# L_2012128EN.01000501.xml

| 16.5.2012 | EN | Official Journal of the European Union | L 128/5 |
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16.5.2012

EN

Official Journal of the European Union

L 128/5

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COMMISSION IMPLEMENTING REGULATION (EU) No 414/2012

of 15 May 2012

amending Regulation (EC) No 554/2008 as regards the minimum content and the minimum recommended dose of an enzyme preparation of 6-phytase as a feed additive in feed for turkeys for fattening

(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 13(3) thereof,

Whereas:

| (1) | An enzyme preparation of 6-phytase (EC 3.1.3.26), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for use for chickens for fattening, laying hens, ducks for fattening, turkeys for fattening and weaned piglets by Commission Regulation (EC) No 554/2008 (2). |
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(1)

An enzyme preparation of 6-phytase (EC 3.1.3.26), belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for use for chickens for fattening, laying hens, ducks for fattening, turkeys for fattening and weaned piglets by Commission Regulation (EC) No 554/2008 (2).

| (2) | In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of authorisation of the preparation concerned by reducing its minimum content and the minimum recommended dose from 1 000 FTU/kg to 500 FTU/kg complete feedingstuff, as regards use for turkeys for fattening. That application was accompanied by the relevant supporting data. |
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(2)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of authorisation of the preparation concerned by reducing its minimum content and the minimum recommended dose from 1 000 FTU/kg to 500 FTU/kg complete feedingstuff, as regards use for turkeys for fattening. That application was accompanied by the relevant supporting data.

| (3) | The European Food Safety Authority concluded in its opinion of 13 November 2011 that the preparation concerned has the potential to improve phosphorus utilisation in turkeys for fattening at the requested minimum dose of 500 FTU/kg (3) complete feedingstuff. |
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(3)

The European Food Safety Authority concluded in its opinion of 13 November 2011 that the preparation concerned has the potential to improve phosphorus utilisation in turkeys for fattening at the requested minimum dose of 500 FTU/kg (3) complete feedingstuff.

| (4) | The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied. |
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(4)

The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

| (5) | Regulation (EC) No 554/2008 should therefore be amended accordingly. |
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(5)

Regulation (EC) No 554/2008 should therefore be amended accordingly.

| (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

Regulation (EC) No 554/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of 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, 15 May 2012.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 158, 18.6.2008, p. 14.

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(3)  
  EFSA Journal 2012; 10(1):2533.

3

EFSA Journal

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ANNEX

The Annex to Regulation (EC) No 554/2008 is replaced by the following:

‘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 |
| 4a5 | AB Enzymes GmbH | 6-phytase
  EC 3.1.3.26 | | Additive composition

  Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of: | Solid form: 2 500 FTU/g (1) |

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

4a5

AB Enzymes GmbH

6-phytase

EC 3.1.3.26

Additive composition

Preparation of 6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) having a minimum activity of:

Solid form: 2 500 FTU/g (1)

| | Liquid form: 5 000 FTU/ml |
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Liquid form: 5 000 FTU/ml

| | Characterisation of the active substance

  6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927) |
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Characterisation of the active substance

6-phytase EC 3.1.3.26 produced by Pichia pastoris (DSM 15927)

| | Analytical method
   (2)

  Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C. |
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Analytical method
   (2)

Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C.

Chickens for fattening

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500 FTU

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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. | Recommended dose per kilogram of complete feedingstuff:






  — | chickens for fattening: 500-2 500 FTU, |
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2.

Recommended dose per kilogram of complete feedingstuff:

—

chickens for fattening: 500-2 500 FTU,

| — | laying hens: 250-2 000 FTU, |
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laying hens: 250-2 000 FTU,

| — | ducks for fattening: 250-2 000 FTU, |
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—

ducks for fattening: 250-2 000 FTU,

| — | turkeys for fattening: 500-2 700 FTU, |
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—

turkeys for fattening: 500-2 700 FTU,

| — | piglets (weaned): 100-2 500 FTU. |
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—

piglets (weaned): 100-2 500 FTU.

| 3. | For use in compound feed containing more than 0,25 % phytin-bound phosphorus. |
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3.

For use in compound feed containing more than 0,25 % phytin-bound phosphorus.

| 4. | For use in weaned piglets up to approximately 35 kg. |
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4.

For use in weaned piglets up to approximately 35 kg.

| 5. | For safety: breathing protection glasses and gloves shall be used during handling. |
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5.

For safety: breathing protection glasses and gloves shall be used during handling.

8.7.2018

Laying hens

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250 FTU

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Ducks for fattening

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250 FTU

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Turkeys for fattening

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500 FTU

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Piglets (weaned)

—

100 FTU

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(1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C.

1

(2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives’

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