Common Position (EC) No 12/2003 of 20 February 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council 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
Date: 2003-02-20
Institutions: Council of the European Union
Subjects: animal breeding, application of EU law, health control, hormone, veterinary drug, veterinary legislation

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 12/2003

adopted by the Council on 20 February 2003

with a view to the adoption Directive 2003/. . ./EC of the European Parliament and of the Council
of . . . 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

(2003/C 90 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) Article 3(a) of Directive 96/22/EC (4) requires Member
States to prohibit the administration to farm animals of
substances having, inter alia, an oestrogenic, androgenic or
gestagenic action. Nevertheless administration of
those
substances to farm animals may be authorised but only
if they are used for therapeutic purposes or zootechnical
treatment, in accordance with the provisions of Articles 4,
5 and 7 of that Directive.

(2) Article 11(2) of Directive 96/22/EC requires Member
States to prohibit the importation from third countries
of farm or aquaculture animals to which substances or
products referred to in Article 3(a) of that Directive have
been administered, unless those products were admin-

(1) OJ C 337 E, 28.11.2000, p. 163 and OJ C 180 E, 26.6.2001,

p. 190.

(2) OJ C 14, 16.1.2001, p. 47.
(3) Opinion of the European Parliament of 1 February 2001 (OJ C 267,
21.9.2001, p. 53), Council Common Position of 20 February 2003
and Decision of the European Parliament of . . . (not yet published
in the Official Journal).
(4) OJ L 125, 23.5.1996, p. 3.

in

compliance with

and
istered
requirements laid down in Articles 4, 5 and 7 thereof as
well as of meat or products obtained from animals the
importation of which is prohibited under Article 3(a)
thereof.

provisions

the

(3)

(4)

In the light of the results of a dispute settlement case
brought before the World Trade Organisation (WTO) by
the United States of America and by Canada (the Hormones
Case) (5) and recommendations made in that respect by the
WTO Dispute Settlement Body on 13 February 1998, the
Commission immediately initiated a complementary risk
assessment,
in accordance with the requirements of the
Agreement on the Application of Sanitary and Phytos-
anitary Measures (WTO-GATT 1994) (6) as interpreted by
the six
the Appellate Body in the Hormones Case, of
hormonal substances (oestradiol 17β, testosterone, proges-
trenbolone acetate, zeranol and melengestrol
terone,
acetate) whose
growth
promotion purposes is prohibited by Directive 96/22/EC.

administration

animal

for

In parallel, the Commission initiated and funded a number
of specific scientific studies and research projects on these
six hormones in order to obtain as much as possible of
the missing scientific information, as identified in the
interpretations and findings of
the WTO panel and
Appellate Body reports in the Hormones Case. Moreover,
the Commission addressed specific requests to the United
third countries,
States of America, Canada and other
which authorise the use of
for
animal growth promotion, and published an open call
for documentation (7)
requesting any interested party,
including the industry,
to provide any relevant and
recent scientific data and information in their possession
to be taken into account
in the complementary risk
assessment.

these six hormones

(5) WT/DS26/R/USA and WT/DS48/R/CAN (panel

reports),

and

AB-1997-4 (Appellate Body report).

(6) OJ L 336, 23.12.1994, p. 40.
(7) OJ C 56, 26.2.1999, p. 17.

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(5) On 30 April 1999, as requested by the Commission, the
Scientific Committee on Veterinary Measures relating to
Public Health (SCVMPH)
issued an opinion concerning
the assessment of potential adverse effects to human
health from hormone residues in bovine meat and meat
products. The major conclusions of that opinion were,
first, that, as concerns excess intake of hormone residues
and their metabolites, and in view of
the intrinsic
properties of hormones and the epidemiological findings,
a risk to the consumer has been identified with different
levels of conclusive evidence
the six hormones
evaluated. Second, for the six hormones endocrine, devel-
opmental,
immunotoxic,
genotoxic and carcinogenic effects could be envisaged
and, of the various susceptible risk groups, prepubertal
children is the group of greatest concern and, third,
in
the hormones and
the intrinsic properties of
view of
taking
no
findings,
account
into
therefore, no Acceptable Daily
threshold levels and,
Intake (ADI) can be established for any of
the six
hormones evaluated when they are administered to
bovine animals for growth promotion purposes.

immunological, neurobiological,

epidemiological

for

(6) As regards, in particular, the use of oestradiol 17β, with
the aim of promoting growth, the SCVMPH assessment is
that a substantial body of recent evidence suggests that it
has to be considered as a complete carcinogen, as it exerts
both tumour initiating and tumour promoting effects and
that the data currently available does not make it possible
to give a quantitative estimate of the risk.

