EN    EN EN 
SANCO/4150/2009 (POOL/E2/20 09/4150/4150DTS-EN.doc) 
 
EN    EN  COMMISSION OF THE E UROPEAN 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 applic ation of the hygiene Regulations (EC) 
No 852/2004, (EC) No 853/2004 and (EC) No 8 54/2004 of the European Parliament and 
of the Council of 29 April 2004 
 
{COM(2009) 403}  
 
EN 2   EN 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 
 
EN 3   EN 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 inform ation 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 act ual legal framework on hygiene; 
– it shows the importance given by the Commi ssion 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 stak eholders' 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. 
 
EN 4   EN 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 re sponsible for the implementation and 
enforcement of the hygiene Regulations 
Co-decision Legislative procedure requiring approva l of measures to be taken by the 
European Parliament and by the Council 
Comitology Legislative procedure requiring approva l of measures to be taken by the 
Commission by a regulatory committee composed of the representatives of 
the Member States and chaired by th e 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 – Directorat e F of Directorate-General Health 
and Consumers located in Grange (Ire land) responsible fo r verification of 
the implementation of Community food safety legislation in the Member 
States and in third countries  
HACCP Hazard analysis critical control point MS Member State(s) 
OV Official veterinarian(s) Primary 
production Notion covering the production, reari ng or growing of primary products 
and including harvesting, milking, farmed animal production prior to slaughter, hunting, fishing and the harvesting of wild products 
SCFCAH Standing Committee on the Food Chain and Animal Health 
SWD Staff working document 
 
EN 5   EN ANNEX II  
STRUCTURE OF THE EU HYGIENE LEGISLATION 
 
 
EN 6   EN ANNEX III  
ACTS ADOPTED IN CONNECTION 
WITH THE HYGIENE PACKAGE 
The basic Acts constituting the hygiene pack age have been further specified in three 
Regulations laying down various implemen ting measures. These three implementing 
Regulations were adopted in 2005 and entere d 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 ar e amending either the three basic Acts or the three 
implementing Regulations. The Commission consid ers 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 Com mission from revising  and updating, where 
necessary, some of the current ru les 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 foodstuffs1 
2. Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down 
implementing measures for certain produc ts under Regulation (EC) No 853/2004 of 
the European Parliament and of the Counc il 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 Regula tions (EC) No 853/2004 and (EC) No 
854/20042 
3. Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down 
specific rules on official controls for Trichinella  in meat3 
4. Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down 
transitional arrangements for the implem entation of Regulations (EC) No 853/2004, 
(EC) No 854/2004 and (EC) No 882/2004 of th e European Parliament and of the 
Council and amending Regulations (EC) No 853/2004 and (EC) no 854/20044 
                                                 
1 OJ L 338, 22.12.2005, p. 1. 
2 OJ L 338, 22.11.2005, p. 27. 
3 OJ L 338, 22.12.2005, p. 60. 
4 OJ L 338, 22.12.2005, p. 83. 
 
EN 7   EN 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 origin5 
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 consumption6 
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 measures7 
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 meat8 
9. Commission Regulation (EC) No 1666/2006 of 6 November 2006 amending 
Regulation (EC) No 2076/2005 laying dow n 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 Council9 
10. Commission Decision 2006/765/EC of 6 November 2006 repealing certain 
implementing acts concerning food hygiene a nd health conditions for the production 
and placing on the market of  certain products of animal  origin intended for human 
consumption10 
11. Commission Decision 2006/766/EC of 6 Nove mber establishing the lists of third 
countries and territories from which im ports of bivalve molluscs, echinoderms, 
tunicates, marine gastropods and fishery products are permitted11 
12. Commission Decision 2006/767/EC of 6 November 2006 ame nding Commission 
Decisions 2003/804/EC and 2003/858/EC, as re gards certification requirements for 
live molluscs and live fish of aquaculture origin and products thereof intended for 
human consumption12 
                                                 
5 OJ L 320, 18.11.2006, p. 1. 
6 OJ L 320, 18.11.2006, p. 11. 
7 OJ L 320, 18.11.2007, p. 13. 
8 OJ L 320, 18.11.2006, p. 46. 
9 OJ L 320, 18.11.2006, p. 47. 
10 OJ L 320, 18.11.2006, p. 50. 
11 OJ L 320, 18.11.2006, p. 53. 
12 OJ L 320, 18.11.2006, p. 58. 
 
