Commission Regulation (EC) No 75/2005 of 18 January 2005 amending Annexes I, II and III 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 moxidectin, linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13 and AcetylisovaleryltylosinText with EEA relevance
Date: 2005-01-18
Institutions: European Commission
Subjects: animal product, chemical product, foodstuff, pharmaceutical legislation, veterinary drug

19.1.2005

EN

Official Journal of the European Union

L 15/3

COMMISSION REGULATION (EC) No 75/2005

of 18 January 2005

amending Annexes I, II and III 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 moxidectin, linear alkyl benzene sulphonic acids with alkyl
chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13 and
Acetylisovaleryltylosin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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
veterinary
establishment of maximum residue
medicinal products in foodstuffs of animal origin (1), and in
particular Articles 2, 3 and 4 thereof,

limits of

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

Whereas:

(5)

(6)

species.

for porcine

The substance acetylisovaleryltylosin is included in Annex
I
the
completion of scientific studies for the extension to
cover poultry species, acetylisovaleryltylosin should be
included in Annex III, excluding animals from which
eggs are produced for human consumption.

to allow for

In order

any

to make

An adequate period should be allowed before the appli-
cability of this Regulation in order to enable Member
adjustment which may be
States
necessary, in the light of this Regulation, to the author-
isations
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 of the Council of 6 November 2001 on
the Community code relating to veterinary medicinal
products (2), to take account of the provisions of this
Regulation.

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

opinion

of

(1)

(2)

(3)

All pharmacologically active substances which are used
within the Community in veterinary medicinal products
intended for administration to food-producing animals
should be evaluated in accordance with Regulation
(EEC) No 2377/90.

HAS ADOPTED THE FOLLOWING REGULATION:

Article 1

Moxidectin has been included in Annex I for bovine,
ovine and equidae for muscle, fat, liver and kidney and
for milk but only for bovine. The entry should be
extended to milk for ovine species.

Linear alkyl benzene sulphonic acids with alkyl chain
lengths ranging from C9 to C13, containing less than
2,5 % of chains longer than C13 has been included in
for bovine for topical use only. The entry
Annex II
should be extended to cover ovine species.

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

(EC) No 2232/2004 (OJ

last amended by
L 379,

Commission Regulation
24.12.2004, p. 71).

Annexes I,
amended in accordance with the Annex to this Regulation.

to Regulation (EEC) No 2377/90 are

II and III

Article 2

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 20 March 2005.

(2) 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 15/4

EN

Official Journal of the European Union

19.1.2005

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

Done at Brussels, 18 January 2005.

For the Commission

Günter VERHEUGEN
Vice-President

19.1.2005

EN

Official Journal of the European Union

L 15/5

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