Commission Regulation (EC) No 205/2006 of  6 February 2006  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 toltrazuril, diethylene glycol monoethyl ether and polyoxyethylene sorbitan monooleate   (Text with EEA relevance)
Date: 2006-02-06
Institutions: European Commission
Subjects: animal product, foodstuff, foodstuffs legislation, veterinary drug

7.2.2006

EN

Official Journal of the European Union

L 34/21

COMMISSION REGULATION (EC) No 205/2006

of 6 February 2006

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 toltrazuril, diethylene glycol monoethyl ether and
polyoxyethylene sorbitan monooleate

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

limits of

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

(3)

(4)

and kidney, excluding animals
from which milk is
produced for human consumption and to poultry for
skin and fat,
muscle,
and kidney excluding
liver
from which eggs are produced for human
animals
consumption.

is
The substance diethylene glycol monoethyl ether
included in Annex II
for bovine and porcine species.
The entry for diethylene glycol monoethyl ether should
be extended to include all ruminants.

The substance polysorbate 80 is included in Annex II to
Regulation (EEC) No 2377/90 for all
food-producing
species. That entry should be replaced by the general
name polyoxyethylene sorbitan monooleate, covering
all
both polysorbate 80 and polysorbate 81 for
food-producing species.

Whereas:

(5)

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

(1)

(2)

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.

and kidney,

The substance toltrazuril is included in Annex I to Regu-
lation (EEC) No 2377/90 for chicken and turkey for
excluding
skin and fat,
liver
muscle,
animals
from which eggs are produced for human
consumption, and for porcine, for muscle, skin and fat,
liver and kidney. Toltrazuril is also included in Annex III
to that Regulation for bovine species for muscle, fat, liver
from which milk is
and kidney, excluding animals
produced for human consumption, awaiting completion
of
scientific studies. Those studies have now been
completed and toltrazuril should therefore be extended
in Annex I to Regulation (EEC) No 2377/90 to include
bovines. The entry should also be extended to all
mammalian food-producing species for muscle, fat, liver

(6)

(7)

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 (2) 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 6/2006 (OJ L 3, 6.1.2006, p. 3).

(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 34/22

EN

Official Journal of the European Union

7.2.2006

HAS ADOPTED THIS REGULATION:

Article 1

Article 2

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 8 April 2006.

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

Done at Brussels, 6 February 2006.

For the Commission

Günter VERHEUGEN
Vice-President

7.2.2006

EN

Official Journal of the European Union

L 34/23

s
e
u
s
s
i
t

t
e
g
r
a
T

s
L
R
M

s
e
i
c
e
p
s

l
a
m
n
A

i

e
u
d
i
s
e
r

r
e
k
r
a
M

)
s
(
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

l

y
l
l
a
c
i
g
o
o
c
a
m
r
a
h
P

s
e
v
i
t
a
v
i
r
e
d

e
n
o
i
r
t
e
n
i
z
a
i
r
T

.

.

1
4
2

.

X
E
N
N
A

:

0
9
/
7
7
3
2

o
N

)

C
E
E
(

n
o
i
t
a
l
u
g
e
R

o
t

I

x
e
n
n
A

n

i

d
e
t
r
e
s
n

i

s
i

e
c
n
a
t
s
b
u
s

i

g
n
w
o

l
l

o
f

e
h
T

.

A

a
o
z
o
t
o
r
p

t
s
n
i
a
g
a

g
n
i
t
c
a

s
t
n
e
g
A

.

4
2

.

s
t
n
e
g
a

c
i
t
i
s
a
r
a
p
i
t
n
A

.

2

e
l
c
s
u
M

)
2
(

t
a
F

r
e
v
i
L

y
e
n
d
K

i

t
a
f

+

i

n
k
S

e
l
c
s
u
M

y
e
n
d
K

i

r
e
v
i
L

g
k
/
g

g
k
/
g

g
k
/
g

g
k
/
g

μ

μ

μ

μ

g
k
/
g

g
k
/
g

g
k
/
g

g
k
/
g

μ

μ

μ

μ

0
0
1

0
5
1

0
0
5

0
5
2

0
0
1

0
0
2

0
0
6

0
0
4

)
1
(

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

n
a
i
l
a
m
m
a
m

l
l

A

e
n
o
f
l
u
s

l
i
r
u
z
a
r
t
l
o
T

l
i
r
u
z
a
r
t
l
o
T

‘

)
3
(

y
r
t
l
u
o
P

.

’

.

”

.

n
o
i
t
p
m
u
s
n
o
c

n
a
m
u
h

r
o
f

d
e
c
u
d
o
r
p

e
r
a

s
g
g
e

h
c
i
h
w

m
o
r
f

s
l
a
m
n
a

i

n

i

e
s
u

r
o
f

n
o
i
t
p
m
u
s
n
o
c

n
a
m
u
h

r
o
f

d
e
c
u
d
o
r
p

s
i

k

l
i

m

h
c
i
h
w

m
o
r
f

s
l
a
m
n
a

i

n

i

e
s
u

r
o
f

s
n
o
i
t
r
o
p
o
r
p

l
a
r
u
t
a
n

n

i

t
a
f

d
n
a

i

n
k
s

o
t

s
e
t
a
l
e
r

L
R
M

s
i
h
t

s
e
i
c
e
p
s

e
n
i
c
r
o
p

“

t
o
N

r
o
F

t
o
N

)
1
(

)
2
(

)
3
(

s
e
i
c
e
p
s

l
a
m
n
A

i

)
s
(
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

l

y
l
l
a
c
i
g
o
o
c
a
m
r
a
h
P

’

e
n
i
c
r
o
p

d
n
a

s
t
n
a
n
m
u
r

i

l
l

A

r
e
h
t
e

l

y
h
t
e
o
n
o
m

l

o
c
y
l
g

e
n
e
l
y
h
t
e
i
D

‘

:

0
9
/
7
7
3
2

o
N

)

C
E
E
(

n
o
i
t
a
l
u
g
e
R

o
t

I
I

x
e
n
n
A

n

i

d
e
t
r
e
s
n

i

e
r
a

s
e
c
n
a
t
s
b
u
s

i

g
n
w
o

l
l

o
f

e
h
T

.

B

s
d
n
u
o
p
m
o
c

c
i
n
a
g
r
O

.

2

s
e
i
c
e
p
s

l
a
m
n
A

i

)
s
(
e
c
n
a
t
s
b
u
s

e
v
i
t
c
a

l

y
l
l
a
c
i
g
o
o
c
a
m
r
a
h
P

’

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

e
t
a
e
l
o
o
n
o
m
n
a
t
i
b
r
o
s

e
n
e
l
y
h
t
e
y
x
o
y
o
P

l

‘

e
f
a
s

s
a

d
e
s
i
n
g
o
c
e
r

y
l
l
a
r
e
n
e
g

s
e
c
n
a
t
s
b
u
S

.

3