CELEX: 51988PC0779(01)
Language: en
Date: 1989-02-09
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) LAYING DOWN A COMMUNITY PROCEDURE FOR THE ESTABLISHMENT OF TOLERANCES FOR RESIDUES OF VETERINARY MEDICINAL PRODUCTS

10. 3. 89                             Official Journal of the European Communities                              No C 61/5
                                                             II
                                                      (Preparatory Acts)
                                                COMMISSION
             Proposal for a Council Regulation (EEC) laying down a Community procedure for the
                        establishment of tolerances for residues of veterinary medicinal products
                                                     COM(88) 779 final
                                    (Submitted by the Commission on 10 January 1989)
                                                        (89/C 61/07)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          Whereas, therefore, it is necessary to lay down a
                                                                  procedure for the establishment of tolerances for
Having regard to the Treaty establishing the European             residues of veterinary medicinal products by the
Economic Community, and in particular Article 43                  Community, following a single scientific assessment of
thereof,                                                          the highest possible quality;
Having regard to the proposal from the Commission,                Whereas the need for the establishment of tolerances by
                                                                  the Community is recognized in the Community rules
Having regard      to  the   opinion   of   the   European        relating to trade in foodstuffs of animal origin:
Parliament,
                                                                  Whereas, therefore, no new veterinary medicinal product
Having regard to the opinion of the Economic and                  containing a new active substance not previously used in
Social Committee,                                                 food-producing animals should be authorized for use in
                                                                  the Community unless a tolerance for residues of that
Whereas the use of veterinary medicinal products in               substance has been established by the Community;
food-producing animals may result in the presence of              whereas the person responsible for marketing a new.
residues in foodstuffs obtained from treated animals;             veterinary medicinal product of this nature should be
                                                                  permitted to avail himself of the procedures established
                                                                  by Council Directive 87/22/EEC of 22 December 1986
Whereas, in accordance with the principles laid down by           on the approximation of national measures relating to
Council Directive 81/851/EEC (*), it is necessary to              the placing on the market of high-technology medicinal
ensure that the withdrawal period between the last                products, particularly those derived from biotech-
administration of a veterinary medicinal product to food-         nology O ;
producing animals and the production of foodstuffs from
such animals is long enough to ensure that such food-
stuffs do not contain any residues which might constitute         Whereas arrangements must also be made for the
a health hazard to the consumer;                                  establishment of tolerances for substances which are
                                                                  currently used in veterinary medicines administered to
Whereas, as a result of scientific and technical progress,        food-producing animals; whereas, however, in view of
it is possible to detect the presence of residues of              the complexity of this matter and the large number of
veterinary medicines in foodstuffs at ever lower levels;          substances involved, long transitional arrangements are
                                                                  required;
Whereas, therefore, it is necessary to establish tolerances
for the maximum levels of residues which may be                   Whereas the tolerances should be adopted by a rapid
accepted in foodstuffs of animal origin in accordance             procedure which ensures close cooperation between the
with generally recognized principles of safety assessment:        Commission and the Member States through the
                                                                  Committee for Veterinary Medicinal Products estab-
Whereas the establishment of different tolerances by              lished by Directive 81/851/EEC; whereas an urgent
Member States may hinder the free movement of                     procedure is also required to ensure the swift review of
veterinary medicinal products and of foodstuffs of                any tolerance which may not be sufficient to protect
animal origin:                                                    public health;
(*) OJ No L 317, 6. 11. 1981, p. 1.                               (2) OJ No L 15, 17. 1. 1987, p. 38.
