Council Regulation (EC) No 1308/1999 pf 15 June 1999 amending Regulation (EC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin
Date: 1999-06-15
Institutions: Council of the European Union
Subjects: European Medicines Agency, animal product, data protection, drug surveillance, food inspection, standing committee (EU), veterinary drug, veterinary legislation, waste

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Official Journal of the European Communities

L 156/1

I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 1308/1999

of 15 June 1999

amending Regulation (EC) No 2377/90 laying down a Community procedure for
the establishment of maximum residue limits of veterinary medicinal products
in foodstuffs of animal origin

THE COUNCIL OF THE EUROPEAN UNION,

(2)

Having regard to the Treaty establishing the European
Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parlia-
ment (2),

Having regard to the opinion of the Economic and Social
Committee (3),

(3)

Whereas:

(1)

for

since the adoption of Council Regulation (EEC) No
2377/90 (4), the regulatory environment for veter-
inary medicinal products has altered radically, in
particular as a result of the entry into force of
Council Regulation (EC) No 2309/93 of 22 July
laying down Community procedures
the
authorisation and supervision of medicinal prod-
ucts for human and veterinary use and establishing
a European Agency for the Evaluation of Medicinal
Products (5) and of
the amendments made by
Directive 93/40/EEC (6) to Council Directive 81/
851/EEC of 28 September 1981 on the approxima-
tion of the laws of the Member States relating to
veterinary medicinal products (7), and to Council
Directive 81/852/EEC of 28 September 1981 on
the approximation of the laws of the Member States
relating to analytical, pharmaco-toxicological and
clinical standards and protocols in respect of the
testing of veterinary medicinal products (8);

(1) OJ C 131, 12.5.1999, p. 14.
(2) Opinion delivered on 4 May 1999 (not yet published in the

Official Journal).

(3) Opinion deliverd on 28 April 1999. (not yet published in the

Official Journal).

(4) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by
Commission Regulation (EC) No 2728/98 (OJ L 343,
18.12.1998, p. 8).

(5) OJ L 214, 24.8.1993, p. 1. Regulation as
649/98

Commission Regulation (EEC) No
24.3.1998, p. 7).

amended by
(OJ L 88,

(6) OJ L 214, 24.8.1993, p. 31.
(7) OJ L 317, 6.11.1981, p. 1.
(8) OJ L 317, 6.11.1981, p. 16.

the Committee for Veterinary Medicinal Products
is henceforth responsible to the European Agency
for the Evaluation of Medicinal Products and it falls
to that Agency, through that Committee, to issue
an opinion on the maximum residue limits of
veterinary medicinal products which are acceptable
in foodstuffs of animal origin in accordance with
Regulation (EEC) No 2377/90;

Council Regulation (EC) No 297/95 of 10 February
1995 on fees payable to the European Agency for
the Evaluation of Medicinal Products (9) establishes
the fees payable to the Agency for examining
applications for the establishment, amendment and
extension of maximum residue limits;

(4)

(5)

it is necessary, consequently, to amend Regulation
(EEC) No 2377/90 by conferring on the Agency
the task of dealing with applications for the estab-
lishment, amendment and extension of maximum
residue limits and by aligning the decision-making
process with respect to the authorisation and super-
vision of medicinal products for veterinary use with
that introduced by Regulation (EEC) No 2309/93;

the Agreement on the application of sanitary and
phytosanitary measures which emerged from the
multilateral negotiations of the Uruguay Round,
approved on behalf of the Community by Council
Decision 94/800/EC of 22 December 1994
concerning the conclusion on behalf of the Euro-
pean Community, as regards matters within its
competence, of
the agreements reached in the
Uruguay Round multilateral negotiations (1986 to
1994) (10) creates transparency obligations as regards

(9) OJ L 35, 15.2.1995, p. 1. Regulation as amended by Regula-

tion (EC) No 2743/98 (OJ L 345, 19.12.1998, p. 3).

(10) OJ L 336, 23.12.1994, p. 1.

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health measures; Regulation (EEC) No 2377/90
must therefore be adapted in order to enable the
Community to fulfil
its obligations under that
Agreement;

(6)

it is also necessary to rectify certain material errors
in Regulation (EEC) No 2377/90,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EEC) No 2377/90 is hereby amended as
follows:

1. Articles 6 and 7 shall be replaced by the following:

‘Article 6

1.
In order to obtain the inclusion in Annexes I, II
or III of a pharmacologically active substance which is
intended for use in veterinary medicinal products for
administration to food-producing animals, an applica-
tion to establish a maximum residue limit shall be
submitted to the European Agency for the Evaluation
of Medicinal Products set up by Council Regulation
(EEC) No 2309/93 (*), hereinafter referred to as “the
Agency”.

This application shall contain the information and
particulars referred to in Annex V of this Regulation
and shall conform with the principles laid down in
Directive 81/852/EEC.

The application shall also be accompanied by the

2.
fee payable to the Agency.

Article 7

1.
The Committee for Veterinary Medicinal Prod-
ucts referred to in Article 27 of Regulation (EC) No
2309/93 (hereinafter “the Committee”) shall be respon-
sible for formulating the Agency’s opinion on the clas-
sification of substances referred to in Annexes I, II, III
or IV to this Regulation.

2.
Articles 52 and 53 of Regulation (EEC) No 2309/
93 shall be applicable for the purposes of this Regula-
tion.

The Agency shall ensure that the Committee’s
3.
opinion is delivered within a period of 120 days
following the reception of a valid application.

If the information submitted by the applicant is not
sufficient to enable such an opinion to be prepared,
the Committee may ask the applicant to supply addi-
tional information within a specific time limit. The
deadline for the opinion shall then be deferred until
the additional information has been received.

4.
The Agency shall forward the opinion to the
applicant. Within 15 days of receipt of the opinion, the
applicant may provide written notice to the Agency

that he wishes to appeal. In that case he shall forward
the detailed grounds for his appeal to the Agency
within 60 days of receipt of the opinion. Within 60
days of the receipt of the grounds for appeal, the
Committee shall consider whether its opinion should
be revised and the reasons for the conclusion reached
on the appeal shall be annexed to the report referred to
in paragraph 5.

The Agency shall forward the definitive opinion
5.
of the Committee within 30 days of its adoption both
to the Commission and to the applicant. The opinion
shall be accompanied by a report describing the safety
evaluation of the substance by the Committee, which
shall give the grounds for its conclusions.

6.
The Commission shall prepare draft measures
taking account of Community legislation and shall
the procedure provided for in Article 8. The
start
Committee referred to in Article 8 shall adapt its rules
of procedure in order to take account of the tasks
conferred on it by this Regulation.

(*) OJ L 214, 24.8.1993, p. 1'.

2. Article 8(1) shall be replaced by the following:

‘1. Where the procedure laid down in this Article is
to be followed, the Chairman shall, without delay, refer
the matter to the Standing Committee on Veterinary
Medicinal Products, hereinafter referred to as “the
Standing Committee”, either on his own initiative or at
the request of a Member State.'

3. In Article 8(2) and (3), the word ‘Committee' shall be

replaced by ‘Standing Committee'.

4. In Article 9(2), the first sentence shall be replaced by

the following:

‘The Commission shall as soon as possible examine
the grounds given by the Member State concerned and,
after consulting the Committee for Veterinary Medi-
cinal Products, it shall then deliver its opinion forth-
with and take appropriate measures;
the person
responsible for marketing may be requested to provide
the Committee with oral or written explanations'.

5. In Article 10, the words ‘Committee for Adaptation to
Technical Progress of
the Directives on Veterinary
Medicinal Products' and the term ‘Committee' shall be
replaced by ‘Standing Committee'.

6. Article 12 shall be replaced by the following:

‘Article 12

the assessment of

As soon as possible after the amendment of Annexes I,
II, III or IV, the Commission shall publish a summary
the substances
of
concerned that have been examined by the Committee
for Veterinary Medicinal Products. The confidential
nature of any proprietary data shall be respected. The

the safety of

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Agency shall provide the competent authorities and
the Commission with appropriate methods for identi-
fying pharmacologically active substances for which
the MRL’s have been determined in Annexes I and II'.

‘ until 1 January 1998 in the case of pyrazolinones
and phenylbuta-

(including pyrazolidinediones
zones), nitroimidazoles and arsalinic acid, and'.

Article 2

7. In Article 14, second paragraph, the first indent shall

be replaced by the following:

This Regulation shall enter into force on the third 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 Luxembourg, 15 June 1999.

For the Council

The President

K.-H. FUNKE