Date: 2022-02-24Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2022/270 corrects Implementing Regulation (EU) 2021/1410, addressing an error in the species designation for the authorization of Bacillus licheniformis DSM 28710 as a feed additive. The correction includes turkeys for breeding, which were previously excluded. A transitional period is provided for feed business operators to adjust labelling, with specific deadlines for placing products on the market under the old rules.
Key Points / Main Content:
Correction of Implementing Regulation EU 2021/1410:
* The Annex to Implementing Regulation EU 2021/1410 is replaced to correct the species designation for which Bacillus licheniformis DSM 28710 is authorized, now including turkeys for breeding.
Transitional Measures:
* Preparation and premixtures produced and labelled before August 25, 2022, according to pre-February 25, 2022 rules, can be placed on the market until existing stocks are exhausted.
* Feed materials and compound feed containing the preparation and premixtures, produced and labelled before February 25, 2023, according to pre-February 25, 2022 rules, can be placed on the market until existing stocks are exhausted.
Entry into Force:
* This Regulation entered into force on the day following its publication in the Official Journal of the European Union (February 24, 2022).
Impact Analysis:
Feed Business Operators:
* Impact: Need to adapt the labelling of the additive and feed containing it to reflect the corrected terms of authorization, which now includes turkeys for breeding.
* Action Required: Adjust labelling of products containing Bacillus licheniformis DSM 28710 to comply with the corrected authorization. Utilize existing stocks produced and labelled before specified dates under the previous regulations before transitioning fully to the new labelling requirements.
Additive and Premixture Users:
* Impact: Must follow established operational procedures and organizational measures to address hazards due to inhalation, dermal contact, or eye contact.
* Action Required: Implement and maintain operational procedures and use appropriate personal protective equipment where exposure cannot be eliminated or minimized.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Regulation EU 2022/270: A regulation correcting Implementing Regulation EU 2021/1410 concerning the authorisation of a preparation of Bacillus licheniformis DSM 28710 as a feed additive.
Bacillus licheniformis DSM 28710: A strain of bacteria used as a feed additive for poultry.
Huvepharma NV: The holder of the authorization for the feed additive Bacillus licheniformis DSM 28710.
Regulation (EC) No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Commission Implementing Regulation EU 2021/1410: Regulation 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.
Standing Committee on Plants, Animals, Food and Feed: A committee providing opinions on measures related to plants, animals, food, and feed within the European Union.
Ursula VON DER LEYEN: The President of the European Commission.
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 2003on
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 2022in accordance with the rules applicable before 25 February 2022may continue to be placed on the
market until the existing stocks are exhausted.
(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).L 43/8 EN Official Journal of the European Union 24.2.2022
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 LEYENANNEX
Maxi-
Minimum mum
content con-
Identifica-
Name of the Species or Maxi- tent
tion number Composition, chemical formula, End of period of
holder of Additive category of mum Other provisions
of the description, analytical method authorisation
authorisation animal age CFU/kg of complete
additive
feedingstuff with a
moisture content of
12 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1828 Huvepharma Bacillus Additive composition Laying hens - 1,6 × 109 - 1. In the directions for use of the additive and 19.9.2031
NV licheniformis Minor poultry premixtures, the storage conditions and sta
Preparation of Bacillus licheniformis
DSM 28710 species for bility to heat treatment shall be indicated.
DSM 28710
laying
containing a minimum of:
Poultry 2. May be used in feed containing the following
3,2 × 109 CFU/g of additive
species for permitted coccidiostats: diclazuril and lasa
Solid form breeding locid A sodium.
Ornamental
Characterisation of the active substance birds 3. For users of the additive and premixtures,
feed business operators shall establish opera
Viable spores of Bacillus licheniformis
tional procedures and appropriate organisa DSM 28710
tional measures to address hazards by inha
Analytical method(1) lation, dermal contact or eyes contact. Where
the dermal, inhalation or eyes exposure can
For the enumeration of Bacillus
not be eliminated or reduced to a minimum
licheniformis DSM 28710 in additive,
by such procedures and measures, the addi
premixture and feedingstuffs:
tive and premixtures shall be used with ap — Spread plate method EN 15784
propriate personal protective equipment, in
For the identification of Bacillus cluding skin, eyes and breathing protection.
licheniformis DSM 28710:
— Pulsed Field Gel Electrophoresis
(PFGE)
(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
24.2.2022
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Official
Journal
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the
European
Union
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