CELEX: 51989PC0379
Language: en
Date: 1989-09-27
Title: PROPOSAL FOR A COUNCIL DECISION CONCERNING THE ADMINISTRATION OF BOVINE SOMATOTROPHIN ( B. S. T. )

COMMISSION OF THE EUROPEAN COMMUNITIES
                                        COM(89) 379 final
                                        Brussels,  27 September 1989
                           Proposal for a
                          COUNCIL DECISION
   concerning the administration of Bovine Somatotrophin (B.S.T.)
                              x     x
                               Report
               concerning Bovine Somatotrophin (B.S.T.)
                              x     x
                    (presented by the Commission)
 ---pagebreak---                                                                    &-
                             Explanatory Memorandum
1. The report annexed deals with the main considerations that need to be taken
   Into account    In connection  with   the  authorization  and  use of   Bovine
   Somatotroph in (BST). When administered to the I actat Ing cow BST is capable
   of bringing about a significant Increase in mille yield.
2. The existing authorization arrangements in relation to BST provide for a
   national   decision-making  procedure   after  the  Committee   on  Veterinary
   Medicinal   Products  (CVMP)  established   under  Directive  81/851/EEC   has
   delivered an opinion. The Committee Is expected to issue an opinion on two
   applications In relation to BST within the next six months.
3. The conclusion of the report Is that It would be Inappropriate to decide on
   the use of BST until all the necessary studies and assessments have been
   completed. Furthermore a decision on BST should await the putting In place
   of revised dispositions in relation to veterinary medicinal products and
   feed additives intended for promotion of yield. Present       indications are
   that, apart from BST, other comparable products applied to livestock nay
   have a significant effect on productivity, with potentially far reaching
    implications for production and socio/economic structures In agriculture.
4. It is, accordingly, proposed to the Council to adopt the annexed proposal
   with a view to establishing an evaluation period,      until 31 December 1990
   as regards the administration of BST. There are no Implications for the
   Community budget.
                                                                      2
 ---pagebreak---                                       Draft Proposal
                                            for a
                                     Counc11 Dec I s Ion
                                      of
         Concerning the administration of Bovine Somatotropin (B.S.T.)
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 of the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas products arising from milk production have a very Important place             In
the Community; Whereas they are an essential source of income for a part of
the agricultural population;
Whereas knowledge acquired gives the possibility for the placing on the market
of substances which may have a significant             impact on productivity    In milk
product ion;
Whereas despite the work accomplished, in particular the evaluation of Bovine
Somatotroph in by the Committee on veterinary Medicinal Products in accordance
with Council Directive 81/851/EEC of 28th September 1981 on the approximation
of   the    laws    of   the   Member    States   relating    to  veterinary  medicinal
           1
products* ) and Council        Directive 87/22/EEC of       22nd December  1986 on the
approximation of national measures relating to the placing on the market of
high-technology        medical    products,     particularly     those   derived    from
                 2
biotechnology* ^, the various effects of new
<1> O.J. N° L 317 of 06.11.1981, p.          1
(2) O.J. N° L      15 Of 12.01.1987, P. 38
                                                                                J
 ---pagebreak---                                              - 2
substances such as Bovine Somatotroph in are not yet               sufficiently clear; in
this respect, a necessary period should be forseen for In-depth studies to be
made;
                             "is
Whereas In the absence of a Community decision, the Member States may adopt
divergent measures; whereas these divergencies may               lead to a distortion of
competition between milk producers and to new barriers to                     Intra-Communlty
trade;
Whereas   In the view of the proceeding considerations,                 it   Is a matter of
overriding   public     interest     to    provide   for   a   temporary     prohibition   of
administration   to    dairy     cows of     the   substances    in question,      until  all
necessary information is obtained;
Whereas it will be necessary to re-examine the overall situation.
HAS ADOPTED THIS DECISION:
                                           Article 1
Notwithstanding the scientific and technical examination of applications in
accordance    with    Community       legislation,     until    31    December      1990  the
administration by any means whatsoever within the Community to dairy cows of
Bovine Somatotroph in, shall not be authorized In the Member States.
                                           Article 2
 In  derogation    from    Article      1,   the   Member    States    may    authorise   the
administration    to   dairy     cows    of   Bovine   Somatotrophln      for   carrying  out
scientific and technical trials.
                                                                                        V
 ---pagebreak---                                       - 3 -
                                    Article 3
                                                         À '• -.- .'•>,.
On a proposal   from the Commission the Council may r acting by a qualified
majority, adopt measures necessary for the implementation of this Decision.
                                    Article 4
The Commission shall, before 1 October 1990, submit a report to the Council
and  to   the  European  Parliament   on  the   development          of  the  situation,
accompanied by any necessary proposals. The Council shall decide before 31
December 1990.
                                    Article S
This Decision Is addressed to the Member States.
Done at Brussels
                                              By the CounclI
                                                                             _r
 ---pagebreak---                REPORT
from the Commission   to the Council
         and to Par I I ament
             concern Ing
   Bovine Somatotroph In (B.S.T.)
                                     G
 ---pagebreak---                Report from the Commission to the Council
                       and to Parliament        concerning
                      Bovine Somatotroph In (B.S.T.)
