Commission Staff Working Document accompanying the Report from the Commission to the European Parliament and the Council on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 - Montesquieu Instituut

COUNCIL OFBrussels, 29 July 2009

THE EUROPEAN UNION

12482/09 ADD 1

AGRILEG 132 DENLEG 68

COVER NOTE

from:

Secretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director

date of receipt: 28 July 2009

to: Mr Javier SOLANA, Secretary-General/High Representative

Subject: Commission Staff Working Document accompanying the Report from the Commission to the European Parliament and the Council on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004

Delegations will find attached Commission document SEC(2009) 1079 final.

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 28.7.2009 SEC(2009) 1079 final

COMMISSION STAFF WORKING DOCUMENT

accompanying the

Report from the Commission to the European Parliament and the Council

on the experience gained from the application of the hygiene Regulations (EC)

No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and

of the Council of 29 April 2004

{COM(2009) 403}

TABLE OF CONTENTS

General Introduction................................................................................................................... 3

ANNEX I .................................................................................................................................... 4

ANNEX II................................................................................................................................... 5

ANNEX III ................................................................................................................................. 6

ANNEX IV ............................................................................................................................... 10

ANNEX V ................................................................................................................................ 12

ANNEX VI ............................................................................................................................... 25

ANNEX VII.............................................................................................................................. 27

ANNEX VIII ............................................................................................................................ 30

GENERAL INTRODUCTION

This working document accompanies the Commission report to the European Parliament and the Council on the experience gained from the application of the hygiene Regulations (EC)

No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004.

The working document provides specific information on certain aspects developed in the report. In particular:

• - 

  it clarifies the acts that have been adopted in connection with the hygiene package and gives a clear picture of the actual legal framework on hygiene;
• - 

  it shows the importance given by the Commission to establishing besides legislative instruments, guidance to food business operators and competent authorities;
• - 

  it illustrates the simplification and consistent efforts made by the Commission when adopting these Regulations;
• - 

  it details the consultation process that was followed by the Commission in order to prepare the report and lists the private stakeholders' organisations who were consulted

in this process;

• - 

  it gives a state of play on the development of guides to good practice at national and Community levels.

ANNEX I

ABBREVIATIONS AND TECHNICAL TERMS

AGFCAPH Advisory Group on the Food Chain and Animal and Plant Health

CA

The authority of a Member State responsible for the implementation and enforcement of the hygiene Regulations

Co-decision

Legislative procedure requiring approval of measures to be taken by the European Parliament and by the Council

Comitology Legislative procedure requiring approval of measures to be taken by the Commission by a regulatory committee composed of the representatives of the Member States and chaired by the representative of the Commission

EFSA European Food Safety Authority: Independent European body that provides assistance and scientific advice concerning risk assessment and risk analysis to the Commission, European Parliament and the Member States

FBO Food business operator(s)

FCI Food chain information

Former small capacity abattoirs Abattoirs excluded from the scope of Directives 64/433/EEC on meat from domestic ungulates and 71/118/EEC on poultrymeat, and benefiting from simplified requirements in relation to construction, layout and equipment of establishments

FVO Food and Veterinary Office Directorate F of Directorate-General Health and Consumers located in Grange (Ireland) responsible for verification of the implementation of Community food safety legislation in the Member States and in third countries

ANNEX II

STRUCTURE OF THE EU HYGIENE LEGISLATION

ANNEX III

ACTS ADOPTED IN CONNECTION

WITH THE HYGIENE PACKAGE

The basic Acts constituting the hygiene package have been further specified in three Regulations laying down various implementing measures. These three implementing Regulations were adopted in 2005 and entered into application at the beginning of 2006 together with the hygiene package. A fourth Regulation was adopted in 2005 to permit the smooth changeover from the old legal regime to the new approach set down in the hygiene package.

All acts adopted since 2006 are amending either the three basic Acts or the three implementing Regulations. The Commission considers that this new legal framework should not, as far as possible, be expanded in order to maintain the benefits of the simplification process. This should not preclude the Commission from revising and updating, where necessary, some of the current rules or adding new implementing rules as has been done since 2006.

A list of all the acts adopted in connection with the three basic Acts is given below:

2005

• 1. 

  Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

1

• 2. 

  Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

2006

• 5. 

  Commission Regulation (EC) No 1662/2006 of 6 November 2006 amending Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

5

• 6. 

  Commission Regulation (EC) No 1663/2004 of 6 November 2006 amending 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

6

• 7. 

