L 220/14
EN
Official Journal of the European Union
17.8.2013
COMMISSION REGULATION (EU) No 786/2013
of 16 August 2013
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council
as regards the permitted limits of yessotoxins in live bivalve molluscs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(3) The
32nd
Session
of
the
CODEX
Committee
on
Fish
and
Fishery Products (1-5 October 2012) confirmed the
Having regard to the Treaty on the Functioning of the European
exclusion of yessotoxins from the list of marine
Union,
biotoxins that should be tested at international level.
Having regard to Regulation (EC) No 853/2004 of the European
(4)
In the light of the EFSA Opinion and of the conclusions
Parliament and of the Council of 29 April 2004 laying down
of the 32nd Session of the CODEX Committee on Fish
specific hygiene rules for food of animal origin ( 1 ), and in
and Fishery Products, it is appropriate to increase the
particular Article 10(1)(d) thereof,
current limit for yessotoxins to 3,75 milligrams
yessotoxin equivalent per kilogram.
Whereas:
(1) Regulation
(EC)
No
853/2004
lays
down
specific
rules (5) Annex
III
to
Regulation
(EC)
No
853/2004
should
on the hygiene of food of animal origin for food
therefore be amended accordingly.
business operators. That Regulation provides that food
business operators are to ensure that live bivalve
(6) The
measures
provided
for
in
this
Regulation
are
in
molluscs placed on the market for human consumption
accordance with the opinion of the Standing
do not contain certain marine biotoxins in total quan
Committee on the Food Chain and Animal Health and
tities, measured in the whole body or any part edible
neither the European Parliament nor the Council has
separately, that exceed the limits set out in point 2 of
opposed them,
Chapter V of Section VII of Annex III thereto. Point 2(d)
of that Chapter sets out the maximum limit for
yessotoxins at 1 milligram of yessotoxin equivalent per
HAS ADOPTED THIS REGULATION:
kilogram.
Article 1
(2) In
December
2008,
the
European
Food
Safety
Authority
(EFSA) adopted an Opinion of the Scientific Panel on
In Annex III to Regulation (EC) No 853/2004, point 2(d) of
Contaminants in the Food chain on a request from the
Chapter V of Section VII is replaced by the following:
European Commission on marine biotoxins in shellfish
— yessotoxin group ( 2 ). According to that Opinion, in a
series of acute toxicity studies following oral adminis
‘(d) for yessotoxins, 3,75 milligrams of yessotoxin equivalent
tration of yessotoxins, no lethality and no clinical signs
per kilogram;’.
of toxicity were observed. In addition, EFSA concluded
that a portion of shellfish should not contain more than
Article 2
3,75 milligrams of yessotoxin equivalent per kilogram.
That level is above the current limit set out in point
This Regulation shall enter into force on the twentieth day
2(d) of Chapter V of Section VII of Annex III to Regu
following that of its publication in the Official Journal of the
lation (EC) No 853/2004.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 August 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 139, 30.4.2004, p. 55.
( 2 ) The EFSA Journal (2009) Journal number, 907, 1-62.

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