EN 8   EN 2007 
13. Commission Regulation (EC) No 479/2007 amending Regulation (EC) No 
2076/2005 laying down transitional arrange ments 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 Counc il 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 ru les for food of animal origin14 
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 (E C) No 1245/2007 of 24 Oct ober 2007 amending Annex I 
to Regulation (EC) No 2075/2005, as regard s the use of liquid pepsin for the 
detection of Trichinella in meat16 
17. Commission Regulation (EC) No 1246/2007 of 24 October 2007 amending 
Regulation (EC) No 2076/2005 as regards th e extension of the transitional period 
granted to food business operators im porting fish oil intended for human 
consumption17 
18. Commission Regulation (EC) No 1441/ 2007 of 5 December 2007 amending 
Regulation (EC) No 2073/2005 on micr obiological crite ria for foodstuffs18 
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 Fiji19 
20. Commission Regulation (E C) No 1019/2008 of 17 Oct ober 2008 amending Annex II 
to Regulation (EC) No 852/2004 of the Europe an Parliament and of the Council on 
the hygiene of foodstuffs20 
21. Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending 
Annexes II and III of Regulation (EC) No 853/2004 of the European Parliament and 
of the Council laying don specific hygiene rules for food of animal origin and 
                                                 
13 OJ L 111, 28.4.2007, p. 46. 
14 OJ L 281, 25.10.2007, p. 8. 
15 OJ L 281, 25.10.2007, p. 12. 
16 OJ L 281, 25.10.2007, p. 19. 
17 OJ L 281, 25.10.2007, p. 21. 
18 OJ L 322, 7.12.2007, p. 12. 
19 OJ L 132, 22.5.2008, p. 16. 
20 OJ L 277, 18.10.2008, p. 7. 
 
EN 9   EN Regulation (EC) No 2076/2005 as regards iden tification marking, raw milk and dairy 
products, eggs and egg products  and certain fishery products21 
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 fo r human consumption and Regulation (EC) 
No 2076/2005 as regards live bivalve mollusc s, certain fishery products and staff 
assisting with official controls in slaughterhouses22 
23. Commission Regulation (EC) No 1022/ 2008 of 17 October 2008 amending 
Regulation (EC) No 2074/2005 as regards th e total volatile basi c nitrogen (TVB-N) 
limits23 
24. Commission Regulation (EC) No 1023/ 2008 of 17 October 2008 amending 
Regulation (EC) No 2076/2005 as regards th e extension of the transitional period 
granted to food business operators im porting fish oil intended for human 
consumption24 
                                                 
21 OJ L 277, 18.10.2008, p. 8. 
22 OJ L 277, 18.10.2008, p. 15. 
23 OJ L 277, 18.10.2008, p. 18. 
24 OJ L 277, 18.10.2008, p. 21. 
 
EN 10   EN ANNEX IV  
GUIDANCE DOCUMENTS 
Besides legislative instruments, guidance documents have been established by the 
Commission and the MS. These documents are main ly directed at food business operators and 
competent authorities in the Member St ates. 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 es tablished 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/biosaf ety/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/biosaf ety/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 
http://ec.europa.eu/food/ international/trade/in terpretation_ imports.pdf  
5. Technical specifications in relation to the master list and the lists of EU approved 
establishments 
http://ec.europa.eu/food/food/bios afety/establishments/techspecs_en.pdf  
6. Guidelines for the development of Comm unity guides to good pr actice for hygiene or 
for the application of the HACCP princi ples, in accordance with Article 9 of 
Regulation (EC) NO 852/2004 on the hygien e of foodstuffs and Article 22 of 
regulation (EC) No 183/2005 laying dow n requirements for feed hygiene 
http://ec.europa.eu/food/ food/biosafety/hygienelegis lation/guidelines_good_practice
_en.pdf  
7. Guidance document on official c ontrols, under regulation (EC) no 882/2004, 
concerning microbiological sampli ng and testing of foodstuffs 
http://ec.europa.eu/food/food/c ontrols/foodfeed/sampling_testing.pdf  
 
