Overview of the food chain system and the European regulatory framework in the fields of food safety and nutrition.
Date: 2016-10-21
Institutions: Joint Research Centre
Subjects: animal feedingstuffs, cancer, cardiovascular disease, chronic illness, food industry, food safety, foodstuffs legislation, human nutrition, public health, research report, safety standard

Overview of the food chain system 
and the European regulatory 
framework in the fields of food safety 
and nutrition  

Kalliopi Mylona, Anastasia Livaniou, Petros Maragkoudakis, 
Anne-Katrin Bock, Jan Wollgast, Sandra Caldeira, Franz Ulberth 

2016  

2016  

EUR 28033 EN  

 
 
 
 
 
 
This publication is a Technical report by the Joint Research Centre (JRC), the European Commission’s science and 
knowledge service. It aims to provide evidence-based scientific support to the European policy-making process. 
The scientific output expressed does not imply a policy position of the European Commission. Neither the 
European Commission nor any person acting on behalf of the Commission is responsible for the use which might 
be made of this publication. 

Contact information 
Name: Franz Ulberth 
Address: Retieseweg 111, 2440 Geel, Belgium 
E-mail: Franz.ULBERTH@ec.europa.eu 
Tel.: 0032 1457-1316 

JRC Science Hub 
https://ec.europa.eu/jrc 

JRC102464 

EUR 28033 EN 

PDF 

ISBN 978-92-79-60536-9 

ISSN 1831-9424 

doi:10.2787/410688 

Luxembourg: Publications Office of the European Union, 2016 

© European Union, 2016 

Reproduction is authorised provided the source is acknowledged. 

How to cite: Mylona K., Livaniou A., Maragkoudakis P., Bock A.-K., Wollgast J., Caldeira S. and Ulberth F.; 
Overview of the food chain system and the European regulatory framework in the fields of food safety and 
nutrition. EUR 28033 EN. Publications Office of the European Union, Luxembourg, 2016, ISBN 978-92-79-60536-9, 
doi:10.2787/410688. 

All images © European Union 2016, except: cover, © ggw, #48611340, Source: fotolia.com 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 

List of Tables ................................................................................................... 8 

List of Figures .................................................................................................. 9 

Abstract ........................................................................................................ 12 

1. 

Introduction ............................................................................................ 13 

The food chain and the associated food safety and nutrition legislation........... 13 

Methodology ........................................................................................... 14 

2.  Food chain overarching legislation ............................................................. 16 

2.1.  Background information ................................................................... 16 

2.1.1.  Treaty of the Functioning of the European Union ..................... 16 

2.1.2.  White Paper on food safety ................................................... 16 

2.2.  General food law ............................................................................. 18 

2.2.1.  Regulation  (EC)  No  178/2002  laying  down  the  general 
principles  and  requirements  of  food  law,  establishing  the 
European Food Safety Authority and laying down procedures in 
matters of food safety .......................................................... 18 

2.3.  Official controls ............................................................................... 21 

2.3.1.  Regulation (EC) No 882/2004 on official controls performed to 
ensure  compliance  with  feed  and  food  law,  animal  health  and 
animal welfare rules ............................................................. 21 

3.  Legislation related to the inputs to food chain system .................................. 26 

3.1.  Fertilisers ....................................................................................... 26 

3.1.1.  Synthetic  fertilisers  –  Regulation  (EC)  No  2003/2003  of  the 

European Parliament and of the Council relating to fertilisers .... 26 

3.1.2.  Organic  fertilisers  –  Regulation  (EC)  No  1069/2009  of  the 
European  Parliament  and  of  the  Council  laying  down  health 
rules  as  regards  animal  by-products  and  derived  products  not 
intended for human consumption........................................... 28 

3.2.  Pesticides and plant protection products ............................................. 31 

3.2.1.  Regulation (EC) No 1107/2009 concerning the placing of  plant 
protection  products  on  the  market  and  repealing  Council 
Directives 91/414/EEC and 79/117/EEC ................................. 31 

3.2.2.  Directive  2009/128/EC  establishing  a 

framework 

for 

Community action to achieve the sustainable use of pesticides .. 33 

3.2.3.  Regulation  (EC)  No  396/2005  on  maximum  residue  levels 
(MRLs) of pesticides in or on food and feed of plant and animal 
origin 

34 

3.3.  Radioactive contamination of food and feed ........................................ 38 

3.3.1.  Council  Regulation  (Euratom)  3954/87  laying  down  maximum 
permitted levels of radioactive contamination of foodstuffs and 
of feedingstuffs following a nuclear accident or any other case 
of radiological emergency ..................................................... 38 

3.3.2.  Council  Regulation  (Euratom)  944/89  laying  down  maximum 
permitted 
in  minor 
levels  of  radioactive  contamination 
foodstuffs  following  a  nuclear  accident  or  any  other  case  of 
radiological emergency ......................................................... 38 

2 

 
 
 
3.3.3.  Council  Regulation  (EURATOM)  770/90  laying down  maximum 
permitted  levels  of  radioactive  contamination  of  feedingstuffs 
following  a  nuclear  accident  or  any  other  case  of  radiological 
emergency ......................................................................... 38 

4.  Legislation related to primary production .................................................... 40 

4.1.  Genetically modified organisms ......................................................... 40 

4.1.1.  Directive  2001/18/EC  on  the  deliberate  release  into  the 

environment of genetically modified organisms ....................... 40 

4.1.2.  Regulation  (EC)  No  1829/2003  on  genetically  modified  food 

and feed 43 

4.1.3.  Regulation (EC) No 1830/2003 on the traceability and labelling 
of  GMOs  and  the  traceability  of  food  and  feed  products 
produced from GMOs and amending Directive 2001/18/EC ....... 44 

4.1.4.  Cartagena Protocol on Biosafety ............................................ 45 

4.2.  Veterinary drug residues .................................................................. 48 

4.2.1.  Directive  2001/82/EC  on  the  Community  code  relating  to 

veterinary medicinal products ............................................... 48 

4.2.2.  Regulation  (EC)  No  470/2009 

laying  down  Community 
limits  of 
procedures 
pharmacologically  active  substances  in  foodstuffs  of  animal 
origin (repealing Regulation (EEC) No 2377/90) ...................... 50 

the  establishment  of  residue 

for 

4.2.3.  Directive 96/23/EC on measures to monitor certain substances 

and residues thereof in live animals and animal products .......... 52 

4.2.4.  Council  Directive  96/22/EC  concerning  the  prohibition  on  the 
use  in  stock-farming  of  certain  active  substances  having  a 
hormonal or thyrostatic action and of beta-agonists ................. 55 

5.  Legislation related to the harvesting / slaughtering / fishing step of the food 

chain ..................................................................................................... 58 

5.1.  Legislation on the hygiene of foodstuffs ............................................. 58 

5.1.1.  Regulation (EC) No 852/2004 of the  European  Parliament and 

of the Council on the hygiene of foodstuffs ............................. 58 

5.1.2.  Regulation (EC) No 853/2004 of the  European  Parliament and 
of  the  Council  laying  down  specific  hygiene  rules  for  food  of 
animal origin ....................................................................... 60 

5.1.3.  Regulation (EC) No 854/2004 of the  European  Parliament and 
of the Council laying down specific rules for the organisation of 
official  controls  on  products  of  animal  origin  intended  for 
human consumption ............................................................ 62 

5.2.  Animal  health  rules  for  the  production,  processing,  distribution  and 

introduction of products of animal origin for human consumption .......... 65 

5.2.1.  Council Directive 2002/99/EC – products of animal origin ......... 65 

5.3.  Commission  Regulation  (EC)  No  2073/2005  on  microbiological  criteria 

for foodstuffs .................................................................................. 66 

5.4.  Regulation (EC) No 2160/2003 on the control of Salmonella and other 

specified food-borne zoonotic agents ................................................. 69 

5.5.  Directive 2003/99/EC of the European Parliament and of the Council on 

the monitoring of zoonoses and zoonotic agents ................................. 71 

6.  Legislation related to the manufacturing step of the food chain ..................... 74 

6.1.  Food improvement agents ................................................................ 74 

3 

 
 
 
6.1.1.  Regulation  (EC)  No  1331/2008  on  a  common  authorisation 

procedure for food additives, enzymes and flavourings ............. 74 

6.1.2.  Regulation (EC) No 1333/2008 on food additives ..................... 74 

6.1.3.  Regulation (EC) No 1332/2008 on food enzymes ..................... 76 

6.1.4.  Regulation (EC) No 1334/2008 on food flavourings .................. 76 

6.1.5.  Regulation (EC) No 2065/2003 on smoke flavourings ............... 79 

6.1.6.  Directive  2009/32/EC  on  extraction  solvents  used  in  the 

production of foods and food ingredients ................................ 80 

6.2.  Contaminants ................................................................................. 82 

6.2.1.  Council  Regulation  (EEC)  No  315/93  laying  down  Community 

procedures for contaminants in food ...................................... 82 

6.2.2.  Commission  Regulation  (EC)  No  1881/2006  setting  maximum 

levels for certain contaminants in foodstuffs ............................ 83 

6.3.  Food and food ingredients treated with ionising radiation ..................... 86 

6.3.1.  Directive  1999/2/EC  of  the  European  Parliament  and  of  the 
Council on the approximation of the laws of the Member States 
concerning  foods  and  food  ingredients  treated  with  ionising 
radiation 86 

6.4.  Novel foods and novel food ingredients .............................................. 88 

6.4.1.  Regulation  (EC)  No  258/97  concerning  novel  foods  and  novel 

food ingredients .................................................................. 88 

7.  Legislation related to the packaging step of the food chain ........................... 90 

7.1.  Packaging materials and materials in contact with food ........................ 90 

7.1.1.  Regulation (EC) No 1935/2004 of the European Parliament and 
of the Council on materials and articles intended to come into 
contact with food ................................................................. 90 

7.1.2.  Council  Directive  82/711/EEC  laying  down  the  basic  rules 
necessary  for  testing  migration  of  the  constituents  of  plastic 
materials  and  articles  intended  to  come  into  contact  with 
foodstuffs ........................................................................... 91 

8.  Legislation related to placing foods on the market ....................................... 94 

8.1.  Food Information to Consumers ........................................................ 94 

8.1.1.  Directive  2000/13/EC  of  the  European  Parliament  and  of  the 
Council of 20 March 2000 on the approximation of the laws of 
the  Member  States  relating  to  the  labelling,  presentation  and 
advertising of foodstuffs ....................................................... 94 

8.1.2.  The  New  Framework  Regulation:  Regulation 

(EU)  No 
1169/2011  of  the  European  Parliament  and  of  the  Council  of 
25  October  2011  on  the  provision  of  food  information  to 
consumers .......................................................................... 95 

8.1.3.  Council  Directive  90/496/EEC  of  24  September  1990  on 

nutrition labelling for foodstuffs ............................................. 98 

8.2.  Nutrition and Health Claims .............................................................. 99 

8.2.1.  Regulation  (EC)  No  1924/2006  on  nutrition  and  health  claims 

made on food ...................................................................... 99 

8.3.  Food for specific groups (FSG) ........................................................ 101 

8.3.1.  Directive  2009/39/EC  of  the  European  Parliament  and  of  the 

Council on foodstuffs intended for particular nutritional uses ... 101 

4 

 
 
 
8.4.  Regulation  (EU)  No  609/2013  on  food  intended  for  infants  and  young 
children, food for special medical purposes, and total diet replacement 
for weight control .......................................................................... 103 

8.5.  Further relevant nutrition policies .................................................... 105 

8.5.1.  EU Platform on Diet, Physical Activity and Health ................... 105 

8.5.2.  White  Paper  on  "A  strategy 

for  Europe  on  Nutrition, 

Overweight and Obesity Related Health Issues" ..................... 105 

8.5.3.  High Level Group on Nutrition and Physical Activity ................ 107 

8.5.4.  School Fruit and Milk Schemes ............................................ 107 
8.5.5.  3rd EU health programme (2014-2020) ................................. 108 
8.5.6.  EU Action Plan on Childhood Obesity .................................... 109 

8.5.7.  Dietary Reference Values (DRVs) ......................................... 109 

9. 

Implementation of EU legislation in the Member States .............................. 111 

9.1.  Responsibilities ............................................................................. 111 

9.2.  Competent authorities and official food control .................................. 112 

9.3.  International and EU level organisations ........................................... 113 

10.  Other food policies ................................................................................. 114 

10.1. Global food safety and nutrition governance ..................................... 114 

10.2. EU  food  safety  information  exchange  networks  and  early  warning 

systems99 ..................................................................................... 118 
10.3. Better Training for Safer Food ......................................................... 119 

10.4. Resource efficiency and food waste ................................................. 120 

10.5. EU agricultural quality product policy – Single CMO and Green Paper ... 121 

10.5.1.  Single CMO and Green Paper............................................... 121 

10.5.2.  EU agricultural quality product policy – Quality scheme .......... 121 

10.5.3.  EU  agricultural  quality  product  policy  –  Organic  farming  and 

products  122 

10.5.4.  EU  agricultural  quality  product  policy  –  Food  Quality 

Certification schemes ......................................................... 123 

10.6. Common Agricultural Policy (CAP) ................................................... 124 

10.7. Common Fisheries Policy (CFP) ....................................................... 127 

10.8. Audio-visual Media Services ............................................................ 128 

10.9. Transatlantic Trade and Investment Partnership (TTIP) ...................... 129 

Annex  I:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

178/2002 and their respective requirements ............................................. 131 

Annex  II:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

882/2004 and their respective requirements ............................................. 137 

Annex  III:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

2003/2003 and their respective requirements ........................................... 145 

Annex  IV:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

1069/2009 and their respective requirements ........................................... 147 

Annex  V:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

1107/2009 and their respective requirements ........................................... 149 

Annex  VI:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

396/2005 and their respective requirements ............................................. 153 

5 

 
 
 
Annex  VII:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

3954/87 and their respective requirements ............................................... 155 

Annex  VIII:  Additional  implementing  measures  for  selected  Articles  of  Directive 

2001/18/EC and their respective requirements .......................................... 156 

Annex  IX:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

1829/2003 and their respective requirements ........................................... 163 

Annex  X:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

1830/2003 and their respective requirements ........................................... 170 

Annex  XI:  Additional  implementing  measures  for  selected  Articles  of  Directive 

2001/82/EC and their respective requirements .......................................... 171 

Annex  XII:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

470/2009 and their respective requirements ............................................. 176 

Annex  XIII:  Additional  implementing  measures  for  selected  Articles  of  Directive 

96/23/EC and their respective requirements ............................................. 178 

Annex  XIV:  Additional  implementing  measures  for  selected  Articles  of  Directive 

96/22/EC and their respective requirements ............................................. 183 

Annex  XV:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

852/2004 and their respective requirements ............................................. 185 

Annex XVI: Additional implementing measures for selected Articles of Regulation 

853/2004 and their respective requirements ............................................. 189 

Annex XVII: Additional implementing measures for selected Articles of Regulation 

854/2004 and their respective requirements ............................................. 197 

Annex  XVIII:  Legislation  implemented  under  Directive  2002/99/EC  and  in 
particular Articles 8 and 9 on lists of approved third countries, special import 
conditions and certification documents ..................................................... 201 

Annex XIX: Additional implementing measures for selected Articles of Regulation 

2073/2005 and their respective requirements ........................................... 203 

Annex  XX:  Additional  implementing  measures  for  selected  Articles  of  Regulation 

2160/2003 and their respective requirements ........................................... 205 

Annex  XXI:  Additional  implementing  measures  for  selected  Articles  of  Directive 

2003/99/EC and their respective requirements .......................................... 208 

Annex XXII: Additional implementing measures for selected Articles of Regulation 

1333/2008 and their respective requirements ........................................... 211 

Annex  XXIII:  Additional  implementing  measures 

for  selected  Articles  of 

Regulation 1332/2008 and their respective requirements ........................... 214 

Annex XXIV: Additional implementing measures for selected Articles of Regulation 

1334/2008 and their respective requirements ........................................... 216 

Annex XXV: Additional implementing measures for selected Articles of Regulation 

2065/2003 and their respective requirements ........................................... 218 

Annex  XXVI:  Additional 

implementing  measures 

for  selected  Articles  of 

Regulations 315/93 and 1881/2006 and their respective requirements ......... 219 

Part I: Regulation 315/93 ....................................................................... 219 

Part II: Regulation 1881/2006 ................................................................ 219 

Annex XXVII: Additional implementing measures for selected Articles of Directive 

1999/2/EC and their respective requirements ........................................... 222 

6 

 
 
 
Annex  XXVIII:  Additional  implementing  measures  for  selected  Articles  of 

Regulation (EC) No 258/97 and their respective requirements ..................... 223 

Annex XXIX: Additional implementing measures for selected Articles of Regulation 

1935/2004 and their respective requirements ........................................... 224 

Annex  XXX:  Additional  implementing  measures  for  selected  Articles  of  Directive 

82/711/EEC and their respective requirements .......................................... 229 

Annex  XXXI:  Additional  implementing  measures  for  selected  Articles  of  Directive 

2000/13/EC and their respective requirements .......................................... 230 

Annex  XXXII:  Additional  implementing  measures  for  selected  Articles  of 

Regulation (EU) No 1169/2011 and their respective requirements ............... 240 

Annex XXXIII: Additional implementing measures for selected Articles of Directive 

90/496/EEC and their respective requirements .......................................... 242 

Annex  XXXIV:  Additional  implementing  measures  for  selected  Articles  of 

Regulation (EC) No 1924/2006 and their respective requirements ............... 244 

Annex  XXXV:  Additional  legislation  related  to  selected  Articles  of  Directive 

2009/39/EC and respective requirements ................................................. 246 

7 

 
 
 
 
 
 
 
List of Tables 

Table 1: Implementing Regulations and Implementing Decisions establishing emergency 
measures for the import of products from third countries under Article 53 of Reg (EC) No 
178/2002 ......................................................................................................... 134 
Table  2:  examples  of  Commission  Decisions  implementing  provisions  for  protection 
measures or for emergency vaccination against certain diseases in the different Member 
States .............................................................................................................. 175 

8 

 
 
 
 
 
 
 
 
 
List of Figures 

Figure 1: Overview of the food chain with the major food safety and nutrition legislation 
fields ................................................................................................................. 15 
Figure 2: Main provisions of the general food law (Regulation (EC) No 178/2002) ....... 19 
Figure 3: Overview of certain provisions of the general food law (Reg. (EC) No 
178/2002) and cross-links with additional implementing documents .......................... 20 
Figure 4: Summary of the provisions of Regulation (EC) No 882/2004 on official controls 
for verification of compliance with food and feed law, animal health and animal welfare.
......................................................................................................................... 22 
Figure 5: Summary of the most important legal documents in the field of official controls 
for verification of compliance with food and feed law, animal health and animal welfare.
......................................................................................................................... 25 
Figure 6: Main requirements of Regulation (EC) No 2003/2003 ................................. 27 
Figure 7: Legislative acts in the field of fertilisers .................................................... 28 
Figure 8: Main requirements of Regulation (EC) No 1069/2009 ................................. 29 
Figure 9: Legislative acts in the field of organic fertilisers ......................................... 30 
Figure 10: Summary of the main requirements of Regulation (EC) No 1107/2009 ....... 32 
Figure 11: Summary of the main provisions of Directive 2009/128/EC ....................... 34 
Figure 12: Summary of the main provisions of Regulation (EC) No 396/2005.............. 36 
Figure 13: Summary of the legal acts related to the placement of plant protection 
products on the market and the establishment of maximum residue levels of pesticides 
in food ............................................................................................................... 37 
Figure 14: Summary of legislation in the field of radioactive contamination of food and 
feed .................................................................................................................. 39 
Figure 15: Main requirements of Directive 2001/18/EC ............................................ 42 
Figure 16: Main requirements of Regulation (EC) No 1829/2003 ............................... 44 
Figure 17: Main requirements of Regulation (EC) No 1830/2003 ............................... 45 
Figure 18: Main legal documents in the field of GMOs, their deliberate release, 
traceability and labelling in food and feed ............................................................... 47 
Figure 19: Main provisions of Directive 2001/82/EC ................................................. 50 
Figure 20: Main provisions of Regulation (EC) No 470/2009...................................... 52 
Figure 21: Main provisions of Directive 96/23/EC .................................................... 54 
Figure 22: Main provisions of Directive 96/22/EC .................................................... 56 
Figure 23: Summary of legislation on veterinary medicinal products, their residues and 
prohibition of use of certain substances in stock farming .......................................... 57 
Figure 24: Main legislation related to the hygiene of foodstuffs ................................. 58 
Figure 25: Summary of the requirements of Regulation 852/2004 on the hygiene of 
foodstuffs ........................................................................................................... 59 
Figure 26: Summary of the requirements of Regulation (EC) No 853/2004 on the 
hygiene of food of animal origin ............................................................................ 61 
Figure 27: Summary of the requirements of Regulation (EC) No 854/2004 on the official 
controls for products of animal origin ..................................................................... 63 
Figure 28: Summary of the legal documents in the field of food hygiene with additional 
implementation legislation and their relationships ................................................... 64 
Figure 29: Summary of the provisions of Regulation (EC) No 2073/2005 on 
microbiological criteria for foodstuffs ..................................................................... 68 
Figure 30: Summary of the provisions of Regulation (EC) No 2160/2003 on the control of 
Salmonella and other food-borne zoonotic agents ................................................... 70 

9 

 
 
 
 
Figure 31: Summary of the requirements of Directive 2003/99/EC on the monitoring of 
zoonoses and zoonotic agents ............................................................................... 72 
Figure 32: Summary of the most important legal documents in the field of 
microbiological criteria for foodstuffs, control of food-borne zoonotic agents and of 
monitoring of zoonoses, zoonotic agents and antimicrobial resistance and cross-links 
between this documents ...................................................................................... 73 
Figure 33: Summary of the requirements of Regulation (EC) No 1333/2008 on food 
additives ............................................................................................................ 75 
Figure 34: Summary of the provisions of Regulation (EC) No 1332/2008 on food 
enzymes ............................................................................................................ 76 
Figure 35: Summary of the provisions of Regulation (EC) No 1334/2008 on flavourings 
and food ingredients with flavouring properties ....................................................... 78 
Figure 36: Summary of the provisions of Regulation (EC) No 2065/2003 on smoke 
flavourings used or intended to be used in or on food .............................................. 79 
Figure 37: Summary of the provisions of Directive 2009/32/EC on extraction solvents for 
the production of food and food ingredients. ........................................................... 80 
Figure 38: Summary of the most important legal documents in the field of food 
additives, food enzymes and food flavourings ......................................................... 81 
Figure 39: Summary of the requirements of Regulation (EEC) No 315/93 on Community 
procedures for contaminants in food ...................................................................... 82 
Figure 40: Summary of the requirements of Regulation 1881/2006 on maximum levels 
for certain contaminants in foodstuffs .................................................................... 84 
Figure 41: Summary of the most important legal documents in the field of contaminants 
in foodstuffs. ...................................................................................................... 85 
Figure 42: Summary of legislative acts in the field of treatment of food and food 
ingredients with ionising radiation ......................................................................... 87 
Figure 43: Summary of the legislation on novel foods and cross interaction with other 
legal acts. Red arrows correspond to legislation referring and /or adding to the main 
novel foods legislation. Blue arrows correspond to legislation referred in the Novel Foods 
legislation .......................................................................................................... 89 
Figure 44: Main provisions of Regulation (EC) No 1935/2004 .................................... 91 
Figure 45: Main provisions of Directive 82/711/EEC ................................................. 92 
Figure 46: Summary of the legal documents in the field of materials and articles 
intended to come into contact with food ................................................................. 93 
Figure 47: Summary of the legislation on labelling, presentation and advertising of 
foodstuffs and cross interaction with other legal acts. .............................................. 95 
Figure 48 (a and b): Summary of the legislation on Food Information to Consumers (FIC) 
and cross interaction with other legal acts. Red arrows correspond to legislation referring 
and /or adding to the FIC legislation. Blue arrows correspond to legislation referred in 
the FIC legislation. .............................................................................................. 97 
Figure 49: Summary of the legislation on Nutrition and health claims and cross 
interaction with other legal acts. Red arrows correspond to legislation referring and /or 
adding to the Nutrition and Health Claims legislation. Blue arrows correspond to 
legislation referred in the Nutrition and Health Claims legislation. ............................ 100 
Figure 50: Summary of the legislation on Food for Specific Groups (FSG) and cross 
interaction with other legal acts. Red arrows correspond to legislation referring and /or 
adding to the FSG legislation. Blue arrows correspond to legislation referred in the FSG 
legislation. ....................................................................................................... 104 
Figure 51: An overview of actors at global, EU and national level ............................ 111 
Figure 52: An overview of actors at global, EU and national level ............................ 112 

10 

 
 
 
Abbreviations  

ALARA: as low as reasonably achievable 

AMR: antimicrobial resistance  

BSE: Bovine Spongiform Encephalopathy 

CEC: Commission of the European Communities  

Dec.: Decision 

EAFRD: European Agricultural Fund for Rural Development 

EAGGF: European Agricultural Guidance and Guarantee Fund 

EC: European Commission 

EMA: European Medicines Agency 

FIC: Food Information to Consumers 

FSG: Food for Specific Groups 

FVO: Food and Veterinary Office 

GAP: Good Agricultural Practice 

GM: Genetically Modified 

GPPP: Good Plant Protection Practice 

HACCP: Hazard Analysis and Critical Control Points 

MRL: Maximum Residue Level 

M.S.: Member States 

MSM: mechanically separated meat 

RASSF: Rapid Alert System for Food and Feed  

Reg.: Regulation 

SCFCAH: Standing Committee on Food Chain and Animal Health 

UHT: Ultra High Temperature 

UK: United Kingdom 

11 

 
 
 
 
 
 
Abstract  

To ensure the highest standards of food safety in the European Union and avoid barriers 
to internal trade, harmonised food legislation is implemented across all steps of the food 
and  feed  chain.  However,  recent  crises  have  revealed  certain  vulnerabilities  that  can 
compromise these high food safety standards. At the same time, public health measures 
must address malnutrition to protect the health and wellbeing of EU citizens from chronic 
diseases such as diabetes, cardiovascular disease or cancer. To preserve the functioning 
of  the  food  system  towards  the  production  of  safe  and  nutritious  food  for  healthy 
populations  also  in  the  future,  policy  must  be  able  to  respond  to  unforeseen  disruptive 
developments.  This  may  only  be  achieved  through  preparedness  and  through  proactive 
rather than reactive policy-making initiatives.  

The aim of this report is to provide an overview of the current food safety and nutrition 
regulatory and policy framework in Europe up to 2014, identifying all the documents that 
are necessary for the implementation of food legislation. The legal acts are presented in 
this report following the flow of raw materials and food products through a model of the 
food  chain.  The  main  legal  text(s)  in  each  step  of  this  chain  were  identified  and  briefly 
summarised.  All  legislation  that  is  directly  related  to  these  main  texts  and  provides 
additional implementation information was also identified and linked to the main texts in 
legislation maps. A detailed description of these legal acts in each field is included in the 
Annexes to the report.  

12 

 
 
 
 
 
1. Introduction 

The food chain and the associated food safety and nutrition 

legislation 

The  food  system  is  complex  and  broad.  The  food  chain  itself  is  often  defined  as  "from 
farm to table" or "from farm to fork", yet it encompasses much more than that. The food 
system is a dynamic system constantly influenced and shaped by several factors such as 
the  environment  and  the  climate,  the  global  political  and  socio-economic  situation,  the 
scientific  and  technological  developments  and  the  consumer  who  shapes  it  through  his 
demands  and  preferences.  The  consumer  is  highly  influenced  by  the  food  system,  food 
supply  and  food  access.  Food  and  dietary  choices  in  turn  are  the  basis  of  human 
nutrition, a key element in individual and population health.  

Food  is  essential  to  life  and  a  prime  channel  for  health.  Hence,  ensuring  the  highest 
standards of food safety is a key policy priority in the European Union (EU) as indicated 
in  the  White  Paper  on  food  safety1.  This  is  based  on  an  integrated  and  comprehensive 
approach  and  achieved  through  the  implementation  of  food  legislation  across  all  the 
steps of the food  and feed chain. Indeed, the  European approach  to food safety covers 
all  sectors:  primary  production,  food  processing,  packaging,  storage,  transport  and 
placing on the market.  This legislation is harmonised in the European Union in order to 
not  pose  barriers  to  internal  trade  within  the  Community.  Despite  the  regulatory 
framework  already  in  place  in  Europe,  recent  crises  have  brought  to  the  surface 
vulnerabilities that can compromise these high standards of food safety. Transparency at 
all levels of food safety policy and the interactions of different stakeholders is identified 
as  a  fundamental  principle  for  ensuring  the  highest  level  of  food  safety  and  for 
enhancing  consumer  confidence.  Food  safety  and  the  development  of  food  policies  are 
also strongly related to environmental policies. Also, new technological developments at 
different steps in the food chain may require new policy responses2.  

The provision of safe food, however, is not sufficient to ensure that food consumption is 
conducive of good health. Indeed, Europe arguably has  one of the safest food chains in 
the  world  but  it  struggles  with  one  of  the  highest  mortality  rates  caused  by  chronic 
diseases such as diabetes, cardiovascular disease or cancer. These are intimately linked 
to  poor  nutrition  and  physical  activity  habits.  Malnutrition  is  unfortunately  a  reality  on 
our continent and public health measures must address this as well – not only to protect 
health  and  wellbeing  of  our  citizens  but  also  because  the  financial  pressure  of  such 
diseases on our healthcare systems is unsustainable.  

The  food  and  drink  sector  (including  agriculture)  is  also  of  great  importance  to  the 
European economy. It employs approximately 1/5 of the European workforce and the EU 
is the biggest exporter and importer of food and drink worldwide.  

In  order  to  be  able  to  preserve  the  functioning  of  the  food  system  towards  the 
production of safe and quality food for healthy populations within a flourishing economy, 
policy must be able to respond to any developments, either slow and gradual or urgent 
and  fast-changing.  This  may  only  be  achieved  through  preparedness  and  through 
proactive rather than reactive policy-making initiatives.  

The aim of this report is to provide an overview of the current food safety and nutrition 
regulatory and policy framework in Europe in 2014. The report is set around a model of 
the  food  chain  as  described  in  Figure  1  (modified  from3).  The  food  chain  is  considered 
here  for  simplification  purposes  as  a  sequence  of  steps  starting  from  raw  materials, 

1 White paper on food safety COM(1999) 719 final 
2 Eurostat, 2011. Food: from farm to fork statistics (Pocketbook) 
3 Commission SWD (2013) 516 final, 'A fitness check of the food chain: State of play and next steps 

13 

 
 
 
 
                                                           
moving  onto  the  manufacturing  stage  and  ending  with  the  placement  of  finished  food 
products on the market and their consumption. This food chain can apply to all different 
food  categories,  however  simple  or  complex.  Figure  1  also  captures  the  major  food 
safety  and  nutrition  legislation  areas  depicted  along  the  food  chain  and  placed 
immediately prior to the step where they are perceived of more direct relevance.  

The  order  by  which  the  legal  acts  are  referred  to  in  this  report  also  follows  the  flow  of 
raw materials and food products through the food chain as represented in Figure 1. The 
legislative  framework  is  preceded  by  background  information  on  the  development  and 
aim  of  food  legislation  in  Europe  and  by  a  description  of  the  general  food  law  and  the 
legislation on official controls, as these apply to all steps of the food chain. For legislation 
applicable to more than one steps in the food chain, this is described in the step where it 
is  considered  more  relevant.  The  report  also  presents  some  additional  food-related 
policies  and  some  brief  information  on  the  implementation  of  food  legislation  in  the  EU 
Member States. 

Methodology  

Even  though  the  main  legislative  texts  can  be  easily  identified  through  different 
websites, for the complete implementation of food legislation across the food chain it is 
necessary  to  identify  all  related  legislative  texts  that  add  information  to  the  main 
document.  The  methodology  followed  is  as  follows:  The  main  legal  text(s)  in  each  field 
were identified and briefly summarised. The most recent consolidated form that includes 
all  amendments  to  the  main  text  was  used  for  this  purpose.  In  instances,  a  repealed 
legislation document is being described because the one replacing it is so recent that the 
surrounding legislation has not been updated to reflect the transposition. In many cases, 
summary  maps  outlining  the  content  of  this  main  legal  text  were  also  prepared. 
Subsequently  the  EUR-LEX4  website  was  screened  for  all  legislation  that  was  directly 
related  to  these  main  texts.  The  documents  identified  were  linked  to  the  main  texts  to 
which  they  provide  additional  information  by  preparing  legislation  maps.  Due  to  the 
complexity of the results, only the legislation maps are presented in the main report and 
for  readers that need further detail in specific  regulatory areas, the detailed description 
of  all  related  legislation  in  each  field is included  in  the  Annexes  to  the  report.  Also  any 
links between different legislative texts were identified and presented, as appropriate, in 
the above maps. The overall aim of this work was to identify the majority of documents 
relevant to each area of legislation that are necessary for its implementation. 

4 http://eur-lex.europa.eu/homepage.html 

14 

 
 
 
 
 
 
                                                           
Figure 1: Overview of the food chain with the major food safety and nutrition legislation fields 

15 

 
 
 
 
2. Food chain overarching legislation  

2.1.  Background information 

2.1.1. 

Treaty of the Functioning of the European Union 

The  Treaty  of  the  Functioning  of  the  European  Union  organises  the  functioning  of  the 
Union  and  determines  the  areas  and  arrangements  for  the  Union  to  exercise  its 
competences and the limitations.  

Article 43 of the Treaty of the Functioning of the European Union (or ex Article 37 of the 
Treaty  of  the  European  Communities)  refers  to  the  implementation  of  a  common 
agricultural policy and a common fisheries policy. 

Article  114  of  the  Treaty  (or  ex  Article  95)  refers  to  the  approximation  of  laws  of  the 
Member States concerning health, safety and environmental and consumer protection. A 
high  level  of  protection  is  sought  taking  into  account  new  developments  based  on 
scientific facts.  

Article 168 (or ex Article 152) refers to public health. The Treaty provides for a high level 
of human health protection in the implementation of all Union policies and activities. The 
European Parliament and the Council can adopt, in the interest of safety, veterinary and 
phytosanitary measures.  

Article  191  refers  to  the  precautionary  principle.  It  aims  at  ensuring  a  high  level  of 
environmental  protection  through  preventative  decision-taking  in  the  case  of  risk. 
However,  in  practice,  the  scope  of  this  principle  is  far  wider  and  also  covers  EU 
legislation concerning food, animal and plant health. 

Article 207 (or ex Article 133) refers to the common commercial policy based on uniform 
principles. 

2.1.2.  White Paper on food safety 

In  the  last  decades  significant  technological  developments  have  been  observed  in 
primary food production methods, food processing and novel technologies. At the same 
time the world's population is increasing and so is the importance of the food industry in 
both feeding this population but also in the economical context. Food safety is of primary 
importance  and  the  increasing  consumer  awareness  and  their  preferences  also 
implement additional criteria. To ensure the highest level of food safety, food legislation 
must  be  up  to  date  in  all  the  above  aspects.  The  legislative  system  in  Europe  was 
reviewed  in  the  Commission  Green  Paper  on  the  "General  principles  of  food  law  in  the 
European Union" and the need for improvement was expressed. 

The  White  Paper  on  food  safety  reflects  the  key  policy  priority  of  ensuring  the  highest 
standards of food safety in Europe. In order to ensure these standards of food safety and 
health  protection  and  also  in  order  to  restore  and  maintain  consumer  confidence,  an 
independent  European  independent  Food  Authority  (EFSA)  was  established,  entrusted 
with the following tasks: 

- 
- 

to provide independent scientific advice relating to food safety,  
to operate the rapid alert systems, 

16 

 
 
 
 
 
 
to communicate food safety and health issues to the consumers,  
to network with national authorities and scientific organisations, 

- 
- 
-  and to provide scientific analysis to the Commission. 

In  the  White  Paper  it is  emphasised  that  food  safety  is  a  shared  responsibility  between 
different  stakeholders  in  the  food  chain  but  similarly  in  the  feed  chain  as  well.  The 
primary  responsibility  lies  with  food  operators  and  food  manufacturers.  The  authorities 
are  responsible  for  monitoring  and  enforcing  food  safety  through  the  national  control 
systems,  while  the  Commission  is  responsible  for  evaluating  the  performance  of  the 
different  competent  authorities.  However,  even  consumers  are  responsible  for  food 
safety,  from  the  moment  they  purchase  food,  through  to  its  storage,  handling  and 
cooking until consumption. 

Traceability is another important aspect highlighted in the White Paper towards ensuring 
food  safety.  Procedures  must  allow  the  traceability  of  raw  materials  and  ingredients  to 
their  source  as  well  as  the  withdrawal  of  products  from  the  market  in  case  of  a  food 
safety risk.  

Food policy must be based on the foundations of Risk Analysis and its three components, 
risk assessment, risk management and risk communication. By using the highest quality 
of  scientific  advice  in  the  analysis  of  information  for  risk  assessment  and  by  employing 
the  precautionary  principle  in  risk  management,  but  also  through  independence, 
excellence  and  transparency,  the  Food  Authority  can  build  consumer  confidence. 
Important  information  for  the  purposes  of  risk  analysis  can  be  gathered  from  controls, 
surveillance,  laboratory  analytical  results  and  epidemiological  studies  and  must  be 
provided  in  a  timely  and  reliable  manner  to  allow  for  decision  making.  Continuous 
monitoring  and  management  of  this  information  will  allow  the  early  identification  of 
potential hazards and therefore allow the Commission to pro-actively respond and act in 
preventing crisis. 

Last  but  not  least,  the  White  Paper  makes  reference  to  other  factors  that  should  be 
considered  in  decision  making  to  ensure  consumer  health  protection.  These  include 
animal  welfare,  sustainability,  product  quality,  consumer  expectations  and  consumer 
information with regards to product characteristics and their production methods.  

It  is  clarified  that  even  though  a  European  Food  Safety  Authority  shall  be  established, 
the Commission, the Parliament and the Council shall still be the bodies responsible for 
the drafting and making of legislation. 

17 

 
 
 
 
 
 
2.2.  General food law 

2.2.1. 

Regulation  (EC)  No  178/2002  laying  down  the  general 
principles  and  requirements  of  food  law,  establishing  the 
European  Food  Safety  Authority  and  laying  down  procedures 
in matters of food safety  

Regulation  (EC)  No  178/20025  establishes  that  food  legislation  must  be  based  on  risk 
analysis.  Risk  management  must  be  based  on  the  advice  provided  by  independent, 
objective  and  transparent  risk  assessment  also  taking  into  account  the  precautionary 
principle.  Consumer  protection  is  established  as  the  main  aim  of  food  legislation.  Food 
law  must  be  subject  to  open  consultation  and  consumers  must  be  informed  of  risks.  It 
also  establishes  the  obligations  of  the  food  business  operators  with  regards  to  food 
safety requirements and traceability and the actions that should be taken in case a risk 
is identified. 

Regulation (EC) No 178/2002 establishes EFSA and its aims and obligations. It provides 
the details on how the Authority should be organised, on the preparation of its opinions 
and  also  on  procedures  to  be  followed  in  case  different  bodies  have  different  opinions. 
The  Regulation  specifies  that  the  Authority  is  responsible  for  identifying  emerging  risks 
and  indicating  how  these  should  be  communicated  to  the  European  Parliament,  the 
Commission  and  the  Member  States.  The  Regulation  also  established  the  Rapid  Alert 
System for Food and Feed (RASFF) and tasked EFSA with monitoring the system in order 
to provide the Commission and the Member States with information for the purposes of 
risk  analysis.  Procedures  are  specified  for  emergency  measures  as  well  as  for  crisis 
management  and  for  the  setting-up  of  a  crisis  unit  when  an  emergency  health  risk  is 
identified in the food chain. The principles of independence, transparency, confidentiality 
and communication in the functions of the Authority are highlighted.  

In order to assist in the interpretation and implementation of Regulation 178/2002, the 
Commission has encouraged discussions with all interested parties and held a meeting in 
2004.  The  Standing  Committee  on  the  Food  Chain  and  Animal  Health  approved  the 
conclusions of this meeting, which were made available to the public through a guidance 
document that was published and reviewed again in 20106. Guidance is provided on the 
following  topics:  food  safety  requirements,  responsibilities  of  the  different  stakeholders 
in  the  food/  chains,  traceability,  withdrawal  from  the  market,  product  recalls  and 
notifications as well as on import and export requirements.  

Figure 2 provides a graphical representation of the main provisions of Regulation (EC) No 
178/2002. However for the complete implementation of the requirements of the general 
food  law  the  above  text  is  not  sufficient.  Additional  requirements  are  laid  down  by 
implementing  Regulations  or  other  legal  instruments  that  must  be  followed  in 
combination  with  the  above  main  text.  This  can  be  better  illustrated  by  the  following 
graph,  while  details  on  the  specific  requirements  introduced  by  the  different  Articles  of 
Regulation  (EC)  No  178/2002  which  are  fulfilled  by  the  connected  documents  can  be 
found in Annex I.  

Figure 3 provides a graphic representation of certain of the provisions of Regulation (EC) 
No  178/2002  and  the  legislative  acts  that  add  information  for  the  implementation  of 
their requirements. 

5 Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (2002). Official Journal of the European Union (OJ) L 31 
6 Conclusions of the Standing Committee on the Food Chain and Animal Health, 2010. Guidance on the implementation of Articles 11, 12, 
14, 17, 18, 19 and 20 of Regulation (EC) No 178/2002 on general food law 

18 

 
 
 
 
                                                           
General food law 
(Reg. (EC) No 
178/2002) 

Precautionary 
principle 

Risk analysis 

Consumer 
protection 

Transparency 

Trade 
obligations 

Food law 
requirements 

EFSA 

public 
consultation 

imports 

food / feed 
safety 

mission / tasks 

organisation 

operation 

public 
information 

exports 

business 
operators' 
responsibilities 

scientific 
opinions 

traceability 

data collection 

liability 

identification of 
emerging risks 

RASFF 

Figure 2: Main provisions of the general food law (Regulation (EC) No 178/2002) 

19 

RASFF, 
emergencies, 
crisis manag. 

independence, 
transparency, 
confidentiality, 
communication 

financial 
provisions 

RASFF 

emergencies 

crisis 
management 

 
 
 
 
 
 
Creation of advisory group on food chain, 
animal and plant health (Dec. 2004/613/EC) 

Traceability for food of animal origin  
(Impl. Reg. 931/2011) 

Procedures applied by EFSA for request of 
Scientific Opinions (Reg. 1304/2003) 

Rules for Implementation of 178/2002 for 
network of organisations within EFSA's 
fields of activity (Reg. 2230/2004) 

Implementing measures for RASFF  
(Reg. 16/2011) 

Adoption of a general plan for food/feed 
crisis management 
(Dec. 2004/478/EC) 

Hygiene Package 
(Regs. 852/2004, 853/2004, 854/2004)  

Appointment of EFSA Management Board 
members (Dec. 2013/C 187/06, 2012/C 192/01) 

Composition, number and names of panels, 
procedures for operation, decision making 
(Reg. 575/2006, Reg. 202/2008) 

Yearly Reports  

Implementing Regulations / Decisions 

General Food Law  
(Reg. 178/2002) 





















Article 9: Public Consultation 

Art. 18: Traceability 

Art. 25: Management Board of 
EFSA 

Art. 28: Scientific Committee 
and Scientific Panels of EFSA 

Art. 29: Scientific Opinions of 
EFSA 

Art. 36: Networking of 
Organisations in the EFSA 
fields of activity 

Art. 44: EFSA's budget 

Art. 51: Implementing 
measures for RASFF 

Art. 53: Emergencies 

Art. 55-57: Crisis Management 

Figure 3: Overview of certain provisions of the general food law (Reg. (EC) No 178/2002) and cross-links with additional implementing 
documents

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.3.  Official controls  

2.3.1. 

Regulation (EC) No 882/2004 on official controls performed to 
ensure  compliance with  feed  and  food  law,  animal  health  and 
animal welfare rules 

Regulation  (EC)  No  882/20047  lays  down  general  rules  for  the  performance  of  official 
controls  in  order  to  verify  compliance  with  EU  legislation  aiming  at  different  aspects  of 
food and feed safety and ensure consumer protection. 

Figure  4  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  882/2004  while  details  on  the  implementation  of  specific 
requirements  introduced  by  the  different  Articles  of  the  Regulation  can  be  found  in 
Annex II.  

This  Regulation  emphasises  the  legal  responsibility  of  the  food  business  operator  to 
ensure  food  safety.  It  lays  down  the  general  obligations  of  the  Member  States  with 
regard to official controls, their basis and their frequency. Generally official controls must 
be  carried  out  without  prior  warning  unless  an  audit is  required,  or  on  an  ad  hoc  basis 
and  they  should  also  cover  products  intended  for  export,  not  only  for  Community  use. 
Regulation  (EC)  No  882/2004  lays  down  provisions  for  the  designation  of  competent 
authorities in the different Member States, their duties and operational criteria but also 
some  principles  to  be  followed  to  ensure  efficiency  and  effectiveness.  The  Regulation 
provides  for  "control  bodies"  delegated  to  carry  out  specific  tasks  and  establishes 
conditions  for  the  fulfilment  of  their  role.  Control  bodies  must  be  accredited  and  must 
conform to requirements established by standards. If they fail in fulfilling their role, they 
may be withdrawn from delegation. Certain provisions are laid down with regard to the 
role of staff performing official controls and specific mention is made to the principles of 
transparency  and  confidentiality  and  to  the  fact  that  information  should  be  publicly 
available as established by Regulation (EC) No 178/2002. 

Official  controls  must  be  carried  out  according  to  specified  procedures  which  must  be 
documented  in  order  to  ensure  their  effectiveness  and  that  corrective  action  is  taken. 
Commission  guidelines  must  be  established 
in  particular  with  regard  to  the 
implementation of Hazard Analysis Critical and Control Points (HACCP) and the operation 
of management systems in order to ensure microbiological, physical and chemical safety 
of food and feed. 

The competent authorities of the Member States must compile reports on the results of 
the official controls which must include their purpose, methods applied, results obtained 
and  action  that  may  need  to  be  taken  by  the  food  business  operator.  Official  controls 
must be carried out using appropriate methodology and including specific tasks detailed 
within the Regulation. Details are provided with regard to the methods for sampling and 
analysis  that  must  follow  internationally  recognised  protocols  or  methods  developed  in 
accordance  with  such  protocols  while  the  Regulation  also  provides  specific  criteria  that 
such methods must fulfil. Also it allows the food business operator under official control 
to  apply  for  a  supplementary  expert  opinion  and  lays  down  relevant  procedures.  The 
analysis of samples taken for official controls must be carried out in official laboratories 
which must be accredited to specific internationally accepted standards. 

Regulation  (EC)  No  882/2004  requires  Member  States  to  draw  up  operational 
contingency plans for crisis management and specifies their set up and responsibilities. 

7 Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure compliance with 
feed and food law, animal health and animal welfare rules. OJ L 165 

21 

 
 
 
 
 
                                                           
Competent authorities 

Transparency, 
confidentiality 

Sampling, analysis 

Official controls 

Contigency plans 

Third country import 
control 

Financing of official 
control 

Official certification, 
registration, approval of 
establishments 

Community 

National 

National multi-annual 

Co-ordinated 

in Member States 

in third countries 

s
l
o
r
t
n
o
c

l

a

i
c
i
f
f

O

4
0
0
2
/
2
8
8
o
N

)
C
E
(
n
o
i
t
a
u
g
e
R

l

Reference laboratories 

Administrative assistance 

Control plans 

Community controls 
(FVO) 

Enforcement measures 

Training 

Figure 4: Summary of the provisions of Regulation (EC) No 882/2004 on official controls 
for verification of compliance with food and feed law, animal health and animal welfare. 

22 

 
 
 
 
 
 
 
 
 
 
 
 
For carrying out controls on products of non-animal origin imported from third countries, 
Regulation (EC) No 882/2004 provides detailed rules related to the checks that need to 
be  performed  and  the  follow-up  action.  Costs  associated  with  re-dispatching  non-
compliant  products  or  their  special  treatment  is  the  responsibility  of  the  food  business 
operator. Details are also provided for pre-export checks of food that may be carried out 
in certain countries. If a significant non-compliance is detected, the RASFF procedures of 
Regulation (EC) No 178/2002 must immediately be followed.  

The  importance  of  cooperation  between  competent  authorities  and  customs  for  the 
purposes  of  Regulation  (EC)  No  882/2004  is  emphasised.  The  Regulation  lays  down 
provisions  for  the  financing  of  official  controls  in  the  Member  States  and  for  the 
establishment  of  relevant  specific  fees.  It  also  highlights  the  responsibility  of  food 
business operators to cover for additional expenses in case of non-compliance.  

Regulation  (EC)  No  882/2004  indicates  that  the  competent  authorities  must  establish 
procedures  for  the  registration  or  approval  of  establishments  in  accordance  with 
Regulation (EC) No 852/2004 and also indicates when the withdrawal of such approvals 
must be initiated. 

Provisions  are  laid  down  with  regards  to  the  Community  Reference  Laboratories,  the 
requirements  they  must  fulfil  and  their  financing.  Also  one  or  more  national  reference 
laboratories  in  each  Member  State  must  be  designated  for  each  Community  reference 
laboratory and for their role provisions are included. 

Member  States  are  required  to  provide  administrative  assistance  to  the  Commission  in 
relation  to  the  outcomes  of  official  controls  and  the  relevant  procedures  are  provided. 
Also the Regulation requires the establishment of "liaison bodies" and indicates their role 
in  assisting  and  coordinating  the  communication  between  authorities  with  regards  to 
requests  for  assistance.  Further  details  are  laid  down  for  providing  assistance  under 
different  circumstances,  in  relation  to  third  countries  or  on  request  for  coordinated 
assistance in special cases. 

Regulation  (EC)  No  882/2004  also  lays  down  requirements  for  the  implementation  of 
multi-annual  control  plans  in  the  different  Member  States  and  the  principles  and  the 
content  of  such  plans  as  well  as  the  need  for  Commission  guidelines  for  their 
preparation. The Regulation also requires that one year after the implementation of the 
multi-annual  national  control  plans  Member  States  must  submit  a  report  to  the 
Commission on their progress and effectiveness and specific instructions are provided for 
the  reparation  of  the  report  and  timelines  for  its  delivery.  The  Commission  must  also 
compile  an  annual  report  on  the  overall  operation  of  official  controls  in  the  Member 
States,  including  recommendations  on  possible  improvements,  specific  actions  or  the 
requirement for coordinated plans for issues of particular interest. 

Regulation (EC) No 882/2004 also lays down  requirements  for  Community controls and 
specific audits and inspections in the Member States, but also for Community controls in 
third countries, their aims, frequency and determination of risks. 

Specific  requirements  are  also  provided  on  the  information  required  for  imports  from 
third  countries,  additional  conditions  not  covered  by  the  hygiene  Regulation  (EC)  No 
854/2004 and on the establishment of lists of third countries from where products may 
be imported and the conditions for granting the status of equivalence of third countries' 
controls  to  the  Commission  ones.  Finally,  measures  are  implemented  for  providing 
assistance to developing countries in order to meet the requirements of the Regulation. 

Regulation  (EC)  No  882/2004  lays  down  provisions  for  the  training  of  staff  performing 
official  controls  in  the  competent  authorities  of  the  Member  States.  Also  provisions  are 
established  for  the  performance  of  other  Community  activities  such  as  coordinated 
control plans. 

23 

 
 
 
Procedures  are  established  for  enforcement  measures  on  national  level  in  case  of  non-
compliance and for relevant sanctions. In case of serious non-conformances, emergency 
measure  must  be  taken  according  to  the  provisions  of  Article  53  of  Regulation  (EC)  No 
178/2002. 

Finally, Regulation (EC) No 882/2004 requires the Commission to submit a report to the 
Parliament  and  the  Council  on  the  experience  gained  from  its  application,  specifically 
focusing  on  whether  need  exists  for  the  review  of  specific  provisions  also  taking  into 
consideration the implementation of the hygiene package Regulations. 

Figure  5  provides  a  graphic  representation  of  the  main  content  of  Regulation  (EC)  No 
882/2004  and  the  legislative  acts  that  add  information  for  the  implementation  of  its 
requirements. 

24 

 
 
 
 
 
General Food Safety 
(Reg. 178/2002) 

Official Controls for verification 
of compliance with feed and food 
law, animal health and animal 
welfare rules  (Reg. 882/2004) 

Common organisation of the markets in 
agricultural products (Reg. 1308/2013) 

Implementing measures for the RASFF system (Reg. 16/2011) 

Health rules for animal by-products and derived products not 
for human consumption (Reg. 1069/2009 and Impl. Reg. 142/2011) 

Plastic materials & articles in contact with food (Reg. 10/2011) 

Active and intelligent materials and 
articles in contact with food (Reg. 450/2009) 

Emergency measures for unauthorised GM rice 
in rice products from China (Impl. Dec. 2011/884/EU) 

Special conditions on imports of guar gum from India due to 
pentachlorophenol and dioxins contamin. risks (Reg. 258/2010) 

Special conditions on imports of sunflower oil from Ukraine 
due to contamination risks by mineral oil (Reg. 1151/2009) 

Hygiene for food 
of animal origin 
(Reg. 853/2004)  

Implementing measures for the 
organisation of official controls 
under Reg. 882/2004 (Reg. 2074/2005) 

Simplified rules/procedures for sanitary controls of fishery 
products & by-products from Greenland (Council Dec. 2011/408/EU) 

Provisions for animal protection during transport (Reg. 1/2005) 

Animal and public health and veterinary certif. 
conditions for introduction in EU of raw milk and 
dairy products for human consumption (Reg. 605/2010) 

Establishing the Consumers Health and Food 
Executive Agency (Impl. Dec. 2013/770/EU) 

Protection of animals at the time of killing (Reg. 1009/2009) 

Commission Recommendations: 2014/118/EU, 
2010/161/EC, 2010/307/EC, 2007/196/EC) 































Article 3: General obligations for 
organisation of official controls 

Articles 4-5: designation of 
competent authorities, 
operational criteria, delegation of 
tasks related to official controls 

Article 11: Methods for sampling 
and analysis 

Article 12: Official laboratories 

Article 19: Action following 
official controls on food/feed 
from third countries 

Article 27: Fees or charges 

Article 31: Registration/approval 
of food/feed business 
establishments 

Article 32: Community reference 
laboratories 

Article 45: Community controls 
in Member States 

Article 48: Specific Import 
conditions 

Article 51: Training of control 
staff 

Article 54: Action in case of non-
compliance 

Annex III: Characterisation of 
methods for analysis 

Annex VI: Criteria for the 
calculation of fees 

Annex VII: European Union 
Reference Laboratories 

Financing, management, monitoring of the common 
agricultural policy (Reg. 1306/2013) 

Quality schemes for agric. products and foods (Reg. 1151/2012) 

Organic production labelling of org. products (Reg. 834/2007) 

Detailed rules for the application of Reg. 1255/1999 on 
methods for analysis and quality evaluation of milk and 
milk products (Reg. 273/2008) 

Protective measures for equine infectious anaemia in 
Romania (Dec. 2010/346/EU) 

Detailed rules for harmonised monitoring and reporting 
of antimicrobial resistance (AMR) in zoonotic and 
commensal bacteria (Impl. Dec. 2013/652/EC) 

Implementing Dir. 2006/88/EC on requirements for the 
quarantine of aquaculture animals (Dec. 2008/946/EC) 

Decisions for provisions for financial aid to EU Ref. Labs 

EU reference laboratory for foot-and-mouth disease 
(Impl. Dec. 2012/767/EU) 

Provisions for renewal procedure for active substances 
as per Reg. 1107/2009 on placing plant protection 
products on the market (Impl. Reg. 844/2012) 

Procedures for residue limits of pharmacologically active 
substances in food of animal origin (Reg. 470/2009) 

Implem. Council Dec. 2000/258/EC on proficiency tests for 
authorisations of laboratories for serological tests to 
monitor effectiveness of rabies vaccines (Dec. 2010/436/EU) 

Community Veterinary Emergency Team to assist Commis. 
in supporting MS and third countries in veterinary matters 
relating to certain animal diseases (Dec. 2007/142/EC) 
Materials and articles in contact with food (Reg. 1935/2004) 

Figure 5: Summary of the most important legal documents in the field of official controls for verification of compliance with food and  feed 
law, animal health and animal welfare. 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Legislation related to the inputs to food chain system 

3.1.  Fertilisers  

3.1.1. 

Synthetic  fertilisers  –  Regulation  (EC)  No  2003/2003  of  the 
European Parliament and of the Council relating to fertilisers  

Regulation (EC) No 2003/20038 applies to products placed on the Community market as 
fertilisers.  Any  fertiliser  belonging  to  the  types  of  products  listed  in  Annex  I  of  the 
Regulation  and  meeting 
fertiliser". 
Manufacturers  of  "EC  fertilisers"  must  be  established  within  the  Community.  Products 
bearing this designation may circulate freely in the EU market.  

its  requirements  may  be  designated  "EC 

The  Regulation  lays  down  requirements  and  formats  for  indicating  the  nitrogen, 
phosphorous and potassium content of the fertilisers as well as the calcium, magnesium, 
sodium  and  sulphur  content  of  primary  and  secondary  nutrient  fertilisers.  Details  are 
also  provided  on  the  declaration  of  the  content  of  micro-nutrients  depending  on  their 
quantities  and  on  whether  there  are  water-soluble  or  chemically  linked  with  other 
organic molecules. EC fertilisers must bear an identification marking which must appear 
on  the  packaging  or  label  for  pre-packed  products  or  on  the  accompanying  documents 
for bulk products. Details are also provided on the compulsory and optional information 
that  must  appear  on  the  label/packaging  or  accompanying  documents  which  must  also 
be  indelible  and  clearly  legible.  Compulsory  and  optional  information  must  be  clearly 
separated  between  them  and  from  any  other  information  appearing  on  the  label.  For 
fluid  fertilisers,  instructions  on  storage  temperature  and  accident  prevention  must  also 
be provided. If the packaging contains a seal, this must bear the name and mark of the 
packager.  Information  must  appear  in  at  least  the  official  languages  of  the  Member 
States where the product is marketed. The packaging of EC fertilisers must be such that 
once they are opened their seal is irreversibly damaged. 

The manufacturer must maintain records of the origin of the fertilisers in order to ensure 
traceability.  The  Regulation  also  lays  down  tolerances  for  the  nutrient  content  of  EC 
fertilisers  which  allow  for  deviations  in  manufacture,  sampling  and  analysis;  these 
however  do  not  apply  to  the  minimum  and  maximum  contents  of  Annex  I  to  the 
Regulation.  The  Regulation  allows  for  safeguard  measures  and  the  procedure  to  be 
followed.  

Regulation  (EC)  No  2003/2003  also  lays  down  provisions  for  specific  types  of  fertilisers 
such  as  inorganic  primary  nutrient  fertilisers,  inorganic  secondary  nutrient  fertilisers, 
inorganic  micro-nutrient  fertilisers  and  ammonium  nitrate  fertilisers  of  high  nitrogen 
content. 

EC  fertilisers  must  be  subject  to  official  controls  to  ensure  compliance  with  the 
requirements  of  Regulation  (EC)  No  2003/2003,  according  to  the  methods  of  sampling 
and  analysis  provided  in  Annexes  III  and  IV  to  the  Regulation.  The  Regulation  also 
requires  the  establishment  of  lists  of  Member  States'  laboratories  that  meet  certain 
standards  laid  down  in  Annex  V  to  the  Regulation  and  may  assist  in  checking  the 
compliance of EC fertilisers to its requirements. New types of fertilisers may be added to 
Annex  I  of  Regulation  (EC)  No  2003/2003  if  required,  provided  the  manufacturer 
provides  the  relevant  technical  information  required.  Finally  Member  States  must 
establish penalties for infringements of the provisions of the Regulation. 

8 Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers (2003). OJ L 304/1 

26 

 
 
 
 
                                                           
Figure  6  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  2003/2003.  More  details  on  legislation  adding  information  for  the 
implementation  of  this  Regulation  can  be  found  in  Annex  III.  Also  Figure  7  below 
summarises the legislative acts in the field of fertilisers. 

Manufactured in the Community 

Compulsory statements 

Identification markings  

Placing on the market 

Traceability 

o
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Provisions for specific types of fertilisers 

Conformity assessment 

New EC fertilisers 

Labelling, packaging 

Tolerances 

Safeguards 

Inorganic primary nutrient fertilisers 

Inorganic secondary nutrient fertilisers 

Inorganic micro-nutrient fertilisers 

Ammonium nitrate fertilisers of high 
nitrogen content 

Control measures 

Laboratories 

Figure 6: Main requirements of Regulation (EC) No 2003/2003 

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Extending the application 
period of national provisions 
on the maximum admissible 
content of cadmium in 
fertilisers (Dec. 2012/230/EU) 

Commission Decisions 
approving national provisions 
(Dec. 2006/347/EC, 2006/348/EC, 
2006/349/EC) 

Rejecting national provisions 
on the maximum admissible 
content of cadmium in 
fertilisers (Dec. 2012/719/EU) 

Control of major-accident 
hazards involving dangerous 
substances (Dir. 2012/18/EU) 

Fertilisers (Reg. 2003/2003) 











Article 5: Free circulation 

Article 37: National provisions 

Annex I: list of types of EC 
fertilisers 

Annex III: Technical provisions for 
ammonium nitrate fertilisers with 
high nitrogen content 

Annex IV: methods for sampling 
and analysis 

Implementing Reg. 834/2007 
on organic production and 
labelling of organic products 
(Reg. 889/2008) 

Restriction on the 
marketing and use of 
certain substances 
(Dec. 1348/2008/EC) 

REACH (Reg. 1907/2006) 

Authorisation of urea as a 
feed additive for ruminants 
(Impl. Reg. 839/2012) 

Figure 7: Legislative acts in the field of fertilisers 

3.1.2. 

Organic  fertilisers  –  Regulation  (EC)  No  1069/2009  of  the 
European  Parliament  and  of  the  Council  laying  down  health 
rules as regards animal by-products and derived products not 
intended for human consumption9 

Regulation  (EC)  No  1069/2009  lays  down  rules  for  animal  by-products  and  derived 
products  with  the  aim  to  minimise  the  risk  to  public  and  animal  health  and  reduce  the 
safety risks to the food and feed chains. Amongst the other provisions of the Regulation, 
certain  provisions  refer  to  the  use  of  animal  by-products  as  organic  fertilisers.  Certain 
restrictions  are  laid  down  with  regard  to  the  feeding  of  animals  on  herbage  from  land 
where  organic  fertilisers  and  soil  improvers  have  been  applied  and  certain  waiting 
periods  are  implemented.  Category  2  material  can  be  used  for  the  manufacture  of 
organic  fertilisers  and  soil  improvers  following  specified  treatments  while  category  3 
material  may  also  be  used  under  specific  conditions.  Establishments  and  plants  where 
organic  fertilisers  and  soil  improvers  are  produced  or  derived  products  intended  to  be 
used  for  the  above  purposes  are  stored  must  be  authorised  by  the  competent 
authorities.  The  Regulation  also  lays  down  certain  provisions  for  the  placing  on  the 
market and use of organic fertilisers and soil improvers. Member States may still adopt 
relevant  national  provisions  on  the  use  of  such  products  if  there  are  concerns  for  the 
protection of public and animal health. 

Figure  8  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  1069/2009.  More  details  on  legislation  adding  information  for  the 
implementation of this Regulation can be found Annex IV. 

9 Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products 
and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (2009) OJ L 300/1 

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
 
 
 
 
 
 
 
d
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Obligations in starting and end points of the 
manufacturing chain 

Animal health restrictions 

Animal by-products and derived products 

Categories 1-3 material 

Disposal and different uses of animal by-
products and derived products 

Obligations of operators 

Collection, transport and traceability 

Registration and approval of operators, 
establishments and plants 

Hygiene requirements 

Handling of animal by-products within food 
businesses 

Own checks and HACCP 

National guides to good practice 

Animal by-producst and derived products 

Placing on the market 

Organic fertilisers and soil improvers 

Import, transit and export 

Derived products covered by other 
legislation 

Official controls 

National provisions 

Approval procedure 

Suspensions, withdrawals, prohibitions on 
operations 

Lists of establishments, plants, operators 

Controls for dispatch to other MS 

Community controls in MS 

Application of Reg. (EC) No 882/2004 for 
certain controls 

Figure 8: Main requirements of Regulation (EC) No 1069/2009 

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 9 below summarises the legislative acts in the field of organic fertilisers. 

Health rules on animal 
by-products and derived 
products not intended 
for human consumption 
(Reg. 1069/2009) 







Article 3: Definitions 

Articles 9-10: Category 2 and 3 
materials 

Article 15: Implementing 
measures 

Rules for the prevention, 
control and eradication of 
certain transmissible 
spongiform encephalopathies 
(Reg. 999/2001) 

Lists of animals and products 
to be subject to controls at 
border inspection posts 
under Dir. 91/496/EC and 
97/78/EC (Dec. 2007/275/EC) 

Figure 9: Legislative acts in the field of organic fertilisers 

Detailed rules on the 
implementation of Reg. 
834/2007 on organic 
production and labelling of 
organic products (Reg. 889/2008) 

Implementing Regulation 
1069/2009 (Reg. 142/2011) 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.  Pesticides and plant protection products 

3.2.1. 

Regulation (EC) No 1107/2009 concerning the placing of plant 
protection  products  on  the  market  and  repealing  Council 
Directives 91/414/EEC and 79/117/EEC 

Regulation (EC) No 1107/200910 lays down rules for the authorisation, placement on the 
market, use and control of plant protection products. It also provides for the approval of 
active substances, safeners,  synergists, adjuvants and co-formulants contained in plant 
protection products. Its aim is to ensure a high level of protection of human and animal 
health and the environment while improving agricultural production. Member States are 
encouraged  to  still  apply  the  precautionary  principle  during  the  authorisation  of  plant 
protection  products  in  case  of  uncertainty  related  to  risks  from  the  use  of  a  certain 
product.  

The  Regulation  applies  to  products  in  the  form  supplied  to  the  users  and  intended  for 
protecting  plants  or  plant  products,  for  hygiene  reasons,  for  influencing  certain  life 
processes  of  plants,  preserving  plant  products  or  destroying/preventing  the  growth  of 
undesired  plants,  unless  they  are  applied  to  water  or  soil.  It  also  applies  to  active 
substances  that  have  a  general  or  specific  action  against  harmful  organisms  or  plants 
and  plant  products.  Finally,  it  also  applies  to  safeners,  synergists,  co-formulants  and 
adjuvants. 

The  Regulation  lays  down  the  criteria  (in  a  specified  order)  for  a  substance  to  be 
approved  as  active  substance.  These  must  be  satisfied  for  one  or  more  representative 
uses  and  for  at  least  one  plant  protection  product  containing  the  active  substance. 
Approved  active  substances  must  be  included in  the list  of  active  substances  that  must 
be electronically available to the public.  

Plant protection products containing an active substance not yet approved may be placed 
on the market under certain conditions. Detailed information is laid down on the content 
of  authorisations  for  plant  protection  products,  their  duration,  the  procedure  for 
applications  and  the  documents  that  need  to  be  submitted  for  the  evaluation.  Also 
details are provided on how Member States should examine the applications. Provisions 
are  also  laid  down  for  the  authorisation  of  authorised  plant  protection  products  for  the 
same  use  and  under  comparable  conditions in another  Member  State  under  the  mutual 
recognition principle.  

The Regulation lays down provisions for placing on the market low-risk plant protection 
products  and  the  conditions  they  must  meet.  Reference  is  made  to  authorisations  of 
plant protection products containing a genetically modified organism. Also requirements 
are laid down for placing on the market seeds treated with plant protection products and 
the information that must appear on their labels and the accompanying documentation.  

Regulation  (EC)  No  1107/2009  lays  down  requirements  for  placing  plant  protection 
products  authorised  in  one  Member  State  on  the  market  of  another,  under  a  parallel 
trade permit. Details are provided on the requirements for products to be considered as 
identical and also on the application procedure. 

Under  emergency  situations  and  where  there  is  a  danger  that  cannot  be  controlled  by 
other  means,  a  Member  State  may  authorise  the  limited  and  controlled  use  of  a  plant 
protection  product  for  a  short  period  of  time,  also  informing  the  other  Member  States 
and  the  Commission,  unless  the  product  contains  GM  material.  Also  unauthorised  plant 

10 Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on 
the market and repealing Council Directives 91/414/EEC and 79/117/EE (2009). OJ L 309/1 

31 

 
 
 
 
                                                           
protection products may be released into the environment for research and development 
purposes. 

If  there  is  information  that  a  plant  protection  product  or  its  ingredients  may  have 
harmful  effects  or  may  no  longer  be  compliant  or  efficient,  the  Regulation  requires  the 
authorisation holder to notify the Member State that granted the authorisation. For each 
approved substance, Member States must maintain a list of tests and study reports. The 
Regulation  also  requires  the  control  of  plant  protection  products  and  specifically  the 
maintenance  of  records  by  producers  and  professional  users  regarding  the  use,  timing 
and  dosage  of  the  products.  Information  on  post-authorisation  monitoring  and  on  the 
sales volume of such products is also required. Official controls and audits must also be 
carried  out  in  the  Member  States  to  confirm  compliance  with  the  requirements  of  the 
Regulation. 

Regulation  (EC)  No  1107/2009  establishes  procedures  for  the  adoption  of  emergency 
measures  in  case  of  serious  risk  to  human  or  animal  health  or  the  environment  in 
relation to a plant protection product or its components where there is need to restrict or 
prohibit its use.  

Figure  10  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  1107/2009.  More  detailed  information  on  certain  of  the  Articles  of 
this  Regulation  and  additional  legislation  establishing  relevant  implementing  measures 
can be found in Annex V. 

t
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Approval criteria and 
procedure 

provisional 
authorisations 

Authorisation 

mutual recognition of 
authorisations 

low-risk plant 
protection products 

9
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Use and information 

Data protection and 
data sharing 

Packaging, labelling and 
advertising 

Controls 

Emergency measures 

special cases of placing 
on the market 

products containing 
GMOs 

use of plant protection 
products 

treated seeds 

information on harmful 
effects 

measures in extreme 
urgency 

other emergency 
measures 

Figure 10: Summary of the main requirements of Regulation (EC) No 1107/2009 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2. 

for 
Directive  2009/128/EC  establishing  a 
Community action to achieve the sustainable use of pesticides 

framework 

Directive 2009/128/EC11 requires Member States to adopt National Action Plans within a 
framework  for  achieving  sustainable  use  of  pesticides  and  set  their  objectives  and 
timeframes  for  moving  towards  integrated  pest  management,  reduction  of  use  of 
pesticides  and  introduction  of  alternative  approaches  thus  reducing  risks  to  human  and 
animal  health  and  the  environment.  Attention  needs  to  be  paid  to  plant  protection 
products  containing  active  substances  of  concern.  The  Directive  also  implements 
requirements  for  the  training  and  certification  of  professional  pesticide  users,  staffing 
requirements, requirements for the sale of such products and for public information and 
awareness-raising on the risks associated with the use of pesticides and on alternatives. 
The  requirement  for  a  system  for  the  monitoring  of  pesticide-related  incidents  or  of 
effects on groups of people more exposed to pesticides is also expressed. 

The  Directive  lays  down  provisions  for  the  inspection,  calibration  and  checking  of 
pesticide  application  equipment.  It  requires  the  prohibition  of  aerial  spraying  in  the 
Member  States,  unless  under  very  special  conditions  in  which  case  the  procedure  is 
detailed. Measures are also laid down for the protection of the aquatic environment and 
drinking  water  and  for  the  reduction  of  use  of  pesticides  in  specified  areas.  Member 
States  are  required  to  adopt  measures  to  prevent  risks  to  human  health  and  the 
environment  from  the  storage  and  handling  of  pesticides.  Use  of  low-risk  substances, 
integrated  pest  management  and  organic  practices  is  promoted.  The  National  Action 
Plans  must  include  details  of  the  implementation  of  integrated  pest  management  by 
professional  users,  while  the  Member  States  must  provide  incentives  and  guidelines. 
Information  is  given  on  how  Member  States  and  at  Community  level  the  Commission, 
may  calculate  risk  indicators  and  identify  trends  in  the  use  of  certain  substances  and 
priorities  and  on  the  assessment  of the efficiency  of  Community policies. The  exchange 
of information and best practice is encouraged.   

Figure  11  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Directive 2009/128/EC. 

11 Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the 
sustainable use of pesticides (2009). OJ L 309/71 

33 

 
 
 
 
 
                                                           
r
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(

National action plans 

Training  

Requirements for sale of pesticides 

Information and awareness-raising 

Pesticide application equipment 

Aerial spraying 

Measures to protect aquatic 
environment and drinking water 

Reduction of pesticide use or risks in 
specific areas 

Integrated pest management 

Harmonised risk indicators 

Figure 11: Summary of the main provisions of Directive 2009/128/EC  

3.2.3. 

Regulation (EC) No 396/2005 on maximum residue levels (MRLs) of 
pesticides in or on food and feed of plant and animal origin 

Regulation (EC) No 396/200512 lays down maximum levels for pesticide residues in food 
and  feed  of  plant  or  animal  origin  aimed  at  ensuring  the  highest  level  of  consumer 
protection.  It  applies  to  fresh,  processed  and/or  composite  food/feed,  while  certain 
exempt  products  are  mentioned.  Annex  I  of  Regulation  (EC)  No  396/2005  lists  all 
products  for  which  harmonised  MRLs  have  been  established  and  those  for  which  MRLs 
must  be  established.  The  Regulation  lays  down  the  procedure,  required  particulars  and 
documents  for  the  submission  of  an  application  for  the  setting,  modification  or  deletion 
of an MRL for an active substance. Details and timeframes on carrying out the evaluation 
of  the  application  (by  EFSA)  are  provided.  A  reasoned  opinion  must  be  reached  that 
must be made publicly available. The result and the inclusion of the new or modified MRL 
in  the  appropriate  Annex  to  the  Regulation  are  published  in  the  form  of  a  Regulation. 
Details  are  also  provided  for  setting  temporary  MRLs  to  be  included  in  Annex  III  of 
Regulation (EC) No 396/2005, provided there are no unacceptable risks to consumers or 
animals  following  monitoring  data  and  risk  assessment  by  the  Authority.  Reference  is 
also made to the revocation of authorisation of a plant protection product in which case 
the relevant MRLs must be deleted. 

Products of plant or animal origin must not exceed the MRLs laid down in Annex I of Reg. 
(EC)  No  396/2005,  or  the  default  values  set.  Specific  derogations  are  authorised  for 
products that may exceed the limits established further to post-harvest treatment with a 
fumigant,  provided  the  Commission  and  the  other  Member  States  have  been  informed. 
Such products may be authorised for placement on the market in a Member State under 

12 Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels (MRLs) of pesticides in or on 
food and feed of plant and animal origin (2005). OJ, L 70/1 

34 

 
 
 
 
 
 
                                                           
 
 
 
 
 
 
 
 
 
exceptional circumstances and provided they do not constitute an unacceptable risk. This 
must be notified to the MS, the Commission and the Authority and must be accompanied 
by a risk assessment with a view to setting temporary MRLs. 

The Regulation prohibits the mixing or dilution of non-compliant products for placement 
on  the  market  as  food  or  feed.  When  there  are  no  MRLs  for  processed  or  composite 
products,  the  product  MRLs  apply  taking  into  account  changes  due  to  processing  or 
mixing.  Specific  concentration  or  dilution  factors  must  be  established  for  certain 
processes.  

The  Regulation  lays  down  the  requirement  for  official  controls  to  be  carried  out  in  the 
Member  States  to  enforce  compliance.  These  should  involve  sampling  and  analysis  for 
identification  and  quantification  of  the  residues  present.  Details  are  also  provided  on 
sampling and methods of analysis. 

The Commission must prepare a coordinated multiannual control programme in order to 
be  able  to  assess  consumer  exposure  to  plant  protection  product  residues  but  also 
assess  the  enforcement  of  the  legislation.  National  control  programmes  must  be 
established  in  the  Member  States  which  must  cover  certain  details  specified  in  the 
Regulation.  Every  year  the  Member  States  must  forward  specific  information  to  the 
Commission,  the  Authority  and  the  other  Member  States  in  order  to  allow  the 
compilation by the Commission of an Annual Report on pesticide residues. 

In case pesticide residues or MRLs may pose risks to health, emergency measures may 
be established under Articles 53 and 54 of Regulation (EC) No 178/2002. The Regulation 
also  lays  down  the  requirement  for  establishment  of  harmonised  MRLs  at  Community 
level  and  of  support  measures  to  this  effect,  while  the  Community  must  contribute 
financially  for  the  related  costs.  Member  States  must  designate  national  authorities  for 
the purposes of this Regulation and certain tasks as detailed therein. One of these tasks 
is  the  development  and  maintenance  of  a  database  containing  all  relevant  information 
for the purposes of establishing MRLs. 

Figure  12  provides  a  graphical  overview  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  396/2005.  More  detailed  information  and  legislation  establishing 
additional implementing measures for certain of the requirements of the Regulation can 
be found in Annex VI. 

35 

 
 
 
 
n

i

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List of porducts for which 
harmonised MRLs apply 

Procedure for application for MRLs 

Setting, modifying or deletion of 
MRLs 

MRLs applicable to products of 
plant and animal origin 

Official controls 

Emergency measures 

Default limit 

Specific limit 

Community control programme 

National control programmes 

Figure 12: Summary of the main provisions of Regulation (EC) No 396/2005 

Figure  13  provides  a  summary  of  the  legal  acts  related  to  the  placement  of  plant 
protection  products  (ppps)  on  the  market  and  the  establishment  of  maximum  residue 
levels of pesticides in food and their interactions. 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Repealed - Placing of plant 
protection products on the 
market (Dir. 91/414/EEC) 

Framework for Community action 
to achieve sustainable use of 
pesticides (Dir. 2009/128/EC) 

List of 
approved 
active 
substances 
(Impl. Reg. 
540/2011) 

Approval of active 
substances under 
Reg. 1107/2009 (i.e. 
Impl. Reg. 788/2011) 

Derogating from Reg. 
540/2011 re the 
expiry of approval of 
active substances 
(Reg. 823/2012) 

Non-inclusion of active 
substances in Annex I of Dir. 
91/414/EC (Dec. 2008/934/EC) 

Com. Dec. for extension of provisional 
authorisations (i.e. Impl. Dec. 2012/363/EU) 

Labelling requirements for 
ppps (Reg. 547/2011) 

Statistics on pesticides 
(Reg. 1185/2009) 

Allocating to MS the evaluation of 
active substances due to expire by 
31/12/2018 (Impl. Reg. 686/2012) 

Measures to control confirmed 
Diabrotica virgifera virgifera Le 
Conte in Union (Rec. 2014/63/EU) 

Placing of plant protection 
products on the market 
(Reg. 1107/2009) 



































Articles 1-3: General provisions 

Articles 4-24: Active substances 

Articles 25-27: Safeners and 
synergists 

Articles 28-54: Authorisation of 
plant protection products (ppps) 

Articles 55-57: Use of ppps and 
information 

Article 58: Adjuvants 

Articles 59-62: Data protection 
and data sharing 

Article 63: Confidentiality 

Articles 64-66: Packaging, 
labelling and advertising of ppps 
and adjuvants 

Articles 67-68 Controls of ppps 

Articles 69-71: Emergencies 

Articles 72-79: Administrative and 
financial provisions 

Articles 80-84: Transitional and 
final provisions 

Annex I: European zones for the 
authorisation of ppps 

Annex II: Procedure and criteria 
for approval of active substances, 
safeners and synergists 

Annex III: Co-formulants not 
accepted for inclusion in ppps 

Annex IV: Comparative 
assessment pursuant to Art. 50 

Environmental quality 
standards for water 
policy (Dir. 2008/125/EC) 

Machinery (Dir. 2006/42/EC) 

Data requirements for active 
substances (Reg. 283/2013) 

Data requirements for plant 
protection products (Reg. 284/2013) 

Uniform principles for evaluation 
and authorisation of plant 
protection products (Reg. 546/2011) 

Support for rural development by the 
European Agricultural Fund for Rural 
Development (Reg. 1305/2013) 

Financing, management and 
monitoring of the common 
agricultural policy (Reg. 1306/2013) 

Provisions for export and import of 
hazardous chemicals (Reg. 649/2012) 

Making available on the market and 
use of biocidal products (Reg. 528/2012) 

Maximum levels for contaminants 
in foodstuffs (Reg. 1881/2006) 

Community control programme for 2015-
2017 on MRL compliance and assessment 
of consumer exposure (Reg. 400/2014) 

Provisions for the renewal procedure 
of active substances (Reg. 844/2012) 

Financing of IT tools in the field of food 
safety, animal and plant health and 
animal welfare (Impl. Dec.  2014/C 72/05) 

Implem. Dir. 91/414/EC for assessment 
of certain active substances (Reg. 188/2011) 

Maximum residue levels (MRLs) 
of pesticides in food/feed of plant 
or animal origin (Reg. 396/2005) 

































Articles 1-5: General provisions 

Articles 6-9: Submission of applications for 
MRLs 

Articles 10-13: Consideration of applications 
by the authority 

Articles 14-17: Setting, modifying, deleting 
MRLs 

Articles 18-20: MRLs for products of plant and 
animal origin 

Articles 21-25: Incorporation of existing MRLs 
into the Regulation 

Articles 26-34: Official controls, reports, 
sanctions  

Article 35: Emergency measures  

Articles 36-37: Support measures for 
harmonised pesticide MRLs 

Articles 38-42: Coordination of applications 
for MRLs 

Articles 43-50: Implementation and final 
provisions 

Annex I: Products of plant and animal origin 

Annex II: Formerly defined MRLs 

Annex III: Temporary MRLs 

Annex IV: List of active substances for which 
no MRLs are required 

Annex VII: Active substance/product 
combinations 

Specific provisions for the 
import of certain products (Impl. 
Reg.  91/2013) 

Figure 13: Summary of the legal acts related to the placement of plant protection products on the market and the establishment of 
maximum residue levels of pesticides in food  

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3.  Radioactive contamination of food and feed 

3.3.1. 

