New chemical substances must be registered and allocated a registration number from the European Chemicals Agency (ECHA), before marketing of the substances is allowed.

To register, a technical dossier must be submitted to ECHA. The technical dossier must contain:

• A range of information on the intrinsic properties of the substance. This information is contained in the technical information on the possible risks of the substance to humans and the environment (i.e. information and test results mentioned in Annex VII-X of the regulatory order). The greater the substance quantity, the more data the information must contain.
• Information on the use of the substance
• Classification of the substance
• Guidance on safe use of the substance

For substances produced in quantities of more than 10 tonnes per year, a risk assessment / Chemical Safety Assessment (CSA) must be performed and documented in a chemical safety report (CSR).

DHI covers the entire process:

Initial Investigations

• Need for notification, including level of notification 
• Contact with ECHA and possible relevant national competent authority
• Data searches for bibliographical data (e.g. read across)
• Test strategy

Project Management

• Planning, monitoring, and interpretation of studies, including selection of CRO / test laboratory

Notification

• Compilation of documentation and guidance for safe use

Risk Assessment (CSA and CSR)

• Toxicological risk assessment, including exposure assessment, DNEL / PNEC, guidance for risk management, etc.
• Proposal for classification and labelling, including GHS / CLP
• Proposal for transport classification
• Preparation of safety data sheets based on CSR