Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003 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: 2003-09-22
Institutions: Council of the European Union
Subjects: animal breeding, application of EU law, hormone, veterinary drug, veterinary legislation

14.10.2003

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Official Journal of the European Union

L 262/17

DIRECTIVE 2003/74/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 22 September 2003

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

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

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

After consulting the Committee of the Regions,

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

Whereas:

(1)

(2)

(3)

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
therapeutic purposes or
only if
zootechnical treatment,
in accordance with the provi-
sions of Articles 4, 5 and 7 of that Directive.

they are used for

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 adminis-
tered in compliance with the provisions and require-
ments 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.

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 phytosanitary measures (WTO-GATT) (6) as

(4)

(5)

interpreted by the appellate body in the Hormones case,
of the six hormonal substances (oestradiol 17β, testos-
trenbolone acetate, zeranol and
terone, progesterone,
melengestrol acetate) whose administration for animal
growth promotion purposes is prohibited by Directive
96/22/EC.

the Commission initiated and funded a
In parallel,
number of
studies and research
specific
scientific
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 USA, Canada and other third countries,
which authorise the use of
these six hormones 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.

On 30 April 1999, as requested by the Commission, the
Scientific Committee on Veterinary Measures relating to
Public Health (SCVPH) issued an opinion concerning the
assessment of potential adverse effects to human health
in bovine meat and meat
from hormone residues
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 prop-
erties of hormones and the epidemiological findings, a
risk to the consumer has been identified with different
levels of conclusive evidence for the six hormones evalu-
ated. Secondly, for the six hormones endocrine, develop-
mental,
immunotoxic,
genotoxic and carcinogenic effects could be envisaged
and, of the various susceptible risk groups, prepubertal
children constitute the group of greatest concern and,
third, in view of the intrinsic properties of the hormones
and taking into account epidemiological
findings, no
threshold levels and, therefore, no acceptable daily 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,

(1) OJ C 337 E, 28.11.2000 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
(OJ C 90 E, 15.4.2003, p. 1) and Decision of the European Parlia-
ment of 2 July 2003 (not yet published in the Official Journal).
Council Decision of 22 July 2003.

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

(6)

As regards, in particular, the use of oestradiol 17β, with
the aim of promoting growth, the SCVPH 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 do not make
it possible to give a quantitative estimate of the risk.

(7) OJ C 56, 26.2.1999, p. 17.

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Official Journal of the European Union

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(7)

(8)

(9)

(10)

regards

the other

five hormones

(testosterone,
As
progesterone, trenbolone acetate, zeranol and melenges-
trol acetate), the SCVPH 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.

Subsequent to the opinion of the SCVPH of 30 April
1999, new and more recent scientific information on
some of the six hormones under consideration was made
available to the Commission from the United Kingdom's
in October 1999, the
Veterinary Products Committee,
Committee on Veterinary Medicinal Products of
the
European Community (CVM),
in December 1999, and
the Joint FAO/WHO Expert Committee on Food Addi-
tives (JECFA), 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 physiolo-
this latest scientific
response. All
gical
information was brought to the attention of the SCVPH,
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 SCVPH confirmed in its
opinion of 10 April 2002 the validity of its previous
opinion, after revising it in the light of the most recent
scientific data.

(oestrogenic)

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 there-
fore be especially relevant. The avoidance of such intake
is of absolute importance 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 envir-
onment.

Taking into account the results of the risk assessment
and all other available pertinent information, it has to be
concluded that, in order to achieve the chosen level of
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 have been administered for growth
promotion,
it is necessary to maintain the permanent
prohibition laid down in Directive 96/22/EC on oestra-
diol 17β and to continue provisionally to apply the
prohibition to the other five hormones (testosterone,
progesterone, trenbolone acetate, zeranol and melenges-
trol acetate). Furthermore, according to Article 7 of
Regulation (EC) No 178/2002 of the European Parlia-
ment and 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 the Community seeks more complete
scientific information from any source, which could shed
light and clarify the gaps in the present state of knowl-
edge of these substances.

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

(12) However, in the light of the existing information it is
appropriate to limit as far the exposure to oestradiol 17β
and only authorise those treatments for which no viable
effective alternatives exist. In general, there are alterna-
tive treatments or strategies available to replace most of
the uses of oestradiol 17β for therapeutic or zootech-
nical 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. In order to allow for the necessary adjust-
ments and in particular for the authorisation or the
the pharmaceutical products
mutual
needed, it is appropriate to phase out the use of oestra-
diol 17β for oestrus induction over a given period. It is
also appropriate to maintain the possibility of author-
ising, under strict and verifiable conditions so as to
prevent any possible misuse and any unacceptable risk
for public health,
its use for the treatment of certain
conditions (foetus maceration or mummification and
pyometra in cattle) which have serious consequences for
animal health and welfare. It is necessary to review this
possibility within a given time.

recognition of

(13)

The proposed amendments to Directive 96/22/EC are
necessary to achieve the chosen level of health protec-
tion 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 interna-
tional obligations of the Community. Moreover, there is
no other means that is reasonably available at present,
taking into account technical and economic feasibility,
which is significantly less restrictive of 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 replace-
ment 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 (2),

(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 311, 28.11.2001, p. 1.

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Official Journal of the European Union

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HAVE ADOPTED THIS DIRECTIVE:

4. the following Article is added:

Article 1

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

1. Articles 2 and 3 are replaced by the following:

‘Article 2

Member States shall prohibit:

(a) the placing on the market of the substances listed in
list A, for administering to animals of all

Annex II,
species;

(b) the placing on the market of the substances listed in
Annex II, list B, 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, and

— the placing on the market or the 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 point (b);

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

in Article 4, point 1, ‘oestradiol 17β’ are deleted;

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

2.

3.

‘Notwithstanding Article 3(a) and without prejudice to
Article 2, Member States may authorise the administering
to farm animals, for the purpose of 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 European
Parliament and of the Council of 6 November 2001 on the
Community
veterinary medicinal
products (*).

relating

code

to

(*) OJ L 311, 28.11.2001, p. 1.’

‘Article 5a

1.
Notwithstanding Article 3(a) and without prejudice
to Articles 2 and 11a, Member States may authorise the
administering to farm animals of veterinary medicinal
products containing oestradiol 17β or its ester-like deriva-
tives for:

— the treatment of foetus maceration or mummification

in cattle, or

— the treatment of pyometra in cattle,

in accordance with Directive 2001/82/EC.

2.
Notwithstanding Article 3(a) and without prejudice
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
oestrus induction in cattle, horses, sheep or goats until 14
October 2006, in accordance with Directive 2001/82/EC.

3.
The treatment must be carried out by the veteri-
narian himself or herself on farm animals which have been
clearly identified. This treatment must be registered by the
veterinarian responsible. The latter must record at least the
following details in a register, which may be that provided
for in Directive 2001/82/EC:

— the 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) is replaced by the following:

‘1.
Hormonal products and beta-agonists the adminis-
tration of which to farm animals is authorised in accor-
dance with Articles 4, 5 or 5a must meet the requirements
of Directive 2001/82/EC.’

6. Article 7(1),
following:

first

subparagraph,

is

replaced by the

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 life which, during the latter period, have under-
gone 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
in the authorisation to place on the market are
for
complied with.’

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7. Article 8 is amended as follows:

10. the following Article is added:

(a) point 1 is replaced by the following:

‘Article 14a

‘1. at the time of the import, manufacture, storage,
distribution, sale and use of the substances 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.’

(b) in point 2(a), ‘Article 2’ is replaced by ‘Articles 2 and

3’;

(c) in point 2(d),

‘in Articles 4 and 5’ is replaced by ‘in

Articles 4, 5 and 5a’;

(d) footnote 2 is deleted and footnote 3 becomes footnote

2;

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

(a) in point (i), ‘point (a) of Article 2’ is replaced by ‘Annex

II, List A,’;

(b) point (ii) is 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 is added:

‘Article 11a

The Commission shall present within two years from 14
October 2003 to the European Parliament and to the
Council, a report on the availability of alternative veter-
inary medicinal products to those containing oestradiol
17β or its ester-like derivatives for the treatment of foetus
maceration or mummification in cattle, and for the treat-
to them the
ment of pyometra in cattle, and present
following year any necessary proposals
intending to
replace these substances in due time.

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 to the Council of any necessary proposals.’

recent

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 14 October 2004 shall be subject to the same provi-
sions as those laid down for the substances authorised in
accordance with Article 4(1) as regards therapeutic use and
Article 5 as regards zootechnical use.’

11. all references to ‘Directive 81/851/EEC’ and ‘Directive 81/
852/EEC’ are construed as references to ‘Directive 2001/
82/EC’;

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

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 14 October 2004 at the latest. They shall forth-
with inform the Commission thereof.

When Member States adopt these measures, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence 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 publica-
tion in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 22 September 2003.

For the European Parliament

The President

P. COX

For the Council

The President

R. BUTTIGLIONE

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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

ANNEX

‘ANNEX II

ANNEX III

List of provisionally prohibited substances:
substances having oestrogenic (other than oestradiol 17β and its ester-like derivatives), androgenic or gestagenic action.’