FOOD BUSINESS OPERATORS' OBLIGATIONS
Article 3
General obligation
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.
Article 4
General and specific hygiene requirements
- 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 ....../2004 *.
- 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 ....../2004 *.
Note to Official Journal: insert No of Regulation laying down specific hygiene rules for food of animal origin.
- Food business operators shall, as appropriate, adopt the following specific hygiene measures:
compliance with microbiological criteria for foodstuffs;
- procedures necessary to meet targets set to achieve the objectives of this Regulation;
- compliance with temperature control requirements for foodstuffs;
- maintenance of the cold chain;
- sampling and analysis.
- The criteria, requirements and targets referred to in paragraph 3 shall be adopted in accordance with the procedure referred to in Article 14(2).
Associated sampling and analysis methods shall be laid down in accordance with the same procedure.
- When this Regulation, Regulation (EC) No ....../2004 * and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other Community or national legislation 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.
- 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.
Article 5
Hazard analysis and critical control points
- Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
- The HACCP principles referred to in paragraph 1 consist of the following:
- identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;
- 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;
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- Note to Official Journal: insert number of Regulation laying down specific hygiene rules for food of animal origin.
- establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;
- establishing and implementing effective monitoring procedures at critical control points;
- establishing corrective actions when monitoring indicates that a critical control point is not under control;
- establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; and
- 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.
- 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.
- Food business operators shall:
- 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;
- ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times;
- retain any other documents and records for an appropriate period.
- Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2). Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1. Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c).
Article 6
Official controls, registration and approval
- Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.
- 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.
- 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 the national law of the Member State in which the establishment is located;
- under Regulation (EC) No ....../2004 *; or
- by a decision adopted in accordance with the procedure referred to in Article 14(2).
Any Member State requiring the approval of certain establishments located on its territory under national law, as provided for in subparagraph (a), shall inform the Commission and other Member States of the relevant national rules.
