REACH (Registration, Evaluation, Authorisation and restriction of CHemicals), is the European Union (EU) programme for the regulation of both new and existing chemical substances manufactured in or imported into the EU in tonnages of 1 tonne per year or more.
Our staff have been involved in hundreds of REACH registrations, including complex UVCB substances (substances of Unknown, Variable or Complex composition, or of Biological origin), inorganics and difficult to test substances. We understand that every registration has unique challenges and work with our clients to identify appropriate solutions. Our personal and tailored approach means that we are able to provide support for all aspects of REACH, on behalf of companies both large and small, including:
• Tailored support and guidance with dossier preparation in IUCLID and submission via REACH IT.
• Dossier preparation for new registrations and updates to existing registrations, including both hazard and exposure assessments.
• Experience with strategies for UVCBs and difficult to test substances, including substance identity, hazard testing, data interpretation and risk assessment
• Assistance with developing industry specific approaches.
• Support with responses to Compliance Check and Substance Evaluation requests from ECHA (the European Chemicals Agency) and Member States, and technical advocacy.
• Registration and consortium administration, including cost sharing calculations for Letters of Access, following the Data Sharing Regulation.
• Maintenance of NONS (previously notified substances) registrations and upgrading of these to full registrations under REACH.
• Providing EU and UK Only Representative services for companies from third countries.
Our services include:
• Substance identity assessment
• Technical information and literature searches, data review and assessment, and data gap analysis
• Non-testing strategies, such as Quantitative Structure Activity Relationship (QSAR) modelling adaptations, review of category and read across options, and preparation of justification documents
• Design of testing strategies and commissioning and monitoring of studies at Contract Research Organisations (CROs)
• Hazard assessment of physico-chemical, environmental fate, ecotoxicity and human health
• Classification and labelling (CLP/GHS), including PBT, vPvB, PMT, vPvM assessment and assessment of endocrine disrupting properties
• Exposure assessment and modelling (environmental, occupational and consumer) to assess whether chemicals pose a risk to humans or the environment
• Determination of predicted no effect concentrations (PNECs) and derived no effect levels (DNELs)
• Using a collaborative approach with our clients to build a detailed knowledge of how a substance is used so that exposure assessments represent realistic conditions.
• Management of environmental monitoring programmes to obtain measured environmental concentrations to further refine assessments, if needed
• Training and bespoke advice on REACH, CLP and other topics tailored to address your company’s specific questions and topics of interest
• Reviewing your company’s specific obligations, this can also address confidential or sensitive information which may not be suitable for discussion with other companies or in consortia.