GENERAL BACKGROUND
      Somatotroph in       is    a   growth      hormone,        secreted      by    the
      pituitary     gland.     In general      the activity        of   this   hormone
       is   species      specific,       so     that      for     example,      Bovine
      Somatotroph in (BST) from          the cow should          have no     Influence
      on   human   growth.      It has been       known    since     the   1930s    that
      the   administration of        BST    to dairy      cattle     could    Increase
      milk yields.       However, since BST could only be extracted as
      a   natural    hormone     post   mortem,       the   quantities       available
      were    too   limited    and   too   expensive        to   permit    commercial
      use.
      Following     the development of recombinant               DNA biotechnology
       In   the    1970s,     It    became      possible       to    produce      large
      quantities of somatotroph Ins at relatively                  low cost.      Apart
      from    use  of   recombinant     BST     (rBST)      for   milk   production,
      for    which    authorisation         is    now    being      sought     by    the
      companies concerned,          research      Is being conducted          into use
      of bovine, porcine and ovine somatotroph Ins for                      fattening
      purposes.
      A   further    factor   delaying      the    commercial      exploitation       of
      BST    was   the    need    to   provide       an   appropriate       sustained
      release     formulation,      which    would      eliminate      the   need    for
      daily     injections.      The  stage      has    now   been    reached     where
      administration       at    two  to   four     weekly     intervals     seems    to
      bring about the desired           increase in milk yields.               Studies
      have indicated       increases of milk yield of upwards of 25% on
      administration of rBST under             controlled       conditions.       It is
                                                                                   ^
 ---pagebreak---                                           .   3 -
estimated        that,        given      the    knowledge          and    ability       required
for  effective           use of       the p r o d u c t ,       yield      Increases        closer
to   12%      are      more       likely       to    be    achieved          In   normal        farm
condItIons.
The   possible          use     of   rBST      in milk       production          has   been       the
subject      of    widespread           public       Interest.          In    the   Council        of
Agriculture          Ministers         several       Member      States        have    expressed
reservations             about         Its      use,      mainly         in      relation          to
potentially          adverse         soclo/structura I consequences                      and      the
implications          as regards supply and demand                       for milk and milk
products.         The       matter        has     been     examined          extensively           by
various       Committees            in    the     European        Parliament         which,        on
                                                             1
5 July 1 9 8 8 ,         adopted        a    resolution            on     the     effects         and
risks of       using        growth      hormones        and    the BST        hormone       In    the
dairy    and      meat       industries.           The    Parliament            called     on     the
Commission         to e x a m i n e    the c o n s e q u e n c e s   of    the use of          rBST,
to   consider,             inter      alia,       the     necessity           for     additional
criteria,          e.g.        social       and     economic          factors,             in     the
examination            of      applications           for      authorisations             and      to
create      a    legal        framework         covering        genetically           engineered
growth      accelerators              or     yield      enhancers.            Under      existing
 legislation         authorisations              are    considered          on   the    basis      of
three    criteria           viz, safety,          quality       and e f f i c a c y .     The     BST
question        was       discussed         at     length      at     a    seminar       held       in
September         1988       under      the     auspices        of     the     Commission.           A
wide range of o r g a n i s a t i o n s (listed                in     Annex      1)    have been
consulted        and have had an o p p o r t u n i t y             to g i v e their        views.
 It  is clear         from      the    reaction        in the Council             of   Ministers
 that,     while         most      Member       States      are     very       hesitant        about
 the   a u t h o r i s a t i o n of     rBST,       there may        not     be u n a n i m i t y  on
 the    issue.          Divergent           positions          of     Member         States        on
authorisation             carries        a   serious        danger       of     distortion         of
competition          and trade         disputes.
O.J. C 235 (Vol. 3 1 ) Of 1 2 . 9 . 1 9 8 8 , pp. 4 1 - 4 4 .
 ---pagebreak---                                                - 4 -
EXISTING  LEGISLATION
6.    The   definition          of     a     medicinal         product        in   Article       1   of
      Directive      65/65/EEC           covers       not     only    products         Intended      to
      prevent     or    treat       disease        but     also     products       which      may    be
      administered        to humans            or animals with a view to modifying
      physiological         functions, such as                  an   increase       in milk     yield
       In  cattle.        BST      is      therefore          regarded        as    a    veterinary
      medicinal      product.
7.    Directive      81/851/EEC            Is designed          to   harmonize        the    laws    of
      the    Member       States         on      the     authorization            of     veterinary
      medicinal       products.            The     approach         to    authorisation           -   a
      matter     for    decision          by     the    Member      State      concerned        -    is
      based    on   three       exclusive          criteria        namely       quality,       safety
      and  efficacy        of    the      products        concerned.          The    procedure       in
      the case of biotechnology products                          Is somewhat         different      in
      that    under       Directive            87/22/EEC,         Member        States      may     not
      decide      on      any       application             for      authorization            for     a
      veterinary        medicinal            product       derived        from      biotechnology
      until     the     Committee             for     Veterinary         Medicinal          Products
      (CVMP)    has given         an o p i n i o n .      Final     evaluation         of   the   test
      results      and     the       decision         on      authorization           remains       the
      responsibility of             the Member          States.
