Commission Regulation (EC) No 2562/1999 of 3 December 1999 linking the authorisation of certain additives belonging to the group of antibiotics in feedingstuffs to persons responsible for putting them into circulation (Text with EEA relevance)
Date: 1999-12-03
Institutions: European Commission
Subjects: animal nutrition, antibiotic, food additive, foodstuffs legislation

4. 12. 1999

EN

Official Journal of the European Communities

L 310/11

COMMISSION REGULATION (EC) No 2562/1999

of 3 December 1999

linking the authorisation of certain additives belonging to the group of antibiotics in feedingstuffs
to persons responsible for putting them into circulation

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Commission Regulation (EC) No 2439/1999 (2),
and in particular Article 9h(3)(b) and Article 9i(3)(b), thereof,

Whereas:

(1)

(2)

(3)

(4)

additives, Directive

because of the risk for human and animal health posed
by the circulation in the Community of poor copies of
zootechnical
as
amended by Council Directive 96/51/EC (3), provides for
the linking of the authorisation of certain classes of
additives to the person responsible for putting them into
circulation;

70/524/EEC,

in particular Article 9h of Directive 70/524/EEC
provides for the replacement of the provisional author-
isations of additives included in Annex I after 31
December 1987 and belonging to the group of antibi-
otics and transferred to Chapter II of Annex B, by
authorisations linked to the person responsible for
putting them into circulation for a period of ten years;

in particular Article 9i of Directive 70/524/EEC provides
for the replacement of the provisional authorisations of
additives included in Annex II before 1 April 1998 and
belonging to the group of antibiotics and transferred to
Chapter III of Annex B by provisional authorisations
linked to the person responsable for putting them into
circulation;

the additives listed in the Annexes to this Regulation
were the subject of new applications for authorisation
by the person responsible for the dossier on the basis of
which the former authorisations were given or by their
successors. The applications relating to those additives
were accompanied by the required monographs and
identification notes;

the following:

fresh assessment of the additives. Although the author-
isations under this Regulations are granted for a speci-
fied period, they may be withdrawn at any time in
accordance with Article 9m and Article 11 of Directive
70/524/EEC. They may be withdrawn in particular in
the Scientific Steering
the light of
Committee has issued an opinion on antimicrobial resis-
tance on 28 May 1999; a re-evaluation of the use of
certain antibiotics
is
currently being undertaken under Article 9g of Directive
70/524/EEC; the Kingdom of Sweden has prohibited the
use on its territory of all antibiotics as additives in
feedingstuffs on the basis of Article 11 of Directive
70/524/EEC. Moreover, the Commission is examining
the data provided and the more general question of
whether the use of antibiotics as additives in feeding-
stuffs meets the conditions set out in Article 3a of
Directive 70/524/EEC for the authorisation of additives;

in feedingstuffs

additives

as

(6)

the measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The provisional authorisations of the additives listed in the
Annex I
to this Regulation are replaced by authorisations
granted to the person responsible for putting the additive in
inserted in the second column of the Annex I.
circulation,

Article 2

The provisional authorisations of the additives listed in Annex
II to this Regulation are replaced by provisional authorisations
granted to the person responsible for putting the additive into
circulation,

inserted in the second column of Annex II.

(5)

the linking of the authorisation to a person responsible
for putting the additive into circulation is based on a
purely administrative procedure and did not entail a

Article 3

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 297, 18.11.1999, p. 8.
(3) OJ L 235, 17.9.1996, p. 39.

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

L 310/12

EN

Official Journal of the European Communities

4. 12. 1999

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

Done at Brussels, 3 December 1999.

For the Commission

David BYRNE

Member of the Commission

4. 12. 1999

EN

Official Journal of the European Communities

L 310/13

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EN

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EN

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