CELEX: 51993PC0251
Language: en
Date: 1993-07-09
Title: Proposal for a COUNCIL DIRECTIVE AMENDING DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                 COM(93) 251 final
                                                 Brussels, 09 July 1993
                                  Proposal for a
                                COUNCIL DIRECTIVE
                         AMENDING DIRECTIVE 70/542/EEC
                     CONCERNING ADDITIVES IN FEEDINGSTUFFS
Jim
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                          (presented by the Commission)
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 ---pagebreak---                            Explanatory memorandum
The experience gained since Directive 70/524/EEC was amended for the third
time has shown that some aspects need to be revised so as to prevent poor
copies of additives orginating in third countries, which might be harmful
to health, from being placed on the market in the Community as has happened
in recent months.
In the interests of transparancy and safety with regard to both animal and
human health and environmental protection, it is important in future to
link to a particular individual authorization to market technological
additives with a very specific composition.
The introduction of this new concept requires a change in the authorization
procedures and the introduction of arrangements to govern the transition
from the old system to the new one.
The procedure to be followed for the examination of dossiers has been
specified and deadlines laid down to ensure the efficiency of the
centralized mechanisms for the authorization to market additives.
It should be noted that in future the examination of dossiers at national
level will be subject to a fee.
In addition, for safety reasons, dossiers on additives must in future be
re-examined regularly to take account of scientific progress, particular
regarding the toxlcological assessment of the substances concerned.
To put an end to distortions of competition and obstacles to trade arising
as a result of considerable delays in the transposition of directives
authorizing the marketing of additives or differences between the Member
States resulting from the conditions for admission into their territory of
the additives listed in Annex II, provision has been made for additives to
be authorized by means of Decisions, and for provisional authorization of
additives which fulfil a minimum number of conditions to be extended
throughout the Community .
With regard to the latter measure, the objective is to avoid possible
confict between Member States arising from national authorization
procedures. Member States will, however, continue to have recourse to a
safeguard clause where an additive is found to be dangerous despite the
precautions taken.
It should be emphasized that the new procedure leaves Member States
completely free with regard to the assessment of the dossiers submitted to
them for transmission to the Commission for authorization.
 ---pagebreak---                                    -M-
To make the text easier to understand, two diagrams have been attached to
this explanatory memorandum:
-  one concerning the organization of the new procedure for authorization
   of additives,
-  the other describing the above-mentioned transitional arrangements.
 ---pagebreak---                                      Procedure for tho authorIzotlon of oddltlvw
                                               Manufacturer
                                       TrarMmiwIon to reporting U.S.
                                          application -f dowler + f w
  309 days
                                            Merber Stote cet Ing
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                                          (Verification end
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                                        HRANSvllSSICN OF DOSSIER-
  49               COMISSIGN                                                   Othor Uerber S t a t w
  doyi
              Inclusion In th»
              ogenca of the
              STANDIHS COVMITTEE                         SCAN
             (Beginning of exanln-
              otlon)
                                                                                                                                                     0
                                                                                                                                                     \
                   OPINION
                     of tho
              STANDING C0OJITTŒ
                 on tho Cormlsslon's
                 draft proposal
    330 day*
                 COMISSICN Decision
                 Conrunlty                Provisional Ccmrunlty                Ccmrunlty AUTHORIZATION of   Provisional AUTHCRIZATION of generic
                AUTHORIZATION             authorization of oddltlvw            generic oddltlvw             oddltlvw ( t w t l n g ) maxlm/n 3 years
            of oddltlvw linked to          I Irked to a person r w p -
            o porion responsible          onelble for marketing
            for marketing      M          ( 1 ) ( t w t l n g ) maxima* 3 yr«
                                          authorization                                                     Inclusion In Chapter IV of
                                                                              Inclusion In Chapter I I I of the annual list
            Protection of data                                                the annual Met
                                          Protect Ion of data
             Inclusion In Chapter I        Inclusion In Chapter 11 of
            of the annuoI list            the annual list
(1) Addltlvw belonging to the groups listed In Council Decision ../.../OX.      (zootechnlcs)
 ---pagebreak---                                                                                           TRANSITIONAL                ARRANGEMENTS
               Generic eddltN                             AUTOMATIC AUTHORIZATION
               Addltlvw m referred to In                           INCLUSION                                                                           PERSON RESPONSIBLE FOR MARKETIN3        COMISSICN DECIDES TO AUTHORIZE
               Article 2(b) Included In                               IN                                                                               LOCOES DOSSIER WITH A VIEW TO ITS       THE ADDITIVE LINKED TO THE PERSON
Addltlv        Annex I K> years before                               ANNEX 8                                                                           RE-CXAMI NATION                         RESPONSIBLE FOR MARKET IN3
former         adaption                                             CHAPTER I
                                                                          AN APPLICATION FOR AUTHOR-                                     DECISION TO GRANT AUTHORIZ-
               Addltlvw es referred to                                    IZATION LINKED TO PERSON                                       ATION LINKED TO PERSON OR
               In Article 2(b) Included                                   RESPONSIBLE FOR MARKETIM3                                      BCOY RESPONSIBLE FOR
               In Ames I low than                                         ISIXDGED                                                       MMCTINB TAKES EFFECT
               10 years before adaption
                                                                                     A.
