Bivalve filter feeding shellfish such as oysters, mussels, clams, cockles,
etc, may become contaminated with human bacteria and viruses if grown in sewage
polluted waters. Such contaminated shellfish may cause outbreaks of infectious
disease when consumed raw or lightly cooked. Consequently, many countries
enact legal controls that govern the sanitary conditions required for growing
and placing on the market of bivalve molluscs. In the European Union requirements
relevant to the microbiology of bivalve molluscs are contained within the
EU Food Hygiene Regulations.
To assist in the uniform application of these sanitary controls, and to encourage
the development of new procedures for tackling contamination of bivalve shellfish,
a network of expert Reference Laboratories for monitoring bacteriological
and viral contamination of bivalve molluscs has been established
across the EU. Information on the designation and responsibilities of reference
laboratories is 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, animal health welfare rules. This regulation designates
the Cefas Weymouth laboratory as the co-ordinating European Community reference
Laboratory (CRL) and requires each European Member State to designate a National
reference laboratory (NRL) to work with the CRL and to co-ordinate activities
in their country. Contact details for each NRL are available from the relevant
page of this web site. (Laboratory Network).
Extracts from the EU Food Hygiene Regulations with specific relevance to
the microbiology of live bivalve molluscs are provided below as guidance to
interested parties. Additional text from the quoted Regulations may also be
relevant and the complete Regulations should be consulted where necessary.
Information contained within Regulation (EC) No 852/2004 (on the hygiene of
foodstuffs) has not been included - 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).
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 vertification of compliance with feed and
food law, animal health and welfare rules.
4. The microbiological criteria relating to bivalve molluscs are included
in Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria
for foodstuffs.
5. The transitional arrangements, including the specification of the use
of ISO TS 16649-3 (Donovan) (Copies of ISO TS 16649-3 can be purchased directly from ISO at http://www.iso.org/iso/store.htm)
for enumeration of E. coli in bivalve molluscs
for the classification of B and C areas are included in Commission Regulation
(EC) No 2074/2005 of 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.
7. Information concerning an amendment to 854/2004 regarding analytical tolerance for class B areas is contained in Commission Regulation
(EC) No. 1666/2006 of 6 November 2006 amending Regulation (EC) No 2076/2005 laying down
transtitional arrangements for the implementation of Regulation (EC) No 853/2004, (EC) No 854/2004 and
(EC) 882/2004 of the European Parliament
and of the Council.
EU Food Hygiene Regulations can be downloaded in full from the Regulation
section of this website or the EURlex website of the European Commission http://eur-lex.europa.eu/.
For further information please contact us.
