Commission Implementing Regulation (EU) 2022/270 of 23 February 2022 correcting Implementing Regulation (EU) 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Date: 2022-02-23
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry




L_2022043EN.01000701.xml










24.2.2022   


EN


Official Journal of the European Union


L 43/7








            COMMISSION IMPLEMENTING REGULATION (EU) 2022/270
of 23 February 2022
         
correcting Implementing Regulation (EU) 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV)
(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)


The use of a preparation of Bacillus licheniformis DSM 28710 as a feed additive was authorised for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds by Commission Implementing Regulation (EU) 2021/1410 (2) for a 10-year period.












(2)


In the Annex to Implementing Regulation (EU) 2021/1410, an incorrect identification of the species, for which the additive is authorised, which excluded turkeys for breeding, was inserted in the column ‘Species or category of animal’.












(3)


Implementing Regulation (EU) 2021/1410 should therefore be corrected accordingly. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation.












(4)


In order to allow feed business operators to adapt the labelling of the additive and feed containing it to the corrected terms of authorisation, a transitional period should be provided for as regards the placing on the market of those products.












(5)


In order to preserve the legitimate expectations of the interested parties in relation to the terms of the authorisation of the additive, this Regulation should enter into force as a matter of urgency.












(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 Annex to Implementing Regulation (EU) 2021/1410 is replaced by the Annex to this Regulation.


Article 2

1.   The preparation specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 August 2022 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.


2.   Feed materials and compound feed containing the preparation and premixtures referred to in paragraph 1 which are produced and labelled before 25 February 2023 in accordance with the rules applicable before 25 February 2022 may continue to be placed on the market until the existing stocks are exhausted.



Article 3
This Regulation shall enter into force on the 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, 23 February 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Implementing Regulation (EU) 2021/1410 of 27 August 2021 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds (holder of authorisation Huvepharma NV) (OJ L 304, 30.8.2021, p. 8).




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





4b1828


Huvepharma NV



Bacillus licheniformis DSM 28710



Additive composition

Preparation of Bacillus licheniformis DSM 28710
containing a minimum of:
3,2 × 109 CFU/g of additive
Solid form

Characterisation of the active substance

Viable spores of Bacillus licheniformis DSM 28710

Analytical method
 (1)

For the enumeration of Bacillus licheniformis DSM 28710 in additive, premixture and feedingstuffs:






—


Spread plate method EN 15784




For the identification of Bacillus licheniformis DSM 28710:






—


Pulsed Field Gel Electrophoresis (PFGE)






Laying hens
Minor poultry species for laying
Poultry species for breeding
Ornamental birds


-


1,6 × 109



-








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 following permitted coccidiostats: diclazuril and lasalocid A sodium.










3.


For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalation or eyes exposure cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin, eyes and breathing protection.






19.9.2031






(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