Commission Regulation (EC) No 1851/2004 of 25 October 2004 amending Annex I to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal originText with EEA relevance
Date: 2004-10-25
Institutions: European Commission
Subjects: food inspection, food safety, health risk, product safety, veterinary drug, waste

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 1851/2004

of 25 October 2004

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

maximum residue limits must also be established for
eggs, milk or honey.

Having regard to the Treaty
Community,

establishing the European

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
Articles 7 and 8 thereof,

Whereas:

(1)

(2)

(3)

(4)

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

substances

active

that

Maximum residue limits should be established only after
the examination within the Committee for Veterinary
infor-
Medicinal Products (CVMP) of all
the
mation concerning the
substance concerned for the consumer of foodstuffs of
animal origin and the impact of residues on the industrial
processing of foodstuffs.

the relevant

residues of

safety of

In establishing maximum residue limits for residues of
veterinary medicinal products in foodstuffs of animal
it is necessary to specify the animal species in
origin,
food
which residues may be present,
obtained from the treated animal (‘target tissue’) as well
as the nature of
for the
the residue that
monitoring of residues (‘marker residue’).

the relevant

is relevant

For the control of residues, as provided for in appropriate
Community legislation, maximum residue limits should
usually be established for the target tissues of liver or
kidney. However,
frequently
removed from carcasses moving in international trade,
and maximum residue limits
should therefore also
always be established for muscle or fat tissues.

and kidney

liver

are

(5)

In the case of veterinary medicinal products intended for
lactating animals or honey bees,
use in laying birds,

(6)

(7)

(8)

(9)

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.

the

Based on an opinion of the CVMP, Annex III of Regu-
lation (EEC) No 2377/90 was amended by Commission
Regulation (EC) No 997/1999 (2) to include provisional
maximum residue limits for morantel, in order to allow
studies, notably
completion of
for
concerning the marker
analytical
method for the determination of residues of morantel
in the target
tissues. These maximum residue limits
were subsequently extended by Commission Regulation
(EC) No 1322/2001 (3) to allow the applicant
further
time for completion of the requested studies.

and the

scientific

residue

laid down in Volume 8 of

The requested data on the marker
residue and the
analytical method was evaluated by the CVMP and
found to be not completely in accordance with the
requirements
the Rules
Governing Medicinal Products in the European Union.
The method was nevertheless considered fully validated
for muscle and milk and either kidney or liver for the
species
and sheep. The CVMP subsequently
proposed to insert morantel in Annex II of Regulation
(EEC) No 2377/90, with the motivation that residues of
morantel depleted rapidly and therefore the establishment
of maximum residue limits was not necessary for the
protection of public health.

cattle

As residues of morantel in foodstuff from treated animals
may supersede the acceptable daily intake 24 hours after
administration, it is considered necessary, for reasons of
safety and to allow adequate withdrawal
consumer
periods
established for veterinary medicinal
to establish maximum
products containing morantel,
residues limits, taking account of the maximum residue
limits previously established.

to be

(10) Morantel

is a pharmacologically active anthelmintic
substance which has been in use
in veterinary
medicinal products for food-producing animal species
for
for
against
considerable
In view of the possible
roundworms and tapeworms.
development of resistance,
it is considered that access
to multiple choices for treatment should remain possible.

treatment

time

a

(1) OJ L 224, 18.8.1990, p. 1. Regulation as last modified by Commission

Regulation (EC) No 1646/2004 (OJ L 296, 21.9.2004, p. 5).

(2) OJ L 122, 12.5.1999, p. 24.
(3) OJ L 177, 30.6.2001, p. 52.

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(11) According to Regulation (EC) No 178/2002 (1),

risk
management shall take into account the results of risk
assessment and other factors legitimate to the matter
under consideration, such as detection methods and
feasibility of controls for the purpose of avoiding risks
from such
relevant Community
Reference Laboratory has confirmed that the methods
proposed by the applicant can be made applicable for
confirmatory analyses of morantel in the target tissues.

substances.

The

(12)

The Commission considers that
include morantel
provide safeguards
relevant controls of morantel
animals.

in Annex I

is appropriate to
for cattle and sheep to
the consumer and to allow
treated
in foodstuffs of

for

it

granted in accordance with Directive 2001/82/EC of the
the Council on the
European Parliament
and of
Community
to veterinary medicinal
products (2).

relating

code

(14)

The measures provided for in this Regulation are in
accordance with
Standing
the
the
Committee on Veterinary Medicinal Products.

opinion

of

HAS ADOPTED THE FOLLOWING REGULATION:

Article 1

Annex I to Regulation (EEC) No 2377/90 is hereby amended as
set out in the Annex hereto.

Article 2

(13) A period of 60 days should be allowed before the entry
into force of this Regulation in order to allow Member
States to make any adjustments which may be necessary
to the authorisations to place the veterinary medicinal
products concerned on the market which have been

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

It shall apply from the sixtieth day following its publication.

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

Done at Brussels, 25 October 2004.

For the Commission

Olli REHN
Member of the Commission

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last modified by Regulation

(2) OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

2004/28/EU (OJ L 136, 30.4.2004, p. 58).

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