Mertens Birgit, Van Bossuyt M, Fraselle S, Blaude M N, Vanhaecke T, Rogiers V, Verschaeve L, Van Hoeck E
Department of Food, Medicines and Consumer Safety, Scientific Institute of Public Health (Site Elsene), J. Wytsmanstraat 14, Brussels, Belgium.
Department of Food, Medicines and Consumer Safety, Scientific Institute of Public Health (Site Elsene), J. Wytsmanstraat 14, Brussels, Belgium; In Vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Laarbeeklaan 103, Brussels, Belgium.
Food Chem Toxicol. 2017 Aug;106(Pt A):496-505. doi: 10.1016/j.fct.2017.05.071. Epub 2017 Jun 3.
Up till now, no harmonized EU regulation exists on chemicals used in coatings for food contact materials (FCM). Therefore, these substances need to comply with the general provisions of EU Regulation 1935/2004 and, if present, with national legislation. Different 'inventory lists' of compounds that might be present in coatings are available, but for hundreds of these substances, the potential human health impact of their use in FCM coatings has not (recently) been evaluated. Since detailed evaluation of all compounds is not feasible, a pragmatic approach was developed to identify substances with a potential concern for human health. First, an inventory was assembled containing all substances potentially used in coatings. Afterwards, the genotoxic potential of the non-evaluated substances was predicted in silico using two structure-activity relationship (SAR) software programs. For substances yielding structural alerts in both models, genotoxicity data were collected from previous European evaluations in a non-FCM context and from the European CHemicals Agency (ECHA) website. In total, 53 substances were identified as genotoxic in both in silico models, of which ten were considered to be of high concern. For most of the substances, additional toxicological information is needed.
截至目前,欧盟尚未对用于食品接触材料(FCM)涂料中的化学品制定统一的法规。因此,这些物质需要符合欧盟法规1935/2004的一般规定,如有相关规定,还需符合国家立法。目前有不同的涂料中可能存在的化合物“清单”,但对于其中数百种物质,其在FCM涂料中的使用对人类健康的潜在影响尚未(近期)进行评估。由于对所有化合物进行详细评估不可行,因此制定了一种务实的方法来识别对人类健康可能存在潜在风险的物质。首先,汇编了一份包含所有可能用于涂料的物质的清单。之后,使用两个构效关系(SAR)软件程序在计算机上预测未评估物质的遗传毒性潜力。对于在两个模型中均产生结构警示的物质,从以前欧洲在非FCM背景下的评估以及欧洲化学品管理局(ECHA)网站收集遗传毒性数据。总共53种物质在两个计算机模型中均被鉴定为具有遗传毒性,其中10种被认为具有高度关注性。对于大多数物质,还需要更多的毒理学信息。