COMMISSION REGULATION

(EC) No 1206/2005

of 27 July 2005

concerning the permanent authorisation of certain additives 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), and in particular Articles 3 and 9d(1) thereof,

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(2), and in particular Article 25 thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

(2) Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.

(3) The applications for authorisation of the additives listed in the Annexes to this Regulation were submitted before the date of application of Regulation (EC) No 1831/2003.

(4) Initial comments on those applications, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. Those applications are therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.

(5) The use of the enzyme preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by

Trichoderma longibrachiatum

(ATCC 74 252) was provisionally authorised for the first time for turkeys for fattening, by Commission Regulation (EC) No 937/2001(3). New data were submitted in support of an application for authorisation without a time-limit of that enzyme preparation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that enzyme preparation, as specified in the Annex, should be authorised without a time-limit.

(6) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced from

Penicillium funiculosum

(IMI SD101) was provisionally authorised for the first time for pigs for fattening by Commission Regulation (EC) No 418/2001(4). New data were submitted in support of an application for authorisation without a time-limit of that enzyme preparation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that enzyme preparation, as specified in the Annex, should be authorised without a time-limit.

(7) The use of the enzyme preparation of endo-1,4-beta-xylanase produced by

Bacillus subtilis

(LMG S-15136) was provisionally authorised for the first time for piglets, by Regulation (EC) No 937/2001. New data were submitted in support of an application for authorisation without a time-limit of that enzyme preparation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that enzyme preparation, as specified in the Annex, should be authorised without a time-limit.

(8) The use of the enzyme preparation of endo-1,3(4)-beta-glucanase produced by

Trichoderma longibrachiatum

(ATCC 2106), endo-1,4-beta-xylanase produced by

Trichoderma longibrachiatum

(ATCC 2105) and subtilisin produced by

Bacillus subtilis

(ATCC 2107) was provisionally authorised for the first time for chickens for fattening, by Commission Regulation (EC) No 1636/1999(5). New data were submitted in support of an application for authorisation without a time-limit of that enzyme preparation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that enzyme preparation, as specified in the Annex, should be authorised without a time-limit.

(9) The assessment of those applications shows that certain procedures should be required to protect workers from exposure to the additives set out in the Annexes. 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(6).

(10) 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 preparations belonging to the group ‘Enzymes’, as specified in the Annex, are authorised for use without a time-limit as additives 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 Union

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

Done at Brussels, 27 July 2005.

For the Commission

Neelie

KROES

Member of the Commission

(1)

OJ L 270, 14.12.1970, p. 1

. Directive as last amended by Commission Regulation (EC) No 1800/2004 (

OJ L 317, 16.10.2004, p. 37

(2)

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

(3)

OJ L 130, 12.5.2001, p. 25

(4)

OJ L 62, 2.3.2001, p. 3

(5)

OJ L 194, 27.7.1999, p. 17

(6)

OJ L 183, 29.6.1989, p. 1

. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (

OJ L 284, 31.10.2003, p. 1

ANNEX

EC No

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff

Enzymes

E 1602

Endo-1,4-beta-glucanase

EC 3.2.1.4

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-glucanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 74 252) having a minimum activity of:

liquid and granular form:

endo-1,4-beta-glucanase: 8 000 U(1)/ml or g

endo-1,3(4)-beta-glucanase: 18 000 U(2)/ml or g

endo-1,4-beta-xylanase: 26 000 U(3)/ml or g

Turkeys for fattening

—

Endo-1,4-beta-glucanase: 400 U

—

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

Recommended dose per kg of complete feedingstuff:

endo-1,4-beta-glucanase: 400-800 U

endo-1,3(4)-beta-glucanase: 900-1 800 U

endo-1,4-beta-xylanase: 1 300-2 600 U

3.	For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans and beta-glucans), e.g. containing more than 25 % wheat or 20 % barley and 5 % rye

Without a time-limit

Endo-1,3(4)-beta-glucanase: 900 U

—

Endo-1,4-beta-xylanase: 1 300 U

—

E 1604

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced from Penicillium funiculosum (IMI SD101) having a minimum activity of:

powder form:

endo-1,3(4)-beta-glucanase: 2 000 U(4)/g

endo-1,4-beta-xylanase: 1 400 U(5)/g

liquid form:

endo-1,3(4)-beta-glucanase: 500 U/ml

endo-1,4-beta-xylanase: 350 U/ml

Pigs for fattening

—

Endo-1,3(4)-beta-glucanase: 100 U

—

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

Recommended dose per kg of complete feedingstuff:

endo-1,3(4)-beta-glucanase: 100 U

endo-1,4-beta-xylanase: 70 U

3.	For use in compound feed rich in non-starch polysaccharides (mainly beta glucans and arabinoxylans), e.g. containing more than 40 % barley or 20 % wheat

Without a time-limit

Endo-1,4-beta-xylanase: 70 U

—

E 1606

Endo-1,4-beta-xylanase

EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Bacillus subtilis (LMG S-15136) having a minimum activity of:

solid and liquid forms:

100 IU(6)/g or ml

Piglets (weaned)

—

10 IU

—

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

Recommended dose per kg of complete feedingstuff:

endo-1,4-beta-xylanase: 10 IU

3.	For use in compound feed rich in arabinoxylan, e.g. minimum 40 % wheat or barley

4.	For use in weaned piglets up to approximately 35 kg

Without a time-limit

E 1633

Endo-1,3(4)-beta-glucanase

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Subtilisin

EC 3.4.21.62

Preparation of endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (ATCC 2106), endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (ATCC 2105) and subtilisin produced by Bacillus subtilis (ATCC 2107) having a minimum activity of:

solid form:

endo-1,3(4)-beta-glucanase: 100 U(7)/g

endo-1,4-beta-xylanase: 300 U(8)/g

subtilisin: 800 U(9)/g

Chickens for fattening

—

Endo-1,3(4)-beta-glucanase: 30 U

—

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

Recommended dose per kg of complete feedingstuff:

endo-1,3(4)-beta-glucanase: 30-100 U

endo-1,4-beta-xylanase: 90-300 U

subtilisin: 240-800 U

3.	For use in compound feed, e.g. containing more than 60 % barley

Without a time-limit

Endo-1,4-beta-xylanase: 90 U

—

Subtilisin: 240 U

—

(1) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from carboxymethylcellulose per minute at pH 5,0 and 40 °C.

(2) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from barley beta-glucan per minute at pH 5,0 and 40 °C.

(3) 1 U is the amount of enzyme which liberates 0,1 micromoles of glucose from oat spelt xylan per minute at pH 5,0 and 40 °C.

(4) 1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley beta-glucan per minute at pH 5,0 and 50 °C.

(5) 1 U is the amount of enzyme which liberates 4,00 micromoles of reducing sugars (maltose equivalents) from birchwood xylan per minute at pH 5,5 and 50 °C.

(6) 1 IU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from birchwood xylan per minute at pH 4,5 and 30 °C.

(7) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 5,0 and 30 °C.

(8) 1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 5,3 and 50 °C.

(9) 1 U is the amount of enzyme which liberates 1 microgram of phenolic compound (tyrosine equivalents) from a casein substrate per minute at pH 7,5 and 40 °C.