Registration of a novel biocidal active substance
Case study
EU manufacturers of biocidal products are required, under the Biocidal Products Regulation (BPR), to submit a dossier of information to the European Chemicals Agency (ECHA). Before a biocidal product can be registered, however, the active substance must also be approved by the Agency.
Updating REACH dossiers following ECHA Evaluation decisions
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”
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).
Δ9-THC – a low-level impurity in food
Case study
The client identified a potential contamination risk in certain of their (non-cannabinoid) food products. Low levels of (-)-trans-delta-9-tetrahydrocannabinol (Δ9-THC) – the main psychoactive component of cannabis – were analytically determined in several foodstuffs, from a specific production line.
Literature review and in silico prediction of metabolites
Case study
As part of their overall regulatory requirements, the client was asked to provide information on the known or predicted metabolites of a number of ingredients in their products. This formed part of a broader programme of work that bibra conducted for this client.
In silico prediction of genotoxicity and carcinogenicity
Case study
As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.
In silico assessment of impurities in a pharmaceutical
Case study
The client presented us with the structures of a number of impurities in a medicine currently in development for advanced cancer indications.
REACH registration of nearly 100 related metal compounds
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to ECHA.
Summarising hazard data on food additives and contaminants
Case study
On a regular basis over a period of nearly 20 years, bibra has provided a multi-national company with first drafts, or updates, of concise reports on individual or groups of food additives and contaminants.
The identification of oral and inhalation Health Criteria Values (HCVs)
Case study
Health Criteria Values (HCVs) are expressed in different ways, using the terminology specific to the authority that is recommending them. Oral values represent a regular ingested dose that is expected to be without appreciable risk to the consumer over a lifetime.