REACH regulation
We are a leading supplier of REACH compliance consulting services, assisting chemical manufacturers, importers and downstream users comply with their REACH Regulation requirements. Our internationally renowned team of experienced scientific experts provide a complete and extensive range of services related to chemical toxicology, supporting you in all stages of your REACH registrations and beyond. Bibra scientists have also contributed to the development of scientific and regulatory content of the official ECHA guidance documents, highlighting our substantial experience in this field.
REACH dossier quality support
As part of our complete REACH compliance services, bibra’s experts, spearheaded by Principal Toxicologist Chris Waine, help our clients improve the quality of their REACH dossiers prior to evaluation. With years of experience in REACH registrations, we ensure your submissions meet the necessary requirements, minimising the risk of delays or non-compliance during evaluations.
Track record
We have extensive industry experience, having worked on hundreds of successful REACH lead and co-registrations for the three REACH deadlines, on for example, precious metals, petrochemical additives, SVHCs, fragrances and intermediates.
Our clients have included Consortia and companies of all sizes across a diverse range of sectors. We continue to be heavily involved in REACH, assisting several Consortia with their responses to complex Evaluation-driven Compliance Check decisions involving human health. When it comes to meeting these REACH requirements, therefore, we are very well placed to assist you.
CLP regulation and its role in REACH
The CLP Regulation goes hand-in-hand with REACH. All registrants are required to consider the human health hazards of their substances and include an appropriate Classification and Labelling proposal in the registration dossier.
As REACH specialists with in-depth knowledge toxicological hazard characterisation and with a long track-record of successful submissions, bibra are your ideal partners for your CLP-related tasks.
Expertise in IUCLID
IUCLID (International Uniform Chemical Information Database) is the official software tool used for preparation and submission of REACH and CLP dossiers. At bibra, we have worked with IUCLID for many years, and are familiar with its formats and peculiarities.
Get in touch with bibra
If you are interested in learning more, contact our team of experts today to discuss how we can support your company through every stage of REACH, from initial registration to dossier improvement and submission.
Helpful information
REACH regulation
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
CLP regulation
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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.
