# L_2005291EN.01000501.xml

| 5.11.2005 | EN | Official Journal of the European Union | L 291/5 |
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5.11.2005

EN

Official Journal of the European Union

L 291/5

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COMMISSION REGULATION (EC) No 1810/2005

of 4 November 2005

concerning a new authorisation for 10 years of an additive in feedingstuffs, the permanent authorisation of certain additives in feedingstuffs and the provisional authorisation of new uses of certain additives already authorised 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, 9, 9d(1) and 9e(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. |
| --- | --- |

(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. |
| --- | --- |

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

The applications for the 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. |
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(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 growth promoter ‘Formi LHS (potassium diformate)’ was provisionally authorised, for the first time, for piglets and pigs for fattening by Commission Regulation (EC) No 1334/2001 (3). The person responsible for putting into circulation ‘Formi LHS (potassium diformate)’ submitted an application to obtain a definitive authorisation for 10 years. 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 this preparation, as specified in Annex I, should be authorised for 10 years. |
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(5)

The use of the growth promoter ‘Formi LHS (potassium diformate)’ was provisionally authorised, for the first time, for piglets and pigs for fattening by Commission Regulation (EC) No 1334/2001 (3). The person responsible for putting into circulation ‘Formi LHS (potassium diformate)’ submitted an application to obtain a definitive authorisation for 10 years. 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 this preparation, as specified in Annex I, should be authorised for 10 years.

| (6) | The use of the additive ‘clinoptilolite of sedimentary origin’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for pigs, chickens and turkeys for fattening and for bovines and salmon by Commission Regulation (EC) No 1887/2000 (4). New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit. |
| --- | --- |

(6)

The use of the additive ‘clinoptilolite of sedimentary origin’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for pigs, chickens and turkeys for fattening and for bovines and salmon by Commission Regulation (EC) No 1887/2000 (4). New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit.

| (7) | The use of the additive ‘sodium ferrocyanide’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for all species or categories of animals by Commission Regulation (EC) No 256/2002 (5). New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit. |
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(7)

The use of the additive ‘sodium ferrocyanide’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for all species or categories of animals by Commission Regulation (EC) No 256/2002 (5). New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit.

| (8) | The use of the additive ‘potassium ferrocyanide’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for all species or categories of animals by Regulation (EC) No 256/2002. New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit. |
| --- | --- |

(8)

The use of the additive ‘potassium ferrocyanide’ as a member of the group of binders, anti-caking agents and coagulants was provisionally authorised, for the first time, for all species or categories of animals by Regulation (EC) No 256/2002. New data were submitted in support of an application for authorisation without time-limit of that additive. 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 additive, as specified in Annex II, should be authorised without a time-limit.

| (9) | The use of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) was provisionally authorised for the first time for laying hens, by Commission Regulation (EC) No 418/2001 (6). 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 Annex III, should be authorised without a time-limit. |
| --- | --- |

(9)

The use of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) was provisionally authorised for the first time for laying hens, by Commission Regulation (EC) No 418/2001 (6). 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 Annex III, should be authorised without a time-limit.

| (10) | The use of the micro-organism preparation of Enterococcus faecium (NCIMB 11181) was authorised without a time-limit for calves and for piglets by Commission Regulation (EC) No 1333/2004 (7). New data were submitted in support of an application to extend the authorisation of the use of that micro-organism preparation to chickens for fattening. The European Food Safety Authority (EFSA) delivered a favourable opinion on 13 April 2005 on the safety of that additive when used in the animal category chickens for fattening, under the conditions of use set out in Annex IV to this Regulation. The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation as specified in Annex IV, should be provisionally authorised for four years. |
| --- | --- |

(10)

The use of the micro-organism preparation of Enterococcus faecium (NCIMB 11181) was authorised without a time-limit for calves and for piglets by Commission Regulation (EC) No 1333/2004 (7). New data were submitted in support of an application to extend the authorisation of the use of that micro-organism preparation to chickens for fattening. The European Food Safety Authority (EFSA) delivered a favourable opinion on 13 April 2005 on the safety of that additive when used in the animal category chickens for fattening, under the conditions of use set out in Annex IV to this Regulation. The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation as specified in Annex IV, should be provisionally authorised for four years.