                                         ADOPTION        ENTRY INTO FORCE OF ARTICLES Sd                                                          TRANSPOSITION
                                                                      TO 91
                                                                       1
                                                                    6 MONTHS                     1 YEAR                                             2YEARS                               9YEARS                                8YEARS I
                                                                                                     •
                                                          EXAMINATION OF DOSSIERS UNDER
                                                          THE NEW RULES
               ConorIc addltlvw                  MAXIMUM 9 YEARS PROVISION AUTHORIZATION TAKINC
                                                 ACCOUNT GF THE PERIOD OF IN0LU5ION IN ANNEX 11
Addltlvw from                                       TRANSFER TO ANNEX B CHAPTER I I
former Amex 11                                      MAXIMUM S YEARS TAX IMS ACCOUNT OF THE
               Addltlvw as referred to              PERIOD OF INCLUSION IN ANNEX I I
               In Article 2(b)
                                                                         LOOCINB CF APPLICATION FOR AUTHORIZATION LINKED TO PERSON RESPONSIBLE FOR MARKET I rC
 ---pagebreak---                                          - 2 -
                                COUNCIL DIRECTIVE
                      amending Council Directive 70/524/EEC
                      concerning additives in feedingstuffs
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 commission1,
Having regard to the opinion of the European Parliament^,
Having regard to the opinion of the Economic and Social Committee3,
Whereas application of Council Directive 70/524/EEC of 23 November 1970
concerning additives in feedingstuffs4, as last amended by Commission Directive
../../EEC5, has shown that certain basic concepts must be revised to take
account of the need to ensure a greater degree of protection of animal and human
health and of the environment;
Whereas experience shows that the current rules on the use of additives in
feedingstuffs do not provide all the necessary assurances as to safety,
particularly because of the marketing in the Community of poor copies of
zootechnical additives; whereas it is therefore necessary to link the
authorization of such additives to the person responsible for the marketing of
additives authorized by the community;
Whereas a distinction should be made between additives known as "generic"
because they are widely used and present no particular dangers, such as
feedingstuff manufacturing aids, and high-tech additives with a very specific
composition for which the person or body responsible for marketing must receive
authorization, in order to avoid the marketing of copies which might not be in
conformity and might therefore be unsafe;
     1
     2
     3
     4  OJ No L 270, 14.12.1970, p. 1.
     5
 ---pagebreak---                                    - 3
Whereas the Council should draw up a list of the groups of additives for
which authorization to market is granted to a specific person;
Whereas, to facilitate application of the Directive, the list of
definitions should be supplemented and certain definitions should be
amended; whereas, in particular, the concept of additives should be defined
so as to take account of their possible effects on animal products, animal
welfare or the environment;
Whereas experience has shown that the authorization of additives by means
of Directives causes considerable delays; whereas such delays in the
transposition of Directives has sometimes resulted in the distortion of
competition and even created obstacles to trade; whereas, to remedy this
situation, additives should be authorized by means of Decisions;
Whereas the authorisation of additives is a Community competence; whereas
the Member States are closely associated with the examination and
evaluation of additives dossiers with a view to their admission.
