作者: 翠盖调味研发团队出版:广东独特风味有限公司最后更新: 九月 14,2026WhatsApp与Telegram: +86 189 2926 7983电子邮件:info@cuiguai.comCMR 代表致癌性、致突变性和生殖毒性——欧洲监管机构对这三种危害的容忍度最低。 CMR 物质是一种可能导致癌症、诱发基因突变或损害生育能力或未出生婴儿的化学物质。在欧盟,这些物质不仅不被鼓励:它们向公众的供应受到 REACH 法规的法律限制,同样的逻辑也直接适用于管理电子液体及其所含调味化合物的规则。对于电子烟油品牌所有者、进口商和合规管理者来说,CMR 禁令并不是一项抽象的布鲁塞尔政策。它决定哪些浓缩香料可以在欧盟成员国合法销售,哪些成分必须出现在烟草产品指令要求的产品通知中,以及哪些供应商可以安全合作。如果您是欧洲市场的新手,我们的指南 EU TPD compliance and the forbidden ingredients list 是一个有用的起点,因为 CMR 限制位于同一监管生态系统内,并且两套规则是一起执行的。定义:欧盟的“CMR 禁令”是指法规 (EC) No 1907/2006 (REACH) 附件 XVII 中的限制,禁止将任何被归类为 1A 或 1B 类致癌、致突变或生殖毒性的物质(单独、以混合物或在物品中)投放市场或向公众供应,前提是该物质的重量浓度等于或高于 0.1%。该限制通过三个平行条目实施:条目 28(致癌物)、条目 29(生殖细胞诱变剂)和条目 30(生殖毒性剂)。由于每种电子烟油和每种浓缩香料都是混合物,因此这个单一阈值是行业中每个配方团队都必须了解的数字。
欧盟 CMR 物质禁令:电子烟油品牌必须了解的知识 |翠拐味
法律基础:REACH、CLP 和附件 XVII
The CMR restriction lives in Annex XVII to the REACH Regulation — the European Union's core chemicals law, formally titled Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. Annex XVII contains the consolidated list of restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles. Entries 28, 29 and 30 are the CMR entries. When industry professionals say “the CMR ban”, they almost always mean these three entries read together, together with the annexes that list the individual restricted substances.
类别 1A 和 1B:分类的含义
这些类别来自分类、标签和包装 (CLP) 法规、法规 (EC) No 1272/2008,该法规在欧盟实施联合国全球化学品分类和标签统一制度 (GHS)。 1A 类涵盖主要基于人类证据的已知对人类具有致癌、致突变或生殖毒性的物质。 1B 类涵盖主要根据动物证据推测对人类具有此类影响的物质。这种区别很重要,因为只有 1A 和 1B 物质属于附件 XVII 的限制——仅归类为第 2 类的物质不属于条目 28-30,尽管它可能会通过其他机制或未来的修正案受到限制。
香料公司或电子烟油品牌的强大筛选工作流程可以通过六个步骤构建。第一步:要求每个原材料供应商提供完整的配方披露或经过验证的合规档案,其中包含每个成分的 CAS 编号。第二步:根据当前附件 XVII CMR 列表和 CLP 协调分类表运行每个 CAS 编号。第三步:对照 ECHA C&L 库存验证供应商安全数据表,而不是相信 SDS 的表面价值——分类可能已经过时或根本就是错误的。第四步:计算最坏情况下的残留量,将浓缩香料中的物质浓度乘以成品电子烟液中的最大使用率。第五步:检查 TPD 第 7(6) 条清单和目标市场的任何国家清单。第六步:每当公式发生变化时,按照固定的日历时间表重新进行整个筛选(至少每年两次),因为限制列表会定期修改。
风味屋的 CMR 筛选:分步工作流程
品牌所有者和进口商的实际合规性
If you buy finished e-liquid or flavor concentrates for resale, the REACH restriction and the TPD notification duty land on your desk, not on your supplier's. As the importer or brand owner you are the party placing the product on the market, which makes you the notifier under Article 20(2) of the TPD and the party that must be able to justify every ingredient in the file. That implies contractual due diligence: written undertakings from suppliers that no CMR 1A/1B substance is present above the applicable thresholds, obligations to notify formula changes in advance, access to updated safety data sheets, and the right to audit the supplier's own screening records.Record keeping is the second half of compliance. The competent authorities can request toxicological data and full composition at any point in the product's life, and a notification that cannot be backed by documentation is a liability, not a compliance file. Keep the master formulation per SKU, the CAS-keyed component list, the screening results with the date of each check, and the supplier correspondence — all versioned, so that a future audit can reconstruct exactly what was declared and why.对于多市场品牌来说,还有一个更实际的问题:CMR 框架并不是您将面临的唯一成分体系。如果你也销往中国,国家标准GB 41700-2022对电子烟油有自己的添加剂限制;我们的指南 GB 41700-2022 compliance for e-liquid additives 映射重叠和差异。如果你的公式依赖于 cooling flavor concentrates 对于消费者期望从薄荷醇和冰类产品中获得的冷感特征,请记住,清凉剂本身必须通过与其他所有成分相同的筛选——单一被忽视的成分就足以破坏整个产品线。Finally, plan for market surveillance. National enforcement authorities sample e-liquids at retail and in import warehouses, and laboratory results travel fast between Member States through the EU's administrative cooperation networks. A product found to contain a CMR 1A/1B substance above the threshold faces withdrawal from the market, notification through the rapid alert systems, and potentially corrective actions that apply to the whole batch family. That is why the compliance file should live with the product manager, not only with the regulatory specialist: formula changes, supplier substitutions and cost-reduction projects are exactly where undocumented CMR exposure tends to slip in.