 ---pagebreak---  No C 61/6                            Official Journal of the European Communities                                   10. 3. 89
Whereas the information necessary to assess the safety of                                  Article 3
residues should be presented in accordance with the
principles laid down by Council Directive 81/852/EEC             Where, having regard to the nature and pattern of use of
 of 28 September 1981 on the approximation of the laws           a substance used as an active ingredient in veterinary
of the Member States relating to analytical, pharmaco-           medicinal products, it is not necessary to establish a
toxicological and clinical standards and protocols in            tolerance for residues of that constituent or its metab-
respect of the testing of veterinary medicinal                   olites, that substance shall be included in a list in Annex
products ('), as amended by Directive 87/20/EEC (2),             II to this Regulation. Annex II shall be adopted in
                                                                 accordance with the procedure laid down in Article 9.
                                                                 Except as provided for in Article 10, any amendments to
                                                                Annex II shall be adopted in accordance with the same
HAS ADOPTED THIS REGULATION:                                    procedure.
                          Article 1                                                        Article 4
For the purposes of this Regulation, the          following     A provisional tolerance may be adopted for a substance
definitions shall apply:                                        used as an active ingredient in veterinary medicinal
                                                                products provided that there are no grounds for
                                                                supposing that residues of the substance concerned at the
 1. 'Residues of veterinary medicinal products', all active     level proposed present a hazard for the health of the
    ingredients of veterinary medicinal products or             consumer. A provisional tolerance shall apply for a
    metabolites thereof which remain in meat or other           defined period of time, which shall not exceed three
    foodstuffs originating from the animal to which the         years, and shall not be renewed more than once.
    medicinal product in question has been administered.
                                                                The list of substances used as active ingredients in
2. 'Tolerance', the maximum level or residues of                veterinary medicinal products in respect of which
    veterinary medicinal products which may be accepted         provisional tolerances have been established shall be
    by the Community and which do not present a hazard          contained in Annex III to this Regulation, which shall be
    for the health of the consumer of foodstuffs of animal      adopted in accordance with the procedure laid down in
    origin.                                                     Article 9. Except as provided for in Article 10, any
                                                                amendments to Annex III shall be adopted in accordance
                                                                with the same procedure.
                          Article 2
A tolerance shall be established in accordance with the                                    Article 5
provisions of this Regulation, having regard to all the
information available, and in accordance with generally         Where it appears that a tolerance cannot be established
recognized principles of safety assessment. A tolerance         in respect of a substance used as an active ingredient in
may be reduced to take account of the level of residues         veterinary medicinal products because residues of the
which is expected to result from the correct adminis-           substances concerned, at whatever level, in foodstuffs of
tration of the veterinary medicinal product to the animal       animal origin constitute a hazard to the health of the
species concerned. It may also be reduced where it              consumer, that substance shall be included in a list in
appears that residues may cause difficulties for the            Annex IV to this Regulation. Annex IV shall be adopted
industrial processing of foodstuffs. A tolerance shall be       in accordance with the procedure laid down in Article 9.
expressed in terms of micrograms per kilogram (parts per        Except as provided for in Article 10, any amendements
billion) on a fresh weight basis. Where necessary, a            to Annex IV shall be adopted in accordance with the
separate tolerance shall be established for each foodstuff      same procedure.
of animal origin (muscle tissue, liver, kidney, fat, skin,
milk, eggs, honey, ect.).
                                                                The administration of the substances listed in Annex IV
                                                                to food-producing         animals shall be prohibited
                                                                throughout the Community.
The list of substances used as active ingredients in
verterinary medicinal products in respect of which
tolerances have been established shall be contained in                                     Article 6
Annex I to this Regulation, which shall be adopted in
accordance with the procedure laid down in Article 9.           A Member State shall not authorize the marketing of a
Except as provided for in Article 10, any amendments to         veterinary medicinal product intended for administration
Annex I shall be adopted in accordance with the same            to food-producing animals containing an active
procedure.                                                      substance which was not authorized for use in veterinary
                                                                medicinal products intended for administration to food-
                                                                producing animals in the Member State concerned on
                                                                the date of entry into force of this Regulation unless the
O OJ No L 317, 6. 11. 1981, p. 16.                              substance concerned has been included in Annex I, II or
O OJ No L 15, 17. 1. 1987, p. 34.                               III.