Council Regulation (Euratom) 3954/87 laying down maximum 
permitted  levels  of  radioactive  contamination  of  foodstuffs 
and of feedingstuffs following a nuclear accident or any other 
case of radiological emergency 

Regulation  3954/8713  lays  down  the  procedure  for  determining  maximum  levels  of 
radioactive  contamination  in  food  or  feed  following  a  nuclear  accident  or  other 
radiological  emergency.  In  such  cases  of  emergency  and  if  the  maximum  levels  laid 
down  in  the  Annex  to  the  Regulation  are  likely  to  be  reached,  a  Regulation  must  be 
adopted  enforcing  those  maximum  permissible  levels  in  order  to  protect  consumer 
health.  Provisions  are  also  laid  down  with  regard  to  the  length  of  validity  of  these 
maximum levels. Non-compliant food and feed must not be placed on the market. More 
detail  and  additional  legislation  relevant  for  its  implementation  are  provided  in  Annex 
VII.  

3.3.2. 

Council  Regulation  (Euratom)  944/89  laying  down  maximum 
permitted 
in  minor 
levels  of  radioactive  contamination 
foodstuffs  following  a  nuclear  accident  or  any  other  case  of 
radiological emergency 

The  Annex  to  Commission  Regulation  (Euratom)  944/8914  lays  down  a  list  of  minor 
foodstuffs under the requirement of Article 7 of Reg. 3954/87. The maximum permitted 
levels  for  radioactive  contamination  for  these  foodstuffs  is  established  at  ten  times  the 
one established for other foodstuffs by Reg. 3954/87. 

3.3.3. 

Council Regulation (EURATOM) 770/90 laying down maximum 
permitted  levels  of  radioactive  contamination  of  feedingstuffs 
following  a  nuclear  accident  or  any  other  case  of  radiological 
emergency 

The Annex to Commission Regulation (Euratom) 770/9015 lays down maximum permitted 
levels for radioactive contamination in feedingstuffs under the requirement of Article 7 of 
Reg. 3954/87. Specifically it lays down maximum levels for the sum of caesium-134 and 
caesium-137  in  feed.  Commission  Implementing  Regulation  (EU)  No  322/201416 
imposing  special  conditions  governing  the  import  of  feed  and  food  originating  in  or 
consigned  from  Japan  following  the  accident  at  the  Fukushima  nuclear  power  station, 
lays  down  maximum  levels  for  the  above  radioactive  materials  in  feed  originating  or 

13  Council  Regulation  (Euratom)  No  3954/87  laying  down  maximum  permitted  levels  of  radioactive  contamination  of  foodstuffs  and  of 
feedingstuffs following a nuclear accident or any other case of radiological emergency (1987). Official Journal L 371 
14  Council  Regulation  (Euratom)  No  944/89  laying  down  maximum  permitted  levels  of  radioactive  contamination  in  minor  foodstuffs 
following a nuclear accident or any other case of radiological emergency (1987). Official Journal L 101 
15 Council Regulation (Euratom) No 770/90 laying down maximum permitted levels of radioactive contamination in feedingstuffs following 
a nuclear accident or any other case of radiological emergency (1987). Official Journal L 083  
16 Commission Implementing Regulation (EU) No 322/2014 imposing special conditions governing the import of feed and food originating 
in or consigned from Japan following the accident at the Fukushima nuclear power station. Official Journal of the European Union, L 95/1 

38 

 
 
 
 
 
 
 
 
                                                           
consigned  from  Japan,  which  replace  the  ones  established  by  Reg.  3954/87  on  a 
provisional basis. 

Figure 14 summarises the legislative acts in the field of radioactive contamination of food 
and feed following a nuclear accident or other radiological emergency. 

Maximum permitted levels of 
radioactive contamination of 
foodstuffs and of feedingstuffs 
following a nuclear accident or 
other radiological emergency 
(Reg. (EURATOM) 3954/87) 







Articles 2 and 3 

Article 7 

Annex 

Special conditions for exporting 
foodstuffs and feedingstuffs 
following a nuclear accident or 
other radiological emergency 
(Reg. 2219/89) 

Conditions for the imports of 
agricultural products from third 
countries following the accident 
at Chernobyl nuclear power 
station (Reg. 733/2008) 

Maximum permitted levels for 
radioactive contamination in 
minor foodstuffs following a 
nuclear accident or other 
radiological emergency  
(Reg. (EURATOM) 944/89) 

Maximum permitted levels for 
radioactive contamination of 
feedingstuffs following a nuclear 
accident or other radiological 
emergency (Reg. (EURATOM) 770/90) 

Special conditions for the import 
of food and feed from Japan 
following the accident at the 
Fukushima nuclear power 
station (Reg. 322/2014) 

Figure  14:  Summary  of  legislation  in  the  field  of  radioactive  contamination  of  food  and 
feed 

39 

 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. Legislation related to primary production 

4.1.  Genetically modified organisms 

4.1.1. 

Directive  2001/18/EC  on  the  deliberate  release  into  the 
environment of genetically modified organisms  

Directive  2001/18/EC17,  in  accordance  with  the  precautionary  principle,  aims  at 
protecting  human  health  and  the  environment  during  the  deliberate  release  of 
genetically  modified  organisms into  the  environment  for  the  purposes  of  placing  on  the 
market  or  other.  Member  States  must  take  all  appropriate  measures  to  achieve  the 
above  aim.  The  Directive  does  not  apply  to  certain  organisms  produced  by  the 
techniques  specified  in  its  Annex  I  B,  nor  to  the  carriage  of  GMOs.  GMOs  may  only  be 
deliberately  released  or  placed  on  the  market  in  accordance  with  Parts  B  and  C  of  the 
Directive.  Before  submitting  a  notification  for  the  deliberate  release  of  GMOs  in  the 
environment, an environmental risk assessment must be carried out in accordance with 
its Annex III.  Member  States must designate competent authorities for the purposes  of 
this Regulation and for organising inspections and controls. 

Part  B  of  Directive  2001/18/EC  lays  down  the  procedure  for  authorisation  of  the 
deliberate  release  of  GMOs  in  the  environment  for  purposes  other  than  placing  on  the 
market.  It  also  lays  down  a  differentiated  procedure  for  the  release  of  certain  GMOs  in 
certain  ecosystems  for  which  sufficient  experience  of  releases  has  been  obtained. 
Material derived from GMOs deliberately released in accordance with Part B may not be 
placed  on  the  market  unless  in  accordance  with  Part  C.  Provisions  are  also  established 
for the action to be taken by the notifier in the event of unintended modification or new 
information  that  may  give  rise  to  risks  to  human  health  or  the  environment.  The 
Directive  requires  the  set-up  of  a  system  of  exchange  of  information  related  to 
notifications.  Member  States  must  submit  to  the  Commission  a  yearly  list  of  all  GMO 
releases  as  well  as  a  list  of  rejected  notifications,  which  must  be  distributed  to  the 
competent authorities of the other Member States.  

Part C of Directive 2001/18/EC lays down the procedure for the placement on the market 
of  GMOs  or  GMOs  in  products,  which  is  subject  to  prior  notification  to  the  competent 
authority  of  the  Member  State  where  it  will  be  placed  on  the  market  for  the  first  time. 
The  details  that  must  be  included  in  the  notification  and  timelines  for  the  assessment 
procedure are also described. The competent authority must send an assessment report 
to the Commission, indicating whether the GMO may be placed on the market or not and 
under what conditions. Specific criteria and information for the placement on the market 
of specified GMOs are also established. 

The  detailed  procedure  for  the  renewal  of  authorisations  and  the  relevant  information 
required is also laid down. Procedures are established in case an objection is  raised and 
maintained by a competent authority or the Commission, in which case a decision has to 
be  adopted.  When  a  written  consent  has  been  given  for  a  GMO  to  be  placed  on  the 
market,  this  product  may  be  used  without  further  notification  throughout  the 
Community,  provided  the  specific  conditions  of  use  and  any  environmental  restrictions 
are followed.  

The Directive defines as the responsibility of the notifier to monitor and report on a GMO 
placed on the market and to submit a report to the competent authorities of the Member 
States  and  the  Commission.  Based  on  this  information,  the  monitoring  plan  may  be 
amended  after  the  first  monitoring  period.  Also,  in  light  of  new  information  relevant  to 

17  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  on  the  deliberate  release  into  the  environment  of  genetically 
modified organisms (2001). Official Journal L 106 

40 

 
 
 
 
                                                           
the risks posed by a GMO, the notified must take measures to protect human health and 
the environment and also notify the competent authority. GMOs and GM products must 
be  labelled  as  specified  in  the  written  consent  at  all  stages  of  placing  on  the  market. 
Minimum thresholds for the adventitious or technically unavoidable presence of traces of 
authorised GMOs must be established. Member States must not inhibit the placing on the 
market  of  GMOs  that  comply  with  the  requirements  of  this  Directive.  Safeguard 
measures are established in case a notified GMO or product poses risks to human health 
or the environment. The Directive requires that all relevant information is made publicly 
available.  Final  provisions  include  confidentiality,  the  labelling  of  GMOs  for  which 
stringent  containment  measures  must  be  used,  measures  to  avoid  the  unintended 
presence of GMOs in other products and the development of relevant guidelines. 

The  Directive  indicates  that  in  cases  of  objection  with  regards  to  the  risks  from  GMOs, 
the  Commission  may  consult  the  relevant  Scientific  Committees.  Also  the  Commission 
must  consult  groups  such  as  the  European  Group  on  Ethics  in  Science  and  New 
Technologies  on  ethical  issues  or  ethical  implications  of  biotechnology.  Public  registers 
must  be  established  that  record  the  locations  of  release  of  GMOs.  Member  States  and 
the  Commission  must  publish  reports  on  their  experience  with  the  placement  on  the 
market  of  GMOs.  Member  States  must  determine  the  penalties  applicable  for  breach  of 
the  national  provisions  of  relevance  to  this  Directive.  The  Directive  finally  requires  the 
Commission  to  take  action  in  order  to  implement  the  provisions  of  the  Cartagena 
Protocol on Biosafety.  

The  following  figure  shows  the  main  requirements  of  Directive  2001/18/EC.  More  detail 
on these requirements and additional legislation required  for the implementation of this 
Directive are provided in Annex VIII.  

41 

 
 
 
Authorisation procedure 

Notification procedure 

Assessment report 

Community procedure for objections 

Consent 

Free circulation 

Safeguards 

Deliberate release of GMOs for purposes other 
than placing on the market 

Placing on the market of GMOs as or in products 

Consultation of and information to the public 

Confidentiality 

Labelling of GMOs 

Measures to avoid unintended presence of GMOs 

Adaptation to technical progress 

Consultation of Scientific Committees 

Consultation of Committee on Ethics 

Exchange of information and reporting 

Implementation of the Cartagena Protocol on 
Biosafety 

)
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Pending notifications 

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Techniques of genetic modification 

Methodology 

Principles for the environmental risk assessment 

Conclusions on potential environmental impact 

Information for the notification of GMO releases of 
higher plants or other 

Monitoring plan 

Guidance on environmental risk assessment 

On the GMO or the genetic modification 

On conditions of release and receiving environment 

On interactions between GMO and the 
environment 

On monitoring, control, waste treatment and 
emergency response  

Figure 15: Main requirements of Directive 2001/18/EC 

42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.1.2. 

Regulation (EC) No 1829/2003 on genetically modified food 
and feed 

Regulation  (EC)  No  1829/200318  lays  down  more  specific  procedures  for  the 
authorisation, supervision and labelling of GM food and feed and the foundations for the 
highest  level  of  human  and  animal  health  and  welfare  protection,  protection  of  the 
environment  and  of  consumer  interests  in  relation to  GM  food  and  feed,  while  ensuring 
the uninterrupted functioning of the internal market. It applies to GMOs for food use, to 
food  containing  or  consisting  of  GMOs  and  to  food  produced  from  or  containing 
ingredients produced from GMOs. The above food products must have no adverse effects 
to human or animal health or the environment, they must not mislead the consumer and 
they must not differ nutritionally from the food they are intended to replace. Applications 
for authorisation of GM foods are sent to the national competent authority of a Member 
State  and  details  are  provided  in  the  Regulation  on  the  information  that  needs  to  be 
submitted and the procedure to be followed.  

The  Regulation  also  lays  down  rules  for  the  labelling  of  foods  intended  for  the  final 
consumer or the mass caterer that contain GM material or are produced from or contain 
GM  material,  excluding  however  food  that  contains  <0.9%  GM  material  due  to 
adventitious  or  unavoidable  contamination.  Specific  labelling  requirements  are  included 
to  indicate  any  differences  of  the  GM  food  from  its  conventional  counterpart.  The 
Regulation  also  lays  down  requirements  for  GM  feed,  for  the  authorisation  and  for  the 
labelling of such products. Information is provided on the status of existing GM food and 
feed products that were authorised prior to the entrance in force of Regulation (EC) No 
1829/2003.  Also  details  are  provided  for  the  supervision  of  authorised  food  and  feed 
products  once  they  are  placed  on  the  market  and  of  any  applicable  conditions  or 
restrictions.  For  products  that  are  likely  to  be  used  both  as  food  and  feed  a  single 
application for authorisation must be submitted requiring a single Authority opinion and 
a  single  Commission  decision.  Also  the  Regulation  requires  the  establishment  and 
maintenance  of  a  Community  register  of  approved  GM  food  and  feed  materials  which 
must  be  publicly  available.  Provisions  apply  for  data  protection  and  confidentiality  of 
information. 

Regulation  (EC)  No  1829/2003  provides  for  a  Community  Reference  Laboratory  for  GM 
products  and  its  tasks  are  outlined.  National  reference  laboratories  may  also  be 
established. The cost of GM product authorisations and of the operation of the Reference 
laboratories  must  be  supported  by  the  applicants.  With  reference  to  ethical  issues  the 
Commission may consult the European Group on Ethics in Science and New Technologies 
and  make  such  opinions  public.  In  case  of  risks  to  human  or  animal  health  or  the 
environment,  emergency  measures  may  be  established in  accordance  with  the  relevant 
procedures of Reg. (EC) No 178/2002. Any authorisation decision reached in accordance 
with  Reg.  (EC)  No  1829/2003  must  also  be  notified  to  the  Parties  to  the  Cartagena 
Protocol. Finally, the Regulation lays down rules for penalties to be implemented in case 
of infringement of its requirements.  

Figure 16 shows the main requirements of Regulation (EC) No 1829/2003. More detail on 
these  requirements  and  additional  legislation  required  for  the  implementation  of  this 
Directive are provided in Annex IX.  

18 Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (2003). Official 
Journal L 268 

43 

 
 
 
 
 
                                                           
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9
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(

.

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Authorisation and supervision of GM food/feed 

Status of existing products 

Modification, suspension, revocation, renewal of 
authorisations 

Labelling of GM food/feed 

Products likely to be used as both food and feed 

Community register 

Public access 

Confidentiality, data protection 

Community Reference Laboratory 

Consultation with European Group on Ethics in 
Science and New Technologies 

Emergency measures 

Information in relation to the Cartagena Protocol 

Penalties 

Adventitious and technically unavoidable presence of 
GM material with favourable evaluation 

Figure 16: Main requirements of Regulation (EC) No 1829/2003 

4.1.3. 

Regulation  (EC)  No  1830/2003  on  the  traceability  and 
labelling  of  GMOs  and  the  traceability  of  food  and  feed 
products  produced  from  GMOs  and  amending  Directive 
2001/18/EC 

Regulation  (EC)  No  1830/200319  lays  down  the  framework  for  traceability  of  products 
consisting of or containing GM material and food/feed produced from GMOs. Its objective 
is to facilitate the accurate labelling, the monitoring of GMOs’ effects  on health and the 
environment  and  the  implementation  of  relevant  risk  management  and  applies  to  all 
steps  of  placing  GM  products  on  the  market.  It  also  specifies  the  responsibilities  of  the 
food business operator with regard to the traceability and labelling at the different steps. 

19  Regulation  (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council  on  the  traceability  and  labelling  of  GMOs  and  the 
traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC (2003). Official Journal L 268 

44 

 
 
 
 
 
 
                                                           
 
 
 
 
 
 
 
 
 
The Regulation requires the Commission to establish a system for the development and 
assignment  of  unique  identifiers  for  GMOs.  Information  is  provided  on  inspection  and 
control  measures  related  to  the  marketing  of  GMOs  and  the  requirement  for  the 
development  and  publication  of  guidance  by  the  Commission  is  expressed.  A  central 
register  with  all  GMO  sequencing  information  and  reference  materials  must  be 
established.  Finally  Member  States  must  establish  penalties  for  non-compliance  and 
measures for their implementation. 

Figure  17  shows  the  main  requirements  of  Regulation  (EC)  No  1830/2003.  More  detail 
and additional legislation relevant for its implementation are provided in Annex X.  

Traceability of GMOs and 
food feed produced from 
GMOs (Reg. (EC) No 
1830/2003) 

Traceability 
and labelling 
requirements 
for porducts 
consiting of or 
containing 
GMOs 

Traceability 
requirements 
for food and 
feed produced 
from GMOs 

Exemptions 

Unique 
identifiers 

Inspection and 
control 
measures 

Penalties 

Figure 17: Main requirements of Regulation (EC) No 1830/2003 

4.1.4. 

Cartagena Protocol on Biosafety 

The  Cartagena  Protocol  on  Biosafety  was  approved  in  the  European  Community  by 
Council Decision 2002/628/EC20. The aim of this Protocol is, based on the precautionary 
principle,  to  contribute  to  ensuring  protection  in  the  trans-boundary  movements 
(transfer,  handling  and  use)  of  living  modified  organisms  resulting  from  modern 
biotechnology  that  may  have  adverse  effects  on  conservation  and  sustainable  use  of 
biological  diversity,  also  considering  risks  to  human  health.  It  lays  down  the  procedure 
for  the  first  intentional  trans-boundary  movement  of  living  modified  organisms  for 
intentional introduction into the environment of the Party of import (excluding for use as 
food or feed or for processing), for the notification process and the decision procedure. A 
procedure  is  also  described  for  the  trans-boundary  movement  of  living  modified 
organisms intended for direct use as food, feed or for further processing. Provisions are 
laid down for bilateral, regional and multilateral agreements between Parties and also for 
the  procedures  for  risk  assessment  and  risk  management  to  be  carried  out  under  the 
requirements of this Protocol. The Protocol also indicates the need for the establishment 
of  measures  for  the  unintentional  trans-boundary  movement  of  organisms  and  for 
emergency measures. 

20  Council  Decision  2002/628/EC  concerning  the  conclusion,  on  behalf  of  the  European  Community,  on  the  Cartagena  Protocol  on 
Biosafety (2002). Official Journal of the European Communities, L 201/48 

45 

 
 
 
 
 
 
                                                           
The  establishment  of  the  Biosafety  Clearing-House  and  its  role  is  included  in  the 
Protocol.  Further  information  is  provided  on  the  handling  of  confidential  information, 
public awareness, illegal actions and liability, financial points of relevance, organisational 
aspects but also monitoring, reporting and review of the effectiveness of the Protocol.  

Figure 18 summarises the legal documents in the field of genetically modified organisms, 
their  deliberate  release  and  their  traceability  and  labelling  in  food  and  feed  produced 
from such organisms. 

46 

 
 
 
General Food 
Safety (Reg. 178/2002) 

Rules for implementing 
Reg. 178/2002 on 
organisations in EFSA's 
field (Reg. 2230/2004) 

Novel foods and novel food 
ingredients (Reg. 258/97) 

Official controls 
(Reg. 882/2004) 

Marketing of vine-
vegetative propagating 
material (Dir. 68/193/EEC) 

Common catalogue of 
varieties of agricultural 
plant species (Dir. 2002/53/EC) 

Marketing of vegetable 
seed (Dir. 2002/55/EC) 

Marketing of fruit plant 
propagating material and 
fruit plants (Dir. 2008/90/EC) 

Food enzymes (Reg. 1332/2008) 

Food additives (Reg. 1333/2008) 

Implementing Reg. 
1331/2008 (Reg. 234/2011) 

Additives for use in animal 
nutrition (Reg. 1831/2003) 

Genetically modified 
food and feed (Reg. 
1829/2003) 















Articles 1-2: Objective and 
definitions 

Articles 3-11: Authorisation 
and supervision of GM food  

Articles 12-14: Labelling of GM 
food 

Articles 15-23: Authorisation 
and supervision of GM feed 

Articles 24-26: Labelling of GM 
feed 

Articles 27-49: Common 
provisions 

Annex: Duties and tasks of the 
Community Reference 
Laboratory 

Traceability and labelling of 
GMOs and their food/feed 
products and amending Dir. 
2001/18/EC (Reg. 1830/2003) 













Articles 1-3: Objective and definitions 

Articles 4-7:Traceability and labelling 
requirements  

Article 8: Unique identifiers 

Article 9: Inspection and control 

Article 10: Committee 

Article 11-13: Penalties and final 
provisions 

Detailed rules for the implementation 
of Reg. 1829/2003 (Reg. 1981/2006) 

Transboundary movements 
of GMOs (Reg. 1946/2003) 

Summary information format 
re. the placing on the market 
of GMOs (Dec. 2002/812/EC) 

Deliberate release of GM 
organisms in the environment 
(Dir. 2001/18/EC) 























Articles 1-4: General provisions (part A) 

Articles 5-11: Deliberate release of GMOs 
for purposes other than placing on the 
market (part B) 

Article 12-24: Placing on the market of 
GMOs as or in products (part C) 

Article 25-38: Final provisions 

Annexes I A and B: Techniques referred 
to in Art. 2 and 3 

Annex II: Principles for the environmental 
risk assessment 

Annex III: Information required in the 
notifications concerning releases of GMO 

Annex IV: Additional information 

Annex V: Criteria for the application of 
differentiated procedures 

Annex VI: Guidelines for the assessment 
reports 

Annex VII: Monitoring plan 

Summary information formats on 
the deliberate release of GMOs 
not for placing on the market  
(Dec. 2002/813/EC, Dec. 2003/701/EC) 

Uniform principles for evaluation 
and authorisation of plant 
protection products (Reg. 546/2011) 

Guidance notes supplementing 
Annex VII (Dec. 2002/811/EC) 

Applications for authorisation of 
GM food and feed (Impl. Reg. 
503/2003) 

Detailed rules for the 
implementation of Art. 32 of 
Reg. 1829/2003 (Reg. 641/2004) 

Decision for the placing 
on the market of an 
oilseed rape product (Dec. 
2005/635/EC, Dec. 2007/232/EC) 

Decision authorising the placing 
on the market of different GM 
products (i.e. Dec. 2006/197/EC) 

Implem. Reg. 1831/2003 re 
applications for feed additive 
authorisation (Reg. 429/2008) 

Standard reporting formats for 
the monitoring of GMO release in 
the environment (Dec. 2009/770/EC) 

Measures for prevention of damage 
to health and the environment after 
accidental spillage of a GM oilseed 
rape (Com. Recom. 2005/637/EC) 

Arrangements for operation of 
registers recording information 
on genetic modifications in GMOs  
(Dec. 2004/204/EC) 

Decisions for placing GM products on 
the market under Dir. 2001/18/EC 
(i.e. Dec. 2004/643/EC, Dec. 2005/465/EC) 

Environmental liability for prevention 
and remedying of environmental 
damage (Dir. 2004/35/EC) 

System for the development and 
assignment of unique identifiers 
for GMOs (Reg. 65/2004) 

Authorisation/supervision of medic. 
prod. for human & veterinary use & 
establishing of European Medicines 
Agency (Reg. 726/2004) 

Establishment of network group 
for exchange & coordination of 
information on coexistence of 
GM, organic & conventional 
crops (Dec. 2005/463/EC) 

Medicinal products for 
human use (Dir. 2001/83/EC) 

Decisions renewing the 
authorisations of GM 
products (i.e. Dec. 2010/419/EU) 

Guidelines for co-existence measures 
to avoid GMO presence in conventional 
/ organic crops (i.e. Recom. 2010/C 200/01) 

Placing of plant protection 
products on the market 
(Reg. 1107/2009) 

Organic production and 
labelling of organic 
products (Reg. 834/2007) 

Decisions on the withdrawal from 
the market of different GM products  
(i.e. Dec. 2007/305/EC, 2007/306/EC) 

Implement. rules for placing 
on the market of seeds for 
which an application to enter 
in the national catalogue of 
varieties has been submitted 
(Dec. 2004/842/EC) 

Emergency measures for unauthorised GM 
rice products from China (Impl. Dec. 2011/884/EU) 

Decisions authorising the placing on the 
market of foods derived from GM material 
as novel foods or novel food ingredients 
(i.e. Dec. 2005/448/EC, Dec. 2006/68/EC) 

Guidance notes 
supplementing Annex 
II (Dec. 2002/623/EC) 

Technical guidance for 
sampling and detection of 
GM (Recomm. 2004/787/EC)  

Methods for sampling and 
analysis for official control of 
feed for presence of GM material 
with pending or expired 
authorisation (Reg. 619/2011) 

Financing of IT tools (Dec. 2014/C 72/05) 

Data requirements for active 
substances (Reg. 283/2013) 

Equivalence of forest 
reproductive material 
produced in third 
countries (Dec. 2008/971/EC) 

Community code for 
veterinary medicinal 
products (Dir. 2001/82/EC) 

Amending Dir. 2010/110/EC 
relating to honey (Dir. 2014/63/EU) 

Figure 18: Main legal documents in the field of GMOs, their deliberate release, traceability and labelling in food and feed 

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.  Veterinary drug residues 

4.2.1. 

Directive  2001/82/EC  on  the  Community  code  relating  to 
veterinary medicinal products 

Directive  2001/82/EC21  laying  down  Community  provisions  on  veterinary  medicinal 
products  applies  to  industrially  prepared  veterinary  medicinal  products  including  pre-
mixes  for  medicated  feedingstuffs,  active  substances  used  as  starting  materials  and 
substances  with  anabolic,  anti-infectious,  anti-parasitic,  anti-inflammatory,  hormonal  or 
psychotropic  properties,  for  placement  in  the  Community  market.  Such  products  may 
only  be  placed  on  the  market  if  they  have  been  granted  an  authorisation  by  the 
competent  authority  of  a  Member  State.  Additional  species,  strengths,  pharmaceutical 
forms,  administration  routes,  presentations,  variations  or  extensions  must  also  be 
granted  a  marketing  authorisation  or  be  included  in  the  initial  marketing  authorisation. 
The  marketing  of  such  products  is  the  responsibility  of  the  authorisation  holder.  Only 
specified  veterinary  medicinal  products  may  be  authorised  for  administering  to  food-
producing species. In case of serious epizoonotic diseases and in the absence of suitable 
medicinal  products,  Member  States  can  provisionally  allow  the  use  of  immunological 
veterinary  medicinal  products  without  marketing  authorisation  after  informing  the 
Commission  on  the  conditions  of  use.  Such  use  may  also  be  authorised  in  animals 
imported  or  exported  to  third  countries,  under  certain  conditions.  Veterinary  medicinal 
products  may  only  be  administered  to  animals  once  the  marketing  authorisation  has 
been  issued.  Detailed  rules  are  also  laid  down  for  the  administration  of  veterinary 
medicinal  products  to  non-food  producing  animals in  a  Member  State  where  authorised 
such  products  are  not  available.  Similarly,  rules  are  provided  in  case  there  is  no 
authorised product for treating specific conditions in food-producing animal species. 

Directive 2001/82/EC also lays down the procedure for obtaining marketing authorisation 
for a veterinary medicinal product, when the pharmacologically active substance has not 
yet  been  approved.  Marketing  authorisations  may  only  be  granted  to  applicants 
established  in  the  Community.  The  Directive  also  lays  down  provisions  on  homeopathic 
veterinary medicinal products and conditions for their registration or authorisation.  

The  authorisation  holder  may  be  requested  by  the  competent  authorities  to  provide 
sufficient  quantities  of  a  substance  to  enable  controls  on  the  presence  of  residues  or 
technical  expertise  in  the  implementation  of  an  analytical  method  for  the  detection  of 
residues  in  products  of  animal  origin  in  accordance  with  the  requirements  of  Directive 
96/23/EC.  The  holder  must  also  inform  the  competent  authorities  of  the  authorising 
Member State of the actual dates when the products are placed on the market or cease 
to be placed on the market, temporarily or permanently.  

The  Directive  lays  down  procedures  for  granting  marketing  authorisations in  more  than 
one  Member  States.  In  case  of  divergent  decisions,  the  matter  can  be  referred  to  the 
Committee  for  Medicinal  Products  for  Veterinary  Use.  The  Directive  also  lays  down 
provisions  in  case  a  marketing  authorisation  needs  to  be  amended  by  the  holder.  The 
Agency must publish an annual report  on these procedures while the Commission must 
prepare  a  report  on  the  experience  gained  at  least  once  every  ten  years;  both  reports 
must be forwarded to the Parliament and the Council. 

Directive  2001/82/EC  also  lays  down  rules,  timeframes  and  obligations  for  the 
manufacture of veterinary medicinal products that are subject to an authorisation even if 
intended  for  export  and  covers  whole  or  partial  manufacture  as  well  as  import  of  such 
products  from  third  countries.  The  Commission  must  implement  good  manufacturing 

21 Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products 
(2001). Official Journal of the European Communities, L311/1 

48 

 
 
 
 
                                                           
practices  and  provide  guidance.  The  manufacturing  authorisation  holder  must 
permanently employ a qualified person whose qualifications and duties are laid down in 
detail.  For  imported  products,  the  Community  must  ensure  that  they  have  been 
manufactured under at least equivalent good manufacturing practices and controls. 

The  information  that  must  appear  on  the  immediate  and  outer  packaging  of  veterinary 
medicinal products is detailed in the Directive  and must be approved  by the competent 
authorities. If it can all be placed on this packaging, the inclusion of a leaflet inside is not 
compulsory. The information must appear in the languages of all Member States where 
the  product  is  marketed  and  must  be  identical  in  all  the  languages.  In  breach  of  these 
provisions,  Member  States  may  revoke  the  authorisation.  Details  are  also  provided  on 
the labelling information of homeopathic veterinary medicinal products. 

Wholesale  of  veterinary  medicinal  products  is  subject  to  an  authorisation  and  the 
requirements  for  obtaining  this  are  laid  down  in  the  Directive.  Retail  supply  of  such 
products  is  subject  to  national  legislation  at  Member  State  level.  For  dispensing 
veterinary  medicinal  products  to  the  public,  a  veterinary  prescription  is  required.  Such 
products  may  only  be  in  the  possession  of  persons  empowered  by  the  national 
legislation,  while  records  of  the  details  of  all  manufacturers  and  dealers  must  be 
maintained.  Owners  of  food  producing  animals  must  be  able  to  provide  evidence  of 
purchase,  possession  and  administration  of  veterinary  medicinal  products  to  their 
animals even after they have been slaughtered. 

The  Directive  implements  the  establishment  of  a  pharmacovigilance  system  by  the 
Member  States  in  order  to  collect  information  on  adverse  reactions  to  veterinary 
medicinal  products  in  animals  and  humans  and  to  be  able  to  evaluate  this  information 
scientifically.  This  information  must  be  communicated  to  the  other  Member  States  and 
the Agency and must be recorded in a database. Information related to lack of expected 
efficacy,  off-label  uses,  deviations  in  the  reported  withdrawal  times,  environmental 
issues etc. may also be maintained in this system. Marketing authorisation holders must 
employ a person tasked with maintaining the pharmacovigilance related information. 

Competent  authorities  of  the  Member  State  must  conduct  inspections  and  where 
appropriate  analysis  of  samples  by  an  Official  Medicines  Control  laboratory  to  confirm 
compliance  with  the  above  legal  requirements.  Inspections  may  also  be  carried  out  on 
starting materials. Provisions are laid down on how Member State competent authorities 
can  suspend,  revoke  or  withdraw  market  authorisations  or  prohibit  a  product  from 
placement on the market. Also it is possible to suspend or withdraw the manufacturing 
authorisation  of  a  preparation.  It  is  prohibited  to  advertise  to  the  general  public 
veterinary  medicinal  products  that  may  be  administered  only  with  a  veterinary 
prescription or which contain substances with narcotic or psychotropic properties. 

The  principle  of  communication  between  the  Member  States  and  the  competent 
authorities concerned is highlighted for the purposes of this Directive.  

Figure  19  provides  a  graphical  overview  of  the  main  content  and  requirements  of 
Directive  2001/82/EC.  More  detail  on  some  of  these  requirements  as  well  as  additional 
information on related implementing measures is provided in Annex XI. 

49 

 
 
 
 
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marketing authorisation 

homeopathic veterinary medicinal products 

mutual recognition procedure and 
decentralised procedure 

manufacture and imports 

labelling and package insert 

possession, distribution and dispensing of 
veterinary medicinal products 

pharmacovigilance 

supervision and sanctions 

chemical, analytical & pharmaceutical 
standards, safety & residue tests, pre-clinical & 
clinical trials for testing of veterinary medicinal 
products 

Figure 19: Main provisions of Directive 2001/82/EC 

4.2.2. 

laying  down  Community 
Regulation  (EC)  No  470/2009 
limits  of 
procedures  for  the  establishment  of  residue 
pharmacologically  active  substances  in  foodstuffs  of  animal 
origin (repealing Regulation (EEC) No 2377/90) 

Regulation  (EC)  No  470/200922  lays  down  rules  and  procedures  for  establishing 
maximum  residue  limits  of  pharmacologically  active  substances  in  foodstuffs  of  animal 
origin or, in case maximum residue limits have not been established, it lays down levels 
of residues of substances for control purposes. 

Pharmacologically  active  substances  for  use  in  veterinary  medicinal  products  to  be 
administered to food producing animals in the Community, must be subject to an opinion 
by the European Medicines Agency (EMA) on the maximum residue limit, formulated by 
the Committee for Medicinal Products for Veterinary Use, unless the Codex Alimentarius 
procedure applies. The opinion of the Agency must consist of a scientific risk assessment 
and  of  risk  management  recommendations  and  must  be  based  on  ensuring  the  highest 
level  of  human  health  protection,  animal  health  and  animal  welfare.  It  must  not  be 
negatively  affected  by  the  lack  of  availability  of  appropriate  veterinary  medicinal 
products. The opinion must also take into consideration any relevant scientific findings of 

22 Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment 
of residue limits of pharmacologically active substances in foodstuffs of animal origin (repealing Council Regulation (EEC) No 2377/90 and 
amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation 726/2004 of the European Parliament and 
of the Council (2009). Official Journal of the European Union, L152/11 

50 

 
 
 
 
 
 
                                                           
 
 
 
 
 
 
 
 
EFSA.  The  Regulation  also  indicates  that  maximum  residue  limits  established  for  one 
pharmacologically active substance in one foodstuff may be used to extrapolate for other 
foodstuffs derived from the same species or even from one species to another. Detailed 
instructions  are  provided  on  carrying  out  the  risk  assessment  and  on  the  factors  to  be 
considered. Also based on the scientific risk assessment, recommendations are provided 
on considerations for the risk management decisions. 

Detailed  provisions  are  laid  down  with  regard  to  the  procedure  and  timelines  for 
application  for  an  opinion  of  the  Agency  on  the  use  of  a  pharmacologically  active 
substance,  either  requested  by  an  individual,  the  Commission  or  by  a  Member  State. 
Also  details  are  provided  on  the  establishment  of  maximum  residue  levels  for 
pharmacologically  active  substances  contained  in  biocidal  products  used  in  animal 
husbandry. A specific budget is provided by the agency to cover the costs of substance 
evaluations. In case a review of an already published opinion is necessary, a request for 
a  new  opinion  may  be  submitted  to  the  Agency  accompanied  by  an  explanation.  The 
above  provisions  also  apply  for  the  establishment  of  maximum  residue  levels  in  certain 
foods or species. Agency opinions must be made public, but any confidential information 
must  be  deleted.  The  Commission,  for  setting  maximum  limits  in  other  species/foods, 
must  adopt  measures  based  on  the  opinions  issued  on  the  use  of  maximum  residue 
limits in one food or species.  

The Commission is required to classify pharmacologically active substances  establishing 
a list of these and the therapeutic classes to which they belong and for each substance 
the  maximum  residue  limits,  or  provisional  limits  for  a  defined  period  of  time,  or  the 
need to establish such limits or the prohibition of use of the substance. Maximum residue 
limits must be established where necessary according to an opinion of the Agency or of 
Codex Alimentarius Commission, unless it is not considered necessary. If the presence of 
residues of a substance may constitute risk to human health or uncertainty persists, the 
administration of the substance must be prohibited. Pharmacologically active substances 
may  be  administered  to  food-producing  animals  only  if  maximum  residue  limits  or 
provisional limits are established, or they are considered unnecessary. Special conditions 
or restriction of use may be included in the classification of substances if it is necessary 
for the protection of human health. In case of an urgent requirement for authorisation of 
a  veterinary  medicinal  product  or  biocidal  product,  in  order  to  ensure  the  protection  of 
public  health  or  animal  health  and  welfare,  an  accelerated  procedure  for  the 
establishment  of  maximum  residue  limits  can  be  followed  and  the  procedure  is  laid 
down. 

The  Regulation  allows  for  the  implementation  of  reference  points  for  action  for 
pharmacologically  active  principles  not  subject  to  classification,  in  order  to  ensure  the 
functioning of controls of food of animal origin. These must be based  on the content of 
an  analyte  in  a  sample  which  can  be  detected  and  confirmed  by  official  control 
laboratories.  A  request  may  be  submitted  to  EFSA  for  assessing  the  risk  of  whether 
reference  points  for  action  can  ensure  consumer  health  protection.  The  Community 
reference  laboratories  must  be  consulted  on  methods  for  the  analysis  of  residues  and 
such  information  must be  forwarded  to  Community  and national  reference  laboratories. 
Depending  on  the  analytical  tests  results,  competent  authorities  may  carry  out 
investigations in accordance with Directive 96/23/EC to check for illegal administration of 
non-authorised  active  substances  and  take  further  action.  The  Commission  must  be 
assisted  by  the  Standing  Committee  on  Veterinary  Medicinal  Products  and  by  the 
Standing  Committee  on  the  Food  Chain  and  Animal  Health.  Finally,  the  Regulation  lays 
down the requirement for adoption by the Commission of a Regulation incorporating the 
pharmacologically  active  substances  and  their  classification  regarding  the  maximum 
residue levels as established under Reg. (EEC) No 2377/90. 

51 

 
 
 
Figure  20  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  470/2009.  More  detail  on  some  of  these  requirements  as  well  as 
additional information on related implementing measures is provided in Annex XII. 

maximum residue limits 

reference points for action 

risk assessment and risk 
management 

PAS for use in veterinary medicinal 
products in the Community 

other PAS for which and Agency 
opinion may be requested 

substance administration to food 
producing animals 

circulation of foodstuffs 

analytical methods 

placing on the market 

Standing Committee on Vet. 
Medicinal products 

action in presence of prohibited or 
non-authorised substance 

Standing Committee on Food 
Chain and Animal Health 

classification of PAS under Reg. 
2377/90 

reporting 

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Figure 20: Main provisions of Regulation (EC) No 470/2009 

4.2.3. 

Directive  96/23/EC  on  measures 
to  monitor  certain 
substances  and  residues  thereof  in  live  animals  and  animal 
products 

Directive  96/23/EC23  lays  down  measures  for  the  monitoring  of  certain  substances  and 
their residues in animals and animal products during the production process in different 
tissues,  body  fluids,  animal  products,  feed  and  drinking  water.  The  Directive  requires 
Member  States  to  assign  to  a  central  public  department  or  body  the  implementation  of 
inspections:  plan  organisation,  coordination  of  related  activities,  data  collection  to 
evaluate  the  results  obtained  and  sending  these  to  the  Commission  together  with  the 
results of any surveys undertaken. The plan must provide for the detection of groups of 

23 Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and 
repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (1996). Official Journal of the European 
Communities, L125/10 

52 

 
 
 
 
 
 
 
                                                           
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
residues  according  to  the  type  of  animal  and  for  substances  and/or  their  residues  in 
certain products and must comply with the rules for sampling, sampling frequencies and 
maximum  levels  laid  down  in  the  Annexes  to  the  Directive.  The  initial  plans  must  take 
into  account  the  existing  situation  in  each  Member  State  in  relation  to  legislation, 
controls,  infrastructure,  methods  of  analysis,  official  sampling  schemes  and  national 
tolerances and the presence of national laboratories. These plans are then examined for 
approval by the Commission. The results of Member States’ plans and control measures 
must also be forwarded to the Commission and must be made public.  

Directive  96/23/EC  establishes  the  responsibility  of  Member  States  to  ensure  that  farm 
operators  and  legal  persons  placing  animals  on  the  market  are  registered  beforehand 
with  the  Authorities.  Owners  of  establishments  of  initial  processing  of  animal  products 
must  take  all  necessary  steps  to  ensure  they  only  accept  animals  that  do  not  contain 
illegal substances or  residues of substances higher that the maximum permitted levels. 
Member  States  must  also  ensure  that  the  requirement  for  quality  monitoring  of  the 
production chain is established in the legislation and that any self-monitoring measures 
are  included  in  the  specifications.  The  responsibilities  and  terms  of  reference  for 
veterinarians monitoring farms are also laid down and specifically the requirement for a 
register of any treatment administered, the animals treated and any withdrawal periods 
to be kept in the farm. Record keeping is also required and records must be available if 
requested by the competent authorities. The Directive allows the Authorities to carry out 
random  official  checks  without  prior  notice  for  the  possession  or  presence  of  prohibited 
substances  at  any  stage  of  the  substance  or  animal  production  chain or  where  fraud  is 
suspected.  For  these  purposes,  the  Authorities  may  perform  sampling  and  checks  as 
required.  Each  Member  State  must  designate at least  one  national  reference  laboratory 
for the purposes of this Directive, while the Community reference laboratories should be 
those  referred  in  Reg.  882/2004.  Official  samples  must  be  taken  as  described  in  the 
Directive  and  according  to  Commission  rules.  Also  the  procedure  for  authorisation  of  a 
veterinary  medicinal  product  to  be  administered  to  a  species  intended  for  human 
consumption is laid down. Procedures are established for action in case test results prove 
positive,  as  well  as  for  the  restriction  of  animals  from  which  samples  were  taken  for 
analysis to leave the farm before the results have been obtained. Investigation must be 
carried  out  to  determine  the  reason  for  non-compliances  and  measures  must  be 
implemented  for  the  protection  of  public  health.  Any  associated  costs  are  the 
responsibility  of  the  person  in  charge  of  these  animals.  In  case  of  suspicion  that  a 
Member State does not carry out the controls required above, the Commission must be 
immediately notified.  

The Directive also establishes measures for the unauthorised possession of unauthorised 
substances  and  the  tasks  of  the  official  veterinarian.  Where  the  use  or  manufacture  of 
unauthorised  substances  is  detected  in  a  holding,  its  authorisation  or  official  approval 
must be suspended or in case of repeated offence withdrawn. 

In  order  for  a  country  to  be  included in  the  list  of  approved  countries  for  the  import  of 
animals  and  animal  products  a  plan  must  be  submitted,  showing  the  guarantees  for 
monitoring  substances  and  their  residues.  Compliance  must  be  verified  through  checks 
and if they reveal unauthorised use of substances or products, the Commission and the 
Member  States  must  be  informed  and  carry  out  checks  in  accordance  with  Reg. 
882/2004. If non-compliance is confirmed, the authorisation of the third country must be 
suspended.  The  Commission  must  be  assisted  by  the  Standing  Committee  on  the  Food 
Chain  and  Animal  Health.  Finally,  the  details  of  the  Annexes  to  the  Directive  may  be 
amended after risk assessment relevant to the toxicity and likelihood of residues in food 
of animal origin. 

Figure  21  shows  the  main  requirements  of  Directive  96/23/EC.  More  detail  on  some  of 
these requirements as well as additional information on related implementing measures 
is provided in Annex XIII. 

53 

 
 
 
 
Measures for monitoring 
substances and residues 
in animals and animal 
products (Dir. 96/23/EC) 

Monitoring 
plans for 
detection of 
residues or 
substances 

Self-
monitoring 
and co-
responsibility 
of operators 

Official 
control 
measures 

Measures in 
the event of 
infringement 

Imports from 
third 
countries 

Substances  
and residues 

Residue or 
substance 
group 
detected by 
animal type, 
feed, water 
and primary 
animal 
products 

Sampling 
strategy, 
levels and 
frequency 

Substances 
having 
anabolic 
effect and 
unauthorised 
substances 

Veterinary 
drugs and 
contaminants 

bovine, 
porcine, 
ovine, 
caprine, 
equine 
animals 

broiler 
chickens, 
spent hens, 
turkeys, 
other poultry 

aquaculture 
products 

Figure 21: Main provisions of Directive 96/23/EC 

54 

 
 
 
 
4.2.4. 

Council  Directive  96/22/EC  concerning  the  prohibition  on  the 
use  in  stock-farming  of  certain  active  substances  having  a 
hormonal or thyrostatic action and of beta-agonists 

implements 

Directive  96/22/EC24 
the  prohibition  or  provisional  prohibition  of 
administration of certain substances in animals intended for human consumption as well 
as  the  prohibition  of  placing  on the  market  animals  treated  with  the above  substances. 
The administration of substances  such as progesterone  or testosterone to  farm animals 
for  therapeutic  purposes  is  permitted,  provided  it  is  performed  by  a  veterinarian  or  for 
authorised  veterinary  medicinal  products  by  a  person  under  his  responsibility  and 
provided the information is registered in a register. Provisions are also laid down for the 
administration of substances to farm animals for zootechnical purposes or to aquaculture 
animals  for  the  purpose  of  sex  inversion.  Specific  prohibitions  are  established  for  the 
administration  of  hormonal  products  and  the  placement  on  the  market  of  breeding  and 
trade animals subjected to treatments. 

The  Directive  also  implements  provisions  for  the  import,  storage,  sale  and  use  of 
chemical substances that fall within its scope. Specific prohibitions are also laid down for 
the import of farm and aquaculture animals as well as of meat and meat products from 
third  countries  where  the  use  of  certain  substances  is  legally  permitted.  Finally  the 
Directive requires the Commission to monitor and review the use of the substances of its 
Annex  III  and  indicates  that  the  use  of  oestradiol  17β  in  animals  intended  for  human 
consumption should be banned in Europe. 

Figure 22 shows the main provisions of Directive 96/22/EC. More detail on some of these 
requirements  as  well  as  additional  information  on  related  implementing  measures  is 
provided in Annex XIV.  

Figure  23  summarises  the  legal  acts  in  the  field  of  veterinary  medicinal  products  and 
their residues in animals and foodstuffs of animal origin and on the prohibition of use in 
stock-farming of substances with certain effects. 

24 Council Directive 96/22/EC concerning the prohibition on the use in stock-farming of certain active substances having a hormonal or 
thyrostatic action and of beta-agonists and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC  (1996). Official Journal of the 
European Communities, L125/3 

55 

 
 
 
 
 
 
 
 
                                                           
Prohibition of use in stock-farming of 
substances with hormonal or 
thyrostatic action and beta-agonists 
(Dir. 96/22/EC) 

Prohibited 
substances 

Provisionally 
porhibited 
substances 

Authorised 
substances 
for 
therapeutic 
purposes 

Authorised 
substances 
for 
zootechnical 
treatment 
purposes 

Hormonal 
products 
and beta-
agonists 

Placing on 
the market 
of treated 
animals 

Possession 
and placing 
on the 
market of 
substances 

Procedures 
in case of 
non-
compliance 

Third 
country 
imports 

Figure 22: Main provisions of Directive 96/22/EC

56 

 
 
 
 
 
Protection of 
animals kept 
for farming 
(Dir. 58/98/EC) 

Support for rural development 
by the European Agricultural 
Fund for Rural Develop. (Reg. 
1305/2013) 

Prohibition of use of subst. 
with hormonal or 
thyrostatic action and beta-
agonists in stock-farming 
(Dir. 96/22/EC) 

Implementing Reg. 
1069/2009 and Dir. 
97/78/EC (Reg. 142/2011) 

Rules for the implementing 
Reg. 1234/2007 (Reg. 
1272/2009) 
Implem. Dir. 96/23/EC on 
analytical method 
performance & interpretation 
of results for official samples 
(Dec. 2002/657/EC) 

Harmonised standards 
for residue testing in 
animal prod. from third 
countries (Dec. 2005/34/EC) 

Official controls 
(Reg. 882/2004) 

Control of substances 
and residues in 
animal products (Dir. 
96/23/EC) 


Articles 3-8: Monitoring 
plans for the detection of 
residues of substances 









Articles 11-21: Official 
control measures 

Articles 29-30: Imports 
from third countries 

Annex III: Sampling 
strategy 

Annex IV: Sampling levels 
and frequency 

Financing of veterinary 
inspections and controls 
(Dir. 85/73/EEC) 

Principles on organisation of veterinary 
checks for third country products (Dir. 
97/78/EC) 

List of national reference 
laboratories for detection 
of residues (Dec. 98/536/EC) 

Rules for official sampling 
for residues and certain 
substances in animal 
products  (Dec. 98/179/EC) 

Approval of third 
countries' plans  
(Dec. 2011/163/EU) 

Levels and frequencies of 
sampling of Dir. 96/23/EC (Dec. 
97/747/EC) 

Health rules for animal by-products  
and derived products not intended for 
human consumption (Reg. 1069/2009) 

Community measures 
for the control of avian 
influenza (Dir. 
2005/94/EC) 

Community measures for  
control of foot-and-
mouth disease (Dir. 
2003/85/EC) 

Fees for authorisation 
of medicinal products 
(Reg. 297/95) 

Implementing Reg. 2160/2003 on 
national programme control 
measures for salmonella in poultry 
(Reg. 1177/2006) 

Community code for 
veterinary medicinal 
products (Dir. 2001/82/EC) 

Articles 5-15: Marketing 
authorisations 

Articles 31-43: Mutual 
recognition procedure and 
decentralised procedure 

Article 67: veterinary 
prescription 

Articles 80-82: financial 
penalties  







Examination of variations 
to market. author. of 
veter. medicinal products 
(Reg. 1234/2008) 

Guidelines on variations 
to mark. authorisations 
of medicinal prod. 
(Communic. 2010/C 17/01, 
2009/C 323/04) 
Implem. Dir. 2001/82 on 
criteria for exempting prod. 
from veter. prescription 
requirement (Dir. 2006/130/EC) 

Rules for implement. 
Reg. 834/2007 on 
organic production 
(Reg. 889/2008) 

Authorisation/supervi
sion of medic. prod. 
for human and 
veterinary use & 
establishing of 
European Medicines 
Agency 

Penalties for 
infringement of authoris. 
obligations under Reg. 
726/2004  

Methods for the identific. 
of equidae (Reg. 504/2008) 

List of substances 
essential for the 
treatment of equidae (Reg. 
1950/2006) 

Colouring matters for 
use in medicinal 
products  

Supplementary 
protection certificate for 
medicinal products (Reg. 
469/2009) 
Environmental quality 
standards in water 
policy (Dir. 2008/105/EC) 

Simplified rules/procedures on 
sanitary controls of fishery 
prod. from Greenland (Dec. 
2011/408/EU) 
Financing of work on IT tools in 
the field of food safety, animal 
health and welfare (Impl. Dec. 2014/C 
72/05 etc) 
Community procedures for 
establishment of residue 
limits of pharmacologically 
active substances in food 
of animal origin (Reg. 
470/2009) 




Articles 9-10: Risk Assessment / 
Risk Management (R.A.R.M.) for 
other Pharmacologically active 
substances (P.A.S.) for which an 
Agency opinion may be requested  







Articles 14-17 Classification of 
P.A.S. 

Articles 18-20: Reference points for 
action 

Articles 21- 24: Miscellaneous 
provisions 

Emergency measures for 
products for human consum. 
(Dec. 2008/630/EC, 2010/381/EU) 

General Food Safety 
(Reg. 178/2002) 

Pharmacol. active subst. 
and their MRL classification 
in animal food (Reg. 37/2010) 

Making available on the 
market and use of biocidal 
products (Reg. 528/2012) 

57 

Community financial aid for the operation of refer. labs in 
the veterinary field (Dec. 98/587/EC, 1999/760/EC) 
Figure 23: Summary of legislation on veterinary medicinal products, their residues and prohibition of use of certain substances in stock 
farming

Animal Health requirements 
for aquaculture (Dir. 
2006/88/EC) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. Legislation  related  to  the  harvesting  /  slaughtering  / 

fishing step of the food chain 

5.1.  Legislation on the hygiene of foodstuffs 

The  hygiene  of  foodstuffs  is  regulated  by  three  main legal  texts,  known  as  the  hygiene 
package. These are Regulations (EC) No 852/2004, 853/3004 and 854/2004 laying down 
requirements  for  the  hygiene  of  foodstuffs,  specific  hygiene  requirement  for  food  of 
animal  origin  and  rules  for  official  controls  on  products  of  animal  origin  for  human 
consumption respectively. These are summarised in Figure 24. 

Hygiene package 

Hygiene of foodstuffs  
(Reg. 852/2004) 

Hygiene rules for food of 

animal origin                 

(Reg. 853/2004) 

Rules for the organisation 
of official controls on 
products of animal origin 
for human consumption 
(Reg. 854/2004) 

Figure 24: Main legislation related to the hygiene of foodstuffs 

5.1.1. 

Regulation (EC) No 852/2004 of the European Parliament and 
of the Council on the hygiene of foodstuffs 

Regulation  (EC)  No  852/200425  lays  down  the  general  provisions  on  the  hygiene  of 
foodstuffs  for  the  food  business  operators  who  are  responsible  for  ensuring  food  safety 
at all stages  of the food chain under Regulation (EC) No 178/2002. Regulation (EC) No 
852/2004 applies to all stages in the food chain as well as to exports  of foodstuffs, but 
excludes primary production for private use, or food prepared for domestic production or 
for  limited  supply  directly  to  the  consumer  or  local  retail  establishments.  Figure  25 
provides a graphical representation of the main content and requirements of Regulation 
(EC) No 852/2004. 

25 Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs (2004). Official Journal of the 
European Union, L204/26 

58 

 
 
 
 
 
 
 
 
                                                           
Hygiene requirements 

Primary production 

Hazard Analysis and Critical Control 
Points (HACCP) 

Food hygiene (Reg. 852/2004) 

Registration and approval of food 
businesses 

Guides to good practice 

Imports and exports 

Training 

Figure  25:  Summary  of  the  requirements  of  Regulation  852/2004  on  the  hygiene  of 
foodstuffs 

According  to  Regulation  (EC)  No  852/2004  the  specific  hygiene  measures  for  all  food 
business operators are: the compliance with microbiological criteria, the establishment of 
procedures  in  order  to  meet  the  food  hygiene  requirements,  the  compliance  with 
temperature  control  requirements,  the  maintenance  of  the  cold  chain  and  the 
requirement  for  sampling  and  analysis.  Specific  criteria,  requirements  and  targets  for 
these parameters as well as methods for the sampling and analysis for control purposes 
are established via other Regulations.  

Regulation  (EC)  No  852/2004  requires  food  business  operators  to  implement  and 
maintain  their  procedures  according  to  the  principles  of  HACCP  which  are  listed  within 
the text of the Regulation. These procedures must be modified if there are modifications 
to  the  manufacturing  process.  It  is  also  required  that  the  food  business  operators 
provide  evidence  of  implementation  of  the  HACCP  principles  and  that  they  maintain 
records  of  these  procedures  and  any  modifications,  as  these  may  be  requested  by  the 
Authorities. Food business operators must notify their  establishments to the Authorities 
which must be registered and approved. 

Additional  measures  are  established  depending  on  the  sector  of  operation.  Food 
businesses  operating  in  primary  production  must  ensure  the  protection  of  primary 
products from contamination through the implementation of adequate control measures 
while  different  requirements  are  specified  for  the  operators  in  primary  production  of 
plant  or  animal  products.  The  maintenance  of  appropriate  records  for  the  control  of 
different hazards is a requirement and they should  be made available to the authorities 
upon inspection.  

Similarly measures are also provided for food businesses that operate in the production, 
processing  and  distribution  of  food,  which  include  requirements  for  the  food  premises, 
such as their layout, airflow, ventilation etc.,  as well as the actual rooms where food is 

59 

 
 
 
 
  
 
prepared with regards to their design and all their surfaces, but also for the utensils and 
equipment used. Requirements are also laid down for movable and temporary premises 
and  vending  machines,  for  conveyances  and  containers  used  for  the  transport  of 
foodstuffs and for the equipment used in order to  ensure it is free  from contamination. 
Also provisions are established for the handling of food waste and for the supply and use 
of  water  depending  on  the  application  where  it  is  used,  as  well  as  for  steam,  ice  or 
treated  water.  The  hygiene  of  personnel  working  in  food-handling  areas  is  also 
considered.  Lastly  provisions  are  laid  down  for  the  condition  of  raw  materials  and  their 
storage, but also for the maintenance of the cold chain, the thawing of frozen products, 
the  heat  treatments  and  the  packaging  materials  to  be  used  and  their  storage.  The 
training on food hygiene of the personnel working in food production is also established 
as a responsibility of the food business operator. Reference is also made to the cleaning 
and disinfection products and their storage in a food production environment. 

The Regulation also lays down provisions for the preparation of guidance documents for 
practices  that  can  be  used  to  control  hygiene  hazards  on  national  or  European  level. 
These  are  to  be  prepared  according  to  specified  guidelines  and  can  be  used  on  a 
voluntary  basis.  Community  guides  may  also  be  prepared.  An important  requirement  is 
that  any  guides  should  be  practicable  and  take  account  of  technological  and  scientific 
developments. 

Regulation (EC) No 178/2002 on food law and food safety requires that food imported in 
the  Community  must  meet  the  food  law  requirements  of  the  Community,  while  similar 
requirements apply to food to be exported to third countries, unless otherwise required 
by the importing country. With regards to the hygiene of imported and exported food all 
the above requirements of Regulation (EC) No 852/2004 apply. 

Finally,  Regulation  (EC)  No  852/2004  allows  for  amendments  to  the  hygiene 
requirements  established  if  considered  necessary  due  to  technological  and  scientific 
developments,  but  also  allows  for  the  adoption  of  national  measures  under  special 
conditions.  Details  on  the  procedure  to  be  followed  for  notification  of  those  national 
measures to the Commission and the other Member States are included. 

More  details  on  certain  of  the  requirements  of  Regulation  (EC)  No  852/2004  and  any 
related implementing measures can be found in Annex XV. 

5.1.2. 

Regulation (EC) No 853/2004 of the European Parliament and 
of the Council laying down specific hygiene rules for food of 
animal origin 

Regulation (EC) No 853/200426 lays down specific provisions on the hygiene of processed 
and  unprocessed  food  of  animal  origin  for  food  business  operators,  supplementing  the 
rules  of  Regulation  (EC)  No  852/2004.  It  is  intended  to  apply  for  wholesale  activities 
rather than retail.  

Regulation (EC) No 853/2004 prescribes that only potable water (or clean water) can be 
used to remove surface contamination from products  of animal origin, unless otherwise 
provided  by  European  legislation.  Provisions  are  established  for  the  registration  and 
approval of establishments manufacturing animal products. In order to place products of 
animal  origin  on  the  market  they  must  bear  a  health  or  identification  mark  which  can 
only  be  applied  for  products  that  have  been  manufactured  in  accordance  with  the 
provisions  of  Regulations  (EC)  No  853/2004  and  854/2004.  Products  of  animal  origin 

26 Regulation (EC) No 853/2004 of the European Parliament and of the Council on specific hygiene rules for food of animal origin (2004). 
Official Journal of the European Union, L139/55 

60 

 
 
 
 
 
                                                           
may  only  be  imported  from  third  countries  if  they  fully  meet  the  requirements  of 
Regulations (EC) No 852/2004, 853/2004 and 854/2004 and any additional Community 
legislation that may be in place for the import controls of such products. Food products 
that  contain  products  of  both  plant  and  animal  origin  must  also  satisfy  the  above 
requirements  for  the  animal  product  ingredients  and  the  food  business  operators  must 
be  able  to  demonstrate  compliance.  Some  special  hygiene  requirements  for  specific 
products originating from specific countries are also laid down. 

The  Regulation  contains  some  final  provisions  for  adaptation  or  amendments  of  the 
requirements for products of plant origin or other more specific requirements, in light of 
future needs. EFSA should be consulted for matters related to this Regulation that could 
have a significant impact on public health. 

The  following  figure  provides  a  graphical  representation  of  the  main  content  and 
requirements  of  Regulation  (EC)  No  853/2004  while  details  on  these  requirements  and 
any related implementing measures can be found in Annex XVI. 

Hygiene for food of 
animal origin (Reg. (EC) 
No 853/3004) 

Registration and approval of 
establishments 

Health and identification 
marking 

Imported products of animal 
origin 

Food chain information 

Certificates 

Specific requirements for food of 
animal origin 

Figure  26:  Summary  of  the  requirements  of  Regulation  (EC)  No  853/2004  on  the 
hygiene of food of animal origin 

61 

 
 
 
 
  
 
 
 
 
5.1.3. 

Regulation (EC) No 854/2004 of the European Parliament and 
of  the  Council  laying  down  specific  rules  for  the  organisation 
of  official  controls  on  products  of  animal  origin  intended  for 
human consumption 

Regulation  (EC)  No  854/200427  lays  down  specific  provisions  for  the  organisation  of 
official  controls  on  products  of  animal  origin  intended  for  human  consumption  and 
applies only to persons and activities to which Regulation (EC) No 853/2004 also applies. 
According to Reg. (EC) No 854/2004 establishments must be approved by the competent 
authorities  and  must  be  provided  with  an  approval  number.  This  applies  for  all 
establishments,  either  operating  before  the  date  of  application  of  the  Regulation  or 
afterwards.  Official  controls  must  verify  food  business  operators  comply  with  the 
requirements  of  Regulations  (EC)  Nos:  852/2004,  853/2004  and  1774/2002  (repealed 
by  Regulation  (EC)  No  1069/2009).  For  official  control  purposes,  audits  must  be 
conducted  to  verify  food  business  operators  comply  with  the  hygiene  requirements  and 
enforce  HACCP-based procedures, but also with regards to the health mark application, 
traceability  requirements  and  record-keeping.  The  Regulation  also  requires  the 
development of lists of third countries approved for the import of certain animal products 
and of lists of approved establishments. All consignments of animal products imported in 
the  Community  must  be  accompanied  by  a  certificate  satisfying  the  requirements  of 
Regulations  (EC)  No  852/2004,  853/2004  and  882/2004  and  any  other  relevant 
Community  legislation.  The  above  provisions  do  not  apply  to  fishery  products  that 
originate  from  fishing  vessels  from  third  countries,  for  which  special  provisions  are 
established. Finally the Regulation lays down some transitional measures and allows for 
amendments  and  adaptations  based  on  scientific  progress.  It  also  allows  for  certain 
exemptions as well as for the implementation of additional measures on national level by 
the  Member  States.  For  the  fulfilment  of  the  requirements  of  this  Regulation,  the 
Commission  should  be  assisted  by  the  Standing  Committee  on  the  Food  Chain  and 
Animal  Health  and  when  necessary  consult  EFSA.  Finally  the  Regulation  requires  the 
Commission  to  submit  a  report  on  the  experience  gained  from  the  application  of  this 
Regulation within 5 years of its enforcement. 

Figure  27  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  854/2004  while  details  for  the  implementation  and  additional 
requirements introduced by related legislative documents can be found in Annex XVII.  

Figure  28  summarises  the  most  important  legal  documents  in  the  field  of  food  hygiene 
and includes any legislation adding information to the main documents or assisting in the 
implementation of their requirements and their relationships. 

27 Regulation (EC) No 854/2004 of the European Parliament and of the Council on specific rules for the organisation of official controls on 
products of animal origin intended for human consumption (2004). Official Journal of the European Union, L204/26 

62 

 
 
 
 
                                                           
Official controls for 
products of animal origin 
(Reg. 854/2004) 

Approval of 
establishments 

Official veterinarian  

Official control for 
establishments 

Responsibilities and 
frequency of controls 

Action following controls 

fresh meat 

live bivalve molluscs 

fishery products 

raw milk and dairy 
products 

lists of third countries 

Procedures for imports 

lists of establishments 

documents 

Figure 27: Summary of the requirements of Regulation (EC) No 854/2004 on the official controls for products of animal origin 

63 

 
 
 
 
 
 
 
Official controls 
(Reg. 882/2004) 

Control of Salmonella 
and food borne zoonotic 
agents (Reg. 2160/2003) 

General Food Safety 
(Reg. 178/2002) 

Animal health requir. for 
aquaculture (Dir. 2006/88/EC) 

Conditions for aquaculture 
products (Reg. 1251/2008) 

Hygiene for food of animal 
origin (Reg. 853/2004)  

Transitional measures for 
Regs 853/2004 and 
854/2004 (Reg. 1079/2013) 

Hygiene of foodstuffs 
(Reg. 852/2004)  

1.

2.

3.

4.

5.

6.

7.

8.

9.

Article 4: General and 
specific hygiene 
requirements 

Article 6: Official controls, 
registration and approval 

Article 8: National guides 

Article 9: Community guides 

Article 10:Imports/Exports 

Article 12: Final provisions 

Article 13: Amendment / 
Adaptation of Annexes 

Annex I, Part A, III: Record-
keeping 

Annex II, Chapter II: 
Specific requirements for 
rooms  

10. Annex II, Chapter X: 

Provisions for wrapping and 
packaging 

11. Annex II, Chapter XI: heat 
treatment of foodstuffs 

Commission Decisions 
(2009/852/EC, 2010/89/EC 
transitional measures) 

Salmonella in poultry 
(Reg. 1086/2011) 

Microbiological criteria  
(Reg. 2073/2005) 

Approval of establishments 
producing sprouts (Reg. 210/2013)  

Marketing standards for eggs 
(Reg. 589/2008 Implementing Reg. 
1234/2007 )  

List of approved guides on hygiene 
of foodstuffs (Notice 2012/C 8/06) 

Implementing / derogating 
from Hygiene Regulations  
(Reg. 2074/2005)  

Health rules for animal by-
products (Reg. 1069/2009) 

Implementing and extension 
of special guarantees (Reg. 
1688/2005, Reg. 427/2012) 

Implementing and extension 
of special guarantees  
(Reg. 1688/2005, Reg. 427/2012) 

Regs. amending Annex III 

Commission Decisions 
(2007/716/EC, 2007/27/EC, 
2006/563/EC transitional 
measures) 

Simplified rules/procedures on 
sanitary controls of fishery prod. 
from Greenland (Dec. 2011/408/EU) 

Commission Decisions 
(2009/861/EC, 2009/852/EC, 2010/89/EC, 
2013/686/EC, 2007/29/EC, 2013/291/EC) 

Methods for the 
identification of 
equidae (Reg. 504/2008) 



























Article 1: Scope 

Article 3: Obligations of food 
business operators 

Article 4: Registration and 
approval of establishments 

Article 5: Health and identification 
marking  

Article 6: Products of animal origin 
from outside the Community 

Article 8: Special guarantees 

Article 9: Transitional measures 

Article 10: Amendment / 
Adaptation of Annexes 

Article 11: Specific Decisions 

Annex I: Definitions 

Annex II, Section I: Identification 
marking 

Annex II, Section III: Food chain 
information 

Annex III: Specific requirements 
for products of animal origin 

Common organisation 
of fishery, aquaculture 
markets (Reg. 1379/2013)  

Provision of food 
information to consumers 
(Reg. 1169/2011) 

Official controls on 
animal origin products  
(Reg. 854/2004) 





















Article 5: Fresh meat 

Chapter III: Imports 

Article 11: Third countries 

Article 12: Establishments 

Article 14: Documents 

Article 15: Fishery products 

Article 18: Specific Decisions 

Annex I: fresh meat 

Annex II: live bivalve 
molluscs 

Annex III: Fishery products 

Use of lactic acid for surface 
decontamination (Reg. 101/2013)  

Agricultural market and specific 
products Reg. 1234/2007 (1308/2013)  

Rules for the official control of 
Trichinella in meat (Reg. 2075/2005) 

Control measures for swine 
vesicular disease (Dir. 92/119/EC)  

Impl. Reg. 1005/2008 Commun. 
list to prevent illegal and 
unregulated fishing (Reg. 2010/2009) 

Animal protection at killing (Reg. 1099/2009) 

Transitional measures for products 
from RO, BU (Dec. 2007/30/EC) 

Certification for import / transit of 
composite products (Reg. 28/2012) 

Animal health control measures for 
swine fever (Impl. Dec. 2013/764/EC) 

Lists of third 
countries   
(Dec. 2006/766/EC) 

Rules against 
diseases (Dir. 
2007/43/EC, Dec. 
2007/554/EC, Reg. 
999/2001) 

Third country lists and vet. cert. req. for animal prod. 
(Regs. 798/2008, 119/2009, 206/2010) 

Conditions for the import of milk and dairy (Reg. 605/2010) 

Animal and public health conditions for import of certain 
meat products from third countries (Dec. 2007/777/EC) 

Rules for application of Reg. 1234/2007 for supply of milk 
in educational establishments (Reg. 657/2008) 

Figure 28: Summary of the legal documents in the field of food hygiene with additional implementation legislation and their relationships

64 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.2.  Animal  health  rules  for  the  production,  processing, 
distribution  and  introduction  of  products  of  animal 
origin for human consumption 

5.2.1. 

Council Directive 2002/99/EC – products of animal origin 

Directive  2002/99/EC28  establishes  the  general  rules  for  animal  health  for  the 
production,  processing  and  distribution  of  products  of  animal  origin  in  the  Community, 
but also for their introduction from third countries. It must be ensured that food business 
operators  prevent  the  spread  of  animal  diseases.  All  products  of  animal  origin  must 
originate  from  establishments  free  from  any  animal  diseases  or  animal  health 
restrictions.  Products  from  a  territory  where  animal  health  restrictions  apply  may  be 
authorised  by  Member  States,  provided  they  are  not  from  an  infected  or  suspected 
establishment,  they  have  been  handled,  stored  and  transported  separately  from 
products  that  fully  meet  the  animal  health  conditions  and  where  conditions  for  the 
transport  of  restricted  products  are  approved  by  the  competent  authority.  These 
products need to undergo treatment to eliminate health risks related to meat and milk, 
they need to be clearly identified as products intended to be treated and the treatment 
must be in an establishment approved  for that purpose.  The Directive also provides for 
veterinary  certificates  for  products  intended  for  human  consumption  and  for  official 
controls  to  be  carried  out.  Products  may  be  imported  from  third  countries  only  if  they 
meet the above requirements. In order to ensure compliance, the Directive provides for 
the  establishment  of  lists  of  third  countries  and  of  the  products  that  may  be  imported 
from  those.  It  also  lays  down  the  criteria  to  draw  these  lists.  Products  entering  the 
Community  market  must  be  accompanied  by  a  veterinary  certificate.  The  Community 
may  carry  out  inspections  or  audits  in  third  countries  during  any  of  the  stages  covered 
by the above provisions. 

A series of legal texts have been subsequently implemented under Directive 2002/99/EC 
and  in  particular  Articles  8  and  9  on  lists  of  approved  third  countries,  special  import 
conditions and certification documents.  They are also directly related to the transitional 
measures  established  in  the  hygiene  Regulations  852/2004,  853/2004  and  854/2004. 
More details can be found in Annex XVIII. 

28 Council Directive 2002/99/EC laying down the animal health rules governing the production, processing, distribution and introduction of 
products of animal origin for human consumption (2002). Official Journal of the European Communities, L 18/11 

65 

 
 
 
 
 
 
 
                                                           
5.3.  Commission  Regulation  (EC)  No  2073/2005  on 

microbiological criteria for foodstuffs 

Regulation  (EC)  No  2073/200529  lays  down  microbiological  criteria  for  foodstuffs  and 
implementing rules for the food business operators. Compliance with the requirements of 
the  Regulation  must  be  verified  by  the  competent  authority  according  to  the  provisions 
of Regulation (EC) No 882/2004 on official controls. 

Microbiological  criteria  are  harmonised  safety  criteria  for  certain  pathogenic  micro-
organisms  and  they  give  guidance  on  the  acceptability  of  foodstuffs  and  their 
manufacturing, handling and distribution processes. Their use should be an integral part 
of  HACCP-based  procedures  and  hygiene  control  measures  and  could  be  used  for  the 
verification  and  validation  of  these  procedures  and  measures.  Food  business  operators 
must  comply  with  the  microbiological  criteria  through  the  control  of  raw  materials, 
hygiene,  temperature  and  shelf-life  of  their  products  and  they  must  test  and  analyse 
samples  according  to  the  values  established  for  the  criteria  and  implement  corrective 
action  accordingly.  For  many  foodstuffs  there  are  not  yet  international  guidelines  for 
microbiological criteria established. The Commission has followed the Codex Alimentarius 
guideline  "Principles  for  the  establishment  and  application  of  microbiological  criteria  for 
foods   CAC/GL  21  –  1997"  as  well  as  advice  provided  by  the  Scientific  Committee  on 
Veterinary  Measures  relating  to  Public  Health  and  also  the  Scientific  Committee  on 
Foodstuffs. 

Annex  I  of  Regulation  (EC)  No  2073/2005  lays  down  the  microbiological  criteria  to  be 
met by the food business operators throughout the shelf-life of their products. These are 
categorised  as  food  safety  criteria  and  process  hygiene  criteria  while  rules  are  also 
established for sampling and preparation of the tests samples. Food  business operators 
must  perform  testing  against  these  criteria  and  they  may  decide  the  appropriate 
sampling  frequencies  according  to  the  size  of  their  business,  unless  it  is  established  in 
the Annex in which case the one provided must be followed. Annex I of Regulation (EC) 
No 2073/2005 also provides analytical methods and sampling plans and methods which 
must  be  used  as  reference  methods.  Other  sampling  and  testing  procedures  may  be 
used as far as the food business operator can demonstrate to the competent authorities 
that they are at least equivalent to the ones provided. Alternative methods must also be 
validated  against  the  reference  method  of  Annex  I  and  according  to  international 
standards and protocols and must be approved by the competent authority. 

When  the  results  of  testing  against  the  food  safety  microbiological  criteria  are 
unsatisfactory,  the  products  concerned  must  be  withdrawn  or  recalled  according  to  the 
provisions of Reg. (EC) No 178/2002. In certain cases and if the products have not yet 
reached the market, they may be submitted for further processing in order to eliminate 
the  hazard  concerned,  provided  such  procedures  are  already  established  in  the  HACCP 
plan and authorised. 

Finally,  the  Regulation  requires  the  food  business  operators  to  conduct  studies  in  order 
to  investigate  the  compliance  of  their  products  with  the  microbiological  criteria 
established  throughout  the  shelf-life  of  the  products,  in  particular  in  the  case  of  ready-
to-eat foods that may support the growth of Listeria monocytogenes and may pose a risk 
to public health.  

Figure  29  provides  a  graphical  representation  of  the  main  content  and  provisions  of 
Regulation  (EC)  No  2073/2005.  Details  on  the  implementation  of  the  specific 

29 Commission Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (2005). Officialk Jourmal of the European Union, L 
283/62 

66 

 
 
 
 
                                                           
requirements  introduced  by  the  different  Articles  of  the  Regulation  and  any  additional 
legislative acts adding information for these requirements can be found in Annex XIX.  

67 

 
 
 
 
 
Microbiological 
criteria (Reg. 
2073/2005) 

Testing and 
sampling 

Labelling 

Food safety 
criteria 

Process hygiene 
criteria 

Compliance 
throughout the 
shelf-life 

Meat/meat 
products 

Milk/dairy 
products 

egg products 

fishery products 

Vegetables, fruits 
and products 
thereof 

Figure 29: Summary of the provisions of Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

68 

 
 
 
 
 
5.4.  Regulation  (EC)  No  2160/2003  on  the  control  of 
Salmonella  and  other  specified  food-borne  zoonotic 
agents  

Regulation  (EC)  No  2160/200330  aims  at  ensuring  that  effective  measures  are  in  place 
for  the  detection  and  control  of  Salmonella  and  other  zoonotic  agents  at  all  stages  of 
production, processing and distribution, at primary production level and for feed in order 
to ensure adequate protection of public health. It covers the adoption of targets for the 
reduction  of  the  prevalence  of  specific  zoonoses  in  animals,  the  approval  of  specific 
control programmes in different Member States and by food business operators and the 
adoption of  specific rules for control methods as well as for intra-Community trade and 
imports from third countries. The Regulation does not apply to private domestic use or to 
the  direct  supply  of  small  quantities  of  primary  products  to  the  consumer,  which  is 
controlled at national level. 

The Regulation requires the Member States to designate the competent authority for its 
purposes and to inform the Commission thereof and lays down the responsibilities of this 
authority.  Detailed  rules  are  provided  on  the  procedure  for  the  establishment  of 
Community targets for the reduction of the prevalence of zoonoses and zoonotic agents 
and  their  specifications,  taking  into  account  the  experience  gained  form  national 
measures  and  also  information  provided  by  EFSA  gained  from  existing  Community 
measures.  Also  procedures  are  established  for  the  timing  of  implementation  of 
Community targets and for any amendments or modifications to those. 

The Regulation also requires Member States to establish national control programmes for 
each  zoonosis  and  zoonotic  agent  providing  details  for  these  control  programmes  and 
their content and to provide testing methods for the assessment of their results. Annex 
II provides the  requirements and minimum  sampling rules for the  control programmes. 
Provisions  are  also  laid  down  for  the  approval  of  national  control  programmes  but  also 
for  control  programmes  established  by  food  business  operators  who  wish  them  to  form 
part of national control programmes. 

