Commission Regulation (EC) No 997/1999 of 11 May 1999 amending Annexes I, II and III of 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: 1999-05-11
Institutions: European Commission
Subjects: animal product, foodstuff, veterinary drug, waste

L 122/24

EN

Official Journal of the European Communities

12. 5. 1999

COMMISSION REGULATION (EC) No 997/1999

of 11 May 1999

amending Annexes I, II and III of 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,

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 veter-
inary medicinal products in foodstuffs of animal origin (1),
as last amended by Commission Regulation (EC) No 954/
1999 (2), and in particular Articles 6, 7 and 8 thereof;

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

(2) Whereas maximum residue limits should be estab-
lished only after
the examination within the
Committee for Veterinary Medicinal Products of all
the relevant information concerning the safety of
residues of
the
consumer of foodstuffs of animal origin and the
impact of residues on the industrial processing of
foodstuffs;

the substance concerned for

the liver and kidney are frequently removed from
carcasses moving in international
and
maximum residue limits
should therefore also
always be established for muscle or fat tissues;

trade,

(5) Whereas, in the case of veterinary medicinal prod-
lactating
ucts intended for use in laying birds,
animals or honey bees, maximum residue limits
must also be established for eggs, milk or honey;

(6) Whereas Nitroxinil should be inserted into Annex

I to Regulation (EEC) No 2377/90;

(7) Whereas pyrantel embonate, bromhexine, mercap-
tamine hydrochloride, biotin, Praziquantel, vitamin
E, sodium glycerophosphate, vitamin B1, vitamin
B2, vitamin B3, vitamin B5, vitamin B6 and
vitamin B12 should be inserted into Annex II to
Regulation (EEC) No 2377/90;

(8) Whereas, in order to allow for the completion of
scientific studies, morantel, halofuginone, difluben-
zuron, difloxacin and Oxyclozanide should be
inserted into Annex III to Regulation (EEC) No
2377/90;

(3) Whereas, in establishing maximum residue limits
for residues 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 residues
(marker residue);

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

the

(4) 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,

(10) Whereas the measures provided for in this Regula-
tion are in accordance with the opinion of the
Standing Committee on Veterinary Medicinal
Products,

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 118, 6.5.1999, p. 28.

(3) OJ L 317, 6.11.1981, p. 1.
(4) OJ L 214, 24.8.1993, p. 31.

12. 5. 1999

EN

Official Journal of the European Communities

L 122/25

HAS ADOPTED THIS REGULATION:

Article 2

Article 1

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

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

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

Done at Brussels, 11 May 1999.

For the Commission

Martin BANGEMANN

Member of the Commission

Annex I to Regulation (EEC) No 2377/90 is amended as follows:

2.

Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.4. Phenol derivatives including salicylanides

ANNEX

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Nitroxinil

Nitroxinil

Bovine, ovine

400 lg/kg Muscle
200 lg/kg
20 lg/kg
400 lg/kg Kidney'

Fat
Liver

Annex II to Regulation (EEC) No 2377/90 is amended as follows:

1.

Inorganic chemicals

Pharmacologically active substance(s)

Animal species

Other provisions

‘Sodium glycerophosphate

All food producing species'

2.

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘Biotin

Bromhexine

All food producing species

Bovine

Not for use in animals from which milk is produced for
human consumption

Porcine

Poultry

Not for use in animals from which eggs are produced
for human consumption

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1
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5

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9
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Pharmacologically active substance(s)

Animal species

Other provisions

Mercaptamine hydrochloride

All mammalian food-producing species

Praziquantel

Pyrantel embonate

Vitamin B1

Vitamin B12

Vitamin B2

Vitamin B3

Vitamin B5

Vitamin B6

Vitamin E

Ovine

Equidae

All food-producing species

All food-producing species

All food-producing species

All food-producing species

All food-producing species

All food-producing species

All food-producing species'

Annex III to Regulation (EEC) No 2377/90 is amended as follows:

1.

Anti-infectious agents

1.2. Antibiotics

1.2.6. Quinolones

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Difloxacin

Difloxacin

Bovine

Not for use in animals from
which milk is produced for
human consumption

Porcine

400 lg/kg Muscle

100 lg/kg
1 400 lg/kg

Fat
Liver

800 lg/kg Kidney

400 lg/kg Muscle
100 lg/kg
800 lg/kg
800 lg/kg Kidney

Skin and fat
Liver

Provisional MRLs expire on 1.1.2001'

1
2

.

5

.

1
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9
9

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O

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2.

Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.1. Phenol derivatives including salicylanides

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Oxyclozanide

Oxyclozanide

Bovine

Ovine

20 lg/kg Muscle
20 lg/kg
500 lg/kg
100 lg/kg Kidney
10 lg/kg Milk

Fat
Liver

20 lg/kg Muscle
20 lg/kg
500 lg/kg
100 lg/kg Kidney

Fat
Liver

Provisional MRLs expire on 1.7.2000'

2.1.3. Tetrahydropyrimides

Pharmacologically active
substance(s)

‘Morantel

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Bovine, ovine

Sum of residues which
may be hydrolysed to N-
Methyl-1,3-propanedia-
mine and expressed as
morantel equivalents

Porcine

100 lg/kg
100 lg/kg
800 lg/kg
200 lg/kg
100 lg/kg

100 lg/kg
100 lg/kg
800 lg/kg
200 lg/kg

Muscle
Fat
Liver
Kidney
Milk

Muscle
Skin and fat
Liver
Kidney

Provisional MRLs expire on 1.7.2001'

2.2. Agents acting against ectoparasites

2.2.5. Acyl urea derivates

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Diflubenzuron

Diflubenzuron

Salmonidae

1 000 lg/kg Muscle and skin in natural
proportions

Provisional MRLs expire on 1.7.2000'

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9
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2.4. Agents acting against protozoa

2.4.2. Quinazolone derivatives

Pharmacologically active
substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘Halofuginone

Halofuginone

Bovine

Provisional MRL’s expire on 1.1.2001'

10 lg/kg Muscle
25 lg/kg
30 lg/kg
30 lg/kg Kidney

Fat
Liver

1
2

.

5

.

1
9
9
9

E
N

O

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