Commission Implementing Regulation (EU) 2021/2092 of 29 November 2021 concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/2092of 29 November 2021concerning the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets(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 nutritionOJ L 268, 18.10.2003, p. 29., 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 an authorisation.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium diformate. 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 potassium diformate as a feed additive for pigs for fattening and weaned piglets, to be classified in the category "technological additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 5 May 2021EFSA Journal 2021;19(5):6617. that, under the proposed conditions of use, potassium diformate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the substance does not raise concerns regarding the effects on the respiratory system and the skin but is an eye irritant. 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 concluded that the substance has the potential to be efficacious as a technological additive in feedingstuffs. 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 potassium diformate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance 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 1The substance specified in the Annex, belonging to the additive category "technological additives" and to the functional group "acidity regulators", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2This 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, 29 November 2021.For the CommissionThe PresidentUrsula von der LeyenANNEX
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.
Identification number of the additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg/kg of complete feedingstuff with a moisture content of 12 %
Category of technological additivesFunctional group: acidity regulators
1j001Potassium diformateAdditive composition:Potassium diformate ≥ 98 %Pigs for fatteningWeaned piglets--60001.In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2.The maximum content of potassium diformate shall be 6000 mg/kg of complete feedingstuff with a moisture content of 12 %, whether used alone as an acidity regulator or used in combination with other sources of potassium diformate.3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes protection.20 December 2031
Characterisation of the active substance:Potassium diformateCAS No: 20642-05-1Einecs No: 243-934-6C2H3O4K
Analytical methodFor the determination of potassium diformate (as total formic acid) in the feed additive, premixture, feedingstuffs:Ion chromatography with conductivity detection (IC-CD) – EN 17294;For the determination of potassium in the feed additive:Atomic absorption spectrometry (AAS) – EN ISO 6869; orInductively coupled plasma-atomic emission spectrometry (ICP-AES) – EN15510.