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

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.

Get in touch

Please read our Privacy Policy here

*mandatory fields

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Contact us