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

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

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

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

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

1.9........ 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.. 38

2........... COMPETITION.. 38

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

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

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

3........... 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

3.1.3..... Evaluation results. 50

3.1.4..... Summary. 51

3.2........ Labour Law.. 52

3.2.1..... Current position. 52

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. 58

3.3.1..... Current position. 58

3.3.2..... Evaluation based on the current situation. 61

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. 80

4.2.1..... General evaluation. 80

4.2.2..... Sector based remarks. 80

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

4.4........ Summary. 87

5........... ENERGY.. 88

5.1........ ENERGY - Internal electricity and gas market.. 89

5.1.1..... Current position. 89

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

5.1.3..... Evaluation results. 92

5.1.4..... Sector summary. 92

5.2........ ENERGY – Coal and oil 93

5.2.1..... Current position. 93

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

5.2.3..... Evaluation results. 95

5.2.4..... Sector summary. 96

5.3........ ENERGY - Renewable energy sources. 97

5.3.1..... Current position. 97

5.3.2..... Evaluation of the current position. 98

5.3.3..... Evaluation results. 98

5.3.4..... Sector summary. 99

5.4........ ENERGY – Energy efficiency.. 99

5.4.1..... Energy performance of buildings. 99

5.4.2..... Energy efficiency of products. 101

5.4.3..... Energy end-use efficiency and energy services. 103

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. 113

5.5.4..... Sector summary. 113

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. 116

6.1.4..... Evaluation results. 116

6.1.5..... Sector summary. 116

6.2........ Inland Waterway Transport 117

6.2.1..... Current position. 117

6.2.2..... Evaluation of the current position. 118

6.2.3..... Evaluation results. 118

6.2.4..... Sector summary. 119

6.3........ Maritime Transport - Internal market 119

6.3.1..... Current position. 119

6.3.2..... Evaluation of the current position. 120

6.3.3..... Evaluation results. 120

6.3.4..... Sector summary. 120

6.4........ Maritime Safety. 121

6.4.1..... Current position. 121

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

6.4.3..... Evaluation results. 124

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. 127

6.5.4..... Sector summary. 127

6.6........ Inland Transport 128

6.6.1..... Current position. 128

6.6.2..... Evaluation. 131

6.6.3..... Evaluation results. 133

6.6.4..... Sector summary. 135

6.7........ Sector: Air Transport 136

6.7.1..... Current position. 136

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

6.7.3..... Evaluation results. 146

6.7.4..... Sector summary. 149

7........... CLIMATE ACTION.. 150

7.1........ Emission Trading Scheme (ETS Directive) 150

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

7.1.2..... Evaluation based on the current situation. 155

7.1.3..... Perspectives. 156

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

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. 161

7.3.1..... Introduction. 161

7.3.2..... Report of work done in 2010. 161

7.4........ Transport related emissions. 162

7.4.1..... Introduction. 162

7.4.2..... Report of work done in 2010. 163

7.5........ Other climate related legislation. 165

7.5.1..... Carbon Capture and Storage (CCS) 165

7.5.2..... EU Effort Sharing Decision (ESD) 166

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

8........... ENVIRONMENT.. 167

8.1........ Nature Conservation. 167

8.1.1..... Current position. 167

8.1.2..... Evaluation based on the current situation. 171

8.1.3..... Evaluation results. 171

8.1.4..... Sector summary. 173

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

8.2.1..... Current position. 174

8.2.2..... Evaluation based on the current situation. 183

8.2.3..... Evaluation results. 184

8.2.4..... Sector summary. 185

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. 191

8.3.3..... Evaluation results. 192

8.3.4..... Sector summary. 193

8.4........ Protecting Water and Marine Resources. 193

8.4.1..... Current position. 193

8.4.2..... Evaluation based on the current situation. 200

8.4.3..... Evaluation results. 202

8.4.4..... Sector summary. 204

8.5........ Air quality and environmental noise. 205

8.5.1..... Current position. 205

8.5.2..... Evaluation based on the current situation. 208

8.5.3..... Evaluation results. 209

8.5.4..... Sector summary. 210

8.6........ Industrial installations. 211

8.6.1..... Current position. 211

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

8.6.3..... Evaluation results. 215

8.6.4..... Sector summary. 217

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

8.7.1..... Current position. 217

8.7.2..... Evaluation based on the current situation. 223

8.7.3..... Evaluation results. 224

8.7.4..... Sector summary. 226

8.8........ Governance. 227

8.8.1..... Current position. 227

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

8.8.3..... Evaluation results. 232

8.8.4..... Sector summary. 234

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

8.9.1..... Current position. 234

8.9.2..... Evaluation based on the current situation. 236

8.9.3..... Evaluation results. 237

8.9.4..... Sector summary. 237

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

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

9.2........ Electronic communications. 238

9.2.1..... Current position. 238

9.2.2..... Evaluation based on the current situation. 245

9.2.3..... Evaluation results: priorities and planned action (2011 and beyond) 245

