(4)

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.’;

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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.