CHAPTER I

GENERAL PROVISIONS

Scope
Article 1
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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:
1. the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply;
or
2. the supply of food of animal origin from the retail establishment is to other retail establishments only and
... is a marginal, localised and restricted activity.
c
The appropriate authority
may adopt
... measures to apply the requirements of this Regulation to retail establishments
... 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.

Definitions
Article 2
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. “
appropriate authority
” means—
  1. in relation to England, the Secretary of State;
  2. in relation to Wales, the Welsh Ministers;
  3. in relation to Scotland, the Scottish Ministers;
6. “
prescribe
” means prescribe by regulations.
CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

General obligations
Article 3
1
Food business operators shall comply with the relevant provisions of Annexes II and III.
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.

Registration and approval of establishments
Article 4
1
Food business operators shall place products of animal origin
... 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:
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
... 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.

Health and identification marking
Article 5
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.

Products of animal origin from outside Great Britain
Article 6
1
Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if:
a
the
... country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of
... countries from which imports of that product are permitted;
b
1. 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,
2. 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 ...,
and
3. 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:
1. the requirements of this Regulation, including the requirements of Article 5 on health and identification marking;
2. the requirements of Regulation (EC) No 852/2004;
and
3. any import conditions laid down in accordance with
... 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;
b
importation complies with the requirements of Directive 2002/99/EC;
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)).
CHAPTER III

TRADE

Documents
Article 7
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.

Special guarantees
Article 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER IV

FINAL PROVISIONS
Article 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment and adaptation of Annexes II and III
Article 10
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.
1A.
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.
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
derogations
from Annexes 2 and 3
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.
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—
1. enabling the continued use of traditional methods, at any of the stages of production, processing or distribution of food; or
2. 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.
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.

Specific decisions
Article 11
Without prejudice to the general application of Article 10(1), the appropriate authority may prescribe implementing measures or amendments ...—
...
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;
......... ...
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
, 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.

Exercise of the delegation
Article 11a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulations and devolved powers
Article 12
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.

Consultation of the ... Food Safety Authority
Article 13
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.

Report to the European Parliament and to the Council
Article 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 15
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:
1. Regulation (EC) No 852/2004;
2. Regulation (EC) No 854/2004;
and
3. Directive 2004/41/EC.
However, it shall apply no earlier than 1 January 2006 .
...
See page 83 of this Official Journal.
Council Directive 97/78/EC of
18 December 1997
laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (
OJ L 24, 30.1.1998, p. 9
). Directive amended by the 2003 Act of Accession.
Council Directive 2002/99/EC of
16 December 2002
laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (
OJ L 18, 23.1.2003, p. 11
).
Council Directive 96/23/EC of
29 April 1996
on measures to monitor certain substances and residues thereof in live animals and animal products (
OJ L 125, 23.5.1996, p. 10
). Directive as amended by Regulation (EC) No 806/2003 (
OJ L 122, 16.5.2003, p. 1
).
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).
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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))
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)
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)
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)
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)
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)
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)
Art. 1(4) omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 9(2)
Art. 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)
Word 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)
Words 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)
Words in Art. 11 omitted (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 9(4)