Proposal for 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: 2000-05-24
Institutions: European Commission
Subjects: animal breeding, application of EU law, hormone, veterinary drug, veterinary legislation

28.11.2000

EN

Official Journal of the European Communities

C 337 E/163

Proposal for 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

(2000/C 337 E/25)

(Text with EEA relevance)

COM(2000) 320 final (cid:14) 2000/0132(COD)

(Submitted by the Commission on 3 July 2000)

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,

Having regard to the opinion of
Committee,

the Economic and Social

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,

Whereas:

(1) Point (a) of Article 3 of Council Directive 96/22/EC (1)
requires Member States to prohibit the administration to
an
farm animals of
oestrogenic, androgenic or gestagenic action. Adminis-
tration of those substances to farm animals may only be
authorised for
therapeutic purposes or zootechnical
treatment, in accordance with the provisions of Articles
4, 5 and 7 of the Directive.

substances having,

inter

alia,

(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 point (a) of Article 3 have been
administered, unless those products were administered in
compliance with the provisions and requirements laid
down in Articles 4, 5 and 7 of the Directive, as well as
of meat or products obtained from animals
the
importation of which is prohibited under point (a) of
Article 3 thereof.

(3) 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) (2) and the recommendations made in
that respect by the WTO Dispute Settlement Body on

and

Sanitary

Phytosanitary Measures

13 February 1998, the Commission immediately initiated
a complementary risk assessment, in accordance with the
requirements of the WTO Agreement on the Application
of
(SPS
Agreement) (3), as interpreted by the Appellate Body in
the six hormonal substances
the Hormones case, of
(oestradiol 17(cid:1),
trenbolone
acetate, zeranol and melengestrol acetate) whose adminis-
tration for
is
animal
prohibited by Directive 96/22/EC.

growth promotion purposes

testosterone, progesterone,

Body

reports

(4) 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
the WTO panel and
interpretations and findings of
Appellate
case.
the Hormones
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 docu-
mentation (4) 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.

in

(5) 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 (5). The major conclusions of
that opinion
were, first, that, as concerns excess intake of hormone
the
residues and their metabolites, and in view of
intrinsic properties of hormones and the epidemiological
findings, a risk to the consumer has been identified with
different
six
conclusive
levels of
the six hormones
hormones evaluated. Second,
neurobi-
endocrine,
ological,
carcinogenic
effects could be envisaged and, of the various susceptible
risk groups, prepubertal children is 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.

evidence
for

immunological,

developmental,

immunotoxic,

genotoxic

and

the

for

(1) OJ L 125, 23.5.1996, p. 3.
(2) WT/DS26/R/USA and WT/DS48/R/CAN (panel

AB-1997-4 (Appellate Body report).

reports),

and

(3) OJ L 336, 23.12.1994, p. 40.
(4) OJ C 56, 26.2.1999, p. 17.
(5) Commission Document XXIV/B3/SC4 of 30 April 1999.

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Official Journal of the European Communities

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(6) As regards,

the SCVPH
in particular, oestradiol 17(cid:1),
assessment is that a substantial body of recent evidence
it has to be considered as a complete
suggests that
initiating and
carcinogen, as
the data currently
tumour promoting effects and that
available does not make it possible to give a quantitative
estimate of the risk.

it exerts both tumour

(7) As regards the other five hormones (testosterone, proges-
trenbolone acetate, zeranol and melengestrol
terone,
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.

(8) Subsequent to the opinion of the SCVPH of 30 April
1999, new and more recent scientific information was
made available to the Commission from the United
Kingdom’s Veterinary Products Committee,
in October
1999, the Committee on Veterinary Medicinal Products
of the EC, in December 1999, and the Joint FAO/WHO
Expert Committee on Food Additives (JECFA), in February
2000, for some of the six hormones under consideration).
All this latest scientific 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
the conclusions
requiring revision of
drawn in its opinion of 30 April 1999.

(9) As regards,

in particular, oestradiol 17(cid:1), 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
residues
to safeguard human health. Moreover,
resulting from its use cannot be detected at present
through the routine analytical methods available.

the

(10)

residues

in order

In accordance with the provisions of Articles 5.1 and 5.7
of the SPS Agreement, taking into account the results of
the risk assessment and all other available pertinent
information,
to
it must be concluded that,
achieve the chosen level of health protection in the
Community from the risks posed to human health by
the consumption of
found in meat derived
from animals to which these hormones had been admin-
istered for growth promotion purposes, it is necessary to
maintain the permanent prohibition laid down in
Directive 96/22/EC on oestradiol 17(cid:1) and to continue
provisionally to apply the prohibition on the other five
hormones (testosterone, progesterone, trenbolone acetate,
acetate). The provisional
zeranol
prohibition of these five hormones should apply while
the
scientific
information from any source, which could shed light
and clarify the gaps in the present state of knowledge
in accordance with Article 5.7 of
on these substances,
the SPS Agreement.

and melengestrol

seeks more

Community

complete

(11) The use of certain of the above substances for therapeutic
treatment may, however,

purposes or

zootechnical

continue to be authorised under the strict conditions
laid down in Directive 96/22/EC in order to prevent
any misuse,
regards oestradiol 17(cid:1) and its
ester-like derivatives whose administration may only be
non-farm
authorised
animals, in view of the results of the risk assessment.

therapeutic

treatment

save as

for

to

(12)

In general, there are alternative treatments or strategies
available to replace the use of oestradiol 17(cid:1) for thera-
the real need for
peutic or zootechnical purposes;
oestradiol 17(cid:1) for
specific limited
conditions in individual animals will be identified by the
Commission in association with competent authorities,
alternative
with a view to developing appropriate
solutions before the entry into force of this Directive.

the treatment of

(13)

In order to ensure effective implementation of Directive
96/22/EC, provision should be made for the adaptation of
its Annexes and the substances contained therein, as
appropriate.