8.    As  regards       other       comparable            legislation          In  agriculture        ,
      somatotroph In           is       not       subject        to     Council          Directives
                                                            2
      1981/602/EEC         of      31      July      1981 ,       85/358/EEC          of    16     July
           3                                                               4
      1985      and    88/146/EEC             of    7    March      1988        in    relation       to
      prohibition        on    the      use     of   certain        hormones       for     fattening
      purposes.        It    is not        affected        either      by    the   provisions        of
      Council      Directive            70/524/EEC            of    23     November         1970     on
                                                       5
      additives       in     feedIngstuffs.                   Under     this      Directive         the
      only    substances         that       may    be    used      as   additives         in   animai
2     O.J. L 222 Of 7.8.1981,                   p. 32.
3     O.J. L 191 Of         2 3 . 7 . 1 9 8 5 , p. 46.
4     O.J. L 70 of        1 6 . 3 . 1 9 8 8 , p. 16.
5     O.J. L 270 Of         14.12.1979, p. 1.
                                                                                                   3
 ---pagebreak---                                                 - 5 -
    feedingstuffs              are     those      approved         by     a Community             procedure
    and      listed       In the A n n e x e s       to the D i r e c t i v e .           Since     no oral
    preparation             Is c u r r e n t l y    available           in     the     case     of   rBST   -
    formulations             are     administered            by     Injection-              the    question
    of a u t h o r i s i n g    rBST as an a d d i t i v e           in f e e d i n g s t u f f s has not
    arisen.           It may be n o t e d , h o w e v e r , that several                      antibiotics
    and     other       chemical        additives,           whose       effect          is to     increase
    productivity             of   livestock,          are either             currently          authorised
    or the subject              of a p p l i c a t i o n s      for    authorisation.
9.  Two a p p l i c a t i o n s    for a m a r k e t i n g       a u t h o r i z a t i o n for BST were
    referred            for      an     opinion          to      the       CVMP          In    1987.     One
    application               would       cover          all         Member            States        except
    Luxembourg             and      the      Netherlands.               A      second         application
    c o n c e r n s France and the United                     Kingdom.
    Under       existing        procedures           It    is a m a t t e r        for     the   applicant
    to      submit        the     data      necessary            to     prove         that      the    three
    criteria          have     been     met;       applications              are      assessed       by  the
    national             authorities              and        by       the        Committee.              The
    authorities              of     the     Member          States         concerned            receive     a
    complete           set    of    the     data      submitted           by     each       company,     and
    have the o p p o r t u n i t y        to submit q u e s t i o n s and                 comment.
    The       commercial            implications              of     receiving             authorisation
    requires            that      the      regulatory             authorities               protect       the
    confidentiality               of    the      data      submitted.             The     Commission       is
    obliged         also      to respect          the c o n f i d e n t i a l i t y      of   discussions
    within         the    CVMP,       a  requirement             that       limits        the    degree    of
    detail         that can be f u r n i s h e d           in this        report.
10.  In      Its     examination            of     this        matter         the       CVMP     has    been
    assisted          by    an    ad-hoc       group        of    experts          on     biotechnology.
     It     is     understood          that      the     assessment            process         within     the
    Committee           may     be     entering         its      final       phase.          Expectations
    are      for     an    opinion       in or       about       the     end      of     this    year.     At
    this       stage,         therefore,          it    is only         possible          to   provide     an
    interim         review of the a u t h o r i s a t i o n             process.
                                                                                                         /o
 ---pagebreak---                                       - 6 -
EXAMINATION BY COMMITTEE ON VETERINARY MEDICINAL PRODUCTS (CVMP)
11.   Following    is an Indication of progress on the main elements
      taken into account        in the Committee's assessment.
      a)        Safety    In the animal
      The   studies     initially     submitted     by   the   applicants      were
      considered to be of insufficient duration.                Both applicants
      have been requested         to provide substantial        additional     data
      covering      three     lactation      periods;     this     involves     the
      monitoring     of a wide range of physiological              parameters     in
      the    cow    and    her     progeny     to   enable    a    comprehensive
      assessment     to be made.        Among the factors which are being
      specifically       considered       under     this    heading      are    the
      potential     effects    of   BST on     reproductive     performance, on
      the   incidence of mastitis, on bone growth               and   development
      In the calf and on the extent and clinical                significance of
      Injection site rejections.
      b)         Human safety
      It Is assumed at present           that any residues of BST          in milk
      should not pose a risk to consumer health since the overall
       level    of    BST     is    not   significantly        Increased      after
      administration.        Besides,       BST      Is     destroyed        during
      pasteurization,       the    hormone    is broken    down    completely     in
      the stomach and       is not active       in man.    The applicants have
      been required       to provide scientific data          to justify      these
      assumptions.       Since    BST   operates     either   directly     or   via
      stimulation       of    another     hormone     (IGFI)     the   effect     as
      regards other hormone levels has to be               considered also.
      While      BST     Is    designed       to    increase      milk     yields,
      consideration       must   be   given    also   to  residues     of   BST   in
      meat,    In particular       to any persistence of residues at the
       injection site.       As with any veterinary medicinal             product,
      the applicant must propose a routine method of analysis of
                                                                              *<i
 ---pagebreak---                                      - 7 -
      sufficient     sensitivity     to  detect      residues    at   low  levels.