9.3........ The Audiovisual and Media. 246

9.3.1..... Current position. 246

9.3.2..... Evaluation based on the current situation. 248

9.3.3..... Evaluation results: priorities and planned action (2011 and beyond) 248

9.4........ Public Sector Information. 248

9.4.1..... Current Position. 248

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

9.4.3..... Evaluation results. 250

9.4.4..... Sector summary. 250

9.5........ Electronic Signatures. 251

9.5.1..... Current Position. 251

9.5.2..... Evaluation based on the current situation. 252

9.5.3..... Evaluation results: priorities and planned action (2011 and beyond) 252

10......... MARITIME AFFAIRS AND FISHERIES. 252

10.1...... General introduction. 252

10.2...... Report of work done in 2010. 253

10.3...... Evaluation based on the current situation. 254

10.4...... Evaluation results. 255

10.4.1... Priorities. 255

10.4.2... Planned action (for 2011 and beyond) 255

10.5...... Summary. 256

11......... INTERNAL MARKET AND SERVICES. 256

11.1...... Freedom to provide services and freedom of establishment (other than financial services) 256

11.2...... Financial Services. 270

11.2.1... Banking. 270

11.2.2... Insurance and occupational pensions. 272

11.2.3... Securities. 275

11.2.4... Asset management 280

11.2.5... Payments and retail financial services. 283

11.3...... Free movement of capital (Articles 63 et seq. TFEU) 286

11.4...... Public procurement 291

11.5...... Professional qualifications. 296

11.6...... Company law, corporate governance and anti-money laundering. 300

11.7...... Auditing – statutory audits. 304

11.8...... Accounting. 307

11.9...... Protection of rights. 308

12......... REGIONAL POLICY.. 311

12.1...... Current situation. 311

12.1.1... General introduction. 311

12.1.2... Report of work done in 2010. 313

12.2...... Evaluation based on the current situation. 315

12.2.1... Assessment of the current situation (satisfactory or problematic nature of the current situation) 315

12.2.2... Importance of the impact of the identified problems on the objectives of the acquis. 316

