The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024

Part 4 Amendment of assimilated direct legislation

Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)

5.—(1) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish, etc.(1), is amended as follows—

(a) omit Articles 2 to 4;

(b) in the Annex, in the table:

(i) in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”;

(ii) in the third column (additive) and the fourth column (composition, etc.), for “Bacillus subtilis C-3102”, in each place, substitute “Bacillus velezensis”;

(iii) in the fifth column (species or category of animal), omit “Laying hens”;

(iv) in the seventh column (minimum content), omit “3 x 10⁸”.

(2) In 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.(2), in the Annex, the table is amended as follows—

(a) in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”;

(b) in the third column (additive) for “Bacillus subtilis” substitute “Bacillus velezensis”;

(c) in the fourth column (composition, etc.)—

(i) in the section headed “Additive composition”, for “Bacillus subtilis C-3102” substitute “Bacillus velezensis”;

(ii) in the section headed “Characterisation of the active substance”, for “Bacillus subtilis” substitute “Bacillus velezensis”.

(3) In 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.(3), in the Annex, the table is amended as follows—

(a) in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness” to the end substitute “Asahi Biocycle Co., Ltd”;

(b) in the third column (additive) and the fourth column (composition, etc.), for “Bacillus subtilis C-1302”, in each place, substitute “Bacillus velezensis”.

Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)

6.  In Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species, etc.(4), in the Annex, the entry for “3b810” is amended as follows—

(a) in the fourth column (composition, etc.), for the section headed “Additive composition” substitute—

“Preparation of organic selenium (Se) produced by Saccharomyces cerevisiae (CNCM I-3060) containing 2,000 to 3,500 mg Se/kg with the below components:

• Organic selenium: 97% minimum of total selenium

• Selenomethionine: 63% minimum of total selenium”;

(b) in the ninth column (other provisions), after point 4 insert—

“5.   The dusting potential of the additive must ensure a maximum selenium exposure of 0.2 mg Se/m^3”,

Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395

7.—(1) In Commission Implementing Regulation (EU) No887/2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening, etc.(5), in the Annex, in the second column of both tables (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)”, substitute “Evonik Operations GmbH”.

(2) In Commission Implementing Regulation (EU) 2017/961 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, etc.(6), in Annex I, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH”.

(3) In Commission Implementing Regulation (EU) 2020/1395 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, etc.(7), in the Annex, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH”.

Amendment of Commission Implementing Regulation (EU) 2016/1095

8.  In Commission Implementing Regulation (EU) 2016/1095 concerning the authorisation of zinc acetate dihydrate, zinc chloride anhydrous, zinc oxide, zinc sulphate heptahydrate, zinc sulphate monohydrate, zinc chelate of amino acids hydrate, zinc chelate of protein hydrolysates, zinc chelate of glycine hydrate (solid) and zinc chelate of glycine hydrate (liquid) as feed additives for all animal species, etc.(8), omit Article 4.

Amendment of Commission Implementing Regulation (EU) 2018/1039

9.  In Commission Implementing Regulation (EU) 2018/1039 concerning the authorisation of copper(II) diacetate monohydrate, copper(II) carbonate dihydroxy monohydrate, copper(II) chloride dihydrate, copper(II) oxide, copper(II) sulphate pentahydrate, copper(II) chelate of amino acids hydrate, copper(II) chelate of protein hydrolysates, copper(II) chelate of glycine hydrate (solid) and copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species, etc.(9), omit Article 5.

(1)

EUR 2016/897.

(2)

EUR 2017/2312.

(3)

EUR 2018/1081.

(4)

EUR 2019/804.

(5)

EUR 2011/887.

(6)

EUR 2017/961.

(7)

EUR 2020/1395.

(8)

EUR 2016/1095.

(9)

EUR 2018/1039.