  Commission Regulation (EC) No 1664/2006 of 6 November 2006 amending Regulation (EC) No 2074/2005 as regards implementing measures for certain products of animal origin intended for human consumption and repealing certain implementing measures

7

• 8. 

  Commission Regulation (EC) No 1665/2006 of 6 November 2006 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat

8

• 9. 

  Commission Regulation (EC) No 1666/2006 of 6 November 2006 amending Regulation (EC) No 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council

9

• 10. 

  Commission Decision 2006/765/EC of 6 November 2006 repealing certain implementing acts concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption

10

• 11. 

  Commission Decision 2006/766/EC of 6 November establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted

11

2007

• 13. 

  Commission Regulation (EC) No 479/2007 amending Regulation (EC) No 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

13

• 14. 

  Commission Regulation (EC) No 1243/2007 of 24 October 2007 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

14

• 15. 

  Commission Regulation (EC) No 1244/2007 of 24 October 2007 amending Regulation (EC) No 2074/2007 as regards implementing measures for certain products of animal origin intended for human consumption and laying down specific rules on official controls for the inspection of meat

15

• 16. 

  Commission Regulation (EC) No 1245/2007 of 24 October 2007 amending Annex I to Regulation (EC) No 2075/2005, as regards the use of liquid pepsin for the detection of Trichinella in meat

16

• 17. 

  Commission Regulation (EC) No 1246/2007 of 24 October 2007 amending Regulation (EC) No 2076/2005 as regards the extension of the transitional period granted to food business operators importing fish oil intended for human consumption

17

• 18. 

  Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

18

2008

• 19. 

  Commission Regulation (EC) No 439/2008 of 21 May 2008 amending Annex II to Regulation (EC) No 2076/2005 as regards imports of fishery products from Fiji

19

Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products

21

• 22. 

  Commission Regulation (EC) No 1021/2008 of 17 October 2008 amending Annexes I, II and III to 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 and Regulation (EC)

No 2076/2005 as regards live bivalve molluscs, certain fishery products and staff assisting with official controls in slaughterhouses

22

• 23. 

  Commission Regulation (EC) No 1022/2008 of 17 October 2008 amending Regulation (EC) No 2074/2005 as regards the total volatile basic nitrogen (TVB-N) limits

23

• 24. 

  Commission Regulation (EC) No 1023/2008 of 17 October 2008 amending Regulation (EC) No 2076/2005 as regards the extension of the transitional period granted to food business operators importing fish oil intended for human consumption

24

ANNEX IV

GUIDANCE DOCUMENTS

Besides legislative instruments, guidance documents have been established by the Commission and the MS. These documents are mainly directed at food business operators and competent authorities in the Member States. They aim at giving guidance on the implementation of the food hygiene requirements introduced by the hygiene package and on related subjects. Although these documents have no legal effect, they have widely contributed to the smooth implementation of the hygiene package.

A list of all the guidance documents established so far is given below:

• 1. 

  Guidance document on the implementation of certain provisions of Regulation (EC)

No 852/2004 on the hygiene of foodstuffs

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_852- 2004_en.pdf

• 2. 

  Guidance document on the implementation of certain provisions of Regulation (EC)

No 853/2004on the hygiene of food of animal origin

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_853- 2004_en.pdf

• 3. 

  Guidance document on the implementation of procedures based on the HACCP principles and facilitation of the implementation of the HACCP principles in certain food businesses

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.p df

• 4. 

  Guidance document on key questions related to import requirements and the new rules on food hygiene and official food controls
• 8. 

  Guidelines on the registration of national guides to good practice in accordance with Article 8 of Regulation (EC) No 852/2004 have been developed and enable Member States to initially submit only certain information concerning their national guides to the Commission (SCFCAH consensus of 15 July 2008)

http://ec.europa.eu/food/food/biosafety/hygienelegislation/national_guides_register_

15-07-2008.pdf

• 9. 

  Guidance document on Listeria monocytogenes shelf-life studies for ready-to-eat foods, under Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs

http://ec.europa.eu/food/food/biosafety/salmonella/docs/guidoc_listeria_monocytoge nes_en.pdf

• 10. 

  Guideline for the detection of Trichinella larvae at the slaughterhouse or connected laboratory in a Quality Assurance System

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guideline_detect_qas_en.p df

• 11. 

  Guideline for the identification and development of sampling methods and design of suitable protocols for monitoring of Trichinella infection in indicator species

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guideline_sampling_indic ator_species_en.pdf

ANNEX V

REPEALED LEGISLATIVE ACTS

With the adoption of the hygiene package, a total of 152 legislative Acts have been repealed: (see lists 1 to 6 below for details)

• - 

  17 at the entry into application of the new rules - 16 previous legislative acts by Directive 2004/41/EC (List 1) and 1 by Regulation (EC) No 852/2004 (List 2).
• - 

  133 further pieces of legislation have been repealed since then by implementing measures (Lists 3, 4 and 5).
• - 

  2 previous acts were also repealed by Commission Decision 2006/766/EC (List 6).

LIST 1. LEGISLATION REPLACED BY THE HYGIENE REGULATIONS AND REPEALED BY

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 2004/41/EC

• 1. 

  Council Directive 64/433/EEC of 26 June 1964 on health conditions for the production and marketing of fresh meat (OJ 121, 29.7.1964, p. 2012)
• 2. 

  Council Directive 71/118/EEC of 15 February 1971 on health problems affecting the production and placing on the market of fresh poultrymeat (OJ L 55, 8.3.1971, p. 23)
• 3. 

  Council Directive 72/461/EEC of 12 December 1972 on health problems affecting the intra-Community trade in fresh meat (OJ L 302, 31.12.1972, p.24)
• 4. 

  Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (Trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine (OJ L 26, 31.1.1977, p. 67)
• 5. 

  Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin (OJ L 26, 31.1.1977, p.85)
• 10. 

  Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (OJ L 268, 24.9.1991, p.15)
• 11. 

  Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (OJ L 268, 24.9. 1991, p. 35)
• 12. 

  Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat (OJ L 268, 24.9.1991, p. 41)
• 13. 

  Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild- game meat (OJ L 268, 14.9.1992, p. 35)
• 14. 

  Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (OJ L 268, 14.9.1992, p. 1)
• 15. 

  Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(1)(a)(i) of Directive 91/493/EEC (OJ L 187, 7.7.1992, p. 41)
• 16. 

  Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations (OJ L 168, 2.7.1994, p. 10)

LIST 2. LEGISLATION REPEALED BY REGULATION (EC) NO 852/2004

• 17. 

  Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs (OJ L 175, 19.7.1993, p. 1)

Import conditions for fishery products

• 21. 

  Commission Decision 93/436/EEC of 30 June 1993 laying down special conditions governing imports of fishery products originating in Chile (OJ L 202, 12.8.1993, p. 31)
• 22. 

  Commission Decision 93/437/EEC of 30 June 1993laying down special conditions governing imports of fishery products originating in Argentina (OJ L 202, 12.8.1993, p. 42)
• 23. 

  Commission Decision 93/494/EEC of 23 July 1993 laying down special conditions governing imports of fishery products originating in the Faroe Islands (OJ L 232, 15.9.1993, p. 37)
• 24. 

  Commission Decision 93/495/EEC of 26 July 1993 laying down special conditions governing imports of fishery products originating in Canada (OJ L 232, 15.9.1993, p. 43)
• 25. 

  Commission Decision 94/198/EC of 7 April 1994 laying down special conditions governing imports of fishery and aquaculture products originating in Brazil (OJ L 93, 12.4.1994, p. 26)
• 27. 

  Commission Decision 94/200/EC of 7 April 1994 laying down special conditions governing imports of fishery products and aquaculture products originating in Ecuador (OJ L 93, 12.4.1994, p. 34)
• 28. 

  Commission Decision 94/269/EC of 8 April 1994 laying down special conditions governing imports of fishery and aquaculture products originating in Colombia (OJ L 115, 6.5.1994, p. 38)
• 29. 

  Commission Decision 94/323/EC of 19 May 1994 laying down special conditions governing imports of fishery and aquaculture products originating in Singapore (OJ L 145, 10.6.1994, p. 19)
• 34. 

  Commission Decision 95/30/EC of 120 February 1995 laying down special conditions governing imports of fishery and aquaculture products originating in Morocco (OJ L 42, 24.2.1995, p. 32, as corrected by OJ L 48, 3.3.1995)
• 35. 

  Commission Decision 95/90/EC of 17 March 1995 laying down special conditions governing the import of fishery and aquaculture products originating in Albania (OJ L 70, 30.3.1995, p. 27)
• 36. 

