EN Official Journal of the European Communities L 139/55

REGULATION (EC) No 853/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 29 April 2004

laying down specific hygiene rules for on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Economic and Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),

Whereas:

(1) By Regulation (EC) No /2004 (4), the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs.

(2) Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported.

(3) In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

(4) With regard to public health, these rules contain common principles, in particular in relation to the manufacturers' and competent authorities' responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

(5) These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing Directives.

(6) It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin.

(7) The requirement in Regulation (EC) No /2004 (5) whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification.

(8) Taken together, these elements justify a recasting of the specific hygiene rules contained in existing Directives.

(9) The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy.

(10) It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin.

(11) Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

(12) The requirements of Regulation (EC) No /2004 (6) are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No /2004 (6) should suffice for wholesale activities consisting only of storage or transport.

(13) Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No /2004 (6) are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments.

(14) In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation.

(15) The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 (7), food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark.

(16) Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community.

(17) The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Decisions 94/968/EC (8), 95/50/EC (9), 95/160/EC (10), 95/161/EC (11), 95/168/EC (12), 95/409/EC (13), 95/410/EC (14) and 95/41 I/EC (15). It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (16) provides for a similar procedure in respect of live animals and hatching eggs.

(18) It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses.

(19) Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures.

(20) The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods.

(21) There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail.

(22) In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identity no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks.

(23) This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory.

(24) It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage.

(25) The present recasting means that the existing hygiene rules can be repealed. Directive 2004/.../EC of the European Parliament and of the Council ofrepealing certain Directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (17) achieves this.

(26) In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs (18) which the repeal of Annex II to Council Directive 92/118/EEC (19) renders void.

(27) Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

(28) To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health.

(29) The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the industries affected time to adapt.

(30) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (20),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1. This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No /2004 (21). They shall apply to unprocessed and processed products of animal origin.

2. Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation.

3. This Regulation shall not apply in relation to:

(a) primary production for private domestic use;

(b) the domestic preparation, handling or storage of food for private domestic consumption;

(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;

(e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

4. Member States shall establish, under national law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such national rules shall ensure the achievement of the objectives of this Regulation.

5. (a) Unless expressly indicated to the contrary, this Regulation shall not apply to retail. (b) However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless: (i) the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply; or (ii) the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity. (c) Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b).

6. This Regulation shall apply without prejudice to:

(a) relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies;

(b) animal welfare requirements; and

(c) requirements concerning the identification of animals and the traceability of products of animal origin.

Article 2

Definitions

The following definitions shall apply for the purposes of this Regulation:

1) the definitions laid down in Regulation (EC) No 178/2002;

2) the definitions laid down in Regulation (EC) No /2004 (22);

3) the definitions laid down in Annex I; and

4) any technical definitions contained in Annexes II and III.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligations

1. Food business operators shall comply with the relevant provisions of Annexes II and III.

2. Food business operators shall not use any substance other than potable water - or, when Regulation (EC) No /2004 (23) or this Regulation permits its use, clean water - to remove surface contamination from products of animal origin, unless use of the substance has been approved in accordance with the procedure referred to in Article 12(2). Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator's duty to comply with the requirements of this Regulation.

Article 4

Registration and approval of establishments

1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments:

(a) that meet the relevant requirements of Regulation (EC) No /2004 (23), those of Annexes II and III of this Regulation and other relevant requirements of food law; and

(b) that the competent authority has registered or, where required in accordance with paragraph 2, approved.

2. Without prejudice to Article 6(3) of Regulation (EC) No /2004 (24), establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only:

(a) primary production;

(b) transport operations;

(c) the storage of products not requiring temperature-controlled storage conditions; or

(d) retail operations other than those to which this Regulation applies pursuant to Article l(5)(b).

3. An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with Regulation (EC) No /2004 of the European Parliament and of the Council oflaying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (25):

(a) granted the establishment approval to operate following an on-site visit; or

(b) provided the establishment with conditional approval.

4. Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No /2004 (26). In particular, food business operators shall ensure that an establishment ceases to operate if the competent authority withdraws its approval or, in the case of conditional approval, fails to prolong it or to grant full approval.

5. This Article shall not prevent an establishment from placing food on the market between the date of application of this Regulation and the first subsequent inspection by the competent authority, if the establishment:

(a) is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation; or

(b) is of a type in respect of which there was no requirement for approval before the application of this Regulation.

Article 5

Health and identification marking

1. Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either:

(a) a health mark applied in accordance with Regulation (EC) No /2004 (27); or

(b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.

2. Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4.

3. Food business operators may not remove a health mark applied in accordance with Regulation (EC) No /2004 (27) from meat unless they cut or process it or work upon it in another manner.

Article 6

Products of animal origin from outside the Community

1. Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if:

(a) the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No [ (28)]/2004, of third countries from which imports of that product are permitted;

(b) (i) the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No [ (28)]/2004, of establishments from which imports of that product are permitted, when applicable, (ii) in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No [ (28)]/2004 or in approved Community establishments, and (iii) in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable;

(c) the product satisfies: (i) the requirements of this Regulation, including the requirements of Article 5 on health and identification marking; (ii) the requirements of Regulation (EC) No [ (29)]/2004; and (iii) any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin, and

(d) the requirements of Article 14 of Regulation (EC) No [ (30)]/2004 concerning certificates and documents are satisfied, when applicable.

2. By way of derogation from paragraph 1, the importation of fishery products may also take place in accordance with the special provisions laid down in Article 15 of Regulation (EC) No [ (30)]/2004.

3. Food business operators importing products of animal origin shall ensure that:

(a) products are made available for control upon importation in accordance with Directive 97/78/EC (31);

(b) importation complies with the requirements of Directive 2002/99/EC (32); and

(c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III.

4. Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification, which need not be in the format specified in paragraph l(d)).

CHAPTER III

TRADE

Article 7

Documents

1. When required in accordance with Annex II or III, food business operators shall ensure that certificates or other documents accompany consignments of products of animal origin.

2. In accordance with the procedure referred to in Article 12(2):

(a) model documents may be established; and

(b) provision may be made for the use of electronic documents.

Article 8

Special guarantees

1. Food business operators intending to place the following food of animal origin on the market in Sweden or Finland shall comply with the rules set out in paragraph 2 in respect of salmonella:

(a) meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM;

(b) meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM; and

(c) eggs.

2. (a) In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation. (b) In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation. (c) In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella. (d) The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland. (e) In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that: (i) the checks referred to in subparagraph (a) have been carried out with negative results; or (ii) the meat is intended for one of the purposes referred to in subparagraph (c); or (iii) the meat comes from an establishment covered by subparagraph (d). (f) In the case of eggs, a certificate stating that the tests referred to in subparagraph (b) have been carried out with negative results, or that the eggs are destined to be used in the manner referred to in subparagraph (c), must accompany consignments.

3. In accordance with the procedure referred to in Article 12(2):

(a) the requirements of paragraphs 1 and 2 may be updated to take account in particular of changes to Member States' control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No /2004 (33); and

(b) the rules laid down in paragraph 2 in respect of any of the foodstuffs referred to in paragraph 1 may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.

4. For the purposes of this Article, "control programme" means a control programme approved in accordance with Regulation (EC) No 2160/2004.

CHAPTER IV

FINAL PROVISIONS

Article 9

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be laid down in accordance with the procedure referred to in Article 12(2).

Article 10

Amendment and adaptation of Annexes II and III

1. Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account:

(a) the development of guides to good practice;

(b) the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No /2004 (34);

(c) the technological developments and their practical consequences and consumer expectations with regard to food composition;

(d) scientific advice, particularly new risk assessments;

(e) microbiological and temperature criteria for foodstuffs;

(f) changes in patterns of consumption.

2. Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they do not affect the achievement of the objectives of this Regulation.

3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 8, national measures adapting the requirements laid down in Annex III.

4. (a) The national measures referred to in paragraph 3 shall have the aim of: (i) enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; or (ii) accommodating the needs of food businesses situated in regions that are subject to special geographic constraints. (b) In other cases, they shall apply only to the construction, layout and equipment of establishments.

5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall:

(a) provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b) describe the foodstuffs and establishments concerned;

(c) explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation; and

(d) give any other relevant information.

6. The other Member States shall have three months from the receipt of a notification referred to in paragraph 5 to send written comments to the Commission. In the case of adaptations arising from paragraph 4(b), this period shall, at the request of any Member State, be extended to four months. The Commission may, and when it receives written comments from one or more Member States shall, consult Member States within the committee referred to in Article 12(1). The Commission may decide, in accordance with the procedure referred to in Article 12(2), whether the envisaged measures may be implemented, subject, if necessary, to appropriate amendments. Where appropriate, the Commission may propose general measures in accordance with paragraph 1 or 2 of this Article.

7. A Member State may adopt national measures adapting the requirements of Annex III only:

(a) in compliance with a decision adopted in accordance with paragraph 6;

(b) if one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6; or

(c) in accordance with paragraph 8.

8. A Member State may, of its own initiative and subject to the general provisions of the Treaty, maintain or establish national rules:

(a) prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption; or

(b) permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section DC, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

Article 11

Specific decisions

Without prejudice to the generality of Article 9 and Article 10(1), implementing measures may be laid down, or amendments to Annex II or III adopted, in accordance with the procedure referred to in Article 12(2):

1) to lay down rules for the transport of meat while it is warm;

2) to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

3) to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

4) to specify recognised testing methods for marine biotoxins;

5) to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including: (a) limit values and analysis methods for other marine biotoxins; (b) virus testing procedures and virological standards; and (c) sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards;

6) to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

7) to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

8) to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

9) to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

10) to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

11) without prejudice to Directive 96/23/EC (35), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk; and

12) to approve equivalent processes for the production of gelatine or collagen.

Article 12

Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its rules of procedure.

Article 13

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Authority on any matter falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex III, Section III, to other animal species.

Article 14

Report to the European Parliament and to the Council

1. The Commission shall, not later than ... (36), 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.

Article 15

This Regulation shall enter into force twenty days after the date of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the following acts have entered into force:

(b) Regulation (EC) No.../2004 (38); and

However, it shall apply no earlier than 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strsbourg, 29.4.2004. For the European Parliament The President P. COX For the Council The President M. McDOWELL

(1) OJ C 365 E, 19.12.2000, p. 58.

(2) OJ C 155,29.5.2001, p. 39.

(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 288), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 23), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.

(4) Page ... of this Official Journal.

(5) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs (as in recital 1).

(6) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs (as in recital 1).

(7) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31,1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245,29.9.2003, p.4).

(8) OJ L 371, 31.12.1994, p. 36.

(9) OJ L 53, 9.3.1995, p. 31.

(10) OJ L 105 9.5.1995, p. 40.

(11) OJ L 105, 9.5.1995, p. 44.

(12) OJ L 109,16.5.1995, p. 44.

(13) OJ L 243,11.10.1995, p. 21.

(14) OJ L 243,11.10.1995, p. 25.

(15) OJ L 243,11.10.1995, p. 29.

(16) OJ L 325, 12.12.2003, p. 1.

(17) Page ... of this Official Journal.

(18) OJ L 168,2.7.1994, p. 34.

(19) Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49). Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60).

(20) OJ L 184, 17.7.1999, p. 23.

(21) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs.

(22) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs.

(23) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs.

(24) Page ... of this Official Journal.

(25) Official Publications Office is to insert official number of Regulation on the hygiene of foodstuffs.

(26) Official Publications Office is to insert official number of Regulation on the organisation of official controls (see Article 4(3)).

(27) Official Publications Office is to insert official number of Regulation on the organisation of official controls.

(28) Official Publications Office is to insert the official number of the Regulation on the organisation of official controls.

(29) Official Publications Office is to insert the official number of the Regulation on the hygiene of foodstuffs.

(30) Official Publications Office is to insert the official number of the Regulation on the organisation of official controls.

(31) Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24,30.1.1998, p. 9). Directive amended by the Act of Accession 2003.

(32) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (OJ L 18, 23.1.2003, p. 11).

(33) Official Publications Office is to insert the official number of the Regulation on the hygiene of foodstuffs.

(34) Official Publications Office is to insert the official number of the Regulation on the hygiene of foodstuffs.

(35) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(36) Five years after the entry into force of this Regulation.

(37) Official Publications Office is to insert the official number of the Regulation on the hygiene of foodstuffs.

(38) Official Publications Office is to insert here the official number of the Regulation referred to in Article 4(3).

(39) Official Publications Office is to insert here the official number of the Directive referred to in recital 25.

ANNEX I DEFINITIONS For the purpose of this Regulation: 1. MEAT 1.1. "Meat" means edible parts of the animals referred to in points 1.2 to 1.8, including blood. 1.2. "Domestic ungulates" means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds. 1.3. "Poultry" means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites. 1.4. "Lagomorphs" means rabbits, hares and rodents. 1.5. "Wild game" means: — wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and — wild birds that are hunted for human consumption. 1.6. "Fanned game" means farmed ratites and farmed land mammals other than those referred to in point 1.2. 1.7. "Small wild game" means wild game birds and lagomorphs living freely in the wild. 1.8. "Large wild game" means wild land mammals living freely in the wild that do not fall within the definition of small wild game. 1.9. "Carcase" means the body of an animal after slaughter and dressing. 1.10. "Fresh meat" means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere. 1.11. "Offal" means fresh meat other than that of the carcase, including viscera and blood. 1.12. "Viscera" means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop. 1.13. "Minced meat" means boned meat that has been minced into fragments and contains less than 1% salt. 1.14. "Mechanically separated meat" or "MSM" means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure. 1.15. "Meat preparations" means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat. 1.16. "Slaughterhouse" means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption. 1.17. "Cutting plant" means an establishment used for boning and/or cutting up meat. 1.18. "Game-handling establishment" means any establishment in which game and game meat obtained after hunting are prepared for placing on the market. 2. LIVE BIVALVE MOLLUSCS 2.1. "Bivalve molluscs" means filter-feeding lamellibranch molluscs. 2.2. "Marine biotoxins" means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins. 2.3. "Conditioning" means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging. 2.4. "Gatherer" means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market. 2.5. "Production area" means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken. 2.6. "Relaying area" means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs. 2.7. "Dispatch centre" means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption. 2.8. "Purification centre" means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption. 2.9. "Relaying" means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening. 3. FISHERY PRODUCTS 3.1. "Fishery products" means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals. 3.2. "Factory vessel" means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing. 3.3. "Freezer vessel" means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging. 3.4. "Mechanically separated fishery product" means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure. 3.5. "Fresh fishery products" means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling. 3.6. "Prepared fishery products" means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping. 4. MILK 4.1. "Raw milk" means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40oC or undergone any treatment that has an equivalent effect. 4.2. "Milk production holding" means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food. 5. EGGS 5.1. "Eggs" means eggs in shell - other than broken, incubated or cooked eggs - that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products. 5.2. "Liquid egg" means unprocessed egg contents after removal of the shell. 5.3. "Cracked eggs" means eggs with damaged shell and intact membranes. 5.4. "Packing centre" means an establishment where eggs are graded by quality and weight. 6. FROGS' LEGS AND SNAILS 6.1. "Frogs' legs" means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae). 6.2. "Snails" means terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and species of the family Achatinidae. 7. PROCESSED PRODUCTS 7.1. "Meat products" means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat. 7.2. "Dairy products" means processed products resulting from the processing of raw milk or from the further processing of such processed products. 7.3. "Egg products" means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products. 7.4. "Processed fishery products" means processed products resulting from the processing of fishery products or from the further processing of such processed products. 7.5. "Rendered animal fat" means fat derived from rendering meat, including bones, and intended for human consumption. 7.6. "Greaves" means the protein-containing residue of rendering, after partial separation of fat and water. 7.7. "Gelatine" means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals. 7.8. "Collagen" means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation. 7.9. "Treated stomachs, bladders and intestines" means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning. 8. OTHER DEFINITIONS 8.1. "Products of animal origin" means: — food of animal origin, including honey and blood; — live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and — other animals destined to be prepared with a view to being supplied live to the final consumer. 8.2. "Wholesale market" means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators.