The  Regulation  also  allows  for  the  application  of  specific  control  methods  for  the 
reduction  of  zoonoses  or  zoonotic  agents  at  primary  production  of  animals  or  at  other 
stages. Also provisions are laid down for the testing of flocks and herds of certain species 
for zoonoses and zoonotic agents for intra-Community trade as well as for imports from 
third  countries.  The  Commission  shall  be  assisted  by  the  Food  and  Veterinary  Office 
(FVO)  for  the  verification  of  equivalence  of  the  controls  programmes  in  place  in  third 
countries  resulting  in  the  admission  and  retention  of  these  countries  in  the  lists  of 
approved  countries.  The  Regulation  requires  the  Commission  to  designate  appropriate 
reference  laboratories  for  the  testing  and  analysis  for  specific  zoonoses  and  zoonotic 
agents  and  lay  down  their  responsibilities  and  tasks.  These  laboratories  must  apply 
quality  assurance  schemes  according  to  the  requirements  of  the  current  EN/ISO 
standards and must participate in collaborative testing. The Commission shall be assisted 
by  the  Standing  Committee  for  the  Food  Chain  and  Animal  Health  and  shall  consult 
EFSA. 

The  following  figure  provides  a  graphical  representation  of  the  main  content  and 
requirements  of  Regulation  (EC)  No  2160/2003.  More  detailed information  on  the  basic 
requirements  of  this  Regulation  as  well  as  on  additional  legislative  documents  adding 
information  and  assisting  in  the  implementation  of  these  requirements  can  be  found  in 
Annex XX. 

30 Commission Regulation (EC) No 2160/2003 on control of Salmonella and other specified food-borne zoonotic agents (2003). Official 
Journal of the European Union, L 325/1 

69 

 
 
 
 
                                                           
Control of Salmonella and 
other food-borne zoonotic 
agents 
Regulation (EC) No 
2160/2003 

Community targets for 
reductions 

Control programmes 

Control methods 

Trade 

Laboratories 

Criteria to determine 
salmonella serotypes with 
public health significance 

reference laboratories 

laboratories approval, 
quality requirements, 
approved testing methods 

Figure 30: Summary of the provisions of Regulation (EC) No 2160/2003 on the control of 
Salmonella and other food-borne zoonotic agents 

70 

 
 
 
  
 
5.5.  Directive  2003/99/EC  of  the  European  Parliament  and 
of  the  Council  on  the  monitoring  of  zoonoses  and 
zoonotic agents 

Directive  2003/99/EC31  aims  to  ensuring  the  appropriate  monitoring  of  zoonoses, 
zoonotic  agents  and  related  antimicrobial  resistance,  as  well  as  at  the  epidemiological 
investigation  of  food-borne  outbreaks,  in  order  to  allow  the  Community  to  evaluate 
relevant  trends  and  sources.  It  details  the  provisions  for  Member  States  to  collect, 
analyse  and  communicate  any  relevant  data.  Member  States  must  also  designate  a 
competent  authority  tasked  with  notifying  the  Commission  on  issues  related  to  this 
Directive, but also with cooperating closely with other competent authorities. 

The  Directive  lays  down  the  rules  on  the  monitoring  of  zoonoses  and  zoonotic  agents 
across all stages of the food chain and lays down the relevant duties of the food business 
operators,  but  also  establishes  the  possibility  for  the  organisation  of  coordinated 
monitoring  programmes  in  case  routine  monitoring  data  are  not  sufficient  for  the 
purposes of this Directive. 

Directive  2003/99/EC  also  implements  the  monitoring  of  antimicrobial  resistance 
according to the  requirements of its Annex  II  for the generation of  comparable data.  It 
also  lays  down  the  procedure  for  the  epidemiological  surveillance  of  food-borne 
outbreaks.  Final  requirements  are  established  for  the  exchange  of  information  between 
Member  States  and  the  Commission  on  the  subjects  covered,  the  designation  and 
coordination  of  Community  and  national  reference  laboratories  within  the  scope  of  the 
Directive  and  the  requirement  for  the  Commission  to  consult  EFSA  for  any  related 
matter. 

Figure  31  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Directive  2003/99/EC.  More  detailed  information  on  the  basic  requirements  of  this 
Directive  as  well  as  on  additional  legislative  acts  that  add  implementing  information  to 
these requirements can be found in Annex XXI. 

31  Directive  2003/99/EC  of  the  European  Parliament  and  of  the  Council  on  the  monitoring  of  zoonoses  and  zoonotic  agents  amending 
Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (2003). Official Journal of the European Union, L 325/31 

71 

 
 
 
 
 
 
 
                                                           
Monitoring of zoonoses and zoonotic 
agents   

Coordinated monitoring programmes 

Monitoring of zoonoses and 
zoonotic agents (Dir. 
2003/99/EC) 

Monitoring of anti-microbial resistance 

Epidemiological investigation of food-
borne outbreaks 

Exchange of information 

Community and national reference 
laboratories 

Figure  31:  Summary  of  the  requirements  of  Directive  2003/99/EC  on  the  monitoring  of 
zoonoses and zoonotic agents  

Figure 32 summarises the most important legal documents in the field of microbiological 
criteria  for  foodstuffs,  control  of  food-borne  zoonotic  agents  and  of  monitoring  of 
zoonoses,  zoonotic  agents  and  antimicrobial  resistance  and  provides  the  cross-links 
between this documents. 

72 

 
 
 
 
 
 
 
Microbiological criteria  
(Reg. 2073/2005) 

















Article 1: Subject matter and 
scope 

Article 3: General requirements 

Articles 4-5: Testing criteria and 
rules for testing and sampling 

Article 6: Labelling requirements 

Article 7: Unsatisfactory results 

Article 9: Analyses of trends 

Annex I: Microbiological criteria 
for foodstuffs 

Annex II: Studies to investigate 
compliance with the 
microbiological criteria 
throughout the shelf-life 

Hygiene of foodstuffs 
(Reg. 852/2004)  

Hygiene for food of animal 
origin (Reg. 853/2004)  

General Food Safety 
(Reg. 178/2002) 

Official controls 
(Reg. 882/2004) 

Monitoring and reporting of 
antimicrobial resistance in 
zoonotic and commensal 
bacteria (Impl. Dec. 2013/652/EU) 

Union financial aid for a 
coordinated control plan for 
antimicrobial resistance 
monitoring in zoonotic agents 
in 2014 (Impl. Dec. 2013/653/EU) 

Certification requirements 
for imports of sprouts and 
seeds (Reg. 211/2013)  

Use of lactic acid for surface 
decontamination (Reg. 101/2013)  

Emergency measures 
for fishery products  
(Dec. 2007/642/EC)  

Official controls for 
products of animal origin  
(Reg. 854/2004) 

Reduction of Salmonella enteritidis and Salmonella 
typhimurium in flocks of broilers  (Reg. 200/2012)  

Implementing Reg. 853/2004 on special guarantees 
for Salmonella in certain meat and eggs (Reg. 1688/2005) 

Control of Salmonella 
and other food-borne 
zoonotic agents  
(Reg. 2160/2003) 



























Article 1: Subject matter and 
scope 

Article 3: Competent authorities 

Article 4: Community targets 
for the reduction of the 
prevalence of zoonoses and 
zoonotic agents 

Articles 5-6: National control 
programmes 

Article 7: Food and feed 
business operators' control 
programmes  

Article 8: Control methods 

Article 9: Intra-community 
trade 

Article 10: Imports from third 
countries 

Articles 11-12: Reference 
laboratories 

Articles 13-16: Implementation 

Annex I: specific zoonoses and 
zoonotic agents with 
established targets 

Annex II: control of zoonoses 
and zoonotic agents 

Annex III: specific criteria for 
Salmonella serotypes with 
public health significance 

Monitoring of zoonoses 
and zoonotic agents 
(Dir. 2003/99/EC) 















Ch.I (Art. 1-3): Introductory 
provisions  

Ch.II (Art. 4-6): Monitoring of 
zoonoses and zoonotic agents 

Ch. III (Art. 7): Antimicrobial 
resistance 

Ch. IV (Art. 8): Food-borne 
outbreaks 

Ch. V (Art. 9): Exchange of 
information 

Ch. VI (Art. 10): Laboratories 

Ch. VII-VIII (Art. 11-18): 
Implementation and final 
provisions 

Baseline study on 
Salmonella prevalence 
in laying flocks  
(Dec. 2004/665/EC) 

Financial contribution 
for survey on 
prevalence and AMR of 
Campylobacter and 
Salmonella in broilers 
(Dec. 2007/516/EC) 

Requirements for 
Community funding of 
national programmes 
for the eradication, 
control and monitoring 
of zoonoses and animal 
diseases (Dec. 2008/425/EC) 

Community ref. labs for 
epidemiology of 
zoonoses and for 
salmonella and national 
ref. labs for salmonella 
(Dec. 2004/564/EC) 

Rules for the official 
control of Trichinella 
in meat (Reg. 2075/2005) 

Implem. Reg. 2160/2003 for a Union target for the 
reduction of Salmonella in Gallus gallus (Dec. 2008/425/EC) 

Financial contribution for studies on Salmonella 
prevalence and AMR in different animal species  
(Dec. 2005/636/EC, 2006/662/EC, 2006/668/EC, 2007/208/EC, 
2007/219/EC, 2008/55/EC) 

List of third countries for import of poultry 
and veterinary cert. req. (Reg. 798/2008) 

Figure  32:  Summary  of  the  most  important  legal  documents  in  the  field  of  microbiological  criteria  for  foodstuffs,  control  of  food-borne 
zoonotic agents and of monitoring of zoonoses, zoonotic agents and antimicrobial resistance and cross-links between this documents 

73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. Legislation  related  to  the  manufacturing  step  of  the 

food chain 

6.1.  Food improvement agents 

6.1.1. 

Regulation (EC) No 1331/2008 on a common authorisation 
procedure for food additives, enzymes and flavourings 

Regulation (EC) No 1331/2008 lays down a common procedure for the assessment and 
authorisation  of  food  additives,  enzymes  and  flavourings  aiming  to  assist  the  free 
movement  of  food  and  ensure  the  protection  of  human  health  and  consumer  interests. 
Approved  substances  are  included  in  Community  lists  which  must  be  published  and 
updated.  The  common  procedure  for  updating  such  lists  can  be  initiated  either  by 
Community  initiative  or  after  a  request  of  any  Member  State  or  interested  party.  The 
Commission may consult EFSA during the procedure. The common procedure ends with 
the  adoption  of  a  Regulation  implementing  the  update  by  the  Commission,  unless  the 
Commission decides that such an update is not justified. 

Regulation  (EC)  No  1331/2008  describes  in  detail  the  procedure  to  be  followed, 
establishes  timelines  for  the  different  steps  and  procedures  for  urgent  situations.  It 
highlights  the  principle  of  transparency  in  the  activities  of  the  Authority  and  lays  down 
provisions for the confidentiality of certain data. 

6.1.2. 

Regulation (EC) No 1333/2008 on food additives 

Regulation  (EC)  No  1333/2008  lays  down  requirements  for  food  additives,  substances 
not  normally  consumed  as  food  themselves  but  added  to  food  intentionally  to  serve  a 
technological  purpose,  thus  resulting  in  their  presence  as  components  of  the  food.  The 
Regulation provides for lists of approved food  additives, conditions for their use in food 
or within food additives, food enzymes and food flavourings and lays down rules for the 
labelling of food additives intended for sale. It also lists products that are not considered 
as food additives and defines processing aids.  

Food  additives  or  foods  containing  food  additives  must  not  be  placed  on  the  market  if 
they  do  not  comply  with  the  provisions  of  the  Regulation.  Additives  are  included in  the 
Community  lists  if  it  can  be  demonstrated  that,  at  their  level  of  use,  they  do  not  pose 
any  risk  to  consumer  health,  they  are  necessary  for  specific  technological  functions  for 
which  there  are  no  alternatives  and  their  use  does  not  mislead  the  consumer.  Some 
specific conditions for the use of certain additives, sweeteners and colours are also laid 
down. 

Depending  on  the  principal  technological  function  they  serve,  food  additives  are 
categorised  in  certain  functional  classes  which  are  laid  down  in  Annex  I  of  the 
Regulation. Additives however may be used for more than one function. For the additives 
included  in  the  Annexes  to  the  Regulation  the  Community  list  must  also  specify  their 
name  and  E  number,  the  foods  in  which  they  may  be  added  and  the  conditions  of  use 
and whether there are any restrictions in their sale to the consumer. Levels of use must 
generally be established at the lowest possible level to achieve the intended function and 
must  consider  any  acceptable  daily  intake  established  or  for  specific  consumer  groups. 
Certain food additives may be used according to the principle of quantum satis, meaning 
in accordance with good manufacturing practice and at a level no higher than necessary 

74 

 
 
 
 
 
 
to  achieve  the  intended  purpose  and  without  misleading  the  consumer.  Also  special 
provisions  are  laid  down  for  the  prohibition  of  use  of  certain  additives  in  specific 
traditional food products in certain Member States. 

The  Regulation  establishes  that  food  additives  manufactured  in  significantly  different 
ways than the one of the original entry of the food additive in the list of the Regulation 
must  be  considered  as  new  additives  and  new  entries  will  be  required.  Food  additives 
must not be used in unprocessed foods or in foods for infants and young children, unless 
specifically  provided  for.  The  Regulation  also  allows  for  the  presence  of  certain  food 
additives  in  compound  food  products,  where  their  presence  is  permitted  in  one  of  their 
ingredients  and  they  have  been  carried  to  the  final  products  through  those  ingredients 
and provided they have no function in the finished product (carry-over principle). Finally 
the Regulation lays down rules for the labelling of food additives intended for sale to the 
final consumer or not, as well as for products that contain food colours. 

The Regulation requires producers and users of food additives to inform the Commission 
with regard to new information on the safety of food additives. Also Member States are 
required to monitor the consumption and use of food additives and inform the Authority 
and the Commission.  

Figure  33  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  1333/2008.  More  details  on  legislation  adding  information  for  the 
implementation of this Regulation can be found in Annex XXII. 

Food additives 
(Regulation (EC) No 1333/2008) 

Use of food additives in food 

Level of use of food additives 

Specifications of food additives 

Labelling 

Monitoring of food additive intake 

Re-evaluation of approved food 
additives 

Functional classes of food additives 

Union list of approved food 
additives 

Figure  33:  Summary  of  the  requirements  of  Regulation  (EC)  No  1333/2008  on  food 
additives 

75 

 
 
 
 
 
 
6.1.3. 

Regulation (EC) No 1332/2008 on food enzymes  

Regulation (EC) No 1332/2008 on food enzymes covers enzymes used in food and those 
used  as  processing  aids  and  establishes  a  Community  list  of  approved  enzymes,  the 
conditions  of  use  of  enzymes  in  food  and  rules  for  their  labelling  when  sold  as  such. 
Enzymes used in the manufacture of food additives or processing aids are excluded from 
the scope of this Regulation as well as microbial cultures used in the production of food 
that  may  produce  enzymes.  Enzymes  that  do  not  comply  with  the  provisions  of  this 
Regulation  or  food  containing  such  enzymes  may  not  be  placed  on  the  market.  The 
Regulation also lays down conditions for the inclusion of enzymes in the Community list: 
they  pose  no  safety  concern  to  consumer  health,  there  is  a  reasonable  technological 
need  for  their  use  and  they  do  not  mislead  the  consumer.  The  details  that  need  to  be 
included in the Community list for each approved additive are also listed.  

The Regulation also lays down details on the labelling of food enzymes and food enzyme 
preparations  intended  or  not  for  sale  to  the  final  consumer.  The  producers  or  users  of 
food  enzymes  are  required  to  inform  the  Commission  of  any  scientific  and  technical 
information  relevant  to  the  safety  assessment  of  food  enzymes,  of  any  changes  in  the 
production method or starting materials used, or of the actual use of the enzyme.  

Figure  34  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation (EC) No 1332/2008. Details of legislation adding implementation information 
to the Regulation can be found in Annex XXIII. 

Community list of approved food 
anzymes 

Food enzymes (Reg. 1332/2008) 

Labelling 

Information obligation 

Figure  34:  Summary  of  the  provisions  of  Regulation  (EC)  No  1332/2008  on  food 
enzymes 

6.1.4. 

Regulation (EC) No 1334/2008 on food flavourings 

Regulation  (EC)  No  1334/2008  establishes  a  list  of  approved  flavourings  and  source 
materials for their production, conditions for their use in food and rules on the labelling 

76 

 
 
 
 
 
 
 
 
of  flavourings.  Definitions  are  laid  down  for  flavourings,  flavouring  substances,  natural 
flavouring  substances,  flavouring  preparations,  thermal  process  flavourings,  smoke 
flavourings,  flavour  precursors  and  other  flavourings.  Flavourings  may  only  be  used  in 
food if they do not pose any safety risk and their use does not mislead the consumer. 

Annex III to the Regulation lays down a list of substances which must not be added as 
such  to  food.  Also  the  same  Annex  lists  maximum  levels  for  certain  naturally  present 
substances  in  flavourings  and  food  ingredients  with  flavouring  properties  in  compound 
foods  to  which  flavourings  or  ingredients  with  flavouring  properties  have  been  added. 
Annex IV lays down a list of source materials which must not be used for the production 
of flavourings or food ingredients with flavouring properties and a list of source materials 
that  may  be  used  but  the  flavourings  or  food  ingredients  with  flavouring  properties 
produced  from  those  must  meet  the  conditions  specified  in  the  Annex.  Also  the 
Regulation lays down a list of flavourings and food ingredients with flavouring properties 
for which an evaluation is not required, provided they are safe and not misleading. 

The  Regulation  also  specifies  flavourings  and  source  materials  for  the  use  of  which  an 
evaluation and approval is required in accordance with Reg. (EC) No  1331/2008. Those 
approved must be included in the Community list of flavourings and source materials and 
their use must conform to the conditions specified therein.  

Specific provisions are established for the use of the term "natural" for the description of 
flavourings in different contexts and finally for the labelling of flavourings for sale directly 
to the final consumer. 

Regulation  (EC)  No  1334/2008  establishes  the  requirement  for  producers  and  users  of 
flavourings  to  inform  the  Commission  of  the  amounts  and  substances  they  use.  Also 
production methods for flavourings significantly different from the one originally included 
in the risk assessment must be communicated to EFSA as well as any new scientific and 
technical knowledge that may affect the safety assessment of flavouring substances.  

Member  States  must  establish  systems  to  monitor  the  consumption  and  use  of 
flavourings  and  of  restricted  substances  included  in  the  Regulation  and  a  common 
methodology must be adopted for gathering this information.  

Figure  35  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation (EC) No 1334/2008 while details on legislation related and adding to certain 
of the requirements of this Regulation can be found in Annex XXIV. 

77 

 
 
 
 
 
 
Flavourings and food 
ingredients with flavouring 
properties 
Regulation (EC) No 1334/2008 

Conditions for use 

Labelling  

requirements for use of the 
term "natural" 

Monitoring and reporting by 
the MS 

flavouring substances 

flavouring preparations 

thermal process flavourings 

flavour precursors 

other flavourings 

source materials 

Union list 

List of traditional food 
preparation processes 

Presence of certain substances 

List of source materials 
restricted for use in the 
production of flavourings 

Conditions for the production 
of themral process flavourings 
and maximum levels 

Figure  35:  Summary  of  the  provisions  of  Regulation  (EC)  No  1334/2008  on  flavourings 
and food ingredients with flavouring properties 

78 

 
 
 
 
 
6.1.5. 

Regulation (EC) No 2065/2003 on smoke flavourings 

Regulation  (EC)  No  2065/2003  lays  down  the  Community  procedure  for  the  evaluation 
and authorisation of primary smoke condensates and primary tar fractions for use in or 
on  foods  or  for  the  production  of  smoke  flavourings  as  well  as  the  procedure  for  the 
establishment  of  Community  lists  of  the  above  substances  and  the  conditions  for  their 
use in food.  

The  Regulation lays  down  the  safety  requirements  for  smoke  flavourings  as  well  as  the 
conditions  for  their  production.  It  implements  the  establishment  of  a  Community  list  of 
authorised primary products and the procedure for such an authorisation. The Regulation 
also lays down certain responsibilities for the  food business  operators that place smoke 
flavourings on the market. 

The  below  figure  provides  a  graphical  representation  of  the  main  content  and 
requirements  of  Regulation  (EC)  No  2065/2003.  Details  on  additional  legislation  laying 
down  implementing  measures  for  certain  of  the  requirements  of  the  Regulation  can  be 
found in Annex XXV. 

Use and safety 
requirements 

Conditions of production 

Community list of 
authorised primary 
products 

Smoke flavourings 
Reg. (EC) No 
2065/2003 

Traceability  

public access 

Treatment of data 

confidentiality 

Inspection and control 
measures 

data protection 

Conditions for the 
production of primary 
products 

Information for the 
scientific evaluationof 
primary products 

Figure  36:  Summary  of  the  provisions  of  Regulation  (EC)  No  2065/2003  on  smoke 
flavourings used or intended to be used in or on food 

79 

 
 
 
 
 
 
6.1.6. 

Directive  2009/32/EC  on  extraction  solvents  used  in  the 
production of foods and food ingredients  

Extraction  solvents  used  for  the  production  of  food  additives,  vitamins  and  nutritional 
additives  are  excluded  from  the  scope  of  this  Directive,  unless  included  in  its  Annex  I. 
The  substances  listed  in  Annex  I  must  be  authorised  in  the  Member  States  under  the 
conditions  of  use  and  maximum  limits  specified  within  the  Annex.  However,  Member 
States must not authorise other substances, nor extend the conditions of use or residues 
authorised. 

The Directive also specifies purity criteria for the authorised extraction solvents of Annex 
I  and  requires  the  establishment  of  Community  procedures  for  the  amendment  of  this 
Annex  and  of  methods  of  analysis  to  ensure  compliance  with  its  requirements.  Specific 
details are also provided on the information that must be indicated on the packaging and 
containers  of  extraction  solvents  for  use  in  foodstuffs.  Also  the  Directive  applies  to 
extraction  solvents  used  in  the  production  of  foodstuffs  to  be  imported  in  the 
Community. Figure 37 summarises the basic requirements of Directive 2009/32/EC. 

Extraction solvents for the 
production of food and food 
ingredients (Dir. 2009/32/EC) 

Authorisation of 
extraction solvents 

General and 
specific purity 
criteria 

Safeguard 
measures 

Labelling 

Extraction solvents 
which may be used 
in processing 

Figure 37: Summary of the provisions of Directive 2009/32/EC on extraction solvents for 
the production of food and food ingredients. 

The  following  figure  summarises  the  most  important  legal  documents  in  the  field  of 
chemical food additives, food enzymes and food flavourings and their inter-relationships. 

80 

 
 
 
 
 
 
Food additives  
(Reg. 1333/2008) 













Articles 1-3: Subject matter, 
scope, definitions 

Articles 4-14: Community lists 
of approved food additives 

Articles 15-20: Use of food 
additives in foods 

Articles 21-25: Labelling 

Articles 26-29: Procedural 
provisions and implementation 

Articles 30-35: Transitional and 
final provisions 

Specifications for food 
additives listed in Annexes II 
and III of Reg. 1333/2008 
(Reg. 231/2012) 

Authorising substances as 
novel food ingredients (Impl. 
Dec. 2012/288/EU, 2013/49/EU) 

Novel foods and novel food 
ingredients (Reg. 258/97) 

National provisions notified 
by Denmark on the addition 
of nitrite to certain meat 
products (Dec. 2010/561/EU) 

Financing for harmonised 
policies implementation 
(Impl. Dec. 2013/C 170/06) 

Financing of the 2014 work 
programme on IT tools for food 
safety (Impl. Dec. 2014/C 72/05) 

Programme for re-evaluation of 
approved food additives (Reg. 257/2010) 

Adoption/financing of the 2014 
work programme on activities to 
ensure the application of food 
legislation (Impl. Dec. 2014/C 166/05) 

Plastic materials and articles 
intended to come into contact 
with food (Reg. 10/2011) 

Union list of 
authorised smoke 
flavouring primary 
products  
(Impl. Reg. 1321/2013) 

Making available on the 
market and use of biocidal 
products (Reg. 528/2012) 

Impl. Reg. 2065/2003 
on quality criteria for 
validated anal. methods 
for primary smoke 
products (Reg. 627/2006) 

Common authorisation 
procedure for food 
additives, enzymes and 
flavourings (Reg. 1331/2008) 

Implementing Reg. 
1331/2008 (Reg. 234/2011) 

Fruit juices and 
similar products for 
human consumption 
(Dir. 2001/112/EC) 

Aromatised wine products 
(definition, description, 
presentation, labelling 
and the protection of 
geographical indications) 
(Reg. 251/2014) 

Provision of food 
information to consumers 
(Reg. 1169/2011) 

Smoke flavourings for use in or 
on food (Reg. 2065/2003) 

1

2

3

4

5

6

7

Articles 1-4: Subject matter, scope, 
definitions, safety 

Article 5: Conditions of production 

Article 6-12: Community list of authorised 
primary products and procedure 

Articles 13-16: Traceability/Confidentiality 

Article 17: Inspection/Control 

Annex I: Conditions for the production of 
primary products 

Anne II: Necessary information for the 
evaluation of primary products 

Food enzymes  
(Reg. 1332/2008) 











Articles 1-3: Subject matter, 
scope, definitions 

Articles 4-9: Community lists of 
approved food enzymes 

Articles 10-13: Labelling 

Articles 14-16: Procedural 
provisions and implementation 

Articles 17-24: Transitional and 
final provisions 

Spirit drinks (definition, 
description, presentation, 
labelling and the 
protection of geographical 
indications) (Reg. 110/2008) 

Transitional measures 
for Reg. 1334/2008 (Reg. 
873/2012) 

Adopting the Union list 
of flavouring substances 
(Reg. 872/2012) 

REPEALED - Community 
procedure for flavouring 
substances for use in 
food (Reg. 2232/96) 

Denial of authorisation of 
a substance as feed 
additive (Impl. Reg. 796/2013) 

Lactoproteins (caseins 
and caseinates) intended 
for human consumption  
(Dir. 83/417/EEC) 

Implem. Reg. 479/2008 
on restrictions of 
grapevine product 
categories and oenological 
processes (Reg. 606/2009) 

Flavourings and food 
ingredients with flavouring 
properties (Reg. 1334/2008) 























Articles 1-3: Subject matter, scope, 
definitions 

Articles 4-8: Conditions for use of 
flavourings, food ingredients with 
flavouring properties and source 
materials 

Articles 9-13: Community list of 
flavourings and source materials 
approved for use in or on foods 

Articles 14-18: Labelling 

Articles 19-23: Procedural provisions 
and implementation 

Articles 24-30: Transitional and final 
provisions 

Annex I: Union list of flavourings and 
source materials 

Annex II: List of traditional food 
preparation processes 

Annex III: Presence of certain 
substances 

Annex IV: List of source materials to 
which restrictions apply for their use 
in the production of flavourings and 
food ingredients with flavouring 
properties 

Annex V: Conditions for the 
production of thermal process 
flavourings and maximum levels for 
certain substances  in thermal 
process flavourings 

Figure 38: Summary of the most important legal documents in the field of food additives, food enzymes and food flavourings 

81 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2.  Contaminants 

6.2.1. 

Council  Regulation  (EEC)  No  315/93  laying  down  Community 
procedures for contaminants in food 

Regulation (EEC) No 315/93 lays down Community procedures for contaminants in food. 
The  Regulation  is  aimed  to  cover  any  substance  present  in  food  as  a  result  of  the 
production,  manufacture,  processing,  preparation,  treatment,  packing,  packaging, 
transport  or  holding  of  food  or  as  a  result  of  environmental  contamination,  while 
extraneous matter that can be present in food is excluded from the scope. 

Contaminant levels in food must be kept as low as can be reasonably achieved (ALARA) 
by  using  good  practices  in  all  the  above  stages  of  manufacturing  or  related  processes, 
while food containing contaminants at levels that are considered not acceptable must not 
be placed on the market. The Regulation requires the establishment of limits for different 
contaminants in different foodstuffs as well as methods for the sampling and analysis for 
such  substances  and  detection  limits.  Any  product  that  complies  with  these  provisions 
must not be restricted from placement on the market for any reason. 

Figure  39  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EEC)  No  315/93,  while  more  detailed  information  on  legislative  documents 
adding implementing information to the above Regulation is provided in Part I of Annex 
XXVI. 

Community 
procedures on 
contaminants in food 
(Reg. 315/93) 

General provisions 

Safeguard measures 

National measures 

Annual report on 
development of 
European legislation 
on contaminants 

Consultation of 
Scientific Committee 
for Food 

Figure 39: Summary of the requirements of Regulation (EEC) No 315/93 on Community 
procedures for contaminants in food 

82 

 
 
 
 
 
  
 
 
6.2.2. 

Commission Regulation (EC) No 1881/2006 setting maximum 
levels for certain contaminants in foodstuffs 

Regulation  (EC)  No  1881/2006  lays  down  maximum  levels  for  certain  contaminants  in 
foodstuffs.  In  order  to  protect  public  health,  contaminants  must  be  kept  at  levels  that 
are  toxicologically  acceptable.  These  maximum  levels  are  strict  but  reasonably 
achievable when following good practices and take into account the risk from consuming 
the  food.  For  contaminants  that  are  genotoxic  carcinogens  and  the  exposure  of 
populations  is  close  to  or  exceeds  the  tolerable  daily  intake,  maximum  levels  are 
established  under  the  principle  of  "as  low  as  reasonably  achievable"  (ALARA).  These 
measures  ensure  that  food  business  operators  take  measures  to  prevent  and  reduce 
contamination.  The  Regulation  lays  down  maximum  levels  for  certain  contaminants  in 
different  foodstuffs  and  products  that  exceed  these  levels  must  not  be  placed  on  the 
market. These maximum levels must be applied taking into consideration concentration 
changes  due  to  drying,  dilution,  relative  proportions  of  ingredients  but  also  considering 
the  analytical  limit  of  quantification.  Specific  concentration  or  dilution  factors  must  be 
applied by the operators, which must also be available to the authorities for inspection.  

When foodstuffs do not comply with the maximum levels established, they must not be 
used  as  food  ingredients,  they  must  not  be  mixed  with  foodstuffs  that  meet  the 
maximum  levels  or  that  are  intended  for  sorting  or  other  physical  treatment  and  they 
must  not  be  detoxified  by  chemical  treatments.  Sampling  and  analysis  must  be 
performed  according  to  specific  Commission  provisions.  Member  States  have  the 
obligation to monitor contaminant levels in different products and communicate these to 
EFSA and they must report on the results of applying different prevention measures for 
different contaminants. 

Figure  40  provides  a  graphical  representation  of  the  main  content  and  requirements  of 
Regulation  (EC)  No  1881/2006.  More  detailed  information  on  legislation  related  and 
adding  to  the  main  requirements  of  this  Regulation  can  be  found  in  Part  II  of  Annex 
XXVI.  

83 

 
 
 
 
 
 
Prohibitions on use, mixing 
and detoxification 

Specific provisions 

nitrate 

Maximum levels for certain 
contaminants in foodstuffs 
(Reg. 1881/2006) 

Sampling and analysis 

mycotoxins 

Monitoring and reporting 

metals 

Maximum levels 

3-MCPD 

dioxins and PCBs 

polycyclic aromatic 
hydrocarbons 

melamine and structural 
analogues 

Figure  40:  Summary  of  the  requirements  of  Regulation  1881/2006  on  maximum  levels 
for certain contaminants in foodstuffs 

Figure  41  provides  a  summary  of  the  most  important  legal  documents  in  the  field  of 
contaminants in foodstuffs. 

84 

 
 
 
 
 
 
 
 
Detailed rules for the implementation 
of Reg. 1234/2007 (Reg. 1272/2009) 

Methods for sampling and analysis for 
the official control of mycotoxins in 
foodstuffs (Reg. 401/2006) 

Maximum levels for 
coccidiostats or histomonostats 
in food as unavoidable carry-
over in non-target feed  
(Reg. 124/2009)  

Procedures for Contaminants 
in food (Reg. 315/93) 



Article 2 

General Food Safety 
(Reg. 178/2002) 

Maximum levels for 
certain contaminants in 
foodstuffs (Reg. 1881/2006)  



Annex: Maximum levels for 
contaminants in foodstuffs 

Special conditions 
for import of 
foodstuffs from 
third countries due 
to aflatoxin risk  
(Reg. 1152/2009)  

Methods for sampling and analysis for 
the official control of: 


lead, cadmium, mercury, inorganic 
tin, 3-MCPD and polycyclic aromatic 
hydrocarbons (Reg. 333/2007) 

 nitrates (Reg. 1882/2006) 
 dioxins, dioxin-like PCBs and non-
dioxin-like PCBs (Reg. 252/2012) 

Reduction of the presence of 
dioxins, furans and PCBs in food 
and feed (Recom. 2013/711/EU)  

Undesirable substances in 
animal feed (Dir. 2002/32/EC) 

Prevention and reduction of 
Fusarium toxins in cereals 
(Recom. 2006/583/EC)  

Official controls for compliance 
with food/feed law, animal health 
and animal welfare (Reg. 882/2004) 

Figure 41: Summary of the most important legal documents in the field of contaminants in foodstuffs. 

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.3.  Food  and  food 

ingredients  treated  with 

ionising 

radiation  

6.3.1. 

Directive  1999/2/EC  of  the  European  Parliament  and  of  the 
Council  on  the  approximation  of  the  laws  of  the  Member 
States  concerning  foods  and  food  ingredients  treated  with 
ionising radiation  

Directive  1999/2/EC  applies  to  the  manufacturing,  marketing  and  importation  of  foods 
and  food  ingredients  treated  with ionising  radiation  excluding  foods  exposed  to  ionising 
radiation generated by  measuring or inspection devices and foods intended for patients 
on a sterile diet. Irradiated foodstuffs may only be placed on the market if they comply 
with this Directive. The Directive lays down conditions for the authorisation of treatment 
of  foodstuffs  with  ionising  radiation.  Foodstuffs  must  be  wholesome  at  the  time  of 
treatment.  It  also  lays  down  the  sources  of  irradiation  that  may  be  used,  while 
treatments  must  follow  the  FAO/WHO  Codex  Alimentarius  Commission  Recommended 
International  Code  of  Practice  for  the  Operation  of  irradiation  facilities  used  for  the 
treatment of foods. The Directive indicates how to calculate the overall average absorbed 
irradiation dose in treated products. It requires the establishment of a Community list of 
foodstuffs  that  may  be  treated  with  ionising  irradiation  and  the  maximum  authorised 
doses  that  may  be  applied  in  partial  doses  or  in  a  single  dose.  Treatment  with  ionising 
radiation  may  not  be  used  in  combination  with  any  other  chemical  treatment  for  the 
same purpose. Provisions are also laid down for the labelling of treated foodstuffs, while 
such treatment must always be indicated in the accompanying documents. 

Directive 1999/2/EC requires the competent authorities appointed for the purposes of its 
implementation  to  be  communicated  to  the  Commission.  Irradiation  facilities  may  only 
be approved if they meet the requirements of the above-mentioned Code of Practice and 
if  they  have  appointed  a  person  responsible  for  the  compliance  with  the  requirements 
related  to  such  treatments.  The  Commission  must  have  the  details  of  all  irradiation 
facilities operating in the Member States and the results of all checks carried out in these 
facilities in relation to types and quantities of treated products and doses administered, 
as  well  as  results  at  the  marketing  step.  This  will  enable  the  Commission  to  publish  a 
relevant report. Irradiation facilities must also keep records of all treatments carried out 
and their details.  

The  Directive  also  lays  down  requirements  for  the  import  of  treated  products  that  may 
only  originate  from  facilities  approved  and  included  in  the  Community  list.  Packaging 
materials  used  for  irradiated  products  must  be  suitable  for  the  purpose.  The  Scientific 
Committee  for  Food  must  be  consulted  for  all  issues  related  to  the  scope  of  this 
Directive.  Finally  the  Directive  allows  for  amendments  in  light  of  new  scientific  and 
technical information and for safeguard measures. More detail and additional legislation 
relevant for the implementation of Directive 1999/2/EC are provided in Annex XXVII.  

Figure  42  summarises  the  legislative  acts  in  the  field  of  treatment  of  food  and  food 
ingredients with ionising radiation.  

86 

 
 
 
 
 
 
 
 
 
Foods and food ingredients 
treated with ionising 
radiation (Dir. 1999/2/EC) 

Community list of foods and food 
ingredients treated with ionising 
radiation (Dir. 1999/3/EC) 

List of approved facilities in third 
countries for the irradiation of 
foods (Dec. 2002/840/EC) 

•

•

•

Article 4 

Article 6 

Article 9 

Provision of food 
information to the 
consumers (Reg. 1169/2011) 

Figure  42:  Summary  of  legislative  acts  in  the  field  of  treatment  of  food  and  food 
ingredients with ionising radiation 

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.4.  Novel foods and novel food ingredients 

Foods  and  food  ingredients  that  have  not  been  used  for  human  consumption  to  a 
significant  degree  in  the  EU  before  15  May  1997  are  considered  novel  foods  and  novel 
food  ingredients.  These  products  are  regulated  by  Regulation  258/97  concerning  novel 
foods and novel food ingredients, which is currently subject to revisions with main focus 
foods  from  clones.  (More  details  on  the  revision  process  can  be  found  here: 
http://ec.europa.eu/food/food/biotechnology/novelfood/initiatives_en.htm) 

6.4.1. 

Regulation  (EC)  No  258/97  concerning  novel  foods  and  novel 
food ingredients 

Reg.  (EC)  258/97  lays  down  the  rules  for  authorisation  of  novel  foods  and  food 
ingredients  and  requires  test  to  be  carried  out  prior  to  placement  on  the  market 
demonstrating  that  these  products  do  not  pose  any  risk  to  both  the  environment  and 
consumer’s  health.  Foods  and  food  ingredients  that  are  not  yet  used  for  human 
consumption  are  defined  as  novel  foods.  It  applies  to  foods:  with  a  modified  primary 
molecular  structure,  that  consists  of  microorganisms,  foods  that  contain  ingredients 
isolated  from  plant  or  animals.  This  Regulation  does  not  apply  to  food  additives, 
flavourings,  extraction  solvents  and  food  enzymes.  Genetically  Modified  Organisms 
(GMO) are now regulated by Regulation (EC) 1823/200332 and are no longer covered by 
Reg.  (EC)  258/97.  Applicants  shall  submit  their  application  along  with  scientific 
information and risk assessment report to the MS authority and a copy of the request to 
the Commission. The MS authority shall provide the initial decision, which can a) be that 
the product can be placed on the market (no additional assessment is necessary and no 
reasoned  objection  from  the  Commission  or  other  EU  countries)  or  b)  that  an 
authorisation  decision  is  required.  In  the  event  of  objections  then  an  authorisation 
decision is required, in accordance with the rules governing the Standing Committee on 
Food  Chain  and  Animal  Health.  For  novel  foods  which  are  likely  to  have  an  effect  on 
public  health,  the  Scientific  Committee  for  Food  is  also  consulted.  As  of  the  labelling  of 
such  products,  without  prejudice  to  labelling  laws,  they  should  also  mention: 
composition  and  nutrition  characteristics,  presence  of  materials  that  might  have  health 
implications or raise ethical concerns.  If a MS considers that a product can pose risk to 
the  consumers  or  the  environment,  because  of  new  information  made  available,  it  can 
suspend or temporarily restrict the marketing of this product and notify the Commission. 

Figure  43  provides  a  summary  of  the  legislation  relevant  for  the  implementation  of 
Regulation  258/97  while  more  details  on  the  related  legislation  is  provided  in  Annex 
XXVIII. 

32 Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed. Official Journal of 
the European Union (2003). L. 268/1 

88 

 
 
 
 
 
 
 
 
                                                           
Figure  43:  Summary  of  the  legislation  on  novel  foods  and  cross  interaction  with  other 
legal  acts.  Red  arrows  correspond  to  legislation  referring  and  /or  adding  to  the  main 
novel foods legislation. Blue arrows correspond to legislation referred in the Novel Foods 
legislation 

89 

 
 
 
 
 
 
7. Legislation  related  to  the  packaging  step  of  the  food 

chain 

7.1.  Packaging materials and materials in contact with food 

7.1.1. 

Regulation  (EC)  No  1935/2004  of  the  European  Parliament 
and of the Council on materials and articles intended to come 
into contact with food 

Regulation  (EC)  No  1935/2004  lays  down  provisions  for  materials  and  articles  intended 
to come into contact with food (directly or indirectly) to be placed on the market with the 
aim to protect human health and consumer interests and ensure the effective functioning 
of  the  internal  market.  The  scope  also  includes  active  and  intelligent  materials  and 
articles,  but  excludes  antiques,  covering  and  coating  materials  and  water  supply 
equipment.  Materials  and  articles  intended  to  come  into  contact  with  food  must  be 
manufactured according to Good Manufacturing Practice (GMP) and the aim is that their 
constituents are not transferred in food in such quantities as to pose a threat to human 
health  or  affect  the  composition  or  the  organoleptic  properties  of  the  food.  It  is  also 
mentioned that the labelling, presentation and advertising of such materials and articles 
must not mislead the consumer. 

Special  provisions  are  laid  down  for  active  and  intelligent  materials  and  articles.  Until 
more  specific  provisions  are  established  for  such  materials,  incorporated  substances 
must  be  authorised  and  must  meet  the  requirements  of  the  Regulation.  They  must  be 
considered as food ingredients and their use must not mislead the consumer in any way. 
The labelling of such materials must indicate their active or intelligent function and allow 
consumers to distinguish possible non-edible parts. The Regulation also lays down a list 
of  materials  and  articles  for  which  more  specific  measures  must  be  established.  In  the 
absence of such more specific measures, Member States may adopt national provisions. 
If  these  provisions  are  likely  to  affect  public  health,  EFSA  must  be  consulted.  Materials 
and  articles  covered  by  the  above  provisions  must  be  accompanied  by  a  written 
declaration  of  compliance  and  appropriate  documentation  must  be  in  place  to 
demonstrate this. 

Substances may only be used in the manufacture of materials and articles to come into 
contact with food, if they are authorised and included in positive lists. Alternatively they 
must  be  subjected  to  an  authorisation  procedure  and  the  details  are  laid  down  in  the 
Regulation. Provisions are also laid down for modifications to such authorisations and for 
emergency  situations.  This  information  must  be  publicly  available,  however  the 
confidentiality of certain information is also recognised. Sharing of certain data between 
applicants  for  the  purposes  of  authorisation  is  encouraged.  Member  States  must 
designate competent authorities for the purposes of this Regulation and they must notify 
their details to the Commission and EFSA. 

Some  additional  labelling  requirements  are  laid  down  for  materials  not  yet  in  contact 
with food but intended for such use. These must be accompanied by the words "for food 
contact" or a more specific indication of their intended use and by the symbol of Annex 
II to the Regulation. The Regulation emphasises that traceability of materials and articles 
must be ensured at all stages. It is the responsibility of the food business operator to be 
able  to  identify  the  businesses  from  and  to  which  materials  and  articles  or  substances 
within the scope of this Regulation are supplied. Also materials and articles placed in the 
Community  market  must  be  identifiable  by  an  appropriate  system.  Finally  official 
controls  must  be  carried  out  in  the  Member  States  to  ensure  compliance  with  the 
requirements of this Regulation and sanctions are in place in case of infringements. 

90 

 
 
 
 
The  following  figure  shows  the  main  requirements  of  Regulation  (EC)  No  1935/2004. 
More  detail  on  some  of  these  requirements  as  well  as  additional information  on  related 
implementing measures is provided in Annex XXIX. 

s
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Special requirements for active and 
intelligent materials and articles 

Specific measures for groups of materials 
and articles 

National specific measures 

Role of EFSA 

Authorisation of substances 

MS competent authorities 

Labelling 

Declaration of compliance 

Traceability 

Safeguards 

Handling of data 

Inspection and control measures 

Sanctions 

Figure 44: Main provisions of Regulation (EC) No 1935/2004  

7.1.2. 

Council  Directive  82/711/EEC  laying  down  the  basic  rules 
necessary  for  testing  migration  of  the  constituents  of  plastic 
materials  and  articles  intended  to  come  into  contact  with 
foodstuffs 

Directive  82/711/EEC  applies  to  plastic  materials  and  articles  intended  to  come  into 
contact  with  food.  It  indicates  that  migration  of  constituents  of  these  materials  in  food 
must  not  exceed  the  specifically  established  limits.  Compliance  of  materials  with  the 
migration limits must be verified under the most extreme conditions of use and with the 
conventional  tests  laid  down  in  the  Annex.  It  also  lays  down  the  rules  for  migration 
testing and details on food simulants, migration test conditions and fat tests for specific 

91 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and overall migration. Figure 45 shows the main requirements of Directive 82/711/EEC. 
More  information  on  certain  of  the  requirements  of  the  Regulation  and  on  additional 
legislation complementing the implementation of its provisions is provided in Annex XXX. 

Rules for testing 
migration of constituents 
of plastic materials and 
articles (Dir. 82/711/EEC)  

Field of 
application 

Migration 
levels of 
constituents in 
food 

Rules for 
verification of 
compliance of 
migration in 
food 

Basic rules for 
overall and 
specific 
migration 
testing 

Food 
simulants 

Migration test 
conditions 

Substitute fat 
test for overall 
and specific 
migration 

Alternative fat 
test for overall 
and specific 
migration 

Figure 45: Main provisions of Directive 82/711/EEC 

Figure 46 summarises the legal documents in the field of materials and articles intended 
to come into contact with food and their inter-relationship. 

92 

 
 
 
 
 
 
 
 
Basic rules for testing migration of 
constituents of plastic materials 
and articles intended to come into 
contact with food (Dir. 82/711/EEC) 





Article 2 

Annex: Basic rules for overall and specific 
migration testing  

Materials and articles intended 
to come into contact with food 
(Reg. 1935/2004) 





















Article 1: Purpose and subject matter 

Article 3: General requirements  

Article 4: Special requirements for active 
and intelligent materials and articles 

Article 5: Specific measures for groups of 
materials and articles 

Articles 8-12: Authorisation requirements  

Article 15: Labelling 

Article 16: Declaration of compliance 

Article 17: Traceability 

Article 18: Safeguard measures  

Article 24: Inspection and control 
measures 

Good manufacturing practice 
for materials and articles 
intended to come into contact 
with food (Reg. 2023/2006) 

Release of N-nitrosamines and 
N-nitrosatable substances from 
elastomer or rubber teats and 
soothers (Dir. 93/11/EEC) 

Simulants to be used in migration 
testing of plastic materials and 
articles intended to come in 
contact with food (Dir. 85/572/EEC) 

Materials and articles made of 
regenerated cellulose film and 
intended to come into contact 
with food (Dir. 2007/42/EC) 

Active and intelligent materials and 
articles intended to come into contact 
with food (Reg. 450/2009) 

Approval of substances as 
active substances for use in 
different biocidal product-
types (Impl. Reg. 1035/2013, 
90/2014, 93/2014, 94/2014) 

Plastic materials and 
articles intended to come 
into contact with food 
(Reg. 10/2011) 

Restriction of use of Bisphenol 
A in plastic infant feeding 
bottles (Impl. Reg. 321/2011) 

Ceramic articles intended 
to come into contact with 
food (Dir. 84/500/EEC) 

Restriction of use of certain 
epoxy derivatives in materials 
and articles intended to come 
into contact with food  
(Reg. 1895/2005) 

Non-inclusion of a substance 
in the Union list of additives 
for use in plastic materials 
and articles intended to come 
into contact with food under 
Directive 2002/72/EC  
(Dec. 2010/169/EU) 

Specific conditions and 
procedures for import of 
plastic kitchenware from 
China and Hong-Kong 
(Reg. 284/2011) 

Figure 46: Summary of the legal documents in the field of materials and articles intended to come into contact with food  

93 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. Legislation related to placing foods on the market 

8.1.  Food Information to Consumers 

Regulation  (EU)  1169/2011  on  the  provision  of  food  information  to  consumers      was 
adopted by the European Parliament and the Council, entered into force on 12 December 
2011  and  applies  from  13  December  2014,  while  the  obligation  to  provide  nutrition 
information will apply from 13 December 2016. Any reference to the repealed Directives 
2000/13/EC  on  labelling,  presentation  and  advertising  of  foodstuffs  and  90/496/EEC  on 
nutrition labelling for foodstuffs   shall be considered as references to Reg. 1169/2011. 

8.1.1. 

Directive 2000/13/EC of the European Parliament and of the Council 
of  20  March  2000  on  the  approximation  of  the  laws  of  the  Member 
States  relating  to  the  labelling,  presentation  and  advertising  of 
foodstuffs 

This  Directive  provides  the  general  principles  for  labelling,  presentation  and  advertising 
of  pre-packaged  foodstuffs.  Compulsory  information  shall  include:  name,  list  of 
ingredients  (in  descending  order  of  weight),  quantity  of  ingredients  or  categories  of 
ingredients  expressed  as  a  percentage,  net  quantity  for  pre-packaged  foods,  date  of 
minimum durability (d/m/y) and shall be preceded by the words: "Best before …" or "use 
by" date (for highly perishable foodstuffs), any special storage conditions or conditions of 
use, the name or business name and address of the manufacturer or packager, the place 
of  origin  or  provenance  where  failure  to  give  such  particulars  might  mislead  the 
consumer,  instructions  for  use,  indication  of  the  alcoholic  strength  by  volume  of 
beverages  containing  more  than  1.2  %  by  volume  of  alcohol.  These  mandatory 
particulars must be  easy to understand, visible, legible and indelible and some  of them 
must appear in the same field of vision. 

Several  Regulations  and  Directives  lay  down  additional  information  necessary  for  the 
implementation  of  the  different  provisions  of  Regulation  (EU)  No  2000/13/EC.  More 
detail on the information relevant to these legal texts can be found in Annex XXXI. 

The following figures summarise these documents and their interactions. 

94 

 
 
 
 
 
 
 
Figure  47:  Summary  of  the  legislation  on  labelling,  presentation  and  advertising  of 
foodstuffs and cross interaction with other legal acts. 

8.1.2. 

The  New  Framework  Regulation:  Regulation  (EU)  No  1169/2011  of 
the  European  Parliament  and  of  the  Council  of  25  October  2011  on 
the provision of food information to consumers 

This  Regulation  provides  the  basis  for  the  general  principles,  requirements  and 
responsibilities  governing  food  and  nutrition  information  (food  labelling),  in  order  to 
guarantee the right of consumers to information and reassure the high level of consumer 
protection.  This  legal  act  establishes  rules  for  mandatory  and  voluntary  food  and 
nutrition information in relation to their content, calculation, expression and presentation 
and applies and sets responsibilities to food business operators at all stages of the food 
chain.  Under  this  regulation  it  is  mandatory  to:  provide  nutrition  information  on 
processed  foods;  provide  origin  labelling  of  unprocessed  meat  from  pigs,  sheep,  goats 
and  poultry;  highlight  allergens  in  the  list  of  ingredients  also  for  non  pre-packed  foods 
(e.g. sold in restaurants, cafés) and ensure better legibility (e.g. minimum size of text). 
In  addition,  the  regulation  requires  that  labelling  presentation  and  advertisement  shall 
not  be  misleading  regarding  properties  or  effects  of  the  food  and  shall  not  attribute 
properties  of  preventing  or  curing  disease  unless  it  also  covers  the  provisions  of  other 
laws  (e.g.  foods  for  specific  groups).  Other  mandatory  particulars  are:  name,  list  of 
ingredients, substances causing allergies /intolerances, quantity of certain ingredients or 
categories  of  ingredients,  net  quantity,  minimum  durability  or  ‘use  by’  date,  special 
storage  conditions  and/or  conditions  of  use;  details  of  food  business  operator  or 
importer, the country of origin or place of provenance for certain types of meat, milk or 
where its absence might be misleading, instructions for use where appropriate, alcoholic 
strength  by  volume  (where  they  contain  more  than  1.2 %),  and  nutritional  declaration 
(energy,  fat,  saturated  fat,  carbohydrates,  sugars,  protein  and  salt).  These  mandatory 
particulars  must  be  easy  to  understand,  visible  and  clearly  legible  (the  height  of  the 
characters  must  be  at  least  1.2  mm).  For  pre  packed  foods,  this  information  should 

95 

 
 
 
 
 
 
appear  on  the  packaging  or  on  the  label  attached  to  it.  For  non-prepacked,  this 
information  must  be  sent  to  the  operators  receiving  the  foodstuffs  so  that  they  can 
provide  the  information  to  the  end  consumer.    Certain  mandatory  particulars  can  be 
omitted for some glass bottles, very small packages etc. The operator is responsible for 
the  presence  and  accuracy  of  the  provided  information.  Old  Dir.  2000/13/EC  on  food 
information  has  been  repealed  and  the  new  rules  apply  from  13  December  2014.  The 
obligation to provide nutrition information will only apply from 13 December 2016. 

Several  Regulations  and  Directives  lay  down  additional  information  necessary  for  the 
implementation  of  the  different  provisions  of  Regulation  (EU)  No  1169/2011.  These 
include  specific  requirements  for  the  labelling  and  marketing  of  diverse  food  products 
such  as,  foods  for  infants  and  special  medical  purposes,  olive  oil,  aromatised  wine 
products,  fishery,  aquaculture  as  well  as  agricultural  products.  More  detail  on  the 
information  relevant  to  these  legal  texts  can  be  found  in  Annex  XXXII.  The  following 
figures summarise these documents and their interactions. 

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a 

b 

Figure 48 (a and b): Summary of the legislation on Food Information to Consumers (FIC) 
and cross interaction with other legal acts. Red arrows correspond to legislation referring 
and  /or  adding  to  the  FIC  legislation.  Blue  arrows  correspond  to  legislation  referred  in 
the FIC legislation. 

97 

 
 
 
 
 
 
 
8.1.3. 

Council  Directive  90/496/EEC  of  24  September  1990  on  nutrition 
labelling for foodstuffs 

As stated in the introduction of Chapter 8.1, Directive 90/496/EEC33  has been repealed 
from  13  December  2014  and  any  reference  to  it  shall  be  considered  as  references  to 
Reg.  1169/2011.  However,  Directive  90/496/EEC  is  still  valid  since  the  obligation  to 
provide nutrition information will fully apply from 13 December 2016. 

Directive 90/496/EEC regards nutrition labelling as optional, but becomes compulsory if 
a nutrition claim is made. The information given shall consist of the energy value and the 
amount  of  nutrients  contained,  i.e.  protein,  carbohydrate,  sugars,  fat,  saturates,  fibre 
and sodium. It may also include amounts of starch, polyols, mono- and poly-unsaturated 
fats, cholesterol, and any of the minerals or vitamins listed in the Annex that present in 
significant amounts. The nutrition claims allowed are only those in relation to the energy 
value and the amount of nutrients contained. The energy value and amount of nutrients 
must  be  expressed  per  100g  or  per  100ml,  but  also  per  package  or  per  portion  of  the 
food as sold or as prepared for consumption. Information on vitamins and minerals must 
also  be  expressed  as  a  percentage  of  the  recommended  daily  allowance.  All  of  these 
must be presented in a tabular or linear form, in a clearly visible place and in a language 
easily  understood.  National  laws  shall  determine  how  this  information  is  communicated 
in the case of non pre-packed foods. 

Several  Regulations  and  Directives  lay  down  additional  information  necessary  for  the 
implementation  of  the  different  provisions  of  Directive  90/496/EEC  and  more  detail  on 
the information relevant to these legal texts can be found in Annex XXXIII.  

33 Council Directive 90/496/EEC on nutrition labelling for foodstuffs. Official Journal of the European Communities (1990). L 276/40 

98 

 
 
 
 
 
 
 
 
 
                                                           
8.2.  Nutrition and Health Claims  

According  to  Regulation  (EC)  1924/200634,  a  health  claim  is  "any  claim  that  states, 
suggests or implies that a relationship exists between a food category, a food or one of 
its constituents and health" and a nutrition claim is "any claim which states, suggests or 
implies that a food has particular beneficial nutritional properties" due to: The energy it 
(i) provides; (ii) provides at a reduced or increased rate; or (iii) does not provide; and/or 
The  nutrients  or  other  substances  it  (i)  contains;  (ii)  contains  in  reduced  or  increased 
proportions; or (iii) does not contain. 

8.2.1. 

Regulation (EC) No 1924/2006 on nutrition and health claims 
made on food 

Regulation  (EC)  1924/2006  lays  down  the  rules  that  harmonise  nutrition  and  health 
claims. It applies to claims intended for labelling, presentation and advertising and to all 
types  of  food  intended  for  final  consumers,  including  foods  at  restaurants,  hospitals, 
canteens  etc.  This  Regulation  prohibits  information  that  is  false,  misleading  (not 
scientifically substantiated) or difficult to understand. Nutrition labelling is mandatory on 
products  for  which  a  nutrition  or  health  claim  is  made,  with  the  exception  of  generic 
advertising  (denomination),  and  shall 
fats, 
carbohydrates, sugars, proteins and salt.  

include  energy  value;  amounts  of 

Nutrition claims:  

A general condition of use is that the presence, absence or reduced content of a nutrient 
or  other  substance  for  which  the  claim  is  made  must  have  a  beneficial  nutritional  or 
physiological effect, and be scientifically proven. The types  of nutritional claims allowed 
are only those listed in the Annex of Reg. (EC) 1924/2006 ; examples include: "with no 
added  sugars",  "very  low  sodium",  "source  of  [vitamin]  and  [mineral],  contains 
[nutrient/substance]",  "reduced/increase [nutrient]" etc. 

Health claims:  

There are two types of health claims:  

a)  Article  13  ("function")  health  claims  referring  i)  to  the  growth,  development  and  the 
functions of the body, ii) to psychological and behavioural functions, and iii) to slimming, 
weight-control, hunger reduction or increase of satiety.  

The  Commission  has  adopted  a  list  of  permitted  Article  13  health  claims.  Article  13 
claims  which  are  based  on  newly  developed  scientific  evidence  and/or  proprietary  data 
shall an authorisation procedure based on individual applications (laid down in Article 18) 

b)  Article  14  health  claims:  reduction  of  disease  risk  claims  and  claims  referring  to 
children's development and health.  

These claims follow a different authorisation procedure (laid down in Articles 15, 16, 17 
and  19  of  this  Regulation)  based  on  individual  applications.  More  specifically, 

34 Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods. Official 
Journal of the European Union (2006). L. 404/9 

99 

 
 
 
 
 
 
 
 
                                                           
authorisation for a new claim is granted (or not) with a Commission decision following an 
opinion from EFSA and the Standing Committee on the Food Chain and Animal Health. 

Labelling,  presentation  and  advertisement  of  health  claims  requires  additional 
information  to  be  provided  such  as:  a  statement  indicating  the  importance  of  a  varied 
diet  or  the  quantity  and  pattern  of  consumption  which  ensures  the  claimed  effect,  a 
statement for those who should avoid using the food, and warning that might bear risks 
if consumed in excess (Article 10). Claims with reference to the rate or amount of weight 
loss,  to  properties  for  the  prevention,  treatment  or  cure  of  a  human  disease,  to  an 
individual  doctor  or  health  professional  and  claims  that  suggest  that  health  could  be 
affected  by  not  consuming  the  food  are  prohibited  (Article  12).  Amendments  made  to 
the  first  and  second  paragraph  of  Article  7  of  this  Regulation  by  the  new  Regulation 
1169/2011 require: mandatory nutrition labelling of products on which a nutrition and/or 
health claim is made, mandatory declaration of the exact amount of a nutrient for which 
a nutrition and/or health claim is made and finally, for substance(s) for which a nutrition 
or health claim is made and the amount does not appear in the nutrition labelling then it 
shall be stated in the same field of vision as the nutrition labelling and be expressed in 
accordance with this regulation. 

The  legal  texts  that  lay  down  additional  information  for  the  implementation  of  the 
provisions  of  Regulation  (EC)  No  1924/2006  are  described  in  more  detail  in  Annex 
XXXIV. A summary of this legislation is presented in Figure 49. 

Figure  49:  Summary  of  the  legislation  on  Nutrition  and  health  claims  and  cross 
interaction  with  other  legal  acts.  Red  arrows  correspond  to  legislation  referring  and  /or 
adding  to  the  Nutrition  and  Health  Claims  legislation.  Blue  arrows  correspond  to 
legislation referred in the Nutrition and Health Claims legislation. 

100 

 
 
 
 
 
 
 
 
8.3.  Food for specific groups (FSG)  

Currently, the "Framework Directive" – Directive 2009/39/EC on foodstuffs intended for 
particular  nutritional  uses  -  establishes  general  rules  for  foods  for  particular  nutritional 
uses.  These  are  defined  as  "foods  specially  manufactured  to  satisfy  the  particular 
nutritional  requirements  of  specific  groups  of  people",  such  as  baby  foods,  foods  for 
people  suffering  from  gluten  or  lactose  intolerance;  foods  for  special  medical  purposes 
etc. This Directive is accompanied by a series of four other legislative acts for each one 
of  the  specific  groups.  The  validity  of  the  Framework  Directive  ends  when  the  new 
Regulation  609/2013  on  food  intended  for  infants  and  young  children,  food  for  special 
medical  purposes,  and  total  diet  replacement  for  weight  control  comes  into  effect,  i.e. 
July 2016. 

8.3.1. 

Directive  2009/39/EC  of  the  European  Parliament  and  of  the 
Council on foodstuffs intended for particular nutritional uses 

This  Directive  concerns  foodstuffs  that  fulfil  the  particular  nutritional  requirements  of  i) 
persons whose digestive processes or metabolism are disturbed, ii) persons who are in a 
special physiological condition, and iiii) infants or young children. Foodstuffs intended for 
the  two  first  categories  of  person  mentioned  above  may  bear  the  words  "dietetic"  or 
"dietary". General rules include: i) It is allowed to enrich foodstuffs by adding nutritional 
substances in order to meet particular nutritional needs, ii) these foodstuffs shall comply 
with  the  general  labelling  rules  (Directive  2000/13)  but  the  designation  must  be 
accompanied by additional information on the composition or manufacturing process, the 
energy value, the carbohydrate, protein and fat content of product, iii) they shall only be 
allowed on the market in pre-packaged form, iv) notifying the competent authority of the 
Member  State  (by  forwarding  them  a  label  of  the  label  used  or  an  indication  of  the 
recipient  of  the  first  notification)  is  a  prerequisite  for  placing  such  a  product  on  the 
market for the first time and v) a Member State may suspend a foodstuff if it does not 
comply with this Directive or the specific directives. 

Such  detailed  provisions  in  relation  to  the  nature  or  composition  of  products  and  their 
labelling have been adopted for the following groups of foodstuffs:  

a)  infant formulae and follow-on formulae (Directive 2006/141/EC); 

b)  processed  cereal-based  foods  and  baby  foods  for  infants  and  young  children 

(Directive 2006/125/EC); 

c)  foods intended for weight reduction (Directive 96/8/EC); 

d)  dietary foods for special medical purposes (Directive 1999/21/EC 35); and 

e)  foodstuffs for persons who are gluten-intolerant 

Certain  delegated  acts  that  will  be  repealed  from  the  date  of  application  of  the  new 
Regulation 609/2013 (FSG) on Food for Specific Groups that shall be adopted by 20 July 
2015,  as  well  as  Regulations  and  Directives  that  lay  down  additional  information 

35 Commission Directive 1999/21/EC on dietary foods for special medical purposes. Official Journal of the European Communities (1999). 
L. 91/29 

101 

 
 
 
 
 
  
 
                                                           
necessary for the implementation of the different provisions of Directive 2009/39/EC can 
be found in Annex XXXV. 

102 

 
 
 
 
 
 
 
 
 
8.4.  Regulation  (EU)  No  609/2013  on  food  intended  for 
infants  and  young  children,  food  for  special  medical 
purposes, and total diet replacement for weight control 

Reg.  (EU)  609/2013  on  food  for  specific  groups  establishes  compositional  and  labelling 
requirements  for:  a)  infant  formula  and  follow-on  formula,  b)  processed  cereal-based 
food  and  baby  food,  c)  food  for  special  medical  purposes  and  d)  total  diet  replacement 
for weight control. Moreover, it establishes a Union list of substances allowed to be used 
in  the  above  mentioned  food  categories  and  lays  down  the  rules  applicable  to  the 
updating  of  that  list.  This  Regulation  also  requires  the  Commission  to  adopt  delegated 
acts for specific compositional and labelling rules for all categories. These delegated acts 
will  replace  Directive  2006/141/EC  (for  infant  and  follow-on  formulae),  Directive 
2006/125/EC  (for  processed  cereal-based  foods  and  baby  foods),  Directive  1999/21/EC 
(foods  for  special  medical  purposes),  and  Directive  96/8/EC  (for  foods  intended  for  low 
calorie  and  very  low  calorie  diets).  Finally,  Reg.  (EU)  609/2013  foresees  that  the 
Commission should prepare a report on milk-based drinks (growing-up milks) and similar 
products  for  young  children  as  well  as  a  report  on  foods  for  sportspeople,  in  order  to 
analyse  the  necessity  to  establish  special  compositional  and  information  rules  for  this 
kind of products. Reg. (EU) 609/2013 will apply from 20 July 2016.  

Regulation  609/2013,  being  a  recent  regulation,  is  only  mentioned  in  one  legal 
document,  namely  the  Commission  Delegated  Regulation  1155/2013  that  updates  Reg. 
(EC)  1169/20011  on  the  information  that  is  provided  to  consumers  on  the  absence  or 
reduced presence of gluten in food (see also 8.3.2.v) 

Figure  50  summarises  the  legislation  on  Food  for  Specific  Groups  (FSG)  and  cross- 
interactions with other legal acts adding information to the FSG legislation or referred in 
the FSG legislation. 

103 

 
 
 
 
 
Figure  50:  Summary  of  the  legislation  on  Food  for  Specific  Groups  (FSG)  and  cross  interaction  with  other  legal  acts.  Red  arrows 
correspond  to  legislation  referring  and  /or  adding  to  the  FSG  legislation.  Blue  arrows  correspond  to  legislation  referred  in  the  FSG 
legislation. 

104 

 
 
 
 
8.5.  Further relevant nutrition policies 

8.5.1. 

EU Platform on Diet, Physical Activity and Health 

The EU Platform on Diet, Physical Activity and Health36 was set up in 2005 with the aim 
of providing a common forum for all interested stakeholders. This European Commission 
(EC)  chaired  forum  includes  participants  ranging  from  food  industry  and  food  science 
associations  to  NGOs;  in  order  to  participate,  stakeholders  must  make  voluntary 
commitments aimed at improving health, diets and physical activity. The platform meets 
regularly  and  is  monitored  and  evaluated  every  year,  and  also  has  joint  meetings  with 
the  High  Level  Group.  Since  its  establishment,  the  Platform  has  resulted  in  over  300 
commitments  made  by  the  participating  stakeholders  in  the  fields  of  marketing  and 
advertising,  composition  of  foods  (reformulation,  portion  sizes),  advertising  of  food  to 
children, consumer information and labelling, education, physical activity promotion and 
information  exchange37.  A  number  of  these  commitments  are  specifically  targeted  at 
vulnerable groups such as children or older adults. 

8.5.2.  White  Paper  on  "A  strategy  for  Europe  on  Nutrition, 

Overweight and Obesity Related Health Issues" 

The  White  Paper  (2007-2013)  on  a  "strategy  for  Europe  on  nutrition,  overweight  and 
obesity  related  health  issues"38  was  the  basis  of  the  EU  strategy  between  2007  and 
2013,  aiming to improve citizen health via better nutrition and reduced overweigh and 
obesity,  through a series of nutrition and lifestyle initiatives . The White paper proposed 
an  integrated  approach  involving  all  stakeholders,  ranging  from  public  to  private  and 
from an EU or national to a regional/local level, which is summarised in the Paper's four 
basic  principles:  i)  Its  actions  aimed  to  address  the  root  causes  of  health  related  risks, 
therefore  contributing  in  reducing  the  risk  factors  linked  to  poor  diets  and  sedentary 
lifestyles.  ii)  The  horizontal  implementation  of  actions  across  various  policy  areas,  and 
the  vertical  implementation  at  different  levels  of  managing  bodies.  iii)    Policy  actions 
should  include  a  wide  range  of  private  and  societal  actors,  such  as  the  private  food 
industry  and  the  local  community.  iv)  all  actions  should  be  monitored  effectively,  in 
order to assess their impact and allow corrective actions when deemed necessary.  

To promote better stakeholder co-operation, the White Paper recognised the value of the 
EU  Platform  as  a  key  tool  for  implementing  its  strategy  and  stated  the  interest  of  the 
Commission  to  pursue  and  further  develop  its  activities.  In  addition,  the  White  Paper 
called for the formation of a High Level Group focused on nutrition and physical activity, 
to ensure the exchange of policy ideas and practices between Member States. 

The  White  Paper 
implementation: 

focused  on  specific  key  areas  which  spearheaded  policy 

  Better informed consumers: Building on previous legislative initiatives legislations 
aiming  to  provide  clear,  precise  and  non-misleading  food  information  to  the 
consumers  (Directives  90/496/EEC,  2000/13/EC,  as  well  as  Regulation  EC 
1924/2006)  the  European  Commission  has  adopted  Regulation  (EU)  1169/2011, 
providing  a  set  of  basic  rules  and  principles  to  be  used  in  food  labelling.  In 
addition, and following up on the report of the EU Round Table on advertising and 

36 EU Platform for Action on Diet, Physical Activity and Health website  
http://ec.europa.eu/health/nutrition_physical_activity/platform/index_en.htm  ((►07/11/2014) 
37 Monitoring the EU Platform on Diet, Physical Activity and Health – Annual Report 2014 
38 White Paper on A Strategy for Europe on Nutrition, Overweight and Obesity related health issues. Com(2007) 279 final 

105 

 
 
 
 
 
 
                                                           
self-regulation39,  the  Commission  has  adopted  the  Audiovisual  Media  Services 
Directive40  (2010/13/EU)  was  introduced,  encouraging  policy  makers  to  take  an 
active  role  in  influencing  media  service  providers,  including  commercial 
advertising of foods to children. 

  Making the healthy option available: Based upon the Common Agricultural Policy 
(CAP), the Common Market organisation aims to promote consumption of healthy 
diets  in  specific  sensitive  environments  such  as  school.  To  this  end,  the  School 
Fruit  Scheme  and  the  School  Milk  Scheme  were  introduced.  Another  initiative 
aiming  at  making  the  healthy  option  available  are  the  voluntary  efforts  of  the 
food  industry  on  reformulating  processed  foods;  these  voluntary  efforts  come  in 
the  form  of  pledges  taken  from  the  participants  of  the  EU  Platform  on  Diet, 
Physical Activity and Health. 

  Encourage physical activity: It is of foremost importance to construct the required 
living  environment  in  order  to  encourage  European  citizens  to  increase  their 
physical activity; to this end, the European Commission published the Action Plan 
on  Urban  Mobility41  and  the  White  Paper  on  Sport42  as  well  as  the  EU  Physical 
activity guidelines43. 

  Priority groups: This action focused on children and lower socio-economic groups; 
the  2007-2013  Lifelong  Learning  Programme44  addressed  health  and  physical 
education as priority, while the Fruit School Milk and Fruit Scheme contributed in 
creating  a  healthy  dietary  environment  in  schools.  More  actions  focused  on 
children's  diets  are  included  in  the  EU  Action  Plan  on  Childhood  Obesity  2014-
2020, a follow-up action of the White Paper. Another priority group focus was the 
active  workforce  of  the  population,  addressed  in  the  EU  Cohesion  Policy  2007-
201345, which aimed to promote the contribution of cities to growth and jobs and 
to maintain a healthy workforce. 

  Supporting  policy  making  with  scientific  evidence:  Recognizing  the  role  of 
research  in  better  understanding  the  role  of  nutrition  and  lifestyle  in  diseases 
such  as  obesity,  diabetes  and  cancer,  as  well  as  the  role  of  individual  food 
choices,  the  7th  Framework  Programme46  funded  research  into  consumer 
behaviour,  health  impact  of  food  and  nutrition,  prevention  of  obesity  in  target 
groups  (infants,  children  and  adolescents)  as  well  as  effective  dietary 
interventions.  The  European  Food  Safety  Authority  has  also  contributed  by 
supporting  the  Commission  with  scientific  opinions  for  foods  bearing  health 
claims, as well as on the setting of dietary reference values for nutrient intake. 

  Monitoring systems: To counteract the lack of harmonisation observed at national 
level  on  issues  such  as  food  intake,  obesity  etc.,  the  White  Paper  called  for  a 
strengthening  of  monitoring  efforts,  based  on  three  key  aspects:  i)  Consistent 
and  comparable  data  on  progress  indicators,  identification  of  initiatives  by 
Member States and monitoring of individual projects and programmes. 

The  White  Paper  also  stressed  the  importance  of  international  collaborations,  e.g.  with 
the  World  Health  Organisation  (WHO)  and  its  2nd  Food  and  Nutrition  Action  Plan  for 

39 Round Table on advertising self-regulation:  A report of some discussion among interested parties (2006) 
40 Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in member states 
concerning  the  provision  of  audiovisual  media  services  (Audiovisual  Media  Services  Directive).  Official  Journal  of  the  European  Union 
(2010) L95/1 
41 Communication form the Commission to the European Parliament, the Council, the European Economic and Social Committee and the 
Committee of the regions – Action Plan on Urban Mobility COM(2009) 490 final 
42 White Paper on Sport Com(2007) 391 Final 
43 EU Physical Activity Guidelines – Recommended Policy Actions in Support of Health-Enhancing Physical Activity (2008) 
44 Lifelong Learning Programme (LLP) of the European Union http://eacea.ec.europa.eu/llp/index_en.php (►07/11/2014) 
45 Council Decision 2006/702/EC on Community strategic guidelines on Cohesion. Official Journal of the European Union (2006)  L291/11 
46 EU Seventh Framework Programme website http://cordis.europa.eu/fp7/home_en.html (► 07/11/2014) 

106 

 
 
 
                                                           
Europe 2007-201247 and its European Childhood Obesity Surveillance Initiative48 (COSI). 
Although the White Paper was foreseen for the 2007-2013, its activities and actions still 
carry  on  and  have  given  birth  to  new  initiatives  such  as  the  Action  Plan  on  Childhood 
obesity 2014-2020. 

8.5.3. 

High Level Group on Nutrition and Physical Activity 

The  High  Level  Group  (HLG)  on  Nutrition  and  Physical  Activity  was  set  up  in  2007 
following  the  White  Paper  "A  strategy  for  Europe  on  Nutrition,  Overweight  and  Obesity 
Related  Health  Issues",  and  consists  of  representatives 
from  Member  States 
governments, plus Norway and Switzerland, and is led by the EC. HLG members inform 
each  other  on  national policies  on  nutrition  and  physical  activity  and share  policy  ideas 
and  practices.  In  addition,  the  HGL  holds  joint  meetings  with  the  EU  Platform  for  Diet, 
Physical  Activity  and  Health,  improving  collaborations  between  governments  and  the 
Platform  members  in  order  to  facilitate  public-private  partnerships.  One  of  the  focus 
areas of the  HLG was  fighting childhood  obesity, and this led to the adoption of the EU 
Action Plan on Childhood Obesity for 2014-2020. Two other examples of HLG initiatives 
were the EU Framework for national initiatives on reduction of selected macro-nutrients. 
The  salt  reduction  initiative49  aimed  at  a  16%  reduction  between  2008-2012  applicable 
to  all  food  products  as  well  as  foods  consumed  in  restaurants,  canteens  and  catering 
facilities  in  general;  the  EU  selected  nutrients  initiatives  focused  in  saturated  fats  in 
particular, proposing a general reduction (compared to 2012) of a minimum of 5% until 
2016 and an additional 5% reduction by 202050. 

8.5.4. 

School Fruit and Milk Schemes 

The School Fruit Scheme (SFS) and School Milk Scheme (SMS) are EU wide aid schemes 
intended to improve children's dietary habits and the distribution of agricultural products 
to  children;  the  main  target  groups  are  children  in  nurseries,  pre-schools,  as  well  as 
primary  or  secondary  level  schooling  establishments  administered  by  the  relevant 
authorities in MS. 

The school fruit scheme started in 2009, following the EU common market organisation 
reform  for  Fruit  and  Vegetables  in  2007,  which  aimed  also  at  encouraging  a  greater 
consumption  of  fruits  and  vegetables51.  The  SFS  aims  to  provide  fruits  and  vegetables, 
processed fruits and vegetables as well as bananas to school children and to encourage 
their  healthy  eating  habits.  Apart  from  provision  of  fruits  and  vegetables,  participating 
MS  need  to  set  up  complementary  strategies  such  as  educational  and  awareness 
initiatives.  The  products  to  be  included  must  be  chosen  by  the  MS,  on  the  basis  of 
criteria  such  as  environmental  considerations/sustainability,  seasonality,  variety  and 
availability of produce, giving priority where possible to EU products and in particular to 

47 WHO European Action Plan for Food and Nutrition Policy 2007-2012 (2008) 
48 WHO European Childhood Obesity Surveillance Initiative website (►07/11/2014) 
49 EU Framework for national salt initiatives 
50 EU Framework for national initiatives on selected nutrients Ares(2012)6999700 
51 Fruit and vegetable reform – Memo/07/28 (2007) 

107 

 
 
 
 
 
 
 
                                                           
local markets. The legal basis for SFS lies with regulation EC/1234/200752 and regulation 
(EC) No 288/200953 (amended by 34/201154).  

The  school  milk  scheme  is  an  EU  wide  initiative  aiming  to  encourage  dairy  product 
consumption  among  school  children.  It  started  in  1977  and  aims  at  increasing 
consumption  of  milk  and  milk  products  in  children  and  young  people.  The  legal  basis 
within CAP was introduced with regulations EC/1234/2007 and EEC/657/200855. As with 
SFS, the SMS  scheme  also has an educational character and includes not only milk but 
also processed milk products. 

Both aid schemes were revisited by regulations (EU) 1306/201356 and (EU) 1308/201357, 
while in early 2014 the commission presented  a legislative proposal58 (probably to take 
effect by 2016), accompanied by an impact assessment, to reform the two schemes and 
bring  them  together  in  a  join  framework.  Key  points  include  creating  a  joint  legal  and 
financial  framework  for  the  distribution  of  fresh  fruit,  vegetables  and  milk,  educational 
measures  to  improve  awareness  on  farming,  healthy  eating  habits  and  environmental 
issues, new funding rules, and simplified implementation rules.  

8.5.5. 

3rd EU health programme (2014-2020) 

Bound by the founding treaty  of the EU to ensure the protection of human health in all 
policies,  the  EU  health  strategy  "Together  for  Health"  is  supporting  the  overall  Europe 
2020  strategy,  which  apart  from  smart,  sustainable  and  inclusive  economy  promoting 
growth also has a healthy population as a main prerequisite. The 3rd programme (2014-
2020)59 draws its legal basis from Reg. (EU) No 282/201460 and is the main instrument 
to  implement  the  EU  health  strategy,  and  has  four  overarching  objectives:  i)  promote 
health,  prevent  diseases  and  foster  supportive  environment  for  healthy  lifestyles  ii) 
protect  citizens  from  serious  cross-border  health  threats,  iii)  contribute  to  innovative, 
efficient  and  sustainable  health  systems  and  iv)  facilitate  access  to  better  and  safer 
healthcare  for  EU  citizens.  The  EU  health  programme  is  implemented  by  annual  work 
plans,  setting  out  priority  areas  and  criteria  for  funding  specific  actions.  Under  the 
"Promote health, prevent disease and foster supportive environment for health lifestyles" 
area,  Paragraph  1.1  refers  to  the  need  of  cost-effective  promotion  and  prevention 
strategies  on  alcohol  and  nutrition,  including  actions  supporting  the  exchange  of 
evidence-based  successful  practices  for  tackling  risk  factors  such  as  alcohol  abuse, 

52 Council Regulation (EC) No 1234/2007 establishing a common organization of agricultural markets and on specific provisions for certain 
agricultural products. Official Journal of the European Union (2007) L 299/1 
53 Commission Regulation (EC) No 288/2009 laying down detailed rules for applying Council Regulation (EC) No 1234/2007 as regards to 
Community  Aid  for  supplying  fruit  and  vegetables,  processed  fruit  and  vegetables  and  banana  products  to  children  in  educational 
establishments, in the framework of a School Fruit Scheme. Official Journal of the European Union (2009) L 94/38 
54 Commission Regulation (EU) No 34/2011 amending Regulation (EC) 288/200. Official Journal of the European Union (2011) L14/6 
55 Commission Regulation (EC) No 657/2008 laying down detailed rules for applying Council Regulation (EC) No 1234/2007 as regards 
Community aid for supplying milk and certain milk products to pupils in educational establishments. Official Journal of the European Union 
(2008) L 183/17 
56 Regulation (EU) No 1306/2013 on the financing, management and monitoring of the common agricultural policy and repealing Council 
Regulations (EEC) No 362/78, (EC) No 165/94, (ECO No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008. Official 
Journal of the European Union  (2013) L 347/549 
57  Regulation  (EU)  No  1308/2013  establishing  a  common  organisation  of  the  markets  in  agricultural  products  and  repealing  Council 
Regulations (EEC) No 922/72, (EEC) 234/79, (EC) No 1307/2001 and (EC) 1234/2007. Official Journal of the European Union (2013) L 
347/671 
58 Proposal for a Regulation amending Regulation (EU) No 1308/2013 and Regulation (EU) 1306/2013 as regards the aid scheme for the 
supply of fruit and vegetables, bananas and milk in the educational establishments. 2014/0014 (COD) 
59 EU Health Programme 2014-2020 website http://ec.europa.eu/health/programme/policy/2014-2020/index_en.htm (►10/11/2014) 
60 Regulation (EU) No 282/2014 on the establishment of a third Programme for the Union's action in the field of health (2014-2020) and 
repealing Decision No 1350/2007/EC (2014). Official Journal of the European Union L 86/1 

108 

 
 
 
 
 
                                                           
unhealthy  dietary  habits  and  physical  inactivity,  taking  into  account  the  public  health 
aspects of underlying factors, e.g. those of a social and environmental nature. 

