REACH (Registration, Evaluation, Authorisation and restriction of CHemicals), is the European Union programme for the regulation of both new and existing chemical substances on the European market.
Coming into force in 2007, with staggered deadlines through to 2018, depending on tonnage and hazard class, the REACH regulation covers all substances manufactured in or imported into the EU in tonnages of 1 tonne per year or more.
The first major REACH registration deadline was 30th November 2010, and the deadline for substances in the 100 - 1000 tonne tonnage band was 31 May 2013. wca has worked for a number of clients across a variety of industries to meet these deadlines, and has been involved in nearly 400 successful registrations and are currently working on over 100 substances that require registration by 2018. These include organic and inorganic substances, substances of Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs), nanomaterials and complex, difficult to test substances.
Our expertise in the REACH Regulation
Building upon our successful 2010 registrations and considerable expertise working under previous regulatory regimes, wca is well placed to assist companies with their REACH registrations for the 2018 deadline, and to provide support with dossier updates for those substances that are already registered. We have considerable experience with all aspects of REACH, including initial data review and assessment, integrated testing strategies and the commissioning and monitoring of testing where necessary, as well as IUCLID file preparation and hosting, and final registration. Specific tasks which wca can help your business to undertake include:
- Technical information searches
- Data review and assessment
- IUCLID 6 dossier preparation, including robust summary preparation, and secure IUCLID software hosting for consortia and single companies
- Substance identity assessment
- Data gap analysis and design of Integrated Testing Strategies
- Review of read across options and preparation of read across justification documents in line with ECHA's Read Across Assessment Framework (RAAF)
- Hazard assessment of physico-chemical properties
- Human health hazard assessment
- Environmental hazard assessment
- Physico-chemical, toxicology, environmental fate and ecotoxicology study commissioning and management
- Classification and labelling (CLP/GHS)
- PBT and vPvB assessment
- Exposure assessment and modelling
- Risk characterisation
- CSA/CSR production
- Assistance with dossier submission via REACH-IT
A particular area of expertise is in the field of risk assessment. wca scientists have had extensive involvement in the derivation of predicted no effect concentrations (PNECs) and limit values for substances in water, soils, sediments and waste, and in producing hazard and exposure assessments for chemicals. In addition, we have successfully developed bespoke monitoring programmes to reduce uncertainty in exposure calculations.
Our expertise is directly relevant to the complex activities involved in preparing Chemical Safety Assessments and Exposure Scenarios required for substance registration under REACH. Please see details of our REACH Compliance Programme.
In addition to registration work, wca are also able to provide assistance for the later stages of REACH, with socio-economic assessments and technical responses to proposals for Authorisation and Restriction. We have experience working with trade associations on industrial advocacy when responding to ECHA proposals for potential Authorisation, and development of Restriction proposals for regulatory bodies.
We are also involved in a range of other REACH-related projects, such as spontaneous updates for existing submissions resulting from novel data or changes in guidance and responding to queries from ECHA.
As well as preparing Classification and Labelling Proposals as part of REACH registration projects, we can also assist clients in preparing their classification and labelling for substances with later REACH registration deadlines, or which do not fall under REACH. Where substances have harmonised classifications under CLP and additional data indicates a revision of this classification and labelling is required, we have experience in completing ‘Proposal for Harmonised Classification and Labelling’ dossiers.