CELEX: 51992PC0551
Language: en
Date: 1992-12-16
Title: Proposal for a COUNCIL DECISION on reference laboratories for the monitoring of marine biotoxins

COMMISSION OF THE EUROPEAN COMMUNITIES
                                       C0M(92) 551 final
                                       Brussels, 16 December 1992
                        Proposal for a
                       COUNCIL PECISIQN
        on reference laboratories for the monitoring of
                        mar ine biotoxins
                 (presented by the Commission)
 ---pagebreak---                                         -     1-
                                   EXPLANATORY MEMORANDUM
Council     Directives    91/492/EEC     of   15 July    1991    laying  down   the   health
conditions     for   the production     and placing     on   the market   of   live bivalve
          1
molluscs     and 91/493/EEC of 22 July 1991          laying down the health       conditions
for the production and the placing on the market of fishery products 2 lay
down requirements concerning marine biotoxins with the aim of guaranteeing the
who Iesomeness of products covered by these Directives.
As   a   consequence,     it   is   necessary    to   designate    a  Community    reference
laboratory capable of ensuring the effectiveness of the systems for monitoring
marine biotoxins implemented         in each Member State; this Community         laboratory
will also coordinate the activities of the national reference laboratories.
The   attached     proposal   defines    the  tasks and     operating   conditions of    the
Community reference laboratory and the national reference laboratories.
The Community laboratory chosen, the "Laboratorio de Sanidad" in Vigo, fulfils
all    the    conditions    necessary     to   be   designated     a  Community    reference
 laboratory.
 It should     be noted   that    the Community     reference    laboratory   qualifies for
Community      assistance    on    the   terms   set   out    in   Article 28   of   Council
                        3
Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field.
The financial impact of this draft proposal for a Council Decision has already
been allowed       for and will     be defined     in the    implementing   Decision   to be
adopted under Article 28 of Council Decision 90/424/EEC.
1    OJ No L 268, 24.9.1991, p.1.
2    OJ No L 268, 24.9.1991, p.15.
3    OJ No L 224, 18.8.1990, p.19.
 ---pagebreak---                                     — /} vn^t? —
                                 Proposal for a
                          Counc11 Dec I s i on    /  /EEC
                on reference laboratories for the monitoring of
                                mar ine biotox ins
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and
in particular Article 43 thereof,
Having regard to the proposal from the Commission 1 ,
Having regard to the opinion of the European Par Iiament2,
Having regard to the opinion of the Economic and Social Committee 3 ,
Whereas 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, and   in particular    in the Annex thereto, various rules
regarding biotoxins affecting live bivalve molluscs;
Whereas Council Directive 91/493/EEC of 22 July 1991       laying down the health
conditions for the production and placing on the market of fishery products 5 ,
sets out, in particular in Article 5 and Chapter V, point 11.3. B of the Annex
thereto, certain rules on marine biotoxins affecting fishery products;
Whereas the monitoring of marine biotoxins is especially       important to ensure
the placing on the market of live bivalve molluscs and fishery products which
conform    to    the   requirements     of     the   aforementioned     Directives-,
 1   OJ No C
2    OJ No C
 3   OJ No C
4    OJ No L 268, 24.09.1991, p.1.
5    OJ No L 268, 24.09.91, p.15.
 ---pagebreak--- Whereas, in order to provide an efficient monitoring system to test for marine
biotoxins, a national       reference   laboratory responsible for coordinating the
necessary analyses in each Member State should be designated;
Whereas, to ensure a standardized system throughout the Community, a Community
reference    laboratory    should   be   designated   which  will  be  responsible  for
coordinating the monitoring of marine biotoxins carried out by each national
reference    laboratory;    whereas    the   tasks  and  operating  conditions   of the
Community reference laboratory should be laid down;
Whereas    the   laboratory   of  the   "Ministerio de Sanidad     y Consumo"   in Vigo
fulfils all the necessary conditions to be designated the Community reference
 laboratory    for  marine   biotoxins; whereas      the officials   in charge   of the
 laboratory have undertaken to carry out the tasks laid down in this Decision
on the terms set out herein;
Whereas this Community reference laboratory is eligible for Community aid in
accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on
expenditure in the veterinary field 6 ,
HAS ADOPTED THIS DECISION:
                                          Article 1
The laboratories listed in the Annex hereto are designated national reference
 laboratories for the monitoring of marine biotoxins.
