Amended 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 (COM(2001) 131 final — 2000/0132(COD)) (Text with EEA relevance)
Date: 2001-03-06
Institutions: European Commission
Subjects: animal breeding, application of EU law, hormone, veterinary drug, veterinary legislation

C 180 E/190

EN

Official Journal of the European Communities

26.6.2001

Amended 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 (1)

(2001/C 180 E/15)

(Text with EEA relevance)

COM(2001) 131 final (cid:151) 2000/0132(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 6 March 2001)

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

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Unchanged

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
the
of meat or products obtained from animals
importation of which is prohibited under point (a) of
Article 3 thereof.

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

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INITIAL PROPOSAL

AMENDED PROPOSAL

(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) (1) and the 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 WTO Agreement on the Application
of
(SPS
Agreement) (2), as interpreted by the Appellate Body in
substances
the Hormones case, of
(oestradiol 17(cid:226),
trenbolone
acetate, zeranol and melengestrol acetate) whose adminis-
tration for
is
animal
prohibited by Directive 96/22/EC.

the six hormonal
testosterone, progesterone,

growth promotion purposes

Phytosanitary Measures

Sanitary

and

(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
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 (3) 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.

(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 (4). 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
six
conclusive
levels of
different
the six hormones
hormones evaluated. Second,
endocrine,
neurobi-
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) WT/DS26/R/USA and WT/DS48/R/CAN (panel

AB-1997-4 (Appellate Body report).

reports),

and

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

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INITIAL PROPOSAL

AMENDED PROPOSAL

(6) As

regards,

the SCVPH
in particular, oestradiol 17(cid:226),
assessment is that a substantial body of recent evidence
it has to be considered as a complete
suggests that
initiating and
carcinogen, as
tumour promoting effects and that
the data currently
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,
in spite of the
acetate), the SCVPH assessment is that,
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
in October
Kingdom’s Veterinary Products Committee,
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.

segments of

(9) As regards, in particular, oestradiol 17(cid:226), this substance can
potentially be used in all farm animals and residue intake
the human population and in
for all
particular
at high risk can
therefore be especially relevant. Avoiding such intake is
important
the
residues resulting from its use cannot be detected at
present through the routine analytical methods available.

to safeguard human health. Moreover,

susceptible groups

the

residues

in order

(10) 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:226) and to continue
provisionally to apply the prohibition on the other five
hormones (testosterone, progesterone, trenbolone acetate,
zeranol
acetate). The provisional
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
on these substances,
in accordance with Article 5.7 of
the SPS Agreement.

and melengestrol

seeks more

Community

complete

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INITIAL PROPOSAL

AMENDED PROPOSAL

zootechnical

(11) The use of certain of the above substances for therapeutic
purposes or
treatment may, however,
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:226) and its
ester-like derivatives whose administration may only be
authorised
non-farm
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:226) for thera-
the real need for
peutic or zootechnical purposes;
oestradiol 17(cid:226) for
specific limited
conditions in individual animals will be identified by the
Commission in association with competent authorities,
with a view to developing appropriate
alternative
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:

(cid:145)Article 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:
___________
(1) OJ L 184, 17.7.1999, p. 23.

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INITIAL PROPOSAL

AMENDED PROPOSAL

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

culture animal, by any means whatsoever;

(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);

(e) the processing of the meat referred to in (d).(cid:146)

2. Article 4 is amended as follows:

(a) In point 1, the words (cid:145)oestradiol 17(cid:226)(cid:146) are deleted.

(b) The following paragraph is added:

(cid:145)Member States shall prohibit oestradiol 17(cid:226) 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.(cid:146)

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

replaced by the following:

(cid:145)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 17(cid:226) and its ester-like derivatives),
androgenic or gestagenic action which are authorised in
accordance with Directives 81/851/EEC and 81/852/EEC.(cid:146)

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

(cid:145)Meat or products from animals to which substances having
an oestrogenic (other than oestradiol 17(cid:226) 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
for human consumption unless the animals in
market
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.(cid:146)

(cid:145)Meat or products from animals to which substances having
an oestrogenic (other than oestradiol 17(cid:226) and its ester-like
derivatives), androgenic or gestagenic action or beta-agonists
have been administered in accordance with the dispensatory
this Directive may not be placed on the
provisions of
for human consumption unless the animals in
market
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 for the
product concerned was observed before the animals were
slaughtered.(cid:146)

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INITIAL PROPOSAL

AMENDED PROPOSAL

5. Article 8 is amended as follows:

Unchanged

(a) In point 1, the words (cid:145)Articles 2 and 3(a)(cid:146) are replaced by

(cid:145)Articles 2 and 3(cid:146).

(b) In point 2(a), the words (cid:145)under Article 2(cid:146) are replaced by

(cid:145)under Articles 2 and 3(cid:146).

6. Article 11 is amended as follows:

(a) In paragraph 2(a)(i), the words (cid:145)point (a) of Article 2(cid:146) are

replaced by (cid:145)Annex II, List A(cid:146).

(b) In paragraph 2(a)(ii), the words (cid:145)point (a) of Article 3(cid:146)

are replaced by (cid:145)Annex II, List B and Annex III(cid:146).

(c) In paragraph 3, the words (cid:145)according to the procedure
laid down in Article 33 of Council Directive 96/23/EC(cid:146)
are replaced by (cid:145)according to the procedure referred to
in Article 11b(2)(cid:146).

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

(cid:145)Article 11a

1.
Provisions in the Annexes may be amended and/or
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.

2. With regard to the substances listed in Annex III, the
Community will seek additional
information, taking into
account recent scientific data from any source and keep
the measures under regular review.

Article 11b

Unchanged

1.
The Commission shall be assisted by the Standing
Veterinary Committee instituted by Article 1 of Council
Decision 68/361/EEC (*)
referred to as (cid:147)the
Committee(cid:148)).

(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.
___________
(*) OJ L 255, 18.10.1968, p. 23.(cid:146)

8. The following Article 14a is added:

(cid:145)Article 14a

The provisions laid down in this Directive with regard to
oestradiol 17(cid:226) shall not apply to farm animals for which it
can be certified that, where oestradiol 17(cid:226) has been admin-
istered to them for therapeutical purposes or zootechnical
treatment, this administration has taken place before 1 July
2001.(cid:146)

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INITIAL PROPOSAL

AMENDED PROPOSAL

9. The Annex to Directive 96/22/EC becomes (cid:145)Annex I(cid:146) and
Annexes II and III in the Annex to this Directive are added.

Article 2

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
reference on the occasion of
their official publication.
Member States shall determine how such reference is to be
made.

Article 3

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

Unchanged

(cid:145)ANNEX II

List of prohibited substances:

List A:

(cid:151) Thyrostatics,

(cid:151) Oestradiol 17(cid:226) and its ester-like derivatives,

(cid:151) Stilbenes, stilbene derivatives, their salts and esters.

List B:

(cid:151) Beta-agonists

ANNEX III

List of provisionally prohibited substances:

Substances having oestrogenic (other
ester-like derivatives), androgenic or gestagenic action.

than oestradiol 17(cid:226) and its