Directive 2008/97/EC of the European Parliament and of the Council of 19 November 2008 amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (Text with EEA relevance)
Date: 2008-11-19
Institutions: Council of the European Union, European Parliament
Subjects: animal welfare, domestic animal, hormone, livestock farming, market approval, therapeutics, veterinary drug

28.11.2008

EN

Official Journal of the European Union

L 318/9

DIRECTIVES

DIRECTIVE 2008/97/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 19 November 2008

amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of
certain substances having a hormonal or thyrostatic action and of beta-agonists

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty
Community, and in particular Article 152(4)(b) thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

(1)

(2)

(3)

Article 2 of Directive 96/22/EC (3) prohibits, inter alia, the
placing on the market of stilbenes, stilbene derivatives,
their salts and esters and thyrostatic substances for
administering to animals of all species.

that absolute prohibition was

that
The reason for
if
potential abuse or misuse would be more difficult
there were no product authorised for any animal
species whatsoever on the market.

However, experience gained in particular with national
residue
under Council Directive
96/23/EC of 29 April 1996 on measures to monitor
certain substances and residues thereof in live animals

submitted

plans

(1) OJ C 10, 15.1.2008, p. 57.
(2) Opinion of

published in the Official
20 October 2008.

the European Parliament of 5 June 2008 (not yet
and Council Decision of

Journal)

(4)

(5)

(6)

(7)

and animal products (4) has shown that the misuse of
product presentations intended for pet animals does
not play a role as a source of abuse or misuse. That is
is economically unattractive to use
partly because it
presentations
for growth
promotion in food-producing animals.

intended for pet animals

Moreover, the prohibition of thyrostatic substances has
harmful consequences for the welfare of pet animals
(dogs and cats) due to the lack of an alternative
treatment for hyperthyroidism in those animals.

The Protocol on protection and welfare of animals
annexed to the Treaty provides that
the Community
and the Member States are to pay full regard to the
welfare requirements of animals in the implementation
of Community policies, in particular with regard to the
internal market.

It is therefore appropriate to limit the scope of Directive
96/22/EC only to food-producing animals and withdraw
the prohibition for pet animals, as well as to adjust the
definition of therapeutic treatment.

The Opinion of the Scientific Committee on Veterinary
Measures relating to Public Health (SCVPH) of 30 April
1999 on the potential risks to human health from
hormone residues in bovine meat and meat products
(which was reviewed on 3 May 2000 and confirmed
on 10 April 2002) concluded that there is a substantial
body of recent evidence suggesting that oestradiol 17ß
has to be considered as a complete carcinogen, as it
exerts both tumour-initiating and tumour-promoting
effects, and that
the data currently available do not
make it possible to give a quantitative estimate of the
risk to human health. As a result, Directive 96/22/EC was
inter alia,
amended by Directive 2003/74/EC so as to,
prohibit permanently the use of oestradiol 17β as a
growth promoter and reduce substantively all other
circumstances in which it can be administered to all
farm animals for therapeutic or zootechnical purposes
pending further examination of the factual and scientific
situation and the veterinary practices in the Member
States.

(3) OJ L 125, 23.5.1996, p. 3.

(4) OJ L 125, 23.5.1996, p. 10.

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EN

Official Journal of the European Union

28.11.2008

(8)

(9)

European

availability of

food-producing animals for

of Directive 96/22/EC required

the
Article 11a
Commission to present a report by 14 October 2005
concerning the
alternative veterinary
medicinal products to those containing oestradiol 17β
therapeutic purposes.
for
The Commission sought expert advice and established
the relevant scientific report, which was forwarded to
the
on
11 October 2005. That Report concludes that oestradiol
17β is not essential in the production of food-producing
animals because the use of
the available alternatives
(especially prostaglandins) by practising veterinarians is
already quite common in the Member States and that
the complete prohibition of the use of oestradiol 17β
for food-producing animals would have no, or only a
negligible, impact on farming and animal welfare.

Parliament

Council

and

the

Proper compliance with the relevant legislation and the
elimination of
unauthorised
substances can be enhanced by means of objective infor­
mation and awareness campaigns.

inappropriate

use

of

(10) A temporary exemption was provided for the use of
oestradiol 17β for oestrus induction in cattle, horses,
sheep or goats until 14 October 2006. Since effective
alternative products exist and are already used, and in
order
to ensure the high level of health protection
chosen in the Community, that exemption should not
be renewed.

(11) Directive 96/22/EC should

therefore be

amended

accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/22/EC is hereby amended as follows:

2. Article 2 shall be replaced by the following:

‘Article 2

Member States shall prohibit the placing on the market of
the substances listed in Annex II for administering to any
animals, the meat and products of which are intended for
human consumption,
than those
provided for in point 2 of Article 4.’.

for purposes other

3. In Article 4, point 2(i) shall be replaced by the following:

‘(i) allyl trenbolone, administered orally, or beta-agonists to
equidae, provided they are used in accordance with the
manufacturer’s instructions;’.

4. Article 5a shall be deleted.

5. In Articles 3, 6, 7, 8, 11 and 14 a,

the references to

Article 5a shall be deleted.

6. In Article 11, paragraph 1 shall be replaced by the following:

legislation authorises

Third countries whose

‘1.
the
placing on the market and administration of
stilbenes,
stilbene derivatives, their salts and esters, or of thyrostatic
substances for administering to all species of animals the
meat and products of which are intended for human
consumption may not appear on any of
the lists of
countries provided for under Community legislation from
which Member States are authorised to import farm or aqua­
culture animals or meat or products obtained from such
animals.’.

7. Article 11a shall be replaced by the following:

‘Article 11a

With regard to the substances listed in Annex III,
the
information, taking into
Commission shall seek additional
account recent scientific data from all possible sources, and
keep the measures applied under regular review with a view
to the timely presentation to the European Parliament and to
the Council of any necessary proposals.’.

1. In Article 1(2), point (b) shall be replaced by the following:

8. The following Article shall be inserted:

‘Article 11b

‘(b) “therapeutic treatment” shall mean the administering —
under Article 4 of this Directive — to an individual farm
animal of an authorised substance to treat, after exam­
ination by a veterinarian, a fertility problem — including
the termination of unwanted gestation — and,
in the
case of beta-agonists, to induce tocolysis in cows when
calving as well as to treat respiratory problems, navicular
disease and laminitis and to induce tocolysis in equidae;’.

The Commission, in collaboration with the Member States,
shall set up an information and awareness campaign on the
complete ban on the use of oestradiol 17β in food-
producing animals, aimed at farmers and veterinary organis­
ations in the EU as well as the relevant organisations outside
the EU which are directly or indirectly involved in the export
to the EU of food of animal origin falling within the scope
of this Directive.’.

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9. Annex II shall be replaced by the text appearing in the

Annex to this Directive.

2. Member States shall communicate to the Commission the
text of the provisions of national law which they adopt in the
field covered by this Directive.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 January 2009. They shall forthwith communicate
to the Commission the text of such laws, regulations and
administrative provisions together with a table showing the
correlation between them and this Directive.

Article 3

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Strasbourg, 19 November 2008.

When they are adopted by Member States, these measures 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 reference shall be laid down by
Member States.

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President

J.-P. JOUYET

ANNEX

‘ANNEX II

List of prohibited substances:

List A: prohibited substances

— Thyrostatic substances,

— Stilbenes, stilbene derivatives, their salts and esters,

— Oestradiol 17β and its ester-like derivatives.

List B: prohibited substances with derogations

— Beta-agonists’