Proposal for a Council Decision concerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Council Decision 90/128/EEC
Date: 1999-10-26
Institutions: European Commission
Subjects: cattle, marketing, protection of animals, veterinary drug

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EN

Official Journal of the European Communities

25.1.2000

Proposal for a Council Decision concerning the placing on the market and administration of
bovine somatotrophin (BST) and repealing Council Decision 90/218/EEC

(2000/C 21 E/15)

(Text with EEA relevance)

COM(1999) 544 final (cid:151) 1999/0219(CNS)

(Submitted by the Commission on 27 October 1999)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of
Committee,

the Economic and Social

Whereas:

(1) Council Decision 90/218/EEC (1) concerning the placing on
the market and administration of bovine somatotrophin
(BST), as last amended by Council Decision 94/936/EC (2),
provides in article 1 that Member States shall ensure that,
until 31 December 1999, the placing on the market of
bovine somatotrophin for the purposes of its marketing
and the administration thereof on their territory to dairy
cows by any means whatsoever will not be authorised;

scientists,

(2) by virtue of Article 2( 2) of this Decision, the Council
instructed the Commission to entrust a Working Party of
independent
in collaboration with Member
States, with the task of assessing the effects of using BST,
taking account of
the Committee for
the opinion of
Veterinary Medicinal Products, in particular as regards the
impact of
this product on the incidence of
mastitis;

the use of

(3) Article 2(1) of this Decision allowed the Member States to
carry out limited practical tests on the use of bovine soma-
totrophin, under the control of an official veterinarian, in
order to obtain any other scientific data that may be taken
into account by the Council when it takes a final decision.
The Commission has not received any information on such
tests and in view of
the prohibition laid down in this
Decision there is no need to continue authorising further
such tests;

(4) the Protocol on protection and welfare of animals annexed
to the Treaty of the European Community calls on the
Community and the Member States, when formulating
and implementing the Community’s agricultural policy, to
pay full regard to the health and welfare requirements of
animals;

(5) by Decision 78/923/EEC (3), the Community has approved
the European Convention for the Protection of Animals
Kept for Farming Purposes (hereinafter called (cid:145)the Conven-
tion(cid:146)) and has deposited its instrument of approval. All
Member States have also ratified this Convention;

(6) Council Directive 98/58/EC (4) concerning the protection
of animals kept for farming purposes states in Annex point
18 that no other substance, with exception of those given
for therapeutic or prophylactic purposes, shall be admin-
istered to an animal unless it has been demonstrated by
scientific
established
experience that the effect of the substance is not detri-
mental to the health or welfare of the animal;

animal welfare

studies

or

of

(7) the Scientific Committee on Animal Health and Animal
Welfare (SCAWAH) adopted on 10 March 1999 its report
the Use of Bovine
on Animal Welfare Aspects of
Somatotrophin and stated that BST increases the risk of
clinical mastitis as well as the duration of treatment of
mastitis, that it increases the incidence of
foot and leg
disorders and that it can affect adversely reproduction as
well as induce severe reactions at the injection site;

(8) it is important for the health and productivity of dairy
cattle that they are subjected to minimum stress which
foot
may lead to increase in diseases such as mastitis,
lesions and reactions to injection site. It results from the
opinion of the SCAWAH that the use of BST has been
shown to lead to increases in these conditions, which are
both painful and debilitating, and which can lead inter alia
to loss of productivity, premature culling and death, as well
as
their
inherently infectious nature, these conditions may spread
to other cattle and cause a deterioration in the overall
health of the herd. Therefore it results from the opinion
of the SCAHAW that BST should not be used in dairy
cows.

to poorer welfare. Furthermore, because of

(9) BST is not made to be used in cattle for therapeutic

purposes, but only to enhance milk production;

HAS ADOPTED THIS DECISION:

Article 1

As of the entry into force of this Decision, Member States shall
ensure that the placing on the market of bovine somatotrophin
on their territory or within their jurisdiction for the purpose of
its marketing and administration thereof to dairy cows by any
means whatsoever shall be prohibited.

(1) OJ L 116, 8.5.1990, p. 27.
(2) OJ L 366, 31.12.1994 p. 19.

(3) OJ L 323, 17.11.1978, p. 12.
(4) OJ L 221, 8.8.1998, p. 23.

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Official Journal of the European Communities

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Article 2

Article 4

Undertakings buying or producing bovine somatotrophin
substances and undertakings authorised in any capacity to
market such substances shall be required to keep registers
in chronological order, quantities produced or
detailing,
acquired and those sold or used and the names of
the
persons to whom such quantities were sold or from whom
they were purchased. The above information must be made
available to the competent authority at its request and, in the
case of computerised records, in the form of a printout.

Article 3

Decision 90/218/EEC is repealed as of the entry into force of
this Decision.

Article 5

This Decision shall enter into force on 1 January 2000.

This Decision shall not affect
somatotrophin in the Member States, or imports,
purposes of its export to third countries.

the production of bovine
for the

Article 6

This Decision is addressed to the Member States.