Borroto Jorge, Castoldi Anna Federica, Chiusolo Arianna, Colagiorgi Angelo, Colas Mathilde, Crivellente Federica, De Lentdecker Chloe, Istace Frederique, Kardassi Dimitra, Mangas Iris, Molnar Tunde, Parra Morte Juan Manuel, Terron Andrea, Tiramani Manuela
EFSA J. 2022 Feb 25;20(2):e07147. doi: 10.2903/j.efsa.2022.7147. eCollection 2022 Feb.
In accordance with Art. 31(1) of Regulation (EC) No 178/2002, the Commission asked EFSA to provide a scientific review on the BfR opinion on the 'Health risk assessment of ethylene oxide residues in sesame seeds' (Opinion No 024/2021) regarding the toxicity of 2-chloroethanol. In addition, EFSA was asked to clarify under which circumstances the use of the MOE approach is considered appropriate. Based on the information available to EFSA, i.e. the studies assessed in the frame of the BfR opinion and additional data provided by stakeholders not assessed by BfR, EFSA considers the genotoxicity of 2-chloroethanol as inconclusive. On this basis, EFSA would not recommend setting reference points for risk assessment or health-based guidance values until the genotoxic potential of 2-chloroethanol is clarified. EFSA therefore recommends performing new in vitro gene mutation and in vitro micronucleus tests with 2-chloroethanol following the recommendations of the most recent OECD technical guidelines to clarify its genotoxic potential. If the result of any of the test is positive, the recommendations of the EFSA Scientific Committee (2011) should be followed. If the genotoxic potential of 2-chloroethanol is finally clarified and overall negative, EFSA would recommend setting the reference point for deriving health-based guidance values based on existing toxicity studies on 2-chloroethanol.
根据欧盟委员会第178/2002号法规第31(1)条，欧盟委员会要求欧洲食品安全局（EFSA）就德国联邦风险评估研究所（BfR）关于“芝麻中环氧乙烷残留的健康风险评估”（第024/2021号意见）中有关2-氯乙醇毒性的内容提供科学审查。此外，还要求EFSA阐明在何种情况下使用边际暴露量（MOE）方法被认为是合适的。基于EFSA所掌握的信息，即BfR意见框架内评估的研究以及利益相关者提供的未被BfR评估的额外数据，EFSA认为2-氯乙醇的遗传毒性尚无定论。在此基础上，在2-氯乙醇的遗传毒性潜力得到阐明之前，EFSA不建议设定风险评估参考点或基于健康的指导值。因此，EFSA建议按照经合组织最新技术指南的建议，对2-氯乙醇进行新的体外基因突变和体外微核试验，以阐明其遗传毒性潜力。如果任何一项试验结果为阳性，则应遵循EFSA科学委员会（2011年）的建议。如果2-氯乙醇的遗传毒性潜力最终得到阐明且总体为阴性，EFSA将建议根据现有的2-氯乙醇毒性研究设定用于推导基于健康的指导值的参考点。