(7) As regards the other five hormones (testosterone, proges-
trenbolone acetate, zeranol and melengestrol
terone,
acetate), the SCVMPH assessment is that, in spite of the
individual toxicological and epidemiological data available,
which were taken into account,
the current state of
knowledge does not make it possible to give a quantitative
estimate of the risk to consumers.

(8) Subsequent to the opinion of the SCVMPH of 30 April
1999, new and more recent scientific information under
consideration on some of the six hormones was made
available to the Commission from the United Kingdom's
the
Veterinary Products Committee,
in October 1999,
Committee on Veterinary Medicinal Products of
the
European Community (CVM),
in December 1999, and
FAO/WHO Expert Committee on Food
Joint
the
Additives
in February 2000. The CVM has
noted in particular that oestradiol 17β has a carcinogenic
effect only after prolonged exposure and at levels which
are considerably higher than those needed for a physio-
this latest scientific
response. All
logical

(oestrogenic)

(JECFA),

to the

attention of

the
information was brought
SCVMPH, which reviewed it and, on 3 May 2000,
concluded that it did not provide convincing data and
arguments requiring revision of the conclusions drawn
in its opinion of 30 April 1999. The SCVMPH
confirmed in its opinion of 10 April 2002 its previous
opinion's validity, after revising it in the light of the most
recent scientific data.

(9) As regards, in particular, oestradiol 17β, this substance can
potentially be used in all farm animals and residue intake
for all segments of the human population and in particular
the susceptible groups at high risk can therefore be
especially relevant. Avoiding such intake is important to
safeguard human health. Furthermore, the routine use of
the above substances
for animal growth promotion
purposes is likely to lead to increased concentration of
those substances in the environment.

it

(10) Taking into account the results of the risk assessment and
it has to be
information,
all other available pertinent
in order to achieve the chosen level of
concluded that,
protection in the Community from the risks posed,
in
particular to human health, by the routine use of these
hormones for growth promotion and the consumption of
residues found in meat derived from animals to which
these hormones had been administered for growth
promotion,
is necessary to maintain the permanent
prohibition laid down in Directive 96/22/EC on oestradiol
17β and to continue provisionally to apply the prohibition
to the other five hormones (testosterone, progesterone,
trenbolone acetate, zeranol and melengestrol acetate).
Furthermore, according to Article 7 of Regulation (EC)
No 178/2002 of
the
Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority
and laying down
procedures in matters of food safety (1), the provisional
prohibition of these five hormones should apply while
in-
the Community seeks more
formation from any source, which could shed light and
clarify the gaps in the present state of knowledge of these
substances.

the European Parliament and of

complete

scientific

(11) However,

is necessary,

the use of certain of

the above substances,
where this
therapeutic purposes or
for
zootechnical treatment may continue to be authorised as
it is not likely to constitute a hazard for public health due
to the nature and the limited duration of the treatments,
strict
the
conditions laid down in Directive 96/22/EC in order to
prevent any possible misuse.

administered

quantities

limited

and

the

(1) OJ L 31, 1.2.2002, p. 1.

