# L_2018262EN.01002701.xml

| 19.10.2018 | EN | Official Journal of the European Union | L 262/27 |
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19.10.2018

EN

Official Journal of the European Union

L 262/27

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1566

of 18 October 2018

concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.)

(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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for weaned piglets by Commission Regulation (EC) No 1453/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. |
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(2)

The preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for weaned piglets by Commission Regulation (EC) No 1453/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

| (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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned). 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-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned). 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 opinions of 8 October 2013 (4), 16 May 2017 (5) and 17 April 2018 (6) that, under the proposed conditions of use, of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) 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 improve the final body weight and the feed to gain ratio in weaned piglets and that conclusion can be can be extrapolated to minor porcine species (weaned). The Authority 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 opinions of 8 October 2013 (4), 16 May 2017 (5) and 17 April 2018 (6) that, under the proposed conditions of use, of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) 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 improve the final body weight and the feed to gain ratio in weaned piglets and that conclusion can be can be extrapolated to minor porcine species (weaned). The Authority 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 assessment of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) 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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(5)

The assessment of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) 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.

| (6) | As a consequence of granting the authorisation for the preparation Regulation (EC) No 1453/2004 should be amended accordingly. |
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(6)

As a consequence of granting the authorisation for the preparation Regulation (EC) No 1453/2004 should be amended accordingly.

| (7) | Since there are no safety concerns requiring 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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(7)

Since there are no safety concerns requiring 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.

| (8) | 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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(8)

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 the Annex.

Article 2

Amendment to Regulation (EC) No 1453/2004

In Annex II to Regulation (EC) No 1453/2004 entry E 1612 on the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase and alpha-amylase is deleted.

Article 3

Transitional measures

The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 8 May 2019 in accordance with the rules applicable before 8 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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, 18 October 2018.

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 feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs (OJ L 269, 17.8.2004, p. 3).

3

(4)  EFSA Journal 2013; 11(10):3430.

4

(5)  EFSA Journal 2017; 15(6):4856.

5

(6)  EFSA Journal 2018; 1(5):5271.

6

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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 |
| 4a1612i | Andrés Pintaluba S.A. | Endo-1,3(4)-beta-glucanase
  EC 3.2.1.6
  Endo-1,4-beta-xylanase
  EC 3.2.1.8
  Alpha-amylase
  EC 3.2.1.1 | Additive composition

  Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) having respectively a minimum activity of.






  — | Endo-1,3(4)-beta-glucanase 900 U (1)/g; |

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

4a1612i

Andrés Pintaluba S.A.

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

EC 3.2.1.6

Endo-1,4-beta-xylanase

EC 3.2.1.8

Alpha-amylase

EC 3.2.1.1

Additive composition

Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) having respectively a minimum activity of.

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Endo-1,3(4)-beta-glucanase 900 U (1)/g;

| — | Endo-1,4-beta-xylanase 1 000 U (2)/g; |
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Endo-1,4-beta-xylanase 1 000 U (2)/g;

| — | Alpha-amylase 3 000 U (3)/g |
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Alpha-amylase 3 000 U (3)/g

Solid form

Characterisation of the active substance

endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222

Analytical methods
   (4)

Determination in the feed additive of:

| — | endo-1,3(4)-beta glucanase: colorimetric method based on the enzymatic reaction of glucanase on barley betaglucan substrate in the presence of 3,5-dinitrosalicylic acid (DNS) at pH 4,0 and 30 °C; |
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endo-1,3(4)-beta glucanase: colorimetric method based on the enzymatic reaction of glucanase on barley betaglucan substrate in the presence of 3,5-dinitrosalicylic acid (DNS) at pH 4,0 and 30 °C;

| — | endo-1,4-β-xylanase in the feed additive: colorimetric method based on the enzymatic reaction of xylanase on rye arabinoxylan substrate in the presence of DNS at pH 4,0 and 30 °C; |
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—

endo-1,4-β-xylanase in the feed additive: colorimetric method based on the enzymatic reaction of xylanase on rye arabinoxylan substrate in the presence of DNS at pH 4,0 and 30 °C;

| — | alpha-amylase: colorimetric method based on the enzymatic reaction of amylase on wheat starch substrate in the presence of DNS at pH 5,0 and 30 °C. |
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alpha-amylase: colorimetric method based on the enzymatic reaction of amylase on wheat starch substrate in the presence of DNS at pH 5,0 and 30 °C.

Determination of the active substances in premixtures and feedingstuffs:

| — | Colorimetric method measuring depolymerised soluble fragments released by action of glucanase on azo-barley-glucan; |
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Colorimetric method measuring depolymerised soluble fragments released by action of glucanase on azo-barley-glucan;

| — | Colorimetric method measuring depolymerised soluble fragments released by action of endo-1,4-β-xylanase on azo-xylan; |
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Colorimetric method measuring depolymerised soluble fragments released by action of endo-1,4-β-xylanase on azo-xylan;

| — | Colorimetric method measuring depolymerised soluble fragments released by action of amylase on p-nitrophenylmaltoheptaoside. |
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Colorimetric method measuring depolymerised soluble fragments released by action of amylase on p-nitrophenylmaltoheptaoside.

Weaned piglets

Minor porcine species

(weaned)

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

450 U

beta-xylanase

500 U

alpha-amylase

1 500 U

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
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1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin, eyes and breathing protections. |
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2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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 skin, eyes and breathing protections.

| 3. | For use in weaned piglets until approximately 35 kg. |
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3.

For use in weaned piglets until approximately 35 kg.

8 November 2028

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(1)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,0 and 30 °C.

(2)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from rye arabinoxylan per minute at pH 4,0 and 30 °C.

(3)  1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from wheat starch per minute at pH 5,0 and 30 °C.

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

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