8.5.6. 

EU Action Plan on Childhood Obesity 

The  EU  Action  Plan  on  Childhood  Obesity  was  published  by  the  HLG  on  Nutrition  and 
Physical Activity in 201461, following a Reflection Process62, and aims at halting the rise 
in overweight and obesity in children and young people (0-18 years) by 2020. The action 
plan  calls  for  the  participation  of  many  actors  on  different  levels,  including  the  EU 
Member States, the European Commission, international organisations such as the WHO 
as  well  as  civil  society  partners  such  as  Non-governmental  organisations  (NGOs), 
research institutes and the private industry. The action plan identifies specific pillars for 
action:  Support  a  healthy  start  in  life,  promote  healthier  environments  (especially 
schools and pre-schools), make the healthy option the easier option,  restrict marketing 
and  advertising  to  children,  inform  and  empower  families,  encourage  physical  activity, 
increase  research  and  implement  monitor  and  evaluation  mechanisms.  In  addition,  it 
proposes  MS  to  engage  in  a  joint  action  and  urges  the  Platform  to  come  up  with  new 
commitments.  

8.5.7. 

Dietary Reference Values (DRVs) 

The  European  Food  Safety  Authority  (EFSA)  has  been  asked  by  the  Commission  to 
review  and  update  the  reference  intake  values  for  nutrients,  micro-nutrients  and 
energy63,  which  were  first  established  in  1993  by  the  Scientific  Committee  on  Food 64. 
EFSA's role was to develop DRVs, i.e. quantitative reference values of intakes for healthy 
individuals  and  populations,  which  could  be  used  for  the  assessment  and  planning  of 
diets. The DRVs include: 

 

 

 

 

 

Population reference intakes (PRIs): "the level of nutrient intake that is adequate 
for virtually all people in a population group".  

Average requirement (AR): "the level of (nutrient) intake that is adequate for half 
of the people in a population group, given a normal distribution of requirement" 

Lower  Threshold  Intake  (LTI):  "the  level  of  intake  below  which,  on  the  basis  of 
current  knowledge,  almost  all  individuals  will  be  unable  to  maintain  "metabolic 
integrity", according to the criterion chosen for each nutrient" 

Adequate  Intake  (AI):  "the  value  estimated  when  a  Population  Reference  Intake 
cannot be established because an average requirement cannot be determined. An 
Adequate  Intake  is  the  average  observed  daily  level  of  intake  by  a  population 
group (or groups) of apparently healthy people that is assumed to be adequate" 

Reference  Intake  ranges  for  macronutrients  (RI):  "the  intake  range  for 
macronutrients,  expressed  as  %  of  the  energy  intake.  These  apply  to  ranges  of 

61 EU Action Plan on Childhood Obesity 2014-2020 (2014) 
62  Council  of  the  EU:  Reflection  process:  Innovative  approaches  for  chronic  diseases  in  public  health  and  health-care  systems  Final 
Report (2013). 12983/13 LIMITE SAN 304 
63Scientific Opinion on principles for deriving and applying Dietary Reference Values. EFSA Journal 2010: 8(3):1458 
64  Food  –  Science  and  Techniques:  Reports  of  the  Scientific  Committee  for  Food  (31st  series):    Nutrient  and  Energy  Intakes  for  the 
European Community (1993). ISBN 92-826-6409-0 

109 

 
 
 
 
 
 
 
                                                           
intakes that are adequate for maintaining health and associated with a low risk of 
selected chronic diseases." 

The  scientific  opinions  of  EFSA  on  the  DRVs  could  be  used  by  MS  authorities  when 
making nutrient recommendations or establishing dietary guidelines (taking into account 
national dietary factors and the health status of the target population). So far, EFSA has 
produced  opinions  on  DRVs65  for  energy,  macronutrients  (carbohydrates,  dietary  fibre, 
fats, protein) and water, as well as for micronutrients (fluoride, molybdenum, vitamin C, 
manganese,  biotin,  pantothenic  acid,  iodine,  niacin,  zing,  chromium,  selenium,  and 
folate, which is about to be published). 

65 EFSA webpage on DRVs:  http://www.efsa.europa.eu/en/topics/topic/drv.htm (►11/11/2014) 

110 

 
 
 
 
 
                                                           
9. Implementation of EU legislation in the Member States 

The  effective  functioning  of  the  internal  European  food  market  and  the  achievement  of 
the  ultimate  goal  of  ensuring  safe  and  nutritious  food  for  the  500  million  European 
citizens relies on the effective implementation of food legislation in all Member States. 

The  initiative  for  the  development  of  European  legislation  remains  with  the  European 
Commission which is also responsible for monitoring the implementation of the European 
legislation.  The  European  Parliament  and  the  Council  have  then  the  power  under  the 
"ordinary legislative procedure" for co-decision on the adoption or not of draft EU law.  

9.1.  Responsibilities 

The  General  Food  Law  requires  food  business  operators  at  all  stages  of  production  that 
all food and feed they place on the market satisfy the requiremts of food law, i.e. that all 
food  is  placed  on  the  market  must  not  be  injurious  to  health  or  unfit  for  human 
consumption. Food business operators are required to verify whether those requirements 
are  met  and  the  competent  authorities  in  the  Member  States  shall  in  turn  verify  that 
food business operators obey the rules of the General Food Law. For doing this, Member 
States shall maintain a system of competent authorities and official controls. The proper 
operation  of  this  system  and  implemenation  of  food  law  in  the  Member  States  is 
monitored and audited by the Food and Veterinary Office, which is part of DG SANCO. An 
overview  of food law implementation actors at global, EU and national level is provided 
in Figure 51. 

Global 

Food safety 
implementatio
n 

EU 

Member 
States 

FAO/WHO 

OIV 

IPPC 

EFSA 

ECDC 

EMA 

CPVO 

EU-RL 

FVO 

NRL 

Official 
control 

Figure 51: An overview of actors at global, EU and national level 

111 

 
 
 
 
 
 
 
9.2.  Competent authorities and official food control 

In  most  Member  States  the  responsibility  for  the  safety  of  the  food  chain  is  shared  by 
the  ministry  of  health  (or  its  equivalent)  and  the  ministry  of  agriculture  (or  its 
equivalent).  In  many  Member  States  the  ministries  of  health  are  responsible  for  food 
safety, animal health and animal welfare, and the ministries of agriculture for feed, plant 
health and plant protection products, although other distributions of responsibilities exist 
as  well.  Several  Member  States  have  created  'food  safety  agencies',  centralising  to  a 
various  degree  coordination  of  risk  assessment,  communication  with  stakeholders, 
science  advice  to  policy  making,  standard  setting,  and  inspection  and  laboratory 
activities (e.g. Food Standards Agency (FSA); UK, Agence nationale de sécurité sanitaire 
de  l’alimentation,  de  l’environnement  et  du  travail    (ANSES),  FR,    Agencia  Española  de 
Seguridad Alimentaria y Nutrición (AESAN), ES). 

Various  models  exist  how  to  organise  food  inspection  services,  official  control  activities 
and law enforcement. A graphical representation is found in Figure 52. 

Inspection 

Inspection 

Inspection 

Analysis 

Analysis 

Analysis 

Enforcement 

Enforcement 

Enforcement 

Figure 52: An overview of actors at global, EU and national level 

The three basic elements of a food control system can be combined in one organisational 
entity or be separated to various degrees (e.g. inspection and enforcement is carried out 
by  one  organisation  and  laboratory  analysis  by  another,  which  could  even  be  a 
commercial service provider). 

112 

 
 
 
 
 
  
 
 
 
 
9.3.  International and EU level organisations  

To  enable  and  facilitate  international  trade  in  food  products  a  system  of  global 
governance is necessary. The Codex Alimentarius Commission, which is a joint FAO/WHO 
undertaking,  coordinates  harmonisation  of  food  standards  and  requirements  for 
contaminants, residues, additives, labelling rules, etc. The World Organisation for Animal 
Health (OIE) develops normative documents relating to rules that Member Countries can 
use  to  protect  themselves  from  the  introduction  of  diseases  and  pathogens,  without 
setting  up  unjustified  sanitary  barriers.    The  organisation  is  placed  under  the  authority 
and control of a World Assembly of Delegates consisting of Delegates designated by the 
Governments  of  all  Member  Countries.  The  International  Plant  Protection  Convention 
(IPPC)  aims  to  protect  cultivated  and  wild  plants  by  preventing  the  introduction  and 
spread  of  pests.  The  standards  set  by  the  three  mentioned  organisations,  sometimes 
referred to as the 'three sisters', are recognised by the World Trade Organization (WTO) 
as  reference  international  sanitary  and  phyto-sanitary  (SPS)  rules.  The  SPS  Agreement 
confirms  the  right  of  WTO  member  countries  to  apply  measures  to  protect  human, 
animal  and  plant  life  and  health.  The  Agreement  covers  all  relevant  laws,  decrees, 
regulations;  testing,  inspection,  certification  and  approval  procedures;  and  packaging 
and labelling requirements directly related to food safety. WTO Member States are asked 
to apply only those measures for protection that are based  on scientific principles, only 
to  the  extent  necessary,  and  not  in  a  manner  which  may  constitute  a  disguised 
restriction on international trade. 

At  EU  level  several  agencies  under  the  responsibilty  of  DG  SANCO  are  tasked  with 
specific functions related to ensuring the safety in the food chain: 

 
 
 
 

European Food Safety Authority 
European Medicines Agency 
European Centre for Disease Prevention and Control 
Community Plant Variety Office 

The EU established a series of European Union Reference Laboratories (EURLs) for food 
and  feed,  as  well  as  animal  health.  coordinate  a  network  of  national  reference 
laboratories (NRLs) to obtain high quality results by the provision of reference methods, 
reference  materials,  proficiency  testing  schemes  and  training  to  laboratory  staff.  They 
support the creation of a well performing network of laboratories throughout the Union. 
The work of the EURLs leads to better implementation of EU legislation, e.g. by enforcing 
legislative  limits  and  reducing  the  need  to  repeat  testing.  As  a  result  the  functioning  of 
the  EU  internal  market  is  strengthened  and  consumers  benefit  from  safe  food  and 
products in the market. 

113 

 
 
 
 
 
 
 
10.  Other food policies 

10.1. Global food safety and nutrition governance 

Global  food  governance  refers  to  the  international  organizations  and  mechanisms  that 
are in place and may impact global governance and cooperation in food and nutrition. In 
an interconnected world, food safety and nutrition related issues can be of concern on a 
bilateral,  regional  or  even  global  scale.  This  is  of  even  greater  importance  with  the 
current  trends  that  foresee  an  increased  role  of  emerging  powers  in  the  global  market 
system. As a result, international food governance can have an important impact in both 
regional  and  global  food  systems,  especially  to  ensure  safe  trade  and/or  effective 
nutrition  policies.  Specific  impacts  can  be  on  harmonizing  and  enforcing  food  safety 
standards,  exchanging  food  safety  alerts  and  information  via  rapid  communication 
networks,  sharing  best  practices  on  food  safety  as  well  as  coordinating  policies  and 
strategies  in  nutritional  issues  such  as  global  food  security,  malnutrition,  public  health 
nutrition action plants etc. Albeit their voluntary application or adoption, the global food 
standards,  guidelines  and  best  practices  that  have  been  put  in  place  by  Codex 
Alimentarius not only form the basis of many specific national food legislations, but are 
also  used  as  reference  by  the  WTO,  which  potentially  increases  their  relevance.  Other 
relevant  intergovernmental  organizations  include  the  World  Organization  for  Animal 
Health,  which  is  also  recognized  as  a  reference  for  animal  health,  as  well  as  the 
International  Plant  Protection  Convention,  a  global  treaty  on  plant  health.  In  addition, 
international  industry  initiatives  or  private  food  standards  could  be  of  increased 
relevance and may affect global food safety governance 

The  Codex  Alimentarius66  of  the  Food  and  Agriculture  Organisation  (FAO)  of  the  United 
Nations  (UN),  established  in  1963,  is  a  set  of  guidelines,  codes  of  practice,  standards 
and  advisory  documents  that  are  aimed  at  protecting  the  health  of  the  consumers  and 
ensure fair practices in the food trade. The Codex includes various standards67; general 
standards  e.g.  on  food  additives,  health  claims  made  on  foods  and labelling in  general, 
specific  standards  on  maximum  residue  levels  (MRLs)  for  veterinary  drugs  and 
pesticides,  as  well  as  thematic  compilations,  e.g.  on  prevention  and  reduction  of  food 
and  feed  contamination,  food  import  and  export  inspection  and  certification  systems, 
specific food categories such as fresh fruits and vegetables, milk and milk products etc. 
Currently  the  Codex  Alimentarius  Commission  has  186  nation-members  (including  the 
EU68  as  a  member  organisation)  which  cover  99%  of  the  world's  population,  as  well  as 
224  observers  (intergovernmental  organisations-IGOs,  NGOs  and  UN  organisations). 
Codex is voluntary reference standard and adhesion to its standards is voluntary also for 
its members, however the Codex standards serve in many cases as the basis for national 
legislation. In addition, the World Trade Organisation uses the Codex as an international 
reference standard when resolving trade disputes, under the Agreement on Sanitary and 
Phytosanitary  measures69  (SPS  Agreement),  meaning  that  the  Codex  can  have  even 
more important and long-reaching impacts. 

Other standards 

The  World  Organisation 
is  an 
intergovernmental organisation aiming to improve animal health and welfare; it numbers 

for  Animal  Health  (OIE),  created 

in  1924, 

66 Codex Alimentarius International Food Standards website http://www.codexalimentarius.org/codex-home/en/ (►10/11/2014) 
67 Codex Alimentarius list of standards http://www.codexalimentarius.org/standards/en/  (►10/11/2014) 
68 Council decision 2003/882/EC on the accession of the European Community to the  Codex Alimentarius Commission (2003). Official 
Journal of the European Union L309/14 
69 Agreement on the Application of Sanitary and Phytosanitary Measures (1995) World Trade Organisation 

114 

 
 
 
 
 
                                                           
180 members, and, via the SPS agreement, it is recognised by WTO  as a  reference for 
standards related to animal health and zoonoses99. 

The International Plant Protection Convention (IPPC, 1952) is an international treaty on 
plant  health,  which  aims  to  protect  cultivated  and  wild  plants  by  preventing  the 
introduction and spread of pests; it currently numbers 181 signatories and is supported 
by FAO99. 

The Global Food Safety Initiative (GFSI) is an industry driven programme, which aims to 
provide leadership and guidance on food safety management, ensuring the safety of the 
form 
food  supply  chain,  and 
manufacturing,  retail  and 
international 
organisations, governments and academia. 

food  services  businesses,  as  well  as 

involves  collaborations  between 

leading  experts 

Private food standards also exist and have risen in importance since the 1990s, e.g.  the 
Food Technical Standard by UK retailers in 1998 or the ISO 22000  standard in 2005. In 
addition,  private  food  standards  have  also  emerged,  especially  in  developing  countries, 
to cope for gaps in public standards, however their impact and future remains uncertain. 

The  increased  trade,  bilateral  or  international, of  foods  and  food  raw  materials,  both  of 
agricultural and animal origin, results in an increased importance of surveillance systems 
to contain the spreading contaminated foods or raw materials and protect the integrity of 
both national and global food chains. WHO supports a number of international networks 
on food safety, such as the INFOSAN and FOSCOLLAB, with the aim of rapidly diffusing 
information  on  food  safety  emergencies  or  act  as  a  global  data  hub  for  food  safety 
information  and  experiences.  The  Global  Early  Warning  System  for  animal  diseases  is 
jointly  run  by  WHO,  FAO  and  OIE;  the  latter  also  operates  the  World  Animal  Health 
Information System, monitoring and informing on the epidemiology of animal diseases. 

The  International  Food  Safety  Authorities  Network  (INFOSAN)  is  a  WHO-run  networks 
which assist member states in managing food safety risks; this is achieved by ensuring 
rapid dissemination of information on food safety emergencies, aiming to contain spread 
of  contaminated  food  material.  INFOSAN  also  acts  as  a  platform  to  share  experiences 
and optimized practices and interventions between countries. 

Another  WHO-run  system  is  FOSCOLLAB,  a  global  platform  for  food  safety  data  and 
information,  dedicated  to  food  safety  professionals,  and  aiming  at  rapid  access  of  food 
safety  date,  utilization  of  existing  experiences  and  sources  to  avoid  efforts  duplication, 
as well as integration and better generation of data. 

The Global Early Warning System for major animal diseases (GLEWS) is a FAO, WHO and 
OIE jointly run system, aimed at combining and coordinating the various information and 
alert mechanisms of WHO, FAO and OIE, as well as performing joint risk assessment.  

OIE  also  operates  the  World  Animal  Health  Information  System  (WAHIS),  an  on-line, 
real-time  animal  disease  monitoring  tool,  composed  of  an  early  warning  system  of 
animal  health  epidemiological  events  for  OIE  members,  as  well  as  a  monitoring  system 
for  presence  of  absence  of  animal  diseases  over  time.  Data  generated  from  WAHIS  is 
stored  in  the  World  Animal  Health  Information  Database  (WAHID),  including  follow-up 
reports, as well as monthly and annual reports on animal health in OIE members. 

Global nutrition governance 

While half of the planet is exhibiting increasingly poor dietary behaviors and suffers from 
over-nutrition,  leading  to  obesity  and  increasing  the  risk  of  major  Non-communicable 
diseases,  the  other  half  is  faced  with  food  insecurity  and  under  nutrition.  Under  this 
scope  FAO  and  WHO  have  designed  a  number  of  policies  to  fight  this  double  burden.  

115 

 
 
 
 
Action  plans  and  policies  to  combat  NCDs  and  obesity  have  been  put  forward,  such  as 
the  WHO  Global  and  European  action  plans  with  at  2020  horizon  or  the  2025  Global 
Targets for maternal, infant and child nutrition. In parallel, the World Food Programme, 
as well as the UN committee on World Food Security are providing global leadership on 
the fight against food insecurity. 

Non-communicable  diseases  (NCDs)  are  responsible  for  the  majority  of  deaths 
worldwide, and represent a significant burden for individual health as well as for national 
health systems. Health compromising lifestyles, such as unhealthy diets are risk factors 
for  major  NCDs,  e.g.  cardiovascular  diseases,  Type  2  diabetes  and  cancer;  in  addition, 
unhealthy dietary behavior is a major determinant for overweight and obesity, which in 
turn  is  a  risk  factor  for  the  above  mentioned  NCDs.  And  while  half  of  the  planet  is 
suffering from malnutrition in the sense of obesity, the other half is suffering from under 
nutrition and is threatened by food insecurity, in the so called "double burden". 

The  Food  and  Agriculture  Organization  of  the  UN  (197  member  nations)  aims  to 
eradicate  hunger,  malnutrition  and  food  insecurity,  eliminate  poverty  and  drive  forward 
economic and social progress, and utilize agricultural production and natural resources in 
sustainable  way.  FAO's  main  activities  are  comprised  of  a)  providing  support  for  a 
transition  to  sustainable  agriculture,  share  experience  in  agricultural  policies  and 
strengthen  political  will,  improve  smallholder  agriculture  by  bolstering  public  private 
collaborations, apply experience and knowledge to the field, as well as support countries 
in preventing or mitigating risks to agriculture, food and nutrition. 

The  World  Health  Organization  of  the  United  Nations  is  responsible  for  providing  global 
leadership  on  health  related  issues,  setting  norms  and  standards,  shaping  the  health 
research  agenda,  as  well  as  presenting  evidence-based  policy  options  and  providing 
technical support and health monitoring.  

On  the  topic  of  nutrition,  various  recent  initiatives  and  policy  actions  have  been  set 
forward  by  WHO;  the  Vienna  Declaration  On  Nutrition  and  Non-communicable  Diseases 
in the Context of Health 2020 , the Global Action Plan for the prevention and control of 
non-communicable  disease  2013-2020  ,  the  European  Food  and  Nutrition  Action  Plan 
2015-2020,  the  global  targets  for  2025  to  improve  maternal,  infant  and  young  child 
nutrition, via its World Health Assembly Policy Brief Series on Global nutrition Targets for 
2025  ,  the  commitment  with  FAO  and  participating  movements  during  the  high-level 
intergovernmental meeting during the 2nd International Conference  on Nutrition (ICN2, 
2014)  as  well  as  the  resulting  Rome  Declaration  on  Nutrition    and  Action  Framework  
aimed  at  establishing  national  policies  to  tackle  malnutrition  in  all  forms  and  transform 
food systems to make nutritious diets available to all. 

The  UN  Standing  Committee  on  Nutrition  (UNSCN,  1977)  is  the  UN  forum  dedicated  to 
food and nutrition policy harmonization, and aims to strengthen cooperation among the 
various UN agencies and partner organizations, with the ultimate goal to end all forms of 
malnutrition. 

The World Food Programme (WFP) of the UN is the world's largest agency committed to 
fighting hunger on a global level, providing food both during emergency situations such 
as  conflicts  and  national  disasters  as  well  on  the  aftermath  in  order  to  help  affected 
communities rebuild their lives. 

The committee on World Food Security (CFS, 1974), is another intergovernmental forum 
in  the  UN,  focusing  on  reviewing  food  security  policies,  including  availability  of-  and 
accessibility  to-  food.  Another  UN  food  security  initiative  is  the  High  Level  Task  Force 
(HLTF)  on  the  Global  Food  Security  Crisis,  which  was  created  after  the  2008  spikes  in 
food  prices  and  aims  to  support  national  authorities  in  facing  food  and  nutrition 
insecurity. 

116 

 
 
 
The Agricultural Market Information System (AMIS) is a G20 initiative aiming to enhance 
food  market  transparency  as  well  as  to  promote  coordination  of  policy  actions 
responding  to  market  uncertainty;  the  main  focus  is  on  four  major  crops  of  significant 
international food market importance, i.e. wheat, maize, rice and soybeans. 

117 

 
 
 
 
 
 
10.2. EU food safety information exchange networks and 

early warning systems99 

The  increased  trade,  bilateral  or  international,  of  food  or  food  raw  materials,  both  of 
agricultural and animal origin, results in an increased importance of surveillance systems 
to contain the spreading contaminated foods or raw materials and protect the integrity of 
both  national  and  global  food  chains.  On  an  EU  level,  RASFF  acts  as  an  early  warning 
information sharing system for food hazards, and it is complemented by TRACEs, an EU-
wide  veterinary  health  monitoring  and  notification  network,  and  by  ADNS,  an  animal 
disease notification system between competent authorities. Similarly, EUROPHYT acts as 
a  notification  system  for  plant  diseases.  In  addition,  EFSAs  Information  Exchange 
Platform  and  the  European  Commission's  Better  Training  for  Safe  Food  projects  act  as 
hubs for sharing risk assessment or food safety practices respectively. 

The  Rapid  Alert  System  on  Food  and  Feed  (RASFF)  of  the  EU  was  created  in  1979  to 
enable  efficient  information  sharing  on  food  safety  risks  between  the  national  food 
authorities  of  the  28  MS,  Norway,  Lichtenstein,  Iceland  and  Switzerland,  as  well  as  the 
Commission  and  EFSA.  The  legal  basis  of  RASFF  lies  with  General  Food  Law  Regulation 
(EC)  No  178/2002,  article  50,  which  establishes  RASFF  as  a  network.  Information 
exchange via RASFF can lead to product recalls and alleviation of food safety hazards for 
the  EU  consumers.  RASFF  can  issue  notifications,  when  a  food,  feed  or  food  contact 
material present in the market bears serious risks for which rapid action is or might be 
required  in  a  country  other  than  the  one  emitting  the  alert.  RASFF  can  also  issue 
Information notifications, which concern food, feed or food contact materials which bear 
risks that do not however require immediate action. RASFF also includes border rejection 
notifications. 

The Trade Control and Expert System (TRACES) is a EU-wide veterinary health network 
dedicated  to  monitoring,  as  well  as  carrying  out  notifications  and  certifications  of 
imports,  exports  and  trade  in  live  animals  and  animal  products.  The  TRACEs  system  is 
supplemented  by  the  Animal  Disease  Notification  System  (ADNS),  an  early  warning 
notification  system  aimed  at  direct  communication  between  competent  authorities  and 
registering  and  documenting  major  infectious  animal  disease  outbreaks  to  ensure  rapid 
containment actions. 

The European Union Notification system for Plant Health Interceptions (EUROPHYT) is a 
rapid alert and notification system that deals with intercepting plant pathogens and pests 
in plants imported from third countries or from intra-EU trade. 

Another  EU-level  food  safety  information  network  is  EFSA's  Information  Exchange 
Platform  (IEP,  2008);  its  aim is  to  connect  and inform  EFSA's  advisory  forum  and  focal 
point  members  on  food  risk  assessment  outputs  by  official  bodies  at  a  MS  level;  in 
addition,  it  acts  as  a  database  on  requests  to  conduct  risk  assessment,  results  of  risk 
assessment  evaluations,  work  plans  of  food  authorities  as  well  as  country  –  specific 
information on food safety (country profiles) 

Apart from information exchange systems, the EC has also set up the Better Training for 
Safe  Food  initiative,  covering  food,  feed,  animal  health  and  welfare  and  plant  health 
rules, aiming to train MS and candidate country national authority staff that is involved 
in  official  controls  in  the  above  areas,  keep  the  updated  on  EU  food  law  and  safety 
practices. 

118 

 
 
 
 
 
 
 
10.3. Better Training for Safer Food 

"Better  training  for  safer  food"  is  a  European  Commission  training  initiative70  covering 
food,  feed,  animal  health  and  welfare  and  plant  health  rules,  aiming  to  train  MS  and 
candidate country national authority staff that is involved in official controls in the above 
areas.  The  goal  is  to  keep  the  participants  updated  with  the  latest  EU  legislation 
developments,  therefore  ensuring  harmonised  and  efficient  controls.  Third  country 
parties,  especially  from  the  developed  world,  can  also  participate,  helping  ease 
exportation  of  third  country  products  into  the  EU.  The  training  programmes  cover 
various  disciplines  such  as  HACCP,  animal  welfare  standards,  animal  by-products,  audit 
systems,  quality  schemes  such  as  organic  or  geographical  indications,  plant  protection 
products, food hygiene and controls etc.  

70 Better training for safer food communication from the Commission to the council and the EU parliament COM(2006) 519 

119 

 
 
 
 
 
 
 
                                                           
10.4. Resource efficiency and food waste 

Resource efficiency in Europe is a Flagship Initiative of the Europe 2020 strategy towards 
a  resource  efficient,  low-carbon  economy  to  achieve  sustainable  growth71,  calling  for 
resource-efficient policies that will weight down different options, for example when land 
is  used  to  produce  food  and  could  compete  with  land  use  for  energy  production.  The 
Roadmap  to  a  Resource  Efficient  Europe72  which  followed  provides  outlines  on  how  to 
achieve a sustainable European economy by 2050, with specific milestones and plans of 
action  to  achieve  them.  Concerning  food,  the  milestone  foresees  that  by  "2020 
incentives  to  healthier  and  more  sustainable  food  production  and  consumption  will  be 
widespread  and  will  have  driven  a  20%  reduction  in  the  food  chain's  resource  inputs. 
Disposal of edible food  waste  should have been halved in the EU".  Specific Commission 
actions include assessing how to best limit waste throughout the supply chain, as well as 
ways  to  lower  the  environmental  impact  of  food  production,  develop  sustainability 
criteria  for  key  food  commodities  and  how  to  further  access  security  of  Pi  supply  and 
sustainable use. MS on the other hand should address food waste in their national waste 
prevention programs. The latest discussion took place in the food losses and food waste 
Working Group of the Commission's Advisory Group on the Food chain, Animal and Plant 
health,  mainly  on  defining  food  losses  and  food  waste,  how  to  facilitate  donations  of 
surplus food to food banks, communicating food sustainability, resource use in the food 
and  feed  chain,  innovation  supporting  food  waste  reduction  and  food  sustainability,  as 
well  as  on  how  to  support  awareness  and  exchange  best  practices73.  In  addition,  a 
number  of  good  practices  have  been  identified  covering  a  wide  range  of  initiatives  on 
food  waste  reduction  at  local,  regional  or  national  levels  on  the  areas  of  research  and 
innovation,  awareness  information  and  education  as  well  as  policy,  awards  and  self-
imposed certification74.  

In  line  with  the  resource  efficiency  and  waste  reduction  policies,  the  EU  Ecolabel  is  a 
voluntary environmental labelling system, launched in 1992 and legally defined in 2010 
with Reg, (EC) No 66/201075, aiming at facilitating the recognition of high-quality, eco-
friendly products by the consumers. It can be awarded to products or services that have 
a  lower  impact  as  other  similar  products  or  services,  but  cannot  apply  to  veterinary 
products or medical products or devices. A number of criteria have to be fulfilled prior to 
the awarding of the Ecolabel, which are in line with EU environmental and ethical policies 
(impact  on  climate  change,  biodiversity,  energy  consumption,  waste  generation, 
durability  &  re-usability,  effects  on  consumer  health  and  safety,  compliance  with  social 
and ethical standards, reduced animal testing etc.) 

71 A resource-efficient Europe – Flagship initiative under the Europe 2020 Strategy. COM(2011) 21 
72 Roadmap to a Resource Efficient Europe communication – COM(2011) 571 Final 
73 3rd Meeting Summary Report: Working Group On Food Losses & Food Waste Of The Advisory Group On The Food Chain, Animal And 
Plant Health (2014) 
74 DG Health and Consumers Good Practices website http://ec.europa.eu/food/food/sustainability/gp_policy_awards_certifications_en.htm 
(►10/11/2014) 
75 Reg. (EU) No 66/2010 on the EU Ecolabel (2010). Official Journal of the European Union L 27/1 

120 

 
 
 
 
 
 
 
                                                           
10.5. EU agricultural quality product policy – Single CMO and 

Green Paper 

10.5.1.  Single CMO and Green Paper 

The  EU  has  been  developing  an  agricultural  product  policy  since  the  creation  of  the 
Common Market Organisations (CMO) in the 1960's for several agricultural products. In 
the 2007 the "Single CMO" was adopted.  The Single CMO refers to the legal framework 
that  the  EU  has  established  for  certain  agricultural  sectors,  providing  common  rules  for 
managing  agricultural  markets,  standards  for  marketing,  importing  or  exporting 
agricultural products to and from the EU. The legal basis lies with Reg. (EC) 1234/2007, 
and  especially  in  Annex  I  and  II  where  the  specific  agricultural  sectors  are  mentioned. 
The salient points of 1234/2007 were:  

 

Internal market: Market intervention: system of price support in parallel with the 
intervention  measures: 
introduction  of  direct  support  schemes,  special 
exceptional  measures  to  protect  markets  in  crisis,  Quota  schemes:  national 
production quotas for sugar and milk – foreseen to be lifted, Aid: sugar, milk and 
milk  products,  fruits  and  vegetables,  promotion  of  fruit  and  milk  product 
consumption in schools, wines) 

  Marketing  and  Production:  marketing  standards  for  certain  products,  protection 
label in wine sectors, recognition of producer and inter-branch organisations 
Trade with third countries: Import licences for products of certain sectors, import 
tariff  quotas,  export  licences,  export  funds  to  support  exportation  of  certain 
products. 

 

Legislation 1234/2007 has been repealed by Reg. (EU) 1308/2013 under the 2014-2020 
CAP reform. 

In  2008  the  EU  adopted  the  Green  Paper  on  "Agricultural  Product  Quality:  product 
standards, farming requirements and quality schemes"76 after completing a consultations 
phase,  which  discussed  policy  on  production  requirements  and  marketing  standards, 
specific  EU  quality  schemes,  as  well  as  certification  schemes.  The  Green  Paper  was 
followed by a Communication77 on agricultural product quality, which laid down strategic 
orientations to improve EU agricultural product quality policy, before the introduction of 
the new quality regulation: Reg. (EU) 1151/2012. 

10.5.2.  EU agricultural quality product policy – Quality scheme 

Apart  from  standard  quality  and  safety  of  foodstuffs,  the  EU  has  also  set  down  laws 
regarding  quality  schemes  for  foods  and  beverages  produced  with  exact  specifications, 
which also included wines and aromatised wines. Geographical indications and traditional 
specialities  are  covered  under  the  Protected  Designation  of  Origin  (PDO),  Protected 
Geographical  Indication  (PGI)  and  Traditional  Specialties  Guaranteed  (TSG)  schemes, 
which protect and promote specialised agricultural products and foodstuffs.   In specific, 
PDO  covers  agricultural  products  and  foodstuffs  which  are  produced,  processed  and 
prepared in a specific geographical zone using recognised know-how. PGI instead covers 
foods and agricultural products linked to a specific geographical area, for at least one of 
the stages of production, processing or preparation. Finally, TSG stresses the traditional 

76 Green Paper  on agricultural product quality: product standards, farming requirements and quality schemes. COM(2008) 641 Final 
77 Communication on agricultural product quality policy COM(2009) 234 final 

121 

 
 
 
 
 
 
                                                           
character, be it in the composition or in the production method. The Commission DOOR 
database78 contains a registry of PDO, PGI and TSG products.  

The food and agricultural products quality schemes were first introduced with Reg. (EC) 
510/200679 for PDO and PGI and Reg. (EC) 509/200680 for the TSG scheme. All of these 
schemes  were  revised  with  Reg.  (EU)  1151/201281.  This  regulation  introduced  a 
simplified regime for several quality schemes, as well as provided a robust framework for 
the protection and promotion of quality products. The main points include  

  more  coherence  and  clarity  in  EU  quality  schemes,  reinforcement  of  existing 
schemes  for  PDO  and  PGI  (faster  registration  procedures,  clarified  rules  on 
controls,  use  of  PDO  and  PGI  to  become  compulsory  for  products  of  EU  origin 
from  early  2016, legal basis  for  having  non-EU  GI,  legal  basis  for  defence  of  EU 
logos recognised role of producer groups) 

 

 

a  new  approach  at  the  TSG  scheme  (simplified  and  strengthened,  as  well  as 
stricter  prerequisites,  e.g.  need  to  have  been  circulating  in  the  market  for  30 
years) 

a  new  framework  for  the  development  of  optional  quality  terms  for  further 
consumer information (e.g. introduction of mountain products). 

Further  legal  support  and  clarification  of  specific  details  was  provided  with  Regulations 
(EU) No 664/201482 (certain rules on sourcing, procedures and transitions), 665/201483 
(regarding  the  use  of  the  optional  term  "mountain  product")  and  668/201484  (specific 
rules  including  naming,  definition  of  geographical  area,  feed,  proof  of  origin),  which 
supplemented Reg. (EU) 1151/2012. 

The  E-BACCHUS  database  is  the  register  for  PDO  and  PGI  wines,  in  accordance  with 
Regulation  (EC)  1234/200752.  The  2008  reform  of  the  wine  sector  aimed  at  making  EU 
wine  more  competitive,  making  market  management  rules  simpler  and  clearer,  and  at 
preserving  the  best  traditions  of  EU  wine  growing  and  boosting  its  social  and 
environmental role in rural areas. The EU plans to lift restrictions on planting vines after 
2015, allowing competitive producers to boost their production. 

10.5.3.  EU agricultural quality product policy – Organic farming and 

products 

To harmonise the production, labelling and control of organic products, and to ensure a 
fair  competition  between  producers  as  well  as  strengthen  consumer  confidence,  the 
Commission has adopted Reg. (EC) No 834/200785, repealing Reg. (EEC) No 2092/9186. 

78 European commission DOOR database: 
http://ec.europa.eu/agriculture/quality/door/list.html;jsessionid=pL0hLqqLXhNmFQyFl1b24mY3t9dJQPflg3xbL2YphGT4k6zdWn34!-
370879141 (►11/11/2014) 
79 Reg. (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs 
(2006) Official Journal of the European Union L 93/12 
80  Reg.  (EC)  No  509/2006  on  agricultural  products  and  foodstuffs  as  traditional  specialities  guaranteed  (2006)  Official  Journal  of  the 
European Union L 93/1 
81 Reg. (EU) 1151/2012 on quality schemes for agricultural products and foodstuffs (2012). Official Journal of the European Union L 343/1 
82 Delegated Reg. (EU) No 664/2014 supplementing Regulation (EU) No 1151/2012 of the European Parliament and of the Council with 
regard to the establishment of the Union symbols for protected designations of origin, protected geographical indications and traditional 
specialities  guaranteed  and  with  regard  to  certain  rules  on  sourcing,  certain  procedural  rules  and  certain  additional  transitional  rules 
(2014). Official Journal of the European Union L 179/17 
83Delegated Reg. (EU) No 665/2014 supplementing Regulation (EU) No 1151/2012 of the European Parliament and of the Council with 
regard to conditions of use of the optional quality term ‘mountain product’ (2014). Official Journal of the European Union L 179/23 
84 Delegated Reg. (EU) No 668/2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament 
and of the Council on quality schemes for agricultural products and foodstuffs (2014). Official Journal of the European Union L 179/36 
85 Reg. (EC) No 834/2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (2007). 
Official Journal of the European Union L 189/1 

122 

 
 
 
 
                                                           
Detailed rules concerning the implementation of 834/2007 were specified with Reg. (EC) 
No  889/200887.  The  legislation  applies  to  products  which  bear  or  intend  to  bear 
indications referring to organic methods of production, and includes non-processed crop 
and  livestock,  farmed  livestock,  agricultural  crop  and  livestock  intended  for  human 
consumption that are processed mainly from one or more agricultural crop or livestock, 
as  well  as  animal  feeds.  The  regulation  lays  down  rules  of  production  as  well  as 
inspection  rules  and  indications  of  conformity.  The  legislation  also  allowed  for  synthetic 
resources  to  be  permitted  in  organic  production,  when  no  alternative  suitable  can  be 
found. With the introduction of Reg. (EU) No 271/201088 (amending 889/2008), the EU 
organic logo was introduced and defined. 

The  European  Commission  has  recently  adopted  a  legislative  proposal89  for  a  new 
regulation  on  organic  production  and  labelling  of  organic  products,  aiming  at  adjusting 
the  EU  legislation  to  the  actual  situation  of  the  EU  organic  market,  which  has  grown 
considerably  in  the  last  decade,  so  the  sector  can  further  develop.  The  legislative 
proposal is accompanied by an impact assessment90. In addition, the EU has adopted an 
Action  Plan91  regarding  the  future  of  European  organic  production,  which  aims  to  help 
organic  producers  and  retailers  to  adjust  to  policy  changes  and  to  better  prepare  for 
future challenges. 

10.5.4.  EU agricultural quality product policy – Food Quality 

Certification schemes 

An  increasing  number  of  voluntary  certification  schemes  operate  in  the  market,  in 
parallel  with  the  EU  agricultural  products  and  foodstuffs  quality  schemes.  Voluntary 
certification  schemes  aim  to  assure  that  certain  aspects  and/or  requirements  of  the 
production method,  or  the product itself, have been adhered to. Such schemes  cover a 
wide range of initiatives at different stages of the supply chain, and can also may make 
use of logos. 

The  Commission  has  communicated  (2010/C  341/0492)  specific  guidelines  to  highlight 
best  practices  for  the  development  and  operation  of  such  voluntary  certification 
schemes. An inventory93 compiled in 2010 counted 441 schemes for agricultural products 
and  foodstuffs,  which  range  from  compulsory  production  standards,  requirements  for 
environmental protection to fair trade and animal welfare. 

86  Reg.  (EEC)  No  2092/91  on  organic  production  of  agricultural  products  and  indications  referring  thereto  on  agricultural  products  and 
foodstuffs. Official Journal of the European Union L 198/1 
87  Reg.  (EC)  No  889/2008  laying  down  detailed  rules  for  the  implementation  of  Council  Regulation  (EC)  No  834/2007  on  organic 
production  and  labelling  of  organic  products  with  regard  to  organic  production,  labelling  and  control  (2008).  Official  Journal  of  the 
European Union L 250/1 
88  Reg,  (EU)  No  271/2010  amending  Regulation  (EC)  No  889/2008  laying  down  detailed  rules  for  the  implementation  of  Council 
Regulation  (EC)  No  834/2007,  as  regards  the  organic  production  logo  of  the  European  Union  (2010).  Official  Journal  of  the  European 
Union L 84/19 
89  Proposal  for  a  regulation  on  organic  production  and  labelling  of  organic  products,  amending  Regulation  (EU)  No  XXX/XXX  of  the 
European Parliament and of the Council [Official controls Regulation] and repealing Council Regulation (EC) No 834/2007. COM(2014) 
180 Final, 2014/0100 (COD)  
90 Executive summary of the impact assessment regarding the proposal for a regulation on on organic production and labelling of organic 
products,  amending  Regulation  (EU)  No  XXX/XXX  of  the  European  Parliament  and  of  the  Council  [Official  controls  Regulation]  and 
repealing Council Regulation (EC) No 834/2007. SWD (2014) 66 final 
91 Action Plan for the future of Organic Production in the European Union. COM(2014) 179 final 
92 Commission Communication 2010/C 341/04. EU best practice guidelines for voluntary certification schemes for agricultural  products 
and foodstuffs (2010). Official Journal of the European Union C 341/5 
93 Inventory of certification scheme for agricultural products and foodstuffs marketed in the EU Member States – Data Aggregations (2010) 
Areté Research & Consulting in Economics 

123 

 
 
 
 
 
 
 
                                                                                                                                                                                     
10.6.  Common Agricultural Policy (CAP) 

CAP  is  the  Common  Agricultural  Policy  framework  of  the  EU.  CAP  is  one  of  the  oldest 
policies  of  the  EU,  dating  back  to  1962,  and  has  been  reformed  on  a  number  of 
occasions. The  four main legislative texts  related to the latest CAP reform (2014-2020) 
were introduced in late 2013 and cover the areas  of rural development  – Reg. (EU) No 
1305/201394,  horizontal  issues  such  as  funding  and  controls  –  Reg.  (EU)  No 
1306/201395,  direct  payments  for  farmers  –  Reg.  (EU)  No  1307/201396  and  market 
measures – Reg. (EU) No 1308/201397, as well as Reg. (EU) 1310/201398 that concerns 
transitional  provisions  regarding  the  application  of  the  four  main  regulations  during 
2014.  

The CAP reform 2014-202099 moves from product to producer support, and a more land-
based approach to tackle challenges in three specific areas:  

i) Economic, focusing on food security, globalisation, declining productivity growth, price 
volatility,  pressures  of  production  costs,  deteriorating  position  of  farmers  in  the  food 
chain, environmental and territorial changes. 

ii)  Environmental,  dealing  with  issues  relating  to  resource  efficiency,  soil/water  quality, 
threats to habitats/biodiversity 

iii)  Territorial,  addressing  demographic  decline  in  rural  areas  as  well  as  social 
developments such as depopulation and relocation of businesses 

The  new  CAP  maintains  the  older  CAP  pillars  of  market  and  price  support  and  rural 
development policy, but aims to increase the links between them, under a more holistic 
approach  to  policy  support.  To  achieve  a  more  competitive  and  sustainable  agricultural 
sector, the new policy framework addresses some specific issues: 

-  Enhancing  competitiveness  of  EU  agriculture.  Production  quotas  and  volume 
restrictions on sugar, dairy and the wine sector will be lifted, allowing farmers to respond 
to growing world demand and enhancing competitiveness. Other outdates commodity aid 
schemes  will  be  abolished,  will  others  will  be  modernised.  CAP  also  foresees  facilitating 
producer  co-operation  under  both  pillars  by  improved  access  to  credit  for  farmers  and 
reducing  their  costs,  setting  up  support  for  producer  groups  as  well  as  implementing 
short  supply  chains.  Added  value  will  come  from  product  differentiation,  quality 
programs  promotion  and  on-farm  processing.  Other  policies  include  start-up  aid  for 
young  farmers,  as  well  as  restructuring  and  modernisation  measures.  Bridging  the  gap 
between  science  and  practice  will  be  done  via  the  Farm  Advisory  system,  as  well  as 
training  programmes,  adapting  farmers  to  new  trends  and  technologies  in  order  to 
become  more  resource  efficient.  The  new  CAP  also  offers  more  responsive  safety  net 

94  Reg.  (EU)  No  1305/2013  on  support  for  rural  development  by  the  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
repealing council regulation (EC) No 1698/2005. Official Journal of the European Union (2013) L 347/287 
95  Reg.  (EU)  No  1306/2013  on  the  financing,  management  and  monitoring  of  the  common  agricultural  policy  and  repealing  Council 
Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (2013). 
Official Journal of the European Union L 347/649 
96 Reg. (EU) No 1307/2013 establishing rules for direct payments to farmers under support schemes within the framework of the common 
agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009. Official Journal of the 
European Union (2013) L 347/608 
97 Reg. (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations 
(EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007. Official Journal of the European Union (2013) L 347/671 
98 Reg. (EU) No 1310/2013 laying down certain transitional provisions on support for rural development by the European Agricultural Fund 
for  Rural  Development  (EAFRD), amending  Regulation (EU)  No 1305/2013 of the European Parliament and of the Council as regards 
resources and their distribution in respect of the year 2014 and amending Council Regulation (EC) No 73/2009 and Regulations (EU) No 
1307/2013, (EU) No 1306/2013 and (EU) No 1308/2013of the European Parliament and of the Council as regards their application in the 
year 2014. Official Journal of the European Union (2013) L 347/865 
99 Overview of CAP reform 2014-2020 (2013) Agricultural Policy Perspectives  Brief No5/2013 

124 

 
 
 
 
                                                           
measures and strengthens the EU's capacity for crisis management, via efficient market 
measures  dealing  with  market  disturbances,  as  well  as  more  flexible  exceptional 
measures.  Thus  measures  also  include  a  new  crisis  reserve  of  €400  million  annually 
(deduction of direct payments, and unused amounts to be reimbursed to farmers in the 
consecutive  budget  years).  Finally  new  CAP  includes  a  new  risk-management  system 
with schemes for crops, animals and plants. 

-  Sustainable  EU  agriculture.  The  new  CAP  introduces  a  number  of  sustainability-driven 
measures  aimed  at  improving  its  environmental  performance.  Concerning  basic 
environmental requirements to receive CAP funding, simplified and more targeted cross-
compliance  procedures  will  be  implemented.  In  addition,  from  2015  and  on  the  Green 
Payment  is  introduced,  accounting  for  30%  of  national  direct  payment  envelope, 
rewarding  farmers  for  respecting  sustainability  the  practices  of  maintaining  permanent 
grasslands,  ecological  focus  areas  and  crop  diversification.  Since  Green  Payment  is 
compulsory, it is expected to drive these environmentally-friendly practices. Concerning 
rural development, 30% of budget of rural development programmes must be reserved 
for voluntary measures that are environmental friendly (such as  organic farming, areas 
of natural constraints, forestry measures etc.).  

- Effective and efficient CAP: It is crucial to be able to distribute resources in a way that 
maximizes  the  achievement  of  CAP  objectives;  better  targeting  for  support,  more 
equitable  distribution  of  payments  across  MS  and  a  strategic  approach  to  spending  can 
enhance the effectiveness and efficiency of CAP. Direct payments will be limited to those 
who  are  actively  engaged  in  agricultural  activities.  In  addition,  from  2015,  all  young 
farmers will have the opportunity to get an additional first pillar payment, which can be 
complementary to the start-up aid mentioned above. MS can also target direct payments 
through other optional schemes, such as redistributive payments to the first hectares of 
a farm, providing support for smaller farmers. Finally, CAP aims to reduce the disparities 
of  direct  payments  between  Ms  (external  convergence),  by  adjusting  the  level  of  direct 
payments  per  hectare  (currently  based  on  historic  parameters  in  many  countries)  with 
the introduction of a minimum national average direct payment per hectare across all Ms 
by  2020.  Payments  will  not  be  based  on  uneven  historical  records  but  on  a  fairer  and 
more converging per hectare payment at national or regional level. 

- Strategic approach to Rural Development spending: As in the past, rural development 
policy  will  be  implemented  through  national/regional  development  programmes  (RDPs). 
However, the new cap will improve policy by strengthening its strategic approach, since 
MS  would  have  to  base  their  RDPs  on  at  least  four  out  of  six  common  EU  rural 
development priorities: 

125 

 
 
 
 
Regarding  EU  quality  and  traditional  foods,  the  CAP  scheme  foresees  also  information 
and promotion measures of agricultural products and their method of production (as well 
as  for  food  products  based  on  agricultural  products)  for  internal  or  third  country 
markets,  as  described  in  Regulation  (EC)  No  3/2008100  and  501/2008101.  Such 
informational and promotional measures can be financed in part by the EC budget. The 
measures include promotion and advertising to draw attention to the intrinsic properties 
and  advantages  of  EU  products,  such  as  on  their  quality  and  safety,  nutritional  and 
health aspects, related animal welfare as well as sustainable production. In addition, the 
measures include informational campaigns on high quality products such for PDOs, PGIs 
and  TSGs,  as  well  as  organic  and  other  labelling  schemes  and  symbols  in  foods  and 
wines.  The  latest  example  comes  from  an  €39  million  EU  support  for  27  programmes 
such as fresh and processed fruits and vegetables, dairy, quality products (PDOs, PGIs, 
TSG, organic), flowers, as well as sheep meat102. 

100 Council Regulation (EC) No 3/2008 on information provision and promotion measures for agricultural products on the internal market 
and in third countries (2008) Official Journal of the European Union L 3, 5.1.2008, p.1). Amendments: (EC) No 479/2008. No 72/2009, No 
153/2009 
101  Council  Regulation  (EC)  No  501/2008  laying  down  detailed  rules  for  the  application  of  Council  Regulation  (EC)  No  3/2008  on 
information provision and promotion measures for agricultural products on the internal market and in third countries (2008) Official Journal 
of the European Union L 147/3 
102 European Commission Press Release: €39 million EU support for the promotion of agricultural products. 30/10/2014 

126 

 
 
 
 
 
 
                                                           
10.7. Common Fisheries Policy (CFP) 

The EU's Common Fisheries Policy is a set of rules managing EU fishing fleets and aiming 
to  conserve  fish  stocks.  The  CFP  was  first  introduced  in  the  1970s,  while  the  latest 
reform was in early 2014, introduced by Reg.  (EU) No 1380/2013103. The aim of CFP is 
to  "ensure  that  fishing  and  aquaculture  is  environmentally,  economically  and  socially 
sustainable and that they provide a source of healthy food for EU citizens. Its goal is to 
foster  a  dynamic  fishing  industry  and  ensure  a  fair  standard  of  living  for  fishing 
communities"104.  CFP  stipulates  that  between  2015-2020  environmentally  sustainable 
catch limits should be set. CFP has four main policy areas: 

i) Fisheries management, aimed at safeguarding stock reproduction for long term yield, 
conserving  marine  resources,  sharing  fishing  opportunities,  reducing  unwanted  catches 
and wasteful practices ( e.g. introducing the landing obligation, from 2015-2019).  

ii) International policy; more than a quarter of the fish in the EU is actually caught by EU 
boats outside EU waters. Around 8% of fish catches are made under fishing agreements 
with  non  EU  countries,  while  approx.  20%  are  caught  on  high  seas.  As  a  major  fishing 
power, the EU therefore plays an important role in promoting better governance through 
a number of international organisations or agreements with its partners. As far as trade 
is  concerned,  every  three  years  the  EU  can  reduce  tariff  rates  in  order  to  increase  the 
import/supply of raw materials to the EU fish processing industry when the EU supply is 
not sufficiently high to meet internal demands 

iii)  Market  and  trade  policy;  the  common  organisation  of  the  markets  was  set  up  to 
stabilise  markets  and  to  guarantee  fair  income  for  producers,  evolving  from  a  system 
doing  market  interventions  to  a  system  focused  on  sustainability,  as  well  as  give  more 
responsibility  for  managing  their  sector  to  fisheries  and  aquaculture.  The  common 
markets  organisation  scheme  covers  mainly  two  areas;  Organisation  of  the  fishery  and 
aquaculture sector (producer organisations, associations of such organisation, as well as 
market  instruments),  and  marketing  of  fishery  and  aquaculture  products  (common 
marketing  standards  for  fishery  products  sold  in  the  EU,  consumer  information  and 
labelling requirements, as well as market intelligence – European Market Observatory for 
Fishery and Aquaculture Products. 

iv) Funding of the policy; this involves the EU fisheries fund (funding for all sectors of the 
industry,  sea/inland  fishing,  aquaculture,  processing  and  marketing  of  fish  products, 
attention to fishing communities affected by recent changes in the industry), as well as 
the  EU  Maritime  and  Fisheries  Fund  (helps  fishermen  in  transition  towards  sustainable 
fishing,  supports  coastal  communities  in  diversifying  their  economies,  finances  projects 
for new jobs and quality of life along the EU coast, makes access to funding easier) 

103 Reg. (EU) No 1380/2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 
and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC. Official Journal of the 
European Union (2013) L 354/22 

104 European Commission's Common Fisheries Policy website: http://ec.europa.eu/fisheries/cfp/index_en.htm (►10/11/2014) 

127 

 
 
 
 
 
 
 
                                                           
10.8.  Audio-visual Media Services 

The  Audio-visual  Media  Services  Directive105  (AVMS),  which  amended  and  replaced  the 
Television  without  Frontiers  Directive106,  aimed  at  providing  less  detailed  but  more 
flexible  regulation  on  the  EU's  audio-visual  policies  as  well  as  modernising  television 
advertising  rules.  Concerning  food,  the  AVMS  directive  states  that  the  Commission  and 
the  MS  should  encourage  media  providers  to  establish  and  follow  codes  of  conduct 
regarding  "inappropriate  audio-visual  commercial  communications,  accompanying  or 
included  in  children’s  programmes,  of  foods  and  beverages  containing  nutrients  and 
substances  with  a  nutritional  or  physiological  effect,  in  particular  those  such  as  fat, 
trans-fatty  acids,  salt/sodium  and  sugars,  excessive  intakes  of  which  in  the  overall  diet 
are not recommended". The first evaluation report of 2012107 concludes that more efforts 
are  needed  to  create  support  and  best  practices  for  codes  of  conduct  concerning 
inappropriate  advertisement  to  children  of  foods  high  in  fat,  salt  and  sugar,  that  the 
effectiveness of such codes of conduct should be further assessed. In addition, it states 
that  the  Commission  will  support  the  development  of  more  stringent  age  and  audience 
thresholds  for  advertising  and  marketing,  as  well  as  more  consistent  nutritional 
benchmarks. 

105 Directive 2010/13/EU on the on the coordination of certain provisions laid down by law, regulation or administrative action in Member 
States concerning the provision of audio-visual media (2010). Official Journal of the European Union  L 95/1 
106 Council Directive 89/552/EEC on the coordination of certain provisions laid down by law, regulation or administrative action in Member 
States concerning the pursuit of television broadcasting activities (1989). Official Journal of the European Union  L 298/23  
107 First Report on the application of Directive 2010/13/EU "Audiovisual Media Services Directive" Com(2012) 203 Final 

128 

 
 
 
 
 
 
 
                                                           
10.9.  Transatlantic Trade and Investment Partnership 

(TTIP) 

The  Transatlantic  Trade  and  Investment  Partnership108  is  a  trade  agreement  that  is 
currently being negotiated between the EU and the US, and aims at removing barriers to 
trade  in  a  broad  spectrum,  facilitating  trade  of  goods  but  also  services.  TTIP  therefore 
extends  to  opening  markets  for  investment,  services  as  well  as  public  procurement 
procedures.  As  a  result,  TTIP  is  not  only  about  cutting  tariffs  across  all  sectors,  but  is 
also  particularly  focused  on  "behind  the  border"  barriers,  such  as  difference  in 
regulations,  standards  and  approval  procedures.  The  main  elements  of  the  EU 
mandate109 (which does not include audiovisual services) for negotiations are: 

  Market access: i) As far as tariffs are concerned, the goal is to remove as much 
as  possible  the  number  of  duties  on  transatlantic  trade  in  industrial  and 
agricultural  products  ii)  Concerning  rules  of  origin,  the  aim  is  to  bring  together 
the EU and US approaches to rules of origin in order to facilitate trade, taking into 
consideration  the interests  of  EU  producers  iii)  Trade  defense  measures:  The  EU 
aim  is  to  establish  a  dialogue  on  anti-dumping  and  anti-subsidy  measures  with 
the US, maintaining its right to use such measures in the framework of WTO rules 
iv) Services: The goal is to open the services sectors to an extent that is at least 
equal  to  other  trade  agreements,  as  well  as  open  services  markets  to  new 
sectors,  such  as  in  the  transport  sector.  The  EU  aims  at  having  European 
professional  qualifications  recognized  in  the  US  and  that  EU  companies  will  be 
able to operate in the US under the same conditions as domestic companies v) As 
far  as  investment  is  concerned,  the  aim  is  to  achieve  the  highest  levels  of 
liberalization and investment protection that nowadays exist in other trade deals 
between  the  EU  and  the  US  vi)  Public  Procurement:  The  aim  is  to  create  new 
business opportunities by opening up access to governmental procurement in the 
US. 

 

Regulatory  issues  and  non-tariff  barriers:  This  addresses  non-tariff  related 
barriers  but  "behind  the  border"  issues  that  could  impede  trade,  and  which 
currently represent the most significant trade barriers. Therefore, a high potential 
economic  benefit  lies  within  the  regulatory  area.  The  aim  is  to  remove 
unnecessary  regulatory/procedural  obstacles  to  trade  and  investment,  by 
reaching  a  regulatory  compatibility  for  goods  and  services,  via  increased 
recognition,  harmonization  and  cooperation  between  regulators.  As  far  as 
Sanitary  and  Phytosanitary  (SPS)  measures  (health  and  hygiene  standards,  e.g. 
for food products) are concerned, EU110 and US will establish provisions based on 
the  WTO  SPS  and  existing  veterinary  agreement,  introducing  subjects  such  as 
plant  health.  In  addition,  and  apart  from  the  principles  of  the  WTO  SPS 
agreement, the negotiations on SPS measures should be based on science and on 
international  standards  or  scientific  risk  assessment,  leaving  however  room  to 
each  party  to  assess  and  manage  risk  in  accordance  with  the  level  of  protection 
that  each  side  deems  appropriate.  This  is  particularly  important  when  scientific 
evidence  is  insufficient;  however  this  process  should  be  transparent  and  applied 
only to the extent necessary to protect human animal or plant health. Finally, the 
agreement should achieve full transparency regarding SPS measures applicable to 
trade,  and  "in  particular  establish  provisions  for  the  recognition  of  equivalence, 
implementation  of  pre-listing  of  food-producing  establishments,  preventing 
implementation of pre-clearance, recognition of disease-free and pest-free health 

108 The Transatlantic Trade and Investment Partnership EU home page http://ec.europa.eu/trade/policy/in-focus/ttip/ (►12/11/2014) 
109  Directives  for  the  negotiation  on  the  Transatlantic  Trade  and  Investment  Partnership  between  the  European  Union  and  the  United 
States of America. Declassified document 11203/13 DCL1 
110 Initial EU position paper: EU-US transatlantic trade and investment partnership: Sanitary and Phytosanitary Issues 

129 

 
 
 
 
 
                                                           
status of the Parties and the principle of regionalisation for both animal diseases 
and plant pests". In addition, regulatory compatibility will be dealt with in sectors 
such as chemical, pharmaceutical and health sectors (e.g. medical devices). Since 
all  regulatory  differences  cannot  be  eliminated  in  a  single  step,  both  parties 
foresee  an  evolving  agreement  that  allows  progressively  greater  regulatory 
convergence via specific milestones. 

 

Addressing Shared Global Trade Challenges and Opportunities in the 21st century: 
The  agreement  goes  beyond  bilateral  trade  and  will  also  contribute  to  the 
strengthening  of  the  multilateral  trading  system  on  specific  issues:  intellectual 
property rights and trade and sustainable development. 

As  far  as  food  safety  is  concerned,  some  critical  points  that  are  expected  to  be 
extensively  discussed  during  the  negotiations  include,  but  are  not  limited  to,  the 
following: 

 

 

 

The  EU's  Precautionary  Principle,  which  relies  on  preventive  decision  making  in 
the  case  of  risk;  the  Precautionary  Principle  may  be  only  invoked  after  specific 
conditions  have  been  met:  the  identification  of  potentially  adverse  effects,  the 
evaluation of the available scientific data, as well as the evaluation of the extent 
of  scientific  uncertainty.  Under  the  Precautionary  Principle,  where  existing 
scientific data do not allow for a certain evaluation of a particular human, animal, 
plant  of  environmental  risk,  then  the  production  or  distribution  of  a  potentially 
hazardous product may be stopped or the product could be withdrawn. 
EU restrictions on genetically modified organisms: GMOs have to undergo a strict 
authorisation  procedure  involving  national  agencies,  EFSA  and  the  GM  reference 
labs of the JRC, before obtaining market approval or ability to be cultivated within 
the  EU.  Currently,  for  food/feed  use,  only  one  GM  maize  plant  is  commercially 
cultivated  in  the  EU  (GM  maize,  MON  810),  in  5  MS  (Spain,  Portugal,  Czech 
Republic,  Romania  and  Slovakia).  In  2010,  a  GM  starch  potato  (Armflora)  was 
authorised  for  industrial  applications,  however  it  is  no  longer  cultivated  since 
2011.  With  the  latest  council  decision  (June  2014),  MS  have  now  more 
possibilities  to  restrict  or  ban  the  cultivation  of  GMOs  that  have  been  authorised 
on an EU level, in all or parts of their territory. 
EU ban on the use of veterinary growth hormones; the EU has banned the use of 
veterinary  growth  hormones  since  the  1981,  and  as  a  result  has  banned  also 
imports  of  hormone-treated  meat,  in  particularly  beef  from  the  US.  Hormones 
banned  included  among  others  estradiol,  progesterone,  testosterone,  zeranol.  In 
the  US,  growth  hormones  for  beef  are  still  in  use,  and  this  has  led  to  a  lengthy 
EU-US dispute and various WTO formal appeals, consultations, settlement panels 
and arbitration proceedings111. Other  EU bans that could be focused by the TTIP 
negotiations include the growth hormone promoter ractopamin, used in pigs and 
cattle,  as  well  as  carcass  treatment  procedures  such  as  chlorinated  rinses  of 
poultry carcasses.  

The  use  of  Investor-State  Dispute  Resolution  (ISDR),  i.e.  the  ability  of investors  to  sue 
governments  and  ask  compensation  over  rules  that  can  affect  expected  trade  profits, 
even though it is argued that both the EU and US legal systems are perfectly capable of 
resolving such disputes without the need of a trade mechanism. 

111 The US-EU Beef Hormone Dispute (2010) Congressional Research Service 

130 

 
 
 
 
 
                                                           
Annex  I:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  178/2002  and  their  respective 
requirements 

In  the  following  paragraphs  certain  requirements  of  Reg.  178/2002  are  highlighted  and 
regulatory documents adding details for their implementation are described. 

Article 7 on the precautionary principle 

a) 
The  precautionary  principle,  as  established  by  Article  7  of  Regulation  (EC)  178/2002, 
indicates that when risk assessment identifies the possibility of harmful effects to life or 
health but scientific uncertainty persists, provisional risk management measures may be 
adopted in order to ensure the highest level of health protection. These measures should 
be  appropriate  for  the  circumstances  and  not  more  restrictive  to  trade  than  necessary 
and  should  also  consider  technical,  economic  and  other  factors.  Also  the  measures 
should be reviewed within a reasonable period of time, once more scientific information 
allows  for  a  more  comprehensive  risk  assessment.  In  2000  a  communication  document 
was published by the Commission on the precautionary principle (COM(2000) 1 final).   

Article 9 on public consultation 

b) 
Article  9  of  Regulation  (EC)  178/2002  establishes  public  consultation  during  the 
preparation,  evaluation and  revision  of  food  law  under  the  principle  of  transparency.  In 
that  respect,  Commission  Decision  2004/613/EC  established  an  Advisory  Group  on  the 
food chain, animal and plant health attached to the Commission. The Commission must 
consult  this  group  on  issues  of  food/feed  safety,  food/feed  labelling  and  presentation, 
human  nutrition  legislation,  animal  health  and  welfare  and  crop  protection,  plant 
protection products and their residues. The Decision also specifies the group's structure 
and operation and highlights the importance of publicity of its work and confidentiality. A 
list of the members of the group was subsequently published under Article 3 of Decision 
2004/613/EC. More recently, additional members were added to the Advisory Group and 
a new list with all the members was published by Decision 2011/242/EU. 

Article 18 on traceability 

c) 
Article  18  of  Regulation  (EC)  178/2002  specifies  requirements  related  to  traceability  at 
all  stages  of  the  food  chain.  The  food  business  operators  must  be  able  to  identify  the 
business  from  which  they  have  been  supplied  food  and  the  businesses  to  which  they 
have  supplied  food.  This  is  known  as  "one  step  back-one  step  forward"  approach.  Also 
accurate  records  and  documentation  must  be  in  place  to  allow  traceability  in  case  of 
emergency.  However,  information  and  experience  from  previous  food  crises  has  shown 
that the documentation gathered is not always sufficient to allow full traceability leading 
to  huge  economic  costs,  in  particular  in the  animal  origin  food  sector.    In  that  respect, 
Implementing  Regulation  (EC)  No  931/2011  (EU,  2011b)  requires  the  food  business 
operators  in  the  field  of  food  of  animal  origin  to  supply  specific  information  to  the 
businesses  to  which  they  supply  products.  This  information  should  be  maintained  in 
accurate  records  and  in  case  of  an  emergency  it  should  be  made  available  to  the 
Authorities.  

131 

 
 
 
 
 
 
 
 
 
Article 25 on management board 

d) 
Article 25 of Regulation (EC) 178/2002 lays down detailed provisions for the composition 
of the Management Board of the European Food Safety Authority, their background and 
their term of service. On the basis of this Article, a series of Council Decisions have been 
published on the appointment of the EFSA members of Management Board (i.e. Council 
Dec. 2013/C 187/06, 2012/C 192/01, 2010/C 171/05). 

Article 28 on Scientific Committee and Scientific Panels 

e) 
Article 28 of Regulation 178/2002 defines the responsibilities of the Scientific Committee 
and  the  Scientific  Panels  of  the  European  Food  Safety  Authority,  their  composition,  the 
number  and  names  of  the  different  Panels  and  also  procedures  for  operation  and 
decision  making.  When  required  by  scientific  and  technical  developments,  the 
introduction  of  new  Panels  or  their  renaming  can  be  fulfilled  through  the  publication  of 
Regulations  amending  Regulation  178/2002  (i.e.  Com.  Reg  (EC)  No  575/2006,  Com. 
Reg. (EC) No 202/2008).  

Article 29 on scientific opinions 

f) 
Article 29 of Regulation 178/2002 provides details on the operation of the European Food 
Safety Authority and specifically on the issuing of Scientific Opinions. Regulation (EC) No 
1304/2003 lays down the procedure to be followed by the Authority on the requests for 
scientific opinions. A register of the different types of requests must be established which 
must  be  available  to  the  public.  The  Authority  forwards  the  requests  to  the  relevant 
scientific  panels  to  prepare  the  opinion.  Timelines  are  also  established  and  procedures 
for the handling of urgent requests. The Authority maintains the right to refuse a request 
for an opinion under specific conditions with reasoning for doing so.  

Article  36  on  networking  of  organisations  operating  in  the  fields 

g) 
within the Authority's mission 
Article  36  of  Regulation  (EC)  178/2002  specifies  that  EFSA  must  promote  networking 
between  the  organisations  operating  in  the  different  fields  under  its  umbrella.  A  list  of 
these  organisations  in  the  different  Member  States  must  be  made  publicly  available. 
Commission  Regulation  (EC)  2230/2004  (EC,  2004b)  lays  down  detailed  rules  for  the 
implementation  the  above  requirements.  It  specifies  the  criteria  that  the  organisations 
must meet in order to be included in the list, the requirement for evidence of compliance 
to  these  criteria  and  timelines  for  review  of  their  competence.  It  also  specifies  the 
scientific  and  technical  tasks  that  can  be  entrusted  to  these  organisations  and 
performance criteria for the monitoring of their competence. 

Article 44 on the implementation of the Authority's budget 

h) 
Article  44  of  Regulation  178/2002  establishes  the  detailed  procedure  for  the 
implementation  of  EFSA's  budget,  together  with  the  persons'  responsibilities  and 
timelines. Each financial year a report is published on the management of the budget. 

Article 51 on implementing measures (for the RASFF) 

i) 
Article  51  of  Regulation  (EC)  178/2002  expresses  the  need  for  the  establishment  of 
implementing  measures  with  regard  to  the  conditions  and  procedures  for  the 
transmission  of  notifications  and  any  additional  information  under  the  Rapid  Alert 

132 

 
 
 
 
 
 
 
 
System  for  Food  and  Feed  (RASFF)  established  by  Article  50.  Regulation  (EU)  No 
16/2011  implements  these  measures,  specifies  the  duties  of  the  different  members  in 
the  RASFF  network,  details  for  the  alert  notification  procedure  and  the  submission 
procedure  and  timelines  where  required,  as  well  as  for  follow-up  notifications.  It  also 
lays down a procedure for the withdrawal of notifications and details for the exchange of 
information with third countries. 

Article 53 on emergency measures for food or feed of Community 

j) 
origin or imported from a third country  
Article  53  of  Regulation  (EC)  No  178/2002  allows  for  the  establishment  of  emergency 
measures for food or feed originating from the Community or from third countries when 
the  products  might  be  of  serious  risk  to  human  or  animal  health  or  the  environment. 
Such measures may be the suspension of placement on the market or of imports of the 
products  under  consideration  or  other  appropriate  measures  to  reduce  the  risk.  These 
emergency  measures  may  be  published  in  the  form  of  Implementing  Decisions  or 
Implementing  Regulations.  The  following  table  shows  examples  of  such  implementing 
acts: 

Article 55-57 on crisis management 

k) 
Articles  55-57  of  Regulation  (EC)  178/2002  on  Crisis  Management  prescribe  that  the 
Commission must establish a general plan for crisis management in food and feed safety 
in collaboration with EFSA and the Member States. When risks cannot be handled by the 
established emergency measures a crisis unit must be set up and its tasks are specified 
by  Commission  Decision  2004/478/EC.  This  Decision  specifies  the  situations  and 
procedures  that  can  lead  to  the  necessity  to  adopt  a  crisis  plan.  It  also  provides 
information  on  how  to  establish  a  network  of  crisis  coordinators  in  different  Member 
States,  how  to  establish  a  crisis  unit,  its  role  and  action  to  be  taken  and  how  this 
information  can  be  used  in  the  decision-making  process  by  the  Commission.  Crisis 
management  decisions  are  not  taken  by  the  unit  but  in  accordance  with  the 
Committology procedures. Nevertheless, the principle of transparency is highlighted and 
also information is given on the communication aspects and confidentiality. 

Extended scope of Regulation (EC) No 178/2002 

l) 
Regulation  (EC)  No  1635/2006  lays  down  rules  for  the  imports  of  agricultural  products 
from  third  countries  following  the  accident  at  the  Chernobyl  nuclear  power  station.  To 
that  respect,  RASFF  applies  for  the  notification  of  products  that  are  not  in  compliance 
with the limits for radioactivity established by Council Regulation (EEC) 737/90 (repealed 
by Council Regulation 733/2008). 

133 

 
 
 
 
 
 
 
 
 
Table 1: Implementing Regulations and Implementing Decisions establishing emergency measures for the import of 
products from third countries under Article 53 of Reg (EC) No 178/2002 

Implementing 
Regulations 
Reg. (EC) No 297/2011  Special conditions for the import of food or feed originating or 

Scope 

consigned from Japan following the accident at the Fukushima nuclear 
power station 

Reg. (EC) No 961/2011  >> 

Reg. (EC) No 284/2012  >> 

Reg. (EC) No 996/2012  >> 

Dec. 2008/352/EC 

Special conditions on the import of guar gum from India due to 
contamination risks with pentachlorophenol and dioxins 

Reg. (EC) No 91/2013 

Dec. 2006/504/EC 

Special conditions on the import of groundnuts from Ghana and India, 
okra and curry leaves from India and watermelon seeds from Nigeria 
Special conditions for certain foodstuffs imported from third countries 
due to the risk of contamination with aflatoxins 

Reg. (EC) No 
1152/2009 

Special conditions for the import of foodstuffs from third countries due 
to aflatoxin contamination risk 

134 

Notes 

Amended by: 
- Reg. 351/2011 
- Reg. 506/2011 
- Reg. 657/2011 
Repealed by Reg. 961/2011 
Amended by: 
- Reg. 1371/2011 
- Reg. 250/2012 
Repealed by Reg. 284/2012 
Amended by: 
- Reg. 561/2012 
Repealed by Reg. 996/2012 
Amended by: 
- Reg. 495/2013 
Amended by: 
- Reg. 258/2010 
- Reg. 647/2011 
Amending Regulations 669/2009 
and 1152/2009 
Amended by: 
- Dec. 2007/459/EC 
- Dec. 2007/563/EC 
- Dec. 2007/759/EC 
- Dec. 2009/669/EC 
Repealed by Regulation 
1152/2009/EC 
Amended by: 
- Reg. 274/2012 
- Reg. 91/2013 

 
 
 
 
Reg. (EC) No 601/2008  Protective measures for fishery products imported from Gabon and 

intended for human consumption 

Reg. (EC) No 884/2007  Emergency measures suspending the use of E128 Red 2G as food 

Dec. 2008/388/EC 

Dec. 2008/866/EC 

colour 
Special conditions on the import of sunflower oil from Ukraine due to 
contamination risk by mineral oil 
Suspending imports from Peru of certain bivalve molluscs intended for 
human consumption 

Dec. 2010/381/EC 

Emergency measures for consignments of aquaculture products 
imported from India and intended for human consumption 

Amended by: 
- Reg. 1114/2011 
Repealed by Reg. (EU) No 
1129/2011 
Repealed by Dec 2008/433/EC. 
Repealed by Reg. 1151/2009 
Amended by: 
- Dec. 2009/297/EC 
- Dec. 2009/862/EC 
- Dec. 2010/641/EC 
- Dec. 2011/723/EC 
Replaced by 2012/729/EC 
Amended by: 
- Dec. 2013/636/EC 
Amended by: 
- Dec. 2012/690/EC 

Dec. 2010/220/EC 

Emergency measures for farmed fishery products imported from 
Indonesia and intended for direct human consumption 

Repealed by: 
- Dec. 2012/690/EC 

Dec. 2011/884/EC 

Dec. 2011/402/EU 

Emergency measures on unauthorised genetically modified rice in rice 
products from China 
Emergency measures on fenugreek seeds and certain seeds and beans 
imported from Egypt 

Dec. 2008/630/EC 

Emergency measures applicable to crustaceans imported from 
Bangladesh and intended for human consumption 

Dec. 2006/601/EC 

Emergency measures regarding the non-authorised genetically 
modified organism "LL Rice 601" in rice products 

Dec. 2010/220/EC 

Dec. 2009/835/EC 

Emergency measures for farmed fishery products imported from 
Indonesia and intended for direct human consumption 
Special conditions on official controls on the import of pears from 

Amended by: 
- Dec. 2013/287/EC 
Amended by: 
- Dec. 2011/662/EC 
- Dec. 2011/718/EC 
- Dec. 2011/880/EC 
Amended by: 
- Dec. 2010/387/EC 
- Dec. 2011/742/EC 
Amended by: 
- Dec. 2006/754/EC 
- Dec. 2008/162/EC 
Repealed by Dec. 2010/315/EC 

135 

 
 
 
 
 
 
 
Dec. 2010/219/EC 

Dec. 2007/642/EC 

Dec. 2007/82/EC 

Dec. 2005/317/EC 

Dec. 2006/694/EC 

Dec. 2006/698/EC 

Dec. 2006/27/EC 

Dec. 2005/402/EC 

Dec. 2004/629/EC 

Dec. 2002/251/EC 

Turkey due to high residue levels of amitraz 

Special conditions on fishery products imported from Indonesia and 
intended for human consumption 
Emergency measures for fishery products imported from Albania and 
intended for human consumption 
Emergency measures suspending imports of fishery products from the 
Republic of Guinea intended for human consumption 
Emergency measures regarding the non-authorised genetically 
modified organisms Bt-10 in maize products 
Prohibiting the placing on the market of curd cheese manufactured in 
a dairy establishment in the UK 
Emergency measures for fishery products from Brazil for human 
consumption 

Special conditions on meat and meat products of equidae imported 
from Mexico and intended for human consumption 
Emergency measures regarding chilli, chilli products, curcuma and 
palm oil 
Protective measures with regards to poultry meat and poultry 
products from Brazil intended for human consumption 
Protective measures on poultrymeat, fishery and aquaculture products 
for human consumption from Thailand 

Dec. 2002/805/EC 

Protective measures for products of animal origin for animal nutrition 
imported from Ukraine 

Repealed by Dec. 2007/157/EC 

Repealed by Dec 2007/148/EC 

Related to Reg. 853/2004 with 
regard to the max. levels for 
histamine in fishery products 

Repealed by Reg. (EC) No 
669/2009 

Amended by: 
- Dec. 2003/477/EC 
- Dec. 2003/559/EC 
- Dec. 2003/895/EC 

136 

 
 
 
 
 
 
 
 
 
 
Annex  II:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  882/2004  and  their  respective 
requirements 

In the following paragraphs the main requirements of Reg. 882/2004 are highlighted and 
regulatory  documents  that  add  requirements  or  assist  in  the  implementation  of  this 
Regulation are described. 

Article 3 on general obligations with regard to the organisation of 

a) 
official controls 
Regulation  178/2002  on  general  food  law  establishes  the  Rapid  Alert  System  for  Food 
and Feed (RASFF) and also requires implementing measures to be set with regard to the 
procedures  for  the  transmission  of  notifications  and  other  supplementary  information. 
Regulation  882/2004  establishes  the  official  controls  for  ensuring  compliance  with  food 
and  feed  law.  RASFF  allows  for  the  rapid  communication  of  food  and  feed  risks,  thus 
allowing Member States to meet their responsibilities according to Regulation 178/2002. 
Regulation  16/2011  lays  down  implementing  measures  for  the  RASFF  system. 
Specifically  with  regard  to  border  rejection  notifications,  the  Regulation  requires  the 
Commission  contact  point  to  transmit  such  rejections  to  designated  points  of  entry  (as 
established under Regulation 882/2004). 

Regulation  142/2011  implements  Regulation  1069/2009  on  health  rules  for  animal  by-
products  and  derived  products  not  intended  for  human  consumption  and  indicates  that 
the competent authority is responsible for the official controls at all stages of the chain 
which  should  be  carried  out  according  to  Article  3  of  Reg.  882/2004.  Regulation 
1069/2009  also  indicates  that  all  controls  related  to  the  products  covered  by  this 
Regulation shall be carried out according to the control plans of Reg. 882/2004. Specific 
reference is made to Articles 41 and 42 of Reg. 882/2004 on multi-annual control plans, 
Article 46 on Community controls in third countries, Article 50 on support for developing 
countries and Article 52 on third county controls in Member States, which apply directly 
to the scope of Regulation 1069/2009. 

