Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance)
Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Regulation (EC) No 854/2004 is amended as follows:
(1)
in Chapter II of Annex II before Part A:
(a)
the sentences: ‘The reference method for analysis of E. coli is the detection and Most Probable Number (MPN) technique specified in EN/ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140’ are added;
(b)
the sentences of paragraphs (4) and (5) Part A ‘the reference method for this analysis is the five-tube, three-dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140’ are deleted;
(2)
paragraph 2 of Part A of Chapter II is replaced by the following:
‘2.
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. It may, where appropriate, do so in cooperation with the food business operator. In order to classify production areas, the competent authority must define a review period for sampling data from each production and relaying area in order to determine compliance with the standards referred to in this paragraph and in paragraphs 3, 4 and 5.’
(3)
paragraph 3 of Part A of Chapter II is replaced by the following:
‘3.
The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs placed on the market from these areas must meet the health standards laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No 853/2004.
Samples of live bivalve molluscs from these areas must not exceed, in 80 % of samples collected during the review period, 230 E. coli per 100 g of flesh and intravalvular liquid. The remaining 20 % of samples must not exceed 700 E. coli per 100 g of flesh and intravalvular liquid.
When evaluating the results for the defined review period for maintenance of a Class A area, the competent authority can, based on a risk assessment on the basis of an investigation, decide to disregard an anomalous result exceeding the level of 700 E. coli per 100 g of flesh and intravalvular liquid.’
In Annex I to Regulation (EC) No 2073/2005, Chapter 1 is amended as follows:
(1)
in the table on food safety criteria, row 1.25 is replaced by the following:
‘1.25
Live bivalve molluscs and live echinoderms, tunicates and marine gastropods
E. coli ( 15 )
5 ( 16 )
1
230 MPN/100 g of flesh and intravalvular liquid
700 MPN/100 g of flesh and intravalvular liquid
EN/ISO 16649-3
Products placed on the market during their shelf-life’
(2)
footnote 16 is replaced by the following:
‘( 16 )
each sample unit comprises a minimum number of individual animals according to EN/ISO 6887-3.’
(3)
(a)
in the notes on the interpretation of the test results, the entry ‘the limits given refer to each sample unit tested, excluding live bivalve molluscs and live echinoderms, tunicates and gastropods in relation to testing E. coli , where the limit refers to a pooled sample.’
is replaced by the following:
‘The limits given refer to each sample unit tested.’
(b)
in the notes on the interpretation of the test results, the entry concerning L. monocytogenes in other ready-to-eat foods and E. coli in live bivalve molluscs' is replaced by the following:
‘
L. monocytogenes in other ready-to-eat foods:
—
satisfactory, if all the values observed are ≤ the limit,
—
unsatisfactory, if any of the values are > the limit.
E. coli in live bivalve molluscs and live echinoderms, tunicates and marine gastropods:
—
satisfactory, if all the five values observed are ≤ 230 MPN/100 g of flesh and intravalvular liquid or if one of the five values observed is > 230 MPN/100 g of flesh and intravalvular liquid but ≤ 700 MPN/100 g of flesh and intravalvular liquid,
—
unsatisfactory, if any of the five values observed are > 700 MPN/100 g of flesh and intravalvular liquid or if at least two of the five values observed are > 230 MPN/100 g of flesh and intravalvular liquid.’
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union .
It shall apply from 1 January 2017.