Whereas a fee should be charged for the examination by the Member State
acting as rapporteur of the dossier on the basis of which the authorization
is to be granted;
Whereas the introduction of fees must be accompanied by the assurance that
a decision will be reached on the application for authorization to market
an additive within a given deadline;
Whereas certain feed additives may reach the human food chain, it is
necessary that the Scientific Committee for Animal Nutrition collaborates
with the Scientific Committee for Food for such matters which may have an
influence on consumer health;
Whereas, in order to put an end to the differences between Member States
regarding the arrangements for admitting the additives in Annex II into
their territory, the provisional authorization of additives meeting a
minimum number of conditions should be extended throughout the Community,
Whereas it is necessary to introduce special arrangements to facilitate the
transition to the new authorization system; whereas the date of entry into
force of the relevant provisions must therefore be moved forward;
Whereas account should be taken of developments in techniques relating to
the use of additives; whereas provision should therefore be made, in
certain cases, for the possibility of administering additives, under
certain conditions, by means other than incorporation in feedingstuffs ;
Whereas monographs of zootechnical additives should no longer be published;
whereas an information note on the additives in question should be
published instead in order to facilitate their identification;
 ---pagebreak---                                          - 4 -
Whereas the national authorities should be provided with a standard sample to
enable them to carry out checks;
whereas, in view of the deletion of Annexes I and II, in the interests of
clarity and transparency lists should be published each year of producers who
have received from an authorized person the right to manufacture additives, on
the one hand, and of all authorized additives on the other,
HAS ADOPTED THIS DIRECTIVE:
                                    Article 1
Council Directive 70/524/EEC of 23 November 1970 concerning additives in
feedingstuffs is hereby amended as follows :
1. The following title is inserted above Article 1:
                                     "SCOPE"
2. The following title is inserted between Articles 1 and 2:
                                  "DEFINITIONS"
3. Article 2(a) is replaced by the following:
 "(a) additives: substances or preparations containing substances other than
      premixtures as referred to in (j) which, when used in animal nutrition,
      are likely to affect the characteristics of feedingstuffs or livestock
      production or animal products or to reduce the possible harmful effects of
      stock farming on the human or animal environment;"
4. The following points are added after Article 2(a):
 ---pagebreak---                                          - 5 -
  "(b) additives subject to authorization linked to the person responsible for
        marketing: additives belonging to the groups of additives listed in
        Council Decision ../.../EEC;
   (c) generic additives: additives belonging to groups not subject to
        authorization linked to the person responsible for marketing;"
5. The former points (b) to (h) in Article 2 become (d), (e), (f), (g), (h), (i)
   and (j) respectively.
6. The following point is added after the new point (j) of Article 2:
   (k) raw materials: the various plant or animal products in their natural
        state, fresh or preserved, and derivatives from the industrial
        processing thereof, as well as organic or inorganic substances, whether
        or not containing additives, intended for marketing as straight
        feedingstuffs or for the preparation of compound feedingstuffs or as
        support to premixtures;"
7. The former points (i) and (j) of Article 2 become points (1) and (m)
   respectively.
8. The following point is added after the new point (m) of Article 2:
   "(n) placing on the market: the holding of additives with a view to their
        use, sale or other form of transfer to third parties, whether free or in
        return for payment, as well as the sale and other forms of transfer
        themselves."
9. Articles 3 to 9 are replaced by the following:
                  "PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES
                                    Article 3
   1. Member States shall require that, as regards feedingstuffs, no additive
      shall be placed on the market unless a Community authorization has been
      granted under a Commission decision in accordance with the following
      procedure.
 ---pagebreak---                                               - 6 -
        2. In order to obtain the Community authorization referred to in paragraph 1,
           Member States shall ensure that:
           (a) the person responsible for marketing submits an application to the
               Commission for all additives or, in the case of an additive which has
               already been authorized, any new use;
           (b) that a dossier, compiled in accordance with paragraph 3 below,
               accompanies the application for authorization submitted to the
               Commission by the person responsible for marketing; the dossier and
               the application shall be transmitted officially by the Member state
               acting as rapporteur to the Commission and to the other Member states,
               which shall acknowledge receipt thereof as quickly as possible.
        3. The application and the dossier referred to in paragraph 2 must be
           prepared in accordance with Council Directive 87/153/EEC.  subsequent
           amendments to the above-mentioned Directive as a result of scientific and
           technical developments shall be adopted in accordance with the procedure
           laid down in Article 23.
                                         Article 4
    1. Member States shall ensure that, from 1 July 1996, a fee is received for the
        examination of the dossier arising from the obligations laid down in Article
        7(2)(a).
    2. Member states shall ensure that direct or indirect reimbursement of the fee
        is prohibited and that the fee does not exceed the real cost of examining the
        dossier.
