Anne Edwards's case studies
Cannabinoids – preparation of several inhalation focused toxicity profiles
Case study
The client requested the production of a series of urgent toxicity profiles for more than a dozen different cannabinoids, to support and inform their Research & Development (R&D) of new inhalable (non nicotine) consumer products (including their possible incorporation as ingredients into e liquids).
Evaluation of the endocrine-disrupting potential of a plant protection product
Case study
The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.
Hazard characterisation of several e-liquid ingredients
Case study
The client is required to provide regulatory authorities with up-to-date toxicological information related to the ingredients used in their products. Bibra were provided with a list of several substances and asked to produce a hazard review (considering the requirements of the European Tobacco Products Directive, TPD2) for each.
Literature Review Report in support of a plant protection product active substance regulatory submission
Case study
The approval or re-registration of pesticide active substances (Plant Protection Products) under Regulation (EC) No 1107/2009 Article 8(5) requires applicants to submit dossiers containing scientific peer-reviewed open literature on the active substance and its relevant metabolites and impurities, dealing with side-effects on human health, the environment and non-target species, published within ten years of the date of dossier submission.