 ---pagebreak---  10. 3. 89                             Official Journal of the European Communities                              No C 61/7
 Unless it is developed by one of the biotechnological                substances, including time limits for submission of the
 processes listed in Part A of the Annex to Directive                 information referred to in Annex V. The Member
 87/22/EEC, a veterinary medicinal product covered by                 States and persons responsible for marketing the
 the provisions of the preceding paragraph shall be                  veterinary medicinal products concerned shall ensure
 regarded as a high-technology medicinal product to                  that all relevant information is submitted to the
 which Part B of the Annex to Directive 87/22/EEC                     Commission in accordance with the requirements of
 applies.                                                            Annex V and in conformity with the principles laid
                                                                     down in Directive 81/852/EEC before the relevant
                                                                     time limits.
                          Article 7
 1.    In order to obtain the inclusion of an active
 substance referred to in Article 6 in Annex I, II or III to      2. After verifying that the information is submitted in
this Regulation, the person responsible for marketing                correct form, the Commission shall forthwith submit
shall submit an application to the Commission. The                   the information to the Committee for examination.
application shall contain the information and particulars            The Committee may request one of its members to
referred to in Annex V and shall conform to the prin-                act as rapporteur and to undertake an initial
ciples laid down in Directive 81/852/EEC.                            evaluation of information.
2.    After verifying that the application is submitted in        3. Having regard to the observations formulated by the
correct form, the Commission shall forthwith submit the              members of the Committee, the Commission shall
application for examination by the Committee for                     prepare a draft of the measures to be taken. However
Veterinary Medicinal Products established by Article 16              if, after consulting the Committee, the Commission
of Directive 81/851/EEC (hereinafter referred to as 'the             considers that the information submitted by the
Committee'). The Committee may request one of its                    person responsible for marketing is insufficient to
Members to act as rapporteur and to undertake an initial             enable such a draft to be prepared, the Commission
evaluation of the application.                                       may request that person to provide additional infor-
                                                                     mation, within a specified period.
3.    Within 120 days of referral of the application to the
Committee, and having regard to the observations                 4. The draft of the measures to be taken shall be
formulated by the members of the Committee, the                      communicated forthwith by the Commission to the
Commission shall prepare a draft of the measures to be               Member States and those persons responsible for
taken. However if, after consulting the Committee, the               marketing who have submitted information to the
Commission considers that the information submitted by               Commission. These persons may, at their request,
the person responsible for marketing is insufficient to              explain themselves orally or in writing before the
enable such a draft to be prepared, the Commission may               Committee.
request that person to provide additional information. If
the person responsible for marketing agrees to provide
such information, the Commission will prepare a draft of         5. The Commission shall forthwith submit the draft
the measures to be taken within 90 days of its receipt.              measures to the Committee for adoption in
                                                                     accordance with the procedure laid down in Article 9.
4.    The draft of the measures to be taken shall be
communicated forthwith by the Commission to the
Member States and to the person responsible for                                            Article 9
marketing. Within a further 60 days the person
responsible for marketing may, at his request, explain           1.     Where the procedure laid down in this Article is to
himself orally or in writing before the Committee. The           be followed, matters shall be referred to the Committee
Commission may, at the request of the applicant, extend          by the chairman either on his own initiative or at the
this time limit.                                                 request of a Member State.
5.    Within a further 60 days the Commission shall              2.     The representative of the Commission shall submit
submit the draft measures to the Committee for adoption          to the Committee a draft of the measures to be adopted.
in accordance with the procedure laid down in Article 9.         The Committee shall deliver its opinion on the draft
                                                                 within a time limit set by the chairman, having regard to
                          Article 8                              the urgency of the matter. It shall act by a qualified
                                                                 majority, the votes of the Member States being weighted
The following provisions shall apply in respect                  as provided for in Article 148 (2) of the Treaty. The
of substances which are authorized for use as active             chairman shall not vote.
ingredients in veterinary medicinal products on the date
of entry into force of this Regulation:
                                                                 3. (a) The Commission shall adopt the measures
1. After consulting the Committee, the Commission shall                   envisaged where they are in accordance with the
    publish a timetable for the consideration of these                    opinion of the Committee.
