2014R0399 — EN — 13.05.2014 — 000.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION IMPLEMENTING REGULATION (EU) No 399/2014 of 22 April 2014 concerning the authorisation of the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 as feed additives for all animal species (Text with EEA relevance) (OJ L 119, 23.4.2014, p.40)





Corrected by:









▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 399/2014

of 22 April 2014

concerning the authorisation of the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 as feed additives for all animal species

(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 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. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable. (2) In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 were entered in the Register of Feed Additives as existing products belonging to the functional group of silage additives, for all animal species. (3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of those preparations as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) The European Food Safety Authority (the Authority) concluded in its opinions of 4 December 2013 ( 2 ) and 5 December 2013 ( 3 ) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations of Lactobacillus brevis DSM 23231, Lactobacillus brevis DSMZ 16680, Lactobacillus plantarum CECT 4528 and Lactobacillus fermentum NCIMB 30169 have the potential to improve the production of silage. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) The assessment of the preparations concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation. (6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







Article 1

Authorisation

The preparations specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

The preparations specified in the Annex and feed containing them, which are produced and labelled before 13 November 2014 in accordance with the rules applicable before 15 May 2014 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3

Entry into force

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.









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 fresh material Category of technological additives. Functional group: silage additives. ►C1 1k20744 ◄ — Lactobacillus brevis DSM 23231 Additive composition Preparation of Lactobacillus brevis DSM 23231 containing a minimum of 1 × 1010 CFU/g additive. Characterisation of the active substance Viable cells of Lactobacillus brevis DSM 23231. Analytical method (1) Enumeration in the feed additive: spread plate methodusing MRS agar (EN 15787). Identification: Pulsed Field Gel Electrophoresis (PFGE). All animal species — — — 1. In the directions for use of the additive and premixture, indicate the storage conditions. 2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 5 × 107 CFU/kg fresh material. 3. For safety: it is recommended to use breathing protection, eye protection and gloves during handling. 13 May 2024 ►C1 1k20745 ◄ — Lactobacillus brevis DSMZ 16680 Additive composition Preparation of Lactobacillus brevis DSMZ 16680 containing a minimum of 2,5 × 1010 CFU/g additive. Characterisation of the active substance Viable cells of Lactobacillus brevis DSMZ 16680. Analytical method (1) Enumeration in the feed additive: spread plate method using MRS agar (EN 15787). Identification: Pulsed Field Gel Electrophoresis (PFGE). All animal species 1. In the directions for use of the additive and premixture, indicate the storage conditions. 2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material. 3. For safety: it is recommended to use breathing protection, eye protection and gloves during handling. 13 May 2024 ►C1 1k20746 ◄ — Lactobacillus plantarum CECT 4528 Additive composition Preparation of Lactobacillus plantarum CECT 4528 containing a minimum of 2,5 × 1011 CFU/g additive. Characterisation of the active substance Viable cells of Lactobacillus plantarum CECT 4528. Analytical method (1) Enumeration in the feed additive: spread plate method using MRS agar (EN 15787). Identification: Pulsed Field Gel Electrophoresis (PFGE). All animal species — — — 1. In the directions for use of the additive and premixture, indicate the storage conditions. 2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 109 CFU/kg fresh material. 3. For safety: it is recommended to use breathing protection, eye protection and gloves during handling. 13 May 2024 ►C1 1k20747 ◄ — Lactobacillus fermentum NCIMB 30169 Additive composition Preparation of Lactobacillus fermentum NCIMB 30169 containing a minimum of 2,5 × 1010 CFU/g additive. Characterisation of the active substance Viable cells of Lactobacillus fermentum NCIMB 30169. Analytical method (1) Enumeration in the feed additive: spread plate method using MRS agar (EN 15787). Identification: Pulsed Field Gel Electrophoresis (PFGE). All animal species — — — 1. In the directions for use of the additive and premixture, indicate the storage conditions. 2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh. 3. For safety: it is recommended to use breathing protection, eye protection and gloves during handling. 13 May 2024 (1) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx