# L_2017033EN.01002301.xml

| 8.2.2017 | EN | Official Journal of the European Union | L 33/23 |
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8.2.2017

EN

Official Journal of the European Union

L 33/23

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/211

of 7 February 2017

concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening, and amending Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 and repealing Regulation (EC) No 516/2007 (holder of authorisation Beldem, a division of Puratos NV)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
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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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), for weaned piglets by Commission Regulation (EC) No 1206/2005 (4), for pigs for fattening and turkeys for fattening by Commission Regulation (EC) No 516/2007 (5) and for laying hens by Commission Regulation (EC) No 322/2009 (6). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. In accordance with Regulation (EC) No 1831/2003, that preparation was also authorised for 10 years for ducks by Commission Regulation (EC) No 242/2007 (7). |
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(2)

The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), for weaned piglets by Commission Regulation (EC) No 1206/2005 (4), for pigs for fattening and turkeys for fattening by Commission Regulation (EC) No 516/2007 (5) and for laying hens by Commission Regulation (EC) No 322/2009 (6). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. In accordance with Regulation (EC) No 1831/2003, that preparation was also authorised for 10 years for ducks by Commission Regulation (EC) No 242/2007 (7).

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 July 2016 (8) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the use of that preparation has the potential to be efficacious in chickens for fattening, laying hens, weaned piglets and pigs for fattening. This conclusion can be extended to chickens reared for laying and breeding hens. The Authority further considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening, for breeding and for laying. It does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the 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 13 July 2016 (8) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the use of that preparation has the potential to be efficacious in chickens for fattening, laying hens, weaned piglets and pigs for fattening. This conclusion can be extended to chickens reared for laying and breeding hens. The Authority further considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening, for breeding and for laying. It does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The Authority also concluded on turkeys for fattening that in two studies there was evidence of a positive effect on final body weight and on feed to gain ratio. A third one with a significant greater feed to gain ratio, as already evaluated and accepted in the previous evaluation for the authorisation, was not considered significant by the Authority. Since these evidences were judged a substantial indication of the improvement of zootechnical parameters, in addition to the long history of use, it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening. |
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(5)

The Authority also concluded on turkeys for fattening that in two studies there was evidence of a positive effect on final body weight and on feed to gain ratio. A third one with a significant greater feed to gain ratio, as already evaluated and accepted in the previous evaluation for the authorisation, was not considered significant by the Authority. Since these evidences were judged a substantial indication of the improvement of zootechnical parameters, in addition to the long history of use, it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening.

| (6) | The assessment of the preparation endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) shows that the conditions for authorisation, as 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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(6)

The assessment of the preparation endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) shows that the conditions for authorisation, as 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.

| (7) | Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 should be amended accordingly. Regulation (EC) No 516/2007 should be repealed. |
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(7)

Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 should be amended accordingly. Regulation (EC) No 516/2007 should be repealed.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
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(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

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

Amendment to Regulation (EC) No 1259/2004

Annex VI to Regulation (EC) No 1259/2004 is deleted.

Article 3

Amendment to Regulation (EC) No 1206/2005

In Annex I to Regulation (EC) No 1206/2005, the entry E 1606 endo-1,4-beta-xylanase (EC 3.2.1.8), is deleted.

Article 4

Amendment to Regulation (EC) No 322/2009

Annex I to Regulation (EC) No 322/2009 is deleted.

Article 5

Repeal

Regulation (EC) No 516/2007 is repealed.

Article 6

Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 28 August 2017 in accordance with the rules applicable before 28 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 7

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

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

Done at Brussels, 7 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  Commission Regulation (EC) No 1259/2004 of 8 July 2004 concerning the permanent authorisations of certain additives already authorised in feedingstuffs (OJ L 239, 9.7.2004, p. 8).

3

(4)  Commission Regulation (EC) No 1206/2005 of 27 July 2005 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 197, 28.7.2005, p. 12).

4

(5)  Commission Regulation (EC) No 516/2007 of 10 May 2007 concerning the permanent authorisation of an additive in feedingstuffs (OJ L 122, 11.5.2007, p. 22).

5

(6)  Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feedingstuffs (OJ L 101, 21.4.2009, p. 9).

6

(7)  Commission Regulation (EC) No 242/2007 of 6 March 2007 concerning the authorisations of endo-1,4-beta-xylanase EC 3.2.1.8 (Belfeed B1100MP and Belfeed B1100ML) as feed additive (OJ L 73, 13.3.2007, p. 1).

7

(8)  
  EFSA Journal 2016; 14(9):4562

8

EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
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| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a1606i | Beldem, division of Puratos NV. | Endo-1,4-beta-xylanase EC 3.2.1.8 | Additive composition

  Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU (1)/g
  Solid form and liquid form. | Poultry | — | 10 IU | — | 1. | In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

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 with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1606i

Beldem, division of Puratos NV.

Endo-1,4-beta-xylanase EC 3.2.1.8

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136 having a minimum activity of 400 IU (1)/g

Solid form and liquid form.

Poultry

—

10 IU

—

1.

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

| 2. | For use in weaned piglets up to 35 kg of body weight. |
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2.

For use in weaned piglets up to 35 kg of body weight.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

28 February 2027

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis LMG-S 15136

Weaned piglets

—

10 IU

—

Analytical method
   (2)

For the quantification of xylanase activity in the feed additive:

| — | colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS). |
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—

colorimetric method measuring reducing sugars released by action of xylanase on birchwood xylan substrate in the presence of 3,5-dinitrosalicylic acid (DNS).

For the quantification of xylanase activity in premixtures and feedingstuffs:

| — | colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates. |
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—

colorimetric method measuring water soluble dye released by action of xylanase from azurine cross-linked wheat arabinoxylan substrates.

Pigs for fattening

—

10 IU

—

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

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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