EU member states strengthen TPD compliance supervision of e-cigarettes 歐盟成員國增強電子煙的TPD符合性監管力度

Issuing time:2018-07-27 17:36

Approval is OnlyTemporary.

批準只是臨時的。

The deadline forTPD compliance was set to a particular day and a particular month back in 2016,since then most of the regulators in each of the European countries have takena light touch approach to overseeing the market.

TPD合規的最后期限定在2016年的特定月份和日期,從那天開始,大多數歐盟成員國的監管機構采取了輕微的方法來監管市場。

In recent monthswe have started to see an increase in regulator activity, one of those areaswhich has effected several manufacturers is the use of extension/bubble tubeswhich have been supplied alongside the 2ml tube, and removable plugs which havebeen used to restrict a tanks volume to 2ml. Any refill containers suppliedwith a squonker must comply with the associated regulations. And only a small partof EU member states currently prohibit the sale of more than 2ml non-prefilled tank.

最近幾個月,我們開始看到監管機構的監管力度有所增加,其中一項監管措施對很多制造商造成了影響,這項措施是限制通過附帶玻璃管或者其他配件的方式使霧化器容量超過2ml,并限制通過在霧化器中填充硅膠塞的方式使大容量霧化器的容量降低為2ml。任何給可填充容器提供煙油的squonker都必須符合相關法規要求(不能超過2ml)。當然,目前只有一小部分歐盟成員國禁止超過2ml非預注油霧化器的銷售。


Such products havealready been reported for sale in European markets where the tank size for bothprefilled and empty tanks is restricted to 2ml. The United Kingdom is one suchmarket and how such actions could become a problem in that country is asfollows:

這些產品已經在某些預注油和空霧化器的填充體積限制在2ml的歐盟國家銷售。而英國就是這樣一個國家,那么這些監管措施是如何在英國執行的呢?


The regulator isthe MHRA, they are centrally based, they handle the notification invoicing andhave the final say on what products can and cannot be sold. A second muchlarger organisation referred to as ‘trading standards’ works with the MHRA andto enforce the law, trading standards has a regional presence so they oftenvisit local stores and businesses to ensure the products being sold comply andare approved for sale. Any products that are found not to match the details inthe notification are reported to the MHRA and the MHRA contacts themanufacturer, other products that are not notified are being removed to preventthem from being sold.

英國的監管機構是MHRA,他們是集中處理通告和發票,并對產品是否可以在英國銷售有最終決定權。第二個更大的組織稱為“Trading Standards”,與MHRA合作并負責執法,Trading Standards配備有區域執法人員,因此他們會經常訪問當地商店和企業,以確保銷售的產品符合相關法律法規要求并被批準銷售。任何發現與通告中的詳細信息不符的電子煙相關產品都會報告給MHRA,這時MHRA會聯系制造商以尋求制造商的解釋,其他未通告的產品將被從商店中移除以防止它們被出售。

Every country hasits own process for enforcing the law and when problems do arise the requiredsolution will differ from country to country. The solution will also differdepending on whether the manufacturer has been warned about the same, or othercompliance issues previously.

每個國家都有自己的執法程序,當出現問題時,所需的解決方案因國家而異。解決方案也會有所不同,具體取決于制造商之前是否已收到相同或其他合規性問題的警告。

If such solutionsare not agreed with the regulator and quickly applied this could lead to asituation where products are removed from the approval list and eventuallybanned from sale. If this should occur regulators are obliged to share thatproduct information with other countries who may decide to do the same.

如果此類解決方案未與監管機構達成一致并迅速實施,則可能導致產品從批準清單中刪除并最終被禁止銷售。如果發生這種情況,監管機構有義務與可能決定采用相同措施的其他國家分享該產品信息。

If anymanufacturers do experience such a problem please forward the relevantcommunications to us as soon as possible so a solution can be agreed andapplied.

如果任何制造商確實遇到此類問題,請盡快將相關溝通記錄轉發給我們,以便商定并實施解決方案。


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