FEM2-Ambiente offers a notification service in order to obtain the authorization to market the products covered by the Directive 2014/40 / EU (TPD-II) in the European Union. This authorization will take the form of an unique code, called EC-ID, that will have to be written on every authorized product and that will be released when submitting a notification by the Common Entry Gate of the European Commission.
Only the products that will be assessed as TPD-II compliant, could obtain the EC-ID.
FEM2-Ambiente will submit a notification on behalf of the manufacturer / importer and in accordance with the authorizations given by the European Commission
The customer (producer / importer) will be in any case responsible for the entered information as established by the European Commission
WHAT THE NOTIFICATION CONSISTS OF:
The second paragraph of Article 20 of Directive 2014/40 / EU provides that:
Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the product.
The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:
(a) the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;
(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
(c) toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
(d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
(e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
(f) a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article;
(g) a 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.
Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned.
Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analyzing the information submitted to them.
What we do to let a product become TPD2 compliant
GETTING TO KNOW YOUR COMPANY PROFILE AND PRODUCTS:
fulfillment of the dedicated form . Of course after having sign an NDA: you can trust us, but we want to be sure you’ll be. After that, you will receive our quote.
SUBMISSION OF SAMPLES TO BE ANALYZED AND PROFILING OF YOUR COMPANY IN THE EU-CEG PORTAL:
we will check that everything’s ok and then we will move forewords; we will get a Submitter ID on behalf of you.
TOXICOLOGICAL LITERATURE SEARCH
and issuing of a complete risk assessment report concerning every relevant ingredient of the blend. After that we will set up a testing solution suitable for your needs.
ANALYSIS OF THE EMISSIONS
and issuing of an analytical report. Parameters and conditions will be set as function of the type of products and markets.
we will check every details to guarantee your product is compliant. If not, we will evaluate together how to proceed to obtain compliance.
PRODUCTION OF TECHNICAL DOSSIER.
through the integrated evaluation of information from manufacturer, analytical labs and from toxicological risk assessment.
SUBMISSION OF NOTIFICATION.
You will receive the EC-ID and you will be then ready to market your products in the European Union.