| (11) | The use of the micro-organism preparation of Enterococcus faecium (CECT 4515) was provisionally authorised, for the first time, for piglets and for calves by Commission Regulation (EC) No 654/2000 (8). New data were submitted in support of an application to extend the authorisation of the use of that micro-organism preparation to chickens for fattening. The EFSA delivered a favourable opinion on 13 April 2005 on the safety of that additive when used in the animal category chickens for fattening, under the conditions of use set out in Annex IV to this Regulation. The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation as specified in Annex IV, should be provisionally authorised for four years. |
| --- | --- |

(11)

The use of the micro-organism preparation of Enterococcus faecium (CECT 4515) was provisionally authorised, for the first time, for piglets and for calves by Commission Regulation (EC) No 654/2000 (8). New data were submitted in support of an application to extend the authorisation of the use of that micro-organism preparation to chickens for fattening. The EFSA delivered a favourable opinion on 13 April 2005 on the safety of that additive when used in the animal category chickens for fattening, under the conditions of use set out in Annex IV to this Regulation. The assessment shows that the conditions laid down in Article 9e(1) of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that micro-organism preparation as specified in Annex IV, should be provisionally authorised for four years.

| (12) | The assessment of these 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 (9). |
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(12)

The assessment of these 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 (9).

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(13)

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 ‘Growth promoters’, as specified in Annex I, is authorised for 10 years for use as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

The additives belonging to the group ‘Binders, anti-caking agents and coagulants’, as specified in Annex II, are authorised without a time limit for use as additives 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, are authorised for use without a time-limit as additives in animal nutrition under the conditions laid down in that Annex.

Article 4

The preparations belonging to the group ‘Micro-organisms’, as specified in Annex IV, are authorised provisionally for four years as additives in animal nutrition under the conditions laid down in that Annex.

Article 5

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, 4 November 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(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).

1

(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).

2

(3)  
  OJ L 180, 3.7.2001, p. 18. Regulation as amended by Regulation (EC) No 676/2003 (OJ L 97, 15.4.2003, p. 29).

3

(4)  
  OJ L 227, 7.9.2000, p. 13.

4

(5)  
  OJ L 41, 13.2.2002, p. 6.

5

(6)  
  OJ L 62, 2.3.2001, p. 3.

6

(7)  
  OJ L 247, 21.7.2004, p. 11.

7

(8)  
  OJ L 79, 30.3.2000, p. 26. Regulation as amended by Regulation (EC) No 2200/2001 (OJ L 299, 15.11.2001, p. 1).

8

(9)  
  OJ L 183, 29.6.1989, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

9

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ANNEX I

| Registration number of additive | Name and registration number of person responsible for putting the additive into circulation | Additive
  (trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Growth promoters |
| E 800 | BASF Aktiengesellschaft | Potassium diformate (Formi LHS) | Additive composition | Potassium diformate, solid min. 98 % |

Registration number of additive

Name and registration number of person responsible for putting the additive into circulation

Additive

(trade name)

Composition, chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff

Growth promoters

E 800

BASF Aktiengesellschaft

Potassium diformate (Formi LHS)

Additive composition

Potassium diformate, solid min. 98 %

| | Silicate max. 1,5 % |
| --- | --- |

Silicate max. 1,5 %

| | Water max. 0,5 % |
| --- | --- |

Water max. 0,5 %

Active substance:

| | Potassium diformate, solid |
| --- | --- |

Potassium diformate, solid

| | KH(COOH)2 |
| --- | --- |

KH(COOH)2

| | CAS No 20642-05-1 |
| --- | --- |

CAS No 20642-05-1

Piglets (weaned)