      Moreover, In addition to studies of the safety of residues,
      the   potential     risk    of    direct      human    contact     with    the
      products must be addressed to ensure the safety of persons
      using the product on the farm.            These elements form part of
      the assessment by the Committee.
      c)       Quality of synthetic B.S.T.
      While    BST     is   a   naturally        occurring       substance,      the
      commercial      formulations      are   complex       products     requiring
      advanced     technology    In   manufacture.        The   applicants      have
      had  to provide appropriate guarantees of                their   ability    to
      produce    a   consistent,    pure    and    homogenous     product    on   an
      i ndustrI a I sea Ie.
      d)        Efficacy of synthetic B.S.T.
      While the effect of BST          In increasing milk         yields   Is well
      documented,      further     Information        has   been    requested     to
      justify     the   proposed     dosage     levels      and   the    intervals
      between Injections.
12.   Resume of examination by CVMP
      The various elements Involved are still under assessment by
      scientists from the national regulatory authorities.
      The examination      process    Is now entering          Its final phase-,
      It  is expected     that    an opinion      will    be  delivered     by   the
      Committee by the end of the year.
OTHER IMPACTS
13.   Apart  from the examination by the Committtee,                  some of the
      elements     involved   are   the subject        of  other   studies    being
      carried out at the request of the Commission eg on quality
      and  composition     of   the   product,       and   likely    consumer    and
      producer     attitudes    to   the   use    of    BST.    Other    important
                                                                               'U
 ---pagebreak---                                                - 8 -
    socio-economic                 and      economic            factors         eg       effects          on
    agricultural             production         and     structures         are      not     at    present
    the subject of               in-depth      studies.
    Food Product             Quality
14. As regards milk q u a l i t y , apart                    from the safety of                residues,
    the        applicants            for      authorisation              must          identify          any
    potential             difficulties             in        the      subsequent             industrial
    processing           of    foodstuffs.            In the course of e x a m i n a t i o n              by
    the     CVMP,       additional          Information           has   been      required         on    the
    effects         of     the      use    of    BST      on    protein,         fat      and     vitamin
    content        of milk         and   on    the e f f e c t s      for   the m a n u f a c t u r e     of
    c h e e s e s and other dairy              products.
15. An     aspect        requiring         particular           attention          relates        to     the
    somatic        cell      count      (SCO     which        is one of        the m a i n      tests of
    milk       bacteriological             quality        and      Is used       as an        indication
    of m a s t i t i s     In a n i m a l s .    R e p o r t s from the United States and
    a    recent       German        study     (Heeschen          1988),      Indicate          that    BST-
    application             leads      to an     increased          number      of     somatic        cells
     in      the     milk        and     to      increased           pyruvate           levels        also.
     Increased          SCC      levels       would       have      implications            as    regards
    the       standards           laid    down      in     Directive         85/397         as    regards
     intra Community               trade     in milk for c o n s u m p t i o n         and the price
    paid       to p r o d u c e r s   for milk         for m a n u f a c t u r i n g .     An    Increase
     in    somatic         cells      affects        the      composition         of     milk      eg    the
     lactose/salts ratio,                   a factor         that could         Influence         product
    quality          and       yield.         A     research          project           is     currently
    underway             (funded         by      resources             from        the       milk        co-
    responsibility                     levy)      at          the        BundesanstaIt                   fur
    MI I c h f o r s c h u n g at Kiel        to e x a m i n e    these        a s p e c t s ; a report
     is e x p e c t e d by the end of              1990.
16. The s t a n d a r d       of   farm m a n a g e m e n t     Is essential            if the       likely
    adverse        e f f e c t s of BST on c o m p o s i t i o n         are     to be        mitigated.
    The a v a i l a b i l i t y of good quality                 feeding and the ability of
    the        cow      to       consume        it       in      Increased          amounts           Is   a
    prerequisite               to     effective          application           of       rBST.       Should
                                                                                                    •/i
 ---pagebreak---                                             - 9 -
        producers       fall    to operate an adequate          feeding     system, the
        fatty      acid   composition        of  milk   fat,   and     in   turn   butter
        quality, would be affected.
         The impact of BST            on milk composition needs to be examined
         more       fully,        in     relation     to,     for      example,       milk
         concentration, the combination               effects of      heat    treatments
         and    the effects on rennetabI Iity, the effect                  of   increases
          In   the    level    of    whey   proteins    and   consequences        for  the
         consumption of          liquid mlik.      These are questions that need
         to be addressed by way of further studies.
                         ECONOMIC AND SOCIAL CONSEQUENCES
   Impact at farm level
   17.    The consequences           have   to be considered        in the context of
           the   milk    quota,       established    as   part    of   the    Community's
          milk     policy,      remaining      beyond   its   review      date   in   1992.
           At   the   individual       farm   level  the main      consequence      of   the
           Introduction of rBST            in milk production        Is an    Increase in
           the   milk    yield     per    cow.   The  actual     level    of  milk    yield
           Increase would be           less (probably      about    12%) than the 25%
           recorded      In   research,       since    farm   management        In   normal
           circumstances        Is likely to be less rigorous than under                 the
           h Ighiy-controlled           conditions     of    experimental         studies.
