Bacillus velezensis (DSM 15544) (Holder of the authorisation Asahi Biocycle Co., Ltd Asahi Calpis Wellness Co. Ltd, represented by Pen & Tec Consulting S.L.U now trading as Argenta.) [Ornamental fish]

Transitional measures applied in the Feed Additives (Authorisations) (England) Regulations 2024

(1) Any substance or product labelled “Bacillus subtilis C-3102 (DSM 15544)” or as containing “Bacillus subtilis C-3102 (DSM 15544)”, but otherwise produced and labelled in accordance with an authorisation contained in assimilated Commission Implementing Regulation (EU) 2016/897, assimilated Commission Implementing Regulation (EU) 2017/2312 or assimilated Commission Implementing Regulation (EU) 2018/1081, may continue to be placed on the market and used under that authorisation.

(2) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.

(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.

(4) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.

(5) “relevant feed additive” means the feed additive of a preparation of Bacillus velezensis (DSM 15544), with the identification number 4b1820 authorised under the prior authorisation;

“prior authorisation” means the authorisations contained in Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., Commission Implementing Regulation (EU) 2017/2312 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, etc., and Commission Implementing Regulation (EU) 2018/1081 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening, etc.(16), as the Regulations had effect immediately before 20th December 2024.

Transitional measures applied in the Feed Additives (Authorisations) (Wales and Scotland) Regulations 2024

(1) Any substance or product labelled “Bacillus subtilis (C-3102)”, or as containing “Bacillus subtilis (C-3102)”, but otherwise produced and labelled in accordance with an authorisation contained in assimilated direct legislation mentioned in regulations 4 to 6, may continue to be placed on the market and used under that authorisation.

(2) The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

(3) Compound feed and feed materials containing the relevant feed additive, and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

(4) Compound feed and feed materials containing the relevant feed additive, and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

(5) “relevant feed additive” means the feed additive of a preparation of Bacillus velezensis (DSM 15544) (formerly Bacillus subtilis C-3102), with the identification number 4b1820, authorised under the prior authorisations;“prior authorisations” means the authorisations contained in—
(i) Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets,
(ii) Commission Regulation (EU) No 184/2011 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,
(iii) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillis subtilis C-3102 (DSM 15544) as a feed additive for laying hens and ornamental fish,
(iv) Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening.