Biocides
Our work
Biocides are designed to kill micro-organisms and vermin. It is bibra's role to assess the risks of their collateral damage. It is important that their use does not present an unacceptable risk to potentially-exposed humans and other non-target animals, or to the environment.
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
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
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.
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.
Helpful link - BPR
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
Exposure Estimation
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.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
