(Registration, Evaluation, Authorisation and Restriction of Chemicals)bibra is a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with their REACH regulatory responsibilities.
Our internationally renowned team of scientific and regulatory experts provide a complete and extensive range of services, supporting you in all stages of your REACH registration and beyond.
Contact us to see how we can assist your organisation with practical support and advice on REACH compliance and REACH regulations.
We managed a large number of successful REACH registrations for the end-November 2010 deadline - that for the high-tonnage and high-hazard chemicals - and are currently working with Consortia on over 50 substances destined for both the 2013 and 2018 deadlines.
The REACH registration process consists of an interlinked set of activities. However these are not necessarily sequential and a high level of expert co-ordination and management is required to ensure a successful and cost-effective process. We always take a holistic view, and can assist with all of the key aspects of your dossier preparation in a planned and integrated manner – either managing the complete process or taking on specific responsibilities as directed by you. This would include SIEF and Consortia management and representation; data searching; Klimisch scoring; data-gap analyses; Integrated Testing Strategies (ITS); the Chemical Safety Assessment (CSA) including physical chemical, human health and environmental hazard assessment; IUCLID 5 input and development of (Robust) study summaries; read-across, (Q)SAR, data waivers, testing proposals; classification and labelling (under CLP and DSD); Technical Completeness Check (TCC); D(M)NEL/PNEC calculation; PBT/vPvB assessment; and (if required) the exposure assessment including exposure scenarios, exposure modeling (EUSES, ECETOC TRA) and emission characterisation; risk assessment including Risk Characterisation Ratios (RCRs), and documenting these along with any Risk Management Measures (RMM) and Operational Conditions in the Chemical Safety Report (CSR) generated using the CSR plug-in or in Chesar). We also offer a secure IUCLID 5 web-hosting facility and can assist with organizing REACH training webinars and generation of Safety Data Sheets (SDS).
REACH regulations put an obligation on registrants to collect all available relevant data on the intrinsic properties of a substance, and to minimise as far as possible the need for additional in vivo testing. Our skills in searching a wide-range of physical chemical and (eco)toxicity data sources are world renowned. Indeed, our own chemical database TRACE is listed in ECHA guidance as a valuable data source. We will assess and evaluate what data is available to establish a reliable data-gap analysis, and look for ways that the information requirements can be satisfied (e.g. data-waivers, read-across, (Q)SAR) without resorting to a costly trip to the testing laboratory. Whilst REACH can seem demanding in required tests, it offers ample opportunity to use data that may already be available. Our many years of hazard data evaluation and risk assessment means that we can regularly identify areas where read-across and weight-of-evidence approaches can be taken if a suitable study on the substance of interest is not available. A well-made scientific justification for non-testing can be a huge time - and cost - saving to our clients.
Where there appears to be no alternative to testing, we can develop a robust ITS and assist in the commissioning and monitoring of tests. Bibra scientists can assess the impact, on the REACH dossier, of the results of any new studies conducted, and provide on-going expert guidance on what is really needed.
The next REACH registration deadline is May 2013 (for substances produced or imported into the EU at 100-1000 tonnes per annum). It is expected that an even greater number of substances will need to be registered by this date than for the 2010 deadline, and it is widely accepted that a shortage of resources and a lack of leadership will be key challenges for companies over the next few years. We can take the hassle out of your registration process thanks to our extensive knowledge of REACH regulations and the requirements for REACH compliance.
Navigating your way through the complex process of dossier preparation can be a daunting task. Bibra can take away the anxiety of coping with REACH registration, and beyond, providing sensible advice as to your various options at each crucial stage. We have a long history of working closely with clients in ways that best suit them, openly discussing problems and the costs associated with the particular task in which we are involved. We will not forget that it is your dossier being prepared, and you call the shots. Contact us today to see how we can assist your organisation with information on REACH regulations and advice and support on REACH compliance.