    3. Not later than 1 January 1998, the Council, acting by qualified majority on a
      , proposal from the Commission, shall fix the flat-rate amounts of the fee
        referred to in paragraph 1.
(3)
 ---pagebreak---                                          - 7 -
                                    Article 5
1. Member States and the Commission shall ensure that any information which, if
   disseminated, could affect industrial and commercial property rights is kept
   confidential.
2. Industrial and commercial secrecy shall not apply to :
   - the denomination and composition of the additive,
   - the physico-chemical and biological characteristics of the additive,
      the interpretation of the pharmacological, toxicological and
      ecotoxicological data,
      the analytical methods for monitoring the additive in the feedingstuffs,
   - the methods for testing for residues of additives in animal products.
                                    Article 6
1. The scientific Committee for Animal Nutrition established by Commission
   Decision 76/791/EEC, hereinafter referred to as 'the Scientific
   Committee',shall be responsible for assisting the Commission, at the latter's
   request, on all scientific questions relating to the use of additives in
   animal nutrition.
2. At the request of the Commission, the Member State acting as rapporteur shall
   ensure that all or part of the dossier referred to in Article 3 is
   transmitted to the members of the Committee referred to in paragraph 1.
                                    Article 7
1. A decision on the application for authorization shall be taken in accordance
   with the procedure laid down in Article 23.
2. An application for authorization shall be included on the agenda of the
   Standing Committee for Feedingstuffs for initial examination provided that:
 ---pagebreak---                                       - 8 -
 (a) the Member State acting as rapporteur has declared during transmission
      of the application, which, unless the latter is rejected or postponed
      for duly justified reasons, must take place not later than one year
      after the submission of the documentation required for the compilation
      of the dossier referred to in Article 3(2)(b):
      - that the dossier complies with Article 3(3),
      - that the product, according to the information given, appears to meet
        the conditions laid down in Article 8,
    (b) that the other Member States, within 45 days of receiving the dossier,
        have not raised any objection on the grounds of non-compliance with
        the rules on presentation of dossiers laid down in Council Directive
        87/153/EEC.
        If, after consulting the Standing Committee for Feedingstuffs, it is
        found that the rules on presentation of dossiers have not been
        complied with, the Commission shall notify this to the person
        responsible for the application for authorization to place on the
        market through the Member State acting as rapporteur.
        As soon as the Member State acting as rapporteur deems the dossier to
        have been brought into compliance with Directive 87/153/EEC, it shall
        communicate this fact to the other Member States and to the Commission
        with a view to its inclusion on the agenda of the above-mentioned
        Committee in accordance with this paragraph.
The Commission shall ensure that a decision is taken on the application for
Community authorization to place on the market within 330 days following
inclusion on the agenda of the Standing Committee for Feedingstuffs in
accordance with paragraph 2. However, this time limit shall be interrupted
where a request is made for additional information.
Where an application for Community authorization to place an additive on the
market is rejected, the Commission shall inform the applicant, through the
Member State acting as rapporteur, of the reasons for such rejection.
 ---pagebreak---                                           - 9 -
                                     Article 8
The decision to authorize an additive shall be taken only if:
   a) when used in animal nutrition, it has a favourable effect on the
      characteristics of the feedingstuffs, on livestock production or on animal
      products, or helps reduce the possible harmful effects of stock farming on
      the human or animal environment;
   b) at the level permitted in feedingstuffs, it does not adversely affect
      human or animal health or the environment, nor harm the consumer by
      altering the characteristics of animal products;
   c) its presence in feedingstuffs can be monitored;
   d) at the level permitted in feedingstuffs, treatment or prevention of animal
      disease is excluded; this condition shall not apply to substances
      belonging to the group of coccidiostats and other medicinal substances;
   e) for serious reasons concerning human or animal health its use must not be
      restricted to medical or veterinary purposes.
                   ARRANGEMENTS CONCERNING ADDITIVES LINKED TO
                       THE PERSON RESPONSIBLE FOR MARKETING
                                    Article 9
1. Community authorization of additives as referred to in Article 2(b) shall be
   valid for ten years from the date on which it takes effect and shall be
   renewable for ten-year periods, on application by the holder at least one
   year before the expiry date.
2. Articles 3, 4, 5, 7 and 8 shall apply to applications for renewal.
 ---pagebreak---                                         - 10 -
                                   Article 9a
1. Notwithstanding Article 8, new additives as referred to in Article 2(b) or
   new uses of additives shall be provisionally authorized at Community level
   provided that the conditions laid down in sections (b), (c) and (e) are met
   and it is reasonable to assume, in view of the available results, that the
   other conditions laid down in that Article are also met.