                                          Article 2
1. Each national reference laboratory shall be responsible for the following
    tasks:
    -   coordinating the activities of the national laboratories responsible for
        analyses of marine biotoxins in the relevant Member State;
6     0J L 224, 18.08.1990, p. 19.
 ---pagebreak---                                          -3-
   -   assisting the competent authority      in the Member State to organize the
       system for monitoring marine biotoxins;
   -   organizing comparative tests between the various national       laboratories
       responsible for analysing marine biotoxins;
   -   ensuring   that  the   information   supplied  by  the Community   reference
       laboratory   is disseminated to the competent authority     in the relevant'
       Member State and to the national laboratories responsible for analysing
       marine biotoxins.
2. The national    reference   laboratories shall collaborate with the Community
   reference laboratory referred to in Article 3.
                                      Article 3
The laboratory of the "Ministerio de Sanidad y Consumo" in Vigo is designated
the Community reference laboratory for the monitoring of marine biotoxins.
                                      Article 4
The Community   reference    laboratory shall   be responsible for   the following
tasks :
-  supplying information on analytical methods and comparative testing to the
   national reference laboratories;
-   coordinating the application by the national reference laboratories of the
   methods referred to in the first       indent above, by organizing comparative
   testing in particular;
-   coordinating the development of new analytical methods and        informing the
   national reference laboratories of progress made in this area;
-  organizing   training and advanced courses for the staff of         the national
   reference laboratories;
 ---pagebreak--- -  collaborating   with   the    laboratories   responsible   for  analysing   marine
   biotoxins in third countries;
-  providing scientific and technical assistance to the Commission, especially
   in cases where the results of analyses are contested between Member States.
                                      Article 5
The Community   reference    laboratory   for marine biotoxins    shall  satisfy  the
following operating conditions:
-  that staff are qualified and have sufficient        knowledge of the techniques
   applied in the analysis of marine biotoxins;
-  that the equipment and substances necessary for carrying out the tasks laid
   down in Article 4 are available,
-   that an appropriate administratve structure is in place,
-   that the confidential    nature of certain subjects, results and reports is
   observed by staff,
-   that  the principles of good     laboratory practice accepted     internationally
   are fol lowed,
-   that an up-to-date list of the reference substances held by the Community
   Bureau of References     is available, along with an up-to-date       list of the
   manufacturers and suppliers of these substances.
                                       Article 6
This Decision is addressed to the Member States.
Done at                                     For the Counc i I
 ---pagebreak---                                              ANNEX
PPlflitf» and Uixeiafrcurfl
      I n s t i t u t d'Hygiène et Epidemiologic
     Av. J u l i e t t e Vytsman 14-16
     1050 Brussels - BELGIUM
     Scandox
     Tornbjergveg 40
     Eyby, DK-4623 Lille Skensved - DENMARK
     Bundeageaundheitaaint (BOA)
     ThielaMee 88-02
     D-1000 Berlin 23 - GERMANY
Qfeeçf
     The Institute of Hygiene
      lèse Odos 75 Botanicos
     11855 Athens - GREECE
Spa. In
      Laborator Io del Ministerlo de Sanidad y Consuroo
      Uni dad AdministrâtWa de Vigo
      Estac Ion «writ he* s/n
      36210 VIgo - SPAIN
 France
       Laboratoire Centra* d'Hygien* Alimentaire
       Rue de Dantzig 43
       75015 Par l# - mmCM
  I retard
        Fisheries Research Centre
        Abbotstown
        Dublin 15 - IRELAND
  itajy
        Consorzio di Studi, Ricerche ed Interventi su lie Risorse Marine
        Via le Voopuccl 2
        47042 Cesenatico (FO) - ITALY
 ---pagebreak---                                 -C-
Nethtriindi
    RiJksinstituut voor Volksgezonheid en Mi Iieuhygiëne (RIVM)
    P.O. Box 1
    3720 BA Bithoven - NETHERLANDS
Portugal
    Laboratorlo do Instituto Naclonal de Investigaçâo das Pescas (INIP)
    Av. Bras 11ia s/n
    1400 Lisbon - PORTUGAL
United Kingdom
    Torry Research Station
    P.O. BOX 31, 135 Abbey Road
    Aberdeen AB9 8DG, UK - UNITED KINGDOM
 ---pagebreak---                                                  ~-1 __              ISSN 0254-1475
                                                              COM(92) 551 final
                                                        DOCUMENTS
EN                                                                         03   10
                                 Catalogue number : CB-CO-92-573-EN-C
                                                             ISBN 92-77-50690-3
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