Council Regulation (EC) No 2584/2001 of 19 December 2001 amending Annexes I and III of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance)
Date: 2001-12-19
Institutions: Council of the European Union
Subjects: animal nutrition, food inspection, foodstuff, health control, veterinary drug, waste

29.12.2001

EN

Official Journal of the European Communities

L 345/7

COUNCIL REGULATION (EC) No 2584/2001

of 19 December 2001

amending Annexes I and III of Regulation (EEC) No 2377/90 laying down a Community procedure
for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of
animal origin

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26
June 1990 laying down a Community procedure for the estab-
lishment of maximum residue limits of veterinary medicinal
products in foodstuffs of animal origin (1), and in particular
Article 7 thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

In accordance with Regulation (EEC) No 2377/90,
maximum residue limits are to be established progres-
sively for all pharmacologically active substances which
are used within the Community in veterinary medicinal
products intended for administration to food-producing
animals.

Maximum residue limits should be established only after
examination within the Committee for Veterinary Medi-
cinal Products of all the relevant information concerning
the safety of residues of the substance concerned for the
consumer of foodstuffs of animal origin and the impact
of residues on the industrial processing of foodstuffs and
taking into account all publicly available relevant
scientific information concerning the safety of residues
of the substance concerned for the consumer of food-
stuffs of animal origin, including for example opinions
the Scientific Committee on Veterinary Measures
of
Relating to Public Health,
from the Joint
FAO/WHO Expert Committee on Food Additives
(JECFA) or
from internationally renowned
research organisations.

reports

reports

In establishing maximum residue limits for residues of
veterinary medicinal products in foodstuffs of animal
origin, it is necessary to specify the animal species in
which residues may be present, the levels at which they
may be present in each of the relevant tissues obtained
from the treated animal (target tissue) and the nature of
the residue which is relevant
for the monitoring of
residues (marker residue). In the case of veterinary medi-
cinal products intended for use in lactating animals
maximum residue limits shall be established for milk.

(4)

(5)

(6)

(7)

(8)

Regulation (EEC) No 2377/90 provides that the estab-
lishment of maximum residue limits shall
in no way
prejudice the application of other relevant Community
legislation.

For the purpose of monitoring residues, as provided for
in appropriate Community legislation, maximum residue
limits should usually be established for the target tissues
of liver or kidney. However, as the liver and kidney are
frequently removed from carcasses moving in inter-
national trade, maximum residue limits should conse-
quently be established always for muscle or fat tissues.

β-agonists (2). Under

The substances chlormadinone, flugestone acetate and
altrenogest are hormones and are therefore subject to
restrictions and control of use as provided for in Council
Directive 96/22/EC of 29 April 1996 concerning the
prohibition on the use in stockfarming of certain
substances having a hormonal or thyrostatic action and
of
these
hormones may be administered to farm animals for
therapeutic or zootechnical purposes only. In particular,
these conditions require the administration of
these
substances by a veterinarian or under his direct responsi-
bility. In addition, the type of treatment, the types of
products authorised, the date of treatment and the iden-
tity of the animals treated must be officially recorded by
the veterinarian.

certain conditions,

Furthermore, the conditions laid down in Directive 96/
22/EC prohibit the administration of hormones for ther-
apeutic or zootechnical purposes to breeding animals
during the fattening period at the end of their reproduc-
tive life. Moreover, they provide that meat or products
from animals to which hormones have been adminis-
tered for therapeutic or zootechnical treatment should
not be placed on the market for human consumption
they have been treated in accordance with
unless
Directive 96/22/EC and insofar as the withdrawal period
laid down was observed before the animals were slaugh-
tered.

The overall evaluation of the available risk assessments
of these substances and of the entire body of available
scientific information and data indicate that, as concerns
the excess intake of hormone residues and their metabo-
lites, and in view of the intrinsic properties of hormones
and epidemiological findings, a risk to the consumer has
been identified.

