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This article is published by European Union on Jan. 24, 2020. Read the original article here.
COMMISSION IMPLEMENTING REGULATION (EU) 2020/106
of 23 January 2020
concerning the authorisation of sodium formate as a feed additive for all animal species
(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 such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of sodium formate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of sodium formate as a feed additive for all animal species to be classified in the category 'technological additives'.
(4) The European Food Safety Authority ('the Authority') concluded in its opinions of 30 April 2015 (2) and 26 February 2019 (3) that, under the proposed conditions of use, the sodium formate does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the substance is mildly irritating to eyes and a skin sensitiser. In addition, given that the exposure to sodium formate via inhalation is considered to present a risk to unprotected workers handling the additive, it is prudent to consider it as a respiratory irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The Authority also concluded that sodium formate liquid has the potential to be efficacious as hygiene condition enhancer in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It 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 sodium formate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of sodium formate should be authorised as specified in the Annex to this Regulation.
(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
Authorisation
The substance specified in the Annex, belonging to the additive category 'technological additives' and to the functional group 'hygiene condition enhancers', is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 January 2020.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2015; 13(5):4113.
(3) EFSA Journal 2019; 17(3):5645.
ANNEX
(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
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