CELEX: 51990PC0135(01)
Language: en
Date: 1990-04-26
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL REGULATION ( EEC ) LAYING DOWN A COMMUNITY PROCEDURE FOR THE ESTABLISHMENT OF TOLERANCES FOR RESIDUES OF VETERINARY MEDICINAL PRODUCTS

No C 131/14                          Official Journal of the European Communities                                           30. 5. 90
                                                                   II
                                                         (Preparatory Acts)
                                                   COMMISSION
             Amendment to the proposal for a Council Regulation (EEC) laying down a Community
             procedure for the establishment of tolerances for residues of veterinary medicinal products (')
                                                        COM(90) 135 final
                (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990)
                                                          (90/C 131/05)
             (*) OJ No C 61, 10. 3. 1989, p. 5 (COM(88) 779 final).
                       ORIGINAL TEXT                                                              AMENDED TEXT
                                       Visas and recitals 1 td 9 unchanged
                       Tenth Recital                                                                Tenth Recital
Whereas the tolerances should be adopted by a rapid                       Whereas the tolerances must be adopted by a rapid
procedure which ensures close cooperation between the                     procedure which ensures close cooperation between the
Commission and the Member States through the                              Commission and the Member States through the
Committee for Veterinary Medicinal Products estab-                        Committee for Veterinary Medicinal Products estab-
lished by Directive 81/851/EEC; whereas an urgent                         lished by Directive 81/851/EEC; whereas an urgent
procedure is also required to ensure the swift review of                  procedure is also required to ensure the swift review of
any tolerance which may not be sufficient to protect                      any tolerance which may not be sufficient to protect
public health;                                                            public health;
                                    Last r e c i t a l and A r t i c l e s 1 to 3 u n c h a n g e d
                         Article 4                                                                    Article 4
A provisional tolerance may be adopted for a substance                    A provisional tolerance may be adopted for a substance
used as an active ingredient in veterinary medicinal                      used as an active ingredient in veterinary medicinal
products provided that there are no grounds for                           products provided that there are no grounds for
supposing that residues of substance concerned at the                     supposing that residues of substance concerned at the
level proposed present a hazard for the health of the                     level proposed present a hazard for the health of the
consumer. A provisional tolerance shall apply for a                       consumer. A provisional tolerance shall apply for a
defined period of time, which shall not exceed three                      defined period of time, which shall not exceed three
years, and shall not be renewed more than once.                           years, and shall not be renewed more than once and only
                                                                          under exceptional circumstances and for the same
                                                                          maximum period.
The list of substances used as active ingredients in                      The list of substances used as active ingredients in
veterinary medicinal products in respect of which                         veterinary medicinal products in respect of which
provisional tolerances have been established shall be                     provisional tolerances have been established shall be
contained in Annex HI to this Regulation, which shall be                  contained in Annex III to this Regulation, which shall be
adopted in accordance with the procedure laid down in                     adopted in accordance with the procedure laid down in
Article 9. Except as provided for in Article 10, any                      Article 9. Except as provided for in Article 10, any
amendments to Annex III shall be adopted in accordance                    amendments to Annex III shall be adopted in accordance
with the same procedure.                                                  with the same procedure. Medicinal products which
                                                                          contain active substances included in Annex III shall be
                                                                          authorized only for the period for which a provisional
                                                                          tolerance has been established; this authorization may be
                                                                          extended if the provisional tolerance is renewed.
 ---pagebreak--- 30. 5. 90                             Official Journal of the European Communities                                    No C 131/15
                       ORIGINAL TEXT                                                            AMENDED TEXT
                                              Articles 5 and 6 unchanged
                         Article 7                                                                Article 7
                                                 Paragraph 1 unchanged
2.    After verifying that the application is submitted in              2.     After verifying that the application is submitted in
correct form, the Commission shall forthwith submit the                 correct form within 30 days, the Commission shall
application for examination by the Committee for                        forthwith submit the application for examination by the
Veterinary Medicinal Products established by Article 16                 Committee for Veterinary Medicinal Products estab-
of Directive 81/851/EEC (hereinafter referred to as 'the                lished by Article 16 of Directive 81/851/EEC (herein-
Committee'). The Committee may request one of its                       after referred to as 'the Committee'). The Committee
members to act as rapporteur and to undertake an initial                may request one of its members to act as rapporteur and
evaluation of the application.                                          to undertake an initial evaluation of the application.