—

6 000

18 000

For use in weaned piglets until approximately 35 kg

25.11.2015

Pigs for fattening

—

6 000

12 000

—

25.11.2015

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ANNEX II

| No
  (or EC No) | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff |
| Binders, anti-caking agents and coagulants |
| E 568 | Clinoptilolite of sedimentary origin | Hydrated calcium aluminosilicate of sedimentary origin containing at least 80 % clinoptilolite and a maximum 20 % of clay minerals, free of fibres and quartz | Pigs for fattening | — | — | 20 000 | All feedingstuffs | Without a time-limit |
| Chickens for fattening | — | — | 20 000 | All feedingstuffs | Without a time-limit |
| Turkeys for fattening | — | — | 20 000 | All feedingstuffs | Without a time-limit |
| Bovines | — | — | 20 000 | All feedingstuffs | Without a time-limit |
| Salmon | — | — | 20 000 | All feedingstuffs | Without a time-limit |
| E 535 | Sodium Ferrocyanide | Na4[Fe(CN)6]. 10H2O | All species or categories of animals | — | — | — | Maximum content: 80 mg/kg NaCl (calculated as ferrocyanide anion) | Without a time-limit |
| E 536 | Potassium Ferrocyanide | K4[Fe(CN)6]. 3H2O | All species or categories of animals | — | — | — | Maximum content: 80 mg/kg NaCl (calculated as ferrocyanide anion) | Without a time-limit |

No

(or EC No)

Additive

Chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg/kg of complete feedingstuff

Binders, anti-caking agents and coagulants

E 568

Clinoptilolite of sedimentary origin

Hydrated calcium aluminosilicate of sedimentary origin containing at least 80 % clinoptilolite and a maximum 20 % of clay minerals, free of fibres and quartz

Pigs for fattening

—

—

20 000

All feedingstuffs

Without a time-limit

Chickens for fattening

—

—

20 000

All feedingstuffs

Without a time-limit

Turkeys for fattening

—

—

20 000

All feedingstuffs

Without a time-limit

Bovines

—

—

20 000

All feedingstuffs

Without a time-limit

Salmon

—

—

20 000

All feedingstuffs

Without a time-limit

E 535

Sodium Ferrocyanide

Na4[Fe(CN)6]. 10H2O

All species or categories of animals

—

—

—

Maximum content: 80 mg/kg NaCl (calculated as ferrocyanide anion)

Without a time-limit

E 536

Potassium Ferrocyanide

K4[Fe(CN)6]. 3H2O

All species or categories of animals

—

—

—

Maximum content: 80 mg/kg NaCl (calculated as ferrocyanide anion)

Without a time-limit

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ANNEX III

| 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 1613 | Endo-1,4-beta-xylanase EC 3.2.1.8 | Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) having a minimum activity of: | Powder form: 70 000  IFP (1)/g |

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 1613

Endo-1,4-beta-xylanase EC 3.2.1.8

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10 W) having a minimum activity of:

Powder form: 70 000  IFP (1)/g

| | Liquid form: 7 000  IFP/ml |
| --- | --- |

Liquid form: 7 000  IFP/ml

Laying hens

—

840 IFP

—

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

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: 840 IFP. |
| --- | --- |

2.

Recommended dose per kg of complete feedingstuff: 840 IFP.

| 3. | For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat. |
| --- | --- |

3.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 40 % wheat.

Without a time-limit

---

(1)  1 IFP is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,8 and 50 °C.

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ANNEX IV

| EC No or No | Additive | 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 |
| Micro-organisms |
| 15 | Enterococcus faecium

  NCIMB 11181 | Preparation of Enterococcus faecium containing a minimum of: | Powder form:
  4 × 1011 CFU/g additive |

EC No or No

Additive

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

Micro-organisms

15

Enterococcus faecium

NCIMB 11181

Preparation of Enterococcus faecium containing a minimum of:

Powder form:

4 × 1011 CFU/g additive

| | Coated form:
  5 × 1010 CFU/g additive |
| --- | --- |

Coated form:

5 × 1010 CFU/g additive

Chickens for fattening

—

2,5 × 108

15 × 109

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

25.11.2009

18

Enterococcus faecium

CECT 4515

Preparation of Enterococcus faecium containing a minimum of:

1 × 109 CFU/g additives

Chickens for fattening

—

1 × 109

1 × 109

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

25.11.2009

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