Industrial & Speciality Chemicals (REACH)
The Regulatory Environment
Two key areas of regulation govern chemicals in the European Union – REACH (Registration, Evaluation, and Authorisation of Chemicals EC/1907/2006) and CLP (Classification, Labelling and Packaging of substances and mixtures EC/1272/2008). The REACH regulation in particular has had a major impact on the chemical industry.
One of the key activities of REACH is the registration process, which places rigorous regulatory requirements on EU manufacturers, importers and representative organisations as well as downstream users of chemical substances. Some substances may be categorised as ‘Substance of Very High Concern’ (SVHC) in which case they will potentially become subject to ‘Authorisation’ or ‘Restriction’.
TSGE’s REACH regulatory consultants have many years’ experience of working in the chemical industry and have guided chemical companies through every aspect of their REACH obligations since the introduction of these legislations. Our REACH consultants are supported by an expert team of human health scientists, ecotoxicologists, chemists and risk assessors who deliver regulatory and scientific support.
Our scientific services include the preparation of REACH (IUCLID) dossiers, the Chemical Safety Report, first and higher tier exposure modelling and risk assessments. Our scientists and consultants are able to provide advice on strategies in response to ECHA ‘Dossier Evaluations’ and Competent Authority ‘Substance Evaluations’. The TSGE skill sets are also available to address Applications for Authorisation.
Our regulatory support deals with compliance for regulations on Safety Data Sheets (SDS) where we undertake thorough reviews of ‘Chemical Safety Reports’ to ascertain potential ‘Exposure Scenarios (CESs), evaluate ‘Risk Management Measures’ and prepare extended Safety Data Sheets (eSDS) to provide concise and informative descriptions of environmental and human exposure for further down the supply chain.
We believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner. We provide dedicated project managers who are committed to effective communication and project implementation.
Should you wish to discuss any of our services, please contact us.
- Strategic advice & guidance
- REACH IUCLID dossier preparation, submission and updates
- REACH Chemical Safety Report (CSR)
- Only representation
- Preparation of Non Lead dossiers
- Data gap analysis (completeness checks)
- Preparation of expert reports and waivers
- Assistance for dossiers under evaluation
- Human health and environmental hazard assessment
- Human health and environmental exposure modelling and risk assessment
- Read-across justification reports
- Authorisation project management and CSRs
- Consortium and SIEF management
- Classification and labelling of substances and mixtures
- eSDS preparation
- Due diligence audits
- Study design and monitoring
- Liaison with Regulatory Authorities
- Supply chain risk management