EN 11   EN 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 info rmation concerning their national guides to 
the Commission (SCFCAH consensus of 15 July 2008) 
http://ec.europa.eu/food/f ood/biosafety/hygienelegislatio n/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/f ood/biosafety/salmonella/doc s/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/f ood/biosafety/hygienelegislation/guideline_detect_qas_en.p
df 
11. Guideline for the identification and deve lopment of sampling methods and design of 
suitable protocols for monitoring of Trichinella infection in indicator species 
http://ec.europa.eu/food/f ood/biosafety/hygienelegisla tion/guideline_sampling_indic
ator_species_en.pdf  
 
EN 12   EN ANNEX V  
REPEALED LEGISLATIVE ACTS 
With the adoption of th e hygiene package, a tota l 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 b een repealed since then by implementing 
measures (Lists 3, 4 and 5). 
– 2 previous acts were also repealed by Commission Decisi on 2006/766/EC (List 6). 
LIST 1. L EGISLATION 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 J une 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 heal th 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 Decembe r 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 Decem ber 1976 on health problems affecting the 
production and marketing of meat products and certain other pr oducts of animal 
origin (OJ L 26, 31.1.1977, p.85) 
6. Council Directive 80/215/EEC of 22 January 1980 on animal health problems 
affecting intra-Community trade in meat products (OJ L 47, 21.2.1980, p. 4) 
7. Commission Directive 89/362/EEC of 26 May 1989 on general conditions of hygiene 
in milk production holdings (OJ L 156, 8.6.1989, p. 30) 
8. Council Directive 89/437/ EEC of 20 June 1989 on hygi ene and health problems 
affecting the production and the placing on the market of egg products (OJ L 212, 
22.7.1989, p. 87) 
9. Council Directive 91/492/EEC of 15 July  1991 laying down the health conditions for 
the production and the placing on the market  of live bivalve molluscs (OJ L 268, 
24.9.1991, p.1) 
 
EN 13   EN 10. Council Directive 91/493/EEC of 22 July  1991 laying down the health conditions for 
the production and the placing on the ma rket of fishery products (OJ L 268, 
24.9.1991, p.15) 
11. Council Directive 91/494/EEC of 26 J une 1991 on animal health conditions 
governing intra-Community trade in and im ports 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 produc tion 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 ga me 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 Decem ber 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. L EGISLATION 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) 
LIST 3. L EGISLATION REPEALED BY REGULATION (EC)  NO 2073/2005 
18. Decision 93/51/EEC of 15 December 1992 on th e microbiological cr iteria applicable 
to the production of cooked crustaceans  and molluscan shellfish (OJ L 13, 21.1.1993, 
p. 11) 
LIST 4. L EGISLATION REPEALED BY REGULATION (EC)  NO 1664/2006 
19. Commission Decision 91/180/ EEC of 14 February 1991 laying down certain 
methods of analysis and testing of ra w milk and heat-treated milk (OJ L 93, 
13.4.1991, p. 1) 
20. Commission Decision 2000/ 20/EC of 10 December 19 99 establishing health 
certificates for the importation from third countries of gelatine intended for human 
consumption and of raw materials destined  for the production of gelatine intended 
for human consumption (OJ L 6, 11.1.2000, p. 60) 
 
EN 14   EN Import conditions for fishery products  
21. Commission Decision 93/436/EEC of 30 J une 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 Ju ly 1993 laying down special conditions 
governing imports of fishery products orig inating in the Faroe Islands (OJ L 232, 
15.9.1993, p. 37) 
24. Commission Decision 93/495/EEC of 26 Ju ly 1993 laying down special conditions 
governing imports of fishery products or iginating in Canada (OJ L 232, 15.9.1993, 
p. 43) 
25. Commission Decision 94/198/EC of 7 Ap ril 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 Ap ril 1994 laying down special conditions 
governing imports of fishery products a nd aquaculture products originating in 
Ecuador (OJ L 93, 12.4.1994, p. 34) 
28. Commission Decision 94/269/EC of 8 Ap ril 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 Ma y 1994 laying down special conditions 
governing imports of fishery and aquacultu re products originating in Singapore (OJ 
L 145, 10.6.1994, p. 19) 
30. Commission Decision 94/324/EC of 19 Ma y 1994 laying down special conditions 
governing imports of fishery and aquaculture  products originati ng in Indonesia (OJ L 
145, 10.6.1994, p. 23) 
31. Commission Decision 94/325/EC of 19 Ma y 1994 laying down special conditions 
governing imports of fishery and aquaculture  products originating in Thailand (OJ L 
145, 10.6.1994, p. 30) 
32. Commission Decision 94/448/EC of 20 J une 1994 laying down special conditions 
governing imports of fishery and aquacultu re products originating in New Zealand 
(OJ L 184, 20.7.1994, p. 16) 
33. Commission Decision 94/766/ EC of 21 November 1994 laying down special 
conditions governing imports of fishery a nd aquaculture products  originating in 
Taiwan (OJ L 305, 30.11.1994, p. 31) 
 
EN 15   EN 34. Commission Decision 95/30/ EC of 120 February 1995 laying down special 
conditions governing imports of fishery a nd 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 Ma rch 1995 laying down special conditions 
governing the import of fishery and aquacultu re products originating in Albania (OJ 
L 70, 30.3.1995, p. 27) 
36. Commission Decision 95/173/EC of 7 Ma rch 1995 laying down special conditions 
governing the import of fishery and aquacultu re products originating in Peru (OJ L 
116, 23.5.1995, p. 41) 
37. Commission Decision 95/190/EC of 17 Ma y 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 Oc tober 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 Ma y 1996 laying down special conditions 
governing the import of fishery and aquacultu re products origina ting in Senegal (OJ 
L 137, 8.6.1996, p. 24) 
41. Commission Decision 96/356/EC of 30 Ma y 1996 laying down special conditions 
governing the import of fishery and aquacultu re products originating in Gambia (OJ 
L 137, 8.6.1996, p. 31) 
42. Commission Decision 96/425/EC of 28 J une 1996 laying down special conditions 
governing the import of fishery and aquacult ure products originating in Mauritania 
(OJ L 175, 13.7.1996, p. 27) 
43. Commission Decision 96/606/EC of 11 Oc tober 1996 laying down special conditions 
governing the import of fishery and aquacu lture products originating in Uruguay (OJ 
L 269, 22.10.1996, p. 18) 
44. Commission Decision 96/607/EC of 11 Oc tober 1996 laying down special conditions 
governing the import of fishery and aquacult ure products originating in South Africa 
(OJ L 269, 22.10.1996, p. 23) 
45. Commission Decision 96/608/EC of 11 Oc tober 1996 laying down special conditions 
governing the import of fishery and aquacultu re products originating in Malaysia (OJ 
L 269, 22.10.1996, p. 32) 
46. Commission Decision 96/609/EC of 14 Oc tober 1996 laying down special conditions 
governing the import of fishery and aquacu lture products origin ating in the Ivory 
Coast (OJ L 269, 22.10.1996, p. 37) 
 
EN 16   EN 47. Commission Decision 97/102/EC of 16 Ja nuary 1997 laying down special conditions 
governing the import of fishery and aquacultu re products originating in Russia (OJ L 
35, 5.2.1997, p. 23)  
48. Commission Decision 97/426/EC of 25 J une 1997 laying down special conditions 
governing the import of fishery and aquacultu re products originati ng 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 a nd 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 pro ducts 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 a nd aquaculture products  originating in 
Bangladesh (OJ L 46, 17.2.1998, p. 13) 
52. Commission Decision 98/420/EC of 30 J une 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 J une 1998 laying down special conditions 
governing imports of fishery and aquacultu re products originat ing in Ghana (OJ L 
190, 4.7.1998, p. 66) 
54. Commission Decision 98/422/EC of 30 J une 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 J une 1998 laying down special conditions 
governing imports of fishery and aquacultu re products originating in Falkland 
Islands (OJ L 190, 4.7.1998, p. 76) 
56. Commission Decision 98/424/EC of 30 J une 1998 laying down special conditions 
governing imports of fishery and aquaculture  products originating in Maldives (OJ L 
190, 4.7.1998, p. 83) 
57. Commission Decision 98/568/EC of 6 Oc tober 1998 laying down special conditions 
governing imports of fishery and aquaculture products orig inating in Guatemala (OJ 
L 277, 14.101998, p. 26, as corrected by OJ L 325, 3.12.1998) 
58. Commission Decision 98/570/EC of 7 Oc tober 1998 laying down special conditions 
governing imports of fishery and aquaculture products orig inating in Tunisia (OJ L 
277, 14.10.1998, p. 36) 
59. Commission Decision 98/572/EC of 12 Oc tober 1998 laying down special conditions 
governing imports of fishery and aquacultu re products originat ing in Cuba (OJ L 
277, 14.10.1998, p. 44) 
 
