# L_2017069EN.01001801.xml

| 15.3.2017 | EN | Official Journal of the European Union | L 69/18 |
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15.3.2017

EN

Official Journal of the European Union

L 69/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/447

of 14 March 2017

concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S)

(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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for sows by Commission Regulation (EC) No 1453/2004 (3), for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (4), for turkeys for fattening and calves by Commission Regulation (EC) No 600/2005 (5). That preparation 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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for sows by Commission Regulation (EC) No 1453/2004 (3), for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (4), for turkeys for fattening and calves by Commission Regulation (EC) No 600/2005 (5). That preparation 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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, piglets, pigs for fattening, calves for rearing and turkeys for fattening. The application in accordance with Article 7 of that Regulation was also for the assessment of this preparation for a new use in water for drinking. 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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, piglets, pigs for fattening, calves for rearing and turkeys for fattening. The application in accordance with Article 7 of that Regulation was also for the assessment of this preparation for a new use in water for drinking. 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 opinion of 12 July 2016 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance in piglets, pigs for fattening, sows and calves for rearing in feed and in water for drinking. Concerning the use of the additive on turkeys for fattening, it was concluded that in two studies there was some evidence of a positive effect on growth and feed to gain ratio and in a third one a significant greater weight gain was found in females, but no significant difference in weight gain in males was detected. 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 opinion of 12 July 2016 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance in piglets, pigs for fattening, sows and calves for rearing in feed and in water for drinking. Concerning the use of the additive on turkeys for fattening, it was concluded that in two studies there was some evidence of a positive effect on growth and feed to gain ratio and in a third one a significant greater weight gain was found in females, but no significant difference in weight gain in males was detected. 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) | However these evidences have been judged a substantial indication of the improvement of zootechnical parameters of weight gain in addition to the long history of use. Therefore it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening to be used in feed and water for drinking. |
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(5)

However these evidences have been judged a substantial indication of the improvement of zootechnical parameters of weight gain in addition to the long history of use. Therefore it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening to be used in feed and water for drinking.

| (6) | The assessment of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) 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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(6)

The assessment of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) 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.

| (7) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 should be amended accordingly. |
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(7)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 should be amended accordingly.

| (8) | 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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(8)

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.

| (9) | 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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(9)

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 1453/2004

Annex I to Regulation (EC) No 1453/2004 is deleted.

Article 3

Amendment to Regulation (EC) No 2148/2004

In Annex II to Regulation (EC) No 2148/2004 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.

Bacillus licheniformis

Bacillus subtilis

Article 4

Amendment to Regulation (EC) No 600/2005

In Annex III to Regulation (EC) No 600/2005 the entry E 1700 on Bacillus licheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) is deleted.

Bacillus licheniformis

Bacillus subtilis

Article 5

Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 4 October 2017 in accordance with the rules applicable before 4 April 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 6

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, 14 March 2017.

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 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)  Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).

4

(5)  Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (OJ L 99, 19.4.2005, p. 5).

5

(6)  
  EFSA Journal 2016; 14(9):4558.

6

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 | 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 % | CFU/l of water for drinking |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1700i | Chr. Hansen A/S | Bacillus subtilis
  (DSM 5750) and Bacillus licheniformis (DSM 5749) | Additive composition

  Preparation of Bacillus subtilis

  (DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive
  (1:1 ratio)
  Solid form

  Characterisation of the active substance

  Viable spores of Bacillus subtilis

  (DSM 5750) and Bacillus licheniformis (DSM 5749)

  Analytical method
   (1)

  Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:






  — | Identification: Pulsed Field Gel Electrophoresis (PFGE) |

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

Minimum content

Maximum content

Other provisions

End of period of authorisation

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

CFU/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1700i

Chr. Hansen A/S

Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749)

Additive composition

Preparation of Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749) containing a minimum of 3,2 × 1010 CFU/g of additive

(1:1 ratio)

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

(DSM 5750) and Bacillus licheniformis (DSM 5749)

Analytical method
   (1)

Identification and enumeration of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:

—

Identification: Pulsed Field Gel Electrophoresis (PFGE)

| — | Enumeration: Spread plate method using tryptone soya agar — EN 15784. |
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—

Enumeration: Spread plate method using tryptone soya agar — EN 15784.

Weaned piglets

Pigs for fattening

Sows

Calves for rearing

Turkeys for fattening

—

1,3 × 109

—

6,5 × 108

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| 1. | In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting. |
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1.

In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting.

| 2. | The additive may be used in water for drinking. |
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2.

The additive may be used in water for drinking.

| 3. | For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured. |
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3.

For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.

| 4. | For use in weaned piglets up to 35 kg of body weight. |
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4.

For use in weaned piglets up to 35 kg of body weight.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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 and skin protection. |
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5.

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

4 April 2027

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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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