Le Decree No. 2016-1139 of August 22, 2016 supplementing the provisions relating to the manufacture, presentation and sale of vaping products has just been published in the official journal this Tuesday, August 23. And if the last decree that we presented to you was very incomplete or even mysterious this one addresses certain sensitive points of the Tobacco Directive, including the cost of notifications.
DISCOVERY OF THE ORDER N ° 2016-1139
- Art. D. 3512-9-2. - Approval for carrying out the analyzes mentioned in article L. 3512-15 is issued for a maximum of five years by the public establishment mentioned in this article. It is renewable under the same conditions.
“The approval is published on the website of the ministry responsible for health and the list of approved laboratories is sent by the ministry responsible for health to the European Commission.
- Art. D. 3512-9-3. - Approval is issued according to the following criteria:
“1 ° Present and maintain all the guarantees of confidentiality, impartiality, integrity and independence. In particular, the approved laboratory and its staff must not be engaged in activities incompatible with their independence of judgment and their integrity with regard to the analytical activities for which the laboratory is approved. The accredited laboratory must not be owned by a manufacturer, importer, distributor or retailer of tobacco products and must not be controlled, directly or indirectly, by them. As such, the turnover of an approved laboratory must not derive significantly from commercial relations with manufacturers, importers, distributors or retailers of tobacco products;
“2 ° Have the skills and equipment necessary to carry out the analyzes mentioned in article L. 3512-15;
"3 ° On the date of filing the application for approval, be accredited according to standard NF EN ISO / CEI 17025 by the French Accreditation Committee (COFRAC) or by any other equivalent European accreditation body signatory of the multilateral agreement made within the framework of the European coordination of accreditation bodies, for the carrying out of samples and analyzes which are the subject of the accreditation request.
- Art. D. 3512-9-4. - I. - The approved laboratory immediately informs the public establishment mentioned in Article L. 3512-15 of any situation that may no longer allow it to meet one or more conditions of the approval.
“Failure to comply with one or more conditions of approval, delay in sending this information to the aforementioned public establishment, as well as false declarations constitute grounds for suspension or withdrawal of approval. The decision to withdraw approval is taken by the public establishment. Beforehand, the laboratory concerned is given formal notice to present its observations.
“II. - The public establishment mentioned in Article L. 3512-15 assesses the information provided by the laboratory when applying for approval and each time it is requested to be renewed. He may ask the latter for any additional information necessary to carry out this assessment.
- Art. D. 3512-9-7. - For control purposes, the approved laboratory sends to the public establishment mentioned in Article L. 3512-15 the results of the analyzes provided for in this article, in accordance with the technical specifications for computer transmission and presentation of the analysis results specified. by this one.
“The laboratory immediately informs the above-mentioned public establishment of any anomaly or non-conformity of the analysis results. "
The big question will obviously be to know which laboratories will be "approved" to perform the analyzes. Obviously this could complicate the approval of a laboratory like LFEL, for example, which has an interest in e-cigarettes.
- Art. D. 3513-10. - I. - The fees mentioned in article L. 3513-12 and in III of article R. 3513-6 are collected by the public establishment mentioned in article L. 3513-10.
“II. - Their amount is set as follows:
"1 ° 550 euros per product listed in any notification or substantial modification of notification, provided for in Article L. 3513-10;
"2 ° 120 euros per product and per year for storage, processing and analysis of the notifications mentioned in Article L. 3513-10.
“III. - The proof of payment of the fee mentioned in 1 ° of II is attached to the notification file.
The duty mentioned in 2 ° of II is paid no later than December 31 of the year during which the declared product is on the market, and this from the first year of notification.
“IV. - The rights referred to in I are collected by the accountant of the public establishment mentioned in Article L. 3513-10. "
At first glance, one can feel reassured by the price of the notifications because much higher prices were expected. Now, it must be remembered that these amounts are calculated by product and that small e-liquid companies may not be able to follow. A sad reality ... The price of notifications will reduce the number of e-liquids available and will clearly slow down innovation. Many small business owners will most likely have to go out of business or stick to drastically reducing their references to cut costs.
- By way of derogation from the time limit provided for in Article L. 3513-10 of the Public Health Code, notifications may be sent until October 1, 2016 for vaping products which are the market is scheduled for the 1er January 2017By derogation from the time limit provided for in I of article D. 3512-9-5 of the public health code, laboratories have a standard time limit until November 15, 2016 to apply for accreditation for 2017. The laboratories authorized, on the date of publication of this decree, to carry out the analyzes mentioned in Article L. 3512-15 of the Public Health Code, may continue to perform these analyzes until May 20, 2017.
Gradually, we begin to see more clearly even if there is still a lot of information missing that will arrive in the next decrees. Hoping not to have too many unpleasant surprises afterwards.
Source : Decree No. 2016 1139-
