法國將公布不符合TPD的產品清單

發表時間：2020-08-12 19:24

近日，法國食品、環境與職業健康安全署（ANSES）對已通告的電子煙及相關產品，通過郵件的方式發布了一個列表，其包含產品清單、不一致性和不符合項列表：

根據2014/40 / EU煙草制品指令通過歐盟門戶（EU-CEG）進入到法國的煙草制品及相關產品，現需遵循法國公共衛生法典。

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.

根據該規定，自2018年中開始，ANSES會在產品首次通告（注冊）的6個月后，在其網站公布相關產品數據（www.anses.fr）。從2020年9月開始，這些數據中將添加報告的不一致和不符合項列表，以下稱其為“偏差”，它們是ANSES對企業的通告文件進行分析后得出的結果。

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.

在收到的郵件附件中，申請商會看到他們通告給ANSES的產品列表，通告的偏差及描述性通知。并且ANSES將會根據申請商對提交信息所做的更改，定期發送更新的文件。這些文件也會同時被抄送給作為監管的主管部門的法國衛生部。

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鼓勵數據的一致性，并對不符合的注冊產品采取適當措施，更正注冊數據或將不合格產品從市場上移除。此外，處理注冊文件中的不一致之處，將提高傳輸給主管部門的數據的質量，并能夠為公眾提供可靠的信息。

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無法修改注冊數據，注冊數據將由申請商全權負責。因此，申請商必須通過EU-CEG報告計劃進行更正和/或撤回產品，而不是使用其他任何處理方式。

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

附表一偏差代碼以及相應不符合描述

偏差代碼 Dev Codes	不符合描述Description
EC-NC-01	上市日期不符合投放到市場前6個月的通告延遲時間（電子煙/電子液體） launch date does not comply with the 6 months notification delay prior placing on the market (e-cigarette/e-liquid)
EC-NC-02	含有違禁成分（具有CMR特性） contains a banned ingredient (with CMR properties)
EC-NC-03	含有違禁成分（維生素、咖啡因等） contains a banned ingredient (vitamin, caffeine...)
EC-NC-04	一年中至少有一次未報告產品的銷售量 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	尼古丁濃度大于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	缺少證書（未勾選生產一致性框） missing certificate (production conformity box is not ticked)
EC-NC-09	缺少證書（未勾選質量和安全框） missing certificate (quality and safety box is not ticked)
EC-NC-10	缺少證書（未勾選防兒童和防篡改框） missing certificate (child resistant and tamper proof box is not ticked)
EC-NC-11	缺少證書（未勾選高純度成分框） missing certificate (high purity ingredients box is not ticked)
EC-NC-12	缺少證書（未勾選正常使用條件下無風險方框） missing certificate (no risk under normal use conditions box is not ticked)
EC-NC-13	缺少證書（未勾選尼古丁持續釋放框） missing certificate (nicotine consistent dosing box is not ticked)
EC-IN-01	成分數量和產品重量不一致 ingredient quantities and product weight are inconsistent
EC-IN-02	產品重量和產品體積不一致 product weight and product volume are inconsistent
EC-IN-03	未知成分（CAS號，名稱） unknown ingredient (CAS#, name)
EC-IN-04	添加的尼古丁和尼古丁濃度不一致 added nicotine and nicotine concentration are inconsistent