# L_2018067EN.01002101.xml

| 9.3.2018 | EN | Official Journal of the European Union | L 67/21 |
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9.3.2018

EN

Official Journal of the European Union

L 67/21

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/347

of 5 March 2018

concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)

(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 Saccharomyces cerevisiae CNCM I-1079 was authorised without a time limit as feed additive for piglets by Commission Regulation (EC) No 1847/2003 (3) and for sows by Commission Regulation (EC) No 2036/2005 (4). That additive 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. |
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(2)

The preparation of Saccharomyces cerevisiae CNCM I-1079 was authorised without a time limit as feed additive for piglets by Commission Regulation (EC) No 1847/2003 (3) and for sows by Commission Regulation (EC) No 2036/2005 (4). That additive 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.

| (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 Saccharomyces cerevisiae CNCM I-1079 as feed additive for sows and piglets. 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 Saccharomyces cerevisiae CNCM I-1079 as feed additive for sows and piglets. 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 20 April 2016 and 4 July 2017 (5) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive is efficacious in sows in order to have a benefit in suckling piglets and in weaned piglets in order to have a significant improvement of feed to gain ratio. 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 20 April 2016 and 4 July 2017 (5) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive is efficacious in sows in order to have a benefit in suckling piglets and in weaned piglets in order to have a significant improvement of feed to gain ratio. 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 Saccharomyces cerevisiae CNCM I-1079 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 Saccharomyces cerevisiae CNCM I-1079 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) | Regulations (EC) No 1847/2003 and (EC) No 2036/2005 should be amended accordingly. |
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(6)

Regulations (EC) No 1847/2003 and (EC) No 2036/2005 should be amended accordingly.

| (7) | 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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(7)

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.

| (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 ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Amendment to Regulation (EC) No 1847/2003

Regulation (EC) No 1847/2003 is amended as follows:

| (1) | Article 2 is deleted; |
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(1)

Article 2 is deleted;

| (2) | Annex II is deleted. |
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(2)

Annex II is deleted.

Article 3

Amendment to Regulation (EC) No 2036/2005

In Annex I to Regulation (EC) No 2036/2005, entry E1703 is deleted.

Article 4

Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 29 September 2018 in accordance with the rules applicable before 29 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5

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, 5 March 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 feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  Commission Regulation (EC) No 1847/2003 of 20 October 2003 concerning the provisional authorisation of a new use of an additive and the permanent authorisation of an additive already authorised in feedingstuffs (OJ L 269, 21.10.2003, p. 3).

3

(4)  Commission Regulation (EC) No 2036/2005 of 14 December 2005 concerning the permanent authorisations of certain additives in feedingstuffs and the provisional authorisation of a new use of certain additives already authorised in feedingstuffs (OJ L 328, 15.12.2005, p. 13).

4

(5)  
  EFSA Journal 2016;14(6):4478 and EFSA Journal 2017;15(7):4932.

5

EFSA Journal

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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| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4d1703 | Danstar Ferment AG represented by Lallemand SAS | Saccharomyces cerevisiae CNCM I-1079 | Additive composition:

  Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:






  — | 1 × 1010 CFU/g of additive (coated form); |

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

CFU/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: gut flora stabilisers

4d1703

Danstar Ferment AG represented by Lallemand SAS

Saccharomyces cerevisiae CNCM I-1079

Additive composition:

Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:

—

1 × 1010 CFU/g of additive (coated form);

| — | 2 × 1010 CFU/g of additive (not-coated form); |
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—

2 × 1010 CFU/g of additive (not-coated form);

Characterisation of the active substance:

Viable cells of Saccharomyces cerevisiae CNCM I-1079

Analytical method
   (1)

Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)

Identification: polymerase chain reaction (PCR) method 15790:2008.

Sows

Weaned piglets

—

1 × 109

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| 1. | In the directions for use of the additive and premixture, 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 premixture, 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 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 breathing protection. |
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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 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 breathing protection.

| 3. | For use in sows in order to have a benefit for suckling piglets. |
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3.

For use in sows in order to have a benefit for suckling piglets.

| 4. | For use in weaned piglets until approximately 35 kg. |
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4.

For use in weaned piglets until approximately 35 kg.

29 March 2028

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(1)  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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