          While Intake of feed has to Increase significantly, perhaps
           by as much as 10%, to achieve optimum results, BST can lead
           to an Increase In the efficiency of feed conversion to milk
          by up to 6%.            There    is a view that on many          farms BST may
          be    used    as   a    tactical     management    tool,      for   example     to
           increase milk output where production seems                    likely to fall
          below quota, or to adjust the seasonalIty of production or
"4        to     treat     individual        cows,   rather     than     as    a   routine
          treatment.
                                                                                        <Kf
 ---pagebreak---                                             - 10 -
    While,    In the        initial       period      at    least,       the     response         to BST
    by way    of      increased        milk     yield      at    farm     level       may     be    below
    the  research         levels,        It    is r e a s o n a b l e   to expect           a    growing
    increase      in yield         levels as further              research         and     management
    are   refined         to     achieve        optimum        results.            It    has       to   be
    assumed      that      BST      would     be    made      available           at    a    price      to
    permit    economic         use.
18. The  Community's              milk     quota      regime        is   designed          to      ensure
    that   milk        production           does     not      Increase          beyond         a    fixed
    level.      Nevertheless,              the present          tendency         for     large      scale
    dairy    farmers         to     produce        in    excess        of     their        individual
    quotas creates             an o n g o i n g     risk of higher milk                 deliveries.
    BST  would        add    to     this     risk.      Furthermore            its     use      by    milk
    producers         to    avoid       production           being        under        quota        would
    remove      an      important          "safety         valve"        from        the       existing
    system.
19. The  general        use of        BST would         likely        lead    to reduced             dairy
    cow n u m b e r s .    T h i s w o u l d affect        the beef sector                through an
    increase,          in the s h o r t - t e r m ,       In the number             of cows          taken
    out   of    milk       production           and    sent       for     slaughter.              In   the
    longer-term          fewer       dairy      cows      should        lead       to     lower       beef
    production.           In     the    normal       course         le    without         BST,        beef
    production         from     the    dairy       herd     would      tend       to   fall       due   to
    the o n g o i n g    Increase       in milk       yield      as a result            of      improved
    feeding     and     housing        techniques         and better           selection           in the
    dairy    herd.        The      use   of     BST    would       accelerate           this       trend;
    some    studies         suggest          that      the     decline          in     cow       numbers
    would accelerate               by some 10 p e r c e n t .
20. Reduction        In dairy        cow     numbers       raises       the q u e s t i o n       of   the
    utilisation         of    the     factors       of   production,             i.e.     labour       and
    capital,        that      would       be     freed      at     the      farm       level.         Many
    farmers affected             by the milk quota are a l r e a d y                   starting        new
    enterprises,          especially            in   beef,        sheepmeat           and      cereals.
    This   tendency        could g r o w d e s p i t e        there      being       few      increased
    outlets       for      further         production;            beef       and       cereals         are
    subject     to the s t a b i l i s e r      mechanisms,              w h i l e sheepmeat           has
                                                                                                        •/r
 ---pagebreak---                                                   - 11 "
            been    the     subject         of    proposals        designed        to     reduce       the
            guarantee,       In    view     of   the   sharp      rise    In   FEOGA      expenditure
            in    the    sector.          The     development          of    opportunities             for
            diversification           and    alternative        rural     enterprises         could     be
            a factor     also.
     Ml Ik Pol Icy A s p e c t s
     21.    In considering          this     question       it    Is necessary         also     to   bear
            In mind      the agricultural             policy     pursued      In recent        years by
            the   Community,          notably       since      1984.     This     has     Involved       a
            programme       to     control        output       directly       and     to     encourage
            farmers    to diversify            and   engage      In  less     Intensive        forms of
            production.        The     policy      was   developed        against      a   background
            of   sharply       increasing         production,         and    mounting        surpluses
            leading    to unsustainable pressures on the Community                               budget.
     22.    Despite      the       quota        system       and     a    satisfactory            market
            situation,           the      milk       regime       costs       about        5 000 MECU
            annually.      The     quota,       central     to    the   Community's          policy     of
            containing          production          and     expenditure,            Is     a     fragile
            mechanism       whose       beneficial        effects       are    at    constant         risk
            from   surplus        production.         Deliveries         In  the    1988/89        season
            were   some     1.8    million       tonnes     above     quota;      this     has     led  to
            requests      to    the    budgetary       authority        for    increased         credits
            for   the milk sector            this year.
     Soclo-StructuraI
     23.    As   regards      the    socio-structural              aspects,       milk      production
             Is  central      to    incomes       of   smaller      producers         ie   those      with
             less  than     10 cows        in the Community.             While     such       producers
            represent      some      5 3 % of    holdings       (1.6 m i l l i o n ) ,   only     12%   of
            dairy    cows      are     kept     on   their      holdings.           Producers         witn
             larger    resources          are     best     placed      to    take      advantage        of
             increases        in      productivity            through        the      use       of     new
            technologies.           Smaller          producers,           traditionally               less
            capable      of      adapting        to    change       and     technical          advances
            are   slow   to b e n e f i t ,    if at    a l l , from     such    opportunities.
