Proposal for a Council Directive amending Directive 70/524/EEC concerning additives in feedingstuffs
Date: 1999-07-26
Institutions: European Commission
Subjects: animal health, animal nutrition, food additive, foodstuffs legislation

C 307 E/38

EN

Official Journal of the European Communities

26.10.1999

Proposal for a Council Directive amending Directive 70/524/EEC concerning additives in feed-
ingstuffs

(1999/C 307 E/08)

COM(1999) 388 final (cid:151) 1999/0168(CNS)

(Submitted by the Commission on 27 July 1999)

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of
Committee,

the Economic and Social

(1) Whereas Council Directive 70/524/EEC of 23 November
1970 concerning additives in feedingstuffs (1), as amended
by Directive 96/51/EC (2), establishes for high technology
additives with a very specific composition (antibiotics,
coccidiostats and other medicinal substances, and growth
promotors) a system where the authorisation will be linked
to a person responsible for putting the additive into circu-
lation, in order to protect for a period fixed at ten years,
scientific data or
costly
investment;

information which require

(2) Whereas it is therefore laid down in Directive 70/524/EEC
that the Commission replaces the existing authorisations by
authorisations linked to a person responsible for putting
the additive into circulation through the adoption of a
regulation; whereas in the case of additives included in
Annex I of Directive 70/524/EEC after the 31 December
1987 and in the case of additives included in Annex II of
the said Directive before April 1998 it is laid down in
Article 9h and 9i respectively that these regulations take
effect no later than 1 October 1999;

(3) Whereas, in contrast, in the case of additives included in
Annex I of Directive 70/524/EEC before 1 January 1988,
according to Article 9g of the said Directive, authorisations
will have to be linked to the person responsible for putting
the additive into circulation by 1 October 2003 in order to
enable their evaluation in accordance with Article 4 of the
directive;

(4) Whereas the fact that a re-evaluation of the substances
authorised before 1 January 1988 is
regarded to be
necessary, does not justify that their copies may continue
to be put into circulation after October 1999, while copies
of the other substances authorised after 1 January 1988

(1) OJ L 270, 14.12.1970, p. 1. Directive as

last amended by
Commission Regulation (EC) No 1411/99 (OJ L 164, 30.6.1999,
p. 56).

may not be put into circulation after 1 October 1999;
whereas in many cases according to the existing provisions
it may occur, that a copy product may still be put into
circulation because a certain use of the substance was auth-
orised before 1988, while the authorisation of the same
substance authorised subsequently for a certain use would
be linked to a person responsible for putting the additive
is necessary to establish
it
into circulation; whereas
coherent
for all additives
respect
in this
belonging to the groups of antibiotics, coccidiostats and
other medicinal substances, and growth promoters;

conditions

(5) Whereas the relevant provision in Directive 70/524/EEC

should be amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The paragraphs 4, 5 and 6 of Article 9g of Directive
70/524/EEC are replaced by the following:

(cid:145)4.

In accordance with the procedure laid down in Article 23,
provisional authorisations of the additives referred to in
paragraph 1 shall be replaced by provisional authorisations
linked to the person responsible for putting them into
circulation through the adoption of a regulation taking
effect no later than 1 October 1999 and the additives
shall be included in Chapter II of the list referred to in
Article 9t(b).

5. Member States shall ensure that the person responsible for
putting an additive referred to in paragraph 1 into circu-
lation submits, as provided for in Article 4 and not later
than 30 September 2000, the dossier referred to in Article
4 with a view to re-evaluation. Where he fails to do so, the
provisional authorisation linked to the person responsible
for putting the additive in question into circulation as
referred to in paragraph 4 shall be withdrawn through
the adoption of a regulation in accordance with Article 23.

6. The Commission shall

take the necessary measures to
ensure that the re-evaluation of the dossiers submitted in
accordance with paragraph 5 is completed no later than
three years after the dossier is submitted.

In accordance with the procedure laid down in Article 23,
authorisations of the additives referred to in paragraph 1:

a) shall be withdrawn through the adoption of a regu-

(2) OJ L 235, 17.9.1996, p. 39.

lation, or

26.10.1999

EN

Official Journal of the European Communities

C 307 E/39

b) shall be replaced by authorisations linked to the person
responsible for putting them into circulation which
shall be given for a period of 10 years, including the
period of the provisional authorisation referred to in
paragraph 4,
through the adoption of a regulation
than 1 October 2003 and
taking effect no later
included in Chapter I of the list referred to in Article
9t(b).

measures, they shall contain a reference to this Directive or
shall be accompanied by such reference on the occasion of
their official publication. The methods of making such
reference shall be laid down by Member States.

2. Member States shall communicate to the Commission the
main provisions of national law which they adopt in the field
covered by this Directive.

7. The provisions of Article 9b (3)

shall apply mutatis

mutandis.(cid:146)

Article 3

Article 2

This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Communities.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 30 September 1999. They shall forthwith inform
the Commission thereof. When Member States adopt these

Article 4

This Directive is addressed to the Member States.