REACH Compliance Consulting
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
Bisphenol A (BPA) Controversy
Blog articles
It is a truth not always recognised that toxicological hazard and risk assessment as currently practiced is a ball-park science, and a health criteria value – a Tolerable Daily Intake (TDI), a Permitted Daily Exposure (PDE) or similar – quoted to 2 significant figures is probably one significant figure more than the data really can confidently support. Occasionally practitioners will let the mask slip...
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).