 ---pagebreak---   No C 61/8                              Official Journal of the European Communities                                 10. 3. 89
     (b) Where the measures envisaged are not in                    2.    The representative of the Commission shall submit
          accordance with the opinion of the Committee, or          to the Committee a draft of the measures to be adopted.
          if no opinion is adopted, the Commission shall            The Committee shall deliver its opinion on the draft
          without delay propose to the Council the                  within a time limit set by the chairman, having regard to
          measures to be adopted. The Council shall act by          the urgency of the matter. It shall act by a qualified
          a qualified majority.                                     majority, the votes of the Member States being weighted
                                                                    as provided for in Article 148 (2) of the Treaty. The
                                                                    chairman shall not vote.
     (c) If within three months of the proposal being
         submitted to it, the Council has not acted, the
         proposed measures shall be adopted by the                  3. (a) The Commission shall adopt the measures
         Commission.                                                       envisaged, where they are in accordance with the
                                                                           opinion of the Committee.
                          Article 10
                                                                       (b) Where the measures envisaged are not in
  1.   Where a Member State, as a result of new infor-                     accordance with the opinion of the Committee, or
 mation or a reassessment of existing information,                         if no opinion is • adopted, the Commission shall
 considers that the urgent amendment of a provision                        without delay propose to the Council the
 contained in Annexes I to IV is necessary in order to                     measures to be adopted. The Council shall act by
 protect human or animal health, and therefore requires                    a qualified majority.
 swift action to be taken, that Member State may tempo-
 rarily suspend the operation of the provision concerned
 in its own territory. In that case, it shall immediately              (c) If within 15 days of the proposals being submitted
 notify the other Member States and the Commission of                      to it, the Council has not acted, the proposed
the measures, attaching a statement of the reasons                         measures shall be adopted by the Commission.
therefor.
                                                                                            Article 12
 2.    The Commission shall as soon as possible examine
the grounds given by the Member State concerned and                Any changes which are necessary to adapt Annex V to
shall consult the Member States within the Committee               take account of scientific and technical progress shall be
and shall then deliver its opinion forthwith and take              adopted in accordance with the procedure laid down in
appropriate measures. The Commission shall immediately             Article 2c of Directive 81/852/EEC.
notify the Council and the Member States of any
measures taken. Any Member State may refer the
Commission's measures to the Council within 15 days of
such notification. The Council, acting by a qualified                                       Article 13
majority may take a different decision within 15 days of
                                                                   As soon as possible after the amendment to Annex I, II,
the date on which the matter was referred to it.
                                                                   III or IV, the Commission shall publish a summary
                                                                   assessment of the safety of the substances concerned.
                                                                   The confidential nature of any proprietary data shall be
3.     If the Commission considers that it is necessary to         respected.
amend the provision of Annexes I to IV concerned in
order to resolve the difficulties referred to in paragraph 1
and to ensure the protection of human health, it shall
initiate the procedure laid down in Article 11 with a view                                  Article 14
to adopting those amendments; the Member State which               Member States shall ensure that the withdrawal periods
has taken measures under paragraph 1 may maintain                  between the last administration of a veterinary medicinal
them until the Council or the Commission has taken a               product to animals and the production of foodstuffs
decision in accordance with the abovementioned                     from such animals are established in such a manner as to
procedure.                                                         ensure that the tolerances provided for in accordance
                                                                  with this Regulation are not exceeded.
