Commission Regulation (EC) No 542/2008 of 16 June 2008 amending Annexes I and II to Council 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, as regards cyfluthrin and lectin extracted from red kidney beans ( Phaseolus vulgaris) (Text with EEA relevance)
Date: 2008-06-16
Institutions: European Commission
Subjects: cattle, foodstuff, goat, material of animal origin, swine, veterinary drug, veterinary legislation

17.6.2008

EN

Official Journal of the European Union

L 157/43

COMMISSION REGULATION (EC) No 542/2008

of 16 June 2008

amending Annexes I and II to Council 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, as regards cyfluthrin and lectin extracted from red kidney beans
(Phaseolus vulgaris)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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
establishment of maximum residue
veterinary
medicinal products in foodstuffs of animal origin (1), and in
particular Articles 2 and 3 thereof,

limits of

(3)

Having regard to the opinion of
the European Medicines
Agency formulated by the Committee for Medicinal Products
for Veterinary Use,

Whereas:

the existing MRLs for bovine species could not be extra-
polated to all ruminants, as residue data from ovine
species was not available. The CVMP concluded that
the extrapolation was possible for caprine species only.
As a consequence, it is considered appropriate to extend
the current entry in Annex I of Regulation (EEC) No
2377/90 for cyfluthrin to include caprine species, with
the same MRLs values as for bovine species, for muscle,
fat, liver, kidney and milk, provided that, for milk, the
further provisions in Directive 94/29/EC are observed.

Lectin extracted from red kidney beans (Phaseolus vulgaris)
is currently not included in the Annexes to Regulation
(EEC) No 2377/90. Following an examination of an
application for the establishment of MRLs for lectin
in
extracted from red kidney beans (Phaseolus vulgaris)
porcine species, the CVMP concluded that there is no
need to establish MRLs for lectin extracted from red
kidney beans (Phaseolus vulgaris) and recommended the
for porcine
that substance in Annex II
inclusion of
species,
is
for oral use only. As a consequence,
found appropriate to insert this substance in Annex II
to Regulation (EEC) No 2377/90 for porcine species, for
oral use only.

it

(1)

(2)

All pharmacologically active substances used in the
Community in veterinary medicinal products intended
should be evaluated in
for
accordance with Regulation (EEC) No 2377/90.

food-producing animals

(4)

Regulation (EEC) No 2377/90 should therefore be
amended accordingly.

The substance cyfluthrin is currently included in Annex I
to Regulation (EEC) No 2377/90 for bovine species for
muscle, fat, liver and kidney and for bovine species for
milk provided that, for milk, the further provisions in
Council Directive 94/29/EC of 23 June 1994 amending
the Annexes to Directives 86/362/EEC and 86/363/EEC
on the fixing of maximum levels for pesticide residues in
and on cereals and foodstuffs of animal origin respect-
ively (2) are observed. Following a request to extend the
existing entry for cyfluthrin for bovine species in Annex I
to all ruminants, the Committee for Medicinal Products
for Veterinary Use (hereinafter CVMP), having reviewed
the maximum residue limits (hereinafter MRLs) already
established for the substance cyfluthrin, concluded that

(5)

(6)

An adequate period should be allowed before the appli-
cability of this Regulation in order to enable Member
States to make any adjustment which may be necessary
in the light of this Regulation to the authorisations to
place the veterinary medicinal products concerned on the
market which have been granted in accordance with
Directive 2001/82/EC of the European Parliament and
the Council of 6 November 2001 on the
of
Community
to veterinary medicinal
products (3) to take account of the provisions of this
Regulation.

relating

code

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

opinion

of

(1) OJ L 224, 18.8.1990, p. 1. Regulation as

last amended by
Commission Regulation (EC) No 203/2008 (OJ L 60, 5.3.2008,
p. 18).

(2) OJ L 189, 23.7.1994, p. 67.

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

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

L 157/44

EN

Official Journal of the European Union

17.6.2008

HAS ADOPTED THIS REGULATION:

Article 2

Article 1

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

Annexes I and II to Regulation (EEC) No 2377/90 are amended
in accordance with the Annex to this Regulation.

It shall apply from 16 August 2008.

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

Done at Brussels, 16 June 2008.

For the Commission

Günter VERHEUGEN
Vice-President

17.6.2008

EN

Official Journal of the European Union

L 157/45

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