(14) The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
the exercise of
conferred on the Commission (1).

for

(15) There is no other means that is reasonably available to the
Community, taking into account technical and economic
feasibility, to achieve the chosen level of health protection
from the residues of these hormones in meat, and which
is significantly less restrictive to international trade, and
Directive 96/22/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/22/EC is amended as follows:

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

DArticle 2

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

for purposes other

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 a farm or aqua-

culture animal, by any means whatsoever;

(1) OJ L 184, 17.7.1999, p. 23.

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(b) the holding, except under official control, of animals
referred to in (a) on a farm, the placing on the market
or slaughter for human consumption of farm animals or
of aquaculture 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 or 5;

(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 of

the animals

referred to in (b);

(b) In point 2(a), the words Dunder Article 2E are replaced by

Dunder Articles 2 and 3E.

6. Article 11 is amended as follows:

(a) In paragraph 2(a)(i), the words Dpoint (a) of Article 2E are

replaced by DAnnex II, List AE.

(b) In paragraph 2(a)(ii), the words Dpoint (a) of Article 3E

are replaced by DAnnex II, List B and Annex IIIE.

(c) In paragraph 3, the words Daccording to the procedure
laid down in Article 33 of Council Directive 96/23/ECE
are replaced by Daccording to the procedure referred to
in Article 11b(2)E.

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

7. The following Articles 11a and 11b are added:

2. Article 4 is amended as follows:

DArticle 11a

(a) In point 1, the words Doestradiol 17(cid:1)E are deleted.

(b) The following paragraph is added:

DMember States shall prohibit oestradiol 17(cid:1) and its
ester-like derivatives for use in growth promotion, for
therapeutic purposes and zootechnical treatment except
for therapeutic treatment under veterinary supervision
of non-farm animals.E

3. In Article 5, the first sentence of the first paragraph is

replaced by the following:

DNotwithstanding 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 17(cid:1) and its ester-like derivatives),
androgenic or gestagenic action which are authorised in
accordance with Directives 81/851/EEC and 81/852/EEC.E

Provisions in the Annexes may be amended and/or
1.
deleted in accordance with the procedure referred to in
Article 11b(2).

2. With regard to the substances listed in Annex III, the
Community will seek additional information and keep the
measures under regular review.

Article 11b

1.
The Commission shall be assisted by the Standing
Veterinary Committee instituted by Article 1 of Council
Decision 68/361/EEC (*)
referred to as Gthe
CommitteeH).

(hereinafter

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision
1999/468/EC shall be set at three months.

4. In Article 7, paragraph 2 is replaced by the following:

___________
(*) OJ L 255, 18.10.1968, p. 23.E

DMeat or products from animals to which substances having
an oestrogenic (other than oestradiol 17(cid:1) and its ester-like
derivatives), androgenic or gestagenic action or beta-agonists
have been administered in accordance with the dispensatory
provisions of
this Directive may not be placed on the
market
for human consumption unless the animals in
question have been treated with veterinary medicinal
products complying with the requirements of Article 6
and in so far as the withdrawal period laid down was
observed before the animals were slaughtered.E

5. Article 8 is amended as follows:

8. The following Article 14a is added:

DArticle 14a

The provisions laid down in this Directive with regard to
oestradiol 17(cid:1) shall not apply to farm animals for which it
can be certified that, where oestradiol 17(cid:1) has been admin-
istered to them for therapeutical purposes or zootechnical
treatment, this administration has taken place before 1 July
2001.E

(a) In point 1, the words DArticles 2 and 3(a)E are replaced by

DArticles 2 and 3E.

9. The Annex to Directive 96/22/EC becomes DAnnex IE and
Annexes II and III in the Annex to this Directive are added.

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Article 2

Article 3

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 1 July 2001 at the latest. They shall forthwith
inform the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
their official publication.
reference on the occasion of
Member States shall determine how such reference is to be
made.

This Directive shall enter into force on the third day following
that of its publication in the Official Journal of
the European
Communities.

Article 4

This Directive is addressed to the Member States.

ANNEX

%ANNEX II

List of prohibited substances:

List A:

J Thyrostatics,

J Oestradiol 17(cid:1) and its ester-like derivatives,

J Stilbenes, stilbene derivatives, their salts and esters.

List B:

J Beta-agonists

List of provisionally prohibited substances:

Substances having oestrogenic (other than oestradiol 17(cid:1) and its ester-like derivatives), androgenic or gestagenic action.E

ANNEX III