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答案（中文）
REACH 附件 XVII 的限制条目 75 涵盖了不同类别的物质，这些物质如果用于纹身，被认为会对人体健康构成风险。限制用于纹身墨水和永久性化妆品的物质包括：1. 符合以下统一分类的物质：致癌和致突变物质 (CM)，如果在用于纹身的混合物中浓度≥0.00005%（重量百分比），则为 1A、1B 和 2 类；生殖毒物 (repro)，为 1A、1B 和 2 类；以及皮肤致敏物 (SS)，为 1 类、1A 类和 1 类。如果在用于纹身的混合物中存在的浓度≥0.001%重量，则为 1B 如果在用于纹身的混合物中存在的浓度≥0.1%重量（如果该物质仅用作 pH 调节剂）或≥0.01%重量（在所有其他情况下），则统一分类为皮肤刺激物（第 2 类）、皮肤腐蚀物（第 1 类、第 1A 类、1B 类、1C 类）、眼刺激物（第 2 类）或严重眼损伤物（第 1 类）的物质；注意：仅因吸入暴露而产生影响的致癌物、诱变剂和生殖毒物第 1A、1B 或 2 类物质不包含在内。 2. 属于法规 (EU) 1223/2009 - 化妆品法规 (CPR) 范围内的物质 – 存在于用于纹身目的的混合物中，浓度≥0,00005%（重量），即： CPR 法规附件 II 中列出的物质（化妆品中禁用物质清单） CPR 法规附件 IV 中列出的物质 由于使用条件受限，使用附件 IV g 栏中指定的一种或多种此类物质：“冲洗型产品”；“不得用于粘膜产品”；“不得用于眼部产品” 物质在混合物中的浓度或其他形式不符合附件 IV h 或 i 栏中指定的条件。 3. REACH 附件 XVII 附录 13 中包含的物质
Answer (EN)
Restriction entry 75 of Annex XVII to REACH covers different categories of substances that are considered to pose risks to human health if they are used for tattooing purposes. The substances restricted for use in tattoo inks and permanent make up include:
1. Substances with the following harmonised classifications:
carcinogenic and mutagenic (CM), categories 1A, 1B and 2 if present in mixtures for use for tattooing purposes in a concentration ≥0,00005 % by weight
reproductive toxicants (repro), categories 1A, 1B and 2 and skin sensitisers (SS) Cat. 1, Cat. 1A and Cat. 1B if present in mixtures for use for tattooing purposes in a concentration ≥0,001 % by weight
Substances with harmonised classification as skin irritant (Cat. 2), skin corrosive (Cat. 1, Cat. 1A, 1B, 1C), eye irritant (Cat. 2) or serious eye damaging (Cat. 1) if present in mixtures for use for tattooing purposes in concentration ≥ 0,1 % by weight (if the substance is used only as a pH regulator) or ≥ 0,01 % by weight, in all other cases;
NOTE: substances with harmonised classification as carcinogen, mutagen and reproductive toxicant category 1A, 1B or 2 for effects due only to inhalation exposure are excluded.
2. Substances in the scope of Regulation (EU) 1223/2009 - Cosmetic Products Regulation (CPR) – present in mixtures for use for tattooing purposes in concentration ≥0,00005 % by weight i.e.:
Substances listed in Annex II of CPR Regulation (list of substances prohibited in cosmetic products)
Substances listed in Annex IV of CPR Regulation
Restricted due to condition of use of one or more of this kind specified in column g of Annex IV: “Rinse-off products”; “Not to be used in products applied on mucous membranes”; “Not to be used in eye products”
the substance is present in the mixture in a concentration, or in some other way, that does not accord with the conditions specified in column h or i of Annex IV.
3. Substances included in Appendix 13 of Annex XVII to REACH