CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

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.
See page 83 of this Official Journal.
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).
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)