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(12) However,

in the light of the existing information it is
appropriate to limit as far as reasonably achievable the
exposure to oestradiol 17β and only authorise those
treatments for which no viable effective alternatives exist
and which are not likely to present an unacceptable risk to
public health. In general, there are alternative treatments
or strategies available to replace most of
the uses of
oestradiol 17β for therapeutic or zootechnical purposes.
Nonetheless, studies appear to show that at present no
viable effective alternatives exist in all the Member States
for certain treatments which are currently authorised
(foetus maceration or mummification, pyometra in cattle
and oestrus induction in cattle, horses, sheep or goats).
The use of oestradiol 17β for such treatments does not
seem to pose an unacceptable risk if appropriate measures
are taken to avoid any abusive use. It therefore appears
necessary to maintain the possibility of authorising the
treatments mentioned above under strict and verifiable
conditions so as to prevent any possible misuse and any
unacceptable risk for public health.
is necessary to
review within a given time the provisions concerning
treatments of farm animals with oestradiol 17β.

It

(13) The proposed amendments to Directive 96/22/EC are
necessary to achieve the chosen level of health protection
from the residues in meat of farm animals treated with
these hormones for growth promotion purposes, whilst
respecting the general principles of food law set out in
Regulation (EC) No 178/2002 and the international obli-
gations of the Community. Moreover, there is no other
means that is reasonably available at present, taking into
technical and economic feasibility, which is
account
significantly less restrictive on trade and can achieve
equally effectively the chosen level of health protection.
In addition, minor drafting amendments are equally
necessary in particular in view of the replacement of a
the
number of Directives by Directive 2001/82/EC of
European Parliament and of the Council of 6 November
2001 on the Community code relating to veterinary
medicinal products (1),

(b) the placing on the market of the substances listed in
Annex II, List B of this Directive for administering to
animals, the flesh and products of which are intended
for human consumption, for purposes other than those
provided for in point 2 of Article 4 and in Article 5a.

Article 3

Member States shall prohibit,
for substances listed in
Annex II, and shall provisionally prohibit, for substances
listed in Annex III:

(a) the administering of those substances to farm or aqua-

culture animals, by any means whatsoever;

(b) the holding, except under official control, of animals
referred to in point (a) on a farm, the placing on the
market or slaughter for human consumption of farm
animals which contain the substances referred to in
Annex II and Annex III or in which the presence of
such substances has been established, unless proof can
be given that the animals in question have been treated
in accordance with Articles 4, 5 or 5a;

(c) the placing on the market for human consumption of
aquaculture animals to which substances referred to
above have been administered and of processed
products derived from such animals;

(d) the placing on the market of meat

from animals

referred to in (b);

(e) the processing of the meat referred to in (d).’;

HAS ADOPTED THIS DIRECTIVE:

2.

in Article 4, point 1, the words ‘oestradiol 17β’ shall be
deleted;

Article 1

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

3.

in Article 5, first paragraph, the first sentence shall be
replaced by the following:

1. Articles 2 and 3 shall be replaced by the following:

‘Article 2

Member States shall prohibit:

(a) the placing on the market of the substances listed in
Annex II, List A for administering to animals of all
species;

(1) OJ L 311, 28.11.2001, p. 1.

for

the purpose of

‘Notwithstanding Article 3(a) and without prejudice to
Article 2, Member States may authorise the administering
to farm animals,
zootechnical
treatment, of veterinary medicinal products having an
oestrogenic (other than oestradiol 17β and its ester-like
derivatives), androgenic or gestagenic action which are
authorised in accordance with Directive 2001/82/EC of
the
the Council of
6 November 2001 on the Community code relating to
veterinary medicinal products (*).

European Parliament

and of

___________
(*) OJ L 311, 28.11.2001, p. 1.’;

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4. the following Article shall be added:

‘Article 5a

Notwithstanding Article 3(a) and without prejudice
1.
to Article 2, Member States may authorise the adminis-
tering to farm animals of veterinary medicinal products
containing oestradiol 17β or its ester-like derivatives for:

— the treatment of foetus maceration or mummification

in cattle,

— the treatment of pyometra in cattle, or

for in the authorisation to place on the market are
complied with.’;

7. Article 8 shall be amended as follows:

(a) point 1 shall be replaced by the following:

sale

‘1. at the time of the import, manufacture, storage,
substances
and use of
distribution,
referred to in Articles 2 and 3, their possession
is restricted to the persons authorised by national
legislation in accordance with Article 68 of
Directive 2001/82/EC.’;

the

— oestrus induction in cattle, horses, sheep or goats,

(b) in point 2(a), the words ‘Article 2’ shall be replaced by

‘Articles 2 and 3’;

in accordance with Directive 2001/82/EC.