Regulation 1169/2011 on the provisions of food information to the consumers indicates 
that Member States should carry out official controls to enforce the requirements of this 
Regulation in accordance with the provisions of Regulation 882/2004. 

Articles  4-5  on  designation  of  competent  authorities,  operational 

b) 
criteria and delegation of specific tasks related to official controls 
Article  4  of  Regulation  882/2004  indicates  that  Member  States  must  designate  the 
competent  authorities  responsible  for  the  official  controls  and  must  also  lay  down  their 
operational criteria. When official controls are conferred to non-central, regional or local 
authorities,  efficient  and  effective  coordination  must  be  ensured  between  all  authorities 
involved, as well as between different units involved.  

Regulation  1143/2014  on  the  prevention  and  management  of  the  introduction  and 
spread  of  invasive  alien  species  indicates  that  Member  States  must  put  in  place 
functioning  structures  to  carry  out  the  appropriate  risk-based  controls  in  product 
categories to be specified in the Union list (to be published), when these are brought into 
the Union, for the prevention of the intentional introduction in the Union of invasive alien 

 
 
 
 
 
species  of  concern.  If  for  these  products  official  controls  are  already  required  at  the 
borders  or  at  points  of  entry  by  Regulation  882/2004  or  Directive  2000/29/EC  on 
protective measures against the introduction in the Community of organisms harmful to 
plants  or  plant  products  and  against  their  spread  within  the  Community,  these  will  be 
conferred to the authorities of Article 4 above. 

On  a  different  context,  Regulation  1306/2013  on  the  financing,  management  and 
monitoring  of  the  common  agricultural  policy  and  specifically  Article  90,  requires  that 
Member  States  take  all  necessary  steps  to  stop  the  unlawful  use  of  designations  of 
origin,  geographical indications  and  protected  traditional  terms  and  that  they  designate 
the  competent  authority  responsible  for  carrying  out  the  checks  in  order  to  meet  the 
obligations  of  Regulation  1308/2013  for  different  grapevine  products  according  to  the 
criteria of Article 4 of Reg. 882/2004. It is also required that the competent authority or 
any of the control bodies as established by Article 5 of Reg. 882/2004 verify compliance 
with  the  product  specification  either  during  the  production  or  during  or  after  the 
conditioning of the wine. 

In a similar context, Regulation 1151/2012 on quality schemes for agricultural products 
and  foodstuffs  establishes  quality  schemes  that  provide  the  basis  for  the  identification 
and  protection  of  names  or  terms  which  indicate  or  describe  agricultural  products  with 
value-adding attributes or characteristics. Regulation 882/2004 requires Member States 
to  designate  competent  authorities  to  carry  out  official  controls  in  order  to  verify 
compliance  with  the  legal  requirements  related  to  the  quality  schemes  established  by 
Regulation  1151/2012,  and  also  competent  authorities  and  control  bodies  to  verify 
compliance  with  the  product  specifications  for  protected  designations  of  origin, 
geographical  indications  and  traditional  specialities  guaranteed.  Also  Member  States 
must  ensure  that  activities  for  the  control  of  the  above  obligations  are  specifically 
included  in  a  separate  section  in  the  multi-annual  control  plans  according  to  the 
specifications for these control plans laid down in Articles 41-44 of Reg. 882/2004.  

Under  the  same  scope  of  designating  competent  Authorities,  their  operational  criteria 
and delegating specific tasks related to official controls, Regulation 834/3007 on organic 
production  and  labelling  of  organic  products  requires  all  Member  States  to  set  up  a 
system of controls in accordance with the requirements of Reg. 882/2004, comprising at 
least  the  application  of  precautionary  and  control  measures.  The  Regulation  also 
specifies conditions under which a competent authority may delegate control tasks to a 
particular  control  body  according  to  Article  5  of  Reg.  882/2004,  certain  criteria  to  be 
considered  by  the  competent  authority  when  approving  a  control  body,  as  well  as 
specific  tasks  that  should  not  be  attributed  to  control  bodies,  procedures  for  the 
withdrawal  of  a  delegation,  additional  provisions  to  those  of  Article  5  and  finally  the 
requirement  that  each  Member  State  must  attribute  a  specific  number  to  each  control 
authority/body performing control tasks.  

Article 11 on methods of sampling and analysis 

c) 
Article 11 of Regulation 882/2004 lays down requirements for methods of sampling and 
analysis  used  for  official  controls.  Regulation  10/2011  on  plastic  materials  and  articles 
intended to come into contact with food requires that analytical methods for testing the 
migration  and  residual  content  of  substances  in  food  must  comply  with  the  criteria 
established  in  this  Article.  With  regard  to  substances  (or  groups  of  similar  compounds) 
not  listed  in  the  Union  list  or  in  provisional  lists,  used  in  the  manufacture  of  a  plastic 
layer  not  in  direct  contact  with  food  and  separated  from  food  by  a  functional  barrier  in 
plastic multilayer materials and articles, their migration in food or food simulants should 
be non-detectable with statistical certainty using a method of analysis set in Article 11 of 
Reg.  882/2004  with  a  limit  of  detection  of  0.01  mg/kg  expressed  in  the  food  or  food 
simulant. Similarly, Regulation 450/2009 on active and intelligent materials and articles 

138 

 
 
 
 
intended  to  come  into  contact  with  food  indicates  that  the  migration  into  food  of 
substances  from  components  not  in  direct  contact  with  food  or  the  environment 
surrounding  food  must  not  exceed  0.01  mg/kg  as  measured  with  statistical  certainty 
with a method of analysis that meets the requirements of Article 11 of Reg. 882/2004. 

The 5th paragraph of Article 11 of Regulation 882/2004 establishes the right of the food 
business operator  whose products are being subjected to  official controls to apply for a 
supplementary  expert  opinion.  Annex  II  of  Implementing  Decision  2011/884/EU  on 
emergency  measures  regarding  unauthorised  genetically  modified  rice  in  rice  products 
originating  from  China,  laying  down  methods  for  the  sampling  and  analysis  for  the 
official  control  of  such  products,  requires  for  a  second  laboratory  sample  to  be 
constituted  from  the  bulk  samples  being  examined,  in  order  to  meet  the  above 
requirement of Reg. 882/2004. 

Article 12 on official laboratories 

d) 
Article 12 of Regulation 882/2004 indicates that the competent authority can designate 
laboratories to carry out the analysis of samples taken during official controls, provided 
they are accredited according to European standards.  

Commission  Implementing  Decision  2013/652/EC  lays  down  detailed  rules  for  the 
harmonised  monitoring  and  reporting  of  antimicrobial  resistance  (AMR)  in  zoonotic  and 
commensal  bacteria  and  allows  for  the  competent  authority  to  designate  laboratories 
other  than  the  national  reference  laboratory  for  AMR  to  perform  the  specific  analytical 
tests required and laid down in the Annex to the Decision. 

Commission  Decision  2010/346/EU  on  protective  measures  with  regard  to  equine 
infectious  anaemia  in  Romania  lays  down  specific  obligations  for  the  country.  Romania 
must ensure that the official laboratory carrying out the Agar Gel Immunodiffusion tests 
for  Equine  infectious  anaemia  (AGID)  meets  the  requirements  of  Article  12  of  Reg. 
882/2004  and  undergoes  each  year  an  annual  proficiency  testing  in  collaboration  with 
the  European  Union  Reference  Laboratory  for  equine  diseases  other  than  African  horse 
sickness.  

In a broader scope, Regulation 273/2008 lays down detailed rules for the application of 
Council  Regulation  1255/1999  regarding  methods  for  analysis  and  quality  evaluation  of 
milk  and  milk  products.  The  Regulation  specifies  that  such  products  may  only  be 
analysed  in  laboratories  that  have  an  analytical  quality  assurance  system  in  place 
including internal quality control procedures. However laboratories that are accredited in 
accordance  with  Article  12  of  Reg.  882/2004  are  exempt  from  the  obligation  to 
participate in proficiency testing.  

Article 19 on action following official controls on feed and food 

e) 
from third countries 
Article  19  of  Regulation  882/2004  lays  down  details  on  action  to  be  taken  following 
official  controls in  case  products  do  not  comply  with  the  requirements  of  food  and  feed 
law.  

Regulation  258/2010 imposing  special  conditions  on  imports  of  guar  gum  originating in 
or  consigned  from  India  due  to  contamination  risks  by  pentachlorophenol  and  dioxins, 
implements that products containing more than 0.01 mg/kg pentachlorophenol following 
official  controls  performed  as  specified  within  the  Regulation  must  not  enter  the  food 
chain and they must be disposed of according to the above provisions of Reg. 882/2004. 

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Regulation 1151/2009 imposing special conditions governing the import of sunflower oil 
originating  in  or  consigned  from  Ukraine  due  to  contamination  risks  by  mineral  oil, 
indicates that sunflower oil imported into the Community must not contain more than 50 
mg/kg  of  mineral  paraffin.  Also  it  is  required  that  each  consignment  of  sunflower  oil 
intended for import into the Community is accompanied by a certificate and an analytical 
report  issued  by  an  accredited  laboratory  indicating  the  analytical  result  as  well  as  the 
measurement  of  uncertainty  and  limits  of  detection  and  quantification  of  the  analytical 
method  used.  The  competent  authorities  must  check  that  each  consignment  is 
accompanied by these documents. In case of non-compliance, measures must be taken 
in accordance with Article 19 of Reg. 882/2004. 

Article 27 on fees and charges 

f) 
Article  27  of  Regulation  882/2004  lays  down  provisions  on  how  Member  States  may 
collect the fees and charges in order to cover the costs associated with official controls. 
Decision 2008/946/EC implementing Directive  2006/88/EC as regards the  requirements 
for  quarantine  of  aquaculture  animals,  indicates  that  certain  activities  relating  to 
quarantine  fall  under  the  definition  of  official  controls  of  Regulation  882/2004  and 
therefore  the  costs  related  with  such  activities  must  be  covered  by  Article  27  of  Reg. 
882/2004.  Also  this  Decision  lays  down  some  minimum  conditions  for  the  construction 
and  equipment  of  quarantine  facilities  as  defined  under  Reg.  882/2004,  as  well  as  for 
their management. 

Article 31 on registration/approval of feed and food business 

g) 
establishments 
Article  31  of  Regulation  882/2004  lays  down  requirements  for  the  registration  and 
approval  of  food  business  establishments  and  requires  the  competent  authorities  to 
maintain up-to-date lists of approved establishments. Regulation 2074/2005 laying down 
implementing  measures  for  Reg.  882/2004  sets  out  requirements  for  these  lists  of 
approved  establishments.  Specifically  each  Member  State  is  required  to  provide  the 
Commission  with  a  link  to  a  single  website  where  an  up-to-date  list  of  all  approved 
establishments  for  products  of  animal  origin  under  Regulation  853/2004  can  be  found. 
More  specific  details  are  provided  for  this  list  in  the  Regulation,  as  well  as  the 
requirement  that  this  website  is  developed  by  the  competent  authority  designated  in 
each  Member  State  for  the  purposes  of  official  controls  according  to  Article  4  of  Reg. 
882/2004.  

Council  Decision  2011/408/EU  lays  down  some  simplified  rules  and  procedures  for  the 
sanitary  controls  of  fishery  products,  live  bivalve  molluscs,  echinoderms,  tunicates, 
marine  gastropods,  their  by-products  and  products  derived  from  their  by-products 
originating from Greenland. Specifically, Member States do not need to apply veterinary 
controls  and  these  products  from  Greenland  may  be  placed  on  the  market  under  the 
sanitary  controls  applicable  in  the  European  Community  provided  that  Denmark  and 
Finland  meet  certain  conditions  one  of  which  is  the  maintenance  by  the  competent 
authorities  in  the  two  countries  of  up-to-date  lists  of  the  food  and  feed  business 
operators that have been registered according to the above Article of Reg. 882/2004. 

Article 32 on Community reference laboratories 

h) 
Article  32  of  Regulation  882/2004  lays  down  the  responsibilities  of  the  different 
Community  reference  laboratories.  Implementing  Decision  2012/767/EU,  taking  into 
consideration that the Pirbright Institute in the UK fulfils all the responsibilities for the EU 
reference  laboratories  provided  by  the  above  Article,  prolongs  the  designation  of  this 

140 

 
 
 
 
 
 
Institute as the EU reference laboratory for foot-and-mouth disease for an undetermined 
period of time. 

Implementing Regulation 844/2012 laying down provisions for the implementation of the 
renewal procedure for active substances as provided for in Regulation 1107/2009 on the 
placing of plant protection products on the market, indicates that EFSA may request the 
Commission  to  consult  one  of  the  European  Union  reference  laboratories  in  order  to 
verify whether the analytical method proposed by the applicant for the determination of 
residues  of  the  active  substance  due  for  renewal  is  satisfactory  and  complies  with  the 
requirements of Regulation 1107/2009. 

Article  32  of  Regulation  882/2004  also  implements  that  Community  Reference 
Laboratories could be granted financial contribution from the Community. Details are laid 
down  in  Implementing  Regulation  926/2011  on  provisions  for  financial  aid  to  the  EU 
reference  laboratories  for  food  and  feed  and  animal  health  sector  and  Regulation 
652/2014 laying down provisions for the management of expenditure relating to the food 
chain,  animal  health  and  animal  welfare  and  relating  to  plant  health  and  plant 
reproductive material.  

Decision  2009/961/EU,  on  financial  aid  from  the  Union  for  2010  for  certain  Community 
reference  laboratories  in  the  field  of  animal  health  and  live  animals,  grants  financial 
assistance to the AFFSA laboratory in France to carry out responsibilities as established 
under Article 32 of Reg. 882/2004 as a Community reference laboratory for brucellosis. 
Similarly, Decision 2008/332/EC laid down financial aid as above for 2008 and Decision 
2007/336/EC  for  2007.  Decision  2008/912/EC  lays  down  the  Community  financial 
contribution  for  2009  for  certain  Community  reference  laboratories  in  the  field  of  food 
and feed control. 

Regulation  470/2009  implements  Community  procedures  for  the  establishment  of 
residue limits  of  pharmacologically  active  substances  in  foodstuffs  of  animal  origin.  The 
Regulation  establishes  that,  when  necessary  for  the  functioning  of  the  controls  of  Reg. 
882/2004,  the  Commission  may  establish  reference  points  for  action  for  residues  of 
pharmacologically  active  substances.  These  must  be  detected  and  confirmed  by  official 
control laboratories according to Reg. 882/2004 and by methods validated according to 
Community  requirements.  Also  the  Community  reference  laboratories  established 
according  to  Reg.  882/2004  must  be  consulted  for  the  establishment  of  analytical 
methods for residues from pharmacologically active substances. The European Medicines 
Agency  must  provide  advice  on  such  methods  to  the  Community  and  the  national 
reference laboratories. 

Article 45 on Community controls in Member States 

i) 
Article  45  of  Regulation  882/2004  lays  down  provisions  for  Community  controls  and 
specifically  general  and  specific  audits  in  the  Member  States.  Regulation  1/2005  lays 
down  provisions  on  the  protection  of  animals  during  transport.  For  the  purposes  of 
ensuring uniform application of this Regulation, veterinary experts from the Commission 
together with Member States' authorities may make on-the-spot checks according to the 
procedures of Article 45 of Reg. 882/2004. 

Article 48 on specific import conditions 

j) 
Article  48  of  Regulation  882/2004  allows  for  the  implementation  of  specific  import 
conditions  not  covered  by  Regulation  854/2004  on  specific  provisions  for  the 
organisation  of  official  controls  on  products  of  animal  origin  intended  for  human 
consumption.  In  that  respect,  Regulation  605/2010  lays  down  animal and  public  health 

141 

 
 
 
 
 
and veterinary certification conditions for the introduction in the Community of raw milk 
and dairy products intended for human consumption. 

Regulation  183/2005  lays  down  requirements  for  feed  hygiene.  Imports  of  feed  from 
third countries are permitted only if the third country of dispatch appears in a list of third 
countries from where import of feed is permitted and if the establishment appears on a 
list of approved establishments from which import of feed is permitted, both established 
under the requirements of Reg. 882/2004. 

Article 51 on training of control staff 

k) 
Article 51 of Regulation 882/2004 allows for the organisation of training courses for staff 
of  the  competent  authorities  that  undertake  official  control  activities.  Commission 
Implementing  Decision  2013/770/EU  establishing  the  Consumers  Health  and  Food 
Executive  Agency,  includes  between  the  objectives  and  tasks  of  this  Authority  the 
implementation of food safety training measures covered by Reg. 882/2004. 

Article 54 on action in case of non-compliance 

l) 
The scope of Regulation 882/2004 also covers animal health and animal welfare 
while Article 54 specifically lays down enforcement measures in case of non-compliance 
with its requirements. Regulation 1009/2009 on the protection of animals at the time of 
killing  adds  for  further  action  to  be  taken  in  case  non-compliance  to  Reg.  882/2004  is 
observed.  

m)  Annex III on characterisation of methods of analysis 
Annex  III  of  Regulation  882/2004  lays  down  specific  criteria  for  the  characterisation  of 
methods  of  analysis  for  official  controls  of  food.  Commission  Recommendation 
2010/133/EC on the prevention and reduction of ethyl carbamate contamination in stone 
fruit spirits and stone fruit marc spirits and on the monitoring of ethyl carbamate levels 
in  these  beverages  suggests  that  Member  States  use  the  criteria  of  Reg.  882/2004 
during the analysis of ethyl carbamate in such products. 

Similarly,  Recommendation  2010/161/EC  on  the  monitoring  of  perfluoroalkylated 
substances  in  food  suggests  that  Member  States  use  the  criteria  of  Reg.  882/2004 
during  the  analysis  of  these  substances.  It  also  suggests  that  a  method  of  analysis 
shown  to  provide  reliable  results  should  be  used  and  that  the  recovery  rate  of  the 
method should be 70-120% while the limit of quantification 1 µg/kg. 

Also  Recommendation  2010/307/EC  on  the  monitoring  of  acrylamide  levels  in  food  and 
Recommendation 2007/196/EC on the monitoring of the presence of furan in foodstuffs, 
indicate that these analyses should be carried out according to the criteria of Annex III 
of Reg. 882/2004. 

Annex VI on criteria to be taken into consideration for the 

n) 
calculation of fees 
Annex VI of Regulation 882/2004 lists certain items. The costs borne by the competent 
authorities in relation to these items allow for calculations to be made for the maximum 
fees  collected  for  the  purposes  of  official  controls.  Decision  2010/436/EU  implementing 
Council  Decision  2000/258/EC  as  regards  proficiency  tests  for  the  purposes  of 
maintaining  authorisations  of  laboratories  to  carry  out  serological  tests  to  monitor  the 

142 

 
 
 
 
 
 
 
effectiveness of rabies vaccines indicates that from the 1st of January 2011 AFSSA Nancy 
may  charge  each  laboratory  taking  part  in  the  proficiency  testing  for  carrying  out  the 
above tests a fee. This fee should be calculated taking into account the criteria set down 
in Annex VI of Regulation 882/2004. 

Annex VII on European Union Reference Laboratories 

o) 
Annex VII of Regulation 882/2004 lays down a list of the EU Reference Laboratories for 
feed and food and for animal health and live animals. Commission Decision 2007/142/EC 
establishes  a  Community  Veterinary  Emergency  Team  to  assist  the  Commission  in 
supporting  Member  States  and  third  countries  in  veterinary  matters  relating  to  certain 
animal  diseases.  This  team  is  composed  of  experts  in  order  to  provide  assistance  in 
control  measures  in  case  of  outbreak  or  suspicion  of  certain  animal  disease  subject  to 
communication, as listed in Annex I of Council Directive 82/894/EEC. Assistance should 
be  provided  in  coordination  with  the  concerned  Community  Reference  Laboratory  listed 
in Annex VII of Regulation 882/2004. 

Regulation  882/2004  also  covers  the  official  controls  for  verification  of  compliance  with 
the safety of materials and articles intended to come into contact with food  covered by 
Regulation  1935/2004.  Compliance  with  Reg.  1935/2004  must  be  enforced  through 
official  controls  carried  out  by  the  Member  States.  In  this  respect,  the  Community 
Reference Laboratory for materials and articles intended to come into contact with food 
as  well  as  the  national  laboratories  established  under  Reg.  882/2004  shall  assist  the 
Member States by contributing to a high quality and uniformity of analytical results. 

Extended scope of Regulation (EC) No 882/2004 

p) 
Regulation  1107/2009  lays  down  requirements  for  the  placement  of  plant  protection 
products on the market. With regards to the approval of an active substance, Regulation 
1107/2009 indicates that in order to verify that the analytical method suggested in the 
dossier  for  the  determination  of  residues  of  the  substance  is  satisfactory  and  that  any 
residues  resulting  from  authorised  uses  and  of  toxicological,  ecotoxicological  or 
environmental  relevance  can  be  determined  by  appropriate  methods  with  appropriate 
limits of determination on relevant samples, EFSA may ask the Commission to consult a 
Community  reference  laboratory  designated  under  Reg.  882/2004.  Furthermore,  the 
applicant  may  be  requested  by  the  Community  reference  laboratory  to  submit  samples 
and analytical standards to the authorities.  

Commission  Recommendation  2014/118/EU  lays  down  recommendations  for  the 
monitoring  of  traces  of  brominated  flame-retardants  in  food.  The  Recommendation 
indicates that the analysis of such compounds in food should be performed in accordance 
with  Annex  III  of  Reg.  882/2004  laying  down  criteria  to  characterise  the  different 
methods of analysis as well as instructions on how to select an appropriate method and 
using a method of analysis that has been proven to generate reliable results. 

Commission  Regulation  669/2009  implements  Regulation  882/2004  with  regard  to  the 
increased  level  of  control  for  certain  non-animal  products  from  certain  third  countries 
and  requires  a  Common  Entry  Document  for  prior  notification  of  such  products  in  the 
Community.  Regulation  1152/2009  imposing  special  rules  for  the  import  of  certain 
foodstuffs  from  certain  third  countries  due  to  contamination  risk  by  aflatoxins  provides 
guidance for the implementation of the above requirements. 

Regulation  110/2008  on  the  definition,  description,  presentation,  labelling  and  the 
protection  of  geographical  indications  of  spirit  drinks  indicates  that,  within  the 
Community,  the  verification  of  compliance  with  the  specifications  of  geographical 
indications  before  placing  a  product  on  the  market,  must  be  ensured  by  one  or  more 

143 

 
 
 
 
 
competent  authorities  and  one  or  more  control  bodies  that  operate  as  product 
certification bodies. The Regulation also implements that Member States are responsible 
for the control of spirit drinks and that they must take all measures for the  compliance 
with  this  Regulation,  as  well  as  for  the  designation  of  the  competent  authorities  for 
official controls according to Reg. 882/2004. 

Council  Directive  2007/43/EC  lays  down  minimum  rules  for  the  protection  of  chickens 
kept for meat production. The competent authority must carry out inspections to ensure 
compliance  with  the  requirements  of  this  Directive  according  to  the  provisions  on 
inspections of Regulation 882/2004. 

144 

 
 
 
 
 
 
Annex  III:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  2003/2003  and  their  respective 
requirements 

In the following paragraphs the main requirements of Regulation (EC) No 2003/2003 are 
highlighted  and  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this Regulation are described. 

Article 5 on free circulation 

a) 
Article 5 of Reg. (EC) No 2003/2003 requires  Member States to not restrict the placing 
on  the  market  of  EC  fertilisers  in  compliance  with  the  requirements  of  the  Regulation. 
Commission Decision 2012/230/EU  extending the period referred to in Article 114(6) of 
the  Treaty  on  the  Functioning  of  the  European  Union  in  relation  to  national  provisions 
concerning  the  maximum  admissible  content  of  cadmium  in  fertilisers  notified  by  the 
Kingdom  of  Sweden  approves  the  request  of  Sweden  to  introduce  national  provisions 
derogating from Reg. (EC) No 2003/2003. 

In  the  same  context,  Commission  Decision  2012/719/EU  on  the  national  provisions 
notified  by  the  Kingdom  of  Sweden  concerning  the  maximum  admissible  content  of 
cadmium in fertilisers rejected the related national conditions that Sweden notified to the 
Commission. 

Article 37 on national provisions 

b) 
Article  37  of  Reg.  (EC)  No  2003/2003  requires  Member  States  to  notify  their  national 
provisions  on  indication  of  nutrient  contents,  control  measures  and  penalties  to  the 
Commission.  Under  this  Article,  several  Commission  Decisions  have  been  implemented, 
approving the national provisions of different Member States until harmonised measures 
are established, such as Dec. 2006/347/EC, 2006/348/EC, 2006/349/EC, 2006/390/EC. 

Annex  I  on  list  of  types  of  EC  fertilisers,  part.  A.2  on  phosphatic 

c) 
fertilisers 
Annex  I  A.2  of  Reg.  (EC)  No  2003/2003  lays  down  the  list  of  phosphatic-type  EC 
for  the 
fertilisers.  Regulation  (EC)  No  889/2008 
implementation  of  Council  Regulation  (EC)  No  834/2007  on  organic  production  and 
labelling  of  organic  products  with  regard  to  organic  production,  labelling  and  control, 
indicates  that  only  fertilisers  included  in  Annex  I  to  the  Regulation  may  be  used  in 
organic  plant  production  or  seaweed  cultivation  and  only  to  the  extent  necessary  when 
the  nutritional  needs  of  plants  cannot  otherwise  be  met.  These  must  meet  the 
specification for the relevant products of Annex I A.2 of Reg. (EC) No 2003/2003. 

laying  down  detailed  rules 

Annex III on technical provisions for ammonium nitrate fertilisers 

d) 
with high nitrogen content 
Annex  III  of  Reg.  (EC)  No  2003/2003  lays  down  certain  technical  requirements  for 
ammonium  nitrate  fertilisers  with  high  nitrogen  content.  Decision  1348/2008/EC  of  the 
European  Parliament  and  of  the  Council  amending  Council  Directive  76/769/EEC  as 
regards  restrictions  on  the  marketing  and  use  of  2-(2-methoxyethoxy)ethanol,  2-(2-
butoxyethoxy)ethanol,  methylenediphenyl  diisocyanate,  cyclohexane  and  ammonium 
nitrate  indicates  that  ammonium  nitrate  must  not  be  placed  on  the  market  as  a 
substance or in a preparation containing more than 28% by mass of nitrogen in relation 

145 

 
 
 
 
 
 
 
to ammonium nitrate for use as fertiliser, unless it meets the requirements of Annex III 
of  Reg. (EC) No 2003/2003. 

The  same  requirement  is  also  laid  down  by  Regulation  (EC)  No  1907/2006  concerning 
the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH)  and 
establishing a European Chemicals Agency for ammonium nitrate. 

The second part of Annex III of Reg. (EC) No 2003/2003 described the test of resistance 
to  denotation  of  ammonium  nitrate  fertilisers  with  high  nitrogen  content.  Directive 
2012/18/EU  of  the  Parliament  and  of  the  Council  on  the  control  of  major-accident 
hazards  involving  dangerous  substances,  amending  and  subsequently  repealing  Council 
Directive  96/82/EC  lists  certain  hazardous  substances  which  are  subject  to  qualifying 
quantities.  Amongst  these  substances  are  included  the  fertiliser  grades  of  ammonium 
nitrate. 

Annex IV methods of sampling and analysis 

e) 
Annex  IV  lays  down  methods  of  sampling  and  analysis  for  fertilisers.  Commission 
Implementing  Regulation  (EU)  No  839/2012  concerning  the  authorisation  of  urea  as  a 
feed  additive  for  ruminants  indicates  that  for  the  determination  of  total  nitrogen  in  the 
additive  and  of  the  biuret  contribution  of  the  additive  certain  methods  of  Annex  IV  of 
Reg. (EC) No 2003/2003 must be used. 

146 

 
 
 
 
 
 
 
 
Annex  IV:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1069/2009  and  their  respective 
requirements 

In  the  following  paragraphs  only  the  main  requirements  of  Regulation  (EC)  No 
1069/2009  referring  to  use  of  animal  by-products  as  fertilisers  or  soil  improvers  are 
highlighted  and  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of these provisions are described. 

Article 3 on definitions 

a) 
Article  3  of  Reg.  (EC)  No  1069/2009  lays  down  definitions  for  animal  by-products  and 
derived products.  

Annex IX of Regulation (EC) No 999/2001 of the European Parliament and of the Council 
laying  down  rules  for  the  prevention,  control  and  eradication  of  certain  transmissible 
spongiform encephalopathies lays down rules for the importation into the Community of 
live animals, embryos, ova and products of animal origin. Specific rules are laid down for 
the  import  of  rendered  fats  derived  from  Category  2  or  Category  3  material  of  bovine, 
ovine  and  caprine  origin  and  their  staring  materials  or  intermediate  products,  intended 
to  be  used  as  organic  fertilisers  and  soil  improvers.  These  products  may  only  be 
imported  if  they  are  accompanied  by  a  health  certificate  showing  a  negligible  risk  of 
spongiform encephalopathies. 

Commission  Decision  2007/275/EC  concerning  lists  of  animals  and  products  to  be 
subject  to  controls  at  border  inspection  posts  under  Council  Directives  91/496/EEC  and 
97/78/EC lays down rules for veterinary checks to be carried out at border control posts 
for  the  above  products.  Chapter  31  of  this  Decision  refers  to  animal  fertilisers  and 
specifically  animal-derived  products  in  an  unadulterated  form,  manure  and  manure 
mixed  with  animal  protein  for  use  as  fertiliser  for  which  veterinary  checks  must  be 
carried out. Specific requirements for these products are laid down in Annex XIV of Reg. 
(EU) No 142/2011. 

Articles 9 and 10 on Categories 2 and 3 materials 

b) 
Article  9  and  10  of  Reg.  (EC)  No  1069/2009  lay  down  provisions  for  Category  2  and  3 
animal  by-products.  Commission  Regulation  (EC)  No  889/2008  laying  down  detailed 
rules  for  the  implementation  of  Council  Regulation  (EC)  No  834/2007  on  organic 
production and labelling of organic products with regard to organic production, labelling 
and  control,  indicates  that  when  the  nutritional  needs  of  plants  cannot  be  met  by  the 
measures  of  Regulation  834/2007,  only  fertilisers  and  soil  conditioners  contained  in 
Annex I of Reg. (EC) No 889/2008 may be used in organic production and to the extent 
necessary,  while  operators  must  keep  evidence  of  the  need  of  use  of  these  products. 
Annex  I  of  Reg.  (EC)  No  889/2008  contains  biogas  digestate  containing  animal  by-
products  co-digested  with  material  of  plant  or  animal  origin  (Category  2  and  3  animal 
by-products)  not  from  factory  farming  origin  under  the  conditions  that  the  processed 
must be in accordance  with Reg. (EU) No 142/2011 and that the products must not be 
applied to the edible parts of the crop.  

Article 15 on implementing measures 

c) 
Article 15 of Reg. (EC)  No 1069/2009 lays down the requirement for the establishment 
of  additional  implementing  measures  for  the  application  to  land  of  animal  by-products, 

147 

 
 
 
 
 
 
 
organic  fertilisers  and  soil  improvers.  Article  32  of  the  Regulation  lays  down  conditions 
for the placement on the market and use of organic fertilisers and soil improvers and the 
requirement  for  additional  implementing  measures  to  be  established.  Commission 
Regulation (EU) No 142/2011, implementing Regulation (EC) No 1069/2009 laying down 
health rules as regards animal by-products and derived products not intended for human 
consumption  and  implementing  Council  Directive  97/78/EC  as  regards  certain  samples 
and  items  exempt  from  veterinary  checks  at  the  border  under  that  Directive  and 
specifically  its  Annex  XI  lays  down  implementing  provisions  for  the  placement  on  the 
market and use of organic fertilisers and soil improvers. 

148 

 
 
 
 
 
 
 
Annex  V:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1107/2009  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1107/2009 and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 8 of Regulation 1107/2009 on dossiers 

a) 
Article  8  of  Regulation  1107/2009  indicates  the  information  that  must  be  included  in  a 
summary  dossier  submitted  for  the  authorisation  of  an  active  substance.  Some  of  the 
required data include those for active substances and plant protection products set out in 
Directive 91/414/EC (now repealed by Regulation 1107/2009) which were implemented 
by  Reg.  544/2011.  Regulation  283/2013  lays  down  the  detailed  data  requirements  for 
the  authorisation  of  active  substances  as  required  by  Article  8  of  Reg.  1107/2009  and 
repeals Reg. 544/2011. 

Similarly,  Regulation  284/2013 
authorisation of plant protection products (and repeals Reg. 545/2011). 

lays  down  detailed  data  requirements 

for  the 

Article 13 of Regulation 1107/2009 on approval Regulation 
b) 
Article  13  of  Regulation  1107/2009  lays  down  the  procedure  for  adopting  an  approval 
Regulation  for  an  active  substance  further  to  the  review  report  presented  by  the 
Commission,  any  accompanying  comments  and  also  taking 
into  account  the 
precautionary  principle.  Commission  Implementing  Regulation  788/2011  approves  the 
active substance fluazifop-P in accordance with Reg. 1107/2009, specifies the conditions 
of  use  and  amends  the  Annex  to  Implementing  Reg.  540/2011.  Several  similar 
Regulations have also been adopted for the approval or not of other active substances in 
accordance with Reg. 1107/2009. When the Regulations concern the non-approval of an 
active  substance,  these  are  published  as  amendments  to  Commission  Decision 
2008/934/EC  concerning  the  non-inclusion  of  certain  active  substances  in  Annex  I  of 
Directive 91/414/EC (repealed by Reg. 1107/2009) and the withdrawal of authorisations 
for plant protection products containing these substances.  

During  the  evaluation  and  decision-making  process  for  a  possible  approval  of  an  active 
substance,  Commission  Decisions  may  be  published  for  the  extension  of  provisional 
authorisations  with  effect  for  a  defined  length  of  time.  For  example,  Commission 
Implementing  Decision  2012/363/EU  allows  Member  States  to  extend  provisional 
authorisations granted for the new active substances bixafen, Candida oleophila strain O, 
fluopyram, halosulfuron, potassium iodide, potassium thiocyanate and spirotetramat. 

Articles 14-21 of Regulation 1107/2009 on renewal and review  

c) 
Articles  14-21  of  Regulation  1107/2009  lay  down  requirements  on  the  renewal  and 
review process for active substances, safeners, synergists and co-formulants. Specifically 
Article  15  establishes  timelines  during  which  the  application  for  renewal  must  be 
submitted, while Article 17 allows for certain extensions to these timelines. Under these 
two  Articles,  Regulation  823/2012  allows  for  derogation  from  the  provisions  of  Reg. 
540/2011 with regard to the expiry of the approval of certain active substances. 

149 

 
 
 
 
 
 
 
Article  19  on  implementing  measures  indicates  that  a  Regulation  must  be  published 
establishing  the  procedures  for  the  implementation  of  the  renewal  process  for  active 
substances  and  where  relevant  also  a  work  programme.  Implementing  Regulation 
686/2012  allocates  to  Member  States,  for  the  purposes  of  the  renewal  procedure,  the 
evaluation of active substances the approval of which expires by 31st of December 2018 
at latest. Also Commission Implementing Regulation 844/2012 lays down the provisions 
necessary  for  the  implementation  of  the  renewal  procedure  for  active  substances  as 
provided for in Reg. 1107/2009.  

Article 29 of Regulation 1107/2009 on requirements for the 

d) 
authorisation for placing on the market   
Article 29 of Reg. 1107/2009 lays down the requirements for the authorisation of placing 
plant protection products on the market. It is required that uniform principles are applied 
for  the  evaluation  and  authorisation  of  such  products  and  that  certain  of  the 
requirements  of  Directive  91/414/EC  (repealed  by  Reg.  1107/2009)  should  be 
maintained.  Regulation  546/2011  implements  Reg.  1107/2009  with  regards  to  the 
uniform principles for evaluation and authorisation of plant protection products which is 
also required under Article 84 of Reg. 1107/2009 (on certain Regulations that need to be 
adopted further to Reg. 1107/2009). 

Article 55 of Regulation 1107/2009 on use of plant protection 

e) 
products  
Article  55  of  Reg.  1107/2009  lays  down  the  requirement  for  the  proper  use  of  plant 
protection  products  in  accordance  with  Good  Plant  Protection  Practice  (GPPP),  with  the 
instructions  provided  on  the  label  of  the  product  based  on  the  authorisation 
requirements  and  also  with  the  principles  of  integrated  pest  management.  Regulation 
1305/2013 on support for rural development by the European Agricultural Fund for Rural 
Development (EAFRD) indicates that support under the advisory, farm management and 
farm relief services may be provided to individual farmers, young farmers and other land 
managers if it is linked to at least one Union priority for rural development and covers at 
least  one  of  certain  elements,  one  of  which  is  compliance  with  Article  55  of  Reg. 
1107/2009  and  specifically  compliance  with  the  principles  of 
integrated  plant 
management.  

Similarly, in order to meet the requirements on proper use of plant protection products 
of  Article  55  of  Reg.  1107/2009  and  also  of  Article  14  of  Dir.  2009/128/EC  on  the 
framework  for  sustainable  use  of  pesticides  and  specifically  the  integrated  pest 
management  policy,  Regulation  1306/2013  on  the  financing,  management  and 
monitoring  of  the  common  agricultural  policy  implements  the  farm  advisory  system,  a 
system  to  provide  advice  on  different  issues  related  to  land  and  farm  management, 
including the above requirements. 

Within  the  scope  of  Article  55  of  Reg.  1107/2009  and  in  order  to  enforce  users' 
compliance  with  the  requirement  for  proper  use  of  plant  protection  products, 
Commission  Recommendation  2014/63/EU  on  measures  to  control  Diabrotica  virgifera 
virgifera Le Conte in Union areas where its presence is confirmed, suggests that Member 
States  should  ensure  that  any  guidelines  for  integrated  pest  management  relevant  to 
Diabrotica and addressed to maize farmers or professional users are in accordance with 
the requirements of Article 55 of Reg. 1107/2009. 

150 

 
 
 
 
 
 
Article 65 of Regulation 1107/2009 on labelling 

f) 
Article  65  of  Regulation  1107/2009  lays  down  requirements  on  the  labelling  of  plant 
protection products. Further to the repeal of Directive 91/414/EEC, it is necessary for the 
implementation  of  Reg.  1107/2009  to  adopt  a Regulation  on  the  labelling  requirements 
for plant protection products. These are now implemented by Regulation 547/2011.  

Regulation  649/2012  lays  down  provisions  for  the  import  and  export  of  hazardous 
chemicals.  Chemicals  intended  for  export  must  be  subject  to  the  above  provisions  of 
Reg. 1107/2009 on packaging and labelling of plant protection products. 

Article 67 of Regulation 1107/2009 on record-keeping 

g) 
Article  67  of  Regulation  1107/2009  with  regard  to  controls  of  plant  protection  products 
to  be  placed  on  the  market  requires  producers,  distributors,  suppliers  and 
importers/exporters  of  plant  protection  products  to  maintain  records  of  the  products 
they produce, import/export, use or store for certain lengths of time. Professional users 
must  also  maintain  records  of  the  products  used  and  the  time,  dose  and  area  of 
application. Regulation 1185/2009 on statistics on pesticides requires Member States to 
collect data on statistics on the placing on the market and use of pesticides as required 
under Annexes I and II. For this purpose, information collected under Article 67 of Reg. 
1107/2009 may be used, along with data from surveys and administrative sources. 

Article 76 of Regulation 1107/2009 on expenditure by the 

h) 
Commission 
Article  76  of  Regulation  1107/2009  indicates  that  the  Commission  shall  cover  certain 
expenses  related  to  activities  covering  the  requirements  of  Regulation  1107/2009. 
Commission  Implementing  Decision  2014/C  72/05  sets  out  the  financing  of  the  2014 
work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare 
and plant health. 

Also under the same Article, Commission Decision 2013/C 170/06 sets out the financing 
for 2013 of activities in the veterinary field related to the European Union's information 
policy  and  support  of  international  organisations  and  to  several  measures  necessary  to 
ensure the application of the food and feed and the plant health legislation. 

Article 83 of Regulation 1107/2009 on repeal 

i) 
Article  83  of  Regulation  1107/2009  implements  the  repeal  of  Directive  91/414/EEC, 
however the active  substances included in Annex  I  of the Directive must be  considered 
as approved under Reg. 1107/2009. Thus, for the implementation of Reg. 1107/2009 a 
Regulation  containing  the  list  of  approved  active  substances  of  Annex  I  of  Dir. 
91/414/EEC  must  also  be  adopted.  This  is  implemented  by  Commission  Implementing 
Regulation  540/2011  implementing  Reg.  1107/2009  as  regards  the  list  of  approved 
active substances. 

Extended scope of Regulation (EC) No 1107/2009 

j) 
Regulation  1107/2009  lays  down  provisions  for  the  authorisation  of  active  substances, 
but also provisions for the review of approvals (Article 21) as well as for the withdrawal 
or  amendment  of  authorisations  (Article  44).  Directive  2008/105/EC  lays  down 
environmental quality standards in the field of water policy and requires the Commission 
to submit a report to the European Parliament and to the Council on the outcome of the 
assessment of whether the EU and the Member States have sufficient measures in place 

151 

 
 
 
 
 
 
 
to achieve the environmental quality standards for priority substances and the phasing-
out  of  priority  hazardous  substances  in  accordance  with  Directive  2000/60/EC 
(establishing  a  framework  for  Community  action  in  the  field  of  water  policy).  If  the 
results  of  the  report  show  that  for  certain  substances  approved  under  Regulation 
1107/2009 additional measures are necessary at European or national level to meet the 
requirements  of  the  above  Directives,  then  the  above  Articles  21  and  44  of  Regulation 
1107/2009  on  the  review,  amendment  or  withdrawal  of  the  authorisation  must  be 
applied. 

Regulation  1107/2009  lays  down  requirements  for  the  placement  of  plant  protection 
products on the market. Directive 2009/128/EC establishes a framework for Community 
action for the sustainable use of pesticides. The specific provisions for the protection of 
the  aquatic  environment  and  drinking  water  must  be  compatible  with  and  support  the 
requirements of Reg. 1107/2009. 

Directive  2006/42/EC  on  machinery  lays  down  requirements  for  different  machinery, 
including for pesticide application machinery used for the application of plant protection 
products. 

152 

 
 
 
 
 
 
 
 
 
Annex  VI:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  396/2005  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Regulation  396/2005  and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 7 of Regulation 396/2005 on requirements relating to 

a) 
applications for MRLs 
Article  7  of  Regulation  396/2005  details  the  particulars  and  documents  that  must  be 
included  in  an  application  for  an  MRL.  Regulation  1107/2009  on  the  placing  of  plant 
protection products on the market indicates that the dossier submitted together with the 
application for the approval of an active substance must include a copy of the application 
for  the  MRL  according  to  the  above  Article.  Also  with  regard  to  the  placing  of  plant 
protection  products  on  the  market,  such  products  may  only  be  authorised  if  maximum 
residue levels have been established in accordance with Reg. 396/2005. 

Regulation 188/2011 lays down rules for the implementation of Dir. 91/414/EC (repealed 
by Reg. 1107/2009) with regards to the assessment of active substances that were not 
on  the  market  2  years  after  the  notification  of  the  Directive.  Where  appropriate,  the 
dossier  submitted  for  the  approval  of  the  substance  must  contain  a  copy  of  an 
application  for  the  establishment  of  relevant  MRLs  or  a  justification  for  not  supplying 
such a document.  

Implementing Regulation 844/2012 laying down the provisions for the implementation of 
the  renewal  procedure  for  active  substances  as  provided  for  in  Regulation  1107/2009 
concerning  the  placing  of  plant  protection  products  on  the  market,  indicates  that  the 
supplementary  dossier  to  be  submitted  to  the  rapporteur  Member  State  for  renewal  of 
the  approval  of  an  active  substance  must  contain,  where  relevant,  a  copy  of  the 
application for MRLs or a justification for not supplying such a document. 

Article  16  of  Regulation  396/2005  on  the  procedure  for  setting 

b) 
temporary MRLs in certain circumstances 
Article  16  of  Reg.  396/2005  lays  down  the  procedure  for  the  establishment  of  MRLs 
under  certain  circumstances.  The  Annex  to  Regulation  283/2013  sets  the  data 
requirements that need to be included in the dossier for active substances in accordance 
with  Reg.  1107/2009  and  also  indicates  that  in  certain  exceptional  cases  MRLs  may  be 
based on monitoring data.  

Article 29 of Regulation 396/2005 on Community control 

c) 
programme 
Article 29 of Reg. 396/2005 lays down the requirement for the Commission to prepare a 
coordinated  multiannual  Community  control  programme  in  order  to  assess  consumer 
exposure  to  pesticide  residues  and  the  application  and  compliance  with  Community 
legislation.  This  has  been  implemented  for  the  years  2015,  2016  and  2017  by 
Implementing Regulation 400/2014. 

153 

 
 
 
 
 
 
 
 
Article 36 of Regulation 396/2005 on support measures relating to 

d) 
harmonised pesticide MRLs 
Article  36  of  Reg.  396/2005  lays  down  support  measures  to  be  established  at 
Community  level  related  to  harmonised  pesticide  MRLs.  One  of  these  measures  is  the 
establishment of a database of all Community legislation on pesticide MRLs. Commission 
Implementing Decision 2014/C 72/05 on the financing of the 2014 work programme on 
IT tools in the field of food safety, animal and plant health and animal welfare lays down 
the  work  programme  and  the  distribution  of  the  budget  between  different  projects  for 
these implementing measures. 

Annex I of Regulation 396/2005 on products of plant and animal 

e) 
origin 
Annex  I  of  Reg.  396/2005  lists  products  of  plant  or  animal  origin  to  which  maximum 
residue  levels  for  pesticides  apply.  The  same  categorisation  of  products  is  also  used  in 
Regulation 1881/2006 setting maximum levels for certain contaminants in foodstuffs.  

Extended scope of Regulation 396/2005 

f) 
Regulation 396/2005 lays down maximum residue levels of pesticides in food and feed of 
plant or animal origin. Directive 91/414/EEC on  the placing of plant protection products 
on  the  market  (repealed  by  Reg.  1107/2009)  indicates  that  plant  protection  products 
may not be authorised unless, amongst other conditions, MRLs have been established for 
the agricultural products affected by the use indicated in the authorisation.  

Regulation  528/2012  lays  down  conditions  for  the  making  available  on  the  market  and 
use  of  biocidal  products.  A  biocidal  product  may  be  granted  authorisation  provided, 
where  appropriate,  maximum  residue  levels  have  been  established  in  food  or  feed  for 
the active substances contained in the product, in accordance with Reg. 396/2005. 

Implementing  Regulation  91/2013  lays  down  some  specific  provisions  for  the  import  of 
groundnuts  from  Ghana  and  India,  okra  and  curry  leaves  from  India  and  watermelon 
seeds  from  Nigeria.  Specific  provisions  are  established  for  okra  and  curry  leaves  form 
India  with  regard  to  the  method  for  analysis  of  pesticide  residues  which  must  be  in 
compliance  with  the  requirements  of  Reg.  396/2005  and  the  frequency  of  physical  and 
identity checks at import.  

154 

 
 
 
 
 
 
 
 
Annex  VII:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  3954/87  and 
their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Regulation  3954/87  and 
provide additional relevant regulatory documents required for their implementation. 

Articles 2 and 3 of Regulation (EURATOM) 3954/87 

a) 
Article  2  and  3  of  Regulation  (EURATOM)  3954/87  indicate  that  a  Regulation  must  be 
adopted laying down maximum levels of radioactive contamination in foodstuffs and feed 
in case of nuclear accident or other radiological emergency. Council Regulation 2219/89 
on  the  special  conditions  for  exporting  foodstuffs  and  feedingstuffs  following  a  nuclear 
accident  or  any  other  case  of  radiological  emergency  indicates  that  food  with  levels  of 
radioactive  contamination  higher  than  those  laid  down  in  the  above  Articles  of  Reg. 
3954/87 must not be exported. 

Until  the  entry  into  force  of  such  a  Regulation  as  required  under  Reg.  3954/87  above 
and  before  31  March  2020,  Council  Regulation  733/2008  on  the  conditions  governing 
imports  of  agricultural  products  originating  in  third  countries  following  the  accident  at 
the  Chernobyl  nuclear  power  station  indicates  that  products  originating  from  third 
countries  may  be  released  for  free  circulation  provided  they  comply  with  the  maximum 
levels laid down in Article 2 of the Regulation. 

Article 7 of Regulation (EURATOM) 3954/87 

b) 
Article  7  of  Regulation  (EURATOM)  3954/87  indicates  that  for  the  application  of  this 
Regulation further Regulations must be adopted to establish rules for its implementation 
and maximum levels of radioactive contamination in certain minor foodstuffs and feed. 

Commission  Regulation  (EURATOM)  944/89  lays  down  maximum  permitted  levels  for 
radioactive  contamination  in  minor  foodstuffs  following  a  nuclear  accident  or  any  other 
case of radiological emergency. 

Commission  Regulation  (EURATOM)  770/90  lays  down  maximum  permitted  levels  for 
radioactive contamination of feedingstuffs following a nuclear accident or any other case 
of radiological emergency. 

Annex to Regulation (EURATOM) 3954/87 

c) 
The  Article  to  Regulation  (EURATOM)  3954/87  lays  down  maximum  permitted  levels  of 
radioactive  contamination  in  food  and  feed.  Commission  Implementing  Regulation 
996/2012  imposes  special  conditions  governing  the  import  of  feed  and  food  originating 
in  or  consigned  from  Japan  following  the  accident  at  the  Fukushima  nuclear  power 
station  and  repealing  Implementing  Regulation  (EU)  No  284/2012  lays  down  maximum 
levels  for  the  sum  of  caesium-134  and  caesium-137  in  food  and  feed  originating  or 
consigned from Japan. These levels replace the ones established by Reg. 3954/87 on a 
provisional  basis.  This  Regulation  was  valid  until  the  31st  March  2014.  Since  that  date, 
the above scope is covered by Commission Implementing Regulation 322/2014 imposing 
special conditions governing the import of feed and food originating in or consigned from 
Japan following the accident at the Fukushima nuclear power station. 

155 

 
 
 
 
 
 
 
 
 
Annex  VIII:  Additional  implementing  measures  for  selected 
Articles  of  Directive  2001/18/EC  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  2001/18/EC  and 
provide additional relevant regulatory documents required for the implementation of the 
Directive. 

a) 
Articles 1-2 of Directive 2001/18/EC on objectives and definitions 
Articles  1  and  2  of  Directive  2001/18/EC  lay  down  the  scope  and  definitions  for  the 
purposes  of  deliberate  release  into  the  environment  of  GMOs.  Council  Directive 
68/193/ECC  on  the  marketing  of  material  for  the  vegetative  propagation  of  the  vine 
indicates  that  GM  vine  varieties  may  be  accepted  for  inclusion  in  the  member  States' 
catalogues  of  officially  accepted  varieties  for  certification  and  as  standard  propagating 
material,  provided  appropriate  measures  have  been  taken  to  avoid  adverse  effects  on 
human health and the environment. Specifically, an environmental risk assessment must 
be carried out in accordance with the requirements of Directive 2001/18/EC. 

Article 4 of Directive 2001/18/EC on general obligations 

b) 
Article  4  lays  down  the  general  obligations  of  the  Member  States  under  the 
precautionary  principle,  to  ensure  that  all  measures  are  taken  in  order  to  prevent  any 
adverse  effects  to  human  or  animal  health  or  the  environment  from  the  deliberate 
release  of  GMOs  to  the  environment.  The  competent  authorities  of  the  Member  States 
must  also  organise  inspections  and  controls  as  well  as  measures  for  the  termination  of 
an  unauthorised  release  and  initiation  of  remedial  action.  In  this  respect,  Commission 
Recommendation  2005/637/EC  lays  down  measures  to  be  taken  by  the  consent  holder 
to  prevent  any  damage  to  health  and  the  environment  in  the  event  of  the  accidental 
spillage  of  an  oilseed  rape  (Brassica  napus  L.,  GT73  line  –  MON-00073-7)  genetically 
modified for tolerance to the herbicide glyphosate.  

Also,  in  a  similar  context,  Commission  Decision  2007/232/EC  on  the  placing  on  the 
market  of  oilseed  rape  products  (Brassica  napus  L.,  lines  Ms8,  Rf3  and  Ms8xRf3) 
genetically  modified  for  tolerance  to  the  herbicide  glufosinate-ammonium  indicates  that 
Member States may carry  out checks and additional monitoring in order to identify any 
accidental  spillage  of  the  above  oilseed  rape  products  and  any  associated  adverse 
effects. 

Articles  5-11  of  Directive  2001/18/EC  (Part  B)  on  deliberate 

c) 
release of GMOs for other purpose than placing on the market 
Part B of Directive 2001/18/EC lays down provisions for the deliberate release of GMOs 
in the environment for other purposes than placing on the market.  

Regulation 726/2004 on Community procedures for the authorisation and supervision of 
medicinal  products  for  human  and  veterinary  use  and  establishing  the  European 
Medicines  Agency  indicates  that  the  application  for  authorisation  of  medicinal  products 
for human or veterinary use consisting of or containing GMOs must be accompanied by a 
copy of the competent authority's written consent for the deliberate release of GMOs in 
the environment for research and development purposes according to the requirements 
of the above section of Dir. 2001/18/EC. 

156 

 
 
 
 
 
 
 
Regulation  1107/2009  on  the  placing  on  the  market  of  plant  protection  products 
indicates  that  the  derogation  established  under  Article  53  of  Reg.  1107/2009  for 
placement  on  the  market  under  special  and  emergency  circumstances  for  limited  and 
controlled uses and for  specified short periods  of time must not be authorised for plant 
protection  products  containing  or  composed  of  GMOs  unless  such  a  release  has  been 
approved  under  the  requirements  of  Dir.  2001/18/EC.  Similarly,  permits  for  trial 
purposes  for  experiments  or  tests  involving  the  release  into  the  environment  for 
research  and  development  purposes  may  not  be  granted  to  plant  protection  products 
containing  or  composed  of  GMOs,  unless  such  a  release  has  been  approved  under  the 
requirements of Dir. 2001/18/EC. 

Article  10  of  Directive  2001/18/EC  on  reporting  by  notifiers  on 

d) 
releases 
Article 10 of Directive 2001/18/EC indicates that at certain intervals after the release of 
a GMO into the environment for purposes other than placing on the market, the notifier 
must  provide  the  competent  authority  with  the  results  of  the  release,  in  particular  in 
relation  to  risks  to  health  and  the  environment  as  well  as  information on  products  that 
the  notifier  intends  to  release  at  a  later  stage.  The  Directive  indicates  that  a  specified 
format must be established for the submission of this information, which is provided by 
Commission Decision 2003/701/EC. 

Article  11  of  Directive  2001/18/EC  on  exchange  of  information 

e) 
between competent authorities and the Commission 
Article 11 of Directive 2001/18/EC indicates that the Commission shall set up a system 
for  the  exchange  of  information  contained  in  notifications  for  the  deliberate  release  of 
GMOs for purposes other than placing on the market and requires a specified format to 
be  developed  for  this  summary  information.  This  is  implemented  by  Council  Decision 
2002/813/EC. 

Articles 12-24 of Directive 2001/18/EC (Part C) on placing on the 

f) 
market of GMOs as or in products 
Articles  12-24  of  Directive  2001/18/EC  lay  down  the  information  required  for  the 
authorisation  of  GMOs  for  placing  on  the  market  as  such  or  in  products.  Article  5  of 
Regulation  1829/2003  indicates  that  when  a  GMO  has  been  authorised  under  Part  C  of 
Dir.  2001/18/EC  above,  the  application  for  authorisation  of  GMOs  or  food  containing  or 
consisting  of  GMOs  under  Reg.  1829/2003  must  also  include  a  copy  of  the  above 
authorisation decision. 

Article  7  of  Regulation  1829/2003  indicates  that  references  in  Parts  A  and  D  (general 
and final provisions respectively) of Dir. 2001/18/EC to GMOs authorised under part C of 
Dir.  2001/18/EC  are  equally  applicable  to  GMOs  authorised  under  Reg.  1829/2003. 
Similar  requirements  are  also  established  under  Article  17  of  Reg.  1829/2003  on 
applications for the authorisation of GM feed. 

Directive  2001/82/EC  on  the  Community  code  relating  to  veterinary  medicinal  products 
indicates  that  for  such  products  containing  or  consisting  of  GMOs  the  authorisation 
application must also include the information required under Part C of Dir. 2001/18/EC. 
Also  the  relevant  information  required  for  the  environmental  risk  assessment  of  the 
release  of  such  products  may  be  presented  according  to  Dir.  2001/18/EC  and  Reg. 
726/2004 considering any relevant guidance documents. 

157 

 
 
 
 
 
 
Regulation 546/2011 implements Reg. 1107/2009 with regards to the uniform principles 
for  evaluation  and  authorisation  of  plant  protection  products.  According  to  this 
Regulation, in order  for GMOs to be authorised for use as plant protection products, an 
evaluation under Dir. 2001/18/EC and the relevant decision by the competent authorities 
must be submitted and taken into account. 

g) 
Article 13 of Directive 2001/18/EC on notification procedure 
Article  13  of  Directive  2001/18/EC  lays  down  the  information  required  during  the 
notification  procedure  for  a  GMO  to  be  placed  on  the  market.  One  of  the  details  that 
need  to  be  submitted  with  the  notification  is  a  summary  of  the  dossier  which  must  be 
provided  in  a  specified  format.  Council  Decision  2002/812/EC  establishes,  pursuant  to 
Directive 2001/18/EC, this summary information format for the placing on the market of 
GMOs as or in products.  

Article  18  of  Directive  2001/18/EC  on  Community  procedure  in 

h) 
case of objections 
Article 18 lays down the procedure to be followed in case the competent authority of a 
Member State raises and maintains an objection on the placing on the market of a GMO 
or  GM  product.  Commission  Decision  2004/643/EC  concerning  the  placement  on  the 
market, in accordance with Directive 2001/18/EC of the European Parliament and of the 
Council, of a maize product (Zea Mays L. line NK603) genetically modified for glyphosate 
tolerance  requires  the  competent  authority  of  Spain  to  issue  a  written  consent  for  the 
placement  of  the  above  product  on  the  market  and  also  lays  down  specific  conditions 
that must be met by the consent. Similarly, Commission Decision  2005/465/EC,  on the 
placing  on  the  market  in  accordance  with  Directive  2001/18/EC  of  an  oilseed  rape 
product (Brassica napus L., GT73 line) genetically modified for tolerance to the herbicide 
glyphosate,  requires  the  competent  authority  of  the  Netherlands,  that  originally  had 
raised  an  objection  for  the  placement  of  this  product  on  the  market,  to  grant  a  written 
consent, as there is no reason to believe that there might be a risk to human or animal 
health  or  the  environment  from  the  above  product.  It  also  specifies  the  conditions  that 
this  consent  must  be  subject  to.  Similar  requirements  are  also  laid  down  by  several 
Commission Decisions (2005/608/EC, 2005/635/EC, 2005/772/EC, 2007/232/EC).  

Commission  Decision  2008/470/EC  on  the  provisional  prohibition  of  use  and  sale  in 
Austria of GM maize (Zea mays L. line T25) pursuant to Directive 2001/18/EC, requests 
Austria  to  terminate  the  prohibition  of  import  and  use  into  food  and  feed  of  the  above 
product,  as  this  is  not  justified  under  Article  23  of  the  Directive  on  safeguard  clause. 
Similar requirements are also laid down under Decision 2008/495/EC. 

Article 19 of Directive 2001/18/EC on consent 

i) 
Article  19  indicates  that  a  GMO  or  GM  product  may  only  be  used  throughout  the 
Community without further notification, provided a written consent has been granted for 
the  placing  on  the  market  of  that  product  and  any  relevant  conditions  are  strictly 
adhered to. Regulation 1107/2009 of the European Parliament and of the Council on the 
placing  of  plant  protection  products  on  the  market  indicates  that  plant  protection 
products that contain GMOs may only be authorised under this Regulation provided they 
have already been granted a written consent under the above Article.  

158 

 
 
 
 
 
 
 
Article 21 of Directive 2001/18/EC on labelling 

j) 
Article 21 laying down provisions for the labelling of GMOs for placement on the market 
as  or  in  products,  requires  for  a  minimum  threshold  to  be  established  below  which 
products  are  exempt  from  the  above  labelling  requirement  and  implements  such  a 
threshold  for  products  intended  for  direct  processing.  This  threshold is  implemented  by 
Article 7 of Regulation 1830/2003. 

Article  26a  of  Directive  2001/18/EC  on  measures  to  avoid  the 

k) 
unintended presence of GMOs 
This Article indicates that appropriate measures must be taken by the Member States in 
order  to  avoid  the  unintended  presence  of  GMOs  in  other  products  and  that  the 
Commission must provide guidance on the coexistence of GM, conventional and organic 
crops. This guidance is provided by Commission Recommendation 2010/C 200/01. 

In  order  to  achieve  the  development  of  this  guidance,  this  Article  also  requires  the 
Commission  to  gather  and  coordinate  information  based  on  studies  conducted  at 
Community  or  Member  State  level  and  to  follow  relevant  developments.  Commission 
Decision 2005/463/EC implements this requirement establishing a network group for the 
exchange  and  coordination  of  information  concerning  coexistence  of  GM,  conventional 
and organic crops. 

Article 30 of Directive 2001/18/EC on Committee procedure 
l) 
Article 30 of Directive 2001/18/EC indicates that the Commission must be assisted by a 
Committee.  Commission  Recommendation  2004/787/EC  on  technical  guidance  on 
sampling and detection of GMOs and material produced from GMOs as or in products, in 
the  context  of  Regulation  1830/2003,  indicates  that  the  above  Committee  has  been 
consulted in developing this guidance document. 

Commission  Regulation  65/2004  establishing  a  system  for  the  development  and 
assignment  of  unique  identifiers  for  GMOs  lays  down  certain  measures  in  accordance 
with the opinion of the above Committee.  

m)  Article  31  of  Directive  2001/18/EC  on  exchange  of  information 
and reporting 
Article  31  of  Directive  2001/18/EC  requires  the  Commission  to  establish  one  or  several 
registers  for  recording  the  information  on  genetic  modification  of  GMOs  which  can  be 
used  for  detecting  and  identifying  specific  GMO  products  during  the  post-marketing 
control and inspection. This is implemented by Commission Decision 2004/204/EC laying 
down  detailed  arrangements  for  the  operation  of  the  registers  for  recording  the 
information on genetic modifications in GMOs.  The information required includes details 
of nucleotide sequences or other information necessary for the identification of the GMO 
product  and  its  progeny  such  as  methods  for  detection  and  identification  of  the  GMO, 
including  methods  for  the  detection  of  thresholds  established  under  Dir.  2001/18/EC. 
This  information  must  be  extracted  by  the  competent  authorities  from  the  information 
that  is  included  in  the  notification  under  Article  13  of  Dir.  2001/18/EC.  These  registers 
must be made publicly available according to Article 25 of Dir. 2001/18/EC. 

Commission  Implementing  Decision  2014/C  72/05  sets  out  the  financing  of  the  2014 
work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare 
and plant health. The budget for the financing of the registers on the information on the 
genetic modifications in the GMOs is also part of this programme. 

159 

 
 
 
 
 
 
Article  32  of  Directive  2001/18/EC  on  implementation  of  the 

n) 
Cartagena Protocol on biosafety 
Article  32  of  Directive  2001/18/EC  invites  the  Commission  to  implement  the 
requirements  of  the  Cartagena  Protocol  on  biosafety.  Regulation  of  the  European 
Parliament  and  of  the  Council  No  1946/2003  aims  to  implement  a  common  system  of 
notification  and  information  for  trans-boundary  movements  of  GMOs  and  to  ensure 
coherent  implementation  of  the  requirements  of  the  Cartagena  Protocol  in  order  to 
ensure the safe transfer, handling and use of GMOs for the conservation and sustainable 
use of biological diversity and considering the risks to human health. With regards to the 
international information procedure, Member States must notify to the Biosafety Clearing 
House any decision on the deliberate release of GMOs into the environment under Part B 
of Directive 2001/18/EC, any decision on safeguard measures under  Article 23 and any 
summary  of  risk  assessments  or  environmental  assessments  of  GMOs  carried  out 
according to Annex II of Dir. 2001/18/EC.  

Annex  I  of  Directive  2001/18/EC  on  techniques  of  genetic 

o) 
modification  
Annex I of Directive 2001/18/EC lays down the different techniques that may be used for 
genetic modification. Commission Regulation 283/2013 lays down the data requirements 
for active substances in accordance with Regulation (EC) No 1107/2009 concerning the 
placing  of  plant  protection  products  on  the  market.  The  Regulation  indicates  that  for 
micro-organisms  to  be  used  as  active  substances  their  identity  must  be  provided 
including  their  name  and  species  category  as  well  as  whether  any  of  the  techniques  of 
genetic  modification  of  the  above  Annex  have  been  used.  In  this  case,  all  known 
differences between the modified and the parent strain must be provided.   

Annex  II  of  Directive  2001/18/EC  on  principles 

p) 
environmental risk assessment 
Annex  II  of  Directive  2001/18/EC  lays  down  the  objectives,  general  principles  and 
the  environmental  risk  assessment  required  under  Directive 
methodology 
2001/18/EC  as  well  as  certain  other  elements  to  be  considered.  This  Annex  is 
supplemented  by  Commission  Decision  2002/623/EC  which  establishes  relevant 
guidance notes and is incorporated as an amendment to the text of the Directive. 

for  the 

for 

Regulation 726/2004 on Community procedures for the authorisation and supervision of 
medicinal  products  for  human  and  veterinary  use  and  establishing  the  European 
Medicines  Agency,  indicates  that  the  application  for  authorisation  of  medicinal  products 
for human or veterinary use consisting of or containing GMOs must be accompanied by 
an environmental risk assessment in accordance with the principles of Annex II above. 

Commission Implementing Regulation 503/2013 on applications for authorisation of GM 
food  and feed in accordance with Reg. 1829/2003 requires, among  other details, a risk 
assessment in accordance with the requirements of Annex II of Dir. 2001/18/EC for the 
purpose  of  compliance  with  the  requirements  of  the  Cartagena  Protocol  on  Biosafety  to 
the Convention of Biological Diversity. 

Annexes  III  and  IV  of  Directive  2001/18/EC  on  information 

q) 
required in the notification and additional information 
Annexes  III  and  IV  of  Directive  2001/18/EC  lay  down  additional  requirements  for 
information  that  needs  to  be  included  in  a  notification  under  Directive  2001/18/EC  for 
the release  of  specific types  of GMOs and in notifications for  GMOs to be placed  on the 

160 

 
 
 
 
 
 
market or for GMOs to be used under contained conditions or for deliberate releases for 
purposes  other  than  placement  on  the  market.  Article  5  of  Regulation  1829/2003 
indicates that a technical dossier containing this information must also be submitted with 
applications under the scope of this Regulation for GMOs or food containing or consisting 
of GMOs together with the conclusions of the risk assessment carried out under Annex II 
of  Dir.  2001/18/EC.  Similar  details  are  also  established  under  Article  17  of  Reg. 
1829/2003 on applications for the authorisation of GM feed. 

Regulation 726/2004 on Community procedures for the authorisation and supervision of 
medicinal  products  for  human  and  veterinary  use  and  establishing  the  European 
Medicines  Agency  indicates  that  the  application  for  authorisation  of  medicinal  products 
for human or veterinary use consisting of or containing GMOs must be accompanied by a 
complete  technical  dossier  containing  the  information  required  under  the  above  two 
Annexes.  A  similar  requirement  for  inclusion  of  the  information  contained  under  the 
above two Annexes is also laid down in Commission Implementing Regulation 503/2013 
on  applications  for  authorisation  of  GM  food  and  feed  in  accordance  with  Reg. 
1829/2003. 

Annex  IV  of  Directive  2001/18/EC  requires  that  proposed  labelling  information  is 
included in the notification for placing a GMO or GM product on the market. Commission 
Regulation  641/2004  on  rules  for  the  implementation  of  Reg.  1829/2003  indicates  that 
together  with  the  application  for  the  authorisation  of  GM  food  and  feed,  a  proposal  for 
labelling complying with the requirements of Annex IV above must also be provided.  

Annex VII of Directive 2001/18/EC on monitoring plan 

r) 
Annex  VII  of  Directive  2001/18/EC  describes  the  objective  and  general  principles  to  be 
followed for the design of a monitoring plan to be carried out following the placing on the 
market  of  a  GMO  and  indicates  that  technical  guidance  may  be  provided  for  the 
implementation of this Annex.  

Regulation  1829/2003  indicates  that  the  application  for  the  authorisation  of  GMOs  or 
food containing or consisting of GMOs under Reg. 1829/2003 must also be accompanied 
by  a  monitoring  plan  conforming  with  Annex  VII  above  as  well  as  a  proposal  for  the 
duration of the monitoring plan. 

Commission  Decision  2010/419/EU  renewing  the  authorisation  for  continued  marketing 
of products containing, consisting of or produced from GM maize Bt11, authorising food 
and food ingredients containing or consisting of field maize Bt11 pursuant to Regulation 
(EC)  No  1829/2003  and  repealing  Decision  2004/657/EC  indicates  that  the  information 
entered in the Community register for the above product must also include details of a 
monitoring plan for environmental effects in accordance with the requirements of Annex 
VII of Dir. 2001/18/EC. A similar  requirement is also laid down in Commission Decision 
2006/197/EC authorising the placing on the market of food containing, consisting of, or 
produced  from  GM  maize  line  1507  (DAS-Ø15Ø7-1)  and  renewing  the  authorisation  to 
place  on  the  market  feed  produced  from  such  maize  pursuant  to  Regulation  (EC)  No 
1829/2003.  Also  similar  requirements  are  laid  down  by  the  following  Commission 
Decisions: 2007/701/EC, 2007/702/EC, 2007/703/EC, 2008/730/EC, 2008/933/EC. 

With  regard  to  the  requirement  for  the  provision  of  technical  guidance,  this is  provided 
by  Council  Decision  2002/811/EC  establishing  guidance  notes  supplementing  Annex  VII 
to  Directive  2001/18/EC.  Also,  Commission  Decision  2009/770/EC  lays  down  in  its 
Annexes standard reporting formats that should be used as technical guidance notes for 
presenting the monitoring results of the deliberate release into the environment of GMOs 
and  GMOs  in  products  for  the  purpose  of  placing  on  the  market  pursuant  to  Directive 
2001/18/EC.  These  formats  should  facilitate  the  implementation  of  the  requirements  of 
Annex VII.  

161 

 
 
 
 
Extended scope of Directive 2001/18/EC 

s) 
The  scope  of  Directive  2001/18/EC  is  to  protect  human  health  and  the  environment 
during  the  deliberate  release  of  GMOs  in  the  environment  for  either  placement  on  the 
market or for other purposes.  

Regulation  178/2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  EFSA  and  laying  down  procedures  in  matters  of  food  safety  indicates  that 
the mission of the Authority also involves providing scientific opinions for products other 
than food and feed, relating to GMOs within the scope of Directive 2001/18/EC. 

Different Commission Decisions have been published rejecting national provisions related 
to  banning  of  GMOs  in  certain  regions  in  different  Member  States.  For  example,  Dec. 
2003/653/EC  rejects  national  provisions  on  banning  the  use  of  GMOs  in  the  region  of 
upper  Austria  notified  by  the  Republic  of  Austria  pursuant  to  Article  95(5)  of  the  EC 
Treaty.   

Directive 2001/83/EC lays down the Community code for medicinal products for human 
use.  The  part  of  the  Directive  on  requirements  that  must  be  submitted  with  the 
marketing  authorisation  dossier  indicates  that  an  environmental  risk  assessment  must 
be  included,  which  must  be  presented  in  accordance  with  the  requirements  of  Dir. 
2001/18/EC and any related guidance document published by the Commission.  

Commission  Decision  2004/842/EC  lays  down implementing  rules  for  Member  States  to 
be  able  to  authorise  the  placing  on the  market  of  seed  belonging  to varieties  for  which 
an  application  for  entry  in  the  national  catalogue  of  agricultural  plant  species  or 
vegetable  species  has  been  submitted.  As  previously  described  under  Reg.  1829/2003, 
in the case of GM varieties, authorisations may only be granted if there are measures in 
place  to  avoid  adverse  effects  to  human  health  or  the  environment  and  the  variety  is 
already approved under Dir. 2001/18/EC or Reg. 1829/2003. 

Council  Directive  2008/90/EC  on  the  marketing  of  fruit  plant  propagating  material  and 
fruit plants intended for fruit production indicates that a GM propagating material or fruit 
plant variety may only be registered officially if the GM organism of which it consists has 
been authorised under Dir. 2001/18/EC or Reg. 1829/2003. 

Directive  2005/34/EC  of  the  European  Parliament  and  of  the  Council  on  environmental 
liability  with  regard  to  the  prevention  and  remedying  of  environmental  damage 
establishes a framework of environmental liability for the prevention and remediation of 
environmental damage based on the principle that the polluter has to pay. This Directive 
also  applies  to  environmental  damage  or  threat  of  such  damage  caused  by  any 
deliberate release in the environment, transport or placement on the market of GMOs as 
defined in Dir. 2001/18/EC. 

Council  Decision  2008/971/EC  on  the  equivalence  of  forest  reproductive  material 
produced in third countries indicates that forest reproductive material may be imported 
in  Europe  from  the  third  countries  listed  in  Annex  I  to  the  Decision,  if  it  satisfies  the 
requirements of Directive 2001/18/EC. 

162 

 
 
 
 
 
 
 
Annex  IX:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1829/2003  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1829/2003 and 
provide additional relevant regulatory documents required for their implementation. 

Articles  3  and  15  of  Regulation  1829/2003  on  the  scope  of  the 

a) 
authorisation and supervision of GM food and feed 
Articles  3  and  15  of  Regulation  1829/2003  lay  down  the  scope  of  the  measures 
applicable to the authorisation and supervision of GM food and feed respectively. Council 
Directive  68/193/ECC  on  the  marketing  of  material  for  the  vegetative  propagation  of 
vine indicates that for products derived from vine-propagating material and intended to 
be  used  as  or  in  GM  food  or  feed  falling  within  the  scope  of  the  above  two  Articles  of 
Reg.  1829/2003,  the  vine  variety  concerned  may  only  be  accepted  if  it  has  been 
authorised in accordance with the requirements of Reg. 1829/2003. 

Council Directive 2002/53/EC on the common catalogue of varieties of agricultural plant 
species  indicates  that  for  material intended  to  be  used  in  feed  under  the  scope  of  Reg. 
1829/2003, the variety may only be accepted  for inclusion in the common catalogue of 
agricultural  plant  species  of  certain  varieties  of  products  that  may  be  marketed  under 
the  provisions  of  specific  Directives  for  the  marketing  of  those  products,  if  it  has 
previously been approved under the requirements of Reg. 1829/2003.  

Similarly,  Directive  2002/55/EC  on  the  marketing  of  vegetable  seed  indicates  that 
material  derived  from  a  plant  variety  and  intended  to  be  used  in  food  or  feed  falling 
under the scope of the above two articles shall be accepted for inclusion in the common 
catalogues  only  if  it  has  been  approved  in  accordance  to  the  requirements  of  Reg. 
1829/2003. 

Directive  2008/90/EC  on  the  marketing  of  fruit  plant  propagating  material  and  fruit 
plants intended for fruit production indicates that such material consisting of GMOs may 
only be placed on the market if they have been authorised under Reg. 1829/2003. Also 
if products derived from fruit plants or propagating material are intended to be used in 
GM  food  or  feed  authorised  under  Articles  3  or  15  of  Reg.  1829/2003,  the  propagating 
material  or  the  fruit  plants  concerned  may  only  be  placed  on  the  market  if  the  food  or 
feed  derived  from  this  material  has  been  authorised  under  Reg.  1829/2003.  Directive 
2008/90/EC  also indicates  that  GM  propagating  material  or  fruit  plant variety  may  only 
be registered officially if the GM organism of which it consists has been authorised under 
Reg. 1829/2003 or under Dir. 2001/18/EC. 

Articles  4  and  16  of  Regulation  1829/2003  on  the  authorisation 

b) 
requirements for GM food and feed 
Articles 4 and 16 lay down the requirements that GM food and feed must meet in order 
to be placed on the market. GM food and feed must not be placed on the market unless 
an authorisation has been granted under Reg. 1829/2003 once it has been demonstrated 
that  the  product  meets  all  the  requirements  established  therein.  Commission  Decision 
2010/428/EU authorises the placement on the market of products, containing, consisting 
or  produced  from  GM  maize  59122x1507xNK603  (DAS-59122-7xDAS-  Ø15Ø7-1xMON-
ØØ6Ø3-6)  pursuant  to  Regulation  1829/2003  according  to  the  conditions  laid  down  in 

163 

 
 
 
 
 
 
the Decision. Similar Decisions authorise the placement on the market of other GM food 
and feed products (i.e. Dec.2010/432/EU). 

Commission  Implementing  Decision  2011/884/EU  lays  down  emergency  measures 
regarding unauthorised GM rice in rice products originating from China. These measures 
apply to certain products listed in Annex I to the Decision. In order to ensure compliance 
with  the  above  Articles  of  Reg.  1829/2003,  Member  States  may  carry  out  random 
physical checks to other products originating from China in accordance with Annex II to 
the Decision. 

Articles  5  and  17  of  Regulation  1829/2003  on  application  for 

c) 
authorisation  
Articles  5  and  17  of  Regulation  1829/2003  lay  down  the  procedure  that  has  to  be 
followed  for  a  GMO  for  food/feed  or  use  in  food/feed  to  be  authorised.  The  Articles 
indicate  that  implementing  rules  must  be  established.  These  rules  are  implemented  by 
Commission  Regulation  641/2004  on  detailed  rules  for  the  implementation  of  Reg. 
1829/2003  as  regards  the  application  for  authorisation  of  new  GM  food  and  feed,  the 
notification  of  existing  products  and  adventitious  and  unavoidable  presence  of  GM 
material  which  has  benefited  from  a  favourable  risk  evaluation.  Also  Reg.  641/2004 
requires the applicant to specify whether the information provided may be notified to the 
biosafety clearing house under the Cartagena Protocol. If not, the procedure of Article 44 
of Reg. 1829/2003 must be followed. Implementing Regulation 503/2013 on applications 
for  authorisation  of  GM  food  and  feed  in  accordance  with  Reg.  1829/2003  applies  to 
applications  for  authorisation  of  GM  plants  submitted  under  Reg.  1829/2003  and  also 
amends Regulations 641/2004 and 1981/2006. 

Articles  5  and  7  also  require  the  applicant  to  submit  samples  of  the  product  seeking 
authorisation  and  their  control  samples.  Annexes  I  and  II  of  Reg.  641/2004  lay  down 
detailed  requirements  with  regard  to  the  above  samples  and  details  for  the  analytical 
method and the reference samples. Reg. 641/2004 also lays down information on how to 
provide  the  summary  of  the  dossier  in  a  standardised  form  as  requested  by  the  above 
Articles of Reg. 1829/2003. 

Articles  6  and  18  of  Regulation  1829/2003  on  opinion  of  the 

d) 
Authority for the authorisation of GM food and feed  
Articles  6  and  18  of  Regulation  1829/2003  lay  down  details  for  the  procedure  to  be 
followed  by  the  Authority  in  providing  its  opinion  after  receiving  an  application  for  the 
authorisation  of  GM  food  and  feed.  Regulation  2230/2004  lays  down  detailed  rules  for 
the implementation of Regulation 178/2002 with regard to the network of organisations 
operating in the fields within EFSA's mission. The Regulation requires Member States to 
forward  to  the  Commission  the  details  of  the  designated  organisations,  evidence  that 
they  comply  with  the  requirements  of  Reg.  2230/2004  and  details  of their  specific  field 
of  competence,  in this case  in  the  field  of  safety  assessment  of  GM  food  and  feed.  The 
Authority may entrust any of the tasks referred in Articles 6 or 18 of Reg. 1829/2003 to 
any of these organisations in order to assist with scientific or technical support. 

