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Safety assessment of the substance ‘Tungsten Oxide’ for use in food contact materials

机译:食品接触材料中使用的氧化钨物质的安全性评估

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摘要

This scientific opinion of Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids ( Panel) deals with the risk assessment of the additive tungsten oxide, No 39318‐18‐8 and No 1064, for use in food contact materials as a reheat agent in polyethylene terephthalate ( ) at a maximum use level of 75 ppm (75 mg/kg ). The substance is a mixture of tungsten oxides with tungsten at different oxidative levels. The average oxidation level of tungsten in the oxides is 2.86 corresponding to 19.93% oxygen content. Detailed information on impurities is provided as confidential. Specific migration from plaques with the substance at 150 mg/kg (double the maximum intended use level of 75 mg/kg) was determined into 95% ethanol, as a worst‐case simulant for due to its swelling effect. Under these test conditions, the specific migration, measured as tungsten using ‐ , was at the level of 1 μg/kg. The Panel considered that due to the insolubility of the substance, this low migration will be typical for any foreseeable use as a reheat additive in . Two genotoxicity studies, a bacterial gene mutation test and an micronucleus assay, performed in accordance with the Guidelines and in compliance with , were provided by the applicant for the substance tungsten oxide and were considered negative by the Panel. According to a scientific opinion on strategy for genotoxicity testing (EFSA, ), the three genotoxic endpoints, gene mutation, chromosomal and numerical aberrations, are covered by these two tests. The Panel concluded that the substance tungsten oxide is not of safety concern for the consumer if the additive is used as a reheat agent in . For other technical functions or for use in other polymers, the migration should not exceed 50 μg/kg (expressed as tungsten).
机译:食品接触材料,酶,调味剂和加工助剂小组(小组)的科学意见涉及用于食品接触材料中作为再热剂的添加剂氧化钨(39318-18-18和1064)的风险评估在聚对苯二甲酸乙二醇酯()中的最大使用量为75 ppm(75 mg / kg)。该物质是氧化钨与不同氧化水平的钨的混合物。氧化物中钨的平均氧化水平为2.86,对应于19.93%的氧含量。杂质的详细信息作为机密信息提供。测定了斑块中物质150 mg / kg的特定迁移(最大预期使用量为75 mg / kg的两倍)向95%乙醇的迁移,由于其溶胀作用,这是最坏的情况。在这些测试条件下,以‐钨测得的比迁移为1μg/ kg。专家小组认为,由于该物质的不溶性,这种低迁移率对于任何可预见的用作再加热添加剂的国家都是典型的。申请人对氧化钨物质进行了两项遗传毒性研究,即一项细菌基因突变试验和一种微核试验,该试验均按照准则进行,并由进行,小组认为该试验为阴性。根据有关基因毒性测试策略的科学观点(EFSA,),这两个基因测试涵盖了三个基因毒性终点,基因突变,染色体和数值畸变。小组得出结论认为,如果将氧化钨物质用作产品中的再热剂,则对消费者而言并不安全。对于其他技术功能或用于其他聚合物,迁移量不得超过50μg/ kg(表示为钨)。

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