  Commission Decision 95/173/EC of 7 March 1995 laying down special conditions governing the import of fishery and aquaculture products originating in Peru (OJ L 116, 23.5.1995, p. 41)
• 37. 

  Commission Decision 95/190/EC of 17 May 1995 laying down special conditions governing imports of fishery and aquaculture products originating in the Philippines (OJ L 123, 3.6.1995, p. 20)
• 38. 

  Commission Decision 95/454/EC of 23 October 1995 laying down special conditions governing imports of fishery and aquaculture products originating in the Republic of Korea (OJ L 264, 7.11.1995, p. 37)
• 39. 

  Commission Decision 95/538/EC of 6 December 1995 laying down special conditions governing the import of fishery and aquaculture products originating in Japan (OJ L 304, 16.12.1995, p. 52)
• 40. 

  Commission Decision 96/355/EC of 30 May 1996 laying down special conditions governing the import of fishery and aquaculture products originating in Senegal (OJ L 137, 8.6.1996, p. 24)
• 41. 

  Commission Decision 96/356/EC of 30 May 1996 laying down special conditions governing the import of fishery and aquaculture products originating in Gambia (OJ L 137, 8.6.1996, p. 31)
• 42. 

  Commission Decision 96/425/EC of 28 June 1996 laying down special conditions governing the import of fishery and aquaculture products originating in Mauritania (OJ L 175, 13.7.1996, p. 27)
• 47. 

  Commission Decision 97/102/EC of 16 January 1997 laying down special conditions governing the import of fishery and aquaculture products originating in Russia (OJ L 35, 5.2.1997, p. 23)
• 48. 

  Commission Decision 97/426/EC of 25 June 1997 laying down special conditions governing the import of fishery and aquaculture products originating in Australia (OJ L 183, 11.7.1997, p. 21)
• 49. 

  Commission Decision 97/757/EC of 6 November 1997 laying down special conditions governing imports of fishery and aquaculture products originating in Madagascar (OJ L 307, 12.11.1997, p. 33)
• 50. 

  Commission Decision 97/876/EC of 21 December 1997 laying down special conditions governing imports of fishery and aquaculture products originating in India (OJ L 356, 31.12.1997, p. 57)
• 51. 

  Commission Decision 98/147/EC of 13 February 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Bangladesh (OJ L 46, 17.2.1998, p. 13)
• 52. 

  Commission Decision 98/420/EC of 30 June 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Nigeria (OJ L 190, 4.7.1998, p. 59)
• 53. 

  Commission Decision 98/421/EC of 30 June 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Ghana (OJ L 190, 4.7.1998, p. 66)
• 54. 

  Commission Decision 98/422/EC of 30 June 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Tanzania (OJ L 190, 4.7.1998, p. 71)
• 55. 

  Commission Decision 98/423/EC of 30 June 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Falkland Islands (OJ L 190, 4.7.1998, p. 76)
• 60. 

  Commission Decision 98/695/EC of 24 November 1998 laying down special conditions governing imports of fishery and aquaculture products originating in Mexico (OJ L 33, 8.12.1998, p. 9)
• 61. 

  Commission Decision 1999/245/EC of 26 March 1999 laying down special conditions governing imports of fishery and aquaculture products originating in the Seychelles (OJ L 91, 7.4.1999, p. 40)
• 62. 

  Commission Decision 1999/276/EC of 23 April 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Mauritius (OJ L 108, 27.4.1999, p. 52)
• 63. 

  Commission Decision 1999/526/EC of 14 July 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Panama (OJ L 203, 3.8.1999, p. 58)
• 64. 

  Commission Decision 1999/527/EC of 14 July 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Oman (OJ L 203, 3.8.1999, p. 63)
• 65. 

  Commission Decision 1999/528/EC of 14 July 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Yemen (OJ L 203, 3.8.1999, p. 68)
• 66. 

  Commission Decision 1999/813/EC of 16 November 1999 laying down special conditions governing imports of fishery products originating in the Socialist Republic of Vietnam (OJ L 315, 9.12.1999, p. 39)
• 67. 

  Commission Decision 2000/83/EC of 21 December 1999 laying down special conditions governing imports of fishery and aquaculture products originating in Pakistan (OJ L 26, 2.2.2000, p. 13)
• 68. 

  Commission Decision 2000/86/EC of 21 December 1999 laying down special conditions governing imports of fishery products originating in China and repealing Decision 97/368/EC (OJ L 26, 2.2.2000, p. 26)
• 73. 

