LegalizeCommission Implementing Regulation (EU) 2017/219 of 8 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance. )
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| 9.2.2017 | EN | Official Journal of the European Union | L 34/18 |
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.
- (2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Bacillus subtilis (DSM 27273). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
- (3) That application concerns the authorisation of a preparation of Bacillus subtilis (DSM 27273) as a feed additive for weaned piglets and weaned minor porcine species to be classified in the additive category ‘zootechnical additives’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 October 2015 2 that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 27273) does not have an adverse effect on animal health, human health or the environment. It was also concluded that the preparation has a potential to improve performance in weaned piglets. This conclusion can be extrapolated to weaned minor porcine species when the additive is used at the same dose. 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) The assessment of the preparation of Bacillus subtilis (DSM 27273) 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.
- (6) 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
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
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 February 2017.
For the Commission
The President
Jean-Claude JUNCKER
EFSA Journal 2015;13(11):4269.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | CFU/Units of active substance/kg of complete feedingstuff with a moisture content of 12 % | CFU/Units of active substance/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1826 | Chr.Hansen A/S | Bacillus subtilis DSM 27273 | Additive composition Preparation of Bacillus subtilis DSM 27273 containing a minimum of 1,6 × 109 CFU/g of additive Solid form Characterisation of the active substance Viable spores of Bacillus subtilis DSM 27273 Analytical method 3 Identification and enumeration of Bacillus subtilis DSM 27273 in the feed additive, premixtures and feedingstuffs: — Identification: Pulsed Field Gel Electrophoresis (PFGE) — Enumeration: Spread plate method using tryptone soya agar — EN 15784 | Weaned piglets | — | 4 × 108 | — | 1. In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting. 2. For use in weaned piglets up to 35 kg of body weight. 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, eyes and skin protections. | 1 March 2027 |
| 4b1826 | Chr.Hansen A/S | Bacillus subtilis DSM 27273 | Additive composition Preparation of Bacillus subtilis DSM 27273 containing a minimum of 1,6 × 109 CFU/g of additive Solid form Characterisation of the active substance Viable spores of Bacillus subtilis DSM 27273 Analytical method 3 Identification and enumeration of Bacillus subtilis DSM 27273 in the feed additive, premixtures and feedingstuffs: — Identification: Pulsed Field Gel Electrophoresis (PFGE) — Enumeration: Spread plate method using tryptone soya agar — EN 15784 | Weaned minor porcine species | — | 4 × 108 | — | 1. In the directions for use of the additive and premixtures, indicate the storage temperature, storage life and stability to pelleting. 2. For use in weaned piglets up to 35 kg of body weight. 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, eyes and skin protections. | 1 March 2027 |
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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