Consolidated versions
THE COMMISSION OF
THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament
and of the Council of 22 September 2003 on additives for use in animal nutrition
[1], and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of
additives for use in animal nutrition and for the grounds and procedures for
granting such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an
application was submitted for the authorisation of the preparation set out in
the Annex. That application was accompanied by the particulars and documents
required under Article 7(3) of that Regulation.
(3) The application concerns authorisation of a new use of the
preparation Saccharomyces cerevisiae (NCYC Sc 47) (Biosaf SC 47) as a feed
additive for lambs for fattening, to be classified in the additive category
"zootechnical additives".
(4) The method of analysis included in the application for authorisation
in accordance with Article 7(3)(c) of Regulation (EC) No 1831/2003 concerns the
determination of the active substance of the feed additive in feed. The method
of analysis referred to in the Annex to this Regulation is therefore not to be
understood as a Community method of analysis within the meaning of Article 11 of
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29
April 2004 on official controls performed to ensure the verification of
compliance with feed and food law, animal health and animal welfare rules
[2].
(5) The use of the preparation of Saccharomyces cerevisiae (NCYC Sc 47)
was authorised for dairy cows by Commission Regulation (EC) No 1811/2005 of 4
November 2005 [3] concerning the provisional and permanent authorisation of
certain additives in feedingstuffs and the provisional authorisation of a new
use of an additive already authorised in feedingstuffs, for cattle for fattening
by Commission Regulation (EC) No 316/2003 of 19 February 2003 concerning the
permanent authorisation of an additive in feedingstuffs and the provisional
authorisation of a new use of an additive already authorised in feedingstuffs
[4], for piglets (weaned) by Commission Regulation (EC) No 2148/2004 of 16
December 2004 concerning the permanent and provisional authorisation of certain
additives in feedingstuffs and the authorisation of a new use of an additive
already authorised in feedingstuffs [5], for sows by Commission Regulation (EC)
No 1288/2004 of 14 July 2004 concerning the permanent authorisation of certain
additives and the provisional authorisation of a new use of an additive already
authorised in feedingstuffs [6] and for rabbits for fattening by Commission
Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for
10 years of a coccidiostat as an additive in feedingstuffs, the provisional
authorisation of an additive and the permanent authorisation of certain
additives in feedingstuffs [7]. New data were submitted in support of an
application for authorisation for lambs for fattening. In its assessment, the
European Food Safety Authority (the Authority) concludes that the safety of this
organism (and its growth medium) for the consumer, the user and the environment
have already been established and will not be changed by the proposed new use.
It further concludes that the use of the preparation does not present a risk for
this additional animal category and that the use of that preparation can improve
average daily weight gain in lambs for fattening. The Authority does not
consider that there is a need for specific requirements of post-market
monitoring. This opinion also verifies the report on the method of analysis of
the feed additive in feed submitted by the Community Reference Laboratory set up
by Regulation (EC) No 1831/2003. The assessment of that preparation shows that
the conditions for authorisation, provided for in Article 5 of Regulation (EC)
No 1831/2003, are satisfied. Accordingly, the use of that preparation should be
authorised, as specified in the Annex to this Regulation.
(6) 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 preparation specified in the Annex, belonging to the additive
category "zootechnical additives" and to the functional group "gut flora
stabilisers", is authorised as an additive in animal nutrition subject to the
conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the 20th day following 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, 29 September 2006.
For the Commission
Markos Kyprianou
Member of the Commission
[1] OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission
Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
[2] OJ L 165, 30.4.2004, as corrected by OJ L 191, 28.5.2004, p. 1.
Regulation as amended by Commission Regulation (EC) No 776/2006 (OJ L 136,
24.5.2006, p. 3).
[3] OJ L 291, 5.11.2005, p. 12.
[4] OJ L 46, 20.2.2003, p. 15.
[5] OJ L 370, 17.12.2004, p. 24. Regulation as amended by Regulation (EC)
No 1980/2005 (OJ L 318, 6.12.2005, p. 3).
[6] OJ L 243, 15.7.2004, p. 10. Regulation as amended by Regulation (EC)
No 1812/2005 (OJ L 291, 5.11.2005, p. 18).
[7] OJ L 99, 19.4.2005, p. 5.
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ANNEX
Identification number of the additive | Name of the holder of
authorisation | Additive (Trade name) | Composition, chemical formula,
description, analytical method | Species or category of animal | Maximum age |
Minimum content | Maximum content | Other provisions | End of period of
authorisation |
CFU/kg of complete feedingstuff with a moisture content of 12 % |
Category of zootechnical additives. Functional group: gut flora
stabilisers.
E 1702 | LFA Lesaffre Feed Additives | Saccharomyces cerevisiae (NCYC Sc
47) (Biosaf Sc 47) | Additive composition:Saccharomyces cerevisiae (NCYC Sc
47)Preparation containing a minimum of 5 × 109 CFU/g of additiveAnalytical
methods [1]Pour plate method using a chloramphenicol yeast extract agar based on
the ISO 7954 methodPolymerase chain reaction (PCR) | Lambs for fattening | — |
1,4 × 109 | 1,4 × 1010 | In the directions for use of the additive and
premixture, indicate the storage temperature, storage life and stability to
pelleting. (Stable for pellets at a temperature up to 83 °C) | 10 years from the
date o
