# L_2015181EN.01006101.xml

| 9.7.2015 | EN | Official Journal of the European Union | L 181/61 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/61

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1104

of 8 July 2015

amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours)

Saccharomyces cerevisiae

Aspergillus niger

(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,

1

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) | The use of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) was authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012 (2), and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013 (3). |
| --- | --- |

(2)

The use of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) was authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012 (2), and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013 (3).

Saccharomyces cerevisiae

Aspergillus niger

2

3

| (3) | In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation to include a liquid form of alpha-galactosidase and endo-1,4-beta-glucanase to be used as a feed additive for chickens for fattening. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’). |
| --- | --- |

(3)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation to include a liquid form of alpha-galactosidase and endo-1,4-beta-glucanase to be used as a feed additive for chickens for fattening. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’).

| (4) | The Authority concluded in its opinion of 28 October 2014 (4) that the liquid form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening. 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. |
| --- | --- |

(4)

The Authority concluded in its opinion of 28 October 2014 (4) that the liquid form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening. 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.

4

Saccharomyces cerevisiae

Aspergillus niger

| (5) | The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the existing authorisation should be modified in order to include the new form. |
| --- | --- |

(5)

The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the existing authorisation should be modified in order to include the new form.

Saccharomyces cerevisiae

Aspergillus niger

| (6) | Therefore, the Annex to Implementing Regulation (EU) No 237/2012 should be amended accordingly. |
| --- | --- |

(6)

Therefore, the Annex to Implementing Regulation (EU) No 237/2012 should be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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

The Annex to Implementing Regulation (EU) No 237/2012 is replaced by the text set out in 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.

Official Journal of the European Union

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

Done at Brussels, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) (OJ L 80, 20.3.2012, p. 1).

2

Saccharomyces cerevisiae

Aspergillus niger

(3)  Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours (OJ L 343, 19.12.2013, p. 31).

3

Saccharomyces cerevisiae

Aspergillus niger

(4)  EFSA Journal 2014; 12(11):3897.

4

EFSA Journal

---

ANNEX

‘ANNEX

| Identi-fication 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 |
| 4a17 | Kerry ingredients and flavors | Alpha-galactosidase
  EC 3.2.1.22
  Endo-1,4-beta-glucanase
  EC 3.2.1.4 | Additive composition

  Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of: | Solid form:






  — | 1 000 U (1) alpha-galactosidase/g |

Identi-fication 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

4a17

Kerry ingredients and flavors

Alpha-galactosidase

EC 3.2.1.22

Endo-1,4-beta-glucanase

EC 3.2.1.4

Additive composition

Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of:

Solid form:

—

1 000 U (1) alpha-galactosidase/g

| — | 5 700 U (2) endo-1,4- beta-glucanase/g |
| --- | --- |

—

5 700 U (2) endo-1,4- beta-glucanase/g

| | Liquid form:






  — | 500 U alpha-galactosidase/g |
| --- | --- | --- |

Liquid form:

—

500 U alpha-galactosidase/g

| — | 2 850 U endo-1,4- beta-glucanase/g. |
| --- | --- |

—

2 850 U endo-1,4- beta-glucanase/g.

Characterisation of the active substance

Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604).

Method of Analysis
   (3)

Determination:

| — | Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate, |
| --- | --- |

—

Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,

| — | endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate. |
| --- | --- |

—

endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

Chickens for fattening

—

50 U alpha-galactosidase

285 U endo-1,4-beta-glucanase

—

| 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:






  — | 100 U alpha-galactosidase/kg; |
| --- | --- | --- |

2.

Maximum recommended dose:

—

100 U alpha-galactosidase/kg;

| — | 570 U endo-1,4-beta-glucanase/kg. |
| --- | --- |

—

570 U endo-1,4-beta-glucanase/kg.

| 3. | For safety: breathing protection glasses and gloves shall be used during handling. |
| --- | --- |

3.

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

9 April 2022

---

(1)  1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.

1

(2)  1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.

2

(3)  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’

3

---