1999/313/EC: Council Decision of 29 April 1999 on reference laboratories for monitoring bacteriological and viral contamination of bivalve molluscs
Date: 1999-04-29
Institutions: Council of the European Union
Subjects: health control, infectious disease, mollusc, research body

L 120/40

EN

Official Journal of the European Communities

8. 5. 1999

COUNCIL DECISION

of 29 April 1999

on reference laboratories for monitoring bacteriological and viral contamination
of bivalve molluscs

(1999/313/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 43 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinions of the European Parlia-
ment (2),

Having regard to the opinion of the Economic and Social
Committee (3),

national
responsible
coordinating the requisite tests in that State;

laboratory

reference

for

(6) Whereas,

to

ensure

standardised

system
a
throughout the Community, the Community refer-
ence laboratory responsible for coordinating the
checks on viral and bacteriological contamination
of bivalve molluscs carried out by each national
laboratory should be designated; whereas the oper-
ating terms and functions of the Community refer-
ence laboratory should be laid down; whereas those
responsible for the laboratory must undertake to
the tasks laid down in this Decision
carry out
under the terms provided for herein;

(1) Whereas

the Annex to Council Directive 91/
492/EEC of 15 July 1991 laying down the health
conditions for the production and the placing on
the market of live bivalve molluscs (4) lays down in
particular requirements on bacteriological and viral
contamination of live bivalve molluscs;

(7) Whereas this Community reference laboratory can
be granted Community financial assistance under
the terms of Article 28 of Council Decision 90/
424/EEC of 26 June 1990 on expenditure in the
veterinary field (5),

(2) Whereas Chapter V(8) of

the Annex to that
Directive states that, in the absence of routine virus
testing procedures and the establishment of viro-
logical standards, health checks must be based on
faecal bacteria counts;

(3) Whereas

scientific progress has

shown faecal
bacteria to be an unreliable indicator of the pres-
ence of viruses in live bivalve molluscs; whereas to
protect public health it is therefore necessary to
base the health check on other indicators;

(4) Whereas the development of new analytical tech-
niques for viruses and reliable indicators of bivalve
mollusc contamination requires coordination of the
activities of the network of national laboratories;

(5) Whereas, to ensure an effective monitoring system
with regard to virus testing and the establishment
of
for virological and bacteriological
contamination, and to introduce routine procedures
and reliable methods for detecting viruses and
bacteria, each Member State should designate a

standards

(1) OJ C 267, 3.9.1997, p. 15.
(2) OJ C 304, 6.10.1997, p. 79 and opinion of 13 April 1999 (not

yet published in the Official Journal).

(3) OJ C 355, 21.11.1997, p. 63.
(4) OJ L 268, 24.9.1991, p. 1. Directive as last amended by

Directive 97/79/EC (OJ L 24, 30.1.1998, p. 31).

HAS ADOPTED THIS DECISION:

Article 1

for monitoring viral

Each Member State shall designate a national reference
laboratory
and bacteriological
contaminations of bivalve molluscs. It shall inform the
Commission, which shall publish the list of the national
reference laboratories and any updates to it in the Official
Journal of the European Communities.

Article 2

Each national reference laboratory shall be respon-

1.
sible for:

(a) coordinating the activities of the national laboratories
responsible for viral and bacteriological analyses of
bivalve molluscs in the relevant Member State;

(5) OJ L 224, 18.8.1990, p. 19. Decision as last amended by

Decision 94/370/EC (OJ L 168, 2.7.1994, p. 31).

8. 5. 1999

EN

Official Journal of the European Communities

L 120/41

(b) assisting the competent authority in the Member State
to organise a system for monitoring viral and bacterio-
logical contamination of bivalve molluscs;

(c) organising on a

regular basis comparative tests
between the various national laboratories responsible
for the said analyses;

(d) disseminating the

information provided by

the
Community reference laboratory referred to in Article
3 to the competent authorities and national labora-
tories responsible for the said analyses.

2.
The national laboratories shall collaborate with the
Community reference laboratory referred to in Article 3.

Article 3

The laboratory of the Centre for Environment, Fisheries
and Aquaculture Science at Weymouth in the United
Kingdom is hereby designated as the Community refer-
ence laboratory for monitoring the viral and bacteriolog-
ical contamination of bivalve molluscs.

Article 4

The Community reference laboratory shall be responsible
for the following tasks:

(a) supplying information on analytical methods and
comparative testing to the national reference labora-
tories;

(b) coordinating the application by the national reference
laboratories of the methods referred to in point (a), by
organising comparative testing in particular;

(c) coordinating research into new analytical methods
and informing the national reference laboratories of
progress made in this area;

(d) organising training and advanced courses for the staff

of the national reference laboratories;

(e) collaborating with the laboratories responsible for the
bacteriological and viral analysis of bivalve molluscs in
third countries;

(f) providing scientific and technical assistance to the
Commission, especially in cases where test results are
contested between Member States;

(g) helping the reference laboratories to implement an
appropriate system of quality assurance based on the
principles of good laboratory practice (GLP) and the
EN 45 000 criteria.

Article 5

The Community reference laboratory shall satisfy the
following operating conditions:

(a) staff must be qualified and have sufficient knowledge
of the techniques applied in the bacteriological and
viral analysis of bivalve molluscs;

(b) the equipment and substances necessary for carrying
out the tasks laid down in Article 4 must be available;

(c) an appropriate administrative structure must be in

place;

(d) the confidential nature of certain subjects, results and

reports must be observed by the staff;

(e) the principles of good laboratory practice accepted

internationally must be followed;

(f) an up-to-date list of the reference substances held by
the Community Bureau of References must be avail-
able, along with an up-to-date list of the manufac-
turers and suppliers of these substances.

Article 6

This Decision shall enter into force on the day of its
publication in the Official Journal of the European
Communities.

Article 7

This Decision is addressed to the Member States.

Done at Luxembourg, 29 April 1999.

For the Council

The President

W. M(cid:154)LLER