Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin intended for human consumption. It provides that Member States are to ensure that the production and placing on the market of live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods undergo official controls as described in Annex II thereto.

Paragraph 2 of Chapter II Part A of Annex II to Regulation (EC) No 854/2004 provides that the competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination.

In order to classify production areas the competent authority should define a review period for sampling data from each production and relaying area in order to determine compliance with the standards specified in that Regulation.

Paragraph 3 of Chapter II Part A of Annex II to Regulation (EC) No 854/2004 states that the competent authority may classify as Class A, areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from those areas are required to meet the health standards laid down in Annex III, Section VII, Chapter V of Regulation (EC) No 853/2004 of the European Parliament and of the Council3.

Commission Regulation (EC) No 2073/20054 lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators in respect of the general and specific hygiene requirements referred to in Article 4 of Regulation (EC) No 852/2004. More particularly, it lays down a food safety criterion for Escherichia coli on live bivalve molluscs and live echinoderms, tunicates and gastropods.

The Codex Alimentarius criterion for E. coli for products placed on the market differs from the criterion contained in European Union legislation. The Codex Alimentarius criterion is a three-class plan (n = 5, c = 1, m = 230 and M = 700 E. coli MPN/100 g of flesh and intravalvular liquid), while the European Union criterion is a two-class plan (n = 1, c = 0, M = 230 E. coli MPN/100 g of flesh and intravalvular liquid). This divergence has implications for international trade. The Codex Alimentarius criterion, based on international standards, should also be reflected in the rules on the classification of Class A production areas laid down in Annex II to Regulation (EC) No 854/2004.

The Codex Alimentarius three-class plan approach is more likely to detect non-compliant batches particularly as contamination levels approach the regulatory limit. The Codex Alimentarius approach for end-product testing is considered scientifically more precise and it offers on average broadly equivalent health protection.

Regulation (EC) No 2073/2005 and Regulation (EC) No 854/2004 should be aligned to the Codex Alimentarius as regards this criterion and should therefore be amended accordingly.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,