Commission Implementing Regulation (EU) 2018/1079 of 30 July 2018 concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG) (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2018/1079of 30 July 2018concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (holder of authorisation Lactosan GmbH & Co. KG)(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 nutritionOJ L 268, 18.10.2003, p. 29., 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 28343. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets to be classified in the additive category "zootechnical additives".(4)The preparation of Bacillus subtilis DSM 28343 belonging to the additive category of "zootechnical additives", was authorised for 10 years as a feed additive for chickens for fattening by Commission Implementing Regulation (EU) 2017/187Commission Implementing Regulation (EU) 2017/187 of 2 February 2017 concerning the authorisation of a preparation of Bacillus subtilis (DSM 28343) as a feed additive for chickens for fattening (holder of authorisation Lactosan GmbH & Co. KG) (OJ L 29, 3.2.2017, p. 35)..(5)The European Food Safety Authority ("the Authority") concluded in its opinion of 6 March 2018EFSA Journal 2018;16(3):5221. that, under the proposed conditions of use, the preparation of Bacillus subtilis DSM 28343 does not have an adverse effect on animal health, human health or the environment, and that it has the potential to increase the weight, weight gain or feed to gain ratio of weaned piglets. 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.(6)The assessment of the preparation of Bacillus subtilis DSM 28343 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.(7)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 1The 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 2This 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, 30 July 2018.For the CommissionThe PresidentJean-Claude JunckerANNEX
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-reportsCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
4b1825Lactosan GmbH & Co. KGBacillus subtilisDSM 28343Additive compositionPreparation of Bacillus subtilis DSM 28343 containing a minimum of 1 × 1010 CFU/g of additiveSolid formCharacterisation of the active substanceViable spores of Bacillus subtilis DSM 28343Analytical methodFor identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:Identification: Pulsed Field Gel Electrophoresis (PFGE)For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs:Enumeration: Spread plate method using tryptone soya agar — EN 15784Piglets (weaned)—1 × 109—1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.For use in weaned piglets up to 35 kg of body weight.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks from their 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.20.8.2028