REACH regulation
+ compliance
REACH services
We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users comply with their REACH Regulation responsibilities. 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. Indeed, bibra scientists contributed to the scientific and regulatory content of the official ECHA guidance documents.
Principal toxicologist, Chris Waine, has written an article for Speciality Chemicals Magazine on "Improving REACH dossier quality prior to evaluation". Click here to read his thoughts on the importance of updating your REACH registration dossier before an ECHA evaluation is underway.
Track record
We have 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. 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
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 experts in toxicological hazard characterisation with a long track-record of successful REACH submissions, we are your ideal partners for CLP-related tasks.
IUCLID
REACH and CLP 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.
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
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.
