COMPLIANCE ASSESSMENT
We assess the current legislative compliance level in your company and define an appropriate strategy to meet your regulatory obligations under TPD, CLP, REACH and PIC. We identify gaps and assist you in determining which tasks should be completed in order to fulfil your obligations.
SUBSTANCE EVALUATION
We evaluate your chemical substances to check if your liquids comply with TPD, German e-cigarette legislation, UK advice on ingredients, French standard (AFNOR), CEN standard on electronic cigarettes (draft) and if they are recognised food flavourings.
HAZARD CLASSIFICATION
We carry out a hazard evaluation of your liquids according to the European CLP Regulation classification criteria.
SAFETY DATA SHEETS
We create safety data sheets complying with the current European regulation. We generate the safety data sheets in the national language for the country where you intend to market your products. Alternatively, we can review your own created safety data sheets to make sure they fulfil all obligations.
TPD/CLP LABELLING
We prepare a labelling document with all required label information considering the content and volume, hazard classification, size of the label and pictograms, type of packaging etc. Alternatively, we can also help you review your own created labels to make sure they fulfil all obligations.
TOXICOLOGICAL EVALUATION
We evaluate the available toxicological information and make an assessment of the suitability of your product for use as an e-liquid. Risk assessment is given for both simple and complex mixtures.
REGULATORY SURVEILLANCE
We monitor any upcoming limitations and restrictions on your substances and update your labels, safety data sheets and any affected notification and registration files if changes occur.
It is your responsibility, as the manufacturer, importer and/or supplier of electronic cigarettes and refill containers like e-liquids, shortfills, and flavouring concentrates, to fulfil your regulatory obligations. This includes that your product meets all statutory safety requirements under European and national law and complies with other reference documents such as European standards, national or international standards, Commission recommendations, and guidance for industry.
Failure to meet these aspects of core compliance could render your products non-compliant with European law and could pose a risk to human health and safety.
Our regulatory consulting experts can help you identify applicable requirements impacting your products, we can guide you about regulations and current practice, or we can manage specific projects within the compliance process for you to achieve your legal obligations.
We can help you plan how your business can expand in certain EU Member States, which will include product development in accordance with national legislations and product leaflet and labelling in the national language for that specific country of interest
