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The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.
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 Biocycle Co. Ltd.’, and the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(2)
in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Biocycle Co. Ltd.’;
(3)
in the third column of the Annex, ‘Additive’, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(4)
in the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(5)
in the fifth column of the Annex, Species or category of animal, ‘Laying hens’ is deleted;
(6)
in the seventh column, ‘Minimum content’, ‘3 × 10 8 ’ is deleted.
Implementing Regulation (EU) 2017/2312 is amended as follows:
(1)
in the title, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Biocycle Co. Ltd.’ and the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(2)
in the recitals, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(3)
in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Biocycle Co. Ltd.’;
(4)
in the third column of the Annex, ‘Additive’, the words ‘ Bacillus subtilis DSM 15544’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(5)
in the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, in the subparagraphs ‘Additive composition’ and ‘Characterisation of the active substance’ the words ‘ Bacillus subtilis C-3102 DSM 15544’ are replaced by the words ‘ Bacillus velezensis DSM 15544’.
Implementing Regulation (EU) 2018/1081 is amended as follows:
(1)
in the title, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Biocycle Co. Ltd.’ and the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(2)
in the recitals, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’;
(3)
in the second column of the Annex, ‘Name of the holder of authorisation’, the words ‘Asahi Calpis Wellness Co. Ltd’ are replaced by the words ‘Asahi Biocycle Co. Ltd.’;
(4)
in the third column of the Annex, ‘Additive’, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by ‘ Bacillus velezensis DSM 15544’;
(5)
in the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘ Bacillus subtilis C-3102 (DSM 15544)’ are replaced by the words ‘ Bacillus velezensis DSM 15544’.
1. The additive specified in the Annex to this Regulation, as well as in Implementing Regulation (EU) 2016/897, in Implementing Regulation (EU) 2017/2312, in Implementing Regulation (EU) 2018/1081 and in Implementing Regulation (EU) 2019/893, and premixtures containing it, which are produced and labelled before 26 November 2022 in accordance with the rules applicable before 26 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the additive specified in the Annex to this Regulation, as well as in Implementing Regulation (EU) 2016/897, in Implementing Regulation (EU) 2017/2312, in Implementing Regulation (EU) 2018/1081 and in Implementing Regulation (EU) 2019/893, which are produced and labelled before 26 May 2023 in accordance with the rules applicable before 26 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the additive specified in the Annex to this Regulation, as well as in Implementing Regulation (EU) 2016/897and in Implementing Regulation (EU) 2017/2312 which are produced and labelled before 26 May 2024 in accordance with the rules applicable before 26 May 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non food-producing animals.
Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 are repealed.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1820
Asahi Biocycle Co. Ltd, represented in the Union by Pen & Tec Consulting S.L.U.
Bacillus velezensis DSM 15544
Additive composition
Preparation of Bacillus velezensis DSM 15544 containing a minimum of 1 × 10 10 CFU/g
Solid form
Weaned piglets
All avian species and categories
-
3 × 10 8
3 × 10 8
-
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
May be used in feed containing the permitted coccidiostats for each avian species and categories.
3.
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 eye and breathing protection.
26 May 2032
Characterisation of the active substance
Viable spores of Bacillus velezensis DSM 15544
Analytical method
( 1 )
Enumeration: spread plate method using tryptone soya agar (EN 15784)
Identification: pulsed-field gel electrophoresis (PFGE).
( 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
Commission Implementing Regulation (EU) 2022/703 of 5 May 2022 concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.) (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32022R0703
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