EN 17   EN 60. Commission Decision 98/695/ EC of 24 November 1998 laying down special 
conditions governing imports of fishery a nd 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 Ap ril 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 Ju ly 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 Ju ly 1999 laying down special conditions 
governing imports of fishery and aquacultu re products originating in Oman (OJ L 
203, 3.8.1999, p. 63) 
65. Commission Decision 1999/528/EC of 14 Ju ly 1999 laying down special conditions 
governing imports of fishery and aquacultu re 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 pr oducts 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 a nd 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 pr oducts originating in China and repealing 
Decision 97/368/EC (OJ L 26, 2.2.2000, p. 26) 
69. Commission Decision 2000/672/EC of 20 October 2000 laying down special 
conditions governing imports of fishery products originating in Venezuela (OJ L 
280, 4.11.2000, p. 46) 
70. Commission Decision 2000/673/EC of 20 October 2000 laying down special 
conditions governing imports of fishery products originating in Namibia (OJ L 280, 
4.11.2000, p. 52) 
71. Commission Decision 2000/675/EC of 20 October 2000 laying down special 
conditions governing imports of fishery products originat ing in the Islamic Republic 
of Iran (OJ L 280, 4.11.2000, p. 63) 
72. Commission Decision 2001/36/EC of 22  December 2000 laying down special 
conditions governing imports of fishery products origina ting in Jamaica (OJ L 10, 
13.1.2001, p. 59) 
 
EN 18   EN 73. Commission Decision 2001/632/EC of 16 August 2001 laying down special 
conditions governing imports of fishery products originat ing 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 originat ing 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 originat ing 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 origin ating 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 origin ating 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 origin ating 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 fisher y products from New Caledonia (OJ L 301, 
5.11.2002, p. 6) 
82. Commission Decision 2002/856/EC of 29 October 2002 laying down special 
conditions governing imports of fishery products from Greenland (OJ L 301, 
5.11.2002, p. 11) 
83. Commission Decision 2002/857/EC of 29 October 2002 laying down special 
conditions governing imports of fisher y products from Suriname (OJ L 301, 
5.11.2002, p. 19) 
84. Commission Decision 2002/858/EC of 29 October 2002 laying down special 
conditions governing imports of fishery products from Mozambique (OJ L 301, 
5.11.2002, p. 24) 
85. Commission Decision 2002/859/EC of 29 October 2002 laying down special 
conditions governing imports of fisher y products from Papua New Guinea (OJ L 
301, 5.11.2002, p. 33) 
 
EN 19   EN 86. Commission Decision 2002/860/EC of 29 October 2002 laying down special 
conditions governing imports of fishery products from Swit zerland (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 fisher y 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 Ap ril 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 fisher y 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 produc ts 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 fish ery 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 produc ts from the United Arab Emirates (OJ 
L 273, 24.10.2003, p. 28) 
95. Commission Decision 2003/762/EC of 15 October 2003 laying down special 
conditions governing imports of fishery pr oducts from the Netherlands Antilles (OJ 
L 273, 24.10.2003, p. 33) 
96. Commission Decision 2003/763/EC of 15 October 2003 laying down special 
conditions governing imports of fishery products from Cape Verde (OJ L 273, 
24.10.2003, p. 38) 
97. Commission Decision 2004/37/EC of 23  December 2003 laying down special 
conditions governing imports of fishery products from Serbia and Montenegro (OJ L 8, 14.1.2004, p. 12) 
98. Commission Decision 2004/38/EC of 23  December 2003 laying down special 
conditions governing imports of fishery products from Egypt (OJ L 8, 14.1.2004, p. 17) 
 
EN 20   EN 99. Commission Decision 2004/39/EC of 23  December 2003 laying down special 
conditions governing imports of fishery pr oducts 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 Ap ril 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 Ap ril 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 pr oducts 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 pr oducts 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 pr oducts from Saudi Arabia (OJ L 69, 
16.3.2005, p. 50) 
107. Commission Decision 2005/498/EC of 12 Ju ly 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 Ju ly 2005 laying down special conditions 
governing imports of fishery produc ts from the Bahamas (OJ L 183, 14.7.2005, 
p. 99) 
109. Commission Decision 2005/500/EC of 28 January 2005 laying down special 
conditions governing imports of fisher y products from Grenada (OJ L 183, 
14.7.2005, p. 104) 
Import conditions for, bivalve molluscs, ech inoderms, tunicates and marine gastropods  
110. Commission Decision 93/387/EC of 7 June  1993 laying down special conditions for 
the import of live bivalve molluscs, echi noderms, tunicates a nd marine gastropods 
originating in Morocco (OJ L 166, 8.7.1993, p. 40. Decision as last amended by 
Decision 96/31/EC) 
111. Commission Decision 94/777/ EC of 30 November 1994 laying down special 
conditions for the import of live bivalve mo lluscs, echinoderms, tunicates and marine 
gastropods originating in Turkey (OJ L 312, 6.12.1994, p. 35) 
 
EN 21   EN 112. Commission Decision 95/453/EC of 23 Oc tober 1995 laying down special conditions 
for the import of live bivalve mollusc s, 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 mo lluscs, 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, echi noderms, tunicates a nd 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, echinode rms, tunicates and marine gastropods 
originating in Thailand (OJ L 232, 23.8.1997, p. 9) 
116. Commission Decision 98/569/EC of 6 Oc tober 1998 laying down special conditions 
governing imports of live bivalve mollusc s, 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 Ap ril 2000 laying down special conditions 
for the import of bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Socialist Republ ic 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 gast ropods 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 mollu scs, echinoderms, tunicates and marine 
gastropods originating in Uruguay (OJ L 10, 12.1.2002, p. 73) 
120. Commission Decision 2002/470/EC of 20 June 2002 laying down special conditions 
for the import of processed or frozen bi valve molluscs, echinoderms, tunicates and 
marine gastropods from Japan (OJ L 163, 21.6.2002, p. 19) 
121. Commission Decision 2004/30/EC of 23  December 2003 laying down special 
conditions for the import of processed a nd frozen bivalve molluscs, echinoderms, 
tunicates and marine gast ropods from Peru and repealing Decisions 2001/338/EC 
and 95/174/EC (OJ L 6, 10.1.2004, p. 53) 
L
IST 5. L EGISLATION REPEALED BY COMMISSION DECISION 2006/765/EC 
122. Commission Directive 83/201/EEC of 12 Ap ril 1983 establishing exceptions from 
Council Directive 77/99/EEC for certain pr oducts which contain other foodstuffs and 
only a small percentage of meat or meat product (OJ L 112, 28.4.1983, p. 28) 
 
EN 22   EN 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 Netherla nds 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 equivale nt 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 gran ting a derogation to the 
United Kingdom and fixing the equivalent health conditi ons 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 Ja nuary 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 cond itions 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 conditi ons to be respected in  relation to cutting 
of fresh meat (OJ L 255, 19.9.1990, p. 16) 
132. Commission Decision 90/514/ EEC of 25 September 1990 recognizing that the staff 
medical check-up scheme submitted by the Netherlands offers equivalent guarantees (OJ L 286, 18.10.1990, p. 29) 
133. Commission Decision 92/92/EEC of 9 Ja nuary 1992 laying down the requirements 
relating to equipment and st ructure of dispatch and pur ification centres for live 
bivalve molluscs, for which derogations may be granted (OJ L 34, 11.2.1992, p. 34) 
134. Commission Decision 93/140/EEC of 19 January 1993 laying down the detailed 
rules relating to the visual inspection for the purpose of detecting parasites in fishery products (OJ L 56, 9.3.1993, p. 42) 
135. Commission Decision 94/14/ EC of 21 December 1993 setting up the list of 
establishments in the Community for which are granted temporary and limited derogations from specific Community hea lth rules on the production and marketing 
of fresh meat (OJ L 14, 17.1.1994, p. 1)  
 
