法國將公布不符合TPD的產(chǎn)品清單

發(fā)表時間：2020-08-12 19:24

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

根據(jù)2014/40 / EU煙草制品指令通過歐盟門戶（EU-CEG）進(jìn)入到法國的煙草制品及相關(guān)產(chǎn)品，現(xiàn)需遵循法國公共衛(wèi)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(jù)該規(guī)定，自2018年中開始，ANSES會在產(chǎn)品首次通告（注冊）的6個月后，在其網(wǎng)站公布相關(guān)產(chǎn)品數(shù)據(jù)（www.anses.fr）。從2020年9月開始，這些數(shù)據(jù)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(yè)的通告文件進(jìn)行分析后得出的結(jié)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(chǎn)品列表，通告的偏差及描述性通知。并且ANSES將會根據(jù)申請商對提交信息所做的更改，定期發(fā)送更新的文件。這些文件也會同時被抄送給作為監(jiān)管的主管部門的法國衛(wèi)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(shù)據(jù)的一致性，并對不符合的注冊產(chǎn)品采取適當(dāng)措施，更正注冊數(shù)據(jù)或?qū)⒉缓细癞a(chǎn)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(shù)據(jù)的質(zhì)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(shù)據(jù)，注冊數(shù)據(jù)將由申請商全權(quán)負(fù)責(zé)。因此，申請商必須通過EU-CEG報告計劃進(jìn)行更正和/或撤回產(chǎn)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(yīng)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(chǎn)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(chǎn)一致性框） missing certificate (production conformity box is not ticked)
EC-NC-09	缺少證書（未勾選質(zhì)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(fēng)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(xù)釋放框） missing certificate (nicotine consistent dosing box is not ticked)
EC-IN-01	成分?jǐn)?shù)量和產(chǎn)品重量不一致 ingredient quantities and product weight are inconsistent
EC-IN-02	產(chǎn)品重量和產(chǎn)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