法国将公布不符合TPD的产品清单

发表时间:2020-08-12 19:24
近日,法国食品、环境与职业健康安全署(ANSES)对已通告的电子烟及相关产品,通过邮件的方式发布了一个列表,其包含产品清单、不一致性和不符合项列表:
根据2014/40 / EU烟草制品指令通过欧盟门户(EU-CEG)进入到法国的烟草制品及相关产品,现需遵循法国公共卫生法典。
Thetobacco products or related products for the French market through the EuropeanCommon Entry Gate (EU-CEG)1 under the 2014/40/EU TobaccoProducts Directive, transposed into the French Public Health Code2.
根据该规定,自2018年中开始,ANSES会在产品首次通告(注册)的6个月后,在其网站公布相关产品数据(www.anses.fr)。从2020年9月开始,这些数据中将添加报告的不一致和不符合项列表,以下称其为“偏差”,它们是ANSES对企业的通告文件进行分析后得出的结果。
Pursuant tothe regulation, ANSES publishes data about the products six months after their first notification, since mid-2018 on its website (www.anses.fr).As of September 2020, these data will be supplemented by a list of reported inconsistencies and non-compliances, hereafter named as “deviations” as theyresult from our analysis of your notified files.
在收到的邮件附件中,申请商会看到他们通告给ANSES的产品列表,通告的偏差及描述性通知。并且ANSES将会根据申请商对提交信息所做的更改,定期发送更新的文件。这些文件也会同时被抄送给作为监管的主管部门的法国卫生部。
You will find, in the attached file, the list of your products, the deviations identified in the notifications sent to ANSES as well as a descriptive notice.This updated file will now be sent to you on a periodic basis following the changes you have made to the submissions by updating them. The Ministry of Solidarities and Health, as the regulatory competent authority, is also therecipient of this information.
ANSES鼓励数据的一致性,并对不符合的注册产品采取适当措施,更正注册数据或将不合格产品从市场上移除。此外,处理注册文件中的不一致之处,将提高传输给主管部门的数据的质量,并能够为公众提供可靠的信息。
ANSES invite you to enhance the consistency of your data and to take immediately appropriate measures for the non-compliant registered products,either by correcting the registered data or by removing the non-compliantproducts from the market. In addition, handling inconsistencies in theregistration files will improve the quality of data transmitted to theauthorities and enable to provide the public with reliable information.
ANSES无法修改注册数据,注册数据将由申请商全权负责。因此,申请商必须通过EU-CEG报告计划进行更正和/或撤回产品,而不是使用其他任何处理方式。
ANSES is not able to modify your registered data, notifications being performed underyour soleresponsibility. Therefore, corrections and/or products withdrawals must be made according to the EU-CEG reporting scheme to the exclusion of anyother way to proceed.

1 http://ec.europa.eu/health/euceg/
2 https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000030466839

附表一偏差代码以及相应不符合描述

偏差代码

Dev Codes

不符合描述Description

EC-NC-01

上市日期不符合投放到市场前6个月的通告延迟时间(电子烟/电子液体)

launch date does   not comply with the 6 months notification delay prior placing on the market   (e-cigarette/e-liquid)

EC-NC-02

含有违禁成分(具有CMR特性)

contains a banned   ingredient (with CMR properties)

EC-NC-03

含有违禁成分(维生素、咖啡因等)

contains a banned   ingredient (vitamin, caffeine...)

EC-NC-04

一年中至少有一次未报告产品的销售量

sales volumes in   product units are not reported for at least one presentation for a year

EC-NC-05

上市日期超出限制

launch date out of   limit

EC-NC-06

尼古丁浓度大于20mg / mL

nicotine concentration   greater than 20mg/mL

EC-NC-07

可填充的容器容量大于10mL

refill container   volume greater than 10mL

EC-NC-08

缺少证书(未勾选生产一致性框)

missing certificate   (production conformity box is not ticked)

EC-NC-09

缺少证书(未勾选质量和安全框)

missing certificate   (quality and safety box is not ticked)

EC-NC-10

缺少证书(未勾选防儿童和防篡改框)

missing certificate   (child resistant and tamper proof box is not ticked)

EC-NC-11

缺少证书(未勾选高纯度成分框)

missing certificate   (high purity ingredients box is not ticked)

EC-NC-12

缺少证书(未勾选正常使用条件下无风险方框)

missing certificate   (no risk under normal use conditions box is not ticked)

EC-NC-13

缺少证书(未勾选尼古丁持续释放框)

missing certificate   (nicotine consistent dosing box is not ticked)

EC-IN-01

成分数量和产品重量不一致

ingredient   quantities and product weight are inconsistent

EC-IN-02

产品重量和产品体积不一致

product weight and   product volume are inconsistent

EC-IN-03

未知成分(CAS号,名称)

unknown ingredient   (CAS#, name)

EC-IN-04

添加的尼古丁和尼古丁浓度不一致

added nicotine and   nicotine concentration are inconsistent




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