解读 | 英国电子烟监管法规TRPR

• 确立对所有电子烟和可填充烟弹的安全性和质量的最低标准；

• 为顾客提供参考信息，确保他们能做出明智的选择；

• 确保儿童不适用电子烟产品。

TRPR第6部分目录中包括共10个章节的要求，分别如下：

• 有关电子烟及可填充烟弹的通告Notification about electronic cigarettes and refill containers

• 年度报告要求Annual reporting requirement

• 资料提交Submission of information

• 国家秘书处有义务发布通知等Secretary of State duty to publish notifications etc.

• 不符合通告的产品不得供应No supply of product where notification not complied with

• 产品要求Product requirements

• 产品信息和标签要求Product information and labelling requirements

• 产品展示要求Product presentation requirement

• 警告信息的要求Vigilance requirements

• 采取行动保护人类健康Action to protect human health

• 含尼古丁的填充容器容量不超过10ml。

  A dedicated refill container in a volume not exceeding 10 millilitres;

• 一次性电子烟储油仓或烟弹其容量不应超过2ml。

  A disposable electronic cigarette, a single use cartridge, or a tank, in a volume not exceeding 2 millilitres.

• 可填充式电子烟的储油仓容量不应超过2ml。
  The capacity of the tank of a refillable electronic cigarette must not exceed 2 millilitres.
• 电子烟烟油中的尼古丁浓度不应超过20mg/ml。

  Nicotine-containing liquid which is presented for retail sale in an electronic cigarette or refill container must not contain nicotine in excess of 20 milligrams per millilitre.

• 电子烟烟油不能含有规定的烟草添加剂（包括维生素，着色剂或者其它禁止的添加剂（咖啡因，牛磺酸或其它与能量和活力有关的兴奋剂化合物））
  Nicotine-containing liquid must not contain any specified additives (Including vitamins, colourings or prohibited additives（caffeine, taurine or other additives and stimulant compounds that are associated with energy and vitality）in tobacco products);
• 必须仅用高纯度的原材料组分进行生产。

  Must be manufactured using only ingredients of high purity;

• 必须不含有除了通告的组分以外的其它物质，除非这些物质在生产的技术上不可避免存在的而且在痕量水平以下。

  Must not contain substances other than the ingredients notified , unless present in trace levels, where such trace levels are technically unavoidable during manufacture;

• 在正常使用中，电子烟能产生烟雾中的尼古丁浓度必须是在一致的水平。

  An electronic cigarette must be able to deliver a dose of nicotine at consistent levels under normal conditions of use.

• 电子烟或可填充烟弹必须可以防止儿童开启或预防损坏和漏液。
  An electronic cigarette or refill container must be：a) child-resistant and tamper-evident; and，b) protected against breakage and leakage.

法规对于产品信息及标签要求

1. 每个单位包装和任何外包装必须包含以下信息：

Each unit packet of the electronic cigarette or refill container must include a leaflet with information on：

• 产品使用和储存的说明，包括产品的参考不建议年轻人和非吸烟者使用Instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;

• 使用禁忌Contra-indications;

• 针对特定风险群体的警告Warnings for specific risk groups;

• 可能产生的不良影响Possible adverse effects;

• 成瘾性和毒性Addictiveness and toxicity;

• 生产商的联系方式Contact details of the producer；

• 如果生产者不在成员国，则需要成员国内的联系人If the producer is not based in a member State, a contact person within a member State.

• 产品中所含所有成分的清单，按重量降序排列A list of all ingredients contained in the product set out in descending order by weight;
• 说明产品的尼古丁含量和每剂量的剂量An indication of the nicotine content of the product and the delivery per dose;
• 批号The batch number;

• 建议将本产品放在儿童接触不到的地方A recommendation to keep the product out of reach of children.

1. TRPR对于通告者在什么机构进行电子烟或可填充烟弹测试未做要求，但通告者需要对测试标准负责，因此他们必须提交声明，声明其对产品的质量和安全承担全部责任。

参考英国官方针对电子烟注册的一些指导性文件，建议进行(2)~(4)的项目测试：

- 附表1. 英国电子烟烟油检测项目列表 -

同时烟油的各成分物质必须能够证明其不含有CMR物质，并且能证明其毒性不至于影响物质的安全性，因此，推荐对烟油进行成分分析检测，并对烟油各成分进行SDS评估。

3. 电子烟气溶胶检测项目要求

- 附表2.英国电子烟气溶胶检测项目列表 -

警告信息的要求

2. 以下第(3)及(4)条款适用于电子烟或可填充烟弹生产商认为或有理由相信其管有并拟供应或已供应的电子烟或可填充烟弹，存在以下情况：Paragraphs (3) and (4) apply where a producer of electronic cigarettes or refill containers considers or has reason to believe that an electronic cigarette or refill container which is in its possession and is intended to be supplied, or which has been supplied,is：

• 不安全Not safe;

• 质量不合格 Of not in good quality；

• 不符合本部分规则的规定Not in conformity with this Part of the Regulations.

• 立即采取必要的纠正措施，使产品符合本法规要求;

  Immediately take the corrective action necessary to bring the product into conformity with this Part of the Regulations;

• 撤回产品Withdraw the product;

• 召回产品Recall the product.

4. 生产商必须立即通知已供应或拟供应该产品的任何其他成员国的国家秘书处和主管当局，特别是提供以下详细内容：The producer must immediately inform the Secretary of State and the competent authority of any other member State in which the product has been supplied or is intended to be supplied, giving details of, in particular：

• 对人类健康和安全的风险The risk to human health and safety;

• 所采取的任何纠正措施Any corrective action taken; 

• 任何纠正措施的结果The results of any corrective action taken.

对于电子烟打广告要求

禁止在报刊上刊登电子烟广告等。

本文指导老师：消费品事业部 Frank