provided you explain and present some sort of evidence I ’ m sure they will take any urgent amendments prior to the 20th deadline . Within this article is a list of member states and their E-cig regulator contact details . I sincerely hope you resolve your issue and your products remain on the EU market for many years to come . Do not hesitate in contacting us at Vape Compliance if you need any further help as we work closely with member states and would be happy to help further with your requirements ! S . B . Q – Notification Content – J . M . Kent UK – Morning , I have a question about notification content , is there anything else I should be sending with my notification other than attachments of product pictures , test results and production file ? Many thanks J A – Hello , at this stage the tool creator asked for the notification of core requirements , as you will see there is room for improvement and some member states declared that this notification was the opportunity for companies to present what they had done and to what extent , to ensure the products were safe for human use and consumption . There are several components to the final XML you sent to the portal and your XML would not validate unless all required fields were filled out . How they were filled out is down to you and / or your compliance provider . In the true light of day , how conscientious do you think you were ? I ’ m sure if there is anything wrong with the content , then individual member states will be writing to you with any amendments that need to be made . I hope this answer helps . S . B . Q – Toxicology Requirements – G . Birtch . USA – Hello , we are hearing now that you do not need Tox for TPD , is this true ? A – No , there has been a lot of misconceptions around Toxicology for TPD . Whilst the XML creator tool requirements were sketchy the guidance from member states was not . In fact , part of your notification contains your declarations relating to risk . If you can prove that a product is safe to use and safe for humans to consume , without any Toxicology study or research , then I am sure the whole industry will be all ears . Member state regulators I ’ m sure will be pawing over what you submitted that scientifically justifies safe use and consumption as this cannot be guaranteed or even validated through just an emissions test result alone . Vape Compliance Ltd provide a final product Toxicology data report to justify the non-risk declaration of conformity and many clients have used it . If you require information on this I will be happy to supply . Most member state requirements also require individual ingredient Toxicology . In short , Toxicology makes the world go round ! Best regards , S . B . Q – Declarations of conformity - A , Shenzhen , China – Hello , it ’ s Apple here from China E-Cig Manufacture , we need declaration of Conformity , can you help ? A - Hello Apple , - I ’ m so sorry for my late reply , surprisingly , my iPhone thought Apple was spam ! There are 6 declarations of conformity that are required to support your full product notification . I have detailed these below and if you need us to validate and even generate these for you we will be happy to do so . # Production Conformity ( field 116 ) Cigarette _ Production _ Conformity - Declaration that the production process ensures conformity ( including but not limited to information on series production ). # Quality Safety ( field 117 ) E-Cigarette _ Quality _ Safety - Declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product , when placed on the market and used under normal or reasonably foreseeable conditions . # Child Tamper Proof ( field 119 ) E-Cigarette _ Child _ Tamper _ Proof - Declaration that the product is child resistant and tamper proof protected against breakage and leakage and has a mechanism that ensures refilling without leakage ( where applicable ). # High Purity ( field 120 ) E-Cigarette _ High _ Purity - Declaration that only ingredients of high purity are used in the manufacture of the liquid . # Non Risk ( field 121 ) E-Cigarette _ Non _ Risk - Declaration that the product ( with an exception for its nicotine content ) does not pose reasonably foreseeable risk to human health under normal conditions of use . # Consistent Dosing ( field 122 ) E-Cigarette _ Consistent _ Dosing - Declaration of nicotine dosing at consistent levels during product use
and across batches under normal or reasonably foreseeable conditions . Declarations of conformity play an important part in not only your notifications but also your company compliance file . They basically state that your company bares full product legal responsibility in six key areas that affect your compliance status . These declarations , like most , are evidence based . Provided you can back up what you declare you are good to go . Kind regards , Stephen . Q – Compliance Files – Dale – The Yorkshire Vaper UK – Hello , when do we get our company compliance file to present to our distributors , wholesalers and retailers ? hear from you soon , Thanks A – Hello Dale , Your Vape Compliance File was ready in electronic format prior to the May 20th deadline for you to distribute amongst your sales channels , your hard copy for wet signature will be presented in person in the weeks after deadline day . Your compliance file is your showcase flagship of your efforts towards TPD . I will include this question in my next magazine article if I may and thank you for your effort and support during these compliant times . Best regards . Q – New products to market – J . Jin , Malaysia – Hi , we have products in the EU but have no notifications , what is the process for new products to market and timings and cost and many thanks , Jin . Hello Jin , I am sorry you do not have any notifications in place . To be honest , you are not alone . We have had almost 50 companies since March 1st contact us in exactly your same position . For a start , as of 20th May this year you must recall all of your products , as you do not want to get on the wrong side of member state regulators from Day 1 . Your products , if not already tested for quantifiable substances , must go to a lab , ideally one that is not owned by a Mickey Mouse or Donald Duck outfit - as we all know there are “ go to ” labs and labs to avoid like the plague .
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