Extracts from the EU Food Hygiene Regulations with specific relevance to the microbiology of live bivalve molluscs are provided below as guidance to interest parties. Additional text from the quoted Regulations may also be relevant and the complete Regulations should be consulted where necessary.

1. Requirements and responsibilities of Food Business Operators are contained within 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.

2. Requirements and responsibilities of Competent Authorities are contained within 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.

3. Requirements for official control laboratories and designation and responsibilities of reference laboratories are contained within Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law and animal health welfare rules.

4. The microbiological criteria relating to bivalve molluscs are included in Commission Regulation (EC) No 2073/2005of 15 November 2005 on microbiological criteria for foodstuffs.

5.The transitional arrangements, including the specification of the use of ISO TS 16649-3 (Donovan) for enumeration of E. coli in bivalve molluscs for the classification of B and C areas are included in Commission Regulation (EC) No 2074/2005of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004.

6. Information concerning a derogation on the accreditation of official control laboratories is contained in Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004, and (EC) No 882/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council and amending Regulation (EC) No 853/2004 and (EC) No 854/2004.

Information contained within Regulation (EC) No 852/2004 (on the hygiene of foodstuffs) has not been included here - this Regulation contains a number of general requirements that cover all types of food business - specifically including both primary production and HACCP and should be consulted in full. (Regulation (EC) No 852/2004 on the hygiene of foodstuffs).

The competent authority for these Regulations is the Food Standards Agency .

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