MHRA updates and advice英國MHRA的更新和建議

Issuing time:2018-08-28 14:57

Welcome to August newsletter of E-cigarette Team. This month we include updates and advice on …


Current Notification Processing Times


Invoices for products submitted on the EU-CEG between 18th
July and 22nd
July were sent out on 30th
July. The list published on our website on 7th
August included all products for which we had received payment for by 3rd


The turn-around-time from submission to publication for the most recent product is 21 days.


Updating Producer Contact Details


We have received several requests from producers to resend invoices or newsletters that they have not been able to find. We have also been unable to contact some producers to notify them of problems with their notifications. This is usually due to changes in email address, mistakes in email addresses or producers being unable to access email addresses registered on the portal for staff who have left the company.


All invoices are sent to the email address registered on the EU-CEG portal.
Please review your submitter details on the portal to ensure that the contact details provided are up-to-date and correct. In addition, please email
to update your company details if these have changed since you first registered.


Revised Invoices


Several producers have asked us to revise invoices where they have decided to cancel some notifications and keep others.
This is not possible.
Instead, you should make a part-payment on the original invoice for the products you intend to notify and send a list of the products you intend to keep and those you want cancelled and credited to
We will then process the paid product submissions and issue a credit note against the existing invoice for cancelled submissions.


XML Creator Tool Update

XML Creator工具更新

Some producers have encountered problems recently where information in notifications is missing even after resubmission of ‘corrected’ xml files. The reason has been found to be the use of an old version of the XML creator tool.
To avoid this, please ensure you are using the latest version of the

XML Creator Tool
(June 2018) to amend your xml files before resubmitting them on the portal. Do check the link regularly for any updates to technical documents related to portal function.

一些生產商最近遇到了問題,即使重新提交更正的”xml文件后,通告中的信息也會丟失。已經發現原因是使用舊版本的XML創建工具。為避免這種情況,請確保您使用最新版本的XML Creator工具(20186月)修改xml文件,然后再在門戶上重新提交。請定期檢查鏈接,以獲取與門戶功能相關的技術文檔的任何更新。

Notification and Health Warnings on Replacement Coils


Replacement coils only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement coils that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified e-cigarette product the coil is for.


Notified coils are required to carry the health warning and companies may wish to consider adopting a consistent approach for all replacement coils, although we do not require this.


Substances Not Permitted as Ingredients in E-liquids


A list of substances that should not be included as ingredients in electronic cigarettes and refill containers is set out below. This list is not exhaustive and may be added to in future as more information becomes available. For the avoidance of doubt, the fact that an ingredient does not appear in this list does not mean that it is safe for use in e-liquids. The notifier should make their own assessment of the safety of each ingredient in their product and the need to control for levels of substances such as formaldehyde that are not present as an ingredient.


From the TPD:


? any ingredient that poses a risk to human health in heated or unheated form

? vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;

? caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;

? additives having colouring properties for emissions;

? additives that have carcinogenic, mutagenic or reprotoxic (CMR) properties in unburnt form.






From national standards:


? Substances classified as carcinogenic, mutagenic or reprotoxic (CMR categories3 1 and 2)

? Substances classified with specific target organ toxicity for the respiratory tract (STOT category3 1)

? Respiratory sensitizers

? Vitamins used as food supplements

? Stimulant additives such as caffeine or taurine

? Diacetyl

? Pentane-2,3-dione

? Diethylene glycol

? Ethylene glycol

? Formaldehyde*

? Acetaldehyde*

? Acrolein*

? Metals, including cadmium, chromium, iron, lead, mercury and nickel

? Preservatives liable to release formaldehyde

*See also requirements for testing these substances in the
emissions guidance.

?歸類為致癌,致突變或生殖毒性的物質(CMR類別3 12

?分類為呼吸道特定目標器官毒性的物質(STOT類別3 1







? 乙二醇







We are constantly reviewing notifications and any products containing the listed ingredients will be subject to review and removal. Please review your products and make appropriate corrections to notification data where errors in submission have been made or reformulate and amend your notifications.


Get in touch聯系方式

For general enquiries please contact our Customer Services team at

If you have any questions about the notification status of your products, please send them directly to our TPD mailbox at

To update company contact details email

For queries regarding invoices and payments email our Finance team at

For any safety concerns contact our Vigilance team at

If you encounter any technical difficulties while using the EU-CEG portal, please contact the EU commission IT helpdesk at
(including in your message a ‘print screen’ of the window where the problem appears).







Thank you for your time in reading and sharing this newsletter with your colleagues.


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