1.Operators and owners of intermediate and processing plants or their representatives shall adopt all measures necessary to comply with the requirements of this Regulation. They shall put in place, implement and maintain a permanent procedure developed in accordance with the principles of the system of hazard analysis and critical control points (HACCP). They shall in particular:
(a)identify and control the critical control points in the plants;
(b)establish and implement methods for monitoring and checking such critical control points;
(c)in the case of processing plants, take representative samples to check compliance:
of each processed batch with the standards for the products established by this Regulation, and
with the maximum permitted levels of physicochemical residues laid down in Community legislation;
(d)record the results of the checks and tests referred to in points (b) and (c) and keep them for a period of at least two years for presentation to the competent authorities;
(e)introduce a system ensuring the traceablility of each batch dispatched.
2.Where the results of a test on samples taken pursuant to paragraph 1(c) do not comply with the provisions of this Regulation, the operator of the processing plant must:
(a)notify the competent authority immediately of the full details of the nature of the sample and the batch from which it was derived;
(b)establish the causes of failures of compliance;
(c)reprocess or dispose of the contaminated batch under the supervision of the competent authority;
(d)ensure that no material suspected or known to be contaminated is moved from the plant before being reprocessed under the supervision of the competent authority and re-sampled officially in order to comply with the standards laid down in this Regulation, unless destined for disposal;
(e)increase the frequency of sampling and testing of production;
(f)investigate animal by-products records appropriate to the finished sample; and
(g)instigate appropriate decontamination and cleaning procedures within the plant.
3.Detailed arrangements for implementing this Article, including rules concerning the frequency of checks and reference methods for microbiological analyses, may be laid down under the procedure referred to in Article 33(2).
1.The competent authority shall at regular intervals carry out inspections and supervision at plants approved in accordance with this Regulation. Inspections and supervision of processing plants shall take place in accordance with Annex V, Chapter IV.
2.The frequency of inspections and supervision shall depend on the size of the plant, the type of products manufactured, risk assessment and guarantees offered in accordance with the principles of the system of hazard analysis and critical control points (HACCP).
3.If the inspection carried out by the competent authority reveals that one or more of the requirements of this Regulation are not being met, the competent authority shall take appropriate action.
4.Each Member State shall draw up a list of plants approved in accordance with this Regulation within its territory. It shall assign an official number to each plant, which identifies the plant with respect to the nature of its activities. Member States shall send copies of the list and updated versions to the Commission and other Member States.
5.Detailed arrangements for implementing this Article, including rules concerning the frequency of checks and reference methods for microbiological analyses, may be laid down under the procedure referred to in Article 33(2).