Commission Implementing Regulation (EU) No 84/2014 of 30 January 2014 concerning the authorisation of preparations of Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 as feed additives for all animal species  Text with EEA relevance
Date: 2014-01-30
Institutions: European Commission
Subjects: animal feedingstuffs, food safety, food supplement, market approval




L_2014028EN.01003001.xml










31.1.2014   


EN


Official Journal of the European Union


L 28/30








            COMMISSION IMPLEMENTING REGULATION (EU) No 84/2014
of 30 January 2014
         
concerning the authorisation of preparations of Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688 or Pediococcus pentosaceus DSM 23689 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 Pediococcus pentosaceus DSM 14021, Pediococcus pentosaceus DSM 23688, Pediococcus pentosaceus DSM 23689 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 opinion of 18 June 2013 (2) that, under the proposed conditions of use, the use of the strains in the production of silage is presumed safe for livestock species, consumers of products from animals fed with the treated silage and for the environment. The Authority also concluded that all three preparations have the potential to improve the production of silage by reducing the pH and increasing the lactic acid concentration, resulting in an increased preservation of dry matter in easy and moderately difficult to ensile forage. 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,





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 20 August 2014 in accordance with the rules applicable before 20 February 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.
Done at Brussels, 30 January 2014.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2013; 11(7):3284.




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






1k1009


—



Pediococcus pentosaceus DSM 14021








 



Additive composition

Preparation of Pediococcus pentosaceus DSM 14021 containing a minimum of 1 × 1011 CFU/g additive










 



Characterisation of the active substance

Viable cells of Pediococcus pentosaceus DSM 14021










 



Analytical method
 (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786)
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 in easy and moderately difficult to ensile material (2).










3.


For safety: it is recommended to use breathing protection, eye protection and gloves during handling.






20 February 2024




1k1010


 



Pediococcus pentosaceus DSM 23688








 



Additive composition

Preparation of Pediococcus pentosaceus DSM 23688 containing a minimum of 1 × 1011 CFU/g additive










 



Characterisation of the active substance

Viable cells of Pediococcus pentosaceus DSM 23688










 



Analytical method
 (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786)
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 in easy and moderately difficult to ensile material (2).










3.


For safety: it is recommended to use breathing protection, eye protection and gloves during handling.






 




1k1011


—



Pediococcus pentosaceus DSM 23689








 



Additive composition

Preparation of Pediococcus pentosaceus DSM 23689 containing a minimum of 1 × 1011 CFU/g additive










 



Characterisation of the active substance

Viable cells of Pediococcus pentosaceus DSM 23689










 



Analytical method
 (1)

Enumeration in the feed additive: spread plate method using MRS agar (EN 15786)
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 in easy and moderately difficult to ensile material (2).










3.


For Safety: it is recommended to use breathing protection, eye protection and gloves during handling.






20 February 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

(2)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. Moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material. Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).