9. 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 OJ L 139, 30.4.2004, p. 55.

In order to achieve the objectives of Regulation (EC) No 853/2004, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annexes II and III to that Regulation and to supplement that Regulation in respect of the use of substances other than potable water to remove surface contamination from products of animal origin, in respect of amendments of the special guarantees relating to the placing of certain food of animal origin on the market in Sweden or Finland and in respect of derogations from Annexes II and III to that Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. Accordingly, Regulation (EC) No 853/2004 is amended as follows: in Article 3, paragraph 2 is replaced by the following: ‘2. Food business operators shall not use any substance other than potable water or, when Regulation (EC) No 852/2004 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 by the Commission. For that purpose the Commission is empowered to adopt delegated acts in accordance with Article 11a supplementing this Regulation. 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.’; in Article 8(3), point (a) is replaced by the following: ‘(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.’; Article 9 is deleted; in Article 10, paragraphs 1 and 2 are replaced by the following: ‘1. 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; 2. 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.’; Article 11 is amended as follows: the introductory phrase is replaced by the following: ‘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):’; points 1, 5, 6, 7 and 8 are deleted; the following Article is inserted: ‘Article 11a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(2), Article 8(3)(a) and Article 10(1) and (2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of powers referred to in Article 3(2), Article 8(3)(a) and Article 10(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making OJ L 123, 12.5.2016, p. 1.’; . 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(2), Article 8(3)(a) and Article 10(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. in Article 12, paragraph 3 is deleted.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-13 · Text as adopted (Official Journal); later amendments are not incorporated in this text.