Commission Regulation (EC) No 121/98 of 16 January 1998 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 (Text with EEA relevance)
Date: 1998-01-16
Institutions: European Commission
Subjects: animal product, food inspection, health control, veterinary drug, veterinary medicinal product, waste

17. 1. 98

‹

EN

‹

Official Journal of the European Communities

L 11/11

COMMISSION REGULATION (EC) No 121/98

of 16 January 1998

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

honey bees, maximum residue limits must also be es-
tablished for eggs, milk or honey;

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 establishment of maximum residue limits of vet-
erinary medicinal products
animal
origin (1), as last amended by Commission Regulation
(EC) No 1850/97 (2) and in particular Articles 6, 7 and 8
thereof,

in foodstuffs of

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

Whereas maximum residue limits should be established
only after the examination, within the Committee for
Veterinary Medicinal Products, of all the relevant informa-
tion 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;

Whereas, in establishing maximum residue limits for res-
idues 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 which may
be present in each of the relevant meat tissues obtained
from the treated animal (target tissue) and the nature of
the residue which is relevant for the monitoring of res-
idues (marker residue);

Whereas, 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; whereas, however, the liver and kidney
are frequently removed from carcasses moving in inter-
national trade, and maximum residue limits should there-
fore also always be established for muscle or fat tissues;

Whereas danofloxacin, cefazolin and trimethoprim should
be inserted into Annex I
to Regulation (EEC) No
2377/90;

folic acid, betain and cefazolin
Whereas lini oleum,
should be inserted into Annex II to Regulation (EEC) No
2377/90;

Whereas, in order to allow for the completion of scientific
studies, the duration of the validity of the provisional
maximum residue limits previously defined in Annex III
to Regulation (EEC) No 2377/90 should be extended for
penethamate;

Whereas 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 adjustment which may be
necessary to the authorisations to place the veterinary
medicinal products concerned on the market which have
been granted in accordance with Council Directive
81/851/EEC (3), as
last amended by Directive 93/40/
EEC (4), to take account of the provisions of this Regula-
tion;

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

Whereas,
intended for use in laying birds,

in the case of veterinary medicinal products
lactating animals or

This Regulation shall enter into force on the 60th day
following its publication in the Official Journal of the
European Communities.

(1) OJ L 224, 18. 8. 1990, p. 1.
(2) OJ L 264, 26. 9. 1997, p. 12.

(3) OJ L 317, 6. 11. 1981, p. 1.
(4) OJ L 214, 24. 8. 1993, p. 31.

L 11/12

‹

EN

‹

Official Journal of the European Communities

17. 1. 98

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

Done at Brussels, 16 January 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

17. 1. 98

‹

EN

‹

Official Journal of the European Communities

L 11/13

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

y
e
n
d
i
k

e
r
a

s
g
g
e

h
c
i
h
w
m
o
r
f

s
l
a
m
i
n
a

n
i

e
s
u

r
o
f

t
o
N

,
r
e
v
i
l

,
t
a
f

d
n
a

n
i
k
s

,

e
l
c
s
u
M

g
k
/
g
µ

0
5

,
r
e
v
i
l

,
t
a
f

d
n
a

n
i
k
s

,

e
l
c
s
u
M

g
k
/
g
µ

0
5

y
e
n
d
i
k

k
l
i

m

l
a
r
u
t
a
n

n
i

n
i
k
s

d
n
a

e
l
c
s
u
M

g
k
/
g
µ

0
5

s
n
o
i
t
r
o
p
o
r
p

y
e
n
d
i
k

,
r
e
v
i
l

,
t
a
f

,

e
l
c
s
u
M

g
k
/
g
µ

0
0
1

e
n
i
c
r
o
P

y
r
t
l
u
o
P

e
a
d
i
u
q
E

h
s
i
F

n
i
F

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

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
i
n
A

e
u
d
i
s
e
r

r
e
k
r
a
M

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

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

e
v
i
t
c
a

s
e
v
i
t
a
v
i
r
e
d

e
n
i
d
i
m

i
r
y
p

o
n
i
m
a
i
D

.

,

y
e
n
d
i
k

,
r
e
v
i
l

,
t
a
f

,

e
l
c
s
u
M

g
k
/
g
µ

0
5

e
n
i
v
o
B

m

i
r
p
o
h
t
e
m

i
r
T

m

i
r
p
o
h
t
e
m

i
r
T

.

2
1
1

.

s
c
i
t
o
i
b
i
t
n
A

.

2
1

.

X
E
N
N
A

:
s
w
o
l
l
o
f

s
a

d
e
i
f
i
d
o
m

s
i

I

x
e
n
n
A

.

A

s
t
n
e
g
a

s
u
o
i
t
c
e
f
n
i
-
i
t
n
A

s
c
i
t
u
e
p
a
r
e
h
t
o
m
e
h
C

.

1
1

.

.

1

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

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
i
n
A

e
u
d
i
s
e
r

r
e
k
r
a
M

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

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

e
v
i
t
c
a

s
n
i
r
o
p
s
o
l
a
h
p
e
C

.

k
l
i

M

g
k
/
g
µ

0
5

e
n
i
r
p
a
c

,

e
n
i
v
O

n
i
l
o
z
a
f
e
C

n
i
l
o
z
a
f
e
C

.

2
2
1

.

s
g
g
e

h
c
i
h
w

m
o
r
f

s
l
a
m
i
n
a

n
i

e
s
u

r
o
f

t
o
N

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

e
l
c
s
u
M

g
k
/
g
µ

0
0
2

n
e
k
c
i
h
C

t
a
f

d
n
a

n
i
k
S

g
k
/
g
µ

0
0
1

y
e
n
d
i
k

,
r
e
v
i
L

g
k
/
g
µ

0
0
4

y
e
n
d
i
k

,
r
e
v
i
L

g
k
/
g
µ

0
0
4

t
a
F

g
k
/
g
µ

0
0
1

k
l
i

m

h
c
i
h
w

m
o
r
f

s
l
a
m
i
n
a

n
i

e
s
u

r
o
f

t
o
N

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

e
l
c
s
u
M

g
k
/
g
µ

0
0
2

e
n
i
v
o
B

n
i
c
a
x
o
l
f
o
n
a
D

n
i
c
a
x
o
l
f
o
n
a
D

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

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
i
n
A

e
u
d
i
s
e
r

r
e
k
r
a
M

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

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

e
v
i
t
c
a

s
e
n
o
l
o
n
i
u
Q

.

.

3
2
1

.

L 11/14

‹

EN

‹

Official Journal of the European Communities

17. 1. 98

e
b

y
a
m

r
e
d
d
u

e
h
t

f
i

t
p
e
c
x
e
(

y
l
n
o

e
s
u

y
r
a
m
m
a
m
a
r
t
n
i

r
o
F

)

n
o
i
t
p
m
u
s
n
o
c

n
a
m
u
h

r
o
f

d
o
o
f

s
a

d
e
s
u

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

e
n
i
r
p
a
c

,

e
n
i
v
O

n
i
l
o
z
a
f
e
C

d
i
c
a

c
i
l
o
F

e
n
i
a
t
e
B

m
u
e
l
o

i
n
i
L

:
s
w
o
l
l
o
f

s
a

d
e
i
f
i
d
o
m

s
i

I
I
I

x
e
n
n
A

.

C

s
t
n
e
g
a

s
u
o
i
t
c
e
f
n
i
-
i
t
n
A

.

1

s
c
i
t
o
i
b
i
t
n
A

.

2
1

.

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

s
e
i
c
e
p
s

l
a

m
i
n
A

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

e
v
i
t
c
a

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

:
s
w
o
l
l
o
f

s
a

d
e
i
f
i
d
o
m

s
i

I
I

x
e
n
n
A

.

B

s
d
n
u
o
p
m
o
c

c
i
n
a
g
r
O

.

2

0
0
0
2

k
l
i

M

g
k
/
g
µ

4

y
e
n
d
i
k

,
r
e
v
i
l

,
t
a
f

,

e
l
c
s
u
M

g
k
/
g
µ

0
5

e
n
i
c
r
o
P

y
r
a
u
n
a
J

1

n
o

e
r
i
p
x
e

s
L
R
M

l
a
n
o
i
s
i
v
o
r
P

y
e
n
d
i
k

,
r
e
v
i
l

,
t
a
f

,

e
l
c
s
u
M

g
k
/
g
µ

0
5

e
n
i
v
O

n
i
l
l
i
c
i
n
e
p
l
y
z
n
e
B

e
t
a
m
a
h
t
e
n
e
P

s
n
o
i
s
i
v
o
r
p

r
e
h
t
O

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
i
n
A

e
u
d
i
s
e
r

r
e
k
r
a
M

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

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

e
v
i
t
c
a

s
n
i
l
l
i
c
i
n
e
P

.

.

0
1
2
1

.