  Commission Decision 2001/632/EC of 16 August 2001 laying down special conditions governing imports of fishery products originating in Nicaragua (OJ L 221, 17.8.2001, p. 40)
• 74. 

  Commission Decision 2001/633/EC of 16 August 2001 laying down special conditions governing imports of fishery products originating in Uganda (OJ L 221, 17.8.2001, p. 45)
• 75. 

  Commission Decision 2001/634/EC of 16 August 2001 laying down special conditions governing imports of fishery products originating in or proceeding from Guinea (OJ L 221, 17.8.2001, p. 50)
• 76. 

  Commission Decision 2002/25/EC of 11 January 2002 laying down special conditions governing imports of fishery products originating in the Republic of Croatia (OJ L 11, 15.1.2002, p. 25)
• 77. 

  Commission Decision 2002/26/EC of 11 January 2002 laying down special conditions governing imports of fishery products originating in the Republic of Gabon (OJ L 11, 15.1.2002, p. 31)
• 78. 

  Commission Decision 2002/27/EC of 11 January 2002 laying down special conditions governing imports of fishery products originating in the Republic of Turkey (OJ L 11, 15.1.2002, p. 36)
• 79. 

  Commission Decision 2002/472/EC of 20 June 2002 laying down special conditions governing imports of fishery products from the Republic of Bulgaria (OJ L 163, 27.6.2002, p. 24)
• 80. 

  Commission Decision 2002/854/EC of 29 October 2002 laying down special conditions governing imports of fishery products from Costa Rica (OJ L 301, 5.11.2002, p. 1)
• 81. 

  Commission Decision 2002/855/EC of 29 October 2002 laying down special conditions governing imports of fishery products from New Caledonia (OJ L 301, 5.11.2002, p. 6)
• 86. 

  Commission Decision 2002/860/EC of 29 October 2002 laying down special conditions governing imports of fishery products from Switzerland (OJ L 301, 5.11.2002, p. 38)
• 87. 

  Commission Decision 2002/861/EC of 29 October 2002 laying down special conditions governing imports of fishery products from Honduras (OJ L 301, 5.11.2002, p. 43)
• 88. 

  Commission Decision 2002/862/EC of 29 October 2002 laying down special conditions governing imports of fishery products from Kazakhstan (OJ L 301, 5.11.2002, p. 48)
• 89. 

  Commission Decision 2003/302/EC of 25 April 2003 laying down special conditions governing imports of fishery products from Sri Lanka (OJ L 110, 3.5.2003, p. 6)
• 90. 

  Commission Decision 2003/608/EC of 18 August 2003 laying down special conditions governing imports of fishery products from Mayotte (OJ L 210, 20.8.2003, p. 25)
• 91. 

  Commission Decision 2003/609/EC of 18 August 2003 laying down special conditions governing imports of fishery products from Saint Pierre et Miquelon (OJ L 210, 20.8.2003, p. 30)
• 92. 

  Commission Decision 2003/759/EC of 15 October 2003 laying down special conditions governing imports of fishery products from Belize (OJ L 273, 24.10.2003, p. 18)
• 93. 

  Commission Decision 2003/760/EC of 15 October 2003 laying down special conditions governing imports of fishery products from French Polynesia (OJ L 273, 24.10.2003, p. 23)
• 94. 

  Commission Decision 2003/761/EC of 15 October 2003 laying down special conditions governing imports of fishery products from the United Arab Emirates (OJ L 273, 24.10.2003, p. 28)
• 99. 

  Commission Decision 2004/39/EC of 23 December 2003 laying down special conditions governing imports of fishery products from Kenya and repealing Decision 2000/759/EC (OJ L 8, 14.1.2004, p. 22)
• 100. 

  Commission Decision 2004/40/EC of 23 December 2003 laying down special conditions governing imports of fishery products from Guyana (OJ L 8, 14.1.2004, p. 27)
• 101. 

  Commission Decision 2004/360/EC of 13 April 2004 laying down special conditions governing imports of fishery products from Zimbabwe (OJ L 113, 20.4.2004, p. 48)
• 102. 

  Commission Decision 2004/361/EC of 13 April 2004 laying down special conditions governing imports of fishery products from Romania (OJ L 113, 20.4.2004, p. 54)
• 103. 

