# COMMISSION REGULATION (EC) No 322/2009

of 20 April 2009

concerning the permanent authorisations of certain additives in feedingstuffs

(Text with EEA relevance)

## Preamble

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 set out 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-xylanase produced b *y Bacillus subtilis* (LMG S-15136) was provisionally authorised for laying hens by Commission Regulation (EC) No 358/2005 [^3] . It was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1259/2004 [^4] , for piglets (weaned) by Commission Regulation (EC) No 1206/2005 [^5] , for pigs for fattening and turkeys for fattening by Commission Regulation (EC) No 516/2007 [^6] and for 10 years for ducks by Commission Regulation (EC) No 242/2007 [^7] . New data were submitted in support of an application for authorisation without a time limit of that enzyme preparation for laying hens. 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 Annex I to this Regulation, should be authorised without a time limit.

**(6)** The use of the enzyme preparation of endo-1,4-beta-xylanase produced by *Trichoderma longibrachiatum* (IMI SD 135) was provisionally authorised for laying hens, pigs for fattening and weaned piglets by Commission Regulation (EC) No 1436/1998 [^8] . It was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 2148/2004 [^9] , for turkeys for fattening by Commission Regulation (EC) No 828/2007 [^10] . New data were submitted in support of an application for authorisation without a time limit of that enzyme preparation for laying hens and weaned piglets. 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 Annex II to this Regulation, should be authorised without a time limit.

**(7)** The use of the enzyme preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by *Penicillium funiculosum* (IMI SD 101) was provisionally authorised for piglets (weaned) and ducks for fattening by Regulation (EC) No 2148/2004. It was authorised for chickens for fattening without a time limit by Regulation (EC) No 1259/2004, for laying hens and turkeys for fattening by Commission Regulation (EC) No 943/2005 [^11] and for pigs for fattening by Regulation (EC) No 1206/2005. New data were submitted in support of an application for authorisation without a time limit of that enzyme preparation for ducks for fattening and weaned piglets. 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 Annex III to this Regulation, should be authorised without a time limit.

**(8)** 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 belonging to the group ‘Enzymes’, as specified in Annex I, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.

## **Article 2**

The preparation belonging to the group ‘Enzymes’, as specified in Annex II, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.

## **Article 3**

The preparation belonging to the group ‘Enzymes’, as specified in Annex III, is authorised without a time limit as additive in animal nutrition under the conditions laid down in that Annex.

## **Article 4**

This Regulation shall enter into force on the 20th day following its publication in the *Official Journal of the European Union* .

## Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 April 2009. *For the Commission* Androulla VASSILIOU *Member of the Commission*

[^1] [OJ L 270, 14.12.1970, p. 1](http://publications.europa.eu/resource/oj/JOL_1970_270_R_TOC) .

[^2] [OJ L 268, 18.10.2003, p. 29](http://publications.europa.eu/resource/oj/JOL_2003_268_R_TOC) .

[^3] [OJ L 57, 2.3.2005, p. 3](http://publications.europa.eu/resource/oj/JOL_2005_057_R_TOC) .

[^4] [OJ L 239, 9.7.2004, p. 8](http://publications.europa.eu/resource/oj/JOL_2004_239_R_TOC) .

[^5] [OJ L 197, 28.7.2005, p. 12](http://publications.europa.eu/resource/oj/JOL_2005_197_R_TOC) .

[^6] [OJ L 122, 11.5.2007, p. 22](http://publications.europa.eu/resource/oj/JOL_2007_122_R_TOC) .

[^7] [OJ L 73, 13.3.2007, p. 1](http://publications.europa.eu/resource/oj/JOL_2007_073_R_TOC) .

[^8] [OJ L 191, 7.7.1998, p. 15](http://publications.europa.eu/resource/oj/JOL_1998_191_R_TOC) .

[^9] [OJ L 370, 17.12.2004, p. 24](http://publications.europa.eu/resource/oj/JOL_2004_370_R_TOC) .

[^10] [OJ L 184, 14.7.2007, p. 12](http://publications.europa.eu/resource/oj/JOL_2007_184_R_TOC) .

[^11] [OJ L 159, 22.6.2005, p. 6](http://publications.europa.eu/resource/oj/JOL_2005_159_R_TOC) .

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 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 form: 100 IU [^1] /g or ml Laying hens - 10 IU - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. Recommended dose per kg of complete feedingstuff: 10 IU 3. For use in compound feed rich in arabinoxylan, e.g. containing minimum 40 % wheat or barley. Without a time limit.

[^1] 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.’

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 1617 Endo-1,4-beta-xylanase EC 3.2.1.8 Preparation of endo-1,4-beta-xylanase produced by *Trichoderma longibrachiatum* (IMI SD 135) having a minimum activity of: Solid form: 6 000 EPU [^1] /g Liquid form: 6 000 EPU/ml Laying hens - 1 050 EPU - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. Recommended dose per kg of complete feedingstuff: 1 050 – 1 500 EPU. 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat or maize. Without a time limit. Piglets (weaned) - 1 500 EPU - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. Recommended dose per kg of complete feedingstuff: 1 500 – 3 000 EPU. 3. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat. 4. For use in weaned piglets until approximately 35 kg Without a time limit.

[^1] 1 EPU is the amount of enzyme which liberates 0,0083 micromoles of reducing sugars (xylose equivalents) from oat spelt xylan per minute at pH 4,7 and 30 °C.’

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 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 [^1] /g Endo-1,4-beta-xylanase: 1 400 U [^2] /g liquid form Endo-1,3(4)-beta-glucanase: 500 U/ml Endo-1,4-beta-xylanase: 350 U/ml Ducks for fattening - Endo-1,3(4)-beta-glucanase: 100 U Endo-1,4-beta-xylanase: 70 U - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. 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 betaglucans and arabinoxylans), e.g. containing more than 50 % barley or 60 % wheat. Without a time limit. Piglets (weaned) - Endo-1,3(4)-beta-glucanase: 100 U Endo-1,4-beta-xylanase: 70 U - 1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. 2. 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 betaglucans and arabinoxylans), e.g. containing more than 30 % barley or 20 % wheat. 4. For use in weaned piglets until approximately 35 kg. Without a time limit.

[^1] 1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley betaglucan per minute at pH 5,0 and 50 °C.

[^2] 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.’

[^1]: 1 U is the amount of enzyme which liberates 5,55 micromoles of reducing sugars (maltose equivalents) from barley betaglucan per minute at pH 5,0 and 50 °C.
[^2]: 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.’
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