欧盟关于电子烟政令

更新时间:2017-07-26 11:12:31点击:1210 Website Optimization

                                  TITLE III

 

 

       ELECTRONIC CIGARETTES AND HERBAL PRODUCTS FOR SMOKING

                      Article 20      Electronic cigarettes

 

1. The Member States sha11 ensure that electronic cigarettes and refi11 containers are only placed on the market if they complywith this Directive and with a11 other relevant Unionlegislation.

 

This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive2001/83/EC or to the requirements set out in Directive93/42/EEC

1. 成员国需确保电子烟和雾化器只有在合乎所有相关联盟的立法指令下投入市场,这项指令不适用于从属于2001/83/EC指令认证要求下或载于93/42/EEC指令认证要求下的电子烟和雾化器。

 

 

 

2. Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers already placed on the market on 20 May2016, the notification sha11 be submitted within six months of that date. A new notification shall be submitted for each substantia1 modification of the product.

 

The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:

2. 电子烟和雾化器的工厂和进口商打算在市场上占有一席之地的任何产品需提交通知给会员国主管当局。并且需以电子表格的形式在产品投放市场前六个月提交通知。所有的通知需在2016年5月20号之前6个月提交完成,并全面实施于电子烟和雾化器市场。

 

通知需依据该产品是否是电子烟或雾化器,包括以下几点:

 

 

(a) the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;

a] 联盟规定下厂商的名字和联系信息需是合法存在的自然人,如果合格的话,进口商可以与之合作。

 

 

(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type,,including quantities thereof;

b] 需把列表所有的产品成分,及使用的排放成分,品名,品牌及型号,包括数量及使用方法等等。

 

 

(c) toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;

c] 列明所有有毒物质数据,关于产品成分和排放物包括加热时成分,特别是这些成分吸入时对消费者健康的危害考虑在内,初次之外,有任何成瘾的影响等。

 

(d) information on the nicotine doses and uptake when consumed under norma1 or reasonably foreseeable conditions

d] 在正常的预见和合理条件下对尼古丁吸食消耗的剂量。

 

 

(e) a description of the components of the product; including, where applicable, the opening and refi11 mechanism of the electronic cigarette or refi11 containers;

e] 对产品含量的描述,包括电子烟和雾化器哪里适用,开关和填装方法。

 

 

(f)  a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article;

f]  生产过程的描述,包括是否涉及连续生产,以及对生产过程确保与此章节要求相一致的描述。

 

(g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product,,when placed on the market and used under norma1 or reasonably foreseeable conditions.

 

Where Member States consider that the information submitted is incomplete, they sha11 be entitled to request the completion of the information concemed.

 

 

Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them.

g] 在产品投入市场并在正常和合理可预见的条件下使用时,对厂家承担产品质量和安全上的所有责任的陈述。

 

成员国认为提交信息不完整的地方,他们有权要求补全完整。

 

成员国为了接受,储存,操作和分析这些已提交的数据可能会对厂商及进口商收取一定比例的费用

 

3. Member States shall ensure that

3. 成员国需确保如下

 

 

 

(a) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2ml;

a] 仅在市场上用于雾化器的含有尼古丁的烟油量不能超过10ml, 在一次性电子烟或者是单一使用的墨盒或烟油仓不能超过2ml。

 

(b) the nicotine-containing liquid does not contain nicotine in excess of 20mg/ml

b] 含有尼古丁的烟油,尼古丁含量不能超过20mg/ml.

 

 

(c) the nicotine-containing liquid does not contain additives listed in Article7(6)

c] 含有尼古丁的烟油不能含第7条所列的添加剂。

 

 

(d) only ingredients of high purity are used in the manufacture of the nicotine_containing liquid. Substances other than the ingredients referred to in point(b) of the second sub-paragraph of paragraph2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;

d] 如果这种微量在生产中技术达不到的情况下,含尼古丁的烟油制造商只有使用高纯度的成分,除了这一条款第二节第二款b点所指的物质成分仅代表微量的含尼古丁烟油。

 

(e) except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;

e] 除了尼古丁,所有成分在作为含尼古丁烟油使用时,加热或无加热情况下不会对人体健康造成伤害。

 

 

(f) electronic cigarettes deliver the nicotine doses at consistent levels under norma1 conditions of use;

f] 电子烟在正常使用的条件下提供尼古丁的剂量在一致的水平上。

 

 

e) electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

e] 电子烟和雾化器是防儿童和防篡改的,以防破裂和泄露,并且有确保填充不会漏油的机制。

 

 

4. Member States shall ensure that:

4. 成员国需确保

 

(a) unit packets of electronic cigarettes and refi11 containers include a leaflet with information on:

 

 

(i) 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;

 

(ii) contra-indications;

 

(iii) warnings for specific risk groups;

 

(iv) possible adverse effects;

 

(v) addictiveness and toxicity; and

 

(vi) contact details of the manufacturer or importer and a lega1 or natura1 contact person within the Union;

a] 每个电子烟和雾化器的包装中含有手册的信息如下:

(i) 使用和储存指南,包括提及产品不建议年轻人和非烟民使用

(ii) 禁忌条目

(iii) 对特殊人群的警告

(iv) 可能会有的副作用

(v) 成瘾性和毒性

(vi) 和制造商或进口商的联系方式以及同盟内合法自然联系人

 

 

b) unit packets and any outside packaging of electronic cigarettes and refill containers:

 

(i) include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;

 

(ii)without prejudice to point(i) of this point, do not include elements or features referred to in Article13, with the exception of Article13(1)(a) and(c) concerning information on the nicotine content and on flavourings; and

 

(iii) carry one of the fo11owing health warnings:

 

'This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers'. or 'This product contains nicotine which is a highly addictive substance.''Member States shall determine which of these health warnings is to be used;

b] 电子烟和雾化器每盒包装和外包装

(i) 包括产品中所含的量降序列出所有成分,并指示产品的尼古丁含量,每剂量交付,批号和推荐保持产品远离儿童;

(ii) 在不违背第(i)点的情况下,不含有第13条款所指的元素和成分,除了第3条款(1)(a)和(c)关于尼古丁内容和口味的信息;

(iii) 和具有以下健康警告其中一个:

这种产品含有高度上瘾物质。 “不建议非烟民使用”或 “该产品含有高上瘾物质”

成员国需决定使用那种健康警告标识。

 

 

(c) health warnings comply with the requirements specified in Article12(2).

c] 健康警告标识遵从第12条款(2)中所示要求。

 

 

5. Member States shall ensure that:

5. 成员国需确保

 

(a) commercia1 communications in Information Society services, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited, except for publications that are intended exclusively for professionals in the trade of electronic cigarettes or refill containers and for publications which arc printed and published in third countries, where those publications arc not principally intended for the Union market;

a] 商业通信在信息社会服务,在报纸和其他出版物,以直接或间接地影响促进电子烟和雾化器为目的的是被禁止的, 除了那是专门用于在电子烟或雾化器的贸易专业和出版物印刷和电弧在第三个国家出版的出版物,其中这些出版物并不主要用于欧盟市场;

 

b) commercial communications on the radio, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers, are prohibited;

b] 在商业广播通信,以直接或间接的影响促进电子烟和雾化器为目的,是被禁止的;

 

(c) any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;

c] 任何形式的公共或私人致于直接或间接的影响促进电子香烟和雾化器的目的广播节目是禁止的;

 

(d) any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;

d] 任何形式的公共或私人从属于的事件,活动或个人,和涉及或发生在几个成员国或其他具有跨境影响,具有直接或间接的影响促进电子烟和雾化器为目的的,是禁止的;

 

(e) audiovisual commercia1 communications to which Directive2010/13/EU of the European Parliament and of the Council(1) applies, are prohibited for electronic cigarettes and refill containers. Article18 of this Directive shall apply to cross-border distance sales of electronic cigarettes and refill containers.

e] 视听商业通讯在欧洲议会2010/13/EU条款和理事会(1)下适用,对电子烟和雾化器是禁止的。第18条款应该适用于跨境距离电子烟和雾化器交易。

 

 

7. Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit annually, to the competent authorities:

7. 成员国需要求所有的电子烟和雾化器制造商和进口商需年度提交并公认:

 

 

(i) comprehensive data on sales volumes, by brand name and type of the product;

(i) 销售量,品名和产品型号完整的数据;

 

(ii) information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;

(ii) 各种消费群体包括年轻人,非烟民和现使用的主流群体的偏好信息;

 

 

(iii) the mode of sale of the products; and

(iii) 产品销售的模式

 

 

(iv) executive summaries of any market surveys carried out in respect of the above, including an English translation thereof

 

Member States shall monitor the market deve1opments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately traditiona1 tobacco consumption among young people and non_smokers.