12.2.3... Underlying reasons for problematic areas. 316

12.2.4... Responsibility for the problems and their correction. 316

12.2.5... Corrective action required (priority character, timing and scale) 317

12.3...... Evaluation results. 317

12.3.1... Priorities. 317

12.3.2... Planned action (2011 and beyond) 317

13......... TAXATION and CUSTOMS UNION.. 319

13.1...... Situation in the sector of CUSTOMS. 319

13.1.1... Current position. 319

13.1.2... Evaluation based on the current situation. 320

13.1.3... Evaluation results. 321

13.1.4... Sector summary. 321

13.2...... Situation in the sector of INDIRECT TAXATION.. 321

13.2.1... Current position. 321

13.2.2... Evaluation based on the current situation. 331

13.2.3... Evaluation results. 332

13.2.4... Sector summary. 333

13.3...... Situation in the sector of DIRECT TAXATION.. 333

13.3.1... Current position. 333

13.3.2... Evaluation based on current situation. 337

13.3.3... Evaluation results. 337

13.3.4... Sector summary. 339

14......... EDUCATION AND CULTURE.. 339

14.1...... Current position. 339

14.1.1... General introduction. 339

14.1.2... Report of work done in 2010. 344

14.2...... Evaluation based on the current situation. 345

14.2.1... Education and training. 345

14.2.2... Sport 345

14.3...... Evaluation results. 346

14.3.1... Priorities. 346

14.3.2... Planned action (2011 and beyond) 346

15......... HEALTH AND CONSUMERS. 347

15.1...... Introduction. 347

15.2...... Public health. 348

15.2.1... Blood and tissues. 348

15.2.2... Tobacco. 350

15.2.3... Pharmaceuticals. 351

15.2.4... Medical devices. 353

15.3...... Consumers. 358

15.3.1... Report of work done in 2010. 358

15.3.2... Evaluation, Priorities & Perspectives. 365

15.3.3... Summary of the Consumer activities' field. 366

15.4...... Food safety and animal health and welfare. 367

15.4.1... General Introduction. 367

15.4.2... Enforcement of the rules applicable to the food chain. 369

15.4.3... GMO Food and Feed. 370

15.4.4... Transmissible spongiform encephalopathies. 377

15.4.5... Food additives. 377

15.4.6... Food enzymes. 379

15.4.7... Food flavourings. 381

15.4.8... Residues of veterinary medicinal products. 383

15.4.9... Contaminants in food. 385

15.4.10. Plant Protection Products – Pesticide Residues. 388

15.4.11. Extraction Solvents. 391

15.4.12. Food Labelling. 391

15.4.13. Nutrition and Health Claims. 394

15.4.14. Dietetic foods. 396

15.4.15. Novel foods. 399

15.4.16. Food contact materials. 401

15.4.17. Plant Health. 404

15.4.18. Plant reproductive material – Plant Variety Rights – Plant Genetic Resources. 406

15.4.19. Animal Health – including non food-borne zoonotic diseases. 408

15.4.20. Zootechnics. 412

15.4.21. Animal by-products. 413

15.4.22. Feed. 414

15.4.23. Import controls on live animals and food from animal origin. 418

15.4.24. Animal welfare. 420

15.5...... Overall evaluation. 425

15.5.1... Better application of the health and consumer acquis is everyone's concern. 425

15.5.2... Prevention. 426

15.5.3... Regular review of legislation. 427

15.5.4... Audits, Inspections and market surveillance. 428

16......... HOME AFFAIRS. 429

16.1...... Immigration and integration. 429

16.1.1... Current position: General introduction. 429

16.1.2... Current position: Report on work done in 2010. 430

16.1.3... Evaluation based on the current situation. 431

16.1.4... Evaluation results: Priorities. 432

16.1.5... Evaluation results: Planned action (2011 and beyond) 432

16.1.6... Summary. 433

16.2...... Asylum.. 433

16.2.1... Current position: General introduction. 433

16.2.2... Current position: Report on work done in 2010. 434

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

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

16.2.5... Summary. 436

16.3...... European visa policy. 436

16.3.1... Current situation: Report on work done in 2010. 436

16.3.2... Evaluation based on the current situation. 436

16.3.3... Evaluation results: Priorities and planned action (2011 and beyond) 437

16.4...... Document Security (European passport and residence permits) 437

16.4.1... Current situation: Report on work done in 2010. 437

16.4.2... Evaluation results: Priorities and planned action (2011 and beyond) 437

16.5...... Border management and return policy. 438

16.5.1... Current position: General introduction. 438

16.5.2... Current position: Report on work done in 2010. 438

16.5.3... Evaluation based on the current situation. 439

16.5.4... Evaluation results: Priorities. 440

16.5.5... Evaluation results: Planned action (2011 and beyond) 440

16.6...... Security. 441

16.6.1... Data Retention Directive. 441

16.6.2... European Programme for Critical Infrastructure Protection. 442

16.6.3... Directive on preventing and combating trafficking in human beings, and protecting victims, replacing Framework Decision 2002/629/JHA.. 443

16.6.4... Third pillar instruments. 443

17......... JUSTICE.. 445

17.1...... Free movement of persons. 445

17.1.1... Current Position. 445

17.1.2... Evaluation based on the current situation. 446

17.1.3... Evaluation results. 447

17.1.4... Summary. 448

17.2...... Citizenship. 448

17.2.1... Current position. 448

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

17.2.3... Evaluation results. 449

17.2.4... Summary. 450

17.3...... Fundamental rights. 450

17.3.1... Current Position. 450

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

17.3.3... Evaluation results. 452

17.3.4... Summary. 452

17.4...... Protection of personal data. 452

17.4.1... Current position. 452

17.4.2... Evaluation based on the current situation. 453

17.4.3... Evaluation results. 453

17.4.4... Summary. 454

17.5...... Judicial cooperation in civil matters. 454

17.5.1... Current position. 454

17.5.2... Evaluation based on the current situation. 456

17.5.3... Evaluation results. 458

17.5.4... Summary. 458

17.6...... Consumer and marketing law.. 459

17.6.1... Current position. 459

17.6.2... Evaluation based on the current situation. 462

17.6.3... Evaluation results. 463

17.6.4... Summary. 464

17.7...... Judicial cooperation in criminal matters. 464

17.7.1... Current position. 464

17.7.2... Evaluation based on the current situation. 466

17.7.3... Evaluation results. 466

17.7.4... Summary. 467

17.8...... Antidiscrimination and gender equality. 468

17.8.1... Current position. 468

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

17.8.3... Evaluation results. 471

17.8.4... Summary. 472

18......... TRADE.. 472

19......... ENLARGEMENT.. 473

19.1...... Current position – Most important legal instruments and related work and reporting on 2010 473

