Commission Regulation (EC) No 666/2003 of 11 April 2003 provisionally authorising the use of certain micro-organisms in feedingstuffs (Text with EEA relevance)
Date: 2003-04-11
Institutions: European Commission
Subjects: animal nutrition, foodstuffs legislation, microorganism

12.4.2003

EN

Official Journal of the European Union

L 96/11

COMMISSION REGULATION (EC) No 666/2003

of 11 April 2003

provisionally authorising the use of certain micro-organisms in feedingstuffs

(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 Regulation (EC) No 1756/2002 (2), and in parti-
cular Articles 3 and 9e(1) thereof,

Whereas:

Directive 70/524/EEC requires that no additive may be
put into circulation unless a Community authorisation
has been granted.

In the case of additives referred to in Part II of Annex C
to Directive. 70/524/EEC, which include micro-organ-
isms, provisional authorisation of a new additive for use
in feedingstuffs may be given if the conditions laid down
that Directive are satisfied, and if it is reasonable to
assume, in view of the available results, that when used
in animal nutrition it has one of the effects referred to in
Article 2(a) of that Directive. Such provisional authorisa-
tion may be given for a period not exceeding four years.

The assessment of
the application for authorisation
submitted, in respect of the micro-organism preparation,
specified in the Annex to this Regulation, shows that the
conditions referred to in Article 9e(1) of Directive 70/
524/EEC are satisfied.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

The Scientific Committee for Animal Nutrition has de-
livered a favourable opinion on the safety of the prepara-
tion, which belongs to the group ‘Micro-organisms’,
under the conditions set out in the Annex to this Regu-
lation for piglets and pigs for fattening.

The assessment of the application shows that certain
procedures are required to protect workers from expo-
sure to the additives set out in the Annexe. However,
such protection is assured by the application of Council
Directive 89/391/EEC of 12 June 1989 on the introduc-
tion of measures to encourage improvements in the
safety and health of workers at work (3).

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION

Article 1

The additive belonging to the group ‘Microorganisms’ referred
to in the Annex is authorised for use as an additive in feeding-
stuffs under the conditions laid down in the Annex.

Article 2

The micro-organism preparation should therefore be
authorised on a provisional basis for a period of four
years.

into force on the third day
This Regulation shall enter
following that of its publication in the Official Journal of the
European Union.

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

Done at Brussels, 11 April 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.

(3) OJ L 183, 29.6.1989, p. 1.

ANNEX

No (or
EC No)

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Minimum content

Maximum content

CFU/kg of complete feedingstuff

Other provisions

End of period of
authorisation

‘Microorganisms

22

Enterococcus
faecium
DSM 7134

Enterococcus
of
Preparation
faecium containing a minimum of:
Powder: 1 × 1010 CFU/g of additive
Granules (micro-encapsulated):
1 × 1010 CFU/g of additive

Piglets

0,5 ×109

4 × 109

The directions for use must indicate
storage temperature,
life and
pelleting stability of the additive and
the premixture

shelf

15.4.2007

Pigs for fattening

0,2 × 109

1 × 109’

L

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