Commission Regulation (EC) No 2316/98 of 26 October 1998 concerning authorisation of new additives and amending the conditions for authorisation of a number of additives already authorised in feedingstuffs (Text with EEA relevance)
Date: 1998-10-26
Institutions: European Commission
Subjects: adjuvant, animal health, animal nutrition, foodstuffs legislation, public health, veterinary drug

L 289/4

EN

Official Journal of the European Communities

28. 10. 98

COMMISSION REGULATION (EC) No 2316/98

of 26 October 1998

concerning authorisation of new additives and amending the conditions for
authorisation of a number of additives already authorised in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

the additive Ethoxyquin, belonging to the group ‘Anti-
oxidants', should be reduced;

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 Directive 98/19/EC (2),
and in particular Articles 9j and 3 thereof,

Whereas a new use for an additive belonging to Part 1
‘Carotenoids and xanthophylls' of the group ‘Colouring
matters including pigments' which has already been
authorised has been successfully tested in some Member
States; whereas the new use should be provisionally
authorised;

Whereas Directive 70/524/EEC provides that new addi-
tives or uses of additives may be authorised,
taking
account of advances in scientific and technical know-
ledge;

Whereas a new use for the additive 3-phytase belonging
to the group ‘Enzymes' which has already been authorised
has been successfully tested in some Member States;
whereas the new use should be provisionally authorised;

Whereas Council Directive 96/51/EC of 23 July 1996
amending Directive 70/524/EEC concerning additives in
feedingstuffs (3) lays down a new procedure for the author-
isation of additives by Regulation, which will be fully
applicable from 1 October 1999; whereas during the
transitional period the Member States must be able to
adopt legal provisions to prevent any confusion as to the
legislation in force; whereas the Member States must
ensure that all legislation not complying with this Regula-
tion is repealed;

Whereas new additives belonging to Part 1 ‘Carotenoids
and xanthophylls' of
the group ‘Colouring matters
including pigments' have been successfully tested in
certain Member States; whereas the new additives should
be provisionally authorised;

Whereas, in the interests of transparency, the Annexes to
this Regulation include, where appropriate, other addi-
tives belonging to the same group or other authorised
uses of the additive; whereas it is appropriate to extend by
a specific period the deadline for authorisation of addi-
tives, which are already authorised at national level but
study of which has not been completed, belonging to the
same groups of additives as the substances newly author-
ised by this Regulation;

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

Whereas, in order to distinguish a new additive belonging
to Part 1 ‘Carotenoids and xanthophylls' of the group
from another
‘Colouring matters including pigments'
additive belonging to the same group which has already
been authorised,
should be
changed;

the name of

the latter

and more

Whereas new additives belonging to the group ‘Trace
elements',
elements
‘Copper-Cu',
‘Manganese-Mn' and ‘Zinc-Zn', have been
widely tested in some Member States; whereas, on the
basis of the studies carried out, it appears that these new
additives can be authorised;

specifically

to the

Whereas, to prevent any negative effects on dogs, the
maximum permitted level in a complete feedingstuff of

(1) OJ L 270, 14. 12. 1970, p. 1.
(2) OJ L 96, 28. 3. 1998, p. 39.
(3) OJ L 235, 17. 9. 1996, p. 39.

HAS ADOPTED THIS REGULATION:

Article 1

Beta-carotene, belonging to Part 1 ‘Carotenoids and
1.
xanthophylls' of the group ‘Colouring matters including
pigments', may be
authorised in accordance with
Directive 70/524/EEC as additive E 160a in feedingstuffs
under the conditions laid down in Annex I to this Regu-
lation.

2. Astaxanthin-rich Phaffia rhodozyma (ATCC 74219),
belonging to Part 1 ‘Carotenoids and xanthophylls' of the
group ‘Colouring matters including pigments', may be
authorised in accordance with Directive 70/524/EEC as
additive 12 in feedingstuffs under the conditions laid
down in Annex I to this Regulation.

28. 10. 98

EN

Official Journal of the European Communities

L 289/5

The substance ‘cupric chelate of

3.
amino acids
hydrate', belonging to the group ‘Trace elements',
element E4 ‘Copper-Cu', shall be authorised in accord-
ance with Directive 70/524/EEC as an additive in
feedingstuffs under the conditions laid down in Annex II
to this Regulation.

4.
The substance ‘manganese chelate of amino hydrate',
belonging to the group ‘Trace elements', element E5
‘Manganese-Mn', shall be authorised in accordance with
Directive 70/524/EEC as an additive in feedingstuffs
under the conditions laid down in Annex II to this Regu-
lation.

5.
The substance ‘zinc chelate of amino acids hydrate',
belonging to the group ‘Trace elements', element E6
‘Zinc-Zn',
authorised in accordance with
Directive 70/524/EEC as an additive in feedingstuffs
under the conditions laid down in Annex II to this Regu-
lation.

shall be

Article 2

1.
The conditions for authorisation of the additive E
324 Ethoxyquin, belonging to the group ‘Antioxidants',
shall be replaced in accordance with Directive 70/

524/EEC by the conditions laid down in Annex III to this
Regulation.

2. Additive E161g Canthaxanthin, belonging to Part 1
‘Carotenoids and xanthophylls' of the group ‘Colouring
matters including pigments' for the category of ‘Pet and
ornamental birds', may be authorised in accordance with
Directive 70/524/EEC under the conditions laid down in
Annex I to this Regulation.

3. Additive 3-phytase (EC 3.1.3.8), belonging to the
group ‘Enzymes', may be authorised in accordance with
Directive 70/524/EEC under the conditions laid down in
Annex IV to this Regulation.

4. Additive 11, Astaxanthin-rich Phaffia rhodozyma,
belonging to Part 1 ‘Carotenoids and xanthophylls' of the
group ‘Colouring matters including pigments'
for the
category of animal ‘Salmon, trout', may be authorised in
accordance with Directive 70/524/EEC under the condi-
tions laid down in Annex I to this Regulation.

Article 3

This Regulation shall enter into force on the 20th day
following its publication in the Official Journal of the
European Communities.

It shall apply from 15 December 1998.

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

Done at Brussels, 26 October 1998.

For the Commission
Franz FISCHLER

Member of the Commission

L 289/6

EN

Official Journal of the European Communities

28. 10. 98

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Official Journal of the European Communities

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EN

Official Journal of the European Communities

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EN

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