Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Anguita Montserrat, Innocenti Matteo L, Galobarts I Cots Jaume, Ortuño Jordi, Pagés Plaza Daniel
EFSA J. 2024 May 8;22(5):e8789. doi: 10.2903/j.efsa.2024.8789. eCollection 2024 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 efficacy of ferrous lysinate sulfate (Plexomin® L-Fe) for all animal species. The additive has not been previously authorised as a feed additive in the European Union (EU). The safety of the additive for the target species, consumer, user and the environment has already been assessed in previous opinions. However, the efficacy remained inconclusive due to the absence of evidence of the bioavailability of the iron contained in the additive in the trials submitted either with chickens for fattening or with weaned piglets. For the present assessment, the applicant submitted a recalculation of the previous data on weaned piglets, which did not show evidence of bioavailability. Therefore, in the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of ferrous lysinate sulfate for all animal species.
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）被要求就硫酸赖氨酸铁（百乐美® L-Fe）对所有动物物种的功效发表科学意见。该添加剂此前未在欧盟被授权作为饲料添加剂。该添加剂对目标物种、消费者、使用者和环境的安全性已在先前的意见中进行了评估。然而，由于提交的关于育肥鸡或断奶仔猪的试验中缺乏该添加剂中铁的生物利用度的证据，其功效仍无定论。对于本次评估，申请人提交了对先前断奶仔猪数据的重新计算，结果未显示出生物利用度的证据。因此，在缺乏充分数据的情况下，FEEDAP小组无法就硫酸赖氨酸铁对所有动物物种的功效得出结论。
