THG has extensive experience in the regulatory process for REACH - the Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals, which governs the export of substances to the European Union (EU) including:
Manufacturers and importers must pre-register substances that are already on the EU market (phase-in substances) in order to benefit from transitional arrangements that allow registering them at a later stage. Pre-registration also enables registrants to share data with other registrants (via a SIEF) and avoid carrying out redundