CELEX: 51996PC0034
Language: en
Date: 1996-09-24
Title: Proposal for a COUNCIL REGULATION (EC) amending Annex II of Council Regulation (EEC) N 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin

COMMISSION OF THE EUROPEAN COMMUNITIES
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                                                  Brussels, 24.09.1996
                                                  COM(96) 34 final
                                   Proposal for a
                         COUNCIL REGULATION (EC)
             amending Annex II of Council Regulation (EEC) N° 2377/90
laying down a Community procedure for the establishment of maximum residue
      limits of veterinary medicinal products in foodstuffs of animal origin
                          (presented by the Commission)
 ---pagebreak---  ---pagebreak---                       EXPLANATORY MEMORANDUM
A. Regulatory framework
   Pursuant to Council Regulation (EEC) No 2377/90 of 26 June 1990,l the
   Commission must adopt legally binding maximum residue limits for veterinary
   medicinal products in foodstuffs of animal origin. These limits (hereinafter
   MRL) are established in accordance with the regulatory committee procedure
   following scientific evaluation by the Committee for Veterinary Medicinal
   Products, which then recommends classification in one of the four annexes to the
   Regulation:
           Annex I: reserved for substances for which a MRL can be set following
           evaluation of the toxicological risk they pose to human health;
           Annex II: substances for which there is no need to set a MRL;
           Annex III: substances for which, given the lack of scientific data, a MRL
           cannot be set definitively but which, without compromising consumer
           health, may be given a provisional MRL for a defined period calculated
           according to the time needed to complete the scientific studies. This
          period may be extended once only in exceptional cases;
           Annex IV: substances for which it appears no MRL can be set because
           they pose a risk to human health in whatever quantity.
   OJL224, 18.8.1990, p. 1.
                                               1
 ---pagebreak--- B.  Scientific evaluation
    The Commission produced a draft Regulation (HI/5425/95) amending the Annex
    to Regulation (EEC) No 2377/90 to include, inter alia, somatosalm.2
    This followed scientific evaluation of this substance by the Committee for
    Veterinary Medicinal Products.
    The Committee recommended that somatosalm (a substance produced by a
    biotechnological process, belonging to the family of somatotrophins), when used
   on young salmon, be included in Annex II on the following grounds:
            it is a protein with a very short half-life ( < 30 min) in fish;
            the method of administration is a single injection of the active substance 1
            or 2 years before killing the fish.
   Along with five other substances, viz: azamethiphos, streptomycin, dihydrostreptomycin,
   gentamicin and neomycin, for which MRL were then established separately.
 ---pagebreak--- C. Regulatory procedure and referral to the Council
1. On 16 October 1995 the Commission sent the Committee on the Adaptation to
   Technical Progress of the Directives on Veterinary Medicinal Products
   (regulatory committee) a draft implementing regulation adding (inter alia)
   somatosalm, on the above grounds, to Annex II of Regulation (EEC)
   No 2377/90.
   The draft failed to elicit a favourable opinion from the Committee.
2. Indeed, claiming that the moratorium adopted by the Council3 on bovine
   somatotrophin (BST) would be "indirectly" called into question if another
   somatotrophin appeared on the Community market, the representatives of four
   Member States opposed the very principle of classifying somatosalm in one of the
   annexes to Regulation (EEC) No 2377/90.
   It should be noted in this connection that (a) the abovementioned Council
   moratorium applies only to bovine somatotrophin and not all somatotrophic
   substances and (b) it emerges from the assessment report by the Committee on
   Veterinary Medicinal Products (and from the file submitted by the pharmaceutical
   company concerned) that, unlike BST, somatosalm is used neither to promote
   growth nor to boost animal productivity, but solely to make it easier for young
   freshwater salmon to adapt to seawater. This single statement explains its specific
   method of administration, which is a single injection of active substance one or
   two years before the fish is killed.
   Following the Commission's request in April 1996 for further information to take
   account of arguments put forward by the representatives of certain Member
   States opposed to the classification of somatosalm, the Committee on
   Veterinary Medicinal Products looked at the possibility of the substance being
   used fraudulently as a growth promoter in salmon and other species. Its opinion,
   delivered on 28 June 1996, is unequivocal: somatosalm is only active in salmon,
   while its use as a performance enhancer in this species may be considered
   impossible owing to the substance's pharmacological properties and the method of
   administration, which guarantee its efficacy (it must be injected directly into the
   stomach of each fish).
   The Commission would also stress that the establishment of a MRL for this
    substance is without prejudice to the contents of any decision to be taken should a
    request be made for marketing authorization, such a decision being subject, under
    Community law, to autonomous assessment criteria and procedures.
3
    Council Decision 94/936/EEC of 20 December 1994 amending Decision 90/218/EEC on the
    marketing and administration of bovine somatotrophin (OJ L 366, 31.12.1994, p. 19).
 ---pagebreak--- 3. As the draft measures are not in accordance with the opinion of the Committee on
   the adaptation to technical progress of the Directives intended to remove technical
   barriers to trade in the veterinary medicinal products sector, the Commission is
   sending the Council a proposal for a regulation under the procedure laid down in
   Article 8 of Regulation (EEC) No 2377/90.
   By virtue of the same Article, the Council is invited to adopt the proposed
   measures within three months of the date of referral.
 ---pagebreak---                                            PROPOSAL FOR A
                                      COUNCIL REGULATION (EC)
                        amending Annex II of Council Regulation (EEC) N° 2377/90
         laying down a Community procedure for the establishment of maximum residue
                   limits of veterinary medicinal products in foodstuffs of animal origin
    THE COUNCIL OF THE EUROPEAN UNION,
    Having regard to the Treaty establishing the European Community,
    Having regard to Council Regulation (EEC) N° 2377/90 of 26 June 1990 laying down a
    Community procedure for the establishment of maximum residue limits of veterinary
    medicinal products in foodstuffs of animal origin' 1 ', as last amended by Commission
    Regulation (EC) N° 1433/96^' and in particular Articles 6 and 8 thereof;
    Having regard to the proposal from the Commission
    Whereas, in accordance with Regulation (EEC) N° 2377/90, maximum residue limits must be
    established progressively for all pharmacologically active substances which are used within
    the Community in veterinary medicinal products intended for administration to food-
    producing animals;
    Whereas maximum residue limits should be established only after the examination within the
    Committee for Veterinary Medicinal Products of all the relevant information concerning the
    safety of residues of the substance concerned for the consumer of foodstuffs of animal origin
    and the impact of residues on the industrial processing of foodstuffs;
     Whereas, in establishing maximum residue limits for residues of veterinary medicinal
    products in foodstuffs of animal origin, it is necessary to specify the animal species in which
    residues may be present, the levels which may be present in each of the relevant meat tissues
(l)
    O J N ° L 2 2 4 , 18.08.1990, p 1
<2)
     OJN°L 184, 24.07.1996, p 21
                                                    ^
 ---pagebreak---      obtained from the treated animal (target tissue) and the nature of the residue which is relevant
     for the monitoring of residues (marker residue);
     Whereas Somatosalm should be inserted into Annex II to Regulation (EEC) N° 2377/90 ;
     Whereas a period of 60 days should be allowed before the entry into force of this Regulation
     in order to allow Member States to make any adjustment which may be necessary to the
     authorisations to place the veterinary medicinal products concerned on the market which have
     been granted in accordance with Council Directive 81/851/EEC^', as last amended by
     Directive 93/40/EEC^' to take account of the provisions of this Regulation;
     Whereas, in accordance with the procedure laid down in Article 8 of Council Regulation
     (EEC) No 2377/90, the draft of the measures to be adopted was submitted to the Committee
     for the Adaptation to Technical Progress of the Directives on the Removal of Technical
     Barriers to Trade in the Veterinary Medicinal Products Sector; whereas the Committee was
     not able to deliver an opinion; whereas the Commission therefore proposed the measures to
     be adopted to the Council;
(3
   >      OJ N ° L 317, 06.11.1981, p 1
,4
   >      O J N ° L 214, 24.08.1993, p 31
 ---pagebreak--- HAS ADOPTED THE FOLLOWING REGULATION :
                                            Article 1
Annex II of Regulation (EEC) N°2377/90 is hereby amended as set out in the Annex hereto.
                                            Article 2
This Regulation shall enter into force on the sixtieth day following its publication in the
Official Journal of the European Communities;
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
                                                         For the Council
                                                    >
 ---pagebreak---                                                                 ANNEX
  A.      Annex II is modified as follows
  2.      Organic chemicals
     Pharmacologically active substances         Animal species       Other provisions
  2.68. Somatosalm                        Salmon
OQ
 ---pagebreak---  ---pagebreak---                                                                    ISSN 0254-1475
                                                             COM(96) 34 final
                                              DOCUMENTS
EN                                                                        05 03
                                     Catalogue number : CB-CO-96-039-EN-C
                                                             ISBN 92-77-99947-0
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