REACH Regulations and REACH Compliance
REACH regulations and REACH compliance
(Registration, Evaluation, Authorisation and Restriction of Chemicals) We are a leading supplier of REACH compliance services, assisting chemical manufacturers, importers and downstream users with their REACH regulatory responsibilities. Our internationally renowned team of experienced scientific and regulatory experts provide a complete and extensive range of services, 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.
A proven track record for REACH compliance
We have worked on 100’s of successful REACH lead registrations for the November 2010 and May 2013 deadlines, and are currently working with companies and Consortia on over 100 substances (including precious metals, petrochemical additives, SVHCs, fragrances and intermediates) destined for the 2018 deadline.
Expert overview and co-ordination
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.
REACH areas of expertise include
- Registration exemption advice (e.g. polymer definition)
- SIEF and Consortia management and representation; SIP preparation; Only Representative – via an expert partner
- Lead and member dossier preparation for REACH registrations
- Data searching; reliability (Klimisch scoring); data-gap analyses (DGA)
- Integrated Testing Strategies (ITS)
- Assist in the commissioning, monitoring and interpretation of new studies (e.g. analytical packages and mammalian toxicity)
- IUCLID 5 input and development of (Robust) study summaries ((R)SS)
- Read-across (including justifications report), (Q)SAR, data waivers, Weight of Evidence (WoE), testing proposals
- TK assessment (based on chemical structure and physical chemical characteristics)
- Chemical Safety Assessment (CSA) including physical chemical, human health and environmental hazard assessment
- Classification and labelling (under CLP and DSD)
- Technical Completeness Check (TCC)
- D(M)NEL and PNEC calculation
- PBT and vPvB assessment (and, if needed, emission characterisation)
- Exposure assessment including exposure scenarios, exposure modelling (e.g. CHESAR, EUSES and ECETOC TRA) and emission characterisation
- Chemical Safety Report (CSR)
- Risk Characterisation Ratios (RCRs)
- Risk Management Measures (RMM) and Operational Conditions (OCs)
- IUCLID 5 web-hosting facility
- Assist with organising REACH training webinars and generation of Safety Data Sheets (SDS)
- Assisting with the Evaluation, Authorisation, Restriction and substitution of substances of concern
Hazard data analysis and risk assessment
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. High quality data is a prerequisite for a robust and reliable dossier. 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 WoE 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.
REACH registration deadline
The next REACH registration deadline is end of May 2018 (for substances produced or imported into the EU at 1-10 and 10-100 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 and 2013 deadlines, and it’s widely accepted that a shortage of resources and a lack of leadership will be key challenges for companies over the next five years. We can take the hassle out of the 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. We 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.
Recent work in this field
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