To ensure a product is TPD compliant, our team of experts will evaluate the products from a toxicological point of view producing a complete risk assessment report with technical information for all of the relevant ingredient of the blend, taking into account the every concentration and according to the toxicology guideline of the Common Entry Gate form conceived by the European Commission.
The dossier will be completed by an exhaustive bibliographic research (PDF files containing ingredient data will be supplied). According to the resulted estimated toxicity, our team will recommend or not to carry out in vitro tests to assess experimentally the actual citotoxicity.
The experience gained so far let us know believe that these kind of tests will not be necessary.
A high concentration of natural extracts that cannot be classified (i.e. that are not liked to a CAS or FL number) is a prerequisite for a following analytical study; otherwise where an e-liquid is mainly made of classifiable synthetic molecules (i.e. owing a CAS number) and present in low percentages won’t need an analytical study.
The toxicological laboratory tests will be suitably selected in cooperation with our scientific staff between a panel of possible solutions, starting from a simple UNI EN ISO 10993-5 test up to a complex test of the cytotoxicity and about the release of inflammatory mediators carried out on a three-dimensional cell culture to mimic the behavior of the blood-alveolar barrier (the functional unit of the lung tissue).
Type of products analyzed: 1,2, 4, 6, 7
If you want to have a look at one example of advance toxicological testing, we designed and carried out, please visit the following site.
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.