An efficient notification process involves the strong collaboration between manufacturers, their suppliers and the regulatory partner. TRUSTiCERT stands beside those companies that consider notification as the first step towards full compliance. Non-disclosure agreements ensure the right handling of business secrets, that can be further protected by a specific agreement.
TRUSTiCERT is willing to contact the flavour houses and other customer suppliers instruct them about the exact requirements of the legislation that apply to their business.
Thanks to this activity, TRUSTiCERT can now be proud of a number of agreements signed with the best players in the flavouring supply sector.
TPD-II requires detailed toxicological assessment of e-liquid ingredients.
To fulfill this requirement, TRUSTiCERT provides unbiased and valuable consultancy and comprehensive reports that collect the most recent toxicological data obtained from robust literature searches (i.e.: Peer-reviewed journal articles, books, news articles, MSDS..).
Our TPD-II database, made up of more than 2000 toxicological reports related to more than 700 compounds, comprises toxicological data covering the following categories:
_ Toxicity endpoints
_ Toxicity of emission
_ Carcinogenic, Mutagenic or Reproductive Toxicity (CMR)
_ CardioPulmonary Toxicity
_ Addictive Toxicity
_ Other Toxicity
TPD-II requires compulsory chemical analysis on e-liquids and their aerosol and toxicological study on final products emissions on voluntary basis.
To build a solid and reliable method for emissions testing, our R&D department developed a vaping machine, continuously improving, that ensures test reproducibility and adaptability to different hardware. The analytical methodologies were transferred to certified laboratories partnerand were validated and confirmed by scientific managers.
We also offer the opportunity to tailor e-liquid and hardware testing to meet different purposes and suit each product needs in order to completely fulfil TPD-II requirements.
TPD-II does not require toxicological testing on finished products, but their safety for consumers can be assessed through these kind of analyses.
Vaping products contain flavours intended for food use, of which inhalation toxicology is almost or entirely unknown. In this scenario, manufacturers or importers market potentially dangerous products for health and, according to his personal sensibility, may wants to ascertain the actual danger. Submitter have to declare that products are not harmful and designed to ensure the highest quality and safety for consumers.
To support these declarations TRUSTiCERT offers three different models of toxicological in vitro analyses: from a standard model to a highly advanced one able to mimic pulmonary alveolar tissue.
An exhaustive product documentation is issued, processed using the software implemented by the European Commission and forwarded to the member States through the Common Entry Gate.
TRUSTiCERT developed an optimized notification system (EunotifyTM) allowing to submit high quality notifications in every State of the European Union. Eunotify enables customers to enter quickly their products information (formula, description, national presentation..) thanks to a simplified graphic interface. A team of experts is available to actively support the customer during each phase of data collection and entry.
Contrary to all other actual available systems, EunotifyTM enables customers real-time monitoring and full awareness of the notification process, displaying updated data about:
_ the complete scenario of submitted notifications
_ the summary of modifications/updates
_ the member States each product was transmitted to
_ the full national fees prospect
_ deadlines/information required by member States