Official Journal of the European Union

L 162/65


of 29 April 2004

concerning the provisional authorization of a new use of an additive already authorized in feedingstuffs (Saccharomyces cerevisiae)

(Text with EEA relevance)


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 particular Articles 3 and 9e(1) thereof,



Directive 70/524/EEC provides 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, which includes micro-organisms, provisional authorisation of a new use of an additive already authorised may be given if the conditions laid down in 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 authorisation may be given for a period not exceeding four years in the case of additives referred to in Part II of Annex C to that Directive.


The use of the micro-organism preparation of Saccharomyces cerevisiae (MUCL 39885) has been provisionally authorised, for the first time, for piglets and cattle for fattening by Commission Regulation (EC) No 1411/1999 (3).


New data were submitted in support of an application to extend the authorisation of this additive to dairy cows.


The assessment of the application for authorisation submitted in respect of the new use of this additive, shows that the conditions provided for in Directive 70/524/EEC for provisional authorisation are satisfied.


The European Food Safety Authority (Scientific Panel on Additives and Products or Substances Used in Animal Feed) delivered a favourable opinion on 27 January 2004 on the safety of the additive when used in the animal category dairy cows, under the conditions of use set out in the annex to this Regulation.


The use of this additive for dairy cows should therefore be provisionally authorised for a period of four years.


The assessment of the application shows that certain procedures should be required to protect workers from exposure to the additive set out in the Annex. Such protection should be assured by the application of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (4).


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


Article 1

The preparation belonging to the group ‘Micro-organisms’ as set out in the Annex is provisionally authorised for use as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 29 April 2004.

For the Commission


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 164, 30.6.1999, p. 56.

(4)  OJ L 183, 29.6.1989, p. 1.



(or EC No.)


Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff



Saccharomyces cerevisiae

MUCL 39885

Preparation of Saccharomyces cerevisiae containing a minimum of:

Powder, spheric and oval granulated forms:

1 × 109 CFU/g additive

Dairy cows

1,23 × 109

2,33 × 109

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

The quantity of Saccharomyces cerevisiae in the daily ration must not exceed 8,4 × 109 CFU per 100 kg body weight till 600 kg. Over 600 kg add 0,9 × 109 CFU for each additional 100 kg body weight.