  Commission Decision 2005/72/EC of 28 January 2005 laying down special conditions governing imports of fishery products from Antigua and Barbuda (OJ L 28, 1.2.2005, p. 45)
• 104. 

  Commission Decision 2005/73/EC of 28 January 2005 laying down special conditions governing imports of fishery products from Hong Kong (OJ L 28, 1.2.2005, p. 54)
• 105. 

  Commission Decision 2005/74/EC of 28 January 2005 laying down special conditions governing imports of fishery products from El Salvador (OJ L 28, 1.2.2005, p. 59)
• 106. 

  Commission Decision 2005/218/EC of 11 March 2005 laying down special conditions governing imports of fishery products from Saudi Arabia (OJ L 69, 16.3.2005, p. 50)
• 107. 

  Commission Decision 2005/498/EC of 12 July 2005 laying down special conditions governing imports of fishery products from Algeria (OJ L 183, 14.7.2005, p. 92)
• 108. 

  Commission Decision 2005/499/EC of 12 July 2005 laying down special conditions governing imports of fishery products from the Bahamas (OJ L 183, 14.7.2005, p. 99)
• 112. 

  Commission Decision 95/453/EC of 23 October 1995 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Korea (OJ L 264, 7.11.1995, p. 35. Decision as last amended by Decision 2001/676/EC)
• 113. 

  Commission Decision 96/675/EC of 25 November 1996 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Chile (OJ L 313, 3.12.1996, p. 38)
• 114. 

  Commission Decision 97/427/EC of 25 June 1997 laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Australia (OJ L 183, 11.7.1997, p. 38)
• 115. 

  Commission Decision 97/562/EC of 28 July 1997 laying down special conditions for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Thailand (OJ L 232, 23.8.1997, p. 9)
• 116. 

  Commission Decision 98/569/EC of 6 October 1998 laying down special conditions governing imports of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Tunisia (OJ L 277, 14.10.1998, p. 31. Decision as last amended by Decision 2002/819/EC)
• 117. 

  Commission Decision 2000/333/EC of 25 April 2000 laying down special conditions for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Socialist Republic of Vietnam (OJ L 114, 13.5.2000, p. 42)
• 118. 

  Commission Decision 2001/37/EC of 22 December 2000 laying down special conditions for the import of marine gastropods originating in Jamaica (OJ L 10, 13.1.2001, p. 64)
• 119. 

  Commission Decision 2002/19/EC of 11January 2002 laying down special conditions for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Uruguay (OJ L 10, 12.1.2002, p. 73)
• 123. 

  Commission Decision 84/371/EEC of 3 July 1984 establishing the characteristics of the special mark for fresh meat referred to in Article 5(a) of Directive 64/433/EEC (OJ L 196, 26.7.1984, p. 46)
• 124. 

  Commission Decision 87/260/EEC of 28 April 1987 granting a derogation to the Netherlands and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 123, 12.5.1987, p. 8)
• 125. 

  Commission Decision 87/266/EEC of 8 May 1987 recognizing that the staff medical check-up scheme submitted by the Netherlands offers equivalent guarantees (OJ L 126, 15.5.1987, p. 20)
• 126. 

  Commission Decision 87/562/EEC of 24 November 1987 granting a derogation to the Federal Republic of Germany and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 341, 3.12.1987, p. 35)
• 127. 

  Commission Decision 88/235/EEC of 7 March 1988 granting a derogation to Denmark and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 105, 26.4.1988, p. 20)
• 128. 

  Commission Decision 88/363/EEC of 13 June 1988 granting a derogation to the United Kingdom and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 177, 8.7.1988, p. 57)
• 129. 

  Commission Decision 90/30/EEC of 10 January 1990 granting a derogation to Spain and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 16, 20.1.1990, p. 35)
• 130. 

  Commission Decision 90/31/EEC of 10 January 1990 granting a derogation to France and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 16, 20.1.1990, p. 37)
• 131. 

  Commission Decision 90/469/EEC of 5 September 1990 granting a derogation to Italy and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 255, 19.9.1990, p. 16)
• 136. 

  Commission Decision 94/92/EC of 17 February 1994 concerning the financial aid from the Community for the operations of the Community Reference Laboratory for marine biotoxins (Laboratorio del Ministerio de Sanidad y Consumo, Vigo, Spain

(OJ L , 18.2.1994, p. 63)

• 137. 

  Commission Decision 94/356/EC of 20 May 1994, laying down detailed rules for the application of Council Directive 91/493 as regards own health checks on fishery products (OJ L 156, 23.6.1994, p. 50)
• 138. 

