Safety of potassium diformate (Formi™ LHS) as a feed additive for sows, from ADDCON EUROPE GmbH.

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of potassium diformate as a feed additive for sows (brand name Formi™ LHS). The additive was re‐evaluated by the Panel in 2009. In its assessment on the renewal of the additive adopted by the FEEDAP Panel in 2020, the Panel concluded that the information provided by the applicant did not fulfil the minimum requirements to support that Formi™ LHS remained safe under the approved conditions for target species, consumers and users. In the same opinion, the Panel concluded that the use of Formi™ LHS under the approved conditions remained safe for the environment. In the present assessment, the applicant conducted a literature search to fulfil the data requirements for the renewal application and no relevant information regarding adverse effects in target animals (pigs, piglets and sows), consumers and users were identified. Based on this, and the fact that the manufacturing and composition of the additive have not been modified, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in the previous re‐evaluation opinion adopted by the FEEDAP Panel in 2009. Therefore, the Panel concludes that the additive remains safe for sows and the consumer under the authorised conditions of use. Regarding user safety, the Panel reiterates that for the additive, ‘except for ocular irritation potential, no effects requiring specific user protection measures were found’.