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

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

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;

(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.

(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).

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:

and

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligations

Article 4

Registration and approval of establishments

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 852/2004, 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.

Without prejudice to Article 6(3) of Regulation (EC) No 852/2004, 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 1(5)(b).

An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with 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 (¹):

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

(b) provided the establishment with conditional approval.

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

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 854/2004; 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.

Article 6

Products of animal origin from outside the Community

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 854/2004, 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 854/2004, 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 854/2004 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 852/2004; 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 854/2004 concerning certificates and documents are satisfied, when applicable.

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 (²);

(b) importation complies with the requirements of Directive 2002/99/EC (³); and

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

CHAPTER III

TRADE

Article 7

Documents

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

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.

(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.

(a) The Commission is empowered to adopt delegated acts in accordance with Article 11a amending paragraphs 1 and 2 of this Article in order to update the requirements set out in those paragraphs, taking into account changes in Member States’ control programmes or the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004.

(b) In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article 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.

CHAPTER IV

FINAL PROVISIONS

Article 10

Amendment and adaptation of Annexes II and III

The Commission is empowered to adopt delegated acts in accordance with Article 11a amending Annexes II and III. The amendments shall have the aim of ensuring and facilitating the achievement of the objectives of this Regulation, taking into account the relevant risk factors, and shall be justified on the basis of:

(a) the experience gained by food business operators and/or competent authorities, in particular on the implementation of HACCP-based systems pursuant to Article 5;

(b) the experience gained by the Commission, in particular on the outcome of its audits;

(c) 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.

The amendments referred to in the first subparagraph shall concern:

(a) the requirements on the identification marking of products of animal origin;

(b) the objectives of HACCP-based procedures;

(c) the requirements on the food chain information;

(d) the specific hygiene requirements for the premises, including means of transport, where products of animal origin are produced, handled, processed, stored or distributed;

(e) the specific hygiene requirements for the operations involving the production, handling, processing, storage, transport or distribution of products of animal origin;

(f) the rules for the transport of meat while it is warm;

(g) the health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

(h) the extension of Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

(i) the 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;

(j) the additional health standards for live bivalve molluscs in cooperation with the relevant Union Reference Laboratory, including: (i) limit values and analysis methods for other marine biotoxins; (ii) virus testing procedures and virological standards; and (iii) sampling plans and the methods and analytical tolerances to be applied to check compliance with the health standards.

The Commission is empowered to adopt delegated acts in accordance with Article 11a in order to supplement this Regulation by granting derogations from Annex II and III, taking into account the relevant risk factors and provided that such derogations do not affect the achievement of the following objectives of this Regulation:

(a) to facilitate the fulfilment, by small businesses, of the requirements laid down in the Annexes;

(b) to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food;

(c) to accommodate the needs of food businesses situated in regions that are subject to special geographic constraints;

(d) to facilitate the work of establishments producing raw material which is intended for the production of highly refined food products and which has undergone a treatment ensuring its safety.

(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.

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.

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.

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 IX, 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 general application of Article 9 and Article 10(1), the Commission may lay down the following measures by means of implementing act. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 12(2):

and

Article 11a

Exercise of the delegation

Article 12

Committee procedure

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

Article 13

Consultation of the European Food Safety Authority