2. Provisional authorization as referred to in paragraph 1 may not exceed three
   years.
                                   Article 9b
1. Where the Commission authorizes additives as referred to in Article 2(b), it
   may not use the scientific data and other information in the dossier for the
   benefit of another applicant unless the latter has agreed with the first
   applicant that such data and information may be used.
2. The measures referred to in paragraph 1 shall apply to applicants from the
   date on which examination of additives as referred to in Article 2(b) has
   been included for the first time on the agenda of the Standing Committee for
   Feedingstuffs in accordance with Article 7(2).
                 PROVISIONAL AUTHORIZATION OF GENERIC ADDITIVES
                                   Article 9c
1. Notwithstanding Article 8, new generic additives or new uses thereof shall be
   provisionally authorized provided that the conditions laid down in
   Article 8(b), (c) and (e) have been met and it is reasonable to assume that
   the other conditions laid down in that Article have also been met.
2. Provisional authorization as referred to in paragraph 1 may not exceed three
   years.
 ---pagebreak---                                          - 11 -
                            TRANSITIONAL ARRANGEMENTS
                                    Article 9d
Notwithstanding Article 3(1), Member States shall permit the marketing of the
additives listed in Annex B.
                                   Article 9e
1. Additives as referred to in Article 2(c) included in [the former] Annex I
   before 1 January 1995 shall be authorized as generic additives.
2. Additives as referred to in Article 2(b) included in [the former] Annex I
   before 1 July 1984 shall be transferred to Chapter I of Annex B with a view
   to their re-evaluation as additives linked to a person responsible for
   marketing.
3. Member States shall ensure that the person responsible for marketing an
   additive as referred to in paragraph 2 submits, not later than 30 June 1999,
   the dossier referred to in Article 3 with a view to re-evaluation, where he
   fails to do so, the additive in question shall be prohibited.
4. The Commission shall take all necessary measures to ensure that re-evaluation
   of dossiers referred to in paragraph 3 is completed not later than three
   years after the dossier is submitted.
                                   Article 9f
1. Additives as referred to in Article 2(b) included in [the former] Annex I
   after 30 June 1984 shall be authorized provided that the persons responsible
   for compiling the dossiers on the basis of which the former authorizations
   were granted submit an application as provided for in Article 3(2) with a
   view to obtaining authorization for an additive linked to a person
   responsible for marketing before 1 July 1995.
 ---pagebreak---                                         - 12 -
2. Member states shall ensure that applications as referred to in paragraph 1
   are transmitted together with the monograph and information note provided for
   in Articles 9m and 9n.
3. The Commission shall ensure that the authorization decision referred to in
   paragraph 1 takes effect on 1 July 1996.
                                   Article 9g
1. Additives as referred to in Article 2(c) included in [the former] Annex II
   before 1 January 1995 shall be authorized for a period of not more than five
   years taking account of the period of inclusion in Annex II referred to
   above.
2. Additives as referred to in Article 2(b) included in [the former] Annex II
   before 1 January 1995 shall be transferred to Chapter II of Annex B with a
   view to their authorization as additives linked to a person responsible for
   marketing, for a period of not more than five years taking account of the
   period of inclusion in Annex II referred to above.
3. The additives included in Chapter II of Annex B must be the subject of an
   authorization application as provided for in Article 3(2) before 1 July 1995.
4. Member States shall ensure that applications as referred to in paragraph 3
   are transmitted together with the monograph and information note provided for
   in Articles 9m and 9n.
5. Detailed rules for carrying out the transfers referred to in paragraphs 1 and
   2 shall be adopted in accordance with the procedure laid down in Article 23.
                                   Article 9h
Applications for authorization to place on the market submitted between
1 January 1995 and 30 June 1996 in respect of which the Commission has not yet
given a ruling at that date shall be examined in accordance with Articles 3, 5,
7, 9, 9a, 9b, 9c, 9k, 9m and 9n as appropriate.
 ---pagebreak---                                          - 13 -
                                    Article 9i
1. Additives as referred to in Article 9g(l) which meet the conditions laid down
   in Article 8 shall be authorized.
2. Additives as referred to in Article 9g(2) which meet the conditions laid down
   in Articles 8 and 9g(3) and (4) before 1 July 1996 shall be authorized.
