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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
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[F11.The appropriate authority may prescribe amendments to Annexes 2 and 3 to take account of—
(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 852/2004;
(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; and
(f)changes in patterns of consumption.]
[F21A.Amendments under paragraph 1 may, in particular, prescribe—
(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 (specific requirements for pectinidae, marine gastropods and echinoderms which are not filter feeders harvested outside classified production areas), 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 (requirements concerning parasites);
(j)the additional health standards for live bivalve molluscs in cooperation with the relevant 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.]
[F32.Without prejudice to the general application of Article 10(1), the appropriate authority may, provided that they do not affect the achievement of the objectives of this Regulation, prescribe [F4derogations] from Annexes 2 and 3 [F5taking 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].]
[F63.Nothing in this Regulation prevents the appropriate authority from using any power which the appropriate authority has to make subordinate legislation adapting the requirements set down in Annex 3 where that legislation does not compromise the achievement of the objectives of this Regulation and—
(a)the adaptations have the aim of—
enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food; or
accommodating the needs of food businesses situated in regions that are subject to special geographical constraints;
(b)in cases not involving the matters at (a), the adaptations apply only to the construction, layout and equipment of establishments.]
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[F88.Nothing in this Regulation prevents the appropriate authority from using any power which the appropriate authority has to make subordinate legislation—
(a)prohibiting or restricting the placing on the market raw milk or raw cream intended for direct human consumption;
(b)permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex 3, Section 9 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.]]
Editorial Information
X1Substituted by Corrigendum to 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 (Official Journal of the European Union L 139 of 30 April 2004).
Textual Amendments
F1Art. 10(1) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 11(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 10(1A) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 9(3)(a)
F3Art. 10(2) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 11(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Art. 10(2) substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 9(3)(b)(i)
F5Words in Art. 10(2) inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 9(3)(b)(ii)
F6Art. 10(3) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 11(c); 2020 c. 1, Sch. 5 para. 1(1)
F7Art. 10(4)-(7) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 11(d); 2020 c. 1, Sch. 5 para. 1(1)
F8Art. 10(8) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 11(e); 2020 c. 1, Sch. 5 para. 1(1)
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