                                         T h e r e s t of A r t i c l e 7 is u n c h a n g e d
                         Article 8                                                                 Article 8
                                                 Paragraph 1 unchanged
2. After verifying that the information is submitted in                     After verifying that the information is submitted in
   correct form, the Commission shall forthwith submit                      correct form within 30 days, the Commission shall
   the information to the Committee for examination.                        forthwith submit the information for examination by
   The Committee may request one of its members to                          the Committee, which shall deliver its opinion within
   act as rapporteur and to undertake an initial                            a period which may be extended to 120 days. The
   evaluation of the application.                                           Committee may request one of its members to act as
                                                                            rapporteur and undertake an initial evaluation of the
                                                                            information.
   Having regard to the observations formulated by the                      Having regard to the observations formulated by the
   members of the Committee, the Commission shall                           members of the Committee, the Commission shall
   prepare a draft of the measures to be taken. However                     prepare a draft with the measures to be taken, within
   if, after consulting the Committee, the Commission                       30 days at the latest. However if, after consulting the
   considers that the information submitted by the                          Committee, the Commission considers that the infor-
   person responsible for marketing is insufficient to                      mation submitted by the person responsible for
   enable such a draft to be prepared, the Commission                       marketing is insufficient to enable such a draft to be
   may request that person to provide additional infor-                     prepared, the Commission may request that person to
   mation, within a specified period.                                       provide additional information, within a specified
                                                                            period.
                                         T h e r e s t of A r t i c l e 8 is u n c h a n g e d
                                              A r t i c l e s 9 to 1 8 u n c h a n g e d
 ---pagebreak---  N o C 131/16                                   Official Journal of the European Communities                                                 30. 5. 90
                              ORIGINAL TEXT                                                                         AMENDED TEXT
                                                                          ANNEX V
                                                              Points 1 to 4.3 unchanged
 4.4. National maximum residue limits.                                              4.4. Maximum residue limits.
                                                                 The rest is unchanged
               Proposal for a Council Directive amending Directive 81/851/EEC on the approximation of the
                                 laws of the Member States relating to veterinary medicinal products (')
                                                          COM(90) 135 final — SYN 189
                   (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990)
                                                                        (90/C 131/06)
               (') OJ No C 61, 10. 3. 1989, p. 11 (COM(88) 779 final — SYN 189).
                             ORIGINAL TEXT                                                                         AMENDED TEXT
                                                         Visas and recitals unchanged
                                 Article 1                                                                             Article 1
                                                             Paragraph 1 unchanged
               Paragraph           2 (Directive 8 1 / 8 5 1 / E E C , Article                 1 (5)) s u b p a r a g r a p h s    1 and 2
                                                                         unchanged
2.     Before the date of implementation of this Directive,                         2.       Before the date of implementation of this Directive,
Member States shall communicate to the Commission a                                 Member States shall communicate to the Commission a
list of the veterinary medicinal products which are                                 list of the veterinary medicinal products which are
available without veterinary prescription.                                          available without veterinary prescription.
                                                                                   When the Commission has received the communication
                                                                                   from the Member States, it shall examine whether to
                                                                                   propose appropriate measures for drawing up lists of
                                                                                   medicinal products which may be administered without
                                                                                   prescription within the Community.
                                                             Paragraph 3 unchanged
                  P a r a g r a p h 4 ( D i r e c t i v e 8 1 / 8 5 1 / E E C , A r t i c l e 4) s u b p a r a g r a p h 1 u n c h a n g e d