   Articles 9, 9b(l) and 9k shall apply.
                        DISTRIBUTION AND USE OF ADDITIVES
                                    Article 9j
1. Member States shall ensure that in the field of animal nutrition only
   additives authorized in accordance with this Directive may be marketed and
   that they may be used only subject to the conditions set out in the
   authorization decision. Unless provision is made for them to be administered
   by another method, such additives may be used only if incorporated into
   feedingstuffs.
2. Member States shall, in particular, ensure that additives are added to raw
   materials and straight feedingstuffs only where their use is expressly
   provided for in the authorization decision.
                                   REGISTRATION
                                    Article 9k
1. Where additives as referred to in Article 2(b) are authorized, the person
   responsible for marketing shall be given a registration number and the
   additive shall be given an EEC registration number.
2. Authorized additives as referred to in Article 2(c) shall be given an EEC
   registration number.
 ---pagebreak---                                          - 14 -
                             WITHDRAWAL OF ADDITIVES
                                    Article 91
Authorization shall be withdrawn from an additive where any of the conditions
set out in Article 8 are no longer met.
However, such additives may continue to be authorized for a specified period if
at least the conditions laid down in Article 8(b) and (e) continue to be met.
                       MONOGRAPHS AND IDENTIFICATION NOTES
                                    Article 9m
1. In accordance with Directive 87/153/EEC, Member States shall ensure that
   applicants present a monograph for additives as referred to in Article 2(b).
2. During the authorization procedure for additives as referred to in
   Article 2(b), the Standing Committee for Feedingstuffs shall give an opinion,
   if appropriate after having made the necessary amendments, on the monograph
   of the additive presented in the dossier provided for in Article 3(2).
   The commission shall approve the opinion given by the standing Committee for
   Feedingstuffs on the monograph and its amendments in accordance with the
   procedure laid down in Article 23.
3. Monographs may also be adopted for additives belonging to groups other than
   those referred to in paragraph 1.
4. The competent authorities of the Member States shall have recourse to the
   monograph :
   (a)  to ascertain whether the additive placed on the market actually
        corresponds to the additive described in the dossier on the basis of
        which the Community authorization was granted;
   (b)  to determine whether an additive for which marketing authorization has
        been requested constitutes an innovation or should be considered as a
        copy.
 ---pagebreak---                                         - 15 -
5. Subsequent amendments to be made to monographs on account of developments in
   scientific and technical knowledge shall be submitted to the standing
   Committee for Feedingstuffs.
                                   Article 9n
1. In accordance with Directive 87/153/EEC, Member States shall ensure that the
   applicant presents an identification note summarizing the most important
   characteristics and properties given in the monograph of additives as
   referred to in Article 9m.
2. The following shall be adopted in accordance with the procedure laid down in
   Article 23:
      the identification note,
      subsequent amendments to the identification note as a result of
      developments in scientific and technical knowledge.
3. in order to facilitate the identification of the additives referred to in
   paragraph 1 during official checks, the identification note provided for in
   that paragraph shall be published in the Official Journal of the European
   Communities.
                                 STANDARD SAMPLE
                                   Article 9o
1. The Member State which presented the dossier referred to in Article 3(2) for
   additivs as referred to in Article 2(b) shall take all the necessary measures
   to ensure that a standard sample having the characteristics and properties
   described in the monograph referred to in Article 9m is made available, upon
   request, to the national inspection authorities of the Member States.
2. If the characteristics or properties of the additive are modified, a new
   standard sample corresponding to the new monograph shall be provided.
3. Detailed rules concerning the provision and maintenance of standard samples
   may be adopted in accordance with the procedure laid down in Article 23.
 ---pagebreak---                                         - 16 -
                            MIXTURES AND PREMIXTURES
                                   Article 9p
1. The maximum and minimum levels listed in the authorization decisions shall
   refer to complete feedingstuffs with a moisture content of 12% in so far as
   no special provisions are laid down in these decisions.
   If the substance permitted as an additive also exists in the natural state in
   certain ingredients of the feedingstuff, the amount of additive to be
   incorporated shall be calculated so that the total of the elements added and
   the elements present naturally does not exceed the maximum level provided for
   in the authorization decisions.
2. The mixing of additives named in this Directive shall be permitted in
   premixtures and feedingstuffs only where there is physico-chemical
   compatibility between the components of the mixture in relation to the
   effects desired.
