CELEX: 51985PC0380
Language: en
Date: 1985-07-15
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE HARMONIZATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS RELATING TO THE APPLICATION OF THE PRINCIPLES OF GOOD LABORATORY PRACTICE AND THE VERIFICATION OF THEIR APPLICATION FOR TESTS ON CHEMICAL SUBSTANCES

No C 219/6                                Official Journal of the European Communities                                   29.8.85
12. Article 48 is replaced by the following:                                                     Article 2
      'Article 48                                                     This Regulation shall enter into force on the day of its
                                                                      publication in the Official Journal of the European
     Transitional measures may be adopted in accordance
                                                                      Communities.
     with the procedure laid down in Article 41 of Regu-
     lation (EEC) No 1785/81.                                         It shall apply from 1 July 1986.
     Such measures shall be applicable until 30 June 1987             This Regulation shall be binding in its entirety and
     at the latest.'                                                  directly applicable in all Member States.
                Proposal for a Council Directive on the harmonization of the laws, regulations and
                administrative provisions relating to the application of the principles of good laboratory practice
                             and the verification of their application for tests on chemical substances
                                                         COM(85) 380 final
                                  (Submitted by the Commission to the Council on 24 July 1985)
                                                           (85/C 219/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              Whereas the Council of the Organization for Economic
                                                                      Cooperation and Development took a decision on
Having regard to the Treaty establishing the European                 12 May 1981 on the mutual acceptance of data for the
Economic Community, and in particular Article 100                     evaluation of chemical products; whereas it issued a
thereof,                                                              recommendation on 26 July 1983 concerning the mutual
                                                                      recognition of compliance with good laboratory practice;
Having regard to the proposal from the Commission,
                                                                      Whereas it is necessary to set up a procedure allowing
Having regard to the opinion of the European Par-                     rapid adaptation of the principles of good laboratory
liament,                                                              practice;
Having regard to the opinion of the Economic and
                                                                      HAD ADOPTED THIS DIRECTIVE:
Social Committee,
Whereas Council Directive 67/548/EEC of 27 June                                                  Article 1
1967 on the approximation of laws, regulations and
administrative provisions relating to the classification,             For the tests specified in Directive 67/548/EEC the
packaging and labelling of dangerous substances ('), as               Member States shall take all measures necessary to
last amended by Directive 84/449/EEC (2), requires tests              ensure that laboratories apply the principles of good
to be carried out on chemical substances;                             laboratory practice specified in Annex 2 to the Decision
                                                                      of 12 May 1981 of the Council of the Organization for
                                                                      Economic Cooperation and Development on the mutual
"Whereas the methods to be used for these are laid down
                                                                      acceptance of data for the calculation of chemical
in Annex V to Directive 67/548/EEC;
                                                                      products.
Whereas it is necessary to comply with the principles of
good laboratory practice in carrying out the tests laid                                          Article 2
down by Directive 67/548/EEC so as to ensure that the
results are comparable and of high quality;                           1.    When submitting results, the laboratories referred
                                                                      to in Article 1 shall certify that the tests have been
Whereas the resources devoted to the tests must not be                carried out in compliance with the principles of good
wasted by having to repeat tests owing to differences in              laboratory practice.
laboratory practice from one Member State to another;
                                                                      2.    To verify compliance with the principles of good
                                                                      laboratory practice, the Member States shall carry out
0) OJ 196, 16. 8. 1967, p. 1.                                         on-the-spot inspections and verifications of studies using
(2) OJ No L 251, 19. 9. 1984, p. 1.                                   procedures that they shall establish for that purpose.
 ---pagebreak--- 29. 8. 85                               Official Journal of the European Communities                             No C 219/7
                         Article 3                                                          Article 5
Member States shall inform the Commission of the pro-              Member States may not, on grounds relating to
cedures they have established to verify compliance with            laboratory practice, prohibit, restrict or impede the
the principles of good laboratory practice. They shall             placing on the market of substances if such practice
notify to the Commission the names of the authorities              complies with the requirements of this Directive.
responsible for verifying compliance by laboratories with
the principles of good laboratory practice.
                                                                                            Article 6
The Commission shall inform the other Member States
                                                                   Member States shall bring into force the laws, regu-
thereof.
                                                                   lations and administrative provisions necessary to comply
                                                                   with this Directive not later than 31 December 1986 and
                         Article 4
                                                                   shall forthwith inform the Commission thereof.
Adaptations of the principles of good laboratory practice
mentioned in Article 1 may be made in accordance with                                       Article 7
the procedure laid down in Article 21 of Directive
67/548/EEC.                                                        This Directive is addressed to the Member States.
              Proposal for a Council Regulation (EEC) amending Council Regulation (EEC) No 1993/83
                             implementing a special programme to combat hunger in the world
                                                      COM(85) 442 final
                               (Submitted by the Commission to the Council on 6 August 1985)
                                                        (85/C 219/06)
             THE COUNCIL OF THE EUROPEAN COMMUNITIES,
             Having regard to the Treaty establishing the European Economic Community,
             Having regard to the proposal from the Commission,
             Having regard to the opinion of the European Parliament,
             Whereas the Community is conducting a special programme to combat hunger in the world;
             Whereas accordingly on 11 July 1983 the Council adopted Regulation (EEC) No 1993/83 ( l ),
             concerning the implementation of that programme; whereas Article 12 of the said Regulation
             provides for its expiry on 31 December 1984;
             Whereas the satisfactory use of the appropriations entered in the 1985 budget of the European
             Communities requires that provision be made for their continued commitment in 1986,
             0) OJ No L 196, 20. 7. 1983, p. 6.