# L_2007175EN.01000801.xml

| 5.7.2007 | EN | Official Journal of the European Union | L 175/8 |
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5.7.2007

EN

Official Journal of the European Union

L 175/8

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COMMISSION REGULATION (EC) No 786/2007

of 4 July 2007

concerning the authorisation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell) as a feed additive

(Text with EEA relevance)

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. |
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(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 to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(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 to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell), produced by Bacillus lentus (ATCC 55045), as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’. |
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(3)

The application concerns the authorisation of the preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell), produced by Bacillus lentus (ATCC 55045), as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (the Authority) concluded in its opinion of 21 November 2006 that the preparation of endo-1,4-beta-mannanase EC 3.2.1.78 produced by Bacillus lentus (ATCC 55045) (Hemicell) does not have an adverse effect on animal health, human health or the environment (2). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. The opinion of the Authority recommends appropriate measures for user safety. It 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. |
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(4)

The European Food Safety Authority (the Authority) concluded in its opinion of 21 November 2006 that the preparation of endo-1,4-beta-mannanase EC 3.2.1.78 produced by Bacillus lentus (ATCC 55045) (Hemicell) does not have an adverse effect on animal health, human health or the environment (2). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. The opinion of the Authority recommends appropriate measures for user safety. It 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.

| (5) | 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. |
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(5)

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, |
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(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 ‘digestibility enhancers’, 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, 4 July 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(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).

1

(2)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzymatic preparation Hemicell® Feed Enzyme (beta-D-mannanase) as a feed additive for chickens for fattening in accordance with Regulation (EC) No 1831/2003. Adopted on 21 November 2006. The EFSA Journal (2006) 412, 1-12.

2

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Unit of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a3 | ChemGen Corp., represented by Disproquima S.L. | Endo-1,4-beta-mannanase
  EC 3.2.1.78 (Hemicell) | | Additive composition:
  Preparation of endo-1,4-beta-mannanase produced by Bacillus lentus (ATCC 55045) having a minimum activity of:
  Liquid form:
  7,2 × 105 U (1)/ml |

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

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a3

ChemGen Corp., represented by Disproquima S.L.

Endo-1,4-beta-mannanase

EC 3.2.1.78 (Hemicell)

Additive composition:

Preparation of endo-1,4-beta-mannanase produced by Bacillus lentus (ATCC 55045) having a minimum activity of:

Liquid form:

7,2 × 105 U (1)/ml

| | Characterisation of the active substance:
  Endo-1,4-beta-mannanase produced by Bacillus lentus (ATCC 55045) |
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Characterisation of the active substance:

Endo-1,4-beta-mannanase produced by Bacillus lentus (ATCC 55045)

| | Analytical method (2)

  Reducing sugar assay for Endo-1,4-beta-mannanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield |
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Analytical method (2)

Reducing sugar assay for Endo-1,4-beta-mannanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield

Chickens for fattening

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79 200 U

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

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

| 2. | Breathing protection during handling and safety glasses shall be used. |
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2.

Breathing protection during handling and safety glasses shall be used.

| 3. | For use in compound feed rich of galactomannan-containing hemicelluloses (e.g. soya, maize) |
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3.

For use in compound feed rich of galactomannan-containing hemicelluloses (e.g. soya, maize)

25 July 2017

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(1)  One unit activity is defined as the amount of enzyme that generates 0,72 micrograms of reducing sugar (mannose equivalents) from mannan containing substrate (locust bean gum) per minute at pH 7,5 and 40 °C.

(2)  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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