3. Unless the mixture concerned is provided for in an authorization decision,
   Member States shall require that:
   (a) antibiotics and growth promoters may not be mixed together, either with
        substances from their own group or with substances from the other group;
   (b) coccidiostats may not be mixed with antibiotics and growth promoters
        where coccidiostats also act, for the same category of animal, as an
        antibiotic or as a growth promoter;
   (c) coccidiostats and other medicinal substances may not be mixed together
        if their effects are similar.
4. Member States may, for experimental or scientific purposes, provide for
   derogations from Article 3 and paragraphs 2 and 3 of this Article on
   condition that there is adequate official supervision.
 ---pagebreak---                                       - 17 -
                         AMENDMENTS TO THE ANNEXES
                                 Article 9q
Amendments to be made to the Annexes shall be adopted in accordance with the
procedure laid down in Article 23.
                   INFORMATION ON PRODUCERS OF ADDITIVES
                                 Article 9r
Member States shall ensure that the beneficiaries of authorizations for
additives as referred to in Article 2(b) transmit to the Commission as
quickly as possible the name or corporate name and the address or registered
office of the producers to whom they have granted the right to manufacture
the additive and, if the producers are established in a third country, also
the name or corporate name and the address or registered office of their
representatives in the Community.
                    PUBLICATION IN THE OFFICIAL JOURNAL
                                Article 9s
The Commission shall publish in the official Journal of the European
Communities, c Series, not later than 30 November each year:
   the list of producers as referred to in Article 9r as well as their
   representatives in the Community if such producers are established in a
   third country,
   the list of authorized additives."
 ---pagebreak---                                            - 18 -
10.    The following title is inserted between Articles 9t and 10:
                                      "PACKAGING"
11.    The following title is inserted between Articles 10 and 11:
                                 "SAFEGUARD MEASURES"
12.     In Article 11, the words "listed in Annex I" are replaced by "authorized"
13.    The following title is inserted between Articles 11 and 12:
                                  "ADDITIVE CONTENTS"
14.    The following title is inserted between Articles 12 and 13:
           "MARKETING OF ANTIBIOTICS, COCCIDIOSTATS AND GROWTH PROMOTERS"
15.    Article 13 is amended as follows:
    (a)   references to "Annex III" are replaced by references to "Annex A";
    (b)   in paragraph 1, the words "listed in Annex I or Annex II" are replaced
          by "authorized";
16.    The following title is inserted between Articles 13 and 14:
                         "MARKETING CONDITIONS FOR ADDITIVES"
17.    Articles 14 to 17 are amended as follows:
    (a)   in Article 14(1):
          - in the first subparagraph, the words "listed in Annex I or Annex II"
            are replaced by "authorized";
          - A(a) is to read as follows : "the specific name of the additive, in
            accordance with the authorization decision or Annex B, the
            registration number and, where applicable, the number given to the
            person responsible for marketing";
    (b)   in Article 15:
          - in paragraph 1, the words "in accordance with Annexes I or II" are
            replaced by "in accordance with the authorization decision or, where
            applicable, with Annex B" and the words "complete feedingstuffs in
            Annexes I or II" are replaced by "complete feedingstuffs in the
            authorization decision or, where applicable, in Annex B";
          - in paragraph 2(a), the reference to Article 4(1)(b) is replaced by a
            reference to Article 9a;
 ---pagebreak---                                             - 19 -
    (c)   in Article 16:
          - the words "in accordance with Annexes I or II" are replaced by "in
            accordance with the authorization decision or, where applicable,
            Annex B", and the words "laid down in Annexes I and II" are replaced
            by "laid down in the authorization decision or, where applicable, in
            Annex B";
          - in paragraph 4, the reference to Article 4(1)(b) is replaced by a
            reference to Article 9;
          - paragraph 8 is deleted and paragraphs 9 and 10 are renumbered 8 and 9;
    (d)   in Article 17(1), the words "of Annexes I and II" are replaced by "of
          the authorization decision and, where applicable, Annex B".
18.    The following title is inserted between Articles 20 and 21:
                                 "INSPECTION MEASURES".
19.    The following is added after Article 21:
                       "VIGILANCE WITH REGARD TO INCOMPATIBILITY
                                       Article 21a
Where there is found to be unforeseen undesirable interaction between additives
as referred to in Article 2(b) and other additives or veterinary medicines,
Member states shall ensure that the person responsible for marketing the
additive gathers all the relevant information and forwards it to the competent
authorities."
