Commission Regulation (EC) No 186/2007 of 21 February 2007 concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed additive (Text with EEA relevance )
Date: 2007-02-21
Institutions: European Commission
Subjects: animal feedingstuffs, equidae, food additive, food safety, market approval, zootechnics

L 63/6

EN

Official Journal of the European Union

1.3.2007

COMMISSION REGULATION (EC) No 186/2007

of 21 February 2007

concerning the authorisation of a new use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed additive

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European Commu-
nity,

the
Having regard to Regulation (EC) No 1831/2003 of
the Council of 22 September
European Parliament and of
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 authorisa-
tion of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.

(2)

(3)

(4)

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.

The application concerns authorisation of a new use of the
preparation Saccharomyces cerevisiae (NCYC Sc 47) (Biosaf SC
47) as a feed additive for horses to be classified in the
additive category ‘zootechnical additives’.

The method of analysis included in the application for
authorisation in accordance with Article 7(3)(c) of Regula-
tion (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).

(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, p. 1, as corrected by OJ L 191, 28.5.2004,
p. 1. Regulation as last amended by Council Regulation (OJ L 363,
20.12.2006, p. 1).

for

cattle

for piglets

authorised for

The use of the preparation of Saccharomyces cerevisiae (NCYC
fattening by
Sc 47) was
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 (3)
(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 (4)
for sows, by Commission Regulation (EC) No 1288/2004
concerning the permanent authorisation of certain addi-
tives and the provisional authorisation of a new use of an
additive already authorised in feedingstuffs (5) 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 (6) for
dairy cows, by Commission Regulation (EC) No 1811/2005
of 4 November 2005 (7) concerning the provisional and
permanent authorisation of certain additives in feeding-
stuffs and the provisional authorisation of a new use of an
additive already authorised in feedingstuffs and for lambs
for fattening by Commission Regulation No 1447/2006 of
29 September 2006 concerning the authorisation of a new
use of Saccharomyces cerevisiae (Biosaf SC 47) as a feed
additive (8).

(6) New data were submitted in support of the application for
authorisation for horses. The European Food Safety
Authority (the Authority) concluded in its opinion of
12 September 2006 that the preparation of Saccharomyces
cerevisiae (NCYC Sc 47) does not have an adverse effect on
animal health, human health or the environment (9).
It
further concluded that the preparation of Saccharomyces
cerevisiae (NCYC Sc 47) does not present any other risk for
this additional animal category which would, in accordance
with Article 5(2) of Regulation (EC) No 1831/2003,
exclude authorisation. According to that opinion, the use
in improving fibre
of

that preparation is efficacious

(3) OJ L 46, 20.2.2003, p. 15.
(4) 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).

(5) 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).

(6) OJ L 99, 19.4.2005, p. 5. Regulation as amended by (EC) No 2028/

2006 (OJ L 414, 30.12.2006, p. 26).

(7) OJ L 291, 5.11.2005, p. 12.
(8) OJ L 271, 30.9.2006, p. 28.
(9) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the safety and efficacy of the
product ‘Biosaf Sc 47’, a preparation of Saccharomyces cerevisiae as a
feed additive for horses. Adopted on 12 September 2006 The EFSA
Journal (2006) 384, p. 1-9.

1.3.2007

EN

Official Journal of the European Union

L 63/7

digestion in horses. 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,
that preparation should be
authorised, as specified in the Annex to this Regulation.

the use of

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive
category ‘zootechnical additives’ and to the functional group
‘digestibility enhancers’, is authorised as an additive in animal
nutrition subject to the conditions laid down in that Annex .

(7)

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 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, 21 February 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

ANNEX

Identi-fication
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

Category of zootechnical additives. Functional group: digestibility enhancers.

Minimum
content

Maximum
content

CFU/kg of complete feeding-
stuff with a moisture content of
12 %

Other provisions

End of period of
authori-sation

4b1702

Société Industrielle
Lesaffre

Saccharomyces cere-
visiae NCYC Sc 47

(Biosaf Sc 47)

Additive composition
Preparation of Saccharomyces cerevisiae
NCYC Sc 47 containing a minimum of 5
x 109 CFU/g

Characterisation of active substance
Saccharomyces cerevisiae NCYC Sc 47

Analytical methods (1)

Pour plate method using a chloramphe-
nicol yeast extract agar based on the ISO
7954 method.

Polymerase chain reaction (PCR)

Horses

8x108

7x109

21.3.2017

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

Recommended doses:

1,25x1010_ 6x1010 CFU per
head per day.

(1) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

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