LegalizeCommission Implementing Regulation (EU) 2022/1374 of 5 August 2022 concerning the authorisation of potassium diformate as a feed additive for weaned piglets, pigs for fattening and sows, and repealing Implementing Regulation (EU) No 333/2012 (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 and renewing such authorisation.
(2) Potassium diformate was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 333/2012 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of potassium diformate as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation. The applicant has later withdrawn the application for all animal species except for weaned piglets, pigs for fattening and sows.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (3) that the applicant had provided evidence that the additive complies with the conditions of authorisation. The Authority further concluded that potassium diformate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additive is an eye irritant, but it could not conclude on the potential of the additive to be an irritant to the skin or a respiratory or skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of potassium diformate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed.
(6) As a consequence of the renewal of the authorisation of potassium diformate as a feed additive, Implementing Regulation (EU) No 333/2012 should be repealed.
(7) 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 authorisation of the substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Implementing Regulation (EU) No 333/2012 is repealed.
Article 3
Transitional measures
The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 28 February 2023 in accordance with the rules applicable before 28 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 28 August 2023 in accordance with the rules applicable before 28 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 28 August 2024 in accordance with the rules applicable before 28 August 2022 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 4
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, 5 August 2022.
For the Commission The President Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Implementing Regulation (EU) No 333/2012 of 19 April 2012 concerning the authorisation of a preparation of potassium diformate as a feed additive for all animal species and amending Regulation (EC) No 492/2006 (OJ L 108, 20.4.2012, p. 3).
(3) EFSA Journal 2022;20(3):7167.
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