  Council Decision 94/371/EC of 20 June 1994 laying down specific health conditions for the putting on the market of certain types of eggs (OJ L 168, 2.7.1994, p. 34)
• 139. 

  Commission Decision 94/383/EC of 3 June 1994 on the criteria to b e applied to establishments manufacturing meat products without having an industrial structure or an industrial production capacity (OJ L 174, 8.7.1994, p. 33)
• 140. 

  Commission Decision 94/837/EC of 16 December 1994 laying down special conditions for the approval of the rewrapping centres referred to in Council directive 77/99/EEC and rules for the marketing of products therefrom (OJ L 352, 31.12.1994, p. 15)
• 141. 

  Commission Decision 95/149/EC of 8 March 1995 fixing the total volatile basic nitrogen (TVB-N) limit values for certain categories of fishery products and specifying the analysis methods to be used (OJ L 97, 29.4.1995, p. 84)
• 142. 

  Commission Decision 95/165/EC of 4 May 1995 establishing uniform criteria for the derogations to certain establishments manufacturing milk-based products (OJ L 108, 13.5.1995, p. 84)
• 143. 

  Commission Decision 96/536/EC of 29 July 1996 establishing the list of milk-based products in respect o which Member States are authorised to grant individual or general derogations, pursuant to Article 8(2) of directive 92/46/EEC and the nature of the derogations applicable to the manufacture of such products (OJ L 230, 11.9.1996, p. 12)

and the methods of analysis of certain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine gastropods (OJ L 75, 16.3.2002, p. 62)

• 148. 

  Commission Decision 2002/477/EC of 20 June 2002 laying down public health requirements for fresh meat and fresh poultrymeat imported from third countries, and amending Decision 94/984/EC (OJ L 164, 22.6.2002, p. 39)
• 149. 

  Commission Decision 2003/380/EC of 22 May 2003 granting to Sweden a derogation from Council Directive 64/433/EEC and fixing the equivalent health conditions to be respected in relation to cutting of fresh meat (OJ L 131, 28.5.2003, p. 18)
• 150. 

  Commission Decision 2003/774/EC of 30 0Ctober 2003 approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods (OJ L 283, 31.10.2003, p. 78)

LIST 6. LEGISLATION REPEALED BY COMMISSION DECISION 2006/766/EC

• 151. 

  Commission Decision 97/20/EC of 17 December 1996 establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods (OJ L 6, 10.1.1997, p. 46)
• 152. 

  Commission Decision 97/296/EC of 22 April 1997 drawing up the list of third countries from which the import of fishery products is authorised for human consumption (OJ L 122, 14.5.1997, p. 21)

ANNEX VI

EXTRACTS FROM THE HYGIENE REGULATIONS

• 1. 

  REGULATION (EC) NO 852/2004 OF THE EUROPEAN PARLIAMENT AND

OF THE COUNCIL OF 29 APRIL 2004 ON THE HYGIENE OF FOODSTUFFS

Article 16

Report to the European Parliament and to the Council

• 1. 

  The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council.
• 2. 

  The report shall, in particular, review the experience gained from the application of this Regulation and consider whether it would be desirable and practicable to provide for the extension of the requirements of Article 5 to food business operators carrying out primary production and those associated operations listed

in Annex I.

• 3. 

  The Commission shall, if appropriate, accompany the report with relevant proposals.
• 2. 

  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

Article14

Report to the European Parliament and to the Council

• 1. 

  The Commission shall, not later than 20 May 2009, submit a report to the European Parliament and the Council reviewing the experience gained from the implementation of this Regulation.
• 2. 

  The Commission shall, if appropriate, accompany the report with relevant proposals.

ANNEX VII

CONSULTATION PROCESS

All major stakeholders have been consulted bilaterally and collectively.

The MS were consulted in the Standing Committee of the food chain and animal health (SCFCAH) and on several occasions in Commission working groups since 2007. MS were also invited at the beginning of 2007 to share their views on their experience since 2006. Two questionnaires were thereafter sent in 2008 to focus on certain aspects of the hygiene Regulations.

Members of the Advisory Group on the Food Chain and Animal and Plant Health (AGFCAPH), and other EU-level private stakeholders' organisations with an interest related to the food chain and animal and public health, have been given the opportunity on a number of occasions to express their views. These organisations were consulted in plenary meetings, but also in working groups of the AGFCAPH. A questionnaire covering the three hygiene Regulations and requesting them specifically to express their position on the appropriateness of extending the HACCP principles to primary production, was then sent to all consulted organisations.

