EFSA食品接触材料小组,酶,根据艺术,欧洲委员会要求食用香料和加工助剂(CEF小组)。法规(EC)No178/2002的291(a),以对有关丙烯酸乙酯[FL-no:09.037]用作调味物质时的安全性的现有文献进行审查。2010年,EFSA在FGE.71中评估了丙烯酸乙酯[FL-no:09.037]作为调味物质,基于2006年JECFA评估。小组的结论是,根据最大化调查衍生每日摄入量(MSDI)方法,丙烯酸乙酯作为调味物质的估计摄入量没有安全问题。专家小组评估了现有的新文献以及JECFA(2006)和EFSA(2010)以前进行的任何评估。此外,有关丙烯酸乙酯作为调味物质的使用量的新数据已提供。用作调味物质,使用添加部分暴露技术(APET)估计的慢性饮食暴露,对于60公斤的成年人,计算为每天3,545μg/人,对于15公斤的3岁儿童,计算为每天2,233μg/人。食品接触材料的暴露量可能高达每天6,000μg/人。小组认为,根据现有数据,涵盖所有相关的遗传终点(即基因突变,结构和数字染色体畸变)与丙烯酸乙酯的遗传毒性无关。专家小组评估了在大鼠和小鼠中进行的现有致癌性研究,并同意NTP评估(1998年)的结论,即在啮齿动物中观察到的前胃鳞状细胞乳头状瘤和癌与人类无关。此外,在短期和亚慢性毒性研究中,没有全身毒性的证据.因此,小组的结论是,使用丙烯酸乙酯作为调味物质不存在安全问题,在预期的使用条件下。
The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No 178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panel concluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panel has evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 μg/person per day for a 60-kg adult and 2,233 μg/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 μg/person per day. The Panel considered that based on the available data, which covers all relevant genetic endpoints (i.e. gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panel evaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Panel concluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.