(1) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commis-
sion Regulation (EC) No 2162/2001 (OJ L 291, 8.11.2001, p. 9).

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

L 345/8

EN

Official Journal of the European Communities

29.12.2001

(9)

(10)

(11)

Furthermore, given the intrinsic properties of sexual
hormones and as it is not possible to exclude that good
veterinary practice is not systematically applied, and that
therefore the authorities should be provided with means
of control of illegal use of these hormones, Council
Directive 96/23/EC of 29 April 1996 on measures to
monitor certain substances and residues thereof in live
animals and animal products (1), requires the authorities
to carry out
investigations in the case of suspected
animals or positive laboratory results.

Taking into account
the identified potential adverse
effects to human health from the administration of these
hormones to farm animals for any purpose and after
consideration of the current need to continue to make
these
available on the Community market some of
substances that are currently used for therapeutic or
zootechnical treatment of farm animals and, taking also
into account the strict conditions under which Directive
these substances for
96/22/EC authorises the use of
therapeutic or zootechnical purposes, it is appropriate to
proceed with the consideration of
these substances
under Regulation (EEC) No 2377/90 for the purpose of
setting up maximum residue limits.

the

the

the health of

substance concerned at

Provided that there are no grounds for supposing that
level
residues of
proposed present a hazard for
the
consumer, maximum residue limits should be estab-
lished in Annex I or Annex III to Regulation (EEC) No
2377/90. However, given the overall evaluation on the
risk assessments of
sexual hormones, as concerns
possible excess intake of hormone residues and their
metabolites, a possible risk to the consumer needs to be
regularly reviewed on the basis of any new scientific
evidence.

(12)

It is thus considered appropriate, without prejudice to
other provisions of Community law,
in particular
Directive 96/22/EC, that chlormadinone and flugestone
acetate (for ovine milk) be inserted into Annex I to
Regulation (EEC) No 2377/90 and that, in order to allow
for the completion of scientific studies, altrenogest and
flugestone acetate (for caprine milk) be inserted into
Annex III thereto.

(13) However, it has to be stressed that, as a result of new
information or a re-assessment of existing information,
Regulation (EEC) No 2377/90 can be amended in order
to protect human or animal health, in accordance with
the procedures provided for in this Regulation.

(14)

The Standing Committee on Veterinary Medicinal Prod-
ucts referred to in Article 8 of Regulation (EEC) No
2377/90 has not delivered a favourable opinion on the
Commission proposed measures,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and III to Regulation (EEC) No 2377/90 are hereby
amended as set out in the Annex to this Regulation.

Article 2

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

It shall apply from the sixtieth day following that of its publica-
tion.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2001.

For the Council

The President

A. NEYTS-UYTTEBROECK

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

ANNEX

A. The following substances are hereby inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed)

‘6. Agents acting on the reproductive system

6.1. Progestogens

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Chlormadinone

Chlormadinone

Bovine

4 µg/kg
2 µg/kg
2,5 µg/kg

Fat
Liver
Milk

For zootechnical use only

Flugestone acetate

Flugetone acetate

Ovine

1 µg/kg

Milk

For intravaginal use for zootechnical purposes only’

B. The following substances are hereby inserted in Annex III to Regulation (EEC) No 2377/90 (List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum

residue limits have been fixed)

‘6. Agents acting on the reproductive system

6.1. Progestogens

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Altrenogest

Altrenogest

Porcine

Equidae

3 µg/kg
3 µg/kg
3 µg/kg

3 µg/kg
3 µg/kg
3 µg/kg

Fat
Liver
Kidney

Fat
Liver
Kidney

Provisional MRLs expire on 01/01/2003; For zootechnical use only

Flugestone acetate

Flugestone acetate

Caprine

1 µg/kg

Milk

Provisional MRLs expire on 01/01/2003; For intravaginal use for
zootechnical purposes only’

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