# L_2010086EN.01001301.xml

| 1.4.2010 | EN | Official Journal of the European Union | L 86/13 |
| --- | --- | --- | --- |

1.4.2010

EN

Official Journal of the European Union

L 86/13

---

COMMISSION REGULATION (EU) No 277/2010

of 31 March 2010

concerning the authorisation of 6-phytase as a feed additive for poultry for fattening and breeding other than turkeys for fattening, for poultry for laying and for pigs other than sows (holder of authorisation Roal Oy)

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

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

(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 enzyme 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) as a feed additive for poultry for fattening and breeding other than turkeys for fattening, for poultry for laying and for pigs other than sows, to be classified in the additive category ‘zootechnical additives’. |
| --- | --- |

(3)

The application concerns the authorisation of the enzyme 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) as a feed additive for poultry for fattening and breeding other than turkeys for fattening, for poultry for laying and for pigs other than sows, to be classified in the additive category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (the Authority) concluded in its opinion of 11 November 2009 (2) that 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (the Authority) concluded in its opinion of 11 November 2009 (2) that 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of that preparation 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. |
| --- | --- |

(5)

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

(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, 31 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  
  The EFSA Journal 2009; 7(11):1380.

2

The EFSA Journal

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a12 | Roal Oy | 6-phytase
  EC 3.1.3.26 | | Additive composition: | Preparation of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei |

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

4a12

Roal Oy

6-phytase

EC 3.1.3.26

Additive composition:

Preparation of 6-phytase (EC 3.1.3.26) produced by Trichoderma reesei

| | (CBS 122001) with a minimum activity of: | 40 000  PPU (1)/g in solid form |
| --- | --- | --- |

(CBS 122001) with a minimum activity of:

40 000  PPU (1)/g in solid form

| | 10 000  PPU/g in liquid form |
| --- | --- |

10 000  PPU/g in liquid form

| | Characterisation of the active substance:
  6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001) |
| --- | --- |

Characterisation of the active substance:

6-phytase (EC 3.1.3.26) produced by Trichoderma reesei (CBS 122001)

| | Analytical method: (2)

  Colorimetric method quantifying the activity of 6-phytase by measuring released inorganic phosphate from sodium phytate by analysing the colour formed by reduction of a phosphomolybdate complex. |
| --- | --- |

Analytical method: (2)

Colorimetric method quantifying the activity of 6-phytase by measuring released inorganic phosphate from sodium phytate by analysing the colour formed by reduction of a phosphomolybdate complex.

Poultry for fattening and breeding other than turkeys for fattening

—

250 PPU

—

| 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. | Maximum recommended dose per kilogram of complete feed for all authorised species: 1 000  PPU |
| --- | --- |

2.

Maximum recommended dose per kilogram of complete feed for all authorised species: 1 000  PPU

| 3. | For use in feed containing more than 0,23 % phytin- bound phosphorus. |
| --- | --- |

3.

For use in feed containing more than 0,23 % phytin- bound phosphorus.

| 4. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

4.

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

21.4.2020

Poultry for laying

125 PPU

Pigs other than sows

250 PPU

---

(1)  1 PPU is the amount of enzyme which liberates 1 μmol of inorganic phosphate from sodium phytate per minute at pH = 5.0 and 37C °.

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

---