Assessment of the feed additive consisting of dimethylglycine sodium salt (Taminizer D) for chickens for fattening for the renewal of its authorisation (Taminco N.V.)

摘要

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 the feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as ‘dimethylglycine sodium salt with a purity of at least 97%’ for chickens for fattening under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives (improvement of zootechnical parameters)’. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.