Date: 2022-02-24Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2022/268 of 23 February 2022 amending Implementing Regulation (EU) 2016/898 as regards the name of the holder of the authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive and Implementing Regulation (EU) 2018/982 as regards the name of the holder of the authorisation of a preparation of benzoic acid, calcium formate and fumaric acid as a feed additive (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2022/268 amends Implementing Regulations (EU) 2016/898 and (EU) 2018/982 to reflect a change in the name of the authorisation holder from Novus Europe SANV/N.A.S.V. to Novus Europe NV. The regulation provides for a transitional period allowing existing stocks to be used up and entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
Amendment of Implementing Regulation (EU) 2016/898:
* The title is amended to replace "holder of authorisation Novus Europe SANV" with "holder of authorisation Novus Europe NV."
* In the Annex, the name of the holder of authorisation is changed from Novus Europe SANV to Novus Europe NV.
Amendment of Implementing Regulation (EU) 2018/982:
* The title is amended to replace "holder of authorisation Novus Europe N.AS.V." with "holder of authorisation Novus Europe NV."
* In the Annex, the name of the holder of authorisation is changed from Novus Europe N.A.S.V. to Novus Europe NV.
Transitional Measures:
* Existing stocks of additives conforming to previous regulations can continue to be placed on the market and used until exhausted.
Entry into Force:
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
Novus Europe NV:
* Impact: Can now exploit marketing rights under its new name.
* Action Required: Ensure all future marketing and documentation reflects the new company name.
Feed Additive Market Operators and Users:
* Impact: Can continue to use existing stocks of the additives under the previous name until they are exhausted.
* Action Required: No immediate action required, but future purchases should reflect the updated name of the authorisation holder.
Member States:
* Impact: The regulation is binding in its entirety and directly applicable.
* Action Required: Ensure the regulation is implemented and enforced within their jurisdiction.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining its scope and governance.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Commission Implementing Regulation (EU) 2016/898: A Commission Implementing Regulation authorising a preparation of Bacillus licheniformis ATCC 53757 and its protease EC 3.4.21.19 as a feed additive.
Bacillus licheniformis ATCC 53757: A bacterial species used in a preparation authorised as a feed additive.
Commission Implementing Regulation (EU) 2018/982: A Commission Implementing Regulation authorising a preparation of benzoic acid, calcium formate and fumaric acid as a feed additive.
European Food and Safety Authority: The European Union agency that provides independent scientific advice on risks related to food and feed safety.
24.2.2022 EN Official Journal of the European Union L 43/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) 2022/268
of 23 February 2022
amending Implementing Regulation (EU) 2016/898 as regards the name of the holder of the
authorisation of a preparation of Bacillus licheniformis (ATCC 53757) and its protease (EC 3.4.21.19)
as a feed additive and Implementing Regulation (EU) 2018/982 as regards the name of the holder of
the authorisation of a preparation of benzoic acid, calcium formate and fumaric acid as a feed
additive
(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 13(3) 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) Commission Implementing Regulation (EU) 2016/898 of 8 June 2016(2) authorised a preparation of Bacillus
licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive. The holder of the authorisation is
Novus Europe SA/NV.
(3) Commission Implementing Regulation (EU) 2018/982 of 11 July 2018(3)authorised a preparation of benzoic acid,
calcium formate and fumaric acid as a feed additive.
(4) Novus Europe NV has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003,
proposing to change the name of the holder of the authorisation as regards Implementing Regulations (EU)
2016/898 and (EU) No 2018/982.
(5) The applicant claims that it changed its name from Novus Europe SA/NV to Novus Europe NV. The application was
accompanied by the relevant supporting data.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) 2016/898 of 8 June 2016 concerning the authorisation of a preparation of Bacillus
licheniformis (ATCC 53757) and its protease (EC 3.4.21.19) as a feed additive for chickens for fattening, chickens reared for laying and
minor poultry species for fattening and reared for laying and ornamental birds (holder of authorisation Novus Europe SA/NV) (OJ
L 152, 9.6.2016, p. 11).
(3) Commission Implementing Regulation (EU) 2018/982 of 11 July 2018 concerning the authorisation of the preparation of benzoic
acid, calcium formate and fumaric acid as feed additive for chickens for fattening and chickens reared for laying (holder of the
authorisation Novus Europe N.A./S.V.) (OJ L 176, 12.7.2018, p. 13).L 43/2 EN Official Journal of the European Union 24.2.2022
(6) The proposed change of the terms of the authorisations is purely administrative in nature and does not entail a fresh
assessment of the feed additives concerned. The European Food and Safety Authority was informed of the
application.
(7) To allow the applicant to exploit its marketing rights under its new name, Novus Europe NV, it is necessary to change
the terms of the authorisations.
(8) Implementing Regulations (EU) 2016/898 and (EU) No 2018/982 should therefore be amended accordingly.
(9) Since safety reasons do not require the immediate application of the amendments made by this Regulation to
Implementing Regulations (EU) 2016/898 and (EU) No 2018/982, it is appropriate to provide for a transitional
period, during which existing stocks of the feed additives concerned may be used up.
(10) 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
Amendments to Implementing Regulation (EU) 2016/898
Implementing Regulation (EU) 2016/898 is amended as follows:
(1) in the title, the words ‘holder of authorisation Novus Europe SA/NV’ are replaced by the words ‘holder of authorisation
Novus Europe NV’;
(2) in the Annex, second column, ‘Name of the holder of authorisation’, the words ‘Novus Europe SA/NV’ are replaced by
the words ‘Novus Europe NV’.
Article 2
Amendments to Implementing Regulation (EU) 2018/982
Implementing Regulation (EU) 2018/982 is amended as follows:
(1) in the title, the words ‘holder of authorisation Novus Europe N.A/S.V.’ are replaced by the words ‘holder of
authorisation Novus Europe NV’;
(2) in the Annex, second column, ‘Name of the holder of authorisation’, the words ‘Novus Europe N.A./S.V.’ are replaced by
the words ‘Novus Europe NV’.
Article 3
Transitional measures
Existing stocks of the additives, which are in conformity with the provisions applying before the date of entry into force of
this Regulation, may continue to be placed on the market and used until they are exhausted.
Article 4
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.24.2.2022 EN Official Journal of the European Union L 43/3
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