The treatment must be carried out by the veterinarian
himself on farm animals which have been clearly
identified. This treatment must be registered by the veter-
inarian responsible. The latter must record at least the
following details
in a register, which may be that
provided for in Directive 2001/82/EC:

— type of product administered,

— the nature of the treatment,

— the date of treatment,

— the identity of the animals treated,

— the date of expiry of the withdrawal period.

The register must be made available to the competent
authority at its request.

Stockfarmers shall be prohibited from holding on their
farms veterinary medicinal products containing oestradiol
17β or its ester-like derivatives.’;

5. Article 6(1) shall be replaced by the following:

Hormonal products and beta-agonists the adminis-
is authorised in
the

‘1.
tration of which to farm animals
accordance with Articles 4, 5 or 5a must meet
requirements of Directive 2001/82/EC.’;

6. Article 7(1), first subparagraph, shall be replaced by the

following:

For

the purpose of

trade, Member States may
‘1.
authorise the placing on the market of animals
for
breeding and breeding animals at the end of their repro-
ductive
latter period, have
undergone a treatment referred to in Articles 4, 5 or 5a
and may authorise the affixing of the Community stamp to
meat from such animals where the conditions laid down in
Articles 4, 5 or 5a and the withdrawal periods provided

life which, during

the

(c)

in point 2(d), the words ‘in Articles 4 and 5’ shall be
replaced by ‘in Articles 4, 5 and 5a’;

(d) footnote 2 shall be deleted and footnote 3 shall

become footnote 2;

8. Article 11(2)(a) shall be amended as follows:

(a)

in point (i), the words ‘Article 2(a)’ shall be replaced by
‘Annex II, List A’;

(b) point (ii) shall be replaced by the following:

‘(ii)

to which substances referred to in Annex II, List B
and Annex III have been administered, unless
those substances were administered in compliance
with the provisions and requirements laid down in
Articles 4, 5, 5a and 7 and the withdrawal periods
allowed in international recommendations have
been observed;’;

9. the following Article shall be added:

‘Article 11a

The Commission shall present within two years from (*) to
the European Parliament and the Council a report on the
availability of alternative veterinary medicinal products to
those containing oestradiol 17β or its ester-like derivatives
to them the following year any necessary
and present
proposals
these
substances.

to replace

intending

in due

time

recent

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

___________
(*) Date of entry into force of this Directive.’;

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10. the following Article shall be added:

‘Article 14a

Notwithstanding Articles 3 and 5a, and without prejudice
to Article 2, farm animals for which it can be certified that
they have been administered oestradiol 17β or its ester-like
derivatives for therapeutic or zootechnical purposes prior
to . . . 2002 (*) shall be subject to the same provisions as
authorised in
those
accordance with Article 4(1) as regards therapeutic use
and Article 5 as regards zootechnical use.

laid down for

substances

the

___________
(*) Date referred to in the first subparagraph of Article

2(1).’;

11. all

references to ‘Directive 81/851/EEC’ and ‘Directive
81/852/EEC’ shall be construed as references to ‘Directive
2001/82/EC’;

12. the Annex to Directive 96/22/EC shall become ‘Annex I’,
and Annexes II and III in the Annex to this Directive shall
be added.

Directive by . . . (*) at the latest. They shall forthwith inform the
Commission thereof.

When Member States adopt these measures, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

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 3

This Directive shall enter into force on the day of its publi-
cation in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Article 2

Done at . . .

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this

For the European Parliament

The President

For the Council

The President

(*) 12 months after the date of entry into force of this Directive.

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ANNEX

‘ANNEX II

List of prohibited substances:

List A:

— thyrostatic substances,

— stilbenes, stilbene derivatives, their salts and esters;

List B:

— oestradiol 17β and its ester-like derivatives,

— beta-agonists.

List of provisionally prohibited substances:

ANNEX III

Substances having oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or gestagenic action.’

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

On 3 July 2000 the Commission submitted its original proposal (1), which it subsequently amended on
6 March 2001 (2).

