Sector
Industrial Chemicals
Industrial and specialty chemicals are regulated in the US by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA). In the EU, these chemicals are subject to the Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation (EC) No 1907/2006 – better known as REACH. Tens of thousands of chemical substances fall under these regulations.
We have significant expertise in the registration of industrial and specialty chemicals in Europe and have been providing support to this sector for over 20 years. The REACH Regulation has presented a unique challenge to the chemical industry throughout the world. CSI has been actively involved with REACH since before the Regulation came into force in 2007 and offers a comprehensive service to companies and consortia faced with its demands. Now that the UK has left the EU, we can also help you comply with UK REACH to allow or maintain access to the UK market.
Experienced Support For:
- Global Regulatory Strategy
- Dossier Preparation & Submission
- Regulatory Agency Liaison
- EU & UK REACH Compliance
- Only Representative (OR) & Third Party Representation
- Chemical Safety Assessments (CSA) & Chemical Safety Reports (CSR)
- Task Force Representation & Administration
- Classification, Labelling, and Packaging (CLP)
REACH Consulting Support in Europe (EU/EEA)
- Acting as Only Representative for non-EU manufacturers under REACH
- Independent Third Party support, including management of confidential business information
- Ongoing REACH account management and regulatory liaison
- Preparation and management of technical dossiers in IUCLID format
- Coordination of data gathering, review of available studies, and identification of data gaps
- Submission of registration dossiers to the European Chemicals Agency (ECHA)
- Hazard assessment, exposure assessment, and risk characterisation
- Development of testing strategies where required
- Coordination and monitoring of studies with Contract Research Organisations (CROs)
- Participation in joint submissions and data sharing negotiations
- Support with consortia activities and communication with co-registrants
- Liaison with suppliers, downstream users, and legal advisors
- QSAR modelling and read-across strategies to address data gaps
- Preparation and review of Safety Data Sheets (SDS)
- General regulatory strategy and compliance advice
- Poison Centre Notifications (PCN)
REACH Consulting Support in the UK
- Acting as Only Representative for non-GB manufacturers under UK REACH
- Independent Third Party support, including management of confidential business information
- Ongoing UK REACH account management and regulatory liaison
- Preparation and management of technical dossiers in IUCLID format
- Coordination of data gathering, review of available studies, and identification of data gaps
- Submission of registration dossiers via the UK REACH IT system (HSE)
- Hazard assessment, exposure assessment, and risk characterisation
- Development of testing strategies where required
- Coordination and monitoring of studies with Contract Research Organisations (CROs)
- Participation in joint submissions and data sharing negotiations
- Support with consortia activities and communication with co-registrants
- Liaison with suppliers, downstream users, and legal advisors
- QSAR modelling and read-across strategies to address data gaps
- Preparation and review of Safety Data Sheets (SDS)
- Support with new substance registrations under UK REACH
- General regulatory strategy and UK REACH compliance advice
Is Your UK Company Importing Chemical Substances From The European Economic Area?
Following the UK’s exit from the EU, CSI can assist you with all aspects of UK REACH and EU REACH – from initial consultation and substance review, through notification, to registration dossier composition and submission.