Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Brozzi Rosella, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo L, Vettori Maria Vittoria, López-Gálvez Gloria
EFSA J. 2021 May 25;19(5):e06621. doi: 10.2903/j.efsa.2021.6621. eCollection 2021 May.
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.
应欧盟委员会的要求,动物饲料添加剂及产品或物质专家小组(FEEDAP)被要求就作为育肥鸡畜牧技术添加剂的二甲基甘氨酸钠盐(商品名:Taminizer D)续期授权申请的评估发表科学意见。2011年,FEEDAP小组就该添加剂的安全性和有效性发表了意见,随后该添加剂在欧盟获得授权。2018年,根据提交的关于修改该添加剂授权条款的卷宗进行了第二次科学评估。该添加剂以“纯度至少为97%的二甲基甘氨酸钠盐”的形式,在“畜牧技术添加剂”类别和“其他畜牧技术添加剂(改善畜牧技术参数)”功能组下被批准用于育肥鸡。申请人提供的证据表明,目前市场上通过两种生产路线生产的添加剂符合授权条件。未发现新的证据会使FEEDAP小组重新考虑其先前关于目标物种、消费者和环境安全性的结论。FEEDAP小组得出结论,Taminizer D不是皮肤刺激物,但可能是眼睛刺激物和皮肤致敏剂;尽管甲醛的存在仍存在不确定性,但认为接触量极低。在续期授权的背景下,无需评估该添加剂的功效。