Article 7 of Regulation 1829/2003 on authorisation  

e) 
Article  7  of  Regulation  1829/2003  lays  down  the  details  of  the  authorisation  procedure 
and the timelines from receipt of the Authority opinion to the adoption and publication of 
a  final  decision.  For  example  Commission  Decision  2006/197/EC  authorises  the  placing 
on the market of food that contains, consists of or is produced from GM maize line 1507 

164 

 
 
 
 
 
 
(DAS-Ø15Ø7-1)  and  renews  the  authorisation  to  place  on  the  market  feed  produced 
from  such  maize  in  accordance  with  the  requirements  of  Reg.  1829/2003.  Similar 
Decisions  are  published  for  the  authorisation  to  place  on  the  market  of  other  GM 
products (i.e. Dec. 2007/692/EC, 2007/701/EC). 

Articles  8  and  20  of  Regulation  1829/2003  on  the  status  of 

f) 
existing products  
Articles 8 and 20 of Reg. 1829/2003 lay down conditions and procedures to be followed 
for the continuation of placement on the market of GM food and feed products that have 
been  lawfully  placed  on  the  market  before  the  date  of  application  of  the  Regulation.  If 
the  required  information  is  not  provided  within  the  timeframe  established  or  they  are 
found to be incorrect, the Commission must adopt measures for the withdrawal from the 
market of the product concerned and the products derived from it. Commission Decision 
2007/305/EC  implements  the  withdrawal  from  the  market  of  Ms1xRf1  (ACS-BNØØ4-
7xACS-  BNØØ1-4)  hybrid  oilseed  rape  and  its  derived  products.  Similar  Decisions  have 
implemented  the  withdrawal  from  the  market  of  other  GM  products  (i.e.  Decision 
2007/306/EC, Decision 2007/307/EC, 2007/304/EC, 2007/305/EC). 

Articles  9  and  21  of  Regulation  1829/2003  on  supervision  of  GM 

g) 
food and feed  
Articles 9 and 21 of Regulation 1829/2003 lay down the requirement for the supervision 
of  compliance  with  the  requirements  of  Reg.  1829/2003  and  with  any  conditions  or 
restrictions  imposed  after  an  authorisation  has  been  granted  for  a  GM  food  or  feed 
product.  Commission  Decision  2009/770/EC  establishes  standard  reporting  formats  for 
presenting  the  monitoring  results  of  the  deliberate  release  into  the  environment  of 
GMOs, as or in products, for the purpose of placing on the market pursuant to Directive 
2001/18/EC and details are laid down in the Annexes to the Regulation concerning both 
monitoring for cultivation and monitoring for GMO uses other than cultivation.  

Articles  11  and  23  of  Regulation  1829/2003  on  the  renewal  of 

h) 
authorisations of GM food and feed 
Articles  11  and  23  of  Regulation  1829/2003  lay  down  details  on  the  procedure  to  be 
followed  for  the  renewal  of  authorisations  of  GM  food  and  feed.  Commission  Decision 
2010/419/EU  renews  the  authorisation  for  the  continued  marketing  of  products 
containing,  consisting  of,  or  produced  from  GM  maize  Bt11  (SYN-BTØ11-1)  and 
authorises foods and food ingredients containing or consisting of field maize Bt11 (SYN-
BTØ11-1) pursuant to Reg. 1829/2003. 

Articles 12 and 24 of Regulation 1829/2003 on the labelling of GM 

i) 
food and feed 
Articles 12 and 24 of Regulation 1829/2003 lay down thresholds for the adventitious or 
technically  unavoidable  GM  content  of  food  and  feed  products  that  contain  or  are 
produced  from  GMOs.  These  thresholds  are  of  relevance  for  the  labelling  of  these 
products.  Regulation  1830/2003  lays  down  rules  for  the  labelling  and  traceability  of 
products that contain or are produced from GMOs, however products that fall under the 
above thresholds are exempt from these requirements.  

Directive  2014/63/EU  amending  Council  Directive  2010/110/EC  relating  to  honey  lays 
down  specific  details  for  the  labelling  of  honey  that  contains  GM  pollen  and  as  a 

165 

 
 
 
 
 
 
 
consequence  falls  under  the  requirements  of  Reg.  1829/2003,  unless  its  presence  is 
under a specified level and is adventitious or unavoidable. 

Articles  13  and  25  of  Regulation  1829/2003  on  the  labelling 

j) 
requirements of GM food and feed 
Articles 13 and 25 of Regulation 1829/2003 lay down specific labelling requirements for 
GM  food  and  feed  products.  Commission  Decision  2010/428/EU  authorising  the 
placement on the market of products, containing, consisting or produced from GM maize 
to 
59122x1507xNK603 
Regulation  1829/2003,  lays  down  some  additional  labelling  requirements  that  must 
appear on the label of the product authorised under this Decision. Similar requirements 
are  also  laid  down  by  other  Decisions  authorising  the  placement  on  the  market  of 
different GM food and feed products (i.e. Dec. 2010/432/EU, Dec. 2005/608/EC).  

(DAS-59122-7xDAS-  Ø15Ø7-1xMON-ØØ6Ø3-6)  pursuant 

In  the  same  context,  Commission  Decision  2005/448/EC  authorising  the  placement  on 
the  market  of  foods  and  food  ingredients  derived  from  GM  maize  line  NK  603  as  novel 
foods  or  novel  food  ingredients  under  Regulation  (EC)  No  258/97,  lays  down  labelling 
requirements  for  the  above  products.  Similarly,  further  Decisions  lay  down  labelling 
requirements for other similar products, for example Commission Decision 2006/68/EC. 

Article  27  of  Regulation  1829/2003  on  products  likely  to  be  used 

k) 
as both food and feed 
Article  27  of  Regulation  1829/2003  indicates  that  when  a  product  is  likely  to  be  used 
both as food and feed  a single application under Articles 5 and 17 of  the Reg. must be 
submitted requiring a single opinion by the Authority and a single Commission Decision. 
Regulation  641/2004  on  detailed  rules  for  the  implementation  of  Reg.  1829/2003 
implements  that  if  an  application  is  limited  to  one  of  the  two  uses,  a  verifiable 
justification must be included in the application explaining the reason. 

Article 28 of Regulation 1829/2003 on Community register 

l) 
Article 28 of Regulation 1829/2003 lays down the requirement for the establishment and 
maintenance  of  a  Community  register  of  GM  food  and  feed.  Commission  Decision 
2010/428/EU  authorising  the  placement  on  the  market  of  products,  containing, 
consisting  or  produced  from  GM  maize  59122x1507xNK603  (DAS-59122-7xDAS- 
Ø15Ø7-1xMON-ØØ6Ø3-6)  pursuant  to  Regulation  1829/2003,  requires  that  the 
information  of  the  Annex  to  the  Decision  is  entered  in  the  Community  register.  Similar 
requirements  are  also  laid  down  by  other  Decisions  authorising  the  placement  on  the 
market  of  different  GM  food  and  feed  products  (Dec.2010/432/EU).  Other  Decisions 
implement modifications to the Community register (Dec. 2008/279/EC). 

Commission  Implementing  Decision  2014/C  72/05  sets  out  the  financing  of  the  2014 
work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare 
and plant health. The budget for the financing of the register of approved GM food and 
feed is also part of this programme. 

m)  Article 30 of Regulation 1829/2003 on confidentiality 
Article  30  of  Regulation  1829/2003  lays  down  rules  related  to  the  confidentiality  of 
information  submitted  with  an  application  for  authorisation  of  GM  food/feed  products. 
Regulation  641/2004  on  detailed  rules  for  the  implementation  of  Reg.  1829/2003 
requires that the application clearly states which parts are to be treated as  confidential 
and provide a justification for the reason. 

166 

 
 
 
 
 
 
Article  32  of  Regulation  1829/2003  on  the  Community  Reference 

n) 
Laboratory 
Article  32  of  Regulation  1829/2003  implements  the  establishment  of  the  Community 
Reference  Laboratory  –  the  Commission's  Joint  Research  Centre  –  the  duties  and  tasks 
of which are detailed in the Annex to the Regulation. It also provides information on how 
the  costs  related  to  its  tasks  may  be  covered.  Detailed  rules  for  the  implementation  of 
this Article are provided by Regulation 1981/2006. 

Regulation 1830/2003 indicates that the Commission must develop and publish technical 
guidance  in  order  to  assist  Member  States  to  fulfil  the  requirements  for  inspection  and 
control  established  within  the  Regulation.  While  developing  this  guidance,  the 
Commission shall consult the work of the national competent authorities, of the Standing 
Committee  of  the  Food  Chain  and  Animal  Health  and  of  the  Community  Reference 
Laboratory established by Reg. 1829/2003.  

Article 44 of Regulation 1829/2003 on information to be provided 

o) 
in accordance with the Cartagena Protocol 
Article  44  of  Regulation  1829/2003  implements  that  any  authorisation  or  any  renewal, 
modification,  suspension  or  revocation  of  an  authorisation  of  GMOs  or  GMO  products 
must be notified by the Commission to the Parties of the Cartagena Protocol through the 
biosafety  clearing  house  and  lays  down  the  details  of  this  procedure.  Reg.  641/2004 
requires  the  applicant  for  an  authorisation  under  Articles  5  or  17  of  Reg.  1829/2003  to 
specify whether the information provided may be notified to the biosafety clearing house 
under  the  Cartagena  Protocol.  If  not,  the  procedure  of  Article  44  of  Reg.  1829/2003 
must be followed. 

p) 
Article  47  of  Regulation  1829/2003  on  transitional  measures  for 
adventitious or technically unavoidable presence of genetically modified 
material which has benefited from a favourable risk evaluation  
Articles  47  of  Regulation  1829/2003  lays  down  certain  conditions  under  which  the 
presence of GM material in food or feed in an amount of no higher than 0,5% shall not 
be considered a breach of the requirements of the Regulation. Directive 2001/18/EC on 
the deliberate release into the environment of GMOs indicates that the placement on the 
market  of  GMO  traces  or  combinations  of  GMOs  in  products  for  use  in  food,  feed  or 
processing  shall  be  exempt  from  the  notification  and  monitoring  and  labelling 
requirements laid down in the Directive, provided they meet the above conditions of Art. 
47 of Reg. 1829/2003. 

Also  Regulation  1830/2003  on  the  labelling  and  traceability  of  products  that  contain  or 
are produced from GMOs indicates that products that fall under the above thresholds and 
meet  the  above  conditions  of  Reg.  1829/2003,  are  exempt  from  its  labelling  and 
traceability requirements. 

Annex  of  Regulation  1829/2003  on  the  duties  and  tasks  of  the 

q) 
Community Reference Laboratory 
The  Annex  to  Regulation  1829/2003  lays  down  the  duties  and  tasks  of  the  Community 
Reference Laboratory. Regulation 882/2004 on the official controls performed to ensure 
compliance  with  feed  and  food  law  and  animal  health  and  welfare  lists  the  Community 
Reference Laboratories in the different  areas of food and feed law, establishes the Joint 
Research  Centre  of  the  European  Commission  as  the  Community  Reference  Laboratory 
for GMOs. 

167 

 
 
 
 
 
 
Commission  Decision  2005/635/EC  concerning  the  placement  on  the  market  in 
accordance  with  Directive  2001/18/EC  of  an  oilseed  rape  product  (Brassica  napus  L., 
GT73  line)  genetically  modified  for  tolerance  to  the  herbicide  glyphosate.  This  product 
can be placed on the market from the date that a method for the detection of the above 
material is validated by the Community Reference Laboratory  established by the Annex 
to  Reg.  1829/2003  and  in  accordance  with  the  details  of  Regulation  641/2004.  Similar 
Decisions are also published for other GM products (i.e. Dec. 2007/232/EC). 

Extended scope of Regulation 1829/2003 

r) 
Regulation  258/97  lays  down  provisions  on  novel  foods  and  novel  food  ingredients. 
Regulation  1829/2003  indicates  that  foods  and  food  ingredients  authorised  under  this 
Regulation  should  be  exempt  from  the  requirements  of  Reg.  258/97,  unless  they  fall 
under  one  of  the  product  categories  to  which  Reg.  258/97  applies  for  a  characteristic 
that has not been considered for the purposes of authorisation under Reg. 1829/2003. 

Regulation  1831/2003  on  feed  additives  for  use  in  animal  nutrition  lays  down  the 
procedure  for  the  authorisation  of  such  additives  in  order  to  ensure  the  protection  of 
consumer  and  animal  health.  Regulation  1829/2003  also  covers  feed  additives 
containing, consisting or produced from GMOs. Since the scope of the two Regulations is 
different,  feed  additives  should  undergo  both  authorisations.  In  the  same  context, 
Regulation 429/2008 lays down detailed rules for the implementation of Reg. 1831/2003 
as regards the preparation and presentation of applications and the assessment and the 
authorisation of feed additives. Applicants are required to indicate whether the additive 
consists,  contains  or  is  produced  from  GMOs  and  to  provide  the  details  of  the 
authorisation granted or of the application for authorisation submitted. 

Regulation  834/2007 indicates  that  GMOs  and  products  produced  by  GMOs  may  not  be 
used  in  organic  production  at  any  step  as  food,  feed,  seeds,  processing  aids,  plant 
protection  products,  fertilisers,  soil  conditioners,  vegetative  propagating  material, 
microorganisms or animals. Food business operators may rely for this information on the 
labelling of the products in accordance with the requirements of Reg. 1829/2003. 

Regulation  1332/2008  on  food  enzymes  indicates  that  food  enzymes  falling  within  the 
scope of Reg. 1829/2003 may be included in the Community list of food enzymes only if 
they  are  authorised  under  Reg.  1829/2003.  For  food  enzymes  already  included  in  the 
Union  list  that  are  produced  from  a  different  source  falling  within  the  scope  of  Reg. 
1829/2003,  a  new  authorisation  is  not  required  provided  the  new  source  is  authorised 
under  Reg.  1829/2003  and  the  food  enzyme  complies  with  the  specifications  of  Reg. 
1332/2008.  Similar  provisions  are  also  laid  down  in  Regulation  1333/2008  on  food 
additives. Food additives falling under the scope of Reg. 1829/2003 may be included in 
Annexes  II  and  III  of  the  Community  list  of  food  additives  only  if  they  are  authorised 
under  Reg.  1829/2003  and  for  food  additives  already  in  the  Community  list  that  are 
produced  from  a  different  source  falling  within  the  scope  of  Reg.  1829/2003,  a  new 
authorisation  is  not  required  provided  the  new  source  is  authorised  under  Reg. 
1829/2003  and  the  food  additive  complies  with  the  specifications  of  Reg.  1333/2008. 
Similarly,  the  above  provisions  relevant  to  the  authorisation  and  the  inclusion  in  the 
Community  list  are  also  established  by  Regulation  1334/2008  for  food  flavourings  and 
source materials that fall within the scope of Reg. 1829/2003.  

Regulation  234/2011  implements  Regulation  1331/2008  on  the  common  authorisation 
procedure  for  food  additives,  food  enzymes  and  food  flavourings.  An  application  for  an 
update  of  the  list  of  approved  substances  (food  additives,  enzymes  or  flavourings) 
requires a technical dossier to be submitted containing all the administrative data for the 
substance.  These  include  any  information  on  authorisation  of  the  substance  under  the 
scope of Regulation 1829/2003. 

168 

 
 
 
 
Commission  Decision  2004/842/EC  lays  down implementing  rules  for  Member  States  to 
be  able  to  authorise  the  placing  on the  market  of  seed  belonging  to varieties  for  which 
an  application  for  entry  in  the  national  catalogue  of  agricultural  plant  species  or 
vegetable  species  has  been  submitted.  In  case  of  GM  varieties,  the  authorisation  may 
only be granted if there are measures in place to avoid adverse effects to human health 
or  the  environment  and  the  variety  is  already  approved  under  Reg.  1829/2003  or  Dir. 
2001/18/EC. 

Regulation  1829/2003  implements  the  establishment  of  the  Community  Reference 
Laboratory. Commission Recommendation 2004/787/EC lays down technical guidance on 
sampling and detection of GMOs and material produced from GMOs as or in products in 
the  context  of  Regulation  1830/2003.  The  Recommendation  indicates  that  alternative 
testing strategies to the ones recommended may be applied provided they are approved 
by the Community Reference Laboratory. Also the Community Reference Laboratory may 
provide  further  guidance  and  assistance  on  sampling  or  testing  methods.  The 
Recommendation  also  indicates  that  further  protocols  for  the  sampling  and  detection 
should  continue  to  be  developed  considering  any  amended  threshold  values  as 
established by Reg. 1829/2003 or Directive 2001/18/EC.  

Regulation 1829/2003 lays down provisions for the authorisation of GM feed but also for 
when  the  authorisation  is  pending  or  has  expired  as  well  as  rules  for  the  presence  of 
residues  of  GM  material.  Commission  Regulation  619/2011  lays  down  the  methods  for 
sampling and analysis for the official control of feed as regards presence of GM material 
for  which  an  authorisation  procedure  is  pending  or  the  authorisation  of  which  has 
expired. 

Commission  Decisions  have  been  published  rejecting  certain  provisions  that  Member 
States  intended  to  implement  in  their  national  law.  For  example  Commission  Decision 
2006/255/EC rejected the implementation by Cyprus of national provisions imposing on 
supermarkets  an  obligation  to  place  GM  foods  on  separate  shelves  from  non-GM, 
pursuant  to  Article  95(5)  of  the  EC  Treaty.  Similarly,  Commission  Decision  2008/62/EC 
relating to Articles 111 and 172 of the Polish Draft Act on Genetically Modified Organisms 
notified  by  the  Republic  of  Poland  pursuant  to  Article  95(5)  of  the  EC  Treaty  rejected 
derogations from the provisions of Directive 2001/18/EC on the deliberate release in the 
environment of GMOs. 

The  authorisation  of  GMOs  for  release  in  the  environment  is  subject  to  health  and 
environmental risk assessments while Reg. 1829/2003 also lays down procedures for the 
establishment of emergency measures and restriction or prohibition of the cultivation of 
GMOs  if  deemed  necessary  in  light  of  new  scientific  information.  Commission 
Recommendation  2010/C  200/01  lays  down  guidelines  for  the  development  of  national 
co-existence  measures  to  avoid  the  unintended  presence  of  GMOs  in  conventional  and 
organic crops. 

169 

 
 
 
 
 
 
 
 
Annex  X:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1830/2003  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1830/2003 and 
provide additional relevant regulatory documents required for their implementation. 

Article 8 of Regulation 1830/2003 on unique identifier  

a) 
Article  8  of  Regulation  1830/2003  requires  the  Commission  to  establish  a  system  for 
development  and  assignment  of  unique  identifiers  to  GMOs.  Regulation  1831/2003  on 
additives for use in animal nutrition indicates that the Regulations granting authorisation 
to additives consisting, containing or produced from GMOs should also include the name 
of the authorisation holder and the unique identifier attributed to the GMO in accordance 
with the above provisions.  

Extended scope of Regulation 1830/2003 

b) 
Regulation  834/2007 indicates  that  GMOs  and  products  produced  by  GMOs  may  not  be 
used  in  organic  production  at  any  step  as  food,  feed,  seeds,  processing  aids,  plant 
protection  products,  fertilisers,  soil  conditioners,  vegetative  propagating  material, 
microorganisms or animals. Food business operators may rely for this information on the 
labelling of the products in accordance with the requirements of Reg. 1830/2003. 

170 

 
 
 
 
 
 
 
 
 
Annex  XI:  Additional  implementing  measures  for  selected 
Articles  of  Directive  2001/82/EC  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  2001/82/EC  and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

a) 
Article 5 of Directive 2001/82/EC on marketing authorisation 
Article 5 of Directive 2001/82/EC indicates that veterinary medicinal  products may  only 
be  placed  on  the  market  if  they  have  been  authorised  in  accordance  with  Directive 
2001/82/EC  or  in  accordance  with  the  provisions  of  Regulation  726/2004.  Regulation 
726/2004  indicates  that  any  marketing  authorisation  granted  in  accordance  with  its 
requirements must have the same validity throughout the Community and in each of the 
Member  States  as  an  authorisation  granted  in  the  same  Member  States  according  to 
Directive 2001/82/EC. 

Regulation 1177/2006 implementing Regulation 2160/2003 on  requirements for the use 
of specific control measures in the framework of the national programmes for the control 
of  salmonella  in  poultry  indicates  that  generally  antimicrobials  must  not  be  used  as  a 
means  of  controlling  salmonella  in  poultry,  unless  under  the  exceptional  circumstances 
described  in  the  Regulation  and  only  provided  they  have  been  authorised  according  to 
the  requirements  of  Article  5  of  Directive  2001/82/EC  or  according  to  Regulation 
726/2004.  Also  Regulation  1177/2006  indicates  that  live  salmonella  vaccines  must  not 
be used within the framework of the national control plans for salmonella in laying hens 
during production, unless they are safe for use and they have been authorised according 
to Directive 2001/82/EC. 

Directive  2006/88/EC  on  animal  health  requirements  for  aquaculture  animals  and 
products thereof and on the prevention and control of certain diseases in aquatic animals 
indicates that vaccines for the control of exotic aquatic diseases may only be used if they 
have been authorised according to Directive 2001/82/EC and Regulation 726/2004. 

Article 10 of Directive 2001/82/EC 

b) 
Article 10 of Directive 2001/82/EC lays down special measures for the administration of 
veterinary medicinal products to non-food producing animals and equidae in the absence 
of  a  suitable  authorised  veterinary  medicinal  product.  Regulation  504/2008  lays  down 
methods  for  the  identification  of  equidae.  According  to  this  Regulation  equidae  are 
intended for human consumption unless irreversibly declared as non-food producing due 
to  the  administration  of  veterinary  medicinal  products  according  to  Directive 
2001/82/EC.  Article  10  also  indicates  that  the  Commission  must  establish  a  list  of 
substances  that  are  essential  for  the  treatment  of  equidae  or  bring  added  clinical 
benefits  compared  to  other  treatments  and  have  a  withdrawal  period  of  at  least  six 
months.  These  are  laid  down  by  Commission  Regulation  1950/2006  which  also  details 
the  conditions  for  their  use.  In  case  an  equine  animal  is  treated  with  such  products, 
Regulation 504/2008 indicates that the  veterinarian must indicate this treatment in the 
identification documents of the animal, as well as the date of the last administration and 
also must inform the keeper of the date when the withdrawal period has lapsed. 

171 

 
 
 
 
 
 
 
Article 11 of Directive 2001/82/EC 

c) 
Article  11  of  Directive  2001/82/EC  lays  down  provisions  for  the  treatment  of  food-
producing  animal  species  in  the  absence  of  suitable  authorised  veterinary  medicinal 
products.  The  Article  also  lays  down  the  withdrawal  periods  that  must  be  observed  for 
the  substances  listed  in  Regulation  2377/90  (now  repealed  by  Regulation  470/2009). 
Regulation  889/2008  lays  down  detailed  rules  for  the  implementation  of  Regulation 
834/2007 on organic production and labelling of organic products with regard to organic 
production,  labelling  and  control.  Special  rules  are  laid  down  with  regard  to  the 
withdrawal  periods  after  the  administration  of  veterinary  medicinal  products  in  animals 
intended  for  the  production  of  organic  foodstuffs  for  the  purposes  of  either  treating  or 
preventing disease. 

Articles 12-14 of Directive 2001/82/EC 

d) 
Articles  12-14  of  Directive  2001/82/EC  and  Annex  I  to  the  Directive  provide  details  of 
the  information  that  must  be  submitted  with  each  application  for  an  authorisation  of  a 
veterinary  medicinal  product  in  a  Member  State.  Under  Regulation  726/2004,  each 
application  must  include  the  particulars  detailed  in  the  above  articles  and  Annex  I  of 
Directive 2001/82/EC and must include the use of a single name for the product. Two of 
the particulars required for the market authorisation of the veterinary medicinal product 
are details on manufacturing method and control. In that respect, Regulation 726/2004 
requires the holder to follow technical and scientific developments in these two fields in 
order to be able to make any variations as may be required and apply for their approval. 
These must then been communicated to the Agency. 

Article  13  of  Directive  2001/82/EC  exempts  applicants  from  the  requirement  to  provide 
certain  details  if  they  can  prove  that  the  medicinal  product  is  a  generic  of  a  reference 
medicinal  product  already  authorised  in  a  Member  State  or  the  Community  within  a 
certain timeframe. Products authorised under Regulation 726/2004 can also benefit from 
these provisions of Directive 2001/82/EC. 

Regulation  469/2009  lays  down  provisions  on  supplementary  protection  certificates  for 
medicinal products in a Member State. A product may be the subject of a certificate if it 
is protected by a patent in the Member State and not already the subject of a certificate 
and  if  a  valid  and  first  authorisation  has  been  granted  under  Directive  2001/82/EC  for 
the  product  to  be  placed  on  the  market  as  a  veterinary  medicinal  product.  Details  are 
also provided on the application procedure for this certificate as well as on the procedure 
for  the  withdrawal  of  this  certificate  in  case  of  a  withdrawal  of  the  marketing 
authorisation of the product. 

Article 38 of Directive 2001/82/EC 

e) 
Article  39  of  Directive  2001/82/EC  lays  down  the  procedure  by  which  the  final  decision 
for  granting  a  marketing  authorisation  is  taken  by  the  Commission.  The  following 
Commission  Communications  have  been  published  on  the  summary  of  Decision  for 
marketing  authorisations  since  2010  (2010/C  258/02,  2010/C  295/02).  They  list  new, 
maintained,  modified  but  also  suspended,  refused  or  revoked  marketing  authorisations 
and provide details on the name, the pharmaceutical form, the strength and the route of 
administration of the medicinal product as well as details on the applicant.  

Article 39 of Directive 2001/82/EC 

f) 
Article 39 of Directive 2001/82/EC indicates that a variation to a marketing authorisation 
may  be  granted,  after  an  application  by  the  authorisation  holder  to  all  the  Member 

172 

 
 
 
 
 
 
States  that  have  authorised  the  veterinary  medicinal  product  concerned.  Regulation 
1234/2008  lays  down  provisions  on  the  examination  of  variations  to  the  terms  of 
marketing authorisations for medicinal products for human use and veterinary medicinal 
products. Details for the notification procedures for the different types of variations are 
laid down in Chapter II of the Regulation. 

Further  on  the  same  subject,  Commission  Communication  2010/C  17/01  lays  down 
guidelines  on  the  details  of  the  different  categories  of  variations  to  the  terms  of 
marketing  authorisations  for  medicinal  products  for  human  or  veterinary  use.  Similarly 
Commission Communication 2009/C 323/04 provides guidelines on the operation of the 
procedures  of  Reg.  1234/2008  on  variations  to  marketing  authorisation  of  medicinal 
products. 

Titles  IV,  VII  and  VIII  of  Directive  2001/82/EC  on  manufacture 

g) 
and imports, pharmacovigilance and supervisions and sanctions 
Titles  IV,  VII  and  VIII  of  Directive  2001/82/EC  lay  down  requirements  on  the 
manufacture  and  imports,  the  pharmacovigilance  and  the  supervision  and  sanctions 
related  to  veterinary  medicinal  products  in  the  Community.  Regulation  726/2004 
requires  the  competent  authorities  of  the  Member  States  to  verify  on  behalf  of  the 
Community  that  the  holders  of  veterinary  medicinal  products'  authorisations  or  the 
manufacturers  or  the  importers  of  such  products  fully  conform  to  all  the  above 
requirements  of  Directive  2001/82/EC.  In  case  the  opinions  of  Member  States  on  the 
conformance  to  the  above  issues  differ  significantly,  the  Commission  may  request 
inspections to be carried out.   

h) 
Article 67 of Directive 2001/82/EC on veterinary prescriptions 
Article  67  of  Directive  2001/82/EC  lays  down  the  requirement  for  a  veterinary 
prescription  in  order  to  supply  certain  veterinary  medicinal  products  to  the  public. 
However,  under  certain  conditions  established  by  the  Commission,  products  may  be 
exempt from this requirement in the Member States. Directive 2006/130/EC implements 
Directive  2001/82/EC  as  regards  the  establishment  of  criteria  for  exempting  certain 
veterinary  medicinal  products  for  food-producing  animals  from  the  requirement  of  a 
veterinary prescription.  

Articles  80-82  of  Directive  2001/82/EC  on  supervisions  and 

i) 
sanctions 
Articles  80-82  of  Directive  2001/82/EC  lay  down  provisions  on  how  the  competent 
authorities  of  the  Member  States  can  ensure  that  the  requirements  of  the  Directive 
relevant  to  veterinary  medicinal  products  can  be  met.  Regulation  658/2007  lays  down 
provisions for financial penalties for infringement of certain obligations in connection with 
marketing  authorisations  granted  under  Regulation  726/2004.  It  is  indicated  that  the 
Agency  may  request  the  authorities  to  cooperate  in  the  investigation  following  an 
infringement  by  performing  inspections  and  other  supervisory  methods  as  in  Directive 
2001/82/EC. 

Extended scope of Directive 2001/82/EC 

j) 
Regulation  (EC)  No  297/95  lays  down  the  fees  payable  to  the  European  Medicines 
Agency  with  the  application  for  the  marketing  authorisation  of  veterinary  medicinal 

173 

 
 
 
 
 
 
 
products under Articles 13 and 34 and 35 of Directive 2001/82/EC. The fees depend on 
the number of pharmaceutical forms, strengths and presentations. 

Regulation  726/2004  lays  down  procedures  for  the  authorisation  and  supervision  of 
medicinal products for human and veterinary use in the Community and establishes the 
European  Medicines  Agency.  The  Regulation  lays  down  the  conditions  under  which  a 
generic medicinal product of a reference medicinal product authorised by the Community 
may  be  authorised  by  the  competent  authorities  of  the  Member  States  under  Directive 
2001/82/EC.  The  Regulation  also  details  the  procedure  followed  by  the  Committee  for 
Medicinal Products for Veterinary Use in order to prepare its opinion on an authorisation. 
In  case  of  an  unfavourable  decision,  the  Agency  must  notify  the  applicant  on  the 
particulars  that  are  not  satisfactory.  If  the  opinion  is  favourable,  certain  of  the 
particulars  submitted  with  the  application  according  to  the  requirements  of  Directive 
2001/82/EC  are  annexed  to  the  decision.  If  the  labelling  and  packaging  information 
provided  is  not  in  accordance  with  the  requirements  of  Directive  2001/82/EC,  the 
authorisation can be refused.  

Directive 2001/82/EC lays down provisions for the authorisation of veterinary medicinal 
products.  Directive  96/22/EC  on  the  prohibition  of  the  use  in  stock-farming  animals  of 
certain  substances  with  hormonal  of  thyrostatic  action  or  beta-agonitsts  indicates  that 
certain products with oestrogenic, androgenic or gestagenic action or hormonal products 
and beta-agonists may be authorised for administration to farm animals for the purposes 
of zootechnical treatment provided they meet the requirements of Directive 2001/82/EC. 
Also  the  possession  of  substances  listed  in  Annexes  II  and  III  of  Directive  96/22/EC  is 
only restricted to persons authorised by the provisions of Directive 2001/82/EC.  

Directive  2009/35/EC  on  colouring  matters  that  may  be  added  to  medicinal  products 
indicates  that  only  colouring  matters  permitted  under  the  provisions  of  Directive 
94/36/EC may be added to veterinary medicinal products for human or animal use. 

Directive 2005/94/EC lays down Community measures for the control of avian influenza. 
It  indicates  that  only  influenza  vaccines  authorised  in  accordance  to  Directive 
2001/82/EC  or  in  accordance  with  Regulation  726/2004  can  be  used  and  only  such 
vaccines can be stored in the Community vaccine bank for Community reserves of avian 
influenza  vaccines.  Similarly,  within  the  scope  of  contingency  planning,  only  avian 
influenza  vaccines  authorised  under  Directive  2001/82/EC  may  be  stored  in  national 
vaccine  banks.  Similar  requirements  are  also  laid  down  in  Decision  2006/147/EC  on 
introducing  preventive  vaccination  against  highly  pathogenic  avian  influenza  H5N1  and 
related  provisions  for  movement  in  the  Netherlands  and  in  Decision  2006/148/EC  for 
France.  Vaccines  can  be  used  only  if  they  are  authorised  in  accordance  with  Directive 
2001/82/EC  or  Regulation  726/2004.  Several  Commission  Decisions  implement  similar 
provisions for protection measures or for emergency vaccination  against avian influenza 
or  foot-and-mouth  disease  in  the  different  Member  States  and  some  examples  are 
provided in the following Table. 

Directive  2008/105/EC  on  environmental  quality  standards  in  the  field  of  water  policy 
lays  down  quality  standards  for  priority  substances  and  other  pollutants  in  order  to 
achieve  good  surface  water  chemical  status.  A  watch-list  of  substances  must  be 
established  by  the  Commission  for  which  monitoring  data  are  to  be  gathered  in  the 
European  Union  to  support  prioritisation  exercises  and  monitoring  programmes.  For 
selecting  the  substances  for  this  list,  information  gathered  according  to  Directive 
2001/82/EC may also be used. 

174 

 
 
 
 
 
 
Table 2: examples of Commission Decisions implementing provisions for 
protection  measures  or  for  emergency  vaccination  against  certain 
diseases in the different Member States 

Commission 
Decision 
Decision 2006/147/EC 

Decision 2006/148/EC 

Decision 2007/590/EC 

Decision 2007/598/EC 

Decision 2008/341/EC 

Implementing  Decision 
2013/651/EU  

Topic  

Preventive  vaccination  for  against  highly  pathogenic  avian 
influenza  H5N1  and  related  provisions  for  movement  in  the 
Netherlands 
Preventive  vaccination  against  highly  pathogenic  avian 
influenza  H5N1  and  related  provisions  for  movements  in 
France 
Preventive  vaccination  for  against  highly  pathogenic  avian 
influenza  H5N1  and  related  provisions  for  movement  in  the 
Netherlands 
Measures  to  prevent  the  spread  of  highly  pathogenic  avian 
influenza  to  other  captive  birds  kept  in  zoos  and  approved 
bodies, institutes or centres in the Member States 
Community  criteria 
for  the 
for  national  programmes 
eradication,  control  and  monitoring  of  certain  animal 
diseases and zoonoses 
Approving  a  preventive  vaccination  plan  against 
low 
pathogenic  avian  influenza  in  a  holding  keeping  mallard 
ducks in Portugal and certain provisions for their movement 
and products thereof (valid until 31/12/2014) 

175 

 
 
 
 
 
Annex  XII:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  470/2009  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Regulation  470/2009  and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 10 on pharmacologically active substances contained in 

a) 
biocidal products used in animal husbandry 
Article  10  of  Regulation  470/2009  lays  down  procedures  for  the  establishment  of 
maximum  residue  limits  of  pharmacologically  active  substances  for  use  in  biocidal 
products. Regulation 528/2012 concerning the making available on the market and use 
of biocidal products lays down procedures for granting authorisation for biocidal products 
not  eligible 
for  the  simplified  authorisation  procedure.  For  granting  such  an 
authorisation,  one  of  the  requirements  is  that,  where  appropriate,  maximum  levels  for 
food  and  feed  must  have  been  established  for  the  substance  under  Reg.  470/2009.  An 
application must be submitted for the establishment of such residue limits. If maximum 
limits have not been established at the time of approval of the active substance through 
a request by the Commission or a Member State (Article 9 of Reg. 470/2009), or if such 
limits  require  amendment,  then  the  maximum  residue  limits  must  be  established  after 
an  application  to  the  European  Medicines  Agency  according  to  Articles  3  and  8  of  Reg. 
470/2009. 

b) 
Article 14 on classification of pharmacologically active substances  
Pharmacologically  active  substances  must  be  classified  by  the  Commission  according  to 
their maximum residue limits. The list must also contain information on the therapeutic 
classes to which they belong, while the maximum limits must be expressed in relation to 
specific foods or species. Consignments of certain products may be imported into the EU 
provided  they  are  accompanied  by  analytical  results  of  official  sample  tests,  aimed  at 
detecting  the  presence  of  certain  substances,  indicating  they  are  safe  for  human 
consumption.  If  residues  of  pharmacologically  active  substances  are  present,  either 
classified  according  to  Article  14  of  Reg.  470/2009  and  above  the  maximum  residue 
limits, or not classified under Article 14, these must be notified to the Commission under 
RASFF.  Commission  Decision  2010/381/EU  lays  down  emergency  measures  for 
aquaculture products imported from India and intended for human consumption. 

Article 23 on placing on the market 

c) 
Article 23 of Regulation 470/2009 indicates that food of animal origin containing residues 
of  pharmacologically  active  substances  at  levels  exceeding  the  maximum  specified,  or 
exceeding  the  reference  points  for  action  where  such  have  been  established,  must  be 
considered  as  non-compliant  with  Reg.  470/2009.  Commission  Decision  2008/630/EC 
establishes  emergency  measures  for  crustaceans  imported  from  Bangladesh  and 
intended  for  human  consumption.  These  can  be  placed  on  the  market  provided  the 
requirements of Article 23 of Reg. 470/2009 are met. 

176 

 
 
 
 
 
 
 
 
Article 27 on classification of pharmacologically active substances 

d) 
under Regulation 2377/90 
Article  23  of  Regulation  470/2009  requires  the  Commission  to  adopt  a  Regulation 
incorporating  pharmacologically  active  substances  and  their  classification  based  on  the 
maximum  residue  levels  as  established  under  Reg.  2377/90.  This  requirement  is 
implemented  by  Regulation  37/2010  on  pharmacologically  active  substances  and  their 
classification regarding maximum residue limits in foodstuffs of animal origin. 

177 

 
 
 
Annex  XIII:  Additional  implementing  measures  for  selected 
Articles  of  Directive  96/23/EC  and 
respective 
requirements 

their 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  96/23/EC  and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Articles 3-8 on monitoring plans for the detection of residues of 

a) 
substances 
Articles  3-8  of  Directive  96/23/EC  lay  down  the  requirements  for  the  establishment  of 
monitoring  plans  in  the  Member  States  in  order  to  detect  the  presence  of  residues  and 
substances in animals and animal products. Council Decision 2011/408/EU on simplified 
rules  and  procedures  on  sanitary  controls  of  fishery  products,  live  bivalve  molluscs, 
echinoderms,  tunicates,  marine  gastropods,  by-products  thereof  and  products  derived 
from  these  by-products  from  Greenland,  requires  Greenland  and  Denmark  to  submit 
their  monitoring  plans  for  the  detection  of  residues  and  substances  in  aquaculture 
animals  in  Greenland  to  the  Commission,  in  accordance  with  the  requirements  of 
Directive 96/23/EC. 

Article  5  of  Directive  96/23/EC  requires  the  Member  States  to  submit  monitoring  plans 
and the national measures in place in order to detect groups of residues of substances in 
different  animals.  Several  Commission  Decisions  have  been  published  approving  the 
monitoring  plans  presented  by  different  Member  States  (i.e.  Dec.  98/151/EC, 
98/152/EC, 98/390/EC).  

Article  8  of  Directive  96/23/EC  also  requires  Member  States  to  monitor  the  residues  of 
substances  in  animals  and  animal  products  and  to  communicate  the  results  to  the 
Commission. Commission Implementing Decision 2012/C 204/03 on the financing of the 
2012  work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal 
welfare  and  plant  health  provides  for  the  financing  of  certain  projects  supporting  the 
implementation of Directive 96/23/EC amongst others. Specifically this funding is aimed 
at supporting the creation and maintenance of IT tools for the successful implementation 
of the monitoring requirements of the official controls and for the purposes of Directive 
96/23/EC  the  residue  monitoring  plans.  In  the  same  context  Implementing  Decisions 
2013/C  127/03  and  2014/C  72/05  provide  for  similar  financing  for  the  2013  and  2014 
work programmes. 

Article 11 on official control measures 

b) 
Article 11 of Directive 96/23/EC allows Member States to conduct official random checks 
aimed  at  detecting  the  possession  or  presence  of  prohibited  substances  during  the 
manufacture,  handling,  storage,  distribution  or  sale  of  substances  with  anabolic  effects 
and  of  unauthorised  substances,  as  well  as  during  the  production  and  distribution  of 
animal  feed  and  during  the  production  of  animals  and  of  materials  of  animal  origin.  In 
case  of  positive  results  or  detection  of  fraud,  the  measures  established  in  the  Directive 
shall  apply.  Directive  96/22/EC  on  the  prohibition  of  use  in  stockfarming  of  substances 
with  hormonal  or  thyrostatic  action  implements  that  in  addition  to  the  official  controls 
relevant  to  the  placing  on  the  market  of  different  products,  the  above  official  random 
checks  of  Dir.  96/23/EC  should  aim  at  ensuring  that  prohibited  substances  listed  in  its 
Annexes  are  not  administered  to  animals  for  fattening  purposes  or  for illegal  treatment 

178 

 
 
 
 
 
 
and  that  the  correct  withdrawal  times  and  restrictions  of  use  in  the  case  of  use  for 
therapeutic  purposes  of  for  zootechnical  treatment  are  being  observed.  Also  Directive 
96/22/EC  requires  that  the  drinking  water  of  animals,  the  places  where  they  are  kept, 
their body fluids, animal tissues and animal products are tested for the presence of the 
above  substances  in  accordance  with  Annexes  III  and  IV  to  Dir.  96/23/EC.  In  the  case 
infringements are identified, the above substances must be confiscated and the affected 
animals and their products placed under supervision while appropriate penalties must be 
implemented by the competent authority.  

In  a  broader  scope  and  for  the  purposes  of  covering  the  inspection  and  control  costs 
implemented  by  Dir.  96/23/EC,  Directive  85/73/EEC  on  the  financing  of  veterinary 
inspections  and  controls  indicates  that  a  Community  fee  must  be  collected.  Annex  B  to 
the  Directive  lays  down  the  procedure  for  establishing  this  fee  for  the  control  of  live 
animals and of products of animal origin. 

Article 14 on national reference laboratories 

c) 
Article  14  of  Directive  96/23/EC  requires  Member  States  to  designate  at  least  one 
national  reference  laboratory  for  the  detection  and  analysis  of  residues  and  lays  down 
their  responsibilities  and  the  requirement  that  a  specific  residue  or  residue  group  may 
not be assigned to more than one laboratory. A list of these laboratories is provided by 
Commission Decision 98/536/EC. 

Article 15 on official samples 

d) 
Article  15  of  Directive  96/23/EC  indicates  that  the  Commission  must  establish  detailed 
rules for the taking of official samples, as well as for the routine and reference methods 
used  for  the  analysis  of  these  samples.  Commission  Decision  2002/657/EC  implements 
Dir.  96/23/EC  with  regard  to  the  performance  of  analytical  methods  and  the 
interpretation  of  the  results  obtained  from  the  official  samples.  Specific  values  are 
established  for  the  α  error  for  substances  having  anabolic  effect  and  for  unauthorised 
substances (of Annex I of Dir. 96/23/EC), while a different value is specified for all other 
substances.  The  Decision  also  specifies  timelines  for  compliance  with  its  provisions  for 
the  different  substances  listed  in  Annex  I  of  Dir.  96/23/EC  and  some  criteria  for 
analytical  techniques  that  can  be  used  for  screening  purposes.  The  Decision  also 
specifies a system of identification points that can be used to interpret the data obtained 
for  different  substances  listed  in  Annex  I  of  the  Directive,  when  mass  fragments  are 
measured without using full-scan techniques. 

Article 16 on positive results 

e) 
Article 16 of Directive 96/23/EC indicates that where positive results are obtained during 
the  examination  of  official  samples,  details  of  the  non-conformance  must  be  obtained 
and  an  investigation  must  be  carried  out  by  the  competent  authority.  Article  24  of 
Regulation  470/2009  requires  similar  investigations  and  action  to  be  taken  in  case  of 
analytical  results 
the  presence  of  prohibited  or  non-authorised 
pharmacologically active substances. 

that  confirm 

Article 29 on imports from third countries 

f) 
Article 29 of Directive 96/23/EC indicates that the inclusion and retention in the lists of 
third  countries  from  where  the  import  of  animals  and  animal  products  is  authorised  is 
subjected  to  the  submission  of  a  plan  setting  guarantees  relevant  to  the  monitoring  of 
certain groups of substances and their residues of at least equivalent effect to those laid 

179 

 
 
 
 
 
 
 
down  in  the  Directive.  The  inclusion  in  the  list  may  be  suspended  in  case  of  non-
compliance  with  the  Directive's  requirements.  Directive  97/78/EC  on  the  principles  for 
the organisation of veterinary checks in products entering from third countries indicates 
that in case of serious or repeated infringements of the Community veterinary legislation 
by  third  countries  that  have  been  granted  equivalence  agreements  and  thus  their 
consignments  are  checked  less  frequently,  the  Commission  must  cease  these  benefits 
until measures and corrective actions have been taken. 

In  the  same  context,  Commission  Decision  2011/163/EU  on  the  approval  of  plans 
submitted by third countries in accordance to Article 29 of Dir. 96/23/EC lays down some 
special rules for third countries that use raw material imported from other third countries 
and  cannot  provide  a  residue  monitoring  plan  equivalent  to  the  one  requested  by  Dir. 
96/23/EC. Special statements that must accompany the plan are also provided. 

Annex III of Directive 96/23/EC on sampling strategy 

g) 
Annex  III  of  Directive  96/23/EC  lays  down  provisions  for  the  sampling  strategy  for  the 
residue control plan. Commission Decision 98/179/EC lays down detailed rules on official 
sampling for the monitoring of certain substances and their residues in live animals and 
animal  products.  It  indicates  that  sampling  must  be  unforeseen  and  unexpected  and 
must  take  place  at  different  times  during  the  year  (considering  that  certain  substances 
are  more  likely  to  be  administered  at  specific  times  of  the  year),  at  different 
establishments  such  as  farms,  slaughterhouses,  dairies,  fish  processing  plants  and  egg 
collecting and packing stations. 

Annex IV of Directive 96/23/EC on sampling levels and frequency 

h) 
Annex  IV  to  Directive  96/23/EC  lays  down  the  sampling  levels  and  frequencies  for  the 
detection  of  certain  substances  in  different  animals  and  animal  products.  Decision 
97/747/EC  fixing the levels  and  frequencies  of  sampling  provided  for  by  Dir.  96/23/EC, 
supplements the ones set out in Annex IV to the Directive. 

Annex  IV  of  Directive  96/23/EC  lays  down  provisions  with  regard  to  the  minimum 
number  of  animals  that  must  be  sampled  for  the  detection  of  one  or  more  substances. 
Commission Decisions allow for financial aid from the Community to the Member States 
for  the  operation  of  certain  Community  reference  laboratories  in  the  veterinary  field 
undertaking analysis for the detection of residues of certain substances in certain animal 
products (98/587/EC, 1999/760/EC). 

Chapter 2 of Annex IV lays down specific requirements for the following animals: broiler 
chickens,  spent  hens,  turkeys  and  other  poultry.  In  order  to  perform  the  monitoring 
tasks  laid  down  within  this  Chapter  for  the  detection  of  residues  of  certain  substances, 
the  Commission  grants  specific  financial  assistance  to  specific  Institutes  through 
Commission  Decisions  (i.e.  2004/142/EC  for  the  year  2004,  2005/161/EC  for  the  year 
2005, 2006/195/EC, 2009/863/EC, 2010/736/EU). 

Extended scope of Directive 96/23/EC 

i) 
Directive  96/23/EC  lays  down  provisions  for  the  monitoring  of  certain  substances  and 
their  residues  in  animals  and  animal  products  and  also  some  requirements  for  the 
authorisation  of  veterinary  medicinal  products  for  species  intended  for  human 
consumption.  

Directive  97/78/EEC  on  the  principles  for  organisation  of  veterinary  checks  on  products 
from third countries allows  for derogation and less frequent checks for  certain products 

180 

 
 
 
 
 
 
for  which  import  conditions  have  been  harmonised  and  which  originate  from  third 
countries  that  offer  satisfactory  health  guarantees.  Products  must  also  come  from 
approved  establishments  with  already  issued  certificates  and  a  report  must  have  been 
submitted to the Standing Veterinary Committee beforehand, taking into account a list of 
requirements  including  the  rules  for  authorisation  of  substances  of  Directives  96/22/EC 
and 96/23/EC. Directive 97/78/EEC also requires that each consignment originating from 
a  third  country  is  subjected  to  veterinary  checks  at  the  border  inspection  posts.  More 
detailed rules for these checks are laid down by Commission Decision 2005/34/EC laying 
down  harmonised  standards  for  the  testing  for  certain  residues  in  products  of  animal 
origin imported from third countries. More specifically, when the presence of residues of 
substances  for  which  minimum  required  performance  limits  have  been  established  in 
imported  products  of  animal  origin  by  Decision  2002/657/EC  is  confirmed  by  the  tests 
carried  out  under  Directive  97/78/EEC,  Decision  2005/34/EC  lays  down  the  reference 
points for action and the action to be taken once non-compliance has been confirmed. 

Regulation  1257/1999 lays  down  provisions  for  support  for  rural  development  from  the 
EAGGF.  The  Regulation  however  excludes  from  such  financial  support  producers,  the 
animals  of  which have  been  found  positive  to  substances  unauthorised  or  illegally  used 
according  to  the  requirements  of  Directives  96/23/EC  and  96/22/EC,  or  when  the 
producers  obstruct  the  inspections  carried  out  according  to  the  provisions  of  the  two 
Directives.  

Regulation 252/2012 lays down methods of sampling and analysis for the official control 
of  levels  of  dioxins  and  dioxin-like  PCBs  and  non-dioxin-like  PCBs  in  certain  foodstuffs. 
Annex  II  specifies  the  sampling  methods  and  the  sampling  plans.  With  regard  to  the 
number  of  incremental  samples  and  in  accordance  with  the  provisions  of  Decision 
97/747/EC  (fixing  the  levels  and  frequencies  of  sampling  provided  for  by  Directive 
96/23/EC), the aggregate sample size for hen eggs must be at least 12 for both bulk lots 
and lots consisting of individual packages.  

Regulation  1069/2009  lays  down  health  rules  for  animal  by-products  and  derived 
products not intended for human consumption. The Regulation specifies that products of 
animal  origin  in  which  substances  are  detected  in  breach  of  Dir.  96/3/EC  should  be 
classified as Category 1 or 2 products depending on the risk they pose to the  food and 
feed  chain.  Specifically,  by-products  from  animals  that  have  been  subjected  to  illegal 
treatment and by-products that contain residues of other substances and environmental 
contaminants  as  listed  in  Annex  I  to  Dir.  96/23/EC,  exceeding  the  permitted  levels 
established  by  Community  or  national  provisions,  can  be  categorised  as  Category  1 
products. Animal by-products exceeding the permitted levels of authorised substances or 
contaminants of Article 15 of Dir. 96/23/EC must be classified as Category 2 materials. 

Regulation  142/2011  implementing  Regulation  1069/2009  allows  for  the  use  of  certain 
animal  products  that  have  been  submitted  to  illegal  treatments  according  to  Dir. 
96/23/EC  under  specific  conditions.  Also  Annex  XII  to  Regulation  142/2011  allows  for 
the  import  and  transit  of  intermediate  products  destined  for  the  production  of  medical 
devices  and  derived  from  animal  products  subjected  to  illegal  treatment  for  use  in  in 
vitro diagnostic medical devices and laboratory reagents.   

Commission  Regulation  1266/2007  lays  down  implementing  rules  for  Directive 
2000/75/EC regarding the control, monitoring, surveillance and restrictions of movement 
of  certain  animals  and  of  susceptible  species  in  relation  to  bluetongue.  Annex  IV  lays 
down  specific  criteria  for  the  competent  authorities  to  consider  for  the  purpose  of 
designating  certain  slaughterhouses  for  exemption  from  the  exit  ban  and  used  for 
channelling the movement of animals from a holding in a restricted zone for immediate 
slaughter,  based  on  a  risk  assessment.  One  of  these  criteria  is  the  possible  use  of 
insecticides and repellents in compliance with Directive 96/23/EC. 

181 

 
 
 
Regulation 396/2005 lays down maximum residue levels of pesticides in or on food and 
feed of plant and animal origin. The Regulation requires EFSA to draw up annual reports 
on  pesticide  residues  based  on  the  information  provided  by  the  Member  States.  The 
Regulation  also  specifies  the  minimum  information  that  must  be  contained  in  these 
reports,  which  among  others  includes  an  assessment  of  the  exposure  of  consumers  to 
pesticide  residues  based  on  the  results  of  the  official  controls  performed,  as  well  as  on 
the results originating from the controls performed under Directive 96/23/EC. 

182 

 
 
 
 
 
 
implementing  measures  for 
Annex  XIV:  Additional 
selected  Articles  of  Directive  96/22/EC  and  their 
respective requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  96/22/EC  and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 1 of Directive 96/22/EC 

a) 
Article  1  of  Directive  96/22/EC  lays  down  certain  definitions,  one  of  which  is 
"zootechnical  treatment".  Council  Directive  98/58/EC  on  the  protection  of  animals  kept 
for farming purposes indicates that no other substances may be given to animals except 
of those that have a therapeutic or prophylactic effect or for the purposes of zootechnical 
treatment, unless they have no detrimental effect to the health or welfare of the animal. 

Article  1  also  provides  a  definition  for  "illegal  treatment".  Regulation  1069/2009  laying 
down health rules for animal by-products and derived products not intended for human 
consumption  indicates  that  animal  by-products  from  animals  subjected  to  illegal 
treatment defined as above must be considered as Category 1 material for the purposes 
of  Reg.  1069/2009.  Also  Commission  Regulation  142/2011,  implementing  Regulation 
(EC) No 1069/2009  on health rules related to  animal by-products and derived products 
not  intended  for  human  consumption  and  implementing  Council  Directive  97/78/EC  as 
regards  certain  samples  and  items  exempt  from  veterinary  checks  at  the  border  under 
that  Directive,  allows  for  the  use  of  material  that  has  gone  through  "illegal  treatment" 
under  the  above  meaning  to  be  used  in  certain  products  not  for  human  consumption 
under specific conditions.  

Articles 3 and 4 of Directive 96/22/EC 

b) 
Articles  3  and  4  of  Directive  96/22/EC  prohibit  the  use  of  certain  substances  in  farm 
animals.  Commission  Regulation  1272/2009  lays  down  rules  for  the  implementation  of 
Regulation  1234/2007  with  regards  to  the  buying  and  selling  of  agricultural  products 
under  public intervention,  according  to  which  the  conditions  and  controls  for  the  taking 
over  of  beef  require  the  absence  of  substances  mentioned  in  the  above  Articles  of  Dir. 
96/22/EC  which  must  be  verified  by  analysis  of  samples  according  to  the  relevant 
provisions. 

Article 6 of Directive 96/22/EC 

c) 
Article 6 of Directive 96/22/EC lays down provisions for the administration of substances 
with hormonal effects and beta-agonists. These substances must meet the requirements 
of  Dir.  2001/82/EC  (on  Community  code  for  veterinary  medicinal  products).  Directive 
97/78/EC on the principles for the organisation of veterinary checks in products entering 
from  third  countries  allows  for  derogations  to  be  granted  by  the  Commission  for  less 
frequent physical checks under specific conditions, provided a report has been previously 
submitted  to  the  Standing  Veterinary  Committee  taking  into  account  the  rules  on  the 
authorisation of substances in the third country and the compliance to the requirements 
of Article 6 above.  

This  Article  also  lays  down  certain  prohibitions  of  use  of  such  substances,  some  also 
related to withdrawal periods. Directive 96/23/EC indicates that the official veterinarian 

183 

 
 
 
 
 
 
 
of  a  slaughterhouse  may  postpone  the  slaughter  of  animals,  if  he  suspects  that  the 
withdrawal  periods  have  not  been  accurately  followed,  by  a  period  that  should  not  be 
less  than  the  ones  specified  in  Article  6  above,  or  the  ones  of  the  marketing 
authorisation of the products. 

Article 11 of Directive 96/22/EC 

d) 
Article  11  lays  down  the  requirement  for  Member  States  to  prohibit  imports  from  third 
countries  of  farm  or  aquaculture  animals  and  meat  and  meat  products  that  have  been 
administered  with  substances  that  fall  under  the  scope  of  this  Directive.  Directive 
96/23/EC implements that third countries, in order to be included in the list of countries 
from where animals and animal products may be imported, must submit a plan covering 
their  guarantees  for  the  monitoring  of  residues  of  substances  included  in  the  Annex; 
these must have an at least equivalent effect to the requirements of Article 11 above. 

Extended scope of Directive 96/22/EC 

e) 
Regulation  1257/1999 lays  down  provisions  for  support  for  rural  development  from  the 
European Agricultural Guidance and Guarantee Fund (EAGGF). However, in case animals 
are found positive to substances unauthorised or illegally used under Directive 96/22/EC 
or when such substances are present in the producers' premises, the producer must be 
excluded from such financial support.  

Commission  Decision  2006/27/EC  on  special  conditions  governing  meat  and  meat 
products  of  equidae  imported  from  Mexico  and  intended  for  human  consumption 
indicates  that  Member  States  must  ensure  that  every  consignment  of  meat  or  meat 
products  of  equidae  is  compliant  with  the  requirements  of  Directive  96/22/EC  for 
substances  with  hormonal  action  and  beta-agonists  through  appropriate  sampling  and 
detection measures. 

Commission  Regulation  37/2010  lays  down  pharmacologically  active  substances  and 
their  classification  regarding  maximum  residue  limits  in  foodstuffs  of  animal  origin. 
Included  in  the  list  are  certain  substances  that  may  only  be  used  for  specific 
therapeutical  or  zootechnical  purposes  in  accordance  with  the  provisions  of  Directive 
96/22/EC. 

Regulation  1306/2013  on  the  financing,  management  and  monitoring  of  the  Common 
Agricultural Policy (CAP) indicates that the requirements of Directive  96/22/EC (Articles 
3, 4, 5 and 7) are considered as Statutory Management Requirements in the area of food 
safety  in  the  field  of  public  health,  animal  and  plant  health  under  the  rules  of  cross-
compliance  of  Article  93  of  the  Regulation  for  beneficiaries  receiving  direct  payments 
under the scope of this Regulation. 

184 

 
 
 
 
 
 
 
 
 
 
Annex  XV:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  852/2004  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of Reg. 852/2004 and provide 
details of regulatory documents that add requirements or assist in the implementation of 
the main Regulation. 

Article 4 on general and specific hygiene requirements 

a) 
Article 4 of Regulation 852/2004 lays down specific hygiene requirements one of which is 
the compliance of food business operators with the microbiological criteria for foodstuffs. 
Commission  Regulation  2073/2005  lays  down  the  microbiological  criteria  for  certain 
microorganisms as well as implementing rules for the food business operators. Operators 
are  also  required  to  conduct  studies  for  the  compliance  of  their  products  with  the 
microbiological  criteria  throughout  their  shelf-life.  Reg.  2073/2005  indicates  that  these 
may be conducted in accordance with guidelines included in guides to good practice, as 
per Article 7 of Reg. 852/2004.  

Article  4  also  indicates  that  more  specific  hygiene  criteria,  requirements  and  targets 
must  be  established  by  the  Commission.  In  that  respect,  Regulation  1086/2011 
establishes  specific  measures  for  salmonella  in  fresh  poultry  meat  and  poultry  carcases 
and  provides  sampling  rules  and  guidelines,  amending  Regulations  2160/2003  on  the 
control  of  salmonella  and  other  specific  food-borne  zoonotic  agents  and  2073/2005  on 
microbiological criteria for foodstuffs. 

Article 6 on official controls, registration and approval 

b) 
Article  6  of  Regulation  852/2004  requires  that  food  business  operators  cooperate  with 
the competent authorities and notify them on the establishments where food production, 
processing  and  distribution  is  carried  out  for  the  purposes  of  registration  and  approval 
after  on-site  visit  confirms  they  are  compliant  with  the  food  hygiene  requirements. 
Article 31 of Regulation 882/2004 on official controls for compliance with feed and food 
law,  animal  health  and  animal  welfare  lays  down  requirements  for  the  registration  and 
approval (conditional or full) of food establishments and recommends the draw up of an 
up-to-date  relevant  list.  Also  there  are  provisions  for  the  withdrawal  or  suspension  of 
establishment  approvals.  In  the  same  context,  Article  4  of  Reg.  853/2004  on  specific 
hygiene  measures  for  food  of  animal  origin  implements  that  animal  products  may  only 
be placed on the market if they are registered with the Competent  Authority under the 
requirements of Reg. 852/2004. 

Also  under  the  scope  of  Article  6  of  Reg.  852/2004,  Regulation  210/2013  (EU,  2013a) 
implements the requirement for approval of the establishments that produce sprouts by 
the  competent  authorities,  provided  they  comply  with  the  requirements  of  Annex  I  of 
Reg.  852/2004  as  well  as  with  the  requirements  established  in  the  Annex  of  this 
Regulation on the design, layout, facilities, washing sinks, equipment and procedures. 

Article 8 on national guides 

c) 
Article 8 of Reg. 852/2004 encourages the voluntary development of national guides for 
the  application  of  HACCP  and  good  practice  in  food  hygiene  by  food  business  sectors. 
Article  3  of  Reg.  589/2008  on  the  implementation  of  Regulation  1234/2007  regarding 
the  marketing  standards  for  eggs,  encourages  the  development  of  national  guides  for 

185 

 
 
 
 
 
 
 
the application of good practice by food business operators in egg-washing systems. This 
is  addressed  to  Member  States  which  authorised  egg-washing  in  packing  centres  on  1 
June 2003, provided that they operate in accordance with the national guides. 

Article 9 on Community guides 

d) 
Article 9 of Reg. 852/2004 allows for preparation of Community Guides on good practice 
for the hygiene and application of HACCP principles. Notice 2012/C 8/06 publishes a list 
of  approved  guides  on  the  hygiene  of  foodstuffs  after  assessment  by  the  Standing 
Committee of Food Chain and Animal Health. 

Articles 10 and 11 on imports and exports 

e) 
Articles 10 and 11 of Reg. 852/2004 refer to the hygiene requirements of imported and 
exported foodstuffs. The requirements of Article 3-6 of this Regulation must be fulfilled, 
as  well  as  the  relevant  requirements  of  food  law  referred  in  Articles  11  and  12  of 
Regulation 178/2002 for imports or exports respectively. 

Article 12 on Transitional measures 

f) 
Article 12 of Regulation 852/2004 allows for the implementation of additional transitional 
measures and further specifications on the requirements of the Regulation. The following 
Decisions have been implemented under this Article: 

-  Commission  Decision  2009/852/EC  which  lays  down  transitional  measures  for  the 
processing  of  non-compliant  raw  milk  in  certain  milk  processing  establishments  in 
Romania and the structural requirements for these establishments. 

-  Decision  2010/89/EC  which  establishes  transitional  measures  for  specific  structural 
requirements  for  establishments  for  meat,  fishery,  egg  products  and  cold  stores  in 
Romania.  The  country  is  also  requested  to  submit  a  report  with  the  progress  made  by 
the  above  establishments  in  implementing  the  specific  requirements.  Until  then, 
products  may  only  be  placed  in  the  Romanian  market  and  must  bear  a  health  or 
identification mark different from the one of Regulation 853/2004. 

Also Regulation 2073/2005 on microbiological criteria for foodstuffs allows for derogation 
in the compliance with the values for Salmonella in minced meat, meat preparations and 
meat products as established in Annex I of the Regulation for a specific Member State. 

g) 
Article 13 on amendment and adaptation of Annexes I and II 
Article  13  (2)  of  Regulation  852/2004  allows  for  derogations  from  Annexes  I  and  II  of 
the Regulation in order to help small businesses into incorporating the HACCP principles 
provided the objectives of the Regulation can still be met. Regulation 2074/2005 allows 
for  specific  derogations  for  foods  with  traditional  characteristics  with  regards  to  the 
rooms  where  the  foodstuffs  are  prepared  so  that  they  can  develop  their  particular 
characteristics, the type of materials from which the equipment and utensils used for the 
manufacture  of  the  products  are  made  and  the  cleaning  and  disinfectant  measures. 
These derogations must be notified to the Commission and the other Member States. 

186 

 
 
 
 
 
 
 
 
Annex I of Regulation (EC) No 852/2004 on primary production 

h) 
Part A, III of Annex I of Regulation 852/2004 lays down requirements for record-keeping 
relevant  to  the  general  hygiene  provisions  for  primary  production  and  associated 
operations.  In  line  with  these  requirements,  Annex  II  of  Regulation  853/2004  on  food 
chain  information  requires  food  business  operators  of  slaughterhouses  to  only  accept 
animals  in  the  slaughterhouse  after  they  have  requested,  received,  checked  and  acted 
upon this information from the records of the establishment of origin at least 24 hours in 
advance. 

Also  in  the  same  context,  Article  20  of  Reg.  589/2008  on  the  implementation  of 
Regulation  1234/2007  regarding  the  marketing  standards  for  eggs,  lays  down 
requirements  with  regards  to  record-keeping  by  producers.  When  there  is  an indication 
of the feed used for the laying hens on the pack of eggs, then the producers must keep 
records  of  the  type  and  quantity  of  feed  supplied  or  mixed  on  the  site  and  the  date  of 
delivery of the feed. 

Annex II, Chapter II of Regulation (EC) No 852/2004  

i) 
Chapter  II  of  Annex  II  of  Regulation  852/2004  lays  down  requirements  for  the  rooms 
where  foodstuffs  are  prepared,  treated  or  processed.  Due  to  the  difficulties  for  certain 
establishments  in  Bulgaria  and  Romania  to  meet  the  structural  requirements  of  this 
Regulation, Commission Decisions provide for some transitional measures: 

- Decision 2007/716/EC: certain establishments in Bulgaria are exempt from the above 
structural  requirements  until  a  specified  date.  Products  may  only  be  placed  in  the 
domestic  market  and  must  bear  a  health  mark  different  than  the  one  specified  by 
Regulation 853/2004. 

-  Decision  2007/27/EC:  provides  a  list  of  establishments  in  Romania  that  meet  the 
requirements  of  Reg.  852/2004  and  may  process  "non-compliant"  milk  as  per  Reg. 
853/2004. Products however may only be placed in the domestic market and must bear 
a different health mark than the one specified by Regulation 853/2004. 

Annex II, Chapter X of Regulation (EC) No 852/2004  

j) 
Chapter  X  of  Annex  II  of  Reg.  852/2004  lays  down  requirements  for  the  wrapping  and 
packaging  of  foodstuffs.  Article  17  of  Reg.  589/2008  on  the  implementation  of 
Regulation 1234/2007 regarding the marketing standards for egg provides specifications 
for the quality of packaging for eggs. Egg packs must be shock-resistant, dry, clean, in 
good  condition  and  the  materials  they  are  made  of  must  protect  the  eggs  from 
extraneous odours and of other quality deterioration. 

Annex II, Chapter XI of Regulation (EC) No 852/2004  

k) 
Chapter XI of Annex II of Reg. 852/2004 lays down requirements for the heat treatment 
of foodstuffs and for the monitoring of the process. Annex III, Section IX, Chapter II of 
Regulation 853/2004 lays down additional specifications for the heat  treatment of dairy 
and colostrum-based products. 

Extended scope of Regulation (EC) No 852/2004 

l) 
Several  of  the  legal  texts  under  Article  53  of  Regulation  178/2002  on  emergency 
measures for food and feed also refer to the hygiene Regulation 852/2004. 

187 

 
 
 
 
 
 
 
Regulation  1187/2009  establishes  detailed  rules  for  the  application  of  Regulation 
1234/2007  as  regards  export  licences  and  export  refunds  for  milk  and  milk  products. 
Article 3 of the Regulation specifies that for  export  refunds to be granted, the products 
must  meet  the  requirements  of  Regulations  852/2004  and  853/2004  and  specifically 
preparations  in  an  approved  establishment  and  compliance  with  the  identification 
marking requirements. 

Regulation  No  1069/2009  lays  down  health  rules  for  animal  by-products  and  derived 
products  not  intended  for  human  consumption.  Products  from  fishing vessels  compliant 
with  Regulations  852/2004  and  853/2004  are  excluded  from  the  scope  of  this 
Regulation, unless the fish material shows signs of disease or parasites transmissible to 
humans.  Also  establishments  producing  animal  by-products  that  are  registered  or 
authorised  in  accordance  with  Regulations  852/2004  and  853/2004  do  not  need  any 
further notification to the Authorities, while registered food businesses should carry  out 
treatment,  processing  and  storage  of  animal  by-products  in  such  a  way  as  to  avoid 
cross-contamination or in separate establishments.  

Decision  2000/572/EC  lays  down  the  animal,  public  health  and  veterinary  certificate 
conditions for the import of meat preparations in the European Union. For such products 
to  be  imported,  the  requirements  of  Regulations  178/2000,  852/2004  and  853/2004 
must be met. The establishments where the products are produced must operate under 
the  principles  of  HACCP  (852/2004)  and  products  must  be  frozen  at  no  more  than  -
18˚C.  Requirements  are  also  established  with  regards  to  the  health  certificates  that 
must accompany all consignments of such products. 

Directive 2005/94/EC lays down Community measures for the control of avian influenza. 
Regulations 852/2004 and 853/2004 on the hygiene of foodstuffs can  be applied under 
certain conditions to the hygiene of eggs originating from establishments where poultry 
may  be  infected  with  the  avian  influenza.  The  competent  authority  may  authorise  the 
dispatch  of  eggs  from  holdings  where  an  influenza  outbreak  is  suspected  directly  to 
establishments  for  the  manufacture  of  egg  products  that  meet  the  requirements  of 
Regulation  853/2004  if  they  are  heat  treated  according  to  the  specific  conditions  of 
Chapter  XI  of  Annex  II  of  Reg.  852/2004.  Provisions  and  derogations  are  also 
established  for  eggs  originating  from  establishments  within  protection  and  surveillance 
zones as well as for eggs in relation to vaccination areas. The competent authorities may 
also  allow  for  derogations  for  establishments  where  an  influenza  outbreak  has  been 
confirmed  under  specific  conditions.  Based  on  Directive  2005/94/EC,  Commission 
Decision  2006/416/EC  establishes  transitional  measures  with  regards  to  highly 
pathogenic  avian  influenza  in  poultry  or  other  captive  birds  in  the  Community.  Similar 
provisions  are  also  laid  down  in  the  following  Decisions  in  specific  Member  States: 
Commission  Decision  2007/590/EC  introducing  preventive  vaccination  against  highly 
pathogenic  avian  influenza  and  related  provisions  for  movements  in  the  Netherlands; 
Commission Decision 2007/638/EC on emergency vaccination of poultry in Italy against 
low pathogenic avian influenza. 

Regulation  578/2010  on  the  implementation  of  Regulation  1216/2009  as  regards  the 
system  of  granting  export  refunds  for  certain  agricultural  products  exported  and  the 
criteria  for  fixing  the  amount  of  such  refunds  implements  that  refunds  may  only  be 
granted  for  certain  goods  if  they  comply  with  the  hygiene  requirements  of  Reg. 
852/2004,  as  well  as  with  the  requirements  for  the  establishments  and  the  hygiene 
marking of Regulation 853/2004. 

188 

 
 
 
Annex  XVI:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  853/2004  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of Reg. 853/2004 and provide 
additional  regulatory  documents  that  add  requirements  or  assist  in  the  implementation 
of this main text. 

Article 1 on the scope of the Regulation 

a) 
According  to  Article  1  of  Regulation  853/2004  the  provisions  of  this  Regulation  do  not 
apply  to  the  direct  supply  of  small  quantities  of  meat  of  poultry  and  lagomorphs 
slaughtered  on  the  farm  by  the  producer  to  the  final  consumer  or  to  local  retail 
establishments  directly  supplying  the  final  consumer.  Regulation  1079/2013  on 
transitional  measures  for  the  application  of  Regulations  853/2004  and  854/2004, 
implements derogation from the above provisions considering the additional burdens for 
small  producers  posed  by  the  limitation  of  supply  of  the  above  products  to  the  final 
consumer as fresh meat only. This applies until the end of validity of this Regulation on 
the 31st December 2016.  

Article 3 on the food business operators' obligations 

b) 
Article  3  of  Regulation  853/2004  lays  down  some  general  obligations  for  food  business 
operators. Specifically they must not use any substance other than potable water for the 
surface decontamination of products of animal origin unless it has been approved by the 
Commission. Also any conditions of use specified must be followed. Regulation 101/2013 
lays down provisions for the use of lactic acid for the reduction of microbiological surface 
contamination  of  bovine  carcases  under  specific  conditions.  Requirements  are  also 
established  in  order  to  ensure  that  the  applicable  food  hygiene  requirements  are  not 
compromised  by  this  treatment.  The  food  business  operators  are  required  to 
communicate the use of this treatment to the operators that receive the product and this 
communication must be documented. 

Article 4 on registration and approval of establishments 

c) 
Article  4  of  Regulation  853/2004  lays  down  requirements  for  the  registration  and 
approval  of  establishments  manufacturing  products  of  animal  origin.  Annex  IV  of 
Regulation 1308/2013 establishing a common organisation of the markets in agricultural 
products,  lays  down  requirements  for  the  classification  of  carcasses  of  bovine  animals 
aged  eight  months  or  more  on  the  Union  scale.  The  Regulation  requires  that 
slaughterhouses  approved  under  Article  4  above  ensure  that  the  above  products 
slaughtered  in  such  establishments  and  bearing  a  health  mark  in  accordance  with  the 
Reg. 854/2004 are classified and identified in accordance with the Union scale. 

Regulation  543/2008  lays  down  detailed  rules  for  the  application  of  Reg.  1234/2007 
(now  repealed  by  Regulation  1308/2013)  as  regards  marketing  standards  for  poultry-
meat.  It is required that the registration number  of the  slaughterhouse or cutting plant 
according  to  Article  4  of  Reg.  853/2004  appears  on  the  packaging  of  pre-packaged 
poultry-meat, or a label attached to it, unless cutting and boning takes place at the point 
of sale. 

189 

 
 
 
 
 
 
 
 
Article 5 on health and identification marking 

d) 
Article 5 of Regulation 853/2004 implements that products of animal origin handled in an 
establishment  under  approval  may  not  be  placed  on  the  market  unless  it  has  either  a 
health mark (according to Reg. 854/2004) or an identification mark (according to Annex 
II, Section I of Reg. 853/2004). Article 16 of Regulation 2075/2005 on specific rules on 
official  control  for  Trichinella  in  meat  requires  that  where  the  trichinoscopic  method  is 
used, the competent authority must ensure that the health mark used on the products is 
clearly different than the one provided in Regulation 853/2004 and the meat is supplied 
directly  to  the  final  consumer  or  to  the  establishment  supplying  directly  the  final 
consumer and that the  meat is not used  for products where the manufacturing process 
does not kill Trichinella. 

Implementing Decision 2013/764 on animal health control measures relating to classical 
swine  fever  in  certain  Member  States  lays  down  measures  to  prevent  the  spread  of 
swine  fever.  Pig  meat  and  meat  preparations  at  risk  of  swine  fever  should  be  marked 
with  special  marks  that  cannot  be  confused  with  the  identification  mark  provided  by 
Regulation 853/2004. Also the health mark used for fresh pig meat at risk of swine fever 
should  be  clearly  different  than  the  health  mark  provided  by  Regulation  854/2004. 
Similar  Decisions  implement  precautionary  measures  in  different  Member  States,  for 
example  Dec.  2007/314/EC,  or  Dec.  2011/508  on  protection  measures  in  Lithuania. 
Decision  2013/764  also  requires  that  products  containing  pig  meat  originating  from 
establishments  from  certain  areas  in  Bulgaria,  Croatia,  Latvia  and  Romania,  are  only 
dispatched  to  other  Member  States  if  there  are  guarantees  that  they  are  not  at  risk  of 
swine fever. In any other case, products must be marked with different marks from the 
identification and health marks of Regulations 853/2004 and 854/2004. 

Directive 92/119/EEC introduced Community measures for the control of certain animal 
diseases and specifically for swine vesicular disease. Meat originating from holding where 
the  disease  was  detected  and  which  have  been  decontaminated  may  be  placed  on  the 
market  if  it  is  marked  with  an  identification  mark  which  is  different  from  the  one  of 
Directive  2002/99/EC  (on  animal  health  rules  covering  the  production,  processing, 
distribution  and  introduction  of  products  of  animal  origin  for  human  consumption)  and 
different from the one of Reg. 853/2004. The code of the approved country as well as of 
the approved establishment must feature on this identification mark. 

Commission  Decision  2007/30/EC  lays  down  transitional  measures  for  the  marketing  of 
products of animal origin from Bulgaria and Romania obtained until the 31st of December 
2006.  Such  products  can  be  placed  on  the  domestic  market  bearing  the  national  mark 
until  the  31st  of  December  2007.  The  above  products  may  also  be  traded  in  other 
Member  States  until  the  above  date,  provided  they  are  produced  in  establishments 
authorised  to  supply  the  Community,  they  bear  the  Community  health  or  identification 
mark  according  to  Regulation  853/2004  and  they  are  accompanied  by  a  document 
certifying  "Produced  before  1  January  2007,  in  conformity  with  Commission  Decision 
2007/30/EC". 

e) 
Article 6 on products of animal origin from outside the Community 
Article  6  of  Regulation  853/2004  implements  specific  conditions  for  the  import  in  the 
Community  of  products  of  animal  origin  from  third  countries.  Products  may  only  be 
imported if they originate from a country that appears in the list of approved countries, if 
the  establishment  (or  slaughterhouse,  or  production  area)  appears  on  the  relevant 
permitted  lists  and  if  the  product  meets  the  requirements  of  Regulations  852/2004, 
853/2004,  854/2004,  the  health  marking  requirements  and  any  other  import  control 
conditions  established  by  Community  legislation.  Products  must  be  accompanied  by 
specific  documents  certifying  compliance  with  the  above  Regulations  and  the 
requirements  for  these  documents  are  laid  down  in  Regulation  854/2004.  Further 

190 

 
 
 
 
completing  these  provisions,  Regulation  2074/2005  (on  implementing  measures  for 
certain  products  under  Regulation  853/2004)  provides  model  health  certificates  and 
documents for certain products of animal origin.  

Regulation  1079/2013  on  transitional  measures  for  the  application  of  Regulations 
853/2004 and 854/2004 excludes the application of the above provisions to products of 
animal  origin  for  which  there  are  no  public  health  import  conditions  established  at 
Community level. Such products may be imported according to the public health import 
conditions in place at the Member State of import. 

With  regards  to  the  import  of  fishery  products  under  Article  6(2)  of  Regulation 
853/2004,  provisions  are  established  by  Article  15  of  Regulation  854/2004.  Specifically 
for  products  imported  directly  from  a  fishing  or  freezer  vessel,  the  documentation 
required may be replaced by a document signed by the captain. This model document is 
provided in Appendix VII to Annex Vi of Regulation 2074/2005. 

Article 6(4) of Regulation 853/2004 lays down provisions for the import of products that 
contain  both  products  of  plant  origin  and  processed  products  of  animal  origin.  These 
products  must  satisfy  all  the  above  requirements.  Regulation  1079/2013  allows  for  an 
exemption  from  these  requirements  for  food  business  operators  that  import  such 
products,  unless  they  are:  composite  products  containing  processed  meat  products, 
processed  milk  products,  or  containing  half  or  more  of  their  substance  of  processed 
fishery  or  egg  products  (as  per  Article  3(1)  of  Regulation  28/2012  on  requirements  for 
certification for import into and transit through the Union of certain composite products). 
For  these  products  harmonised  Union  rules  apply  where  applicable,  or  national  rules  of 
the Member States. 

Article 8 on special guarantees 

f) 
Article  8  of  Regulation  853/2004  lays  down  special  guarantees  for  salmonella  in  meat 
and  egg  products  intended  for  placement  on  the  market  in  Finland  and  Sweden.  For 
eggs, packing centres must provide a guarantee that all consignments have been tested 
negative to specific microbiological tests. Regulation 1688/2005 lays down implementing 
measures  for  the  above  guarantees  of  Reg.  853/2004.  According  to  Article  4  the 
sampling  of  flocks  for  the  required  test  shall  be  carried  out  according  to  the  minimum 
sampling plans of Part B of Annex II of Regulation 2160/2003.  

Article 8 also specifies that the above provisions on any of the products covered by this 
Article  may  be  extended  wholly  or  partly  to  other  Member  States  that  have  control 
programmes  in  place  that  can  be  recognised  as  equivalent  to  those  of  Sweden  and 
Finland.  In  that  respect,  Implementing  Regulation  427/2012  extends  the  special 
guarantees concerning salmonella in eggs intended for Sweden and Finland of Regulation 
853/2004,  to  eggs  intended  for  Denmark.  The  sampling  of  the  flocks  as  well  as  the 
microbiological  testing  for  salmonella  must  be  carried  out  as  described  in  Regulation 
1688/2005 and the consignments must also be accompanied by a certificate as per this 
Regulation. 

Article 9 on transitional measures 

g) 
Article 9 of Regulation 853/2004 allows for transitional measures to be adopted in order 
to  supplement 
the  Regulation.  Commission  Decision  2009/861/EC  establishes 
transitional  measures  with  regard  to  milk  non-compliant  with  the  requirements  of 
Regulation  853/2004  originating  from  certain  establishments  in  Bulgaria,  provided  it  is 
only  used  or  further  processed  within  the  country.  Bulgaria  must  submit  reports  to  the 
Commission  on  the  progress  achieved  towards  meeting  the  requirements  of  Reg. 
853/2004.  Recent  Decision  2013/686/EC  amends  Decision  2009/861/EC  extending  the 

191 

 
 
 
 
 
dates  until  when  establishments  in  Bulgaria  may  continue  to  produce  non-compliant 
milk.  Further  provisions  are  implemented  indicating  the  target  annual  percentage 
reduction of establishments producing non-compliant milk that has to be met in Bulgaria. 
Also  Commission  Decision  2009/852/EC  lays  down  transitional  measures  for  the 
processing  of  non-compliant  raw  milk  in  certain  milk  processing  establishments  in 
Romania  and  structural  requirements.  Decision  2010/89/EC  establishes  transitional 
measures  for  specific  structural  requirements  for  establishments  for  meat,  fishery,  egg 
products and cold stores in Romania. 

Decision  2007/29  established  transitional  measures  for  animal  products  that  fall  under 
the  scope  of  Regulation  853/2004  but  do  not  meet  the  relevant  requirements  and  that 
were  released  for  free  circulation  in  Bulgaria  and  Romania  from  third  countries  before 
the  1st  of  January  2007.  These  products  could  be  placed  on  the  national  markets  until 
31st  December  2007,  bearing  the  national  mark  and  could  not  be  processed  in 
establishments  preparing  products  for  other  Member  States.  They  could  be  exported 
directly  to  third  countries  and  any  unused  quantities  on  the  1st  of  January  2008  were 
destroyed at the expense of the food business operator. Similar provisions to the above 
are  also  established  by  Implementing  Decision  2013/291/EC  for  products  of  animal 
origin introduced in Croatia from third countries before 1 July 2013. 

Regulation  (EC)  No  1079/2013  lays  down  transitional  measures  and  extends  the 
deadline  for  the  application  of  Regulations  853/2004  and  854/2004  from  the  beginning 
of 2014 until the end of 2016, repealing the previous Regulation 1162/2009. 

Also under Article 9, Regulation 798/2008 lays down a list of third countries, territories, 
zones  or  compartments  from  which  poultry  products  may  be  imported  into  and  transit 
through  the  Community  and  the  veterinary  certification  requirements.  Similarly, 
Regulation  119/2009  lays  down  conditions  for  the  import  into  or  transit  through  the 
European  Union  of  wild  leporidae,  certain  wild  land  mammals  and  of  farmed  rabbits  as 
well as a list of countries from where these products may be imported and the veterinary 
certification requirements. 

Regulation  No  (EU)  605/2010  lays  down  conditions  for  animal  and  public  health  and 
veterinary  certification  for  the  import  of  raw  milk  and  dairy  products  for  human 
consumption in the EU and establishes a list of countries from where such products can 
be  introduced.  Authorised  consignments  should  be  accompanied  by  a  health  certificate, 
drawn up and completed according to the instructions provided in the Regulation which 
certifies that the product meets the health requirements of Reg. 853/2004 and Directive 
2002/99/EC. 

Regulation  206/2010  lays  down  specific  veterinary  certification  requirements  for  the 
import  in  the  European  Union  of  ungulates,  bumble  bees  and  queen  bees  and  bumble 
bees and fresh meat and lists of third countries from where the above products may be 
introduced. 

Article 10 on amendment and adaptation of Annexes II and III 

h) 
Article  10  of  Regulation  853/2004  allows  for  amendments  and  adaptations  of  the 
Annexes  II  and  III  to  the  Regulation  in  order  to  take  into  account  guides  to  good 
practice,  experience  gained,  technological  developments,  consumer  expectations, 
scientific  advice,  microbiological  and  safety  criteria  for  foodstuffs  and  changes  in 
patterns  of  consumption.  Several  Regulations  have  been  adopted  under  this  Article 
amending  the  Annexes  to  Regulation  853/2004  (i.e.  Regs.  1243/2007,  558/2010, 
150/2011, 1276/2011, 786/2013). 

192 

 
 
 
 
 
Article 11 on specific decisions 

i) 
Article  11  of  Regulation  853/2004  allows  for  implementing  measures  and  amendments 
to the Annexes of the Regulation to be adopted on varying issues.  

In  that  respect,  freshness  criteria  and  limits  for  histamine  and  total  volatile  nitrogen 
need  to  be  established  for  fisheries  products.  These  are  provided  by  Annex  II  of 
Regulation 2074/2005 on implementing measures for certain products under Regulation 
853/2004 and include the obligations of the food business operators and details for the 
visual  inspection  of  fisheries  products,  the  obligations  of  the  competent  authorities  and 
the limits for total volatile nitrogen and relevant methods for analysis.  

Also  implementing  measures  according  to  Reg.  853/2004  are  required  on  recognised 
testing  methods  for  detecting  certain  marine  biotoxins.  These  analytical  methods  are 
also  implemented  by  Annex  III  to  Regulation  2074/2005  and  must  be  used  by  the 
competent  authorities  to  ensure  compliance  with  the  maximum  limits  for  marine 
biotoxins established in Annex III, Section VII, Chapter V(2) as well as by food business 
operators where appropriate. 

Reg.  853/2004  also  allows  for  implementing  measures  to  specify  the  calcium  content 
that  is  not  significantly  higher  than  that  of  minced  meat  in  respect  of  mechanically 
separated  meat  (MSM).  Annex  IV  of  Regulation  2074/2005  specifies  the  maximum 
calcium content of MSM as determined by an international standardised method. 

Annex I of Regulation (EC) No 853/2004 on Definitions 

j) 
Annex I of Regulation 853/2004 lays down definitions for meat products and for treated 
stomachs,  bladders  and  intestines.  Commission  Decision  2007/777/EC  lays  down  the 
animal and public health conditions and model certificates for imports of the above meat 
products from third countries for human consumption. 

Annex II, Section I of Regulation (EC) No 853/2004 on 

k) 
Identification marking 
Regulation  657/2008  lays  down  detailed  rules  for  the  application  of  Regulation 
1234/2007  (now  repealed  by  Regulation  1308/2013)  with  regard  to  supplying  milk  and 
milk  products  to  pupils  in  the  educational  establishments.  Such  products  must  be  in 
compliance with the hygiene requirements of Regulation 852/2004, must be produced in 
approved establishments and must bear the identification health mark indicated in Reg. 
853/2004. 

Decision 2011/408/EU lays down simplified rules and procedures on sanitary controls of 
certain fishery products, by-products and products derived from the by-products coming 
from  Greenland.  Consignments  of  products  dispatched  form  Greenland  to  the  European 
Union must bear the identification mark for Greenland according to the rules of Section 
I(B) of the above Annex.  

Annex II, Section III on Food Chain Information 

l) 
Annex  II,  Section  III  of  Regulation  853/2004  requires  food  business  operators  of 
slaughterhouses  to  request,  receive,  check  and  act  upon  food  chain  information  for  all 
the  animals  to  be  sent  to  the  slaughterhouse.  Regulation  2074/2005  on  implementing 
measures  for  certain  products  under  Regulation  853/2004,  lays  down  obligations  for 
both the food business operators and the competent authorities with regard to the food 
chain information.  

193 

 
 
 
 
 
 
Regulation  504/2008  (implementing  Council  Directives  90/426/EEC  and  90/427/EEC  as 
regards  methods  for  the  identification  of  equidae)  requires  food  business  operators  to 
obtain the above information of  Reg. 853/2004 while for domestic solipeds they  should 
request the accompanying passports. However, an equine animal may be authorised for 
slaughter  without  the  above  passport,  if  it  is  transported  directly  from  the  holding  of 
birth  to  the  slaughterhouse  within  the  same  Member  State  and  provided  the 
consignment is accompanied by the food chain information of Annex II of Reg. 853/2004 
which should also make a reference to the animal's unique identification. 

m)  Annex III on specific requirements for products of animal origin 
Annex III to Regulation 853/2004 lays down specific requirements for the hygiene during 
the slaughter of specific animal products. Commission Decision 2006/563/EC lays down 
certain  protection  measures  in  relation  to  highly  pathogenic  avian  influenza  of  subtype 
H5N1  in  wild  birds  in  the  Community.  In  case  H5N1  is  detected  in  a  Member  State, 
control and monitoring areas must be  established around the area where the virus was 
detected  as  well  as  control  measures  and  prohibitions.  As  derogation  from  these 
prohibitions,  fresh  meat  from  poultry  or  game,  and  certain  meat  products  may  be 
dispatched from the control area for placement on the market or export provided it has 
been produced in accordance to the provisions of Sections II, III, V and VI of Annex III 
to  Regulation  853/2004  and  controlled  in  accordance  to  Regulation  854/2004.  There  is 
an array of Commission Decisions introducing preventive vaccination against H5N1 
 or 
other related provisions for meat products or eggs for movement in the different Member 
States  (i.e.  2006/147,  2006/135,  2006/115,  2006/105,  2006/104,  2006/94,  2006/91, 
2006/90, 2006/416, 2006/415, 2006/148). 

Annex  III  of  Regulation  853/2004  also  lays  down  structural  requirements  for  the 
establishments where foodstuffs of animal origin are prepared. Due to the difficulties for 
certain  establishments  in  Bulgaria  to  meet  these  requirements,  Commission  Decision 
2007/716/EC  (on  transitional  measures 
for  structural  requirements  of  certain 
establishments  in  the  meat  and  milk  sectors  in  Bulgaria  provided  for  in  Regulations 
852/2004 and 853/2004) provides for transitional measures and certain establishments 
in Bulgaria are exempt from the above requirements until a specified date. Products may 
only  be  placed  in the  domestic  market  and  must  bear  a  health  mark  different  than  the 
one specified by Regulation 853/2004. 

Annex  III,  Section  V,  Chapter  III  of  Regulation  853/2004  lays  down  hygiene 
requirements  during  and  after  production  for  specific  meat  products.  Regulation 
2073/2005  on  microbiological  criteria  for  foodstuffs  establishes  salmonella  criteria 
specific to mechanically separated meat produced by the techniques of the above Annex. 

Annex III, Section V, Chapter IV of Regulation 853/2004 lays down specific requirements 
for  the  labelling  of  minced  meat,  meat  preparations  and  MSM.  In  addition  to  the 
requirements established by the food labelling Regulations, packages containing minced 
meat from poultry and solipeds, or meat preparations containing MSM intended for sale 
to  the  final  consumer  must  bear  a  note  that  the  product  must  be  cooked  before 
consumption. In addition to these provisions, Regulation 1169/2011 on the provision of 
food information to the consumers also requires that the following expressions appear on 
the packages of such products: "percentage of fat content under…" and "collagen/meat 
protein ration under…".   

Annex  III,  Section  VIII  to  Reg.  853/2004  lays  down  specific  requirements  for  fishery 
products.  Regulation  1379/2013  on  the  common  organisation  of  the  markets  in  fishery 
and  aquaculture  products  requires  that  such  products  may  only  be  offered  to  the 
consumer  if  they  display  some  mandatory  consumer  information,  additional  to  the 
requirements of Regulation 1169/2011. Specifically the products need to display whether 

194 

 
 
 
 
they  have  been  defrosted,  unless  they  have  been  previously  frozen  for  health  safety 
purposes in accordance with Annex III, Section VIII to Reg. 853/2004. 

Section  IX  of  Annex  III  to  Regulation  853/2004  lays  down  requirements  for  raw  milk, 
colostrum,  dairy  products  and  colostrum-based  products.  Chapter  I,  Part  III  lays  down 
specific criteria for the plate counts from milk of different animal species and residues of 
antibiotics  for  food  business  operators  producing  or  collecting  raw  milk  and  colostrum. 
Also  Chapter  II,  part  II  of  this  Annex  lays  down  specific  requirements  for  the  heat 
treatments  (pasteurisation  and  ultra-high  temperature  treatment  -  UHT)  in  addition  to 
the  requirements  of  Regulation  852/2004.  Article  6a  of  Regulation  2074/2005  (on 
implementing  measures  for  certain  products  under  Regulation  853/2004)  establishes 
analytical  methods  for  compliance  with  the  above  requirements  for  the  competent 
authorities and the food business operators.  

Furthermore, Chapter II, part III of this Annex implements specific criteria for raw cow's 
milk beyond its period of acceptance and before heat treatment. Milk that complies with 
these  requirements  can  be  received  and  processed  in  establishments  that  are  listed  in 
Chapter  II  of  the  Annex  to  Commission  Decision  2007/27/EC  (on  certain  transitional 
measures  concerning  deliveries  of  raw  milk  to  processing  establishments  and  the 
processing  of  this  raw  milk  in  Romania  with  regard  to  the  requirements  of  Regulations 
852/2004 and 853/2004) together with non-compliant milk, provided the  food business 
operators  can  guarantee  the  following:  that  the  establishments  comply  with  the 
requirements of Regulation 852/2004, the process is carried out in separate production 
lines,  there  are  procedures  to  ensure  separation  of  the  different  milks  in  the 
establishments  and  traceability,  that  a  specific  minimum  heat  treatment  is  carried  out 
and that the identification mark of Reg. 853/2004 is only applied when appropriate. Also 
the  above  Decision  requires  competent  authorities  in  Romania  to  verify  the  compliance 
of  the  establishments  listed  in  the  Annex,  to  carry  out  unannounced  controls  and 
appropriate  analysis  to  ensure  compliance  of  milk  products  with  the  specific  criteria  of 
Annex III, Chapter  II to Regulation 853/2004, as well as the microbiological  criteria for 
dairy  products.  Products  from  non-compliant  milk  produced  in  the  establishments  of 
Annex  II  of  Dec.  2007/27  may  only  be  placed  on  the  domestic  market  or  be  further 
processed and must bear a different identification mark from the one of Reg. 853/2004. 

Annex  III,  Section  XIV,  Chapter  I(5)  and  Section  XV,  Chapter  I(5)  lay  down  specific 
requirements  for  the  authorisation  of  collection  centres  and  tanneries  to  supply  raw 
materials  for  the  manufacture  of  collagen  and  gelatine  for  human  consumption, 
structural requirements and requirements for the cleanliness and segregation from non-
compliant  material.  Regulation  1069/2009  on  health  rules  for  animal  by-products  and 
derived  products  not  intended  for  human  consumption  indicates  that  raw  materials  for 
the  production  of  gelatine  and  collagen  not  intended  for  human  consumption  may  be 
stored, treated or processed in the above establishments, provided they are segregated 
from raw materials for the production of products of animal origin to prevent the risk of 
disease transmission.  

Extended scope of Regulation (EC) No 853/2004 

n) 
Directive 2005/94/EC lays down Community measures for the control of avian influenza. 
Regulations 852/2004 and 853/2004 on the hygiene of foodstuffs can  be applied under 
certain conditions to the hygiene of eggs originating from establishments where poultry 
may be infected with the avian influenza   

Regulation 1272/2009 lays down  rules for the  implementation of Regulation 1234/2007 
(now  repealed  by  Regulation  1308/2013)  with  regard  to  the  buying  and  selling  of 
agricultural  products  under  public  intervention.  This  Regulation  makes  reference  to 
certain  requirements  of  Reg.  853/2004.  Specifically,  only  operators  of  bovine  animal 

195 

 
 
 
 
slaughterhouses  registered  and  approved  under  Reg.  853/2004  may  participate  in  the 
public  intervention  scheme.  Also  the  boning  of  beef  can  only  be  carried  out  in  cutting 
plants  that  are  registered  and  approved  according  to  Reg.  853/2004  while  boned  cuts 
must also meet the hygiene requirements of this Regulation. Boned beef must be packed 
in cartons that bear an identification mark according to the provisions of Reg. 853/2004. 
Establishments  for  the  production  of  butter  and  of  skimmed  milk  powder  must  also  be 
registered and approved under Reg. 853/2004, while raw milk used for the production of 
skimmed  milk  powder  must  meet  the  requirements  of  Annex  III,  Section  IX  of  this 
Regulation and must also be free from antimicrobial substances. 

Regulation  1069/2009  on  health  rules  for  animal  by-products  and  derived  products  not 
intended for human consumption. 

Regulation  142/2011  implementing  Regulation  1069/2009  lays  down  health  rules  as 
regards  animal  products  and  derived  products  not  intended  for  human  consumption. 
Processing  plants  must  not  be  situated  on  the  same  site  as  slaughterhouses  approved 
under  Reg.  853/2004,  unless  risks  are  mitigated.  Also  animal  by-products  must  be 
accompanied by a commercial document as set out in the Annex to this Regulation or by 
a health certificate. However such a document is not required for milk and milk products 
which  are  to  be  returned  to  establishments  approved  under  Reg.  853/2004.  Specific 
requirements  relevant  to  Regulation  853/2004  are  also  laid  down  for  other  product 
categories.  

Regulation  1187/2009  establishes  detailed  rules  for  the  application  of  Regulation 
1234/2007  as  regards  export  licences  and  export  refunds  for  milk  and  milk  products. 
Article  3  specifies  that  for  export  refunds  to  be  granted,  the  products  must  meet  the 
requirements  of  Regs  852/2004  and  853/2004  and  specifically  preparation  in  an 
approved establishment and compliance with the identification marking requirements. 

Regulation  175/2010  lays  down  implementing  measures  for  Directive  2006/88/EC  with 
regard to the control of increased mortality of oysters of the species Crassostrea gigas in 
connection with the detection of  Ostreid herpesvirus 1µvar. When this virus is detected 
in oysters, the competent authority must establish a containment area. Consignments of 
oysters may only be removed from this area if they are intended for human consumption 
and they are packed in retail-sale packages as such according to the provisions of Reg. 
853/2004. 

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Annex  XVII:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  854/2004  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of Reg. 854/2004 and provide 
additional  regulatory  documents  that  add  requirements  or  assist  in  the  implementation 
of this main text. 

Article 5 on fresh meat 

a) 
Article  5  of  Regulation  854/2004  establishes  requirements  for  the  official  controls  of 
fresh meat and details are provided in Annex I to the Regulation. Also requirements are 
laid  down  for  the  application  of  the  health  marking  and  specifically  with  regards  to 
Trichinella examination, the health mark may only be applied once the negative testing 
results are available. Regulation 2075/2005 on specific rules for the control of Trichinella 
allows  for  derogation  and  thus  the  health  mark  may  be  applied  prior  to  the  Trichinella 
test results for establishments approved by the competent Authorities. 

b) 
Chapter III (Articles 10-15) on procedures concerning imports 
Chapter  III  of  Regulation  854/2004 lays  down procedures  for  the  import  of  products  of 
animal  origin  in  order  to  ensure  the  uniform  application  of  Regulations  178/2002  and 
882/2004. Regulation 1079/2013 establishes transitional measures for the application of 
Regulations  853/2004  and  854/2004.  Products  of  animal  origin  for  which  there  are  no 
harmonised  import  conditions,  approved  lists  of  import  countries  or  establishments 
established  at  Community  level  are  excluded  from  the  above  provisions.  Such  imports 
must  comply  with  the  import  requirements  laid  down  at  national  level  in  the  importing 
Member States. 

Article  11  of  Reg.  854/2004  specifically  requires  the  establishment  of  lists  of  third 
countries from where specific products of animal origin may be imported. Countries may 
only appear on the lists if Community controls have demonstrated that their competent 
Authorities  can  provide  appropriate  guarantees  as  required  by  Regulation  882/2004  on 
official  controls  performed  to  ensure  the  verification  of  compliance  with  feed  and  food 
law,  animal  health  and  animal  welfare  rules.  Commission  Decision  2006/766/EC  thus 
lays  down  a  list  of  countries  from  where  bivalve  molluscs,  tunicates,  echinoderms  and 
marine  gastropods  may  be  imported  as  well  as  a  list  of  countries  from  where  fishery 
products  may  be  imported.  Furthermore,  Regulation  1251/2008 implementing  Directive 
2006/88/EC  on  the  conditions  and  certification  requirements  for  the  placing  on  the 
market and import into the Community of aquaculture animals and products thereof and 
laying  a  list  of  vector  species,  implements  that  such  products  may  only  be  imported  in 
the Community from third countries and territories which are included in the above lists 
of Regulation 854/2004. 

Article  12  on  lists  of  establishments  from  which  imports  of 

c) 
specified products of animal origin are permitted 
Article 12 of Regulation 854/2004, provides the conditions under which an establishment 
may be placed on a list of approved establishments for imports of specified products of 
animal  origin.  One  of  the  conditions  is  that  there  are  guarantees  from  the  competent 
authorities  in  the  third  country  that  the  particular  establishment  as  well  as  any  other 
establishments  handling  any  of  the  raw  materials  used  in  the  manufacture  of  the 

197 

 
 
 
 
 
 
 
products  of  animal  origin  concerned,  comply  with  the  Community  legislation  and  in 
particular  with  the  requirements  of  Regulation  853/2004.  Regulation  1099/2009  on  the 
protection of animals at the time of killing lays down some general requirements for the 
killing  and  stunning  of  animals,  standard  operating  procedures  and  instructions  for  the 
use  of  restraining  and  stunning  equipment.  Also  some  additional  structural  and 
equipment  requirements  for  slaughterhouses  are  described,  monitoring  procedures  and 
finally  the  duties  of  an  animal  welfare  officer  to  assist  slaughterhouses  in  fulfilling  the 
requirements of this Regulation. 

Furthermore, with regard to approved establishments, a fishing vessel not appearing in 
the  list  of  approved  establishments  for  the  import  of  animal  products  under  Regulation 
854/2004  should  be  one  of  the  criteria  of  the  benchmarks  for  port  inspections.  This  is 
enforced by Regulation 1010/2009 laying down detailed rules for the implementation of 
Regulation  1005/2008  establishing  a  Community  list  to  prevent,  deter  and  eliminate 
illegal, unreported and unregulated fishing.  

In  addition,  Article  14  of  Regulation  2075/2005  on  the  official  controls  of  Trichinella  in 
meat allows for meat of domestic swine to be imported in the Community without having 
undergone  a  Trichinella  test  provided  that  it  originates  from  an  establishment  officially 
recognised  as  free  from  Trichinella  under  Regulation  854/2004  or  provided  it  has 
undergone a freezing treatment in accordance with Annex II to the Regulation. 

Article 14 on documents 

d) 
Article 14 of Regulation 854/2004 lays down requirements for the documents that must 
accompany consignments of products of animal origin to be imported in the Community 
certifying  compliance  with  Regulations  852/2004,  853/2004  and  882/2004.  The  same 
Article  also  allows  for  exemptions  from  the  above  requirements  when  these  can  be 
guaranteed  in  a  different  way.  In  that  respect,  Regulation  2075/2005  requires  that  a 
document certifying the above requirements accompanies meat products to be imported, 
unless an exemption has been granted by the above provisions. 

Commission  Decision  2007/30/EC  on  transitional  measures  for  the  marketing  of  animal 
products from Bulgaria and Romania obtained until the 31st of December 2006 allows, as 
previously  discussed,  for  such  products  to  be  placed  on  the  domestic  market  under 
specific conditions. 

Article 15 on special provisions for fishery products 

e) 
Article  15  of  Regulation  854/2004  lays  down  special  provisions  for  fishery  products 
imported  from  fishing  or  freezer  vessels.  Additional  requirements  as  well  as  the  model 
documents for this category of products are provided by Regulation 2074/2005. 

Article 18 on specific decisions 

f) 
Article  18  of  Regulation  854/2004  lays  down  provisions  for  the  establishment  of 
implementing  measures  amending  the  Regulation  for  different  criteria,  rules  etc. 
Amongst these, the cold treatment to be applied to meat in relation to trichinosis as well 
as  the  conditions  for  certification  of  establishments  and  regions  as  free  from  trichinae 
are  included.  In  that  respect,  Regulation  2075/2005  lays  down  specific  rules  for  the 
official  controls  of  Trichinella  in  meat.  When  a  slaughterhouse  has  a  formally  approved 
procedure by the competent authority for ensuring that no part of carcasses may leave 
the  premises  before  the  Trichinella  tests  is  found  to  be  negative,  the  health  mark  of 
Regulation 854/2004 may be applied before the Trichinella test results are available. 

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With  regards  to  fishery  products  and  the  organoleptic  criteria  for  their  freshness, 
additional  requirements  are  provided  by  Regulation  2074/2005.  This    Regulation  also 
lays  down  the  recognised  chemical  and  biological  methods  for  the  detection  of  marine 
biotoxins in live bivalve molluscs. 

Annex I: fresh meat 

g) 
Annex I of Regulation 854/2004 lays down detailed requirements for the official controls 
of fresh meat. Some additional requirements with regards to the food chain information 
as well as for the controls in establishments carrying out discontinuous slaughtering are 
established  by  Regulation  2074/2005  (laying  down  implementing  measures  for 
Regulations  853/2004,  854/2004  and  882/2004  and  derogating  from  Regulations 
implements  certain 
852/2004,  853/2004  and  854/2004).  The  Regulation  also 
amendments to Annexes I, II and III of Reg. 854/2004.  

Annex  I  to  Regulation  854/2004  also  specifies  the  tasks  of  the  official  veterinarians  for 
different  categories  of  meat  products.  Directive  2007/43/EC  on  minimum  rules  for  the 
protection  of  chickens  kept  for  meat  production  lays  down  additional  requirements  to 
those  of  Reg,  854/2004  with  regard  to  the  post-mortem  examination  of  chickens  to 
identify signs of poor welfare in the holding. 

Chapter  V  of  Section  II  of  Annex  I  of  Regulation  854/2004  lays  down  the  conditions 
under  which  meat  may  be  declared  as  unfit  for  human  consumption.  Regulation 
504/2008  on  methods  for  the  identification  of  equidae  implements  that  when  the 
transponder  cannot  be  recovered  from  an  equine  animal  slaughtered  for  human 
consumption, the official veterinarian shall declare the meat or the part of the meat that 
contains the transponder as unfit for human consumption.  

Annex  I  also  establishes  the  scope  of  ante-mortem  inspection  to  be  able  to  determine 
signs  of  compromised  animal  welfare  or  the  presence  of  zoonotic  or  other  regulated 
animal  diseases.  Regulation  999/2001  on  the  prevention,  control  and  eradication  of 
certain transmissible spongiform encephalopathies requires all bovine animals older than 
24  months  of  age  to  be  tested  for  BSE  when  there  are  specific  findings  identified  in 
accordance with Annex I of Regulation 854/2004. Also it establishes that carcasses used 
for this testing must not be marked with the health marking of Reg. 854/2004 before a 
negative test result has been obtained. 

In light of the outbreaks of foot-and-mouth disease in the UK, meat products bearing the 
health  mark  according  to  the  requirements  of  Chapter  III,  Section  I  of  Annex  I  of  Reg. 
854/2004  are  exempt  from  the  prohibition  of  dispatching  if  originating  from  specific 
areas  listed  in  the  Annex  to  Decision  2007/554/EC,  provided  they  also  meet  certain 
provisions laid down within the same Decision. Similar rules are also established in other 
countries by different Commission Decisions (i.e. 2007/718/EC). 

Implementing  Decision  2013/764/EU  on  animal  health  control  measures  relating  to 
classical swine fever in certain Member States lays down measures to prevent the spread 
of  swine  fever.  As  already  discussed,  the  health  mark  used  for  fresh  pig  meat  and  for 
products  containing  pig  meat  at  risk  of  swine  fever,  originating  from  certain  areas  in 
Bulgaria,  Croatia,  Latvia  and  Romania  should  be  clearly  different  than  the  health  mark 
provided by Regulation 854/2004.  

Annex II: Live bivalve molluscs 

h) 
Regulation  2074/2005  implements  certain  amendments  to  Annex  II  of  Regulation 
854/2004 with regard to the production areas of such products. 

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Annex III: Fishery products 

i) 
Regulation  2074/2005  implements  certain  amendments  to  Annex  III  of  Regulation 
854/2004  regarding  the  prohibition  of  placement  on  the  market  of  certain  fishery 
products derived from poisonous fish. 

Extended scope of Regulation (EC) No 854/2004 

j) 
Commission  Decision  2006/415  lays  down  certain  protection  measures  in  relation  to 
highly pathogenic avian influenza of the type H5N1 in poultry in the Community. In order 
to  prevent  the  spread  of  the  disease,  products  derived  from  wild  feathered  game 
intended for human consumption may not be dispatched from high or  low risk areas to 
other  Member  States  or  to  third  countries.  As  derogation,  fresh  meat  products 
originating outside of high or low risk areas but produced in establishments within such 
areas may be dispatched, provided they meet the requirements of Regulations 853/2004 
and 854/2004. 

Commission Decision 2006/563/EC lays down certain protection measures in relation to 
highly  pathogenic  avian  influenza  of  subtype  H5N1  in  wild  birds  in  the  Community.  As 
discussed before. In case H5N1 is detected in a Member State, fresh meat from poultry 
or  game  and  certain  meat  products  may  be  dispatched  from  the  control  area  for 
placement on the market or export, provided it has been produced in accordance to the 
provisions  of  Sections  II,  III,  V  and  VI  of  Annex  III  to  Regulation  853/2004  and 
controlled  in  accordance  with  Regulation  854/2004.  There  is  an  array  of  Commission 
Decisions  introducing  related  provisions  for  the  movement  of  different  products  in  the 
different Member States. 

200 

 
 
 
 
 
 
implemented  under  Directive 
Annex  XVIII:  Legislation 
2002/99/EC  and  in  particular  Articles  8  and  9  on  lists  of 
approved  third  countries,  special  import  conditions  and 
certification documents 

Conditions for milk and dairy products 

a) 
Commission Regulation No (EU) 605/2010 lays down conditions for the animal and public 
health and the veterinary certification for the import of raw milk and dairy products for 
human  consumption  in  the  European  Union.  It  also  establishes  a  list  of  countries  from 
which  such  products  can  be  introduced  in  the  Union.  Milk  products  can  be  imported  by 
specific  countries  provided  they  have  undergone  the  heat  treatments  specified  in  the 
Regulation depending on the risk of foot-and-mouth disease. The same heat treatments 
apply  for  countries  where  there  is  a  risk  of  the  disease  or  where  there  has  been  an 
outbreak  of  the  disease  or  relevant  vaccination  has  been  carried  out  in  the  last  year. 
Authorised  consignments  should  be  accompanied  by  a  health  certificate,  drawn  up  and 
completed  according  to  the  instructions  provided  in  the  Regulation.  Also  the  above 
requirements apply for products in transit or storage in the European Union, which must 
also  be  accompanied  by  a  certificate  suitable  for  this  purpose  according  to  Regulation 
136/2004. Regulation 605/2010 also lays down some specific provisions for products in 
transit through Croatia, or to Russia through certain countries. Also Decision 2011/44/EU 
lays down protection measures against foot-and-mouth disease in Bulgaria. 

Conditions for certain animals and fresh meat  

b) 
Commission  Regulation  (EU)  No  206/2010  lays  down  specific  veterinary  certification 
requirements for the import in the European Union of ungulates, bumble bees and queen 
bees  and  bumble  bees  and  fresh  meat.  It  also  establishes  lists  of  third  countries  from 
which the above products may be introduced in the Union. The Regulation also provides 
protocols  for  the  standardisation  of  materials  and  sampling  and  testing  procedures 
needed  for  the  purposes  of  testing  for  certain  diseases  for  the  veterinary  certificates. 
Specific  conditions  are  also  established  for  the  introduction  of  certain  animal  species  in 
the  EU,  for  the  transport  of  live  animals  and  for  relevant  time  limits.  Similarly  detailed 
requirements  are  established  for  the  import  of  fresh  meat  or  transport,  transit  and 
storage requirements. 

Conditions for live ungulate animals 

c) 
Council  Directive  2004/68/EC  lays  down  the  animal  health  rules  for  the  import  and 
transit of live ungulates into the European Union.  Imports are only authorised from the 
listed  countries  and  specific  criteria  are  provided  for  the  compilation  of  the  country  list 
which must also be published by the Commission. The Directive specifies animal health 
conditions  for  the  animals  to  be  imported,  the  guarantees  that  are  required  from  the 
third  country  and  finally  details  for  the  veterinary  certificate.  The  Commission  reserves 
the right to conduct audits and inspections in the third country. 

Conditions for composite products 

d) 
Council  Regulation  28/2012  lays  down  requirements  for  the  certification  of  certain 
composite products imported in the Union from third countries or in transit through the 
Union.  Composite  products,  according  to  the  definitions  of  Decision  2007/275/EC,  may 
only be imported in the European Union by certain authorised countries and provided the 
establishments  in  which  they  are  manufactured  meet  the  requirements  of  Reg. 

201 

 
 
 
 
 
 
 
853/2004.  These  must  be  accompanied  by  a  health  certificate  prepared  according  to 
Reg. 28/2012. 

Conditions for meat of wild leporidae, wild land mammals and 

e) 
farmed rabbits  
Commission  Regulation  119/2009  lays  down  conditions  for  the  import  into  or  transit 
through  the  European  Union  of  the  above  species,  a  list  of  countries  from  where  these 
products may be imported and the veterinary certification requirements. 

202 

 
 
 
 
 
Annex  XIX:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  2073/2005  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Reg.  2073/2005  and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this main text. 

Article 1 on subject matter and scope 

a) 
Article  1  of  Regulation  2073/2005  indicates  that  the  competent  authority  must  verify 
compliance with the rules and the criteria laid down, in accordance with the provisions of 
Reg.  882/2004.  Implementing  Decision  2013/652/EU  lays  down  provisions  on  the 
monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria. 
The  monitoring  of  antimicrobial  resistance  (AMR)  in  Salmonella  species  should  be 
focused  to  isolates  obtained  during  the  national  control  programme  according  to  Reg. 
2073/2005. If a Member State cannot meet the minimum number of Salmonella isolates 
required  for  antimicrobial  resistance  testing,  the  competent  authority  may  use  samples 
collected  by  food  business  operators,  provided  they  have  been  obtained  under  the 
national  control  programme  established  by  Reg.  2160/2003  and  they  meet  the  process 
hygiene  criteria  of  Annex  I  of  Reg.  2073/2005.  The  Annex  to  Implementing  Decision 
2013/652/EU  lists  certain  animal  populations  and  food  categories  from  which  samples 
must  be  collected  for  the  purposes  of  AMR  monitoring  (in  accordance  with  Regs. 
2160/2003 and 2073/2005). 

Annex I on microbiological criteria for foodstuffs 

b) 
Annex  I  of  Regulation  2073/2005  lays  down  the  microbiological  criteria  for  foodstuffs: 
food  safety  criteria,  process  hygiene  criteria  and  rules  for  sampling  and  preparation  of 
tests samples.  

Regulation 101/2013 lays down provisions for the use of  lactic acid for the reduction of 
microbiological  surface  contamination  of  bovine  carcasses.  The  Regulation  clarifies  that 
the  use  of  lactic  acid  should  not  be  considered  as  a  substitution  of  good  hygienic 
slaughtering  practices.  It  also  specifies  that  sampling  of  carcasses  for  the  purposes  of 
assessing compliance with the microbiological requirements of Reg. 2073/2005 must be 
carried out before surface treatment of the carcasses with lactic acid. 

Regulation  211/2013  lays  down  certification  requirements  for  imports  into  the  Union  of 
sprouts  and  seeds  for  the  production  of  sprouts.  Consignments  of  these  products  must 
comply  with  the  requirements  of  Regulations  852/2004  on  the  hygiene  of  foodstuffs, 
208/2013  on  traceability  requirements  and  with  the  microbiological  criteria  of  Reg. 
2073/2005  in  order  to  be  imported  into  the  European  Union  from  third  countries  and 
they must be accompanied by a certificate in accordance with the model of the Annex to 
Reg. 211/2013.  

Regulation 200/2012 lays down a Union target for the reduction of Salmonella enteritidis 
and Salmonella typhimurium in flocks of broilers in accordance with the requirements of 
Regulation  2160/2003  on  the  control  of  salmonella  and  other  zoonotic  agents.  This 
target reduction is key, in order to meet the requirements of Regulations 2160/2003 and 
2073/2005 for Salmonella in fresh meat of broilers. 

Annex I to Regulation 854/2004 on specific rules for the organisation of official controls 
on  products  of  animal  origin  intended  for  human  consumption,  lays  down  the  tasks  of 

203 

 
 
 
 
 
 
the official veterinarian for certain hazards. The process hygiene criterion for Salmonella 
on  carcasses  established  by  Reg.  2073/2005  should  also  be  supervised  in  the  pigmeat 
inspection  and  action  should  be  enforced  in  case  of  non-compliance.  Therefore,  specific 
measures  are  added  to  Annex  I  of  Reg.  854/2004  so  that  the  competent  authority  can 
verify the correct implementation of the process hygiene criterion for  Salmonella on pig 
carcasses by food business operators, also in accordance with the provisions of Article 5 
of Reg. 2073/2005.   

Commission Decision 2007/642/EC lays down emergency measures for fishery products 
imported from Albania and intended for human consumption. According to this Decision, 
Member  States  may  only  import  fishery  products  originating  from  Albania,  if  they  are 
accompanied  by  analytical  results  of  tests  carried  out  according  to  Annex  I  of  Reg. 
2073/2005  which  show  that  the  histamine  levels  are  below  the  limits  specified  in  that 
Regulation.  Consignments  of  such  products  may  be  imported  without  test  results, 
provided  the  competent  authorities  detain  them  until  the  importing  country  has 
conducted  the  above  tests  with  favourable  results.  If  the  limits  are  exceeded,  the 
Member State must immediately inform the Commission. 

204 

 
 
 
 
 
 
 
Annex  XX:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  2160/2003  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Reg.  2160/2003  and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of the Regulation. 

Article 3 on competent authorities 

a) 
Article  3  of  Regulation 2160/2003  establishes  the  requirement  that  each  Member  State 
must  designate  a  competent  authority  for  the  purposes  of  the  Regulation  and  also lays 
down  the  responsibilities  of  this  authority.  These  include  the  drawing  of  the  national 
control  programmes,  collecting  data  and  evaluating  the  results  obtained  through  these 
programmes  and  carrying  out  checks  in  order  to  ensure  compliance  with  the 
requirements of the Regulation. Directive 2003/99/EC on the monitoring of zoonoses and 
zoonotic agents indicates that each Member State must assess the sources and trends of 
zoonoses and zoonotic agents within its territory and they must provide the Commission 
every  year  with  a  report  of  the  results.  These  must  be  public  and  must  contain  the 
results of the above evaluation carried out by the competent authority. 

Article 4 on Community targets for the reduction of the prevalence 

b) 
of zoonoses and zoonotic agents 
Article 4 of Regulation 2160/2003 lays down the requirement for Community targets to 
be established for the reduction of the prevalence of zoonoses and zoonotic agents and 
lays  down  detailed  rules  and  specifications  for  these  targets  and  timeframes  for  their 
establishment. Commission Decision 2004/665/EC requires the Commission to undertake 
a one-year baseline study on the prevalence of  Salmonella spp. in flocks of laying hens 
of  Gallus  gallus  for  the  production  of  table  eggs  at  the  end  of  their  production  period. 
The results of this study should be used for the establishment of the Community targets 
required by Article 4. 

In the same context, Commission Decision 2005/636/EC provides a Community financial 
contribution  for  the  costs  involved  for  carrying  out  a  one-year  survey  to  assess  the 
prevalence of Salmonella spp. in flocks of broilers of  Gallus gallus sampled within three 
weeks of leaving the holding for slaughter. Similarly Commission Decision 2006/662/EC 
provides a Community financial contribution for carrying out a one-year survey to assess 
the  prevalence  of  Salmonella  spp.  in  fattening  turkeys  three  weeks  after  leaving  the 
holding  for  slaughter  and  in  flocks  of  breeding  turkeys  within  nine  weeks  before 
depopulation.  The  results  of  both  surveys  should  be  used,  as  above,  for  the 
establishment of the Community targets required by Article 4. Within the same  context 
similar  Commission  Decisions  provide  for  financial  contribution  for  similar  studies  for 
assessing  the  prevalence  of  Salmonella  in  other  animal  species  (Dec.  2006/668/EC, 
2007/208/EC,  2007/219/EC).  Also  other  Commission  Decisions  provide  financial 
contribution for studies assessing the prevalence  of antimicrobial resistance to different 
zoonotic agents in different animal species (2007/516/EC, 2008/55/EC). 

Article 5 on National control programmes 

c) 
Article  5  of  Regulation  2160/2003  lays  down  the  requirement  for  establishment  of 
national  control  programmes  in  the  Member  States  in  order  to  achieve  the  Community 

205 

 
 
 
 
 
 
 
targets  for  the  reduction  of  zoonoses  and  zoonotic  agents.  Implementing  Decision 
2013/652/EU  lays  down  provisions  on  the  monitoring  and  reporting  of  antimicrobial 
resistance  in  zoonotic  and  commensal  bacteria.  If  a  Member  State  cannot  meet  the 
minimum  number  of  Salmonella  isolates  required  for  antimicrobial  resistance  testing 
through the national control programme according to Reg. 2073/2005, samples collected 
by  food  business  operators  may  be  used,  provided  they  have  been  obtained  under  the 
national  control  programme  established  by  Reg.  2160/2003  and  they  meet  the  process 
hygiene  criteria  of  Annex  I  of  Reg.  2073/2005.  Also  the  Annex  to  the  above 
Implementing  Decision  lists  certain  animal  populations  and  food  categories  from  which 
samples must be collected for the purposes of AMR monitoring in accordance with Regs. 
2160/2003 and 2073/2005. 

Article 10 on imports from third countries 

d) 
Article  10  of  Regulation  2160/2003 indicates  that  the  admission  of  third  countries  from 
which animals and hatching eggs may be imported in an approved list should depend on 
the  submission  of  their  national  control  programme  for  zoonoses  and  zoonotic  agents 
which should provide equivalent guarantees to the European ones. Regulation 798/2008 
lays  down  a  list  of  third  countries  from  where  poultry  and  poultry  products  may  be 
imported  into  the  Community  and  Annex  II  to  this  Regulation lays  down  the  veterinary 
certification  requirements  for  these  products  and  any  additional  specific  conditions. 
Specifically,  the  veterinary  certificates  for  the  import  of  poultry,  hatching  eggs  and  day 
old  chicks,  meat  and  eggs  from  certain  countries  bear  a  specific  requirement  that  the 
import  is  prohibited  if  there  are  no  Salmonella  control  programmes  in  place  in  the 
country  in  accordance  with  Reg.  2160/2003  or  they  have  not  been  approved  by  the 
Commission. 

e) 
Annex  I  on  specified  zoonoses  and  zoonotic  agents  for  which 
Community targets for the reduction of prevalence are to be established 
pursuant to Article 4  
Annex I to Regulation 2160/2003 lists certain zoonoses and zoonotic agents and specific 
animal  populations  for  the  reduction  of  the  prevalence  of  which,  Community  targets 
must be established. Directive 2003/99/EC implements that Member States must collect 
data  in  order  to  assess  the  risks  related  to  specific  zoonoses  and  zoonotic  agents  in 
specific  animal  populations  and  that  this  monitoring  shall  cover  all  stages  of  the  food 
chain.  It  also  indicates  that  if  the  results  obtained  during  the  routine  monitoring 
programmes are not sufficient, coordinated monitoring programmes may be established. 
Coordinated  monitoring  programmes  must  make  specific  reference  to  the  zoonoses, 
zoonotic agents and animal populations of Annex I to Regulation 2160/2003. 

Annex  II  on  control  of  zoonoses  and  zoonotic  agents  listed  in 

f) 
Annex I 
Annex II to Regulation 2160/2003 lays down provisions for the control of zoonoses and 
zoonotic agents specified in Annex I. 

Part  B  of  the  Annex  specifies  minimum  sampling  requirements  in  order  to  test  for  the 
zoonoses  and  zoonotic  agents  of  Annex  I.  Regulation  1688/2005  implementing  Reg. 
853/2004  as  regards  special  guarantees  concerning  Salmonella  for  consignments  to 
Finland  and  Sweden  of  certain  meat  and  eggs  indicates  that  the  sampling  of  flocks  of 
eggs according to the requirements of Regulation 853/2004 and intended for these two 
countries must be carried out according to the sampling plans of Part B of the Annex II. 

206 

 
 
 
 
 
 
Part  E  of  the  Annex  specifies  requirements  for  fresh  meat.  Fresh  poultry  meat  from 
animal  species  listed  in  Annex  I  must  meet  the  microbiological  criteria  set  in  Reg. 
2073/2005,  unless  the  meat  is  destined  for  heat  or  other  treatment  aimed  at  reducing 
salmonella.  In  that  respect,  Reg.  854/2004  section  II  of  Annex  I  on  action  following 
controls indicates that the official veterinarian may impose requirements for meat where 
a treatment will be applied according to Annex II of Reg. 2160/2003. 

207 

 
 
 
 
 
 
 
Annex  XXI:  Additional  implementing  measures  for  selected 
Articles  of  Directive  2003/99/EC  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  2003/99/EC  and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this main text. 

Article  4  on  general  rules  for  the  monitoring  of  zoonoses  and 

a) 
zoonotic agents 
Article  4  of  Directive  2003/99/EC  lays  down  the  general  rules  for  the  monitoring  of 
zoonoses  and  zoonotic  agents.  This  information  must  also  be  provided  under  the 
requirements  for  the  National  Control  programmes  for  the  achievement  of  Community 
targets  for  the  reduction  of  the  prevalence  of  specific  zoonoses  and  zoonotic  agents 
included under Regulation 2160/2003. 

Commission Decision 2008/425/EC lays down standard requirements for the submission 
by Member States of national programmes for the eradication, control and monitoring of 
certain  animal  diseases  and  zoonoses  for  Community  financing.  Specifically  for  the 
control  of  salmonellosis  the  Member  States  must  submit  a  summary  of  the  information 
on the occurrence of this zoonosis collected under the monitoring programme of Art. 4 of 
Directive  2003/99/EC,  highlighting  the  prevalence  values  of  the  salmonella  serotypes 
targeted. 

Article 5 on coordinated monitoring programmes 

b) 
Article  5  of  Directive  2003/99/EC  establishes  the  possibility  for  the  organisation  of 
coordinated  monitoring  programmes  if  the  routine  monitoring  data  collected  are  not 
sufficient for the monitoring purposes of this Directive. The data collected through these 
coordinated  programmes  may  also  be  used  for  the  purposes  of  Article  4  of  Reg. 
2160/2003  laying  down  the  requirement  of  establishing  Community  targets  for  the 
reduction of the prevalence of zoonoses and zoonotic agents and providing detailed rules 
and  specifications  for  the  establishment  of  these  targets  and  timeframes  for  their 
establishment. 

Article 7 on monitoring of antimicrobial resistance 

c) 
Article 7 of Directive 2003/99/EC lays down the requirement for Member States to obtain 
comparable  data  on  the  occurrence  of  antimicrobial  resistance  in  zoonotic  agents 
through monitoring programmes. Detailed rules must be adopted for the implementation 
of this Article. These are laid down by Implementing Decision 2013/652/EU on provisions 
for  the  monitoring  and reporting  of  antimicrobial  resistance  in  zoonotic  and  commensal 
bacteria,  specifically  with  regard  to  the  harmonised  monitoring  and  reporting.  Member 
States  must  assess  the  results  obtained  according  to  the  requirements  of  this  Decision 
and include them in the reports required under Article 9 of Dir. 2003/99/EC. In order to 
facilitate  the  implementation  of  the  provisions  of  Decision  2013/652/EU  and  also 
considering the requirements of Reg. 882/2004 on official controls, the Community must 
contribute  financially  to  the  costs  incurred.  This  is  implemented  by  Commission 
Implementing  Decision  2013/653/EC  as  regards  a  Union  financial  aid  towards  a 
coordinated  control  plan  for  antimicrobial  resistance  monitoring  in  zoonotic  agents  in 
2014. 

208 

 
 
 
 
 
 
 
Article  8  of  Directive  2003/99/EC  on  the  epidemiological 

d) 
investigation of food-borne outbreaks 
Article  8  lays  down  the  procedure  for  the  epidemiological  investigation  of  food-borne 
outbreaks.  This information is also required under the National Control programmes for 
the  achievement  of  Community  targets  for  the  reduction  of  the  prevalence  of  specific 
zoonoses and zoonotic agents included under Reg. 2160/2003. 

Article  9  on  assessment  of  trends  and  sources  of  zoonoses, 

e) 
zoonotic agents and antimicrobial resistance 
Article  9  of  Directive  2003/99/EC  establishes  the  requirement  that  each  Member  State 
must  assess  the  sources  and  trends  of  zoonoses,  zoonotic  agents  and  antimicrobial 
resistance  within  its  territory  and  provide  the  Commission  with  a  yearly  report  of  the 
results and lays down specific rules for this procedure. 

Commission  Decision  2006/662/EC  provides  a  Community  financial  contribution  for 
carrying out a baseline survey on the prevalence of Salmonella in turkeys in the Member 
States. The results obtained through this survey should be used for the report on trends 
and  sources  of  zoonoses,  zoonotic  agents  and  antimicrobial  resistance  requested  under 
Article 9 above. Similarly, Commission Decision 2006/668/EC on a financial contribution 
from  the  Community  towards  a  baseline  survey  on  the  prevalence  of  Salmonella  in 
slaughter pigs to be carried out in the Member States, indicates that the results obtained 
should  be  used  for  the  annual  reports  on  trends  and  sources  of  zoonoses,  zoonotic 
agents  and  antimicrobial  resistance  under  Directive  2003/99/EC.  It  also  specifies  some 
details  on  the  sampling  procedure  and  specific  data  on  the  animals  tested,  that  should 
be included as a minimum in this report. 

Commission  Regulation  200/2010  implementing  Regulation  2160/2003  as  regards  a 
Union  target  for  the  reduction  of  the  prevalence  of  Salmonella  serotypes  in  adult 
breeding flocks of Gallus gallus, indicates that the results and any additional information 
obtained under the testing scheme necessary to ascertain the achievement of the Union 
target  for  the  reduction  of  the  relevant  Salmonella  serotypes  in  these  species  must  be 
reported  as  part  of  the  report  on  trends  and  sources  of  zoonoses,  zoonotic  agents  and 
antimicrobial resistance requested under Article 9 above. 

Article  9  also  requires  the  Commission  to  send  the  reports  prepared  by  the  Member 
States  to  EFSA.  After  examining  them,  EFSA  must  publish  a  summary  report  on  the 
trends  and  sources  of  zoonoses,  zoonotic  agents  and  antimicrobial  resistance  in  the 
Community.  Commission  Implementing  Decision  2013/652/EU  on  provisions  for  the 
monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria 
indicates that EFSA must publish these national isolate-based quantitative antimicrobial 
resistance data. 

Article 10 on Community and national reference laboratories 
f) 
Article  10  of  Directive  2003/99/EC  lays  down  the  requirement  for  the  designation  of 
Community and reference laboratories tasked with the analysis and testing for zoonoses 
and zoonotic agents and antimicrobial resistance. The responsibilities and tasks of these 
laboratories  established  by  Commission  Decision  2004/564/EC  concerning  Community 
reference laboratories for the epidemiology of zoonoses and for salmonella and national 
reference  laboratories  for  salmonella,  under  the  requirements  of  Directive  2003/99/EC 
and Reg. 2160/2003. 

209 

 
 
 
 
 
 
Annex  IV  on  requirements  for  the  reports  to  be  submitted 

g) 
pursuant to Article 9(1) 
Annex  IV  of  Directive  2003/99/EC  lays  down  the  minimum  information  required  to  be 
submitted  in  the  reports  to  be  submitted  to  the  Commission  on  the  assessment  of  the 
sources and trends of zoonoses, zoonotic agents and antimicrobial resistance within the 
territories  of  the  Member  States.  Commission  Regulation  2075/2005 on  official  controls 
for  Trichinella  in  meat  indicates  that  the  number  of  tests  conducted  for  Trichinella  in 
domestic  swine,  wild  boar,  horses,  game  and  any  other  susceptible  animals  and  their 
results must be included in the above reports and lays down some minimum information 
required for domestic swine. 

210 

 
 
 
 
 
Annex  XXII:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1333/2008  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1333/2008 and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this main text. 

Article 6 of Regulation (EC) No 1333/2008 on general conditions 

a) 
for the inclusion and use of food additives in Community lists 
Article 6 of Reg. 1333/2008 lays down certain conditions that substances must meet in 
order  to  be  included  as  authorised  food  additives  in  the  Community  lists  of  Reg. 
1333/2008.  Regulation  234/2011,  implementing  Regulation  1331/2008  on  a  common 
authorisation procedure for food additives, food enzymes and food flavourings, requires 
that  applications  for  updating  the  Community  lists  must  include  a  summary  dossier 
indicating  that the  use  of  the  substance  complies  with  the  conditions  laid  down in  Reg. 
1333/2008.  

Article 10 of Regulation (EC) No 1333/2008 on the content of the 

b) 
Community lists of food additives  
Article  10  of  Reg.  1333/2008 lays  down  requirements  for  the  entry  of  food  additives  in 
the Community lists. This information must be amended and maintained in databases in 
accordance  with  the  requirements  of  Reg.  1331/2008  on  the  common  authorisation 
procedure.  Implementing  Decision  2014/C  72/05  lays  down  the  financing  of  the  2014 
work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare 
and plant health. 

Article 14 of Regulation (EC) No 1333/2008 on specifications for 

c) 
food additives 
Article 14 of Reg. 1333/2008 lays down the requirement for adoption of specifications of 
food  additives  relating  in  particular  to  the  origin,  purity  criteria  and  other  necessary 
information when a food additive is included in the Community lists of Annexes II and III 
of  the  Regulation  for  the  first  time.  The  same  is  also  required  by  Article  30  of  the 
Regulation on the establishment of Community lists of  food additives.  This requirement 
is fulfilled by Regulation 231/2012 laying down specifications for food additives listed in 
Annexes II and III of Reg. 1333/2008. 

Article 18 of Regulation (EC) No 1333/2008 on the carry-over 

d) 
principle 
Article  18  of  Reg.  1333/2008  establishes  the  carry-over  principle,  according  to  which 
food additives may be present in a compound food product, provided they are permitted 
in  any  of  its  ingredients  and  have  been  carried  over  to  the  finished  product  through 
these and provided they have no technological function in the finished product. Also food 
additives  may  be  present  in  a  food  intended  to  be  used  for  the  manufacture  of  a 
compound food that complies with the provisions of Reg. 1333/2008. 

211 

 
 
 
 
 
 
 
 
Regulation  1169/2011 on  the  provision  of  food  information  to  consumers  indicates  that 
food additives present in a food as a result of the carry-over principle described in Reg. 
1333/2008 do not need to be declared in the list of ingredients of the finished product, 
provided they have no technological function in that product.  

Article 20 of Regulation (EC) No 1333/2008 on traditional foods 

e) 
Article  20  of  the  Regulation  allows  Member  States  to  continue  to  prohibit  the  use  of 
certain additives in traditional foods. In that respect, Decision 2010/561/EU on national 
provisions  notified  by  Denmark  on  the  addition  of  nitrite  to  certain  meat  products 
implements  that  Denmark  may  continue  to  apply  the  restriction  of  use  of  certain 
additives  and  preservatives  in  the  traditional  Danish  Kodboller  (meatballs)  and 
Leverpostej (liver pate). 

from 

resulting 

Article 29 of Regulation (EC) No 1333/2008 on Community 

f) 
financing of harmonised policies 
Article  29  of  Regulation  1333/2008  establishes  the  legal  basis  for  financing  certain 
measures 
the  Regulation.  Commission 
implementation  of 
Implementing  Decision  2013/C  170/06  concerning  the  financing  for  the  year  2013  of 
activities  in  the  veterinary  field  relating  to  the  European  Union's  information  policy  and 
support  of  international  organisations,  to  several  measures  necessary  to  ensure  the 
application  of  the  food  and  feed  and  the  plant  health  legislation,  implements  financial 
support  measures  for  the  gathering  of  information  for  the  purposes  of  monitoring  the 
consumption and use of food additives in the Member States for the determination of the 
dietary intake of such substances.  

the 

In the same context, Commission Implementing Decision 2014/C 166/05 implements the 
adoption of the work programme and the financing for the year 2014 of activities in the 
food and feed area to ensure the application of the food and feed legislation. 

Article  32  of  Regulation  (EC)  No  1333/2008  on  re-evaluation  of 

g) 
approved food additives 
Article 32 of Regulation 1333/2008 lays down the requirement for a re-evaluation of all 
food  additives  that  have  been  approved  before  20  January  2009.  This  shall  comprise  a 
new risk assessment by EFSA, while  an evaluation programme for these additives must 
be  adopted  and  published.  This  programme  has  been  implemented  by  Regulation 
257/2010. 

Extended scope of Regulation (EC) No 1333/2008 

h) 
Regulation 1333/2008 lays down the Community lists of food additives approved for use 
in certain products and the conditions for their use.  

Regulation  1331/2008 lays  down  a  common  authorisation  procedure  for  food  additives, 
enzymes and flavourings. This procedure shall indicate the details for  updating the lists 
of substances approved under Regulations 1332/2008, 1333/2008 and 1334/2008. 

Regulation  1334/2008  on  flavourings  and  certain  food  ingredients  with  flavouring 
properties for use in and on food indicates that flavourings may contain food additives as 
authorised under Regulation 1333/2008. 

212 

 
 
 
 
 
 
 
Directive  2001/112/EC  relating  to  fruit  juices  and  certain  similar  products  intended  for 
human consumption indicates that the labelling of concentrated fruit juice must indicate 
the  presence  and  quantity  of  added  acidifying  agents  in  accordance  with  the  above 
Regulation. Also with regard to the manufacture of fruit nectars without added sugars or 
with  reduced  energy  value,  the  Directive  indicates  that  sugars  may  be  replaced  by 
sweeteners according to the provisions of Reg. 1333/2008. Additives may only be added 
in  products  covered  by  the  Directive  provided  they  meet  the  provisions  of  Reg. 
1333/2008.  

Regulation  251/2014  on  the  definition,  description,  presentation,  labelling  and  the 
protection  of  geographical  indications  of  aromatised  wine  products  indicates  that  the 
provisions  of  Regulation  1333/2008  on  food  additives  and  colours  also  apply  to 
aromatised wine products.  

Regulation 10/2011 on plastic materials and articles intended to come into contact with 
food indicates that additives authorised as food additives or flavourings must not migrate 
into food in such quantities as to have a technological function in the product and must 
not  exceed  the  maximum  levels  established  by  Regulations  1333/2008  and  1334/2008 
or by Reg. 10/2011 in foods where their use is not authorised as additive or flavouring. 

Annex  III  to  Regulation  1169/2011  on  the  provision  of  food  information  to  consumers 
lays down a list of additional labelling particulars that must be included in the labelling of 
products that contain specific additives in accordance with Reg. 1333/2008. 

Implementing  Decision  2012/288/EU  authorises  the  placement  on  the  market  of 
gamma-cyclodextrin  as  a  novel 
ingredient  under  Reg.  258/97.  Similarly 
Implementing Decision 2013/49/EU authorises the placement on the market of synthetic 
zeaxanthin  as  a  novel  food  ingredient  under  Reg.  258/97.  The  intentional  addition  of 
these  substances  in  food  for  technological  purposes  falls  under  the  scope  of  Reg. 
1333/2008. 

food 

Regulation 528/2012 concerning the making available on the market and use of biocidal 
products indicates that biocidal products eligible for a simplified authorisation procedure 
must meet certain conditions one of which is that all the active substances in the product 
are included in Annex I to the Regulation. This Annex also contains a list of substances 
authorised as food additives under Regulation 1333/2008. 

213 

 
 
 
 
 
 
 
Annex XXIII: Additional implementing measures for selected 
Articles  of  Regulation  1332/2008  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1332/2008 and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 6 of Regulation (EC) No 1332/2008 on general conditions 

a) 
for inclusion of food enzymes in the Community list 
Article  6  of  Reg.  1332/2008  indicates  that  food  enzymes  may  be  included  in  the 
Community list if their use has a reasonable technological function and does not mislead 
the  consumer.  Regulation  234/2011 implementing  Regulation  1331/2008  on  a  common 
authorisation  procedure  for  food  additives,  food  enzymes  and  food  flavourings  requires 
that  dossiers  submitted  for  an  application  for  the  safety  evaluation  of  a  substance 
include information to verify compliance with the above two requirements.  

Article 16 of Regulation (EC) No 1332/2008 on Community 

b) 
financing of harmonised policies 
Article  16  of  Reg.  1332/2008  indicates  that  financing  measures  resulting  from  Reg. 
1332/2008  have  their  legal  basis  in  Article  66  of  Reg.  882/2004.  Commission 
Implementing  Decision  2014/C  72/05  lays  down  the  financing  of  the  2014  work 
programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare  and 
plant  health.  IT  Projects  to  support  the  RASFF  must  have  an  informed  view  on  non-
authorised  substances  and  maintain  registers  of  authorised  substances  including 
enzymes.  The  legal  basis  for  the  procurement  of  these  Projects  is  Article  16  of  Reg. 
1332/2008. 

Article 17 of Regulation (EC) No 1332/2008 on the establishment 

c) 
of the Community list of food enzymes 
Article 17 of Reg. 1332/2008 lays down the Community list of food  enzymes. From the 
date  of  application  of  this  list,  the  authorisations  for  E1103  Invertase  and  E1105 
Lysozyme of the old additives Directive 95/2/EC must be repealed.  

Extended scope of Regulation (EC) No 1332/2008 

d) 
Regulation  1332/2008  lays  down  requirements  for  food  enzymes  and  establishes  the 
Community list of food enzymes. 

Directive 83/417/EEC on the approximation of the laws of the Member States relating to 
certain  lactoproteins  (caseins  and  caseinates)  intended  for  human  consumption  lays 
down  standards  for  edible  rennet  casein.  According  to  these,  rennet  and  other  milk-
coagulating  enzymes  must  meet  the  requirements  of  Reg.  1332/2008  in  order  to  be 
used in "edible rennet casein". 

Directive 2001/112/EC lays down provisions on fruit juices and similar products intended 
for  human  consumption.  Annex  I  to  this  Directive  lays  down  provisions  on  ingredients, 
treatments  and  substances  that  may  be  used  in  products  covered  by  the  Directive. 

214 

 
 
 
 
 
 
 
 
Enzyme  preparations,  pectinases  and  amylases  may  be  used  provided  they  meet  the 
requirements of Reg. 1332/2008. 

Regulation  606/2009  laying  down  detailed  rules  for  the  implementation  of  Regulation 
479/2008 as regards the categories of grapevine products, oenological practices and the 
applicable  restrictions  requires  that  enzymes  and  enzymatic  preparations  used  in  the 
authorised  oenological  practices  and  processes  of  the  Annex  to  the  Regulation  should 
meet the requirements of Reg. 1332/2008. 

215 

 
 
 
 
 
 
Annex  XXIV:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1334/2008  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1334/2008 and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 3 of Regulation (EC) No 1334/2008 on definitions 

a) 
Article  3  of  Regulation  1334/2008  lays  down  the  definitions  for  different  categories  of 
flavourings. Annex I to Regulation 251/2014 on the definition, description, presentation, 
labelling and the protection of geographical indications of aromatised wine products lists 
the  flavouring  products  that  are  authorised  for  the  flavouring  of  aromatised  wines  and 
those  authorised  for  the  flavouring  of  aromatised  wine-based  drinks  and  aromatised 
wine-product cocktails.  

The  above  definitions  are  also  used  in  Regulation  110/2008  on  the  definition, 
description, presentation, labelling and the protection of geographical indications of spirit 
drinks  to  indicate  the  type  of  flavourings  that  may  be  used  in  different  product 
categories.  

Regulation  1169/2011  on  the  provision  of  food  information  to  consumers  also  uses  the 
above  definitions  in  order  to  indicate  the  designation  of  flavourings  in  the  list  of 
ingredients of food products. 

Article  4  of  Regulation  (EC)  No  1334/2008  on  general  conditions 

b) 
for use of flavourings or food ingredients with flavouring properties 
Article 4 of Reg. 1334/2008 indicates that only substances that do not pose a safety risk 
to  consumer  health  and  do  not  mislead  the  consumer  may  be  used  in  or  on  foods. 
Regulation  234/2011  implementing  Regulation  1331/2008  on  a  common  authorisation 
procedure  for  food  additives,  food  enzymes  and  food  flavourings  requires  that 
applications for updating the Community list must include a summary dossier indicating 
that  the  use  of  the  substance  complies  with  the  above  conditions  laid  down  in  Reg. 
1334/2008. 

c) 
Article 25 of Regulation (EC) No 1334/2008 on introduction of the 
list  of  flavouring substances  into the Community  list  of  flavourings  and 
source materials and traditional regime 
Article 25 of Reg. 1334/2008 indicates that the Community list of flavouring substances 
must  be  established  by  introducing  the  list  of  flavouring  substances  of  Article  2  of 
Regulation  2232/96  (now  repealed  by  Implementing  Reg.  872/2012)  into  Annex  I  of 
Reg. 1334/2008. It also allows for transitional measures for this process. This has been 
introduced  by  Commission  Implementing  Regulation  872/2012  adopting  the  list  of 
flavouring substances of Reg. 2232/96 as the Union list and introducing it in Annex I of 
Reg. 1334/2008. However the Regulation indicates that for substances under evaluation 
at the date of implementation of the Union list, certain provisions of Reg. 2232/96 shall 
continue to apply. 

Commission  Implementing  Decision  2014/C  72/05  lays  down  the  financing  of  the  2014 
work  programme  on  IT  tools  in  the  field  of  food  safety,  animal  health,  animal  welfare 

216 

 
 
 
 
 
 
 
and plant health. IT Projects to support the RASFF must have an informed view on non-
authorised  substances  and  maintain  registers  of  authorised  substances  including 
flavourings.  The  legal  basis  for  the  procurement  of  these  Projects  is  Article  25  of  Reg. 
1334/2008 

Annex  I  of  Regulation  (EC)  No  1334/2008  on  the  Union  list  of 

d) 
flavourings and source materials  
Articles  9  and  10  of  Reg.  1334/2008  indicate  the  flavourings  and  source  materials  for 
which an evaluation is required. Only approved flavourings and source materials that are 
included  in  the  Union  list  (Annex  I)  may  be  placed  on  the  market  or  used  in  food. 
Regulation 873/2012 lays down some transitional measures concerning the Union list of 
flavouring  substances  and  source  materials  with  regard  to  products  lawfully  placed  on 
the market prior to the implementation of Reg. 1334/2008 but which do not comply with 
Annex I to the Regulation and the date until which they may be consumed. 

Annex  III  of  Regulation  (EC)  No  1334/2008  on  the  presence  of 

e) 
certain substances 
Annex  III  of  Reg.  1334/2008  establishes  some  maximum  levels  for  certain  naturally 
present  substances  in  flavourings  and  food  ingredients  with  flavouring  properties  in 
compound foods to which flavourings or ingredients with flavouring properties have been 
added. Implementing Regulation 131/2012 concerning the authorisation of a preparation 
of  caraway  oil  and  lemon  oil  with  certain  dried  herbs  and  spices  as  a  feed  additive  for 
weaned  piglets  implements  that  the  maximum  levels  for  dried  herbs  and  spices  laid 
down in Part B of Annex III must be respected for the above preparation. 

Extended scope of Regulation (EC) No 1334/2008 

f) 
Regulation  1334/2008  lays  down  provisions  for  the  use  of  flavourings  and  certain  food 
ingredients with flavouring properties in and on foods. 

Regulation 10/2011 on plastic materials and articles intended to come into contact with 
food indicates authorised flavourings must not migrate into food in such quantities as to 
have  a  technological  function  in  the  product  and  must  not  exceed  the  maximum  levels 
established by Regulations 1334/2008 or 10/2011. 

Annex  I  to  Regulation  1334/2008  lays  down  the  Union  list  of  approved  flavourings  and 
source  materials.  3-acetyl-2,5-dimethylthiophene  was  authorised  and  included  in  the 
Union  list  as  a  substance  under  evaluation  for  which  more  scientific  data  needed  to  be 
submitted.  New  data  showed  the  substance  is  mutagenic  and  poses  a  risk  to  human 
health.  The  substance  is  considered  to  also  pose  a  risk  to  animal  health  and  therefore 
Implementing  Regulation  796/2013  denies  authorisation  of  this  substance  for  use  as  a 
feed additive.  

217 

 
 
 
 
 
 
 
 
 
 
Annex  XXV:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  2065/2003  and  their  respective 
requirements 

The following paragraphs highlight the main requirements of  Regulation 1332/2008 and 
provide  additional  regulatory  documents  that  add  to  the  main  text  or  assist  in  the 
implementation of this main text. 

Article 6 of Regulation (EC) No 2065/2003 on the Community list 

a) 
of authorised primary products  
Article  6  of  Reg.  2065/2003  indicates  that  a  Community  list  must  be  established 
containing  all  authorised  primary  products  that  may  be  used  in  or  on  foods  and/or  for 
the  production  of  derived  smoke  flavourings.  This  Community  list  is  implemented  by 
Implementing  Regulation  1321/2013  establishing  a  Union  list  of  authorised  smoke 
flavouring primary products for use as  such in or  on foods and/or for  the production of 
derived smoke flavourings. 

Article  17  of  Regulation  (EC)  No  2065/2003  on  inspection  and 

b) 
control measures 
Article 17 of Reg. 2065/2003 indicates that the Commission with the scientific assistance 
of  EFSA  may  adopt  quality  criteria  for  validated  analytical  methods  for  the  sampling, 
identification  and  characterisation  of  the  primary  products,  as  indicated  in  Annex  II  of 
the  Regulation  laying  down  the  required  information  for  the  evaluation  of  the  primary 
smoke  products.  These  quality  criteria  are  adopted  by  Regulation  627/2006 
implementing Reg. 2065/2003. 

218 

 
 
 
 
 
 
 
 
 
 
 
 
Annex  XXVI:  Additional  implementing  measures  for  selected 
Articles  of  Regulations  315/93  and  1881/2006  and  their 
respective requirements 

Part I: Regulation 315/93 

The  following  paragraphs  highlight  the  main  requirements  of  Regulation  315/93  and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this main text. 

Article 2 of Regulation (EEC) No 315/93 

a) 
Article  2  of  Regulation  315/93  allows  for  the  establishment  of  maximum  tolerances  for 
certain  contaminants  in  order  to  protect  public  health.  Under  this  Article,  Regulation 
1881/2006  lays  down  maximum  levels  for  certain  contaminants  in  foodstuffs.  This 
Regulation is analysed in more detail in Paragraph 6.2.2. 

Under  the  same  Article,  Regulation  124/2009  lays  down  maximum  levels  for  the 
presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-
over  of  these  substances  in  non-target  feed.  This  may  happen  when  residues  of  such 
substances used as legal feed additives remain in the production line and are transferred 
as  carry-overs  to  the  feed  produced  subsequently,  but  also  in  the  other  stages  of  the 
production  and  processing,  storage  or  transport.  This  unavoidable  presence  of 
coccidiostats  or  histomonostats  in  feed,  even  below  maximum  levels  as  established  in 
Directive 2002/32/EC, may result in the presence of residues in food products of animal 
origin. Foodstuffs listed in the Annex to the Regulation must not be placed on the market 
if they contain the contaminants listed at levels higher than the maximum established. It 
is  also indicated  that products  with  residue levels  higher  than  the  established  must  not 
be mixed with compliant foodstuffs. Finally, when applying the maximum levels, changes 
in the concentration of the contaminants due to drying, diluting or processing or due to 
the relative proportion of ingredients in a product must be taken into account. 

Extended scope of Regulation (EEC) No 315/93 

b) 
Regulation  401/2006  lays  down  methods  for  the  sampling,  sample  preparation  and 
analysis for the official control of mycotoxins in foodstuffs. 

Article 7 of Regulation 1272/2009 on detailed rules for the implementation of Regulation 
1234/2007  (on  the  buying-in  and  selling  of  agricultural  products  under  public 
intervention)  lays  down  some  additional  criteria  for  different  products  in  order  to  be 
eligible for public intervention in addition to being sound, fair and of marketing quality. 
Cereals and in particular common wheat and durum wheat must meet the requirements 
for  maximum  contaminants  levels  of  Regulation  315/93  and  those  of  Regulation 
1881/2006 for fusarium toxins. 

Part II: Regulation 1881/2006 
The following paragraphs highlight the main requirements of  Regulation 1881/2006 and 
provide  additional  regulatory  documents  that  add  requirements  or  assist  in  the 
implementation of this main text. 

219 

 
 
 
 
 
 
 
 
Annex of Regulation (EC) No 1881/2006 

a) 
The  Annex  to  Regulation  1881/2006  lays  down  the  maximum  levels  for  certain 
contaminants  in  different  food  products.  Amongst  other  contaminants,  Regulation 
1881/2006  lays  down  maximum  levels  for  Ochratoxin  A  and  implements  that  only 
compliant foodstuffs may be placed on the Community market. Implementing Regulation 
844/2011  approves  the  pre-export  checks  carried  out  by  Canada  on  wheat  and  wheat 
flour  for  presence  of  Ochratoxin  A,  in  order  to  ensure  compliance  with  Community 
legislation.  Each  consignment  of  products  subjected  to  this  pre-export  check,  must  be 
accompanied  by  a  report  containing  the  results  of  sampling  and  analysis  in  accordance 
with Regulation 401/2006 and a  certificate in accordance with the model set out in the 
Annex to Regulation 844/2011. 

Regulation  1881/2006  also  lays  down  maximum  levels  for  dioxins,  furans  and  PCBs  in 
food,  while  Directive  2002/32/EC  lays  down  maximum  levels  for  such  compounds  in 
feed.  Commission  Recommendation  2013/711/EU  on  the  reduction  of  the  presence  of 
dioxins,  furans  and  PCBs  in  food  and  feed,  indicates  that  in  cases  of  non-compliances 
with the above maximum levels, Member States in collaboration with the food business 
operators  should  initiate  investigations  in  order  to  identify  the  source  of  contamination 
and  also  take  measures  to  reduce  or  eliminate  the  source.  Also  Member  States  are 
required to submit the occurrence data for the above contaminants to EFSA and inform 
the  Commission  on  the  results  of  their  investigations  and  the  action  taken  in  case  of 
non-conformances in order to eliminate the problem.  

With regard to the maximum levels for aflatoxins laid down by Regulation 1881/2006, it 
has  been  observed  that  these  have  frequently  been  exceeded  in  certain  products 
originating  from  certain  countries.  Commission  Regulation  1152/2009  lays  down  some 
special conditions for the import of certain foodstuffs from certain third countries due to 
contamination  risk  with  aflatoxins.  These  products  may  only  be  imported  from  the 
specified  countries  provided  they  are  accompanied  by  the  results  of  aflatoxin  sampling 
and analysis (according to Regulation 401/2006) and a health certificate as specified in 
the  Annex  to  the  Regulation,  verified  and  authorised  by  a  representative  of  the 
competent  Authority  of  the  country.  The  Regulation  also  specifies  the  frequency  of 
official controls for the products concerned. 

Regulation 333/2007 lays down methods for sampling and analysis for the official control 
of  the  levels  of  lead,  cadmium,  mercury,  inorganic  tin,  3-MCPD  and  polycyclic  aromatic 
hydrocarbons  in  foodstuffs.  Instructions  are  provided  on  sampling  methods,  sampling 
plans,  sample  preparation  and  analysis.  The  importance  of  a  representative  and 
homogeneous  laboratory  sample  free  from  secondary  contamination  is  emphasised. 
Compliance or not of the sample with the levels of Reg. 1881/2006 is established on the 
basis  of  the  results  obtained  from  the  laboratory  sample.  Also  performance  criteria  are 
established  for  the  methods  of  analysis  for  lead,  cadmium,  mercury  and  inorganic  tin, 
which  can  help  in  choosing  an  appropriate  validated  method  of  analysis  from  specific 
matrices  in  the  absence  of  official  methods  of  analysis.  The  Annex  also  specifies  that 
results must be expressed in the same units as the maximum levels of Reg. 1881/2006 
and  with  the  same  number  of  significance  figures.  Also,  if  an  extraction  step  has  been 
used,  the  results  must  be  corrected  for  recovery  and  the  recovery  level  must  also  be 
reported. Finally, the Regulation explains how the analytical results should be interpreted 
and how a lot or sublot can be accepted or rejected. 

Regulation  1882/2006  lays  down  methods  of  sampling  and  analysis  for  the  official 
control  of  the  level  of  nitrates  in  certain  foodstuffs  and  specifically  in  spinach,  lettuce, 
iceberg-type lettuce, baby foods and processed cereal-based foods for infants and young 
children.  Samples  taken  from  the  field  or  lot  according  to  the  methods  of  sampling 
provided  in  the  Annex  to  the  Regulation  are  considered  representative  of  the  whole  lot 
and  compliance  has  to  be  established  based  on  the  results  obtained  for  the  laboratory 
sample. 

220 

 
 
 
Similar  to  the  above,  Regulation  252/2012  establishes  provisions  for  the  sampling, 
sample preparation, analysis, expression of the results obtained and acceptability of not 
of  the  samples  for  the  official  control  of  dioxins,  dioxin-like  PCBs  and  non-dioxin-like 
PCBs in certain foodstuffs.  

Extended scope of Regulation (EC) No 1881/2006 

b) 
Regulation 1881/2006 on maximum levels for certain contaminants in foodstuffs requires 
Member States to examine foodstuffs other than those included in the Regulation for the 
occurrence  of  3-MCPD,  in  order  to  consider  whether  it  is  required  to  establish  further 
maximum  limits  in  further  foodstuffs.  For  example,  the  French  authorities  have 
discovered  3-MCPD  in  glycerol  used  in  several  different  food  products  and  therefore 
maximum  levels  should  be  established  for  3-MCPD  in  this  product  in  order  to  avoid 
contamination  of  other  foods  with  3-MCPD  in  levels  above  the  acceptable.  These  levels 
are established by Regulation 231/2012 on specifications for food additives of Annexes II 
and III of Regulation 1333/2008. 

Commission Recommendation 2006/583/EC lays down the principles for prevention and 
reduction  of  fusarium  toxins  in  cereals  and  cereal  products.  Different  risk  factors  that 
need  to  be  taken  into  consideration  in  relation  to  Good  Agricultural  Practices  are 
described and different ways for these to be managed at the different steps in the cereal 
production chain from crop planning through to harvesting, storage and transportation. 

221 

 
 
 
 
 
 
Annex XXVII: Additional implementing measures for selected 
Articles  of  Directive  1999/2/EC  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Directive  1999/2/EC  and 
provide additional relevant regulatory documents required for their implementation. 

Article 4 of Directive 1999/2/EC  

a) 
Article 4 of Directive 1999/2/EC requires the establishment of an exhaustive Community 
list of foodstuffs that may be treated with ionising radiation also including the authorised 
maximum  doses  that  may  be  applied.  This  is  implemented  by  Directive  1999/3/EC  on 
the establishment of a Community list of foods and food ingredients treated with ionising 
radiation. 