19.2...... Evaluation based on the current situation. 473

19.3...... Evaluation results. 474

19.4...... Summary. 474

20......... EUROSTAT.. 474

20.1...... General introduction. 474

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

21......... HUMAN RESOURCES and SECURITY.. 475

21.1...... Current position – Most important legal instruments and related work and reporting on 2010 475

21.1.1... General introduction. 475

21.1.2... Report of work done in 2010. 476

21.2...... Evaluation based on the current situation. 476

21.3...... Evaluation results. 477

21.3.1... Priorities. 477

21.3.2... Planned action. 477

22......... BUDGET.. 477

22.1...... Current situation. 477

22.1.1... General introduction. 477

22.1.2... Report of work done in 2010. 478

22.2...... Evaluation. 478

22.3...... Evaluation results. 478

22.4...... Summary. 479

23......... Annex I - List of measures in force and other relevant instruments referred to in the text of the document 479

I............ ENTERPRISE AND INDUSTRY.. 479

I.1......... REACH.. 479

I.2 Classification, labelling and packaging: 479

I.3 Pyrotechnic Articles and Explosives. 479

I.4 Drug precursors. 479

I.5 Detergents. 480

I.6 Fertilisers. 480

I.7 Textiles/clothing, footwear and wood. 480

I.8 Non-harmonised area. 480

II.......... EMPLOYMENT, SOCIAL AFFAIRS AND INCLUSION.. 480

II.1....... Free movement of workers and coordination of social security schemes. 481

II.1.1..... Free movement of workers. 481

II.1.2..... Social Security. 481

II.2....... Labour Law.. 482

II.2.1..... Working conditions. 482

II.2.2..... Information and consultation of workers. 482

II.2.3..... Protection of workers. 483

II.3........ Health and safety at work. 484

III ........ ENERGY.. 486

III.1....... Legislation in force. 486

III.2....... Legislation adopted in 2010. 488

III.3....... New measures proposed or in preparation in 2010. 490

IV ........ MOBILITY and TRANSPORT.. 491

V........... TAXATION and CUSTOMS UNION.. 492

V.1 ....... Situation in the sector of CUSTOMS. 492

V.2 ....... INDIRECT TAXATION.. 493

V.3........ DIRECT TAXATION.. 495

VI......... EDUCATION AND CULTURE.. 496

VII........ HEALTH AND CONSUMERS. 496

VII.1..... Public Health. 496

VII.2..... Consumers. 499

VII.3..... Food Safety. 501

GMO.. .. 501

FOOD HYGIENE.. 503

FOOD.. .. 505

PLANT HEALTH.. 510

SEEDS – PLANT VARIETY. 511

ANIMAL HEALTH.. 515

FEED.. .. 519

ANIMAL WELFARE.. 521

VIII...... BUDGET.. 521

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 equipment (R&TTE) Directive) and as part of an alignment package involving ten new approach directives[1].

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

§ 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 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

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 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;

o 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

o 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

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 2010[3] 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 2010[4]. 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 vehicles[5] and two Regulations, one amending several Annexes to Framework Directive 2007/46/EC[6] and the other on type-approval of hydrogen-powered motor vehicles[7]. 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 systems[9]. Then, in November, the Commission adopted four more regulations implementing the GSR, concerning rear registration plates[10], towing devices[11], windscreen washers and wipers[12] and wheel guards[13]. Later, two 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 Regulations[14] – 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 2010[15]. 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 2010[16] and a proposal for a Directive on emission from narrow tractors was finalised at the end of 2010[17].

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 authorities[18] – 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 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 2010[19]. 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 2010[20]. 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 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 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

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 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.

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 amendments to Annex XVII relating to restrictions of the following substances: dimethylfumarate, mercury in measuring devices, phenylmercury compounds and lead in jewellery.

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 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

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 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 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

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 precursors[21]. 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

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

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 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 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 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.

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).

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.

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 issues in 2010. Most infringement proceedings concerned the non-communication of national transposition measures.

Directive 2008/47/EC of 8 April 2008[22], 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) 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.

(b) 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.

(c) 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

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 2007[23] 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/EEC[24], 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. 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 transposition measures were closed following communication of the measures. 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 Directives[25] 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 the absence of an up-to-date 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.

(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. Following up notifications of transposition measures for Directive 2009/137/EC and launching infringement proceedings where such measures have not been 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, 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(20