CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

General obligation
Article 3
Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

General and specific hygiene requirements
Article 4
1
Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in part A of Annex I and any specific requirements provided for in Regulation (EC) No 853/2004.
2
Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No 853/2004.
3
Food business operators shall, as appropriate, adopt the following specific hygiene measures:
a
compliance with microbiological criteria for foodstuffs;
b
procedures necessary to meet targets set to achieve the objectives of this Regulation;
c
compliance with temperature control requirements for foodstuffs;
d
maintenance of the cold chain;
e
sampling and analysis.
4
The criteria, requirements and targets referred to in paragraph 3, and associated sampling and analysis methods shall be prescribed by the appropriate authority.
5
When this Regulation, Regulation (EC) No 853/2004 and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other applicable legislation in force in the relevant constituent territory of Great Britain or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.
6
Food business operators may use the guides provided for in Articles 7, 8 and 9 as an aid to compliance with their obligations under this Regulation.

Hazard analysis and critical control points
Article 5
1
Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
2
The HACCP principles referred to in paragraph 1 consist of the following:
a
identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;
b
identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;
c
establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;
d
establishing and implementing effective monitoring procedures at critical control points;
e
establishing corrective actions when monitoring indicates that a critical control point is not under control;
f
establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively;
and
g
establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f).
When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.
3
Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.
4
Food business operators shall:
a
provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business;
b
ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times;
c
retain any other documents and records for an appropriate period.
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Official controls, registration and approval
Article 6
1
Food business operators shall cooperate with the competent authorities in accordance with the legislation in force in the relevant constituent territory of Great Britain.
2
In particular, every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.
Food business operators shall also ensure that the competent authority always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment.
3
However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required under Regulation
(EC) No. 853/2004
.
Art. 4(4) substituted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 5(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 4(5) substituted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 5(b) (as substituted by S.I. 2020/1504, regs. 1(2), 11(4)); 2020 c. 1, Sch. 5 para. 1(1)
Art. 5(5) omitted (31.12.2020) by virtue of The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 6; 2020 c. 1, Sch. 5 para. 1(1)
Art. 6(1) substituted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 7(a) (as amended by S.I. 2020/1504, regs. 1(2), 11(5)); 2020 c. 1, Sch. 5 para. 1(1)
Art. 6(3) substituted (31.12.2020) by The General Food Hygiene (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/642), regs. 1, 7(b); 2020 c. 1, Sch. 5 para. 1(1)