20.    The following title is inserted between Articles 21a and 22:
                             "EXPORTS TO THIRD COUNTRIES".
21.    The following title is inserted between Articles 22 and 23:
                      "IMPLEMENTATION POWERS OF THE COMMISSION".
22.     In Articles 23 paragraph 4, second line and 24 paragraph 4, second line
       the part of the sentence "except where the Council has voted by a simple
       majority against such measures" is deleted in each case.
23.    The following title is inserted between Articles 24 and 25:
                                   "FINAL PROVISIONS".
24.    Annex III becomes Annex A.
 ---pagebreak---                                         - 20 -
                                    Article 2
1. Member States shall bring into force the laws, regulations and administrative
   provisions necessary to comply with:
   (a)  the provisions headed "TRANSITIONAL ARRANGEMENTS" laid down in
        Article 1(9) by 1 January 1995,
   (b)  the other provisions of this Directive by 1 July 1996.
   They shall forthwith inform the Commission thereof.
   When these measures are adopted by the Member states, they shall contain a
   reference to this Directive or shall be accompanied by such reference on the
   occasion of their official publication. The methods of making such a
   reference shall be laid down by the Member states.
2. Member States shall communicate to the Commission the text of the provisions
   of national law which they adopt in the area covered by this Directive.
                                   Article 3
This Directive is addressed to the Member States.
Done at Brussels,
                             For the Council
                             The President
 ---pagebreak---                               FINANCIAL STATEMENT
Proposal for a Council Directive amending Directive 70/524/EEC concerning
additives in feedingstuffs
1. Budget heading involved: B2-5102     Plant health measures
2. Amount of appropriations entered under this(these) heading(s) for 1993
   Differentiated appropriations    Commitment appropriations  : ECU 4 000 000
                                    Appropriations for payments: ECU 3 000 000
3. Amount of carry-overs authorized or requested (to be specified)
   - Automatic
   - Non-automatic
4. Amount of expenditure arising from the proposal made to the Commission:
   (Estimate)
   ECU 0.492 million in CA and AP as from 1996
   (a)  For the current year: None
        - using appropriations entered under
          the budget headings referred to
        - using carry-overs
        - applying other procedures (1)
          (transfers, supplementary budgets)
   (b)  For subsequent years
                           CA               AP
        1996            0.492             0.492
        1997            0.492             0.492
        1998            0.501             0.501
        1999            0.501             0.501
5. Other financial implications of the proposal (if any)
   None
6. Method of calculation adopted (give details):
   See Annex
Opinion of Director-General for Budgets:
(1) In this exceptional situation, give detailed reasons.
 ---pagebreak---                                     - 21-
                       ANNEX (Method of calculation)
Estimate of the cost for the scientific examination of dossiers (experts'
reports)
A. Major dossier(1)
   1.   Toxicology (5 to 6 pages)(2)             48  hours work
   2.   Effectiveness (5 to 6 pages)             48  hours
   3.   Metabolism (4 pages)                     32  hours
   4.   Pharmacology (3 pages)                   24  hours
   5.   Environment (2 pages)                    16  hours
   6.   Product quality (2 pages)                16  hours
                                TOTAL    :       184 hours
                                Rounded up to    200 hours
ECU 75 X 200                    = ECU 15 000 x    4 requests = ECU 60 000
B. Complex dossier(3)           = ECU   9 000 X   8 requests = ECU 72 000
c. Standard dossier             = ECU   4 500 x  40 requests = ECU 180 000
D. Simple dossier               = ECU   1 500 x 120 requests = ECU 180 000
E. Adjustment                   = ECU 900
   1996 - 1997:                 = None
   1998 - 1999:                 = ECU 9 000 per annum
                                  (10 adjustments)
TOTAL:                                   1996    ECU  492  000
                                         1997    ECU  492  000
                                         1998    ECU  501  000
                                         1999    ECU  501  000
(1) Zootechnical additives (study of a new molecule).
(2) one page equivalent to +/- 8 hours.
(3) Average price asked for an expert's report on an "additive" or
"medicinal preparation" dossier.
 ---pagebreak---                                                                       ISSN 0254-1475
                                                               COM(93) 251 final
                                                      DOCUMENTS
EN                                                                               03
                                 Catalogue number : CB-CO-93-280-EN-C
                                                             ISBN 92-77-56315-X
Office for Official Publications of the European Communities
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