Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca Fašmon, 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, Brantom Paul, Chesson Andrew, Dierick Noël, Martelli Giovanna, Westendorf Johannes, Anguita Montserrat, Galobart Jaume, Manini Paola
EFSA J. 2020 Dec 16;18(12):e06338. doi: 10.2903/j.efsa.2020.6338. eCollection 2020 Dec.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty-two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The FEEDAP Panel concluded that the 22 compounds are safe for these species at the proposed use level and conclusions were extrapolated to all animal species for all the compounds except for α-damascone [07.134]. In the absence of data that would allow the FEEDAP Panel to rule out the genotoxicity concern, the FEEDAP Panel cannot extend the conclusions for α-damascone [07.134] to all animal species and cannot conclude on the safety for the consumer, the user and the environment. No safety concern would arise for the consumer from the use of the remaining 30 compounds up to the highest levels considered safe for target animals. The revised maximum safe levels for the 30 compounds are not expected to further impact on the previous conclusions on user safety. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds except β-damascone [07.083] and (E)-β-damascone [07.224], for which in the absence of ecotoxicity data, the FEEDAP Panel cannot conclude on the safety for the terrestrial compartments. For the marine environment, the safe use level for 2-methyl-1-phenylpropan-2-ol [02.035], α-irone [07.011], β-damascone [07.083] and (E)-β-damascone [07.224], phenethyl isovalerate [09.466], 4-(p-hydroxyphenyl) butan-2-one [07.055] and 2-isopropyl-4-methylthiazole [15.026] is confirmed to be 0.05 mg/kg.
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31种属于不同化学类别的化合物用作所有动物饲料的感官添加剂时的安全性提供科学意见。31种化合物中的22种在育肥鸡、仔猪和育肥牛的耐受性研究中进行了测试。对于其余9种化合物,建议从结构相似的化合物进行类推。在预期水平的10倍剂量下进行的耐受性研究中未观察到不良影响。FEEDAP小组得出结论,22种化合物在所建议的使用水平下对这些物种是安全的,并且除α-大马酮[07.134]外,所有化合物的结论都外推至所有动物物种。由于缺乏能让FEEDAP小组排除遗传毒性担忧的数据,FEEDAP小组无法将α-大马酮[07.134]的结论扩展至所有动物物种,也无法就其对消费者、使用者和环境的安全性得出结论。使用其余30种化合物直至对目标动物而言被认为安全的最高水平,不会引起消费者的安全担忧。30种化合物修订后的最大安全水平预计不会对先前关于使用者安全的结论产生进一步影响。对于目标物种而言被认为安全的浓度,除β-大马酮[07.083]和(E)-β-大马酮[07.224]外,所有化合物对环境不太可能产生有害影响,由于缺乏生态毒性数据,FEEDAP小组无法就其对陆地环境的安全性得出结论。对于海洋环境,2-甲基-1-苯基丙-2-醇[02.035]、α-鸢尾酮[07.011]、β-大马酮[07.083]和(E)-β-大马酮[07.224]、苯乙基异戊酸酯[09.466]、4-(对羟基苯基)丁-2-酮[07.055]和2-异丙基-4-甲基噻唑[15.026]的安全使用水平经确认均为0.05毫克/千克。