# L_2020031EN.01000301.xml

| 4.2.2020 | EN | Official Journal of the European Union | L 31/3 |
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4.2.2020

EN

Official Journal of the European Union

L 31/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/146

of 3 February 2020

amending Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive

(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) | 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. |
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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.

| (2) | The preparation of Bacillus subtilis C-3102 (DSM 15544) was authorised as a feed additive for weaned piglets by Commission Regulation (EU) No 333/2010 (2), for sows, suckling piglets and dogs by Commission Implementing Regulation (EU) 2017/2312 (3), for pigs for fattening by Commission Implementing Regulation (EU) 2018/1081 (4), for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5), for chickens for fattening by Commission Implementing Regulation (EU) 2019/893 (6), and for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (7). |
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(2)

The preparation of Bacillus subtilis C-3102 (DSM 15544) was authorised as a feed additive for weaned piglets by Commission Regulation (EU) No 333/2010 (2), for sows, suckling piglets and dogs by Commission Implementing Regulation (EU) 2017/2312 (3), for pigs for fattening by Commission Implementing Regulation (EU) 2018/1081 (4), for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 (5), for chickens for fattening by Commission Implementing Regulation (EU) 2019/893 (6), and for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EU) No 184/2011 (7).

| (3) | On 31 August 2018, Asahi Calpis Wellness Co. Ltd., represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office, submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to modify the minimum content of the additive for use in chickens for fattening from the authorised concentration of 5 × 108 CFU/kg feed to a concentration of 3 × 108 CFU/kg feed. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’). |
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(3)

On 31 August 2018, Asahi Calpis Wellness Co. Ltd., represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office, submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to modify the minimum content of the additive for use in chickens for fattening from the authorised concentration of 5 × 108 CFU/kg feed to a concentration of 3 × 108 CFU/kg feed. 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 22 January 2019 (8) that the reduced minimum content of the additive with a concentration of 3 × 108 CFU/kg feed has the potential to be efficacious 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. |
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(4)

The Authority concluded in its opinion of 22 January 2019 (8) that the reduced minimum content of the additive with a concentration of 3 × 108 CFU/kg feed has the potential to be efficacious 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.

| (5) | On 26 March 2019, Asahi Calpis Wellness Co. Ltd., represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office, submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to amend the name of its representative. The applicant claimed that Pen & Tec Consulting S.L.U. is to be considered its representative in the Union for the additive. The application was accompanied by the relevant supporting data. |
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(5)

On 26 March 2019, Asahi Calpis Wellness Co. Ltd., represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office, submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to amend the name of its representative. The applicant claimed that Pen & Tec Consulting S.L.U. is to be considered its representative in the Union for the additive. The application was accompanied by the relevant supporting data.

| (6) | That proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The Authority was informed of the application. |
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(6)

That proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The Authority was informed of the application.

| (7) | The assessment of the applications shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. |
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(7)

The assessment of the applications shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

| (8) | Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011 should therefore be amended accordingly. |
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(8)

Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011 should therefore be amended accordingly.

| (9) | Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to provide for a transitional period during which the existing stocks of the preparation of Bacillus subtilis C-3102 (DSM 15544), which are in conformity with the provisions applying before the date of entry into force of this Regulation, may continue to be placed on the market and used until they are exhausted. |
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(9)

Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to provide for a transitional period during which the existing stocks of the preparation of Bacillus subtilis C-3102 (DSM 15544), which are in conformity with the provisions applying before the date of entry into force of this Regulation, may continue to be placed on the market and used until they are exhausted.

| (10) | 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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(10)

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

Amendments to Regulation (EU) No 333/2010

Regulation (EU) No 333/2010 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
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(2)

in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

Article 2

Amendments to Regulation (EU) No 184/2011

Regulation (EU) No 184/2011 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
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(2)

in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

Article 3

Amendments to Implementing Regulation (EU) 2016/897

Implementing Regulation (EU) 2016/897 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
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(2)

in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

Article 4

Amendments to Implementing Regulation (EU) 2017/2312

Implementing Regulation (EU) 2017/2312 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
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(2)

in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

Article 5

Amendments to Implementing Regulation (EU) 2018/1081

Implementing Regulation (EU) 2018/1081 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
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(2)

in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

Article 6

Amendments to Implementing Regulation (EU) 2019/893

Regulation (EU) 2019/893 is amended as follows:

| (1) | in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in theEuropean Union by Pen & Tec Consulting S.L.U.’; |
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(1)

in the title, the words ‘Asahi Calpis Wellness Co. Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in theEuropean Union by Pen & Tec Consulting S.L.U.’;

| (2) | in the second column of the Annex, ‘Name of the holder of authorisation’ the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’. |
| --- | --- |

(2)

in the second column of the Annex, ‘Name of the holder of authorisation’ the words ‘Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office’ are replaced by the words ‘Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.’.

| (3) | in column 7 ‘Minimum content’, the word ‘5 × 108’ is replaced by ‘3 × 108’. |
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(3)

in column 7 ‘Minimum content’, the word ‘5 × 108’ is replaced by ‘3 × 108’.

8

8

Article 7

Transitional measures

Bacillus subtilis C-3102 (DSM 15544), as set out in Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011, and premixtures containing that substance and compound feed containing that substance, which are produced and labelled before 24 February 2020 in accordance with the rules applicable before 24 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

Bacillus subtilis

Article 8

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, 3 February 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 102, 23.4.2010, p. 19).

2

Bacillus subtilis

(3)  Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 331, 14.12.2017, p. 41).

3

Bacillus subtilis

(4)  Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 194, 31.7.2018, p. 137).

4

Bacillus subtilis

(5)  Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).

5

Bacillus subtilis

(6)  Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 142, 29.5.2019, p. 60).

6

Bacillus subtilis

(7)  Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (OJ L 53, 26.2.2011, p. 33).

7

Bacillus subtilis

(8)  
  EFSA Journal 2019; 17(3):5605.

8

EFSA Journal

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