COMMISSION IMPLEMENTING REGULATION (EU) 2021/507

of 23 March 2021

concerning the renewal of the authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species and repealing Implementing Regulation (EU) No 515/2011

(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) Pyridoxine hydrochloride (vitamin B6) was authorised for 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 515/2011 (2).

(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of pyridoxine hydrochloride as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (3) that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority concluded that pyridoxine hydrochloride under the current authorised conditions of use does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is non-irritant to skin and eyes and is not a skin sensitiser but it may cause photosensitisation and in the absence of inhalation toxicity studies, adverse effects in the respiratory tract could not be fully excluded. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to the users of the additive. The Authority also concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

(5) The assessment of pyridoxine hydrochloride 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 pyridoxine hydrochloride as a feed additive, Implementing Regulation (EU) No 515/2011 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 additive specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemical well-defined substances having a similar effect’ for all animal species, is renewed subject to the conditions laid down in that Annex.

Article 2 Implementing Regulation (EU) No 515/2011 is repealed.

Article 3 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, 23 March 2021. For the Commission The President Ursula VON DER LEYEN

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

(2) Commission Implementing Regulation (EU) No 515/2011 of 25 May 2011 concerning the authorisation of vitamin B6 as a feed additive for all animal species (OJ L 138, 26.5.2011, p. 40).

(3) EFSA Journal 2020;18(11):6289.