EN 23   EN 136. Commission Decision 94/92/EC of 17 Fe bruary 1994 concerning the financial aid 
from the Community for the operations of  the Community Reference Laboratory for 
marine biotoxins (Laboratorio del Mini sterio 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 deta iled 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 certai n 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 rewrappi ng 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 Ma rch 1995 fixing the to tal volatile basic 
nitrogen (TVB-N) limit values for certa in 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 ma nufacturing 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) 
144. Commission Decision 96/658/EC of 13 November 1996 laying down the special 
conditions for the approval of  establishments situated in wholesale markets (OJ L 
302, 26.11.1996, p. 22) 
145. Commission Decision 98/470/EC of 9 Ju ly 1998 implementing Council Directive 
89/662/EEC as regards information on veterinary checks (OJ L 208, 24.7.1998, 
p. 54) 
146. Commission Decision 2001/471/EC of 8 June 2001 laying down rules for the regular 
checks on the general hygiene carried out by the operators in establishments 
according to directive 64/433/EEC on hea lth conditions for the production and 
marketing of fresh meat and directive 71/118/EEC on health problems affecting the 
production and placing on the market of fresh poultry meat (OJ L 165, 21.6.2001, p. 48) 
147. Commission Decision 2002/225/EC of 15 Ma rch 2002 laying down detailed rules for 
the implementation of council Directive 91/492/EEC as regards the maximum levels 
 
EN 24   EN and the methods of analysis of certain marine biotoxins in bivalve molluscs, 
echinoderms, tunicates and mari ne 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 poultr ymeat 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 Di rective 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 0C tober 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. L EGISLATION 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 conditi ons for the production and placing on the 
market of bivalve molluscs, echinoderms, t unicates 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 fish ery products is authorised for human 
consumption (OJ L 122, 14.5.1997, p. 21) 
 
EN 25   EN 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 th an 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 appropriat e, 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 th an 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 appropriat e, accompany the report with relevant 
proposals. 
3. REGULATION
 (EC)  NO 854/2004  OF THE  EUROPEAN  PARLIAMENT  AND  
OF THE  COUNCIL  OF 29 APRIL  2004  LAYING  DOWN  SPECIFIC  RULES  
FOR  THE  ORGANISATION  OF OFFICIAL  CONTROLS  ON  PRODUCTS  OF 
ANIMAL  ORIGIN  INTENDED  FOR  HUMAN  CONSUMPTION 
Article 21 
Report to the European Parliament and to the Council  
1. The Commission shall, not later th an 20 May 2009 submit a report to the 
European Parliament and the Council reviewing the experience gained from the application of this Regulation. 
 
EN 26   EN 2. The Commission shall, if appropriat e, accompany the report with relevant 
proposals. 
 
EN 27   EN ANNEX VII  
CONSULTATION PROCESS 
All major stakeholders have been co nsulted bilaterally and collectively. 
The MS were consulted in the Standing Comm ittee of the food chain and animal health 
(SCFCAH) and on several occasions in Co mmission 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 F ood Chain and Animal and Plant Health 
(AGFCAPH), and other EU-level private stakehol ders' organisations with an interest related 
to the food chain and animal and public health, have been given the op portunity on a number 
of occasions to express their views. These orga nisations were consulted in plenary meetings, 
but also in working groups of the AGFCAPH. A questionnai re covering the three hygiene 
Regulations and requesting them specifically to  express their position on the appropriateness 
of extending the HACCP principles to primar y production, was then se nt to all consulted 
organisations. 
An overview of the private stakeholders' orga nisations that have been consulted in the 
consultation process is given below: 
1. AGFCAPH  MEMBERS  
AIPCE-CEP Association des Industrie s de Poisson de la CE/Comité 
Import/Export Poissons 
ANIMALS 
ANGELS Animal Welfare Association 
AVEC Association of Poultry Pro cessors and Poultry Import and 
Export Trade 
BEUC European Consumers' Organisation CEFIC Chemical Industry C ouncil Food Regulation Panel 
CELCAA Commerce Agro-Alimentaire CES/ETUC Confédération Eu ropéenne des Syndicats 
CIAA  Confédération des Industries Agro-Alimentaires CLITRAVI Association of Meat Processing Industry 
COCERAL EU Association for Trade in Cereals, Oilseeds, Feedstuffs COPA-COGECA Agri-Cooperation 
 