Article 6 of Directive 1999/2/EC  

b) 
Article  6  of  Directive  1999/2/EC  lays  down  requirements  for  the  labelling  of  foodstuffs 
treated with ionising radiation. The terms "irradiated" or "treated with ionising radiation" 
must  be  used  and  details  are  provided  on  how  these  should  appear  under  different 
conditions  of  sale  or  depending  on  whether  the  foodstuff  is  sold  as  a  product  or  it  is 
included as an ingredient in another product.  Regulation 1169/2011 on the provision of 
food  information  to  the  consumers  also  indicates  that  foods  treated  with  ionising 
radiation must bear the above indications in accordance with Directive 1999/2/EC. 

Article 9 of Directive 1999/2/EC  

c) 
Article  9  of  Directive  1999/2/EC  requires  the  Commission  to  establish  lists  of  approved 
facilities  from  which  the  importation  of  foodstuffs  treated  with  ionising  radiation  is 
permitted. Commission Decision 2002/840/EC adopts a list of approved facilities in third 
countries for the irradiation of foods which is set out in its Annex.  

Extended scope of Directive 1999/2/EC  

d) 
Directive 1999/2/EC lays down requirements for foodstuffs and food ingredients treated 
with  ionising  radiation.  Commission  Decision  2007/363/EC  on  guidelines  to  assist  the 
Member  States  in  preparing  the  single  integrated  multi-annual  national  control  plan 
provided  by  Regulation  882/2004  of  the  European  Parliament  and  of  the  Council 
indicates that the scope of the national controls plans should cover all legislation related 
to  food  and  feed,  thus  including  the  legislation  on  irradiation  covered  by  Directive 
1999/2/EC. 

222 

 
 
 
 
 
 
 
 
 
 
for 
Annex  XXVIII:  Additional 
selected  Articles  of  Regulation  (EC)  No  258/97  and  their 
respective requirements 

implementing  measures 

The following legal documents add information required for the complete implementation 
of Regulation (EC) No 258/97. 

Regulation 609/2013 (Foods for specific groups) 

a) 
Substances  falling  within  the  scope  of  Reg.  (EC)  258/97  shall  be  contained  in  products 
covered  by  Article  1  of  Reg.  (EU)  609/2013  provided  that  they  fulfil  the  conditions  for 
being placed on the market set out in both Regulations. 

Regulation (EU) No 1169/2011 (Food information to consumers) 

b) 
Regulation (EU) No 1169/2011 on the provision of food information to consumers, in the 
introductory  part,  calls  the  Commission  to  provide  for  a  definition  of  engineered 
nanomaterials in the context of the upcoming review of this Regulation on novel foods.  

Catalogue  and  Decisions  that  authorise  novel  food  or  novel  food 

c) 
ingredients under Regulation 258/97  
Decisions and Implementing Decisions that authorise the placing of products on the 
market as novel food or novel food ingredients can be found on the site of DG Health 
and Consumers. 112 113 

112 European Commission, DG Health and Consumers, Novel Food catalogue    
http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_search/index.cfm (►on 14/01/2015) 
113 European Commission, DG Health and Consumers, Novel foods and novel food ingredients – Authorisations 
http://ec.europa.eu/food/food/biotechnology/novelfood/authorisations_en.htm (►on 14/01/2015) 

223 

 
 
 
 
 
 
 
 
 
                                                           
 
Annex  XXIX:  Additional  implementing  measures  for  selected 
Articles  of  Regulation  1935/2004  and  their  respective 
requirements 

The  following  paragraphs  highlight  the  main  requirements  of  Regulation  1935/2004 
providing  additional  relevant  regulatory  documents  required  for  the  implementation  of 
the main text. 

Article 1 of Regulation 1935/2004 on purpose and subject matter 

a) 
Article 1 of Regulation 1935/2004 lays down the scope of the Regulation: the placing on 
the market materials and articles intended to come into contact with food while ensuring 
the effective functioning of the internal market and a high level of protection of human 
health  and  consumer  interests.  Commission  Implementing  Regulation  1335/2013 
approving  benzoic  acid  as  an  existing  active  substance  for  use  in  biocidal  products  for 
product-types  3  and  4  indicates  that  benzoic  acid  should  not  be  used  in  materials  and 
articles  intended  to  come  into  contact  with  food,  unless  specific  migration  limits  have 
been established for benzoic acid into food in accordance with Reg. 1935/2004, or it has 
been established that these are not necessary. A similar requirement is laid down: 

  for  decanoic  acid  by  Commission  Implementing  Regulation  90/2014  approving 
decanoic acid as an existing active substance for use in biocidal products for product-
types 4, 18 and 19,  

  for  octanoic  acid  by  Commission  Implementing  Regulation  93/2014  approving 
octanoic acid as an existing active substance for use in biocidal products for product-
types 4, 18 and 19, 

  for  iodine,  including  polyvinylpyrrolidone  by  Commission  Implementing  Regulation 
94/2014  approving  iodine,  including  polyvinylpyrrolidone  as  an  existing  active 
substance for use in biocidal products for product-types 1, 3, 4 and 22. 

b) 
Article 3 of Regulation 1935/2004 on general requirements 
Article  3  of  Regulation  1935/2004  lays  down  the  general  requirements  that  materials 
and articles intended to come into contact with food must be manufactured under GMP, 
they  must  not  transfer  their  constituents in  food  in  quantities  that  may  pose  danger  to 
human health or alter the composition and organoleptic properties of food and that their 
labelling, presentation and advertising must not be misleading.  

Commission  Regulation  2023/2006  on  good  manufacturing  practice  for  materials  and 
articles  intended  to  come  into  contact  with  food  lays  down  the  GMP  rules  for  the 
materials  listed  in  Annex  I  to  Reg.  1935/2004,  their  combinations  and  for  recycled 
materials  and  articles  used  in  their  manufacture.  Regulation  2023/2006  also  lays  down 
provisions  for  the  formulation,  application,  handling  and  storage  of  printing  inks  in 
accordance  with  GMP,  in  order  to  avoid  transfer  of  the  inks  to  the  food-contact  side  of 
the materials in levels that do not meet the requirements of Article 3 of Reg. 1935/2004. 

Regulation  450/2009  on  active  and  intelligent  materials  and  articles  intended  to  come 
into contact with food indicates that these materials may only be placed on the market if 
they  meet  the  requirements  of  Article  3  of  Reg.  1935/2004.  Also  it  implements  that 
substances to be used in the manufacture of intelligent materials and articles may only 
be placed on the Community list if they also meet the requirements of Articles 3 and 4 
where applicable.  

224 

 
 
 
 
 
 
Commission Regulation 10/2011 on plastic materials and articles intended to come into 
contact with food indicates that plastic materials and articles may only be placed on the 
market  if  they  meet  the  above  requirements  of  Reg.  1935/2004.  Regulation  10/2011 
also indicates that the compliance with the requirements of Article 3 of Reg. 1935/2004 
for  certain  substances  covered  by  derogations  to  the  Union  list  (such  as  polymer 
production  aids,  colourants,  solvents,  mixtures,  monomers,  additives  of  Art.  6  of  Reg. 
10/2011 and multi-material multi-layer materials and articles of Art 14 of Reg. 10/2011) 
must  be  assessed  in  accordance  with  internationally  recognised  principles  of  risk 
assessment. 

Directive  93/11/EEC  concerning  the  release  into  release-test  liquid  of  N-nitrosamines 
and  N-nitrosatable  substances  from  elastomer  or  rubber  teats  and  soothers  lays  down 
requirements that fall within the scope of Article 3 of Regulation 1935/2004. 

Article  4  of  Regulation  1935/2004  on  special  requirements  for 

c) 
active and intelligent materials and articles  
Article 4 of Regulation 1935/2004 indicated that for active and intelligent materials and 
articles  additional  and  more  specific  rules  to  those  of  Reg.  1935/2004  should  be 
established. It also lays down some specific requirements for such materials.  These are 
implemented via Regulation 450/2009, which also indicates that for such materials to be 
placed  on  the  market  the  additional  requirements  of  Article  4  above  must  also  be  met. 
Regulation 450/2009 also implements that substances to be used in the manufacture of 
intelligent  materials  and  articles  may  only  be  placed  on  the  Community  list if  they  also 
meet the requirements of Article 4 where applicable. 

Article 5 of Regulation 1935/2004 on specific measures for groups 

d) 
of materials and articles 
Article 5 of Regulation 1935/2004 indicates that specific measures must be adopted for 
the  categories  of  materials  listed  in  Annex  I  of  the  Regulation,  as  well  as  for  materials 
manufactured  by  combinations  or  recycling  of  these  materials  and  articles.  Within  the 
scope of this Article, the following legislative documents have been implemented: 

  Commission  Regulation  10/2011  on  plastic  materials  and  articles  intended  to  come 
into  contact  with  food,  establishing  specific  requirements  for  the  manufacturing  and 
marketing of such materials.  

  Commission  Directive  2007/42/EC  laying  down  specific  requirements  for  materials 
and  articles  made  of  regenerated  cellulose  film  and  intended  to  come  into  contact 
with food. 

Articles  8-12  of  Regulation  1935/2004  on  authorisation 

e) 
requirements 
Articles  8-12  of  Regulation  1935/2004  lays  down  requirements  for  the  authorisation  of 
substances  to  be  used  in  the  manufacturing  of  materials  and  articles.  Commission 
Regulation 10/2011 on plastic materials and articles intended to come into contact with 
food  indicates  that  only  materials  included  in  the  Union  list  of  approved  substances  of 
Annex  I  to  the  Regulation  may  be  used  in  the  manufacture  of  plastic  layers  for  use  in 
plastic materials and articles. 

Article 9 of Reg. 1935/2004 specifically lays down the procedure for the authorisation of 
substances to be included in Community lists of substances for use in the manufacture of 
materials  and  articles  and  in  active  and  intelligent  materials  and  articles.  Regulation 

225 

 
 
 
 
 
 
450/2009 on active and intelligent materials and articles intended to  come into contact 
with  food  indicates  that  the  Community  list  for  such  materials  must  be  drawn  up  in 
accordance  with  the  above  requirements  of  Reg.  1935/2004.  Reg.  450/2009  also 
specifies  that  the  Community  list  must  be  adopted  by  the  Commission  in  accordance 
with  the  provisions  of  Articles  10  and  11  of  Reg.  1935/2004  which  lay  down  the 
procedure  to  be  followed  by  the  Authority  to  give  an  opinion  and  for  the  Community 
authorisation.  It  also  specified  that  the  above  provisions  must  also  be  followed  for  the 
addition of new substances in the Community list. 

Article 11 specifically indicates that Community authorisations of substances to be used 
in active and intelligent materials and articles must be implemented via the adoption of a 
specific  measure.  Commission  Decision  2010/169/EU  implements  the  non-inclusion  of 
2,4,4’-trichloro-2’-hydroxydiphenyl  ether  in  the  Union  list  of  additives  which  may  be 
used  in  the  manufacture  of  plastic  materials  and  articles  intended  to  come  into  contact 
with  foodstuffs  under  Directive  2002/72/EC  (now  incorporated  in  Reg.  10/2011, 
repealing Dir. 2002/72/EC). 

Article 15 of Regulation 1935/2004 on labelling 

f) 
Article  15  of  Regulation  1935/2004  lays  down  specific  labelling  requirements  for 
materials and articles placed on the market but not yet in contact with food. Commission 
Regulation 10/2011 on plastic materials and articles intended to come into contact with 
food  indicates  that  these  may  only  be  placed  on  the  market,  if  they  comply  with  the 
above requirements of Article 15. The same requirement is also expressed for materials 
falling  within  the  scope  of  Regulation  450/2009  on  active  and  intelligent  materials  and 
articles  intended  to  come  into  contact  with  food.  In  addition,  Regulation  450/2009 lays 
down  some  more  specific  labelling  requirements  for  non-edible  parts  of  active  and 
intelligent materials and articles in order to enable them to be recognised as non-edible. 

Article 16 of Regulation 1935/2004 on declaration of compliance 

g) 
Article 16 of Regulation 1935/2004 indicates the materials and articles listed in Annex I 
of  the  Regulation  and  covered  by  the  specific  measures,  must  be  accompanied  by  a 
written declaration confirming their compliance. This compliance must also be supported 
by appropriate documentation.  

Council  Directive  84/500/EEC  on  the  approximation  of  the  laws  of  the  Member  States 
relating  to  ceramic  articles  intended  to  come  into  contact  with  food  indicates  that 
ceramic articles not yet in contact with food at the marketing or retail stage must also be 
accompanied by the above declaration of compliance, signed by the manufacturer or the 
seller and including the information of Annex III to the Directive. 

Similarly, a declaration of compliance must also accompany plastic materials and articles 
intended  to  come  into  contact  with  food  and  falling  within  the  scope  of  Regulation 
10/2011,  as  well  as  intermediate  products  of  their  manufacture  or  substances  used 
during  this  process,  at  marketing  stages  other  than  retail  sale.  This  written  declaration 
must  contain  the  information  of  Annex  IV  to  the  Regulation  and  be  issued  by  the  food 
business operator. 

Commission Regulation 1895/2005 on the restriction of use of certain epoxy derivatives 
in materials and articles intended to come into contact with food indicates that materials 
and  articles  that  contain  the  substance  2,2-bis(4-hydroxyphenyl)propane  bis(2,3-
epoxypropyl)  ether  (BADGE)  and  its  derivatives  must  be  accompanied  by  a  written 
declaration of compliance in accordance with Article 16 of Reg. 1935/2004, at all stages 
of marketing other than retail. 

226 

 
 
 
 
 
A written declaration of compliance must also accompany materials and articles made of 
regenerated cellulose film and intended to come into contact with food falling under the 
scope of Commission Directive 2007/42/EC, at all stages of marketing other than retail. 
The same requirement also applies active and intelligent materials and articles intended 
to come into contact with food falling within the scope of Regulation 450/2009. 

Article 17 of Regulation 1935/2004 on traceability 

h) 
Article 17 of Regulation 1935/2004 requires that traceability of materials and articles is 
established at all stages, in order to be able to ensure control, product recalls, consumer 
information and attribution of responsibilities. Commission Regulation 10/2011 on plastic 
materials and articles intended to come into contact with food indicates that these may 
only be placed on the market, if they comply with this traceability requirement. 

Article 18 of Regulation 1935/2004 on safeguard measures 
i) 
Article  18  of  Regulation  1935/2004  allows  for  safeguard  measures  for  temporary 
restriction of use of a material or article in case a Member State has reasons to believe 
that  a  material  or  article  may  be  posing  a  threat  to  human  health  and  lays  down  the 
procedure  to  be  followed.  In  that  respect,  Commission  Implementing  Regulation 
321/2011  restricts  the  use  of  Bisphenol  A  in  plastic  infant  feeding  bottles.  This 
Regulation  is  implemented  as  an  amendment  to  Annex  I  of  Regulation  10/2011  on 
plastic materials and articles intended to come into contact with food, which includes the 
Union  list  of  approved  substances  for  use  in  such  materials  and  specifically  as  a 
restriction of use. 

Article  24  of  Regulation  1935/2004  on  inspection  and  control 

j) 
measures 
Article  24  of  Reg.  1935/2004  lays  down  requirements  for  the  official  controls  to  be 
implemented by the Member States in order to ensure compliance with the requirements 
of  the  Regulation.  Regulation  284/2011  lays  down  specific  conditions  and  detailed 
procedures for the import of polyamide and melamine plastic kitchenware originating in 
or consigned from the People’s Republic of China and Hong Kong Special Administrative 
Region, China. 

Extended scope of Regulation 1935/2004 

k) 
Regulation  1935/2004  lays  down  requirements  for  materials  and  articles  intended  to 
come into contact with food. Regulation 450/2009 on active and intelligent materials and 
articles  intended  to  come  into  contact  with  food  lays  down  more  specific  requirements 
for  this  category  of  materials.  Only  substances  that  are  included  in  Community  lists  of 
materials  may  be  used  in  the  manufacture  of  active  and  intelligent  materials  and 
articles.  However,  released  active  substances  and  substances  which  in  order  to  have  a 
technological  effect  in  food  must  be  incorporated  in  active  materials  and  articles  by 
techniques such as grafting or immobilisation, may be used without being included in a 
Community list. 

Council  Directive  2001/112/EC  relating  to  fruit  juices  and  certain  similar  products 
intended  for  human  consumption  indicates  that  certain  substances  such  as  chemically 
inert  filtration  aids  and  precipitation  agents  and  chemically  inert  adsorption  aids  may 
only  be  applied  or  added  to  products  covered  by  the  Directive  if  they  comply  with  the 
requirements of Regulation 1935/2004. 

227 

 
 
 
 
 
 
 
Regulation 606/2009 lays down certain detail rules for implementing Council Regulation 
(EC) No 479/2008 as regards the categories of grapevine products, oenological practices 
and  the  applicable  restrictions.  According  to  these,  ion  exchange  resins,  cationic  resins 
used  for  the  tartaric  stabilisation  of  wine  or  for  acidification  by  cation  exchangers  and 
membranes  used  for  acidification  by  electro-membranary  treatment  may  be  used  as 
authorised oenological practices and processes provided they meet the  requirements  of 
Reg.  1935/2004.  Also  membranes  used  in  the  treatment  for  reduction  of  the  sugar 
content  of  must  by  membrane  coupling,  those  used  in  de-acidification  by  electro-
membrane treatment and also those used in membrane-contractors for the management 
of dissolved gas in wine must comply with the requirements of Reg. 1935/2004 and Reg. 
10/2011. 

Directive  2009/48/EC  on  the  safety  of  toys  indicates  that  the  requirements  of  Reg. 
1935/2004  on  materials  and  articles  intended  to  come  into  contact  with  food  may  be 
considered by the Commission in order to adopt specific limits for chemicals used in toys 
intended  for  children  younger  than  36  months  or  for  toys  intended  to  be  placed  in  the 
mouth. 

Regulation 528/2012 of the European Parliament and of the Council on making available 
on  the  market  and  use  of  biocidal  products  indicates  that  biocidal  products  may  be 
authorised  provided  specific  migration  limits  have  been  established  in  accordance  with 
Reg. 1935/2004.  

Commission Implementing Decision 2013/674/EU on Guidelines on Annex I of Regulation 
1223/2099  on  cosmetic  products  indicates  that  the  characteristics  of  the  packaging 
materials which are in direct contact with cosmetic products are of particular importance 
for  the  safety  of  these  products  and  therefore  the  requirements  of  Reg.  1935/2004 
should be taken into consideration. 

228 

 
 
 
 
 
 
Annex  XXX:  Additional  implementing  measures  for  selected 
Articles  of  Directive  82/711/EEC  and  their  respective 
requirements 

The  following  paragraphs  highlight  certain  requirements  of  Directive  82/711/EEC  and 
provide  the  additional  relevant  regulatory  documents  for  the  implementation  of  the 
Directive. 

Article 2 of Directive 82/711/EEC 

a) 
Article  2  of  Directive  82/711/EEC  indicates  that  the  overall  and  specific  migration  of 
plastic materials and articles into food or food simulants must not exceed the limits laid 
down by relevant legislation. The simulants to be used for the migration testing of plastic 
materials and articles intended to come into contact with foodstuffs are laid down in the 
Annex to Directive 85/572/EEC. 

Annex  to  Directive  82/711/EEC  on  basic  rules  for  overall  and 

b) 
specific migration testing 
The  Annex  to  Directive  82/711/EEC  lays  down  the  rules  for  migration  testing  and 
provides details on the food  simulants to be used, migration test conditions and details 
on fat tests for specific and overall migration. Commission Regulation 10/2011 on plastic 
materials and articles intended to come into contact with food indicates that from the 1st 
January  2013  and  until  the  end  of  2015  the  supportive  documents  demonstrating 
compliance  with  the  requirements  of  Dir.  82/711/EEC,  such  as  testing  conditions  and 
results,  calculations,  modelling,  analysis,  safety  evidence  and  reasoning  of  compliance 
that accompany materials, articles and substances placed on the market must be based 
on the rules for migration testing of Annex to Directive 82/711/EEC. 

Commission Regulation 1895/2005 on the restriction of use of certain epoxy derivatives 
in  materials  and  articles  intended  to  come  into  contact  with  food  indicates  that  the 
migration  testing  for  BADGE  and  certain  of  its  derivatives  must  be  carried  out  in 
accordance with the rules of Dir. 82/711/EEC. 

Commission  Directive  2007/42/EC  laying  down  specific  requirements  for  materials  and 
articles made of regenerated cellulose film and intended to come into contact with food 
indicates  that  the  verification  of  compliance  with  migration  limits  of  materials  falling 
within the scope of this Directive must be carried out in accordance with the rules of Dir. 
82/711/EEC  and  must  be  tested  on  simulants  in  accordance  with  the  provisions  of  Dir. 
85/572/EEC. 

229 

 
 
 
 
 
 
 
 
 
Annex  XXXI:  Additional  implementing  measures  for  selected 
Articles  of  Directive  2000/13/EC  and  their  respective 
requirements 

The  following  Regulations  and  Directives  lay  down  additional  information  necessary  for 
the implementation of the different provisions of Directive 2000/13/EC.  

Regulation  (EC)  No 589/2008  on  implementing  rules  as  regards 

a) 
marketing standards for eggs 

Reg.  (EC)  589/2008114  adds  some  egg-specific  labelling  rules  to  Dir.  2000/13/EC. 
Weight-grading of Class A eggs shall be indicated on the packaging by the corresponding 
letters  or  terms  or  both  (S-small,  M-medium,  L-large,  XL-extra  large),  which  may  be 
supplemented  by  the  corresponding  weight  ranges  (Article  4).  An indication  of  advising 
consumers  to  keep  eggs  chilled  after  purchase  shall  also  be  added  (Article  12(1)f). 
Moreover, the date of minimum durability shall be fixed at not more than 28 days after 
laying (Articles 6(3) -12(1)d- 13). 

Regulation (EU) No 1151/2012 on quality schemes for agricultural 

b) 
products and foodstuffs 
Article  12  of  Reg.  (EU)  1151/2012  115  allows  that  the  collective  geographical  marks, 
guarantee marks and certification marks authorised by Member States (as referred to in 
Article  15  of  Directive  2008/95/EC  to  approximate  the  laws  of  the  Member  States 
relating  to  trade  marks  116)  may  be  used  on  labels,  together  with  the  protected 
designation of origin or protected geographical indication. 

Regulation (EC) No 834/2007 on organic production and labelling 

c) 
of organic products and repealing Regulation (EEC) No 2092/91 
Articles  23-26  of  Reg.  (EC)  No  834/2007117  lay  down  specific labelling  rules  for  organic 
products. Labelling, advertising or commercial documents may use terms such as  "eco" 
and "bio" (i.e. as listed in the Annex) to describe an organic product, its ingredients, or 
raw  materials.  The  labelling  must  be  clearly  visible  on  the  packaging  or  in  the 
ingredients’ list (for processed foods, indicating which of the ingredients are organic), it 
must  contain  the  code  number  of  the  control  body  that  certifies  the  product,  the 
Community  logo  (optional  for  products  imported  from  third  countries)  accompanied  by 
an  indication  of  the  origin  of  raw  materials  (EU  or  non-EU  agriculture,  or  both)  used  in 
the  product  placed  in  the  same  field  of  vision.  National  and  private  logos  may  also  be 
used  in  the  labelling,  presentation  and  advertising  of  products  which  satisfy  the 
requirements  set  out  under  this  Regulation.  Competence  authorities  of  Member  States 
shall take additional measures to ensure compliance.   

114 Commission Regulation (EC) No 589/2008 laying down detailed rules for implementing Council Regulation (EC) No 1234/2007 as 
regards marketing standards for eggs. Official Journal of the European Union (2008). L. 163/6 
115 Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and 
foodstuffs. Official Journal of the European Union (2012). L. 343/1 
116 Directive 2008/95/EC of the European Parliament and of the Council to approximate the laws of the Member States relating to trade 
marks. Official Journal of the European Union (2008). L. 299/25 
117 Council Regulation (EC) No 834/2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 
2092/91. Official Journal of the European Union (2007). L. 189/1 

230 

 
 
 
 
 
 
 
 
                                                           
Regulation (EC) No 1333/2008 on food additives 

d) 
Labelling  of  food  additives  must  comply  with  the  general  labelling  conditions  defined  in 
Dir.  2000/13/EC.  In  addition,  Articles  21-25  of  Reg.  (EC)  No  1333/2008  118    lay  down 
specific  labelling  rules  for  food  additives.  In  particular,  this  information  must  include, 
among  others:  name  and  or  E-number,  information  on  batch  or  lot,  manufacturer,  the 
statement  "for  food"  or  the  statement  "restricted  use  in  food",  an  indication  of  the 
maximum  quantity  that  can  be  used,  special  conditions  of  storage,  instructions  of  use, 
specific  warnings  for  the  food  colours  listed  in  Annex  V  and  the  sweeteners  containing 
polyols and/or aspartame and/or aspartame-acesulfame  salt and minimum durability or 
use-by date. 

Regulation (EU) No1379/2013 on the common organisation of the 

e) 
markets in fishery and aquaculture products 
Originally, it is Regulation (EC) No 2065/2001 that refers to Directive 2000/13/EC but it 
has  been  repealed  by  Regulation  (EU)  No  1379/2013  that  in  turn  refers  to  the  new 
Framework  Regulation  2011/13.  Please,  refer  to  the  respective  part  in  the  chapter 
dealing with this new Regulation. 

f) 
Regulation  (EC)  No  543/2008  laying  down  detailed  rules  for  the 
application  of  Council  Regulation  (EC)  No  1234/2007  as  regards  the 
marketing standards for poultry meat 
Originally,  it  was  Regulation  (EC)  1321/2002  amending  Regulation  (EEC)  1538/91 
introducing  detailed  rules  for  implementing  Council  Regulation  (EEC)  No  1906/90  on 
certain  marketing  standards  for  poultry  meat  119referring  to  Dir.  2000/13/EC.  However, 
Reg. (EC) 1321/2002 has been repealed by Reg. (EC) No 543/2008  120 which lays down 
specific rules for the marketing of poultry meat (Articles 3-5). Hence, it is required that 
the  accompanying  commercial  documents  (as  defined  by  Article  13(1)b  of  Reg. 
2000/13/EC)  of  poultry  meat  shall  also  indicate:  classification  (Class  A  or  Class  B) 
according to the conformation and appearance of the carcasses or cuts and the condition 
in  which  the  poultry  meat  is  marketed  (fresh,  frozen,  quick-frozen).  For  fresh  poultry 
meat,  the  date  of  minimum  durability  shall  be  replaced  by  the  "use  by"  date  in 
accordance  with  Article  10  of  Dir.  2000/13/EC.  In  the  case  of  pre-packaged  poultry 
meat,  the  following  particulars  shall  also  appear  on  the  pre-packaging  or  on  a  label 
attached  thereto:  the  class  (as  above),  the  total  price  and  the  price  per  weight  unit  at 
the  retail  stage  (for  fresh  poultry),  the  registered  number  of  the  slaughterhouse  or 
cutting  plan,  indication  of  the  country  of  origin  if  imported  by  third  countries.  Where 
poultry  meat  is  offered  for  sale  to  the  ultimate  consumer  or  to  mass  caterers  without 
pre-packaging  then,  Article  14  of  Dir.  2000/13/EC  shall  apply,  i.e.  the  Member  States 
shall  adopt  detailed  rules  concerning  the  manner  in  which  the  above  mentioned 
particulars are to be shown. Other indications that may appear on the labelling include: 
the  methods  of  chilling  (air  chilling,  air-spray  chilling,  immersion  chilling,  Art.10)  and 
types  of  farming  (excluding  biological/organic,  and  including  statements  as  "fed  with", 
"free range", "extensive indoor" etc., Art.11). 

118 Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Official Journal of the European 
Union (2008). L. 354/16 
119 Commission Regulation (EC) No 1321/2002 amending Regulation (EEC) No 1538/91 introducing detailed rules for implementing 
Council Regulation (EEC) No 1906/90 on certain marketing standards for poultrymeat. Official Journal of the European Communities 
(2002). L. 194/17 
120 Commission Regulation (EC) No 543/2008 of 16 June 2008 laying down detailed rules for the application of Council Regulation (EC) 
No 1234/2007 as regards the marketing standards for poultrymeat. Official Journal of the European Union (2008). L. 157/46 

231 

 
 
 
 
  
                                                           
Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and 
g) 
feed and Regulation (EC) No 1830/2003 concerning the traceability and 
labelling  of  genetically  modified  organisms  and  the  traceability  of  food 
and  feed  products  produced  from  genetically  modified  organisms  and 
amending Directive 2001/18/EC 
Articles  12-14  of  Reg.  (EC)1829/2003  121  and  Article  4  of  Reg.  (EC)  1830/2003  122 
require  mandatory  labelling  for  products  that  consist  of  GMO  or  contain  GMO  and  for 
products  derived  from  GMO  but  no  longer  containing  GMO.  Operators  of  authorised 
products  consisting  of  or  containing  GMOs  shall  ensure  that  the  words  "This  product 
contains genetically modified organisms" or "This product contains (name of ingredient) 
produced  from  genetically  modified  [name  of  organism(s)]"  or  "produced  from 
genetically  modified  (name  of  organism)"  appear  in  the  list  of  ingredients  for  pre-
packaged products, and on, or in connection with, the display of the product for non-pre-
packaged products. This labelling shall not apply to traces of GMOs in products provided 
that  these  traces  are  adventitious  or  technically  unavoidable,  in  a  proportion  no  higher 
than  the  thresholds  established  in  accordance  with  Directive  2001/18/EC  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms123  and  Reg. 
(EC) No 1829/2003. 

h) 
Regulation (EC) No 1935/2004 of the European Parliament and of 
the  Council  of  27 October  2004  on  materials  and  articles  intended  to 
come into contact with food and Regulation (EC) No 450/2009 on active 
and intelligent materials and articles intended to come into contact with 
food 
Materials and articles, which are not yet in contact with food when placed on the market, 
shall  be  accompanied  by  the  words  "for  food  contact"  or  a  specific  indication  for  their 
use, special instructions for safe and appropriate use, if necessary, and other information 
(e.g.  related  to  traceability  (trade  name,  processor,  seller),  according  to  Article  15  of 
Reg.  (EC)  1935/2004124.  Under  Article  4  of  the  same  Regulation,  active  and  intelligent 
food  contact  materials  are  considered  as 
ingredients  within  the  meaning  of 
Article 6(4)(a) of Dir. 2000/13/EC and thus, shall be listed in the ingredients’ list. Active 
and  intelligent  materials  when  in  contact  with  food  and  to  allow  identification  of  non-
edible parts shall a) be labelled so that it is clear that they are active and/or intelligent, 
and  b)  add  a  label  that  bears  the  words  "DO  NOT  EAT"  as  well  as  (if  possible)  the 
respective symbol, as required in Article 11 and Annex I of Reg. (EC) 450/2009. 

Regulation  (EC)  No  1925/2006  on  the  addition  of  vitamins  and 

i) 
minerals and of certain other substances to foods 
Article  7  of  Reg.  (EC)  1925/2006  125  contains  specific  labelling  provisions  for  vitamins 
and  minerals  added  to  foods  that  shall  apply  in  addition  to  the  requirements  of  Dir. 
2000/13/EC  and  Regulation  1924/2006  on  health  and  nutrition  claims  (see  Directive 

121 Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed. Official Journal of 
the European Union (2003). L. 268/1 
122 Regulation (EC) No 1830/2003 of the European Parliament and of the Council concerning the traceability and labelling of genetically 
modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 
2001/18/EC. Official Journal of the European Union (2003). L. 268/24 
123 Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically 
modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Communities (2001). L. 106/1 
124 Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact 
with food and repealing Directives 80/590/EEC and 89/109/EEC. Official Journal of the European Union (2004). L. 338/4 
125 Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals 
and of certain other substances to foods. Official Journal of the European Union (2006). L. 404/26 

232 

 
 
 
 
 
                                                           
90/496  on  nutrition  labelling),  e.g.  that  the  labelling,  presentation  and  advertising  of 
foods with added vitamins and minerals should not imply that a balanced and varied diet 
cannot achieve appropriate quantities of vitamins or minerals 

Regulation (EC) No 1924/2006 on nutrition and health claims 

j) 
made on food 
Reg.  (EC)  1924/2006  complements  the  general  principles  of  Dir.  2000/13/EC  and  lays 
down  specific  provisions  concerning  the  use  and labelling  of  nutrition  and  health  claims 
concerning food. In particular, the labelling, presentation and advertising related to them 
must  provide  certain  obligatory  information,  such  as  a  statement  indicating  the 
importance of a varied and balanced diet and a healthy lifestyle, the quantity of the food 
and pattern of consumption which will ensure the claimed beneficial effect, a statement 
addressed  to  persons  who  should  avoid  the  substance  concerned,  a  warning  of  the 
health  risks  caused  by  excessive  consumption  (Article  10).  Moreover,  this  Regulation 
prohibits: claims that imply that health could be affected by not consuming the particular 
food,  health  claims  which  refer  to  the  rate  or  amount  of  weight loss,  and  references  to 
an individual health professional or other associations (only national medical associations 
and health-related charities are allowed). Claims related to human disease or children’s 
development and health (Article 14) can only be allowed if a) they have been authorised 
in accordance with Articles 15 to 18 of this Regulation, and b) it also bears a statement 
that a disease can have multiple risk factors and altering of one may or may not have a 
beneficial effect. For the nutrition labelling of such products see chapter 8.1.3 

k) 
Regulation (EU) No 1308/2013 of the European Parliament and of 
the Council of 17 December 2013 establishing a common organisation of 
the markets in agricultural products 
Originally,  it  is  Regulation  700/2007  on  the  marketing  of  the  meat  of  bovine  animals 
aged  12  months  or  less  that  refers  to  Directive  2000/13.  However,  this  Regulation  has 
been  repealed  by  Regulation  (EC)  No  361/2008  which  amends  Regulation  (EC) 
No 1234/2007, which in turn has been repealed by Regulation (EU) No 1308/2013 which 
already  partially  applies  since  2013  and  only  few  provisions  shall  apply  from  2015  and 
2017 onwards. Since there are two legal acts for the labelling requirements of foodstuffs, 
for reasons of clarity, only Regulation 1308/2013 and its relation with Directive 2000/13 
(or  the  new  Framework  Regulation  1169/2011)  will  be  reported  hereby.  (For  further 
details on Reg. 1169/2011, please refer to Ch. 8.1.2).  

Thus,  according  to  Article  87,  a  term  shall  be  eligible  to  be  reserved  as  an  additional 
optional reserved term only if the conditions and use of the term are in conformity with 
Directive 2000/13 (or Regulation 1169/2011). For labelling and presentation in the wine 
sector,  according  to  Article  118,  horizontal  rules  of  Directive  2000/13  (or  Regulation 
1169/2011) for shall apply unless is otherwise provided by this regulation. Articles 117-
123 lay down specific (mandatory and optional) labelling and presentation requirements 
for  wine  (e.g.  category  of  the  grapevine,  indication  of  provenance,  indication  of  the 
bottler,  sugar  content  for  sparkling  wine,  the  vintage  year,  name  of  one  or  more  wine 
grape varieties etc.). For meat of bovine animals aged less than 12 months, according to 
Annex VII, Part I, Point IV, operators shall label the meat with the sales description and 
the  age  of  the  animals  on  slaughter  ("less  than  8  months"  or  "from  8  to  less  than  12 
months").  For  milk  and  milk  products,  names  that  are  actually  used  for  milk  products 
within  the  meaning  of  Article  5  of  Directive  2000/13  (or  Article  17  of  Regulation 
1169/2011)  shall  also  be  reserved  exclusively  for  milk  products  (Annex  VII,  Part  III, 
3(b)). 

233 

 
 
 
 
 
 
Commission  Implementing  Regulation  (EU)  No  543/2011  of  7 
l) 
June  2011  laying  down  detailed  rules  for  the  application  of  Council 
Regulation  (EC)  No  1234/2007  in  respect  of  the  fruit  and  vegetables 
and processed fruit and vegetables sectors 
Regulation (EU) 543/2011126 (which repealed Regulation (EC) No 1580/2007 laying down 
implementing rules of Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) 
No 1182/2007 in the fruit and vegetable sector127) refers to Dir. 2000/13/EC in relation 
to  information  particulars  required  by  marketing  standards  of  fruits  and  vegetables 
(Articles  5  and  6).The  information  particulars  shall  be  shown  legibly  and  obviously  on 
one side of the packaging, either directly onto the package or on a label affixed to it, and 
should  be  available  to  consumers  before  purchase  (e.g.  in  distance  selling).  For  goods 
shipped in bulk, information particulars shall be given in a document accompanying the 
goods.  The  retailer  should  display  prominently  the  information  particulars  relating  to 
country  of  origin  and,  where  appropriate,  class  and  variety  or  commercial  type. 
According  to  Annex  I,  general  marketing  standards  in  relation  to  labelling  include:  The 
name and the address of the packer and/or the dispatcher or of a seller (in case of pre-
packages) and full name of the country of origin in the language of the country of origin 
or  any  other  language  understandable  by  the  consumers  of  the  country  of  destination. 
For  apples,  citrus  fruit (lemons,  oranges  etc.),  kiwifruit,  lettuces  and  varieties,  peaches 
and  nectarines,  pears,  strawberries,  sweet  peppers,  tomatoes  and  table  grapes  more 
specific requirements apply (Annex I, Part B, Part 1-10). 

m)  Regulation  (EC)  No  110/2008  of  the  European  Parliament  and  of 
the  Council  of  15  January  2008  on  the  definition,  description, 
presentation, labelling and the protection of geographical indications of 
spirit drinks 
In Articles 7-14, Regulation (EC) 110/2008128 provides specific labelling and presentation 
rules  for  spirit  drinks  in  addition  to  labelling  requirements  of  Dir.  2000/13/EC.  In 
particular,  where  a  raw  material  was  used  to  produce  the  ethyl  alcohol  of  agricultural 
origin,  or  the  drink  is  comprised  of  mixtures,  each  agricultural  alcohol  ingredient  used 
shall  be  mentioned  in  a  descending  order  of  the  quantity  used.  If  the  spirit  drink  is  a 
blend of two or more spirit drinks belonging to the same category then the term "blend", 
"blending"  or  "blended"  may  be  used.  Maturation  period  or  age  may  be  specified  only 
where it refers to the youngest alcoholic component.  

n) 
Regulation  (EC)  No  41/2009  of  20  January  2009  concerning  the 
composition and labelling of foodstuffs suitable for people intolerant to 
gluten 
Reg.  (EC)  41/2009  provides  the  specific  composition  and  labelling  requirements  for 
foodstuffs  for  people  intolerant  to  gluten,  in  addition  to  rules  laid  down  in  Directive 
2000/13. Products processed to contain a level of gluten less than 100 mg/kg, shall bear 
the term "very low gluten". They may bear the term "gluten-free" if the gluten content is 
less than 20 mg/kg in the food. These terms shall appear in proximity to the name under 

126 Commission Implementing Regulation (EU) No 543/2011 laying down detailed rules for the application of Council Regulation (EC) No 
1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors. Official Journal of the European Union 
(2011). L. 157/1 
127 Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of Council Regulations (EC) No 
2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector. Official Journal of the European Union (2007). L. 
350/1 
128 Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and 
the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89. Official Journal of the 
European Union (2008). L. 39/16 

234 

 
 
 
 
 
                                                           
which the food is sold. Products intended for normal consumption or other particular use 
but  are  nevertheless  suitable  to  meet  the  special  dietary  needs  of  people  intolerant  to 
gluten shall not bear the term  "very low gluten". This Regulation  129 has been repealed 
by  Regulation  (EU)  609/2013  on  food  intended  for  infants  and  young  children,  food  for 
special medical purposes, and total diet replacement for weight control130, which will only 
however  apply  from  July  2016;  Regulation  (EU)  609/2013  states  that  "For  the  sake  of 
clarity  and  consistency,  the  rules  on  the  use  of  the  statements  "gluten-free"  and  "very 
low gluten" should also be regulated under Regulation (EU) No 1169/2011." 

Commission  Implementing  Regulation  (EU)  No  29/2012  of  13 

o) 
January 2012 on marketing standards for olive oil 
Regulation  (EU)  29/2012  131  lays  down  specific  standards  for  retail-stage  marketing  of 
olive oils and olive-pomace oils (referred to in points 1(a) and (b), 3 and 6 of Annex XVI 
to  Regulation  (EC)  1234/2007  establishing  a  common  organisation  of  agricultural 
markets and on specific provisions for certain agricultural products132), in addition to the 
general provisions of Dir. 2000/13/EC. According to Articles 3-4: a) the labelling of oils 
shall  bear  in  clear  and  indelible  lettering,  in  addition  to  the  name  under  which  the 
product  is  sold,  information  on  the  category  of  oil  (e.g.  for  extra  virgin  olive  oil: 
"superior  category  olive  oil  obtained  directly  from  olives  and  solely  by  mechanical 
means"), b) extra virgin olive oil and virgin olive oil shall bear a designation of origin on 
the  labelling,  c)  in  the  case  of  blends  of  olive  oils  originating  from  more  than  one 
Member State or third country shall also be labelled as appropriate (e.g.  "blend of olive 
oils of European Union origin" or a reference to the Union). Optional indications of Article 
5  include:  indication  of  the  extraction  system  only  for  extra  virgin  or  virgin  olive  oils 
(e.g.  "first  cold  pressing",  "cold  extraction"),  indications  of  organoleptic  properties 
referring to taste and/or smell only for extra  virgin or virgin olive oils, indication of the 
peroxide value, the wax content and the ultraviolet absorption. Indication of the acidity 
or maximum acidity may appear only if it is accompanied by an indication, in lettering of 
the same size and in the same visual field. Article 6 refers to specific provisions for blend 
of oils and the presence of oils in foodstuffs. 

p) 
Regulation  (EC)  No  853/2004  of  the  European  Parliament  and  of 
the Council of 29 April 2004 laying down specific hygiene rules for food 
of animal origin 
This  Regulation133  lays  down  specific  labelling  hygiene  standards  for  food  of  animal 
origin. These can be found in Annex II and III. In the case of frozen food of animal origin 
intended for human consumption, the food business operator should have information on 
the  date  of  production  and  freezing.  The  form  in  which  the  information  must  be  made 
available is up to the choice of the supplier of the frozen food, as long as the information 
requested  will  be  clearly  available.  Requirements  for  specific  products  can  be  found  in 

129 Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. 
Official Journal of the European Union (2009). L. 16/3 
130 Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for 
special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission 
Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council 
and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009. Official Journal of the European Union (2013). L. 181/35 
131 Commission Implementing Regulation (EU) No 29/2012 on marketing standards for olive oil. Official Journal of the European Union 
(2012). L. 12/14 
132 Council Regulation (EC) No 1234/2007 establishing a common organisation of agricultural markets and on specific provisions for 
certain agricultural products. Official Journal of the European Union (2007). L. 299/1 
133 Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal 
origin. Official Journal of the European Union (2004). L. 139/55 

235 

 
 
 
 
 
                                                           
Annex  III  and  refer  to  foods  such  as  minced  meat,  bivalve  molluscs,  raw  cow’s  milk, 
dairy and egg products, gelatine. 

Directive  2011/91/EU  of  the  European  Parliament  and  of  the 
q) 
Council  on  indications  or  marks  identifying  the  lot  to  which  a  foodstuff 
belongs 
Directive  2011/91/EU134  requires  that  an  identification  of  the  lot  to  which  a  foodstuff 
belongs  shall  be  added  on  the  label.  The  lot  shall  be  determined  by  the  business 
operator  (producer,  packager  etc.)  and  shall  be  preceded  by  the  letter  "L".  Date  of 
minimum durability or "use by" date, may also serve as the lot identification, provided it 
is indicated precisely. 

Council  Directive  2001/112/EC  relating  to  fruit  juices  and  certain 

r) 
similar products intended for human consumption 
Labelling  of  fruit  juices  and  similar  products  are  subject  to  specific  rules  laid  down  in 
Directive 2001/112/EC135. In addition to Dir. 2000/13/EC, specific provisions of Articles 3 
and 4 include rules, for example, on the labelling of single or mixed fruit juices, on the 
presence of added sugars or the presence of fruit pulps. 

Council Directive 2001/110/EC of 20 December 2001 relating to 

s) 
honey 
According to Articles 2 and 3 of this Directive136, in addition to the general provisions of 
Dir. 2000/13/EC, the labelling of honey must include the country of origin (or to indicate 
if  the  blend  is  a  mix  of  EC,  non-EC  or  both),  the  product  names  (Annex  I:  names, 
product descriptions and definitions), information on regional, territorial or topographical 
origin, or on floral or vegetable origin, or specific quality criteria. 

Council  Directive  2001/111/EC  of  20  December  2001  relating  to 

t) 
certain sugars intended for human consumption 
In accordance with both Directive 2000/13/EC and Article 2 of Directive 2001/111/EC137, 
labelling  of  certain  sugars  intended  for  human  consumption  must  include:  the  term 
"crystallised"  for  invert  sugar  syrup  incorporating  crystals  in  the  solution,  the  levels  of 
dry  matter  and  invert  sugar  content  for  invert  sugar  solutions  and  invert  sugar  syrup, 
the  term  "glucose-fructose  syrup"  or  "fructose-glucose  syrup"  and  "dried  glucose-
fructose syrup" or "dried fructose-glucose syrup" for glucose syrups which contain more 
than 5 % of fructose. 

134 Directive 2011/91/EU of the European Parliament and of the Council on indications or marks identifying the lot to which a foodstuff 
belongs. Official Journal of the European Union (2011). L. 334/1 
135 Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption. Official Journal of 
the European Communities (2002). L. 10/58 
136 Council Directive 2001/110/EC relating to honey. Official Journal of the European Communities (2002). L. 10/47 
137 Council Directive 2001/111/EC relating to certain sugars intended for human consumption. Official Journal of the European 
Communities (2002). L. 10/53 

236 

 
 
 
 
 
 
 
 
                                                           
Council  Directive  2001/113/EC  of  20  December  2001  relating  to 
u) 
fruit  jams,  jellies  and  marmalades  and  sweetened  chestnut  purée 
intended for human consumption 
According  to  Article  2  of  Directive  2001/113/EC138,  labelling  of  these  products  shall 
include:  the  product  name  supplemented  by  an  indication  of  the  fruit  or  fruits  used  (in 
descending order of weight), fruit content per 100 grams of product, total sugar content 
(if no nutrition claim is made for sugars on the labelling) and residual content of sulphur 
dioxide where it is more than 10 mg/kg. 

v) 
Directive  2002/46/EC  of  the  European  Parliament  and  of  the 
Council of 10 June 2002 on the approximation of the laws of the Member 
States relating to food supplements 
In  accordance  with  both  Dir.  2000/13/EC  and  Articles  6-9  of  Directive  2002/46/EC  139, 
labelling  of  food  supplements  that  are  marketed  as  foodstuffs  and  presented  as  such, 
must include: the names of the categories of the nutrients or substances, the portion of 
the  product  recommended  for  daily  consumption,  a  declaration  that  the  supplement  is 
not a substitute for a varied diet, the reference "This is not a medicinal product" where 
the its presentation is similar to that of a medicinal product and the warning "should be 
stored  out  of  the  reach  of  young  children".  The  labelling  of  food  supplements  must  not 
contain  statements  attributing  properties  of  preventing  or  treating  a  disease  nor  any 
mention stating or implying that a balanced and varied diet cannot provide appropriate 
quantities  of  nutrients  in  general.  The  amount  of  the  nutrients  or  substances  shall  be 
declared  on  the  labelling  in  numerical  form,  per  portion,  as  recommended  for  daily 
consumption,  expressing  average  values  based  on  the  manufacturer's  analysis  of  the 
product. 

w) 
Commission  Directive  2006/141/EC  of  22  December  2006  on 
infant  formulae  and  follow-on  formulae  and  amending  Directive 
1999/21/EC 
Directive  2006/141/EC140,  in  Articles  13  and  14,  adopts  additional  labelling  and 
advertising rules to those of Dir. 2000/13/EC, on infant formulae and follow-on formulae 
in order to promote and protect breast feeding. In particular, infant formulae and follow-
on  formulae  can  be  sold  under  the  name:  "infant  formulae"  and  "follow-on  formulae", 
unless they are entirely manufactured from cows' milk proteins and the name shall be: 
"infant  milk"  and  "follow-on  milk"  respectively.  Mandatory  particulars 
include 
statements:  on  the  superiority  of  breast  feeding,  that  the  product  is  suitable  for 
particular nutritional use by infants from birth when they are not breast fed or by infants 
aged over six months, recommendation for use after advice from qualified professionals, 
the energy value and protein, carbohydrate and fat content, instructions concerning the 
preparation  etc.  The  labelling  of  infant  formulae  shall  not  include  pictures  of  infants. 
Advertising  shall  be  restricted  to  publications  specialising  in  baby  care  and  scientific 
publications  and  MS  shall  ensure  that  it  does  not  favour  bottle-feeding  over  breast 
feeding.  These  rules  shall  only  be  valid  until  the  implementation  of  Regulation  (EU) 
609/2013  on  food  intended  for  infants  and  young  children,  food  for  special  medical 
purposes, and total diet replacement for weight control, i.e. July of 2016. 

138 Council Directive 2001/113/EC relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human 
consumption. Official Journal of the European Communities (2002). L. 10/67 
139 Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to 
food supplements. Official Journal of the European Communities (2002). L. 183/51 
140 Commission Directive 2006/141/EC on infant formulae and follow-on formulae and amending Directive 1999/21/EC. Official Journal of 
the European Union (2006). L. 401/1 

237 

 
 
 
 
 
                                                           
Commission  Directive  2006/125/EC  of  5  December  2006  on 
x) 
processed  cereal-based  foods  and  baby  foods  for  infants  and  young 
children 
Article 8 of Directive 2006/125/EC141 lays down additional labelling rules to those of Dir. 
2000/13/EC,  on  processed  cereal-based  foods  and  baby  foods.  Labelling  must  bear  the 
following  mandatory  information:  i)  the  age  from  which  the  product  may  be  used  (not 
less  than  four  months),  ii)  the  presence  or  absence  of  gluten  (if  for  less  than  six 
months),  iii)  energy  value,  protein,  carbohydrate  and lipid  content,  average  quantity  of 
each mineral substance and of each vitamin (expressed in numerical form, per 100 g or 
100 ml  of  the  product),  iv)  instructions  for  appropriate  preparation.  Non-mandatory 
information includes  the  average  quantity  of  the  other  nutrients  set  out  in  Annex  IV  or 
information on vitamins and minerals expressed as a percentage of the reference values. 
These rules shall only be valid until full implementation of Regulation (EU) 609/2013 on 
food intended for infants and young children, food for special medical purposes, and total 
diet replacement for weight control, i.e. July of 2016. 

y) 
Directive  2009/39/EC  of  the  European  Parliament  and  of  the 
Council  of  6  May  2009  on  foodstuffs  intended  for  particular  nutritional 
uses 
Foodstuffs intended for particular nutritional uses shall comply with the general rules of 
Directive  2000/13/EC.  However,  according  to  Articles  7-9  of  Regulation  2009/39/EC142, 
the  designation  under  which  a  dietetic  product  is  sold  must  be  accompanied  by  an 
indication  of  its  particular  nutritional  characteristics  and  include  information  on:  the 
composition  or  manufacturing  process,  the  energy  value  (in  Kj  and  Kcal),  the 
carbohydrate, protein and fat content per 100 grams or 100 millilitres of product. These 
products  shall  only  be  allowed  on  the  market  in  pre-packaged  form.  These  rules  shall 
only  be  valid  until  full  implementation  of  new  Regulation  (EU)  609/2013  on  food 
intended for infants and young children, food for special medical purposes, and total diet 
replacement for weight control, i.e. July of 2016. 

z) 
Directive  2009/54/EC  of  the  European  Parliament  and  of  the 
Council  of  18  June  2009  on  the  exploitation  and  marketing  of  natural 
mineral waters 
Directive 2009/54/EC143, in Articles 7-9, adopts additional labelling rules to those of Dir. 
2000/13/EC,  on  natural  mineral  waters.  Mandatory  labelling  information  includes:  the 
statement  of  analytical  composition,  the  name  of  the  spring  and  the  place  of 
exploitation, information on any treatments. Claims attributing properties relating to the 
prevention  or  treatment  of  a  disease  are  prohibited.  Member  States  may  authorise  the 
indications "stimulates digestion", "may facilitate the hepato-biliary functions" or similar 
indications, under certain circumstances.  

141 Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children. Official Journal of 
the European Union (2006). L. 339/16 
142 Directive 2009/39/EC of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses. Official 
Journal of the European Union (2009). L. 124/21 
143 Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural 
mineral waters. Official Journal of the European Union (2009). L. 164/45 

238 

 
 
 
 
 
 
                                                           
aa)  Council  Directive  2001/114/EC  of  20  December  2001  relating  to 
certain  partly  or  wholly  dehydrated  preserved  milk  for  human 
consumption 
Article  3  of  Directive  2001/114/EC  144  adopts  additional  provisions  to  those  of  Directive 
2000/13  on  labelling  of  preserved  milk  products.  Thus,  the  labels  must  state:  the 
percentage  of  fat  (except  for  condensed  milk,  sweetened  condensed  partly  skimmed 
milk,  and  dried  skimmed  milk),  the  percentage  of  fat-free  dried  milk  extract  (for  the 
different types of partially dehydrated milk), the method of dilution or reconstitution (for 
dehydrated  milk),  that  the  product  ‘is  not  intended  as  a  food  for  infants  under  twelve 
months’ (for dehydrated milk).  

144 Council Directive 2001/114/EC of 20 December 2001 relating to certain partly or wholly dehydrated preserved milk for human 
consumption. Official Journal of the European Communities (2002). L. 15/19 

239 

 
 
 
 
 
                                                           
Annex XXXII: Additional implementing measures for selected 
Articles  of  Regulation  (EU)  No  1169/2011  and  their 
respective requirements 

These regulations include specific requirements for the labelling and marketing of diverse 
food  products  such  as,  foods  for  infants  and  special  medical  purposes,  olive  oil, 
aromatised wine products, fishery, aquaculture as well as agricultural products. 

a) 
Regulation  (EU)  No  609/2013  on  food  intended  for  infants  and 
young  children,  food  for  special  medical  purposes,  and  total  diet 
replacement for weight control.  
The  labelling  of  these  products  shall  be  regulated  by  Reg.  (EU)  1169/2011  (see 
respective section of Regulation 609/2013) 

Regulation  (EU)  No  1335/2013  amending  Regulation  (EU)  No 

b) 
29/2012 on marketing standards for olive oil 
For  the  labelling  of  olive  oil  Regulation  29/2012  145  refers  back  to  the  old  labelling 
Directive 2000/13/EC (see Chapter 8.1.1). 

Regulation  (EU)  No  251/2014  supplementing  the 

c) 
labelling 
provisions  of  Regulation  (EC)  No  1169/2011  on  the  definition, 
description,  presentation,  labelling  and  the  protection  of  geographical 
indications of aromatised wine products 
According  to  Article  5  of  Reg.  (EU)  251/2014146,  aromatised  wine  products  shall  follow 
the labelling rules laid down in Reg. (EU) 1169/2011 and are allowed to accompany their 
sales  denominations  (set  out  in  Annex  II)  with  a  customary  name  as  defined  in  Article 
2(2)(o) of Reg. (EU) 1169/2011. 

Regulation (EU) No 1379/2013 on the common organisation of the 

d) 
markets in fishery and aquaculture products 
For  the  purposes  of  Regulation  (EU)  1379/2013147  the  definitions  of  Article  2  of  Reg. 
(EU) 1169/2011 shall apply. In addition, Reg. (EU) 1379/2013 clarifies that "pre-packed 
fishery  and  aquaculture  products"  mean  fishery  and  aquaculture  products  which  are 
"pre-packed  food"  (as  referred  to  in  Article  2  of  Reg.  (EU)  1169/2011.  Moreover,  it 
complements  rules  on  mandatory  labelling  information  (Articles  35-39).  Specifically, 
products referred to in points (a), (b), (c) and (e) of Annex I to this Regulation (e.g. live 
fish; fish fresh, chilled, frozen; fish fillets and other fish meat; fish dried, smoked, salted 
or  in  brine;  crustaceans/molluscs  whether  in  shell  or  not;  seaweeds  and  other  algae) 
may be offered for sale to the final consumer or to a mass caterer with some additional 

145 Commission Implementing Regulation (EU) No 29/2012 on marketing standards for olive oil. Official Journal of the European Union 
(2012). L. 12/14 
146 Regulation (EU) No 251/2014 of the European Parliament and of the Council on the definition, description, presentation, labelling and 
the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91. Official 
Journal of the European Union (2014). L. 84/14 
147 Regulation (EU) No 1379/2013 of the European Parliament and of the Council on the common organisation of the markets in fishery 
and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation 
(EC) No 104/2000. Official Journal of the European Union (2013). L. 354/1 

240 

 
 
 
 
 
 
 
 
                                                           
indications, such as the commercial designation of the species and their scientific name, 
the area where the product was caught or farmed, the production method, whether the 
product has been defrosted, date of minimum durability etc. For non-pre-packed fishery 
and  aquaculture  products  this  information  may  be  provided  by  means  of  commercial 
information.  For  mixed  products  consisting  of  the  same  species  but  has  been  derived 
from different production methods, the method for each batch shall be stated. Products 
sold  directly  from  fishing  vessels  to  consumers,  are  exempted  from  this  Regulation. 
Regulation  (EU)  No  1308/2013  of  the  European  Parliament  and  of  the  Council 
establishing a common organisation of the markets in agricultural products and repealing 
Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 
1234/2007 

 Regulation  1308/2013  of  the  European  Parliament  and  of  the 
e) 
Council  establishing  a  common  organisation  of  the  markets 
in 
agricultural  products  and  repealing  Council  Regulations  (EEC)  No 
922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 
Reg.  (EU)  1308/2013148  refers  to  Reg.  (EU)  1169/2011  with  regard  to:  a)  Content  of 
marketing  standards  of  agricultural  products  (Art.  75):  they  should  follow  the  labelling 
requirements  for  the  country  of  origin  or  place  of  provenance  (Reg.  (EU)  1169/2011, 
Article  26),  shall  be  determined  by  sector  or  product  basis  and  based  on  the 
characteristics  of  each  sector;    b)  Additional  optional  reserved  terms  for  agricultural 
products  (that  are  not  listed  in  Annex  IX)  (Art.  87):  they  shall  be  eligible  only  if  the 
conditions and use of the term are in conformity with Reg. (EU) 1169/2011; c) Labelling 
and  presentation  in  the  wine  sector  (Articles  117-123):  in  addition  to  the  provisions  of 
Reg.  (EU)  1169/2011  specific  (mandatory  and  optional)  labelling  requirements  apply. 
Mandatory  particulars  include:  designation  of  the  category  of  the  grapevine,  the  term 
"protected designation of origin", indication of provenance, alcoholic strength, indication 
of  the  bottler  and  importer,  sugar  content  for  sparkling  wine;  d)  Compulsory  indication 
on  the  label  of  bovine  animals  aged less  than  12  months  (Annex  VII,  Part  I,  Point  IV): 
operators  shall label the meat with the sales description and the age of the animals on 
slaughter ("less than 8 months" or "from 8 to less than 12 months"); e) Names that are 
actually  used  for  milk  products  (i.e.  legal  name  of  the  food  under  which  the  product  is 
legally  manufactured  and  marketed  in  the  Member  State,  Article  17,Reg.  (EU) 
1169/2011):they  shall  also  be  reserved  exclusively  for  milk  products  (Annex  VII,  Part 
III,  3(b));  f)  In  relation  to  milk  for  human  consumption,  if  the  milk  has  been  enriched 
with milk proteins, mineral salts or vitamins or if the lactose content has been reduced, 
it also has to be indelibly indicated on the packing of the product so that it can be easily 
seen  and  read  along  with  the  nutrition  labelling  laid  down  by  Reg.  (EU)  1169/2011 
(Annex VII, Part IV, 2). 

148 Regulation (EU) No 1308/2013 of the European Parliament and of the Council establishing a common organisation of the markets in 
agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007. 
Official Journal of the European Union (2013). L. 347/671 

241 

 
 
 
 
 
 
                                                           
Annex  XXXIII:  Additional 
selected  Articles  of  Directive  90/496/EEC  and 
respective requirements 

implementing  measures 

for 
their 

The  following  Regulations  and  Directives  lay  down  additional  information  necessary  for 
the implementation of the different provisions of Directive 90/496/EEC. 

Regulation  (EC)  No  1925/2006  on  the  addition  of  vitamins  and 

a) 
minerals and of certain other substances to foods 
Article  7  of  Reg.  (EC)  1925/2006  contains  specific  labelling  provisions  for  vitamins  and 
minerals  added  to  foods  that  shall  apply  in  addition  to  the  requirements  of  Directive 
2000/13.  In  particular,  Nutrition  labelling  of  products  to  which  vitamins  and  minerals 
have  been  added  and  which  are  covered  by  this  Regulation  shall  be  compulsory.  This 
information  shall  consist  of  that  specified  in  Article 4(1),  Group 2  of  Dir.90/496/EEC 
(energy  value,  amounts  of  protein,  carbohydrate,  sugars,  fat,  saturates,  fibre  and 
sodium)  and  of  the  total  amounts  present  of  the  vitamins  and  minerals  when  added  to 
the  food.  Labelling,  presentation  and  advertising  of  these  products  shall  not  state  or 
imply that a balanced and varied diet cannot provide appropriate quantities of nutrients 
but  may  bear  a  statement  indicating  such  addition  under  the  conditions  laid  down  in 
Regulation (EC) No 1924/2006 on health and nutrition claims. 

Regulation (EC) No 1924/2006 on nutrition and health claims 

b) 
made on food 
Regulation  (EC)  No  1924/2006  complements  the  general  principles  in  Dir.  2000/13/EC 
and  90/496/EEC  and  lays  down  specific  provisions  concerning  the  use  and  labelling  of 
nutrition and health claims concerning food. In particular, the information to be provided 
shall  consist  of  information  in  Group  2  as  defined  in  Article  4(1)  of  Dir.  90/496/EEC 
(energy  value,  amounts  of  protein,  carbohydrate,  sugars,  fat,  saturates,  fibre  and 
sodium). If a substance(s) to which a nutrition or health claim relates does not appear in 
the  nutrition  labelling  it  shall  be  stated  in  the  same  field  of  vision  as  the  nutrition 
information and be expressed in accordance with Article 6 of Dir. 90/496/EEC. Moreover, 
the  Annex  of  Reg.  (EU)  1924/2006  (i.e.  authorised  nutrition  claims)  refers  to  Dir. 
90/496/EEC for clarifications of the claims: "source of [name of vitamin/s] and/or [name 
of mineral/s]" and "reduced [name of the nutrient]". 

c) 
Council  Directive  2001/113/EC  of  20  December  2001  relating  to 
fruit  jams,  jellies  and  marmalades  and  sweetened  chestnut  purée 
intended for human consumption 
According  to  Article  2,  labelling  of  these  products  shall  also  include  the  total  sugar 
content by the words ‘total sugar content ... g per 100 g’. If no nutrition claim is made 
for  sugars  on  the  labelling  in  accordance  with  Dir.  90/496/EEC,  this  indication  is  not 
needed.  

242 

 
 
 
 
 
 
 
 
 
Commission  Directive  96/8/EC  of  26  February  1996  on  foods 

d) 
intended for use in energy-restricted diets for weight reduction 
Directive 96/8/EC149 in Article 5, adopts specific nutrition labelling requirements for foods 
intended  for  weight-reduction  diets.  These  products  shall  bear  mandatory  particulars 
that include:  the  name  'Total  diet  replacement  for  weight  control'  or  'Meal  replacement 
for  weight  control'  accordingly,  the  energy  value  and  the  content  of  proteins, 
carbohydrates  and  fat,  the  average  quantity  of  each  mineral  and  each  vitamin,  if  a 
product  provides  a  daily  intake  of  polyols  in  excess  of  20 g  per  day  there  shall  be  a 
statement  that  the  food  may  have  a  laxative  effect,  a  statement  on  the  importance  of 
maintaining  an  adequate  daily  fluid  intake  etc.  These  rules  shall  only  be  valid  until  the 
Reg.  (EU)  609/2013  on  food  intended  for  infants  and  young  children,  food  for  special 
medical  purposes,  and  total  diet  replacement  for  weight  control  fully comes  into  effect, 
i.e. July of 2016. 

Council  Directive  2001/112/EC  of  20  December  2001  relating  to 
for  human 
juices  and  certain  similar  products 

e) 
fruit 
consumption 
This Directive, in particular Article 2, authorises the addition of vitamins and minerals to 
the products, subject to Directive 90/496/EEC.  

intended 

f) 
Directive  2002/46/EC  of  the  European  Parliament  and  of  the 
Council of 10 June 2002 on the approximation of the laws of the Member 
States relating to food supplements 
In accordance with Articles 8 and 9 of Dir. 2002/46/EC, nutrition labelling of certain food 
supplements  must  include  the  names  of  the  categories  of  the  nutrients  or  substances 
and the portion of the product recommended for daily consumption. The amount of the 
nutrients or substances shall be declared on the labelling in numerical form, per portion, 
as  recommended  for  daily  consumption,  expressing  average  values  based  on  the 
manufacturer's analysis of the product (see also Chapter 8.1.1).  

149 Commission Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Official Journal of the 
European Communities (1996). L 55/22 

243 

 
 
 
 
 
 
                                                           
for 
Annex  XXXIV:  Additional 
selected Articles of Regulation (EC) No 1924/2006 and their 
respective requirements 

implementing  measures 

The  following  Regulations  and  Directives  lay  down  additional  information  necessary  for 
the implementation of the different provisions of Regulation (EC) No 1924/2006. 

Regulation 1925/2006 on the addition of vitamins and minerals 

a) 
and of certain other substances to foods  
As  regards  the  maximum  amounts  of  vitamins  and  minerals  and  the  conditions 
restricting  their  addition,  Reg.  (EC)  1925/2006  requires  (in  Article  3)  that  the  nutrient 
profile of the product established as provided for by Reg. (EC) 1924/2006, shall be also 
taken  into  account.  Additionally,  Article  7  requires  that  for  products  to  which  vitamins 
and  minerals  have  been  added,  any  statement  indicating  such  addition  shall  follow  the 
conditions laid down in this Regulation. 

b) 
Directive 2006/141/EC on infant formulae and follow-on formulae  
Directive 1925/2006/EC150 sets out additional specific conditions for the use of nutrition 
and  health  claims  concerning  infant  formulae.  With  this  Directive,  nutrition  and  health 
claims to be used for labelling of infant formulae are allowed only in the cases listed in 
Annex IV and in accordance with the conditions set out therein. (This Directive has been 
repealed  by  Reg.  609/2013  and  its  validity  shall  stop  when  the  Commission  adopts 
delegated acts or the latest by the 20/7/2015). 

Regulation (EU) 609/2013 on food intended for infants and young 

c) 
children, food for special medical purposes, and total diet replacement 
for weight control 
Foods  for  specific  groups  shall  follow  the  requirement  for  health  and  nutrition 
claims  laid  down  in  Reg.  (EC)  1924/2006,  unless  otherwise  specified  in  Reg.  (EC) 
609/2013.  Reg.  (EU)  609/2013  requires  that  a  delegated  act  should  be  adopted  that 
transfers  the  rules  that  regulate  foods  presented  as  ‘meal  replacement  for  weight 
control’ (i.e. the conditions of use of such claims) to Reg. (EC) 1924/2006. 

d) 
Commission Directive 2007/29/EC amending Directive 96/8/EC as 
regards  labelling,  advertising  or  presenting  foods  intended  for  use  in 
energy-restricted diets for weight reduction  
As long as conditions laid down in Article 13, paragraph 1 of Regulation 1924/2006 are 
fulfilled,  then  health  and  nutrition  claims  are  allowed  to  products  for  use  in  energy-
restricted  diets  for  weight  reduction.  (This  Directive  has  also  been  repealed  by 
Regulation  609/2013  and  its  validity  shall  stop  when  the  Commission  adopts  delegated 
acts or the latest by the 20/7/2015). 

150 Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 
1999/21/EC. Official Journal of the European Union (2006). L. 401/1 

244 

 
 
 
 
 
 
 
 
 
                                                           
Regulations 462/2014 and 563/2014 

e) 
These  two  Regulations,  after  examination  carried  out  by  EFSA  in  accordance  with 
Regulation  1924/2006,  approve  that  the  basic  substances  Equisetum  arvense  L.  and 
chitosan  hydrochloride  (Reg.  (EU)  462/2014151  and  569/2014152  respectively)  can  be 
considered as foods as they fulfil the criteria of a foodstuff according to the General Food 
Law (Article 2 of Reg. (EC) 178/2002). 

Regulation 907/2013 Commission Regulation (EU) No 907/2013 

f) 
setting the rules for applications concerning the use of generic 
descriptors (denominations) 
According  to  Article  1  of  Reg.  (EU)  907/2013  153  specific  generic  descriptors 
(denominations)( as described in Article 1(4) of Reg. (EU) 1924/2006) which could imply 
an  effect  on  health  and  which  have  traditionally  been  used  in  a  Member  State  (e.g. 
"digestive  biscuits")  may  be  exempted  from  Reg.  (EC)  1924/2006  following  an 
application  by  the  food  business  operators  concerned.  The  procedure  is  similar  to  the 
one followed for health and nutrition claims authorisation (rules set out in the Annex of 
Reg. (EU) 907/2013. 

151 Commission Implementing Regulation (EU) No 462/2014 approving the basic substance Equisetum arvense L., in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Implementing Regulation (EU) No 540/201. Official Journal of the European Union (2014). L. 134/28 
152 Commission Implementing Regulation (EU) No 563/2014 approving the basic substance chitosan hydrochloride in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011. Official Journal of the European Union (2014). L. 156/5 
153 Commission Regulation (EU) No 907/2013 setting the rules for applications concerning the use of generic descriptors (denominations). 
Official Journal of the European Union (2013). L. 251/7 

245 

 
 
 
 
 
 
 
 
 
                                                           
Annex  XXXV:  Additional 
Articles 
requirements 

of  Directive 

legislation  related  to  selected 
respective 
2009/39/EC 

and 

The  following  delegated  acts  are  repealed  from  the  date  of  application  of  the  new 
delegated acts that shall be adopted by 20 July 2015, as referred to in Article 11 of the 
new Regulation 609/2013 (FSG) on Food for Specific Groups.  

a) 
Commission  Directive  2006/141/EC  of  22  December  2006  on 
infant  formulae  and  follow-on  formulae  and  amending  Directive 
1999/21/EC  
This  Directive  lays  down  compositional  and  labelling  requirements  for  infant  formulae 
and follow-on formulae intended for use by infants in good health. These products shall 
be  manufactured  from  cows’  or  goats’  milk  proteins  or  soya proteins  and  other  food 
substances  (minerals,  vitamins,  amino  acids,  etc.)  set  out  in  Annex  I.  Compositional 
criteria (energy, proteins, lipids, carbohydrates, minerals, vitamins, nucleotides etc.) for 
infant formulae are set out in Annex I taking into account the specifications in Annex V, 
and for  follow-on formulae in Annex II.  Only the substances listed in Annex  III may be 
used  in  the  manufacture  of  infant  formulae  and  follow-on  formulae.  Before  placing  on 
the  market,  the  manufacturer  (or  importer)  shall  forward  a  model  of  the label  used  for 
the product to the competent authority of the Member State where the product is to be 
marketed. Residues of individual pesticides shall be less than 0.01 mg/kg of the product. 
As for the labelling and advertising of such products, please refer to the relevant part of 
Chapter 8.1.2.   

b) 
Commission  Directive  2006/125/EC  of  5  December  2006  on 
processed  cereal-based  foods  and  baby  foods  for  infants  and  young 
children 
This Directive lays down standards for the composition (list of authorised products) and 
labelling of processed cereal-based foods and baby foods which are intended for use by 
weaning  infants  and  by  young  children.  Annex  I  sets  out  the  compositional  criteria  for 
processed  cereal-based  foods  and  Annex  II  for  baby  foods.  Only  the  nutritional 
substances  listed  in  Annex  IV  may  be  added  in  their  manufacture  and  residues  of 
individual  pesticides  shall  be  less  than  0.01  mg/kg  of  the  product.  Moreover,  this 
Directive prohibits the use of certain pesticides in agricultural products intended for baby 
foods  (list  in  Annex  VII).  As  for  the  labelling  of  such  products,  please  refer  to  the 
relevant part of Chapter 8.1.2. 

Commission  Directive  1999/21/EC  of  25  March  1999  on  dietary 

c) 
foods for special medical purposes 
This  Directive  lays  down  compositional  and  labelling  requirements  for  dietary  foods 
which  are  intended  for  special  medical  purposes.  Such  foods  are  classified  in  three 
categories: i) nutritionally complete foods with a standard nutrient formulation and may 
constitute  the  sole  source  of  nourishment,  ii)  nutritionally  complete  foods  with  a 
nutrient-adapted  formulation  (for  a  medical  condition)  and  may  constitute  the  sole 
source  of  nourishment  or  as  a  partial  replacement  to  the  patient’s  diet,  and  iii) 
nutritionally incomplete foods with a standard nutrient formulation or a nutrient-adapted 
formulation  which  cannot    to  be  used  as  the  sole  source  of  nourishment  but  only  as  a 
partial  replacement  or  as  a  supplement  to  the  patient’s  diet.  The  formulation  of  such 

246 

 
 
 
 
 
 
 
products shall be based on sound medical and nutritional principles and comply with the 
compositional criteria specified in the Annex to this Directive. In addition to the general 
labelling  provisions  (Directive  79/112/EC  but  repealed  by  Directive  2000/13)  and  as 
provided for in Article 4 to Directive 1999/21/EC, such products shall bear the following 
mandatory  particulars:  energy  value,  the  content  of  protein,  carbohydrate  and  fat,  the 
average quantity of mineral substances and vitamins present in the product, the content 
of  components  of  protein,  carbohydrate  and  fat  or  of  other  nutrients  the  declaration  of 
which  would  be  necessary  for  the  appropriate  use  of  the  product  (all  expressed  in 
numerical  form  per  100 g  or  per  100 ml  of  the  product  as  sold  or  ready  for  use). 
Labelling shall also bear i) information on the origin and the nature of the protein and/or 
protein hydrolysates contained, ii) on the osmolality or the osmolarity of the product, iii) 
the  statement  "For  the  dietary  management  of...(medical  condition)…",  iv)  a  statement 
on adequate precautions and contra-indications, v) a description of the properties and/or 
characteristics that make the product useful and the rationale of the use of the product, 
vi)  a  warning  that  the  product  is  not  for  parenteral  use  (where  appropriate),  and  vii) 
instructions  for  the  appropriate  preparation,  use  and  storage  of  the  product.  The 
following  statements  must  be  preceded  by  the  words  "important  notice"  or  their 
equivalent: i) that the product must be used under medical supervision, ii) suitability to 
be  used  as  the  sole  source  of  nourishment  (where  appropriate),  iii)  specific  age  group 
(where appropriate), and iv) potential hazardous effects when consumed by persons who 
do  not  have  the  medical  conditions  for  which  the  product  is  intended  (where 
appropriate). Before placing on the market, the manufacturer (or importer) shall forward 
a  model  of  the  label  used  for  the  product  to  the  competent  authority  of  the  Member 
State where the product is to be marketed. 

Commission  Directive  96/8/EC  of  26  February  1996  on  foods 

d) 
intended for use in energy-restricted diets for weight reduction 
This Directive lays down compositional and labelling requirements for foods intended for 
use in energy-restricted diets and are classified in two categories: i) products  replacing 
the whole of the daily diet and ii) products replacing one or more meals of the daily diet. 
The  name  under  which  the  product  is  sold  shall  be  "Total  diet  replacement  for  weight 
control" or "Meal replacement for weight control", accordingly. In addition to the general 
labelling  provisions  (Directive  79/112/EC  but  repealed  by  Directive  2000/13)  and  as 
provided  for  in  Article  5  to  Directive  96/8/EC,  such  products  shall  bear  the  following 
mandatory  particulars:  energy  value,  the  content  of  protein,  carbohydrate  and  fat,  the 
average quantity of mineral substances and vitamins present in the product (expressed 
in  numerical  form,  per  specified  quantity),  instructions  for  appropriate  preparation,  a 
statement that the food may have a laxative effect if it provides a daily intake of polyols 
more than 20 g per day, a statement that the product should not be used for more than 
three  weeks  without  medical  advice  (for  products  replacing the  whole  of  the  daily  diet) 
or  a  statement  to  that  the  products  are  useful  for  the  intended  use  only  as  part  of  an 
energy-restricted diet and that other foodstuffs should be a necessary part of such diet 
(for products replacing one or more meals), a statement on the importance of adequate 
daily fluid intake. Such products shall not make any reference to the rate or amount of 
weight loss which may result from their use. 

The  following  Regulations  and  Directives  lay  down  additional  information  necessary  for 
the implementation of the different provisions of Directive 2009/39/EC. 

247 

 
 
 
 
 
Commission Regulation (EC) No 1135/2009 of 25 November 2009 
a) 
imposing  special  conditions  governing  the  import  of  certain  products 
originating in or consigned from China 
Article 2 of Reg. (EC) 1135/2009154 prohibits the import into the Community of products 
containing  milk,  milk  products,  soya  or  soya  products  intended  for  the  particular 
nutritional  use  of  infants  and  young  children  within  the  meaning  of  Directive 
2009/39/EC, originating from China. Member States shall withdraw and destroy any such 
product found on the market. 

b) 
Regulations  on  the  authorisation  and  conditions  of  use  of  food 
additives, flavourings, and other substances that may be added in foods  
Regulation  (EC)  No  1333/2008  on  food  additives:  According  to  Annex  II,  Part  A,  the 
carry over principle set out in Article 18(1)(a) of the same regulation, shall not apply and 
the  presence  of  a  food  colour  shall  not  be  permitted  for  foods  for  infants  and  young 
children  as  mentioned  in  Directive  2009/39/EC,  including  foods  for  special  medical 
purposes  for  infants  and  young  children.  Moreover,  the  use  of  an  additive  shall  not  be 
permitted  for  dry  pasta,  excluding  gluten-free  and/or  pasta  intended  for  hypo-proteic 
diets, in accordance with Directive 2009/39/EC. Part E, category 13 of the same Annex 
contains  the  authorised  food  additives  and  conditions  of  use  in  foods  intended  for 
particular nutritional uses as defined by Directive 2009/39/EC.  

Regulation  (EC)  No  1334/2008  on  flavourings  and  certain  food  ingredients  with 
flavouring properties for use in and on foods155: Annex I, Part A of Regulation 1334/2008 
contains  the  authorised  flavourings  and  conditions  of  use  in  foods  (including  for  those 
foods intended for particular nutritional uses as defined by Directive 2009/39/EC). 

Commission Regulation (EC) No 953/2009 on substances that may be added for specific 
nutritional  purposes  in  foods  for  particular  nutritional  uses156:  Annex  of  Regulation 
953/2009  lists  the  substances  (vitamins,  minerals,  amino-acids,  nucleotides  etc.)  that 
may  be  added  for  specific  nutritional  purposes  in  foods  for  particular  nutritional  uses 
(excluding  infant  and  follow-on  formulae  and  processed  cereal-based  foods  and  baby 
foods). 

154 Commission Regulation (EC) No 1135/2009 imposing special conditions governing the import of certain products originating in or 
consigned from China, and repealing Commission Decision 2008/798/EC. Official Journal of the European Union (2009). L. 311/3 
155 Regulation (EC) No 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with 
flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and 
(EC) No 110/2008 and Directive 2000/13/EC. Official Journal of the European Union (2008). L. 354/34 
156 Commission Regulation (EC) No 953/2009 on substances that may be added for specific nutritional purposes in foods for particular 
nutritional uses. Official Journal of the European Union (2009). L. 269/9 

248 

 
 
 
 
 
 
 
 
                                                           
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doi: 10.2787/410688 

ISBN 978-92-79-60536-9 

doi:10.2787/410688 

ISBN 978-92-79-60536-9