The European Parliament delivered its opinion on that proposal at first reading on 1 February 2001 (3).

The Economic and Social Committee delivered an opinion on 19 October 2000 (4).

The Committee of the Regions decided not to deliver an opinion.

After examining the opinions delivered, the Council adopted a Common Position on 20 February 2003.

II. OBJECTIVE OF THE PROPOSAL

The aim of the proposed directive is to ensure that the Community rules concerning the use of
hormones in stockfarming are in accordance with the general principles of food law set out in
regulation (EC) No 178/2002. In particular it aims at ensuring that the high level of health protection
mandated by article 152(1) of the Treaty is attained, in conformity with the international obligations of
the Community, through measures based on a comprehensive assessment of the available scientific
evidence, or, as far as the available evidence on the extent of the harmful effects of certain substances is
incomplete, on the precautionary principle.

In order to reach this aim the proposed directive updates Directive 96/22/EC in the light of extensive
risk assessments of the available scientific information performed by the Scientific Committee on
Veterinary Measures relating to Public Health (SCVMPH) and other pertinent
information from
relevant sources.

III. ANALYSIS OF THE COMMON POSITION

There is no difference of opinion between the Council, the European Parliament and the Commission
regarding the essential elements of the proposed directive and in particular on the need for maintaining
a prohibition on the use of oestradiol 17β and its ester-like derivatives for growth promotion purposes
and to introduce a temporary precautionary prohibition on the use of other hormones while additional
scientific information, necessary for a fuller assessment of the risk, is gathered.

In deciding such measures the Council has taken into account the latest scientific evidence and risk
assessments, in particular the opinion of the SCVMPH of April 2002, together with other possible
consequences, in particular environmental, of the large scale use of hormones in stockfarming. The
recitals of the proposed directive have been modified accordingly.

Contrary to the Commission's proposal, but in accordance with amendments 4, 5, 6, 7, 9, 12, 13 and
14, which have been followed in substance even if using a different drafting, the Council considered
preferable to let Parliament and the Council take future risk management decisions concerning the
updates of the directive's provisions in the light of the new evidence which the Commission is required
to gather taking into account recent scientific data from all possible sources and present to them.

(1) OJ C 337 E, 28.11.2000, p. 163.
(2) OJ C 180 E, 26.6.2001, p. 190.
(3) OJ C 267, 21.9.2001, p. 53.
(4) OJ C 14, 16.1.2001, p. 47.

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The Council, in agreement with the Commission and Parliament, has decided to maintain the use of
certain of the substances, where this is strictly necessary, for therapeutic purposes or zootechnical
treatment as this is not likely to constitute an unacceptable hazard for public health due to the nature
and the limited duration of the treatments, the limited quantities administered and the strict conditions
under which their administration can take place, laid down in Directive 96/22/EC in order to prevent
any possible misuse. The Council has, however, considered appropriate, in the light of the existing
information to limit as far as reasonably achievable the exposure to oestradiol 17β and only authorise
those very few treatments (foetus maceration or mummification, pyometra in cattle and oestrus
induction in cattle, horses, sheep or goats)
for which no viable and effective alternatives seem
presently to be available. Such treatments are not likely to present an unacceptable risk to public
health, especially in the light of the new very stringent conditions required to be taken to avoid any
possible abusive use. The Council has equally provided for a timely review of the provisions concerning
treatments of farm animals with oestradiol 17β.

The Council incorporated amendments 8 and 10 which present useful clarifications but did not incor-
porate amendments 1, 2, 3, 10 et 11 the content of which is already largely reflected in the proposed
directive which the Council, like the Commission, considered would have been made redundant by
those additions.

For the sake of clarity the Council added some minor drafting improvements to Directive 96/22/EC, in
particular in view of the replacement of a number of Directives by Directive 2001/82/EC of the
European Parliament and of the Council of 6 November 2001 on the Community code relating to
veterinary medicinal products (1).

IV. CONCLUSIONS

The Council feels that the fact that it has to a very large extent taken account of the European
Parliament's position ought to lead to an early adoption of the Directive.

(1) OJ L 311, 28.11.2001, p. 1.