EN 28   EN ECCA European Crop Care Association 
ECPA EU Crop Protection Association ECSLA European Cold Storag e and Logistic s 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 Ch ambers 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 Fa bricants Aliments Composés 
FERCO Fédération Européenne de  la Restauration Collective 
Concédée 
FESASS Fédération Européenne Santé Animale et Sécurité 
Sanitaire 
FRESHFEL Forum for the Fresh Produce Industry FVE Federation Veterinarians of Europe HOTREC Hotels, restaurants and Cafés in Europe IFAH EU Animal Health Industry IFOAM EU Federation of Organic Agriculture Movements UEAPME Artisanat et Petites/Moyennes Entreprises UECBV European Livestock and Meat Trading Union 
 
EN 29   EN UGAL Union des Groupements de Détaillants Indépendants de 
l'Europe 
2. O THER 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 A ssociations of Health Product 
Manufacturers 
EMMA European Minced Meat Association EUCOLAIT European Association of Dairy Trade EUROPECHE Association of national or ganisations of fishing enterprises 
in the E.U. 
EUWEP European Union of Whol esale 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 
IFFO International Fishmeal and Fish Oil Organisation WUWM World Union of Wholesale Markets 
 
EN 30   EN 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 gui des enable food business sectors to describe in more detail 
how operators can comply with the legal requir ements which are expressed in more general 
terms in the Regulation. According to the Re gulation, two types of guides may be developed 
depending on the level at which they are es tablished: national and Community level. 
When national guides are develope d, they have to be assessed by national authorities in order 
to ensure suitability of their contents with Co mmunity legislation and their practicability for 
the sectors to which they refer. Member Stat es must thereafter forward to the Commission the 
national guides they agreed upon. Gu idelines 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 devel oped or updated in almo st all food sectors, 
including primary production in most Member  States. A register has been created at 
Community level for ease of re ference of interested  food sectors and competent authorities. 
The number of guides is highly variable but se ems in general adequate and increasing. The 
number is dependent on the strength of profes sional 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 su ch guides should be established by private 
stakeholders' organisations a nd evaluated at Comm unity level. A list of Community guides 
being evaluated or in prep aration is given below: 
1. D RAFT COMMUNITY GUIDES TO GOOD PRACTICE ACCEPTED BY SCFCAH  AND 
UNDER EVALUATION  
– Draft Community Guide to Good Practic e for Wholesale Market Authorities 
(Submitted by WUWM) 
– Draft Community Guide to Good Practice for Public Cold Store Facilities 
(Submitted by ECSLA) 
– Draft Community Guide to Good Manufacturing Practice for Liquid, 
Concentrated, Frozen and Dried Egg Pr oducts Used as Food Ingredients (non-
ready to eat egg products) (Submitted by EEPA) 
– Draft Community Guide to Good Practice for the processing of natural sausage 
casing (Submitted by ENSCA) 
– Draft Community Guide to Good Hygi ene Practice for the Prevention and 
Control of Microbiologi cal Infections focused on Salmonella Control of 
Chickens reared for Meat (Submitted by COPA-COGECA) 
 
EN 31   EN 2. D RAFT COMMUNITY GUIDES TO GOOD PRACTICE ACCEPTED BY SCFCAH  AND IN 
PREPARATION  
– Draft Community Guide to Good Practice fo r Hygiene in the C ontract Catering 
sector (To be submitted by FERCO) 
– Draft Community Guide to Good Practic e for the Bottling of Water (To be 
submitted by EFBW) 
3. D RAFT 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)