(iv) 执行摘要对于以上各个方面的一些市场调查,包括英文翻译方法

成员国需监控关于电子烟和雾化器市场发展,包括任何表明尼古丁成瘾和最终的传统烟草消费的年轻人和非烟民之间途径。

 

8. Member States shall ensure that the information received pursuant to paragraph2 is made publicly available on a website. The Member States shall take the need to protect trade secrets duly into account when making that information publicly available.

 

Member States shall, upon request, make all information received pursuant to this Article available to the Commission and other Member States. The Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.

8. 各成员国应确保依照本条第2款所收到的信息是公开的网站上。 成员国应采取必要保护商业秘密,适当考虑将信息公开的时候。

成员国应当根据请求,让所有收到的信息是根据本条适用于委员会和其他成员国。成员国和欧盟委员会应确保商业秘密和其他机密信息以保密的方式处理。

 

9. Member States shall require manufacturers, importers and distributors of electronic cigarettes and refill containers to establish and maintain a system for collecting information about all of the suspected adverse effects on human health of these products.

 

Should any of these economic operators consider or have reason to believe that electronic cigarettes or refill containers, which are in their possession and are intended to be placed on the market or are placed on the market. are not safe or are not of good quality or are otherwise not in conformity with this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate. In such cases the economic operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available or is intended to be made available, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action.

 

Member States may also request additional information from the economic operators, for example on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

9. 各成员国应要求电子香烟和雾化器的制造商,进口商和分销商建立和维持一个关于所有这些产品的不良影响人类健康的收集信息怀疑系统。

如果任何这些经济经营者认为或有理由相信电子烟或雾化器,这是在他们身上,要放在市场或在市场上销售。不安全或是质量不好或不符合本指令,经济经营者应当立即采取必要的纠正措施使产品成本指令一致,适当撤回或召回。在这种情况下,经营者还应立即对成员国在该产品可向市场监督机构或是可用的,特别是细节,风险,对人体健康和安全的任何纠正措施的采取,和这样的纠正措施结果。

成员国也可以从经济运营商要求附加信息,例如任何电子烟或雾化器在安全和质量方面的不利影响。

 

 

10. The Commission shall submit a report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes by20 May2016 and whenever appropriate thereafter.

10. 截至2016年5月20号或一定时间后,委员会应向欧洲议会和委员会提交关于充装电子烟使用相关对公共健康的潜在风险的报告。

 

11. In the case of electronic cigarettes and refill containers that comply with the requirements of this Article, where a competent authority ascertains or has reasonable grounds to believe that specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, could present a serious risk to human health, it may take appropriate provisional measures. It shall immediately inform the Commission and the competent authorities of other Member States of the measures taken and shall communicate any supporting data. The Commission shall determine, as soon as possible after having received that information, whether the provisional measure is justified. The Commission shall inform the Member State concerned of its conclusions to enable the Member State to take appropriate follow-up measures.

 

 

 

Where, in application of the first sub-paragraph of this paragraph, the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article27 to extend such a prohibition to all Member States, if such an extension is justified and proportionate.

11. 在符合本条的要求的电子烟和雾化器的情况下,在主管机关确定的或有合理理由相信特定或一种的电子烟或雾化器,可能对人体健康带来严重风险,可采取相应的临时措施。应立即通知委员会和其他成员国所采取的措施,主管部门应当提供任何数据支持。 委员会须决定,无论是临时措施是不是合理的,应尽快收到信息后。委员会应将有关的结论通知成员国采取适当的后续措施。

在这里,在这一段的第一款应用,放置在特定或一种的电子烟或雾化器的市场已经在至少三个成员国中被禁止, 欧盟委员会将有权通过授权行为依照第二十七条拓展禁止,如果这种扩展是合理的和适度的。

 

 

12. The Commission shall be empowered to adopt delegated acts in accordance with Article27 to adapt the wording of the health warning in paragraph4(b) of this Article. When adapting that health warning, the Commission shall ensure that it is factual.

12. 欧盟委员会将采取委托授权行为依照第二十七条第四段适用于款健康警告的措辞。当使用合适的健康警告,委员会应确保它是真实的。

 

 

13. The Commission shall, by means of an implementing act, lay down a common format for the notification provided for in paragraph2 and technical standards for the refill mechanism provided for in paragraph3(g).

 

These implementing acts shall be adopted in accordance with the examination procedure referred to in Article25(2).

13. 委员会规定,在本条第2款第三段由实施行为的方式,制定规定和技术标准提供所规定的补充机制。

这些行为的实施必须根据指第二十五条(2)审批程序。

Recommended Reading