Regulation (EC) No 853/2004 of the European Parliament and of the CouncilShow full title

[X1 CHAPTER I U.K. GENERAL PROVISIONS

Article 1 U.K. 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 852/2004. 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. [F1 The appropriate authority] shall establish, according to F2 ... law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such F2 ... 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 F3 ... is a marginal, localised and restricted activity.

(c) [F4 The appropriate authority] may adopt F5 ... measures to apply the requirements of this Regulation to retail establishments F5 ... 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.

Textual Amendments

F1 Words in Art. 1(4) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 4(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 1(4) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 4(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 1(5)(b)(ii) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 4(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 1(5)(c) substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 4(b)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 1(5)(c) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 4(b)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. 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 852/2004;

3.

the definitions laid down in Annex I;

and

4.

any technical definitions contained in Annexes II and III.

5.

[F6 “appropriate authority” means—

(a)

in relation to England, the Secretary of State;

(b)

in relation to Wales, the Welsh Ministers;

(c)

in relation to Scotland, the Scottish Ministers;

6.

“prescribe” means prescribe by regulations.]

Textual Amendments

F6 Art. 2(5)(6) inserted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 5 (as amended by S.I. 2020/1504, regs. 1(2), 9(3)); 2020 c. 1, Sch. 5 para. 1(1)

Editorial Information

X1 Substituted 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).

CHAPTER II U.K. FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3 U.K. General obligations

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

[F7 2 . Food business operators must 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 prescribed by the appropriate authority. Food business operators must comply with any conditions of use that may be prescribed by the appropriate authority. The use of a prescribed substance does not affect the food business operator’s duty to comply with the requirements of this Regulation.]

Textual Amendments

F7 Art. 3(2) substituted (31.12.2020) by The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1247), regs. 1(3), 4; 2020 c. 1, Sch. 5 para. 1(1)

Article 4 U.K. Registration and approval of establishments

1 . Food business operators shall place products of animal origin F8 ... 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.

2 . 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).

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 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.

4. Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No 854/2004. 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 F9 ... 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.

Textual Amendments

F8 Words in Art. 4(1) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 7(a); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 4(5)(a) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 7(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 5 U.K. 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 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.

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 854/2004 from meat unless they cut or process it or work upon it in another manner.

Article 6 U.K. Products of animal origin from outside [F10 Great Britain]

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

(a) the F11 ... country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of F11 ... 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 F12 ...,

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 F13 ... 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.

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 854/2004.

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(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.

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 1(d)).

Textual Amendments

F10 Words in Art. 6 heading substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), reg. 8(a) (as substituted by S.I. 2020/1504, regs. 1(2), 9(4)); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Art. 6(1)(a) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 8(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 6(1)(b)(ii) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 8(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in Art. 6(1)(c)(iii) omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 8(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER III U.K. TRADE

Article 7 U.K. 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.

F14 Article 8 U.K. Special guarantees

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Textual Amendments

F14 Art. 8 omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 9; 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER IV U.K. FINAL PROVISIONS

F15 Article 9 U.K.

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Textual Amendments

F15 Deleted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).

Article 10 U.K. Amendment and adaptation of Annexes II and III

[F16 1. 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.]

[F17 2. 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 exemptions from Annexes 2 and 3.]

[F18 3. 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—

(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 geographical constraints;

(b) in cases not involving the matters at (a), the adaptations apply only to the construction, layout and equipment of establishments.]

F19 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F19 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F19 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F19 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F20 8. 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.]

Textual Amendments

F16 Art. 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)

F17 Art. 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)

F18 Art. 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)

F19 Art. 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)

F20 Art. 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)

Article 11 U.K. Specific decisions

[F21 Without prejudice to the general application of Article 10(1), the appropriate authority may prescribe implementing measures or amendments to Annex 2 or 3—]

1.

F15 ...

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.

F15 ...

6.

F15 ...

7.

F15 ...

8.

F15 ...

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 (4) , 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.

Textual Amendments

F15 Deleted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).

F21 Words in Art. 11 substituted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 12(a); 2020 c. 1, Sch. 5 para. 1(1)

F22 Article 11a U.K. Exercise of the delegation

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Textual Amendments

F22 Art. 11a omitted (31.12.2020) by virtue of S.I. 2019/640, reg. 12A (as substituted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(7))

[F24 Article 12 U.K. [F23 Regulations and devolved powers]

1 . Any power to make regulations under this Regulation—

(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.

2 . For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

3. Any power to make regulations under this Regulation includes power—

(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);

(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

4. Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—

(a) in the case of England, of either House of Parliament;

(b) in the case of Wales, of Senedd Cymru;

(c) in the case of Scotland, of the Scottish Parliament.

5. In this Regulation, any power—

(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.]

Textual Amendments

F23 Art. 12 heading substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 13(a); 2020 c. 1, Sch. 5 para. 1(1)

F24 Art. 12 substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 13(b) (as amended by S.I. 2020/1504, regs. 1(2), 9(8)); 2020 c. 1, Sch. 5 para. 1(1)

[F26 Article 13 U.K. Consultation of the F25 ... Food Safety Authority

The appropriate authority must consult the Food Safety Authority on matters falling within the scope of this Regulation that could have a significant impact on public health and, in particular, before proposing to extend Annex 3, Section 3, to other animal species.]

Textual Amendments

F25 Word in Art. 13 heading omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 14(a); 2020 c. 1, Sch. 5 para. 1(1)

F26 Art. 13 substituted (31.12.2020) by The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 14(b); 2020 c. 1, Sch. 5 para. 1(1)

F27 Article 14 U.K. Report to the European Parliament and to the Council

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Textual Amendments

F27 Art. 14 omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 15; 2020 c. 1, Sch. 5 para. 1(1)

Article 15 U.K.

This Regulation shall enter into force on the 20th day after that 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:

(a)

Regulation (EC) No 852/2004;

(b)

Regulation (EC) No 854/2004;

and

(c)

Directive 2004/41/EC.

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

F28 ...

Textual Amendments

F28 Words in Signature omitted (31.12.2020) by virtue of The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/640), regs. 1, 16; 2020 c. 1, Sch. 5 para. 1(1)