Our work
Biocides are designed to kill micro-organisms and vermin, but regulatory approval under the Biocidal Products Regulation (BPR) requires submission of a comprehensive package of data. Bibra provides expert biocidal product consulting services, supporting manufacturers and importers to navigate the human health hazard and risk assessment requirements of BPR, including advising on the appropriate classification of substances and mixtures. It is critical for companies to ensure that their products do not present an unacceptable risk to potentially-exposed humans and other non-target animals, or to the environment.
Toxicological Risk Assessment for Biocides
A high-quality assessment of the toxicology of a biocidal active or product is a cornerstone of any submission for approval. Our extensive experience in identifying, interpreting and summarising toxicological data makes us an ideal partner for this aspect of your BPR submissions.
CLP & its role in biocidal product classification
Good communication – as intended by the CLP legislation – is a vital part of the biocides regulatory scene. As experts in hazard characterisation, we are your ideal partners for CLP-related tasks. We are also experienced in using the CLP regulatory text and associated guidance to derive classifications for mixtures such as biocidal products, which can greatly reduce the need for testing.
IUCLID for BPR submissions
BPR submissions are prepared in the IUCLID software. We have worked with this programme for many years, and are familiar with its formats and peculiarities. Our dedicated IUCLID server is constantly backed up, ensuring the utmost protection of your data.
Assessment of Endocrine Disruptors
Recent guidance jointly issued by ECHA and EFSA provides a detailed methodology for gathering and evaluating the information critical for the assessment of the endocrine-disrupting properties of biocidal products. We are experienced in identifying the relevant data and preparing the summaries and assessment in the required format.
Find out more about our recent work evaluating endocrine disruptors.
Estimation of exposure to biocides
Once a chemical’s toxicological hazards have been characterised, it is crucial to understand what the potential human exposure might be. This is always difficult, particularly so for biocidal products, where very different groups might be at risk (e.g. professional users, bystanders and even inadvertently-exposed children).
We always treat exposure estimation as a collaborative process, guiding our clients to identify the information necessary for a robust health risk assessment. We are, though, familiar with many of the key software tools for exposure estimation, including ECHA’s Chesar, EasyTRA, BEAT, EUSES and ConsExpo, as well as the key guidance relating to modelling of biocide exposures.
Helpful information
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Some of our case studies in this area
A human health risk assessment of API-related impurities
Case study
Whilst developing an inhalation spray drug product, the client identified two impurities with chemical structures related to the Active Pharmaceutical Ingredient (API). Click through to read more about how we dealt with this interesting project.
Human health risk assessment of unknown contamination
Case study
The client reported that small “brown spots” had been observed on the inside surface of a batch of aluminium tubes that contain a topical drug product. The source and chemical composition of the brown spots was unknown. Click through to read more about how we dealt with this interesting project.
Toxicological risk assessment of a disinfecting agent in a syringe medical device
Case study
The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients. Click through to read more about how we dealt with this interesting project.
