Proposal for a Council Regulation (EC) amending 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
Date: 1999-03-18
Institutions: European Commission
Subjects: chemical product, health policy, manufactured feedingstuffs, material of animal origin, veterinary drug

C 131/14

EN

Official Journal of the European Communities

12.5.1999

Article 10

Waiver of immunity

illegal economic or
Director of the Office for his opinion.

financial activity shall be transmitted to the

Any request from a national police or judicial authority regarding the
waiver of immunity from jurisdiction of an official or servant of [insti-
tution] concerning an internal case of irregularities, fraud or any other

Article 11

Effective date

This Decision shall take effect on 1 June 1999.

Done at Brussels,

. . .

For [institution]

Proposal for a Council Regulation (EC) amending 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

(1999/C 131/05)

COM(1999) 130 final. (cid:151) 1999/0072(CNS)

(Submitted by the Commission on 18 March 1999)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 43 thereof,

Having regard to the proposal from the Commission,

Having regardt to the opinion of the European Parliament,

Having regard to the opinion of
Committee,

the Economic and Social

Whereas, since the adoption of Council Regulation (EEC) No
2377/90 (1), as last amended by Commission Regulation (EC)
2728/98 (2) the regulatory environment of veterinary medicinal
products has been radically altered, in particular as a result of
the entry into force of Council Regulation (EEC) No 2309/93
of 22 July 1993 laying down Community procedures for the
authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (3) and of the amendments
to Council Directive
made
81/851/EEC of 28 September 1981 on the approximation of
the laws of the Member States relating to veterinary medicinal
products (5) and to Council Directive 81/852/EEC of 28
Sepember 1981 on the approximation of
the
Member States relating to analytical, pharmacotoxicological

by Directive 93/40/EEC (4)

the laws of

(1) OJ L 224, 18.8.1990, p. 1.
(2) OJ L 343, 18.12.1998, p. 8.
(3) OJ L 214, 24.8.1993, p. 1.
(4) OJ L 317, 6.11.1981, p. 16.
(5) OJ L 214, 24.8.1993, p. 31.

and clinical standards and protocols of the testing of veterinary
medicinal products (6);

Whereas the Committee for Veterinary Medicinal Products is
the
henceforth responsible to the European Agency for
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;

Whereas Council Regulation (EC) No 297/95 of 10 February
1995 on fees payable to the European Agency for
the
Evaluation of Medicinal Products (7) as amended by Regulation
(EC) No 2743/98 (8) establishes the fees payable to the Agency
for examining applications for the establishment, amendment,
and extension of maximum residue limits;

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

Whereas 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
European Community by Council Decision 94/800/EC of 22
December 1994 concerning the conclusion on behalf of the
its
European Community,

regards matters within

as

(6) OJ L 317, 6.11.1981, p. 1.
(7) OJ L 35, 15.2.1995, p. 1.
(8) OJ L 345, 19.12.1998, p. 3.

12.5.1999

EN

Official Journal of the European Communities

C 131/15

competence, of the agreements reached in the Uruguay Round
multilateral negotiations (1986-1994) (9), creates transparency
obligations as regards health measures; whereas Regulation
therefore be adapted in order to
(EEC) No 2377/90 must
enable the Community to fulfil
its obligations under that
Agreement,

HAS ADOPTED THIS REGULATION:

Article 1

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

1. Articles 6 and 7 are replaced by the following:

(cid:145)Article 6

1.
In order to obtain the inclusion in Annex 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 application to establish a
maximum residue
to the
European Agency for the Evaluation of Medicinal Products
set up by Council Regulation (EEC) No 2309/93, hereinafter
referred to as the (cid:147)Agency(cid:148).

submitted

shall be

limit

application shall

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

contain the

The application shall aslo be accompanied by the fee

2.
payable to the Agency.

Article 7

1.
The Committee for Veterinary Medicinal Products
referred to in Article 27 of Regulation (EEC) No 2309/93,
shall be responsible for formulating the Agency’s opinion on
the classification of substances in Annexes I, II, III or IV of
this Regulation.

Articles 52 and 53 of Regulation (EEC) No 2309/93

2.
are applicable for the purposes of this Regulation.

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

the information submitted by the applicant

If
is not
sufficient to enable such an opinion to be prepared, the
Committee may ask the applicant
to supply additional
information within a specific time limit. The deadline for
the opinion shall
tha additional
information has been received.

then be deferred until

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
the conclusion
should be revised and the reasons

for

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

reached on the appeal shall be annexed to the report
referred to in paragraph 5.

The Agency shall forward the definitive opinion of the
5.
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.

The Commission shall prepare draft measures taking
6.
the
account of Community legislation and shall
procedure provided for
in Article 8. The Standing
Committee for Veterinary Medicinal Products referred to in
Article 8 shall adapt its rules of procedure in order to take
account of the tasks conferred upon it by this Regulation.(cid:146)

start

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

The words (cid:147)Committee for the Adaption to Technical
(cid:145)1.
Progress of the Directives on Veterinary Medicinal Products(cid:148)
are
for Veterinary
Medicinal Products(cid:148). (cid:146)

replaced by (cid:147)Standing Committee

3. In Article 8(2) the words (cid:145)Committee for the Adaption to
Technical Progress of the Directives on Veterinary Medicinal
Products(cid:146)
for
by
Veterinary Medicinal Products(cid:146).

(cid:145)Standing Committee

replaced

are

4. In Article 9(2) the first sentence is replaced by the following:

the Committee

(cid:145)The Commission shall as soon as possible examine the
grounds given by the Member State concerned and, after
consulting
for Veterinary Medicinal
then deliver its opinion forthwith and
it shall
Products,
take appropriate measures;
the person responsible for
marketing may be requested to provide the Committee
with oral or written explanations(cid:146).

5. In Article 10, the words (cid:145)Committee for the Adaptation to
Technical Progress of the Directives on Veterinary Medicinal
Products(cid:146)
for
by
Veterinary Medicinal Products(cid:146).

(cid:145)Standing Committee

replaced

are

6. Article 12 is replaced by the following text:

(cid:145)Article 12

the Commission shall publish a summary of

As soon as possible after the amendment of Annexes I, II, III
the
or IV,
assessment of the safety of the substances concerned that
have been examined by the Committe for Veterinary
Medicinal
any
proprietary data shall be respected. The Agency shall
provide the competent authorities and the Commission
with appropriate methods of analysis for tracing residues.(cid:146)

confidential nature of

Products. The

Article 2

This Regulation shall enter into force on . . . 1999.

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