An overview of the private stakeholders' organisations that have been consulted in the consultation process is given below:

• 1. 

  AGFCAPH MEMBERS

AIPCE-CEP Association des Industries de Poisson de la CE/Comité Import/Export Poissons

ANIMALS ANGELS Animal Welfare Association

ECCA European Crop Care Association

ECPA EU Crop Protection Association

ECSLA European Cold Storage and Logistics Association

EDA European Dairy Association

EFFAT European Federation of Food, Agriculture and Tourism Trade Unions

EFPRA European Fat Processors and Renderers Association

EMRA European Modern Restaurants Association

ESA European Seed Association

EUROCHAMBRES Association of EU Chambers of Commerce and Industries

EUROCOMMERCE Retail, Wholesale and International Trade Representation

to the EU

EUROCOOP EU Community of Consumer Co-operatives

EUROGROUP EU Animal Welfare Organisation

EUROPABIO EU Association of Bioindustries

FEDIAF Alimentation pour Animaux Familiers

FEFAC Fédération Européenne Fabricants Aliments Composés

FERCO Fédération Européenne de la Restauration Collective Concédée

UGAL Union des Groupements de Détaillants Indépendants de l'Europe

• 2. 

  OTHER ORGANISATIONS

CIBC Confédération Internationale de la Boucherie et de la Charcuterie

EAPA European Animal Protein Association

EEPA European Egg Processors Association

EHPM European Federation of Associations of Health Product Manufacturers

EMMA European Minced Meat Association

EUCOLAIT European Association of Dairy Trade

EUROPECHE Association of national organisations of fishing enterprises

in the E.U.

EUWEP European Union of Wholesale with Eggs, Egg-Products, Poultry and Game

FACE Federation of Associations for Hunting and Conservation

of the EU

FEDFA Federation of European Deer Farmers Associations

FRUCOM European Federation of the Trade in dried fruit, edible nuts, honey, spices, canned fruits and vegetables and similar foodstuffs

ANNEX VIII

GUIDES TO GOOD PRACTICE

Articles 7 to 9 of Regulation (EC) No 852/2004 provide for the development of guides to good practice for hygiene and for the application of the HACCP principles. Although they are a voluntary instrument, such guides enable food business sectors to describe in more detail how operators can comply with the legal requirements which are expressed in more general terms in the Regulation. According to the Regulation, two types of guides may be developed depending on the level at which they are established: national and Community level.

When national guides are developed, they have to be assessed by national authorities in order to ensure suitability of their contents with Community legislation and their practicability for the sectors to which they refer. Member States must thereafter forward to the Commission the national guides they agreed upon. Guidelines on the registration of such national guides have been developed and enable Member States to initially submit only certain information concerning their national guides to the Commission.

National guides to good practice have been developed or updated in almost all food sectors, including primary production in most Member States. A register has been created at Community level for ease of reference of interested food sectors and competent authorities. The number of guides is highly variable but seems in general adequate and increasing. The number is dependent on the strength of professional organisations in the relevant Member States as these bodies produce the guides. In general, many more guides are available for retail activities.

Guidelines for the development of Community guides to good practice have also been set down to codify the procedure under which such guides should be established by private stakeholders' organisations and evaluated at Community level. A list of Community guides being evaluated or in preparation is given below:

• 1. 

  DRAFT COMMUNITY GUIDES TO GOOD PRACTICE ACCEPTED BY SCFCAH AND
• 2. 

  DRAFT COMMUNITY GUIDES TO GOOD PRACTICE ACCEPTED BY SCFCAH AND IN

PREPARATION

• - 

  Draft Community Guide to Good Practice for Hygiene in the Contract Catering sector (To be submitted by FERCO)
• - 

  Draft Community Guide to Good Practice for the Bottling of Water (To be submitted by EFBW)
• 3. 

  DRAFT COMMUNITY GUIDES TO GOOD PRACTICE TO BE SENT FOR ACCEPTANCE BY

SCFCAH

• - 

  Draft Community Guide to Good Practice for Processed Cheese (To be submitted by ASSIFONTE)
• - 

  Draft Community Guide to Good Practice for the Bottled Watercooler Industry (To be submitted by EBWA)