 
feedingstuffs 

•  Commission  Regulation  (EC)  No  429/2008  of  25  April  2008  on  detailed  rules  for  the 

EN 

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implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council as regards the preparation and the presentation of applications and the assessment 
and the authorisation of feed additives 

•  Regulation  (EC)  No  183/2005  of  the  European  Parliament  and  of  the  Council  of  12 

January 2005 laying down requirements for feed hygiene 

•  Commission  Regulation  (EC)  No  378/2005  of  4  March  2005  on  detailed  rules  for  the 
implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council  as  regards  the  duties  and  tasks  of  the  Community  Reference  Laboratory 
concerning applications for authorisations of feed additives 

•  Regulation (EC) No 767/2009 of the European Parliament and  of the Council of 13 July 
2009  on  the  placing  on  the  market  and  use  of  feed,  amending  European  Parliament  and 
Council  Regulation  (EC)  No  1831/2003  and  repealing  Council  Directive  79/373/EEC, 
Commission  Directive  80/511/EEC,  Council  Directives  82/471/EEC,  83/228/EEC, 
93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC 

•  Regulation  (EC)  No  1831/2003  of  the  European  Parliament  and  of  the  Council  of  22 

September 2003 on additives for use in animal nutrition 

•  Directive  2002/32/EC  of  the  European  Parliament  and  the  Council  of  7  May  2002  on 

undesirable substances in animal feed 

•  Commission  Directive  2005/7/EC  of  27  January  2005  amending  Directive  2002/70/EC 
establishing requirements for the determination of levels of dioxins and dioxin-like PCBs 
in feedingstuffs 

•  Commission  Directive  2009/8/CE  of  10  February  2009  amending  Annex  I  to  Directive 
2002/32/EC of the European Parliament and of the Council as regards maximum levels of 
unavoidable carry-over of coccidiostats or histomonostats in non-target feed 

•  Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels 
for the presence of coccidiostats or histomonostats in food resulting from the unavoidable 
carry-over of these substances in non-target feed 

•  Commission  Directive  2008/38/EC of 5 March 2008  establishing  a list of intended uses of 

animal feedingstuffs for particular nutritional purposes 

•  Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the 
preparation, placing on the market and use of medicated feedingstuffs in the Community 

•  Commission Decision 2010/277/EU of 12 May 2010 amending Decision 2009/821/EC as 

regards the lists of border inspection posts and veterinary units in Traces 

•  Commission Decision 2010/617/EU of 14 October 2010 amending Decision 2009/821/EC 

as regards the lists of border inspection posts and veterinary units in Traces 

•  Commission  Regulation  (EU)  No  242/2010  of  19  March  2010  creating  the  Catalogue  of 

feed materials 

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ANIMAL WELFARE 

Relevant EU Treaty provisions: 

Article 13 TFEU 

Relevant secondary European Union law acts: 

•  Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for 

farming purposes 

•  Council Directive 91/629/EEC of 19 November 1991 laying down the minimum standards 

for the protection of calves codified in Council Directive 2008/119/EC 

•  Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for 

the protection of pigs codified in Council Directive 2008/120/EC 

•  Council  Directive  2007/43/EC  of  28  June  2007  laying  down  minimum  rules  for  the 

protection of chickens kept for meat production 

•  Council  Directive  1999/74/EC  of  19  July  1999  laying  down  minimum  standards  for  the 

protection of laying hens 

•  Council  Regulation  (EC)  No  1/2005  of  22  December  2004  on  the  protection  of  animals 
during  transport  and  related  operations  and  amending  Directives  64/432/EEC  and 
93/119/EC  and  Regulation  (EC)  No  1255/97,  Council  Regulation  (EC)  No  1/2005  of  22 
December  2004  on  the  protection  of  animals  during  transport  and  related  operations  and 
amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 

•  Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time 

of slaughter or killing 

•  Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals 

at the time of killing 

•  Regulation  (EC)  No  1523/2007  of  the  European  Parliament  and  of  the  Council  of  11 
December 2007 banning the placing on the market and the import to, or export from, the 
Community of cat and dog fur, and products containing such fur 

VIII 

BUDGET 

Relevant EU Treaty and secondary EU law acts:  

• 

● 

● 

Articles 311 and 322(2) TFEU 

Council  Decision  2007/436/EC,  Euratom  on  the  system  of  the  Communities'  own 
resources. 

Council Regulation (EEC, Euratom) No 1553/89 of 29 May 1989 on the definitive 
uniform arrangements for the collection of own resources accruing from value added 
tax 

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● 

• 

Council  Regulation  (EC,  Euratom)  No  1150/2000  of  22  May  2000  implementing 
Decision 94/728/EC, Euratom on the system of the Communities' own resources 

Protocol  (No  7)  on  the  privileges  and  immunities  of  the  European  Union,  in 
particular Articles 3 and 4. 

New measures already proposed and due to be adopted in the sector: 

• 

Proposal for a Regulation of the European Parliament and of the Council on the 
Financial Regulation applicable to the general budget of the European Union 
(Recast) {SEC(2010) 639} /* COM/2010/0260 final - COD 2010/0154 */. 

EN 

520 

   EN