ANNEX II REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN SECTION I: IDENTIFICATION MARKING When required in accordance with Article 5 or 6, and subject to the provisions of Annex III, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions. A. APPLICATION OF THE IDENTIFICATION MARK 1. The identification mark must be applied before the product leaves the establishment. 2. However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place. 3. An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (1) lays down requirements concerning labelling or marking. 4. Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received, and to whom they have delivered, products of animal origin. B. FORM OF THE IDENTIFICATION MARK 5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. 6. The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard. In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK. Food business operators may continue to use stocks and equipment that they ordered before the entry into force of this Regulation until they are exhausted or require replacement. 7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. 8. When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY. C. METHOD OF MARKING 9. The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material. 10. In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping. 11. For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging. 12. In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in paragraphs 6, 7 and, where appropriate, 8. 13. When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only. 14. When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs. SECTION II: OBJECTIVES OF HACCP-BASED PROCEDURES 1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No.../2004 (2) meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in paragraph 2. 2. The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises: (a) is properly identified; (b) is accompanied by the relevant information from the holding of provenance referred to in Section III; (c) does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits; (d) is clean; (e) is healthy, as far as the food business operator can judge; and (f) is in a satisfactory state as regards welfare on arrival at the slaughterhouse. 3. In the event of failure to comply with any of the requirements listed under paragraph 2, the food business operator must notify the official veterinarian and take appropriate measures. SECTION III: FOOD CHAIN INFORMATION Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse. 1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and been provided with relevant food safety information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No.../2004 (3). 2. Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7. 3. The relevant food safety information referred to in point 1 is to cover, in particular: (a) the status of the holding of provenance or the regional animal health status; (b) the animals' health status; (c) veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods; (d) the occurrence of diseases that may affect the safety of meat; (e) the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonoses and residues; (f) relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian; (g) production data, when this might indicate the presence of disease; and (h) the name and address of the private veterinarian normally attending the holding of provenance. 4. (a) However, it is not necessary for the slaughterhouse operator to be provided with: (i) the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme); or (ii) the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report. (b) The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer. 5. Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned. 6. If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits. 7. If the competent authority so permits, food chain information may accompany the animals to which it relates to the slaughterhouse, rather than arriving at least 24 hours in advance, in the case of: (a) porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of provenance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding and found them to be healthy accompanies them; (b) domestic solipeds; (c) animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the favourable outcome of the ante-mortem inspection accompanies them; and (d) animals that are not delivered directly from the holding of provenance to the slaughterhouse. Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the animals may not take place until the official veterinarian so permits. 8. Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian." (1) Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs (OJ L 173, 6.7.1990, p. 5). Regulation as last amended by Regulation (EC) No 2052/2003 (OJ L 305, 22.11.2003, p. 1). (2) Official Publications Office is to insert the official number of Regulation on the hygiene of foodstuffs. (3) Official Oublications Office is to insert the official number of Regulation on the hygiene of foodstuffs.