ïfi-
                                                                                                  -/s
#:
 ---pagebreak---                                      - 12 -
    in the case of BST, the management                techniques required and
    the  need   to   provide       supplementary       high    quality     feed   for
    cows, would      limit any possible advantages                in the case of
    small    herds.     Besides,         there     would      normally       be     no
    incentive    to   a herdowner         with   less   than    a given      minimum
    number    (8)     of    cows       to    use     BST.    This     would      have
    Implications     as   regards       the   regional     distribution      of   BST
    usage in the Community.
24. The  ability    of   BST     to   Increase     further     the   economies      of
    scale  and   profits      of    larger    producers      would    give    them a
    greater   capacity      to    engage     in other      forms   of    production
    and/or  to purchase smaller holdings with milk quotas.                          It
    Is  likely   also    to   lead    to growing      pressures      to break     the
    link,   In existing         legislation,       between the quota and the
    holding - quotas may not be purchased                 Independently of the
    corresponding      holding        -    as   larger      producers      seek     to
    consolidate their positions and make optimum use of the new
    techno logy.
25. Consumer View
    No detailed studies have been made, of the                   likely consumer
    reaction   to meat      and     dairy    products     In the    event     of  BST
    being   authorised.         Consumers       organisations        have      warned
    that  this   could    be    very     negative. At       the meeting       of  the
    Veterinary     Advisory       Committee      on    15    March    and    at   the
    Advisory   Committee       for milk and milk products on 31 March
    1989.   BEUC,     the     umbrella       consumer      group    organization,
    called  for a total        ban on BST. The consumer             view     is that
    research    carried      out     to   date    does    not   demonstrate       any
    advantage for the consumer eg by reducing retail prices for
    dairy  products      or    by    Improving      the   quality     of  milk    and
    meat  products or       the     health    and   nutritional      standards of
    milk.      On    the    contrary        BST    Is   claimed       to    engender
    mistrust   and suspicion of the quality of meat and of dairy
    products.     Consumers        are    concerned      also    at    the     animal
    welfare aspects (see par 2 9 ) .
                                                                                   /-?
 ---pagebreak---                                        - 13 -
26. Market Aspects
    As regards the market             for dairy products,           consumptIon has
    been     Increasing        steadily      in    recent     years.      There    is    a
    growing trend away from traditional products such as butter
    -   perceived      by some consumers           as harmful       to health       - to
    cheeses      and     diversified        products.       Dairy     products       face
    increasing           competition          from       substitute          products.
    Producers,      the     dairy      Industry     and   Indeed      the   Community,
    through    some     400 MECU      committed      from    the coresponsIbI I Ity
    funds,     have       invested heavily        In recent years In promoting
    an   image    of    milk     and   dairy    products      as  natural,      healthy
    products.
27. It   would     be    a   serious     setback      to   producers       and   to   the
    Community's        milk      policy       were        present         trends        In
    consumption        to be reversed as a result of adverse consumer
    reaction.       This     points     to   the    need   for    the    most   careful
    evaluation      of     this aspect.         Since existing          techniques do
    not    permit      the     ready     identification        of    rBST     in   dairy
    products,      the concerns         of   consumers      cannot     at   present    be
    met    through        labelling.       An    Important       research      project,
    financed      by    the     milk    co-r espons I b I I 11 y       funds,     Is   being
    carried out at the University of Munich with the object of
    finding      a    method       to   Identify       rBST    In    milk:     this     is
    expected to be completed              in the second half of 1990.
28.  It  Is   intended       that   other    studies     currently       under   way at
    the   Institute        fur WIrtshaftsforshung            In Munich and at the
    University of Glessen due to be completed                      In November       1990
    will provide mora            Information on       likely consumer         reaction.
    The studies will cover farmer reaction also to use of BST.
29. Animal Welfare
    Concern     at   the animal        welfare      Implications of         the use of
    BST    relates        to    short-term       and    long-term       effects,      and
    administration.           As regards the short-term,               the concern is
    that    cattle     treated      with   BST    could    suffer     from   a greater
 ---pagebreak---                                  - 14 -
    Incidence of metabolic diseases.             In relation to the longer
    term   the  concern    is that     the    administration       of  BST   over
    several    lactations      could      result      in    changes      in   the
    calcium/phosphorus       balance,       leading     to    musculo-skeI eta I
    deformities,     and  that   there     could   be    unforeseen     problems
    for the calves of treated cows. The CVMP is examining these
    aspects.
    The  need   to  administer     BST    by   injection      and   to  restrain
    animals for the purpose of administration are seen also as
    undesirable on animal welfare grounds.
30. Other Somatotroph Ins
    While the immediate subject of this report relates to rBST
    for milk production, somatotroph In has a potential to be an
    effective   commercial     growth    and carcase enhancer           in other
    livestock.     Significant      Improvements       in    daily    gains   and
    feed conversion efficiency have been recorded                 in the course
    of  experimental     work   on   cattle, sheep         and   especially    in
    pigs.   While results are more variable than                in the case of
    milk and the techniques involved have not reached the stage
    of commercialisation - the need for frequent                  Injections is
    a  major   drawback    -   further      research     and    development    in
    these fields may open the way for a substantial                  increase in
    productivity and production of livestock products.
31. Views of Pharmaceutical        Industry
    The   pharmaceutical      industry       would     be     concerned     about
    possible adverse impact of changes in present authorisation
    procedures    not   founded    on   a   sound   scientific       basis.   The
    industry would be opposed         to     criteria relating to social
    and economic     factors.    The contention         is    that    departures
    from     criteria      established          by     legislation         create
    uncertainty,      and   reduce      the     likelihood       of    research,
    development, innovation and investment.
                                                                        ^3
 ---pagebreak---                                                - 15 -
      The      industry          supports      the    authorization          of    BST    which,        It
      claims,            will       bring      economic        benefits         for      Industrial
      s u p p l i e r , farmer and         consumer.
Feed Additives
32.   Apart        from B S T ,        concern     has been e x p r e s s e d      In the     Council
      of     Ministers            in   relation      to   the      authorisation          of     growth
      promoters              in     animal      feedIngstuffs            (see     par      8).       This
      concern          relates        to  Owconsumer              protection,         market        imbaianc
      and       budgetary           costs.      The     Commission         has     undertaken            to
      present          the r e s u l t s of s t u d i e s    in this area with a view                    to
      discussion               In    Council.       It    Is     accordingly          intended           to
       launch          shortly        a   wide-ranging          study      of     the     impact         of
      growth          factors        in   the    production         of    livestock        products.
      This         will       cover      the     economic        aspects        in    relation           to
      agricultural                 productivity,          research          and       consumption;
      together            with     the   socio-economic          elements.           The    study        is
      expected             to    be    completed       by    October       1990.       Nine      growth
      promoters             have      been   authorised          as    feed     additives          under
      existing               legislation          and       further         applications               for
      authorisation                are    currently       being        considered;         one       such
      application               relates     to   a   substance         considered       capable          of
       Increasing milk y i e l d s by u p w a r d s of 5%.                    No a u t h o r i s a t i o n s
       for milk p r o d u c t i o n have been given to d a t e .
33.    CONCLUSIONS
(a)   The use of recombinant                   BST ( r B S T ) is c a p a b l e of      significant
       Increase             in     milk    yields.          It      Is    likely       to     be       the
       forerunner            of    other    products       capable       of   bringing        about        a
       substantial             Increase     in meat       production.
 (b)  On      the       assumption        of    the    Community's          milk     quota       regime
       c o n t i n u i n g beyond       1992,      the use of BST should be                 reflected
       in a r e d u c t i o n        In the number        of    dairy     cows     rather      than      an
       increase           In overall       milk p r o d u c t i o n ;    this    Is   likely       to be
                                                                                                   <b
 ---pagebreak---                                         -   16 -
    accompanied       by a release of           resources of       labour     and   capital
    Into other      sectors of a g r i c u l t u r e , greater        concentration of
    milk   production         in   the   hands    of    the   larger     milk    producers
    and greater       pressure on the quota              regime.
(c) Apart    from     the    Member     States      and    the   European       Parliament
    which    has    adopted        a  resolution        on   the    Issue,      this     is   a
    matter     of    considerable          public      Interest      especially        among
    consumers,            producers,             Industry,          animal          welfare
    organisations          and      scientific        Interests.       While       directly
    opposing     positions        have    been    taken    up by consumers          and    the
    pharmaceutical         Industry, most         other     interested      parties       have
    taken    a more     cautious       position,       advocating      further       studies
    and   i nformatIon.
(d) Apart    from    the    purely     scientific       aspects,      the    reservations
    expressed      by   the Member       States and        the position       taken up In
    the Parliament         on these       Issues, as well         as the     considerable
    uncertainty          In       relation        to     consumer         reaction         and
    consequences        for    the market,        requires      that    the   Community's
    approach      to   be    based    on    the   fullest      awareness       of   all    the
     Imp I I cat Ions .
(e) The   present      authorisation          process      for   use   of   BST    provides
    for a decision         at national         level.     Other    chemical       products,
    administered        to    livestock       by   means    of   an   oral    preparation
    for    nutritional         purposes        as   additives       in    feedingstuffs,
    are   subject      to   a Community         authorisation        procedure.         While
    several     Member     States have expressed             reservations         about    use
    of BST      there may not be unanimity                on the     issue. This could
    have    Implications         in relation       to free movement         of    products.
    Examination        of    the    matter     by   the    Committee      on    Veterinary
    Medicinal      Products         (CVMP),      conducted      on   the   basis      of    the
    "safety",      "efficacy"         and    "quality" of       the product        is at an
    advanced      stage.        It   is   likely     that    Member     States      will     be
    faced with       the decision of whether               to authorise       rBST by       the
    end of    this year.            Studies under        way   into other       aspects eg
    milk   composition         and quality, consumer            reaction      etc are due
    to    be completed         in the second        half of      1990.
                                                                                          *7
 ---pagebreak---                                                    - 17 -
(f)    It     is     clear      that     a    situation         in w h i c h     Member      States       may
       take      divergent          decisions         on   BST must        be     avoided;        to     this
       end       the C o m m i s s i o n will present c o m p r e h e n s i v e p r o p o s a l s to
       Council          by    the     end     of     this    year.       Having        regard       to    the
       position           of   Parliament           and    the    general        public      concern       on
       these         issues,        preparation           of   the    proposals           will     require
       detailed            examination            of    the     most      appropriate            decision
       making          arrangements             and     structures           In     connection           with
       authorisation              of   all       productivity         enhancing          substances        In
       agriculture,               whether           veterinary            medicinal             products,
       including p r o d u c t s . o f b i o t e c h n o l o g y ,        or feed a d d i t i v e s .
 (g)   It     Is clear         also     that      sufficient        time      should      be    available
       to     assess         the    results        of    the    current        studies,        under      the
       a e g i s of       the CVMP       and of        the C o m m i s s i o n .   At   the same         time
       it     Is e s s e n t i a l    to avoid         prolonged       uncertainty            that     would
       be       harmful          to    the        Interests        of      Industry,          especially
       biotechnology,                which          has     an     important            role       in     the
       C o m m u n i t y , not      least     in the d e v e l o p m e n t of       agriculture.
(h)    It will          be    important        also     to have an e x c h a n g e          of   views on
       the      issues raised with                 any    interested         third     countries,          as
       it Is c e r t a i n that           the q u e s t i o n s raised are of deep                  concern
       and       interest         not    Just       In   the     Community         but     also      in   the
       major p r o d u c e r and c o n s u m e r          countries.
RecommendatIons
it  Is a c c o r d i n g l y   proposed         that    the Council           adopt     a decision         to
establish       an     evaluation          period        up    to   the      end     of    1990     on    the
administration            of    rBST.        Th i s      period      Is    considered          to     be   the
minimum     necessary          to    assess        the    results      of    ongoing        studies       and
complete      the     new     arrangements           to be     adopted        on    procedures.           The
target date for c o m p l e t i o n of some of the s t u d i e s will                         have to be
brought     forward          to    enable        the    Commission          to    fully      review       all
aspects     in twelve m o n t h s          t i m e . This will        provide         the    opportunity
also    to       compIete           the      necessary           contacts          with        Interested
                                                                                                  * <
 ---pagebreak---                                                 - 18 -
third c o u n t r i e s .     In k e e p i n g with       the C o m m u n i t y ' s o p e n n e s s on the
definitive         conclusion         on    this q u e s t i o n ,    it    is not      the      intention
to  prohibit            Imports       of    BST   or      of     products         derived        from   BST
treated     animals during               the e v a I u a t I o n   period.         This approach         is
not c o n s i d e r e d   to place C o m m u n i t y      milk p r o d u c e r s at a        competitive
disadvantage           in p r a c t i c e .
                                                                                                      ^
 ---pagebreak---                                 Annex I
Bodies    consulted    a) THE VETERINARY        ADVISORY      COMMITTEE
representative of Agricultural Producers (COPA), Agricultural
Cooperatives (COGECA). industry, Confederation of the Food and
Drink   Industries of      the EEC (C.I.A.A.). Commerce, Comité
Européen      de    Liaison     des     Commerces     AgroaIImenta I res
(C.E.L.C.A.A.). Workers, European Trade Union Confederation
(E.T.U.C). Consumers,        Bureau     Européen    des    Unions    de
Consommateurs     (B.E.U.C.),    European    Community   of    Consumer
Cooperatives (E.U.R.0.C.0.0.P . ) , Confederation des Organisations
Familiales de la CE (C.0.F.A.C . E . ) . Federation of Veterinarians
of the European Economic Community (FVE). b) The ADVISORY
COMMITTEE      ON MILK AND MILK PRODUCTS, (representatives of
Producers/Cooperatives, Dairy and Dairy Related             Industries,
Trade, Workers and Consumers) c) OTHER HEARINGS/
REPRESENTATIVES/OBSERVERS, European Community Dairy Industries
(A.S.S.I.L.E.C.v A.S.S.I.F.O.N.T.E., A.S.F.A.L.E.C.), European
Community Dairy Traders (U.N.E.C.O.L.A.I.T. , E.U.C.0.L.A.I.T),
Eurogroup for Animal Welfare, European Federation of Animal
Health (F.E.D.E.S.A.), Compassion in World Farming (C.I.W.F.),
European     Farmers    Coordination,     Deutscher    Tlerschutzbund,
Tierverschunger     -   NordrheIn-Westpha I I a    E.V.,   Gen-ethisches
Netzwork G.E.N. , EvangeI Isches Bauernwerk in Wurttemberg, Die
Verbraucher Initiative, European Campaign Against B.S.T., Working
group for Lactlcal Veterinary Medicine (A.G.K.T.), EC Livestock
and Meat Trade (U.E.C.B.V.) , EC Meat Processing                Industry
(C.L.I.T.R.A.V.I . ) , European Retail Trade Associations (C.L.D.,
C.E.C.D.), EC Meat Wholesale Trade (A.E.C.G.V.) , The London Food
CommIss ion.
                                                                 <v
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                                                              COM (89) 379 final
                                                      DOCUMENTS
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                                 Catalogue number :CB-CO-89-430-EN-C
                                                             ISBN 92-77-53228-9
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