                          Article 11
                                                                                            Article 15
1.     Where the procedure laid down in this Article is to
be followed, matters shall be referred to the Committee            Member States may not prohibit or impede the putting
by the chairman either on his own initiative or at the             into circulation within their territories of foodstuffs of
request of a Member State.                                         animal origin on the ground that they contain residues of
 ---pagebreak--- 10. 3. 89                                  Official Journal of the European Communities                                       N o C 61/9
veterinary medicinal products if the quantity of residue                                                 Article 17
does not exceed the tolerance provided for in Annex I or              ,_,,._,..                 . „ .               . ..    .     ^ .
                                                                      T hl R e u l a t l o n s h
Ill, or if the substance concerned is listed in Annex II.              r *     S                 * } l n no way prejudice the application
                                                                      or Community legislation prohibiting the use in livestock
                            Article 16                                farming of certain substances having a hormonal action.
With effect from 1 January 1997, the administration to
food-producing animals of veterinary medicinal products                                                  Article 18
containing active substances which are not mentioned in               T,  • D     , .          • n » • . r                1T
         T TT         TTT i ii L            i •!_• J   • L-   i_      This Regulation shall enter into torce on 1 January 11992.     flQ1
Annex I, II or III shall be prohibited within the                               °                                           J     J
Community, except in the case of clinical trials which
have been notified to or approved by the competent                    This Regulation shall be binding in its entirety and
authorities.                                                          directly applicable in all Member States.
                                                               ANNEX V
              Information and particulars to be included in an application for the establishment of a tolerance for
              residues of a veterinary medicinal product
              1.     Administrative particulars
              1.1.   Name or corporate name and permanent address of the person responsible for placing the veterinary
                     medicinal product on the market.
              1.2.   Name of the veterinary medicinal product.
               1.3.  Qualitative and quantitative composition in terms of active principles, with mention of the interna-
                     tional non-proprietary name recommended by the World Health Organization where such name
                     exists.
               1.4.   Manufacturing authorization.
               1.5.   Marketing authorizations.
               1.6.   Summary of the characteristics of the veterinary medicinal product prepared in accordance with
                      Article 5a of Directive 81/851/EEC.
               2.     Identity
               2.1.   International non-proprietary name.
               2.2.   IUPAC name.
               2.3. ' CAS name.
               2.4.   Classification:
                      — therapeutic,
                      — pharmacological.
               2.5.   Synonyms and abbreviations.
               2.6.   Structural formula.
               2.7.   Molecular formula.
               2.8.   Molecular weight.
               2.9.   Degree of impurity.
               2.10. Qualitative and quantitative composition of impurities.
 ---pagebreak--- N o C 61/10                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s     10. 3. 89
            2.11. Description of physical properties:
                  — fusion point,
                  — boiling point,
                  — vapour pressure,
                  — solubility in water and organic solvents expressed in grams per litre with indication of
                      temperature,
                  — density,
                  — spectra of refraction, rotation, etc.
            3.    Toxicological studies
            3.1.  Short term toxicological studies.
            3.2.  Long-term studies.
            3.3.  Studies on reproduction.
            3.4.  Studies on teratogenicity.
            3.5.  Studies on mutagenicity.
            3.6.  Studies for carcinogenicity.
            3.7.  Studies of immunological effects.
            3.8.  Studies of microbiological effects.
            3.9.  Observations in humans.
            3.10. Other biological effects.
            4.    Metabolic and residue studies
            4.1.  Absorption, distribution, excretion and biotransformations.
            4.2.  Determination of residues.
            4.3.  Methods of residue analysis.
            4.4.  National maximum residue limits.
            5.    Recommendations
          . 5.1.  Level causing no toxicological effect.
            5.2.  Estimate of temporary acceptable daily intake for man.
            5.3.  Estimate of maximum residue levels in food with the specification of the residue of concern.
            5.4.  Methods of residue analysis.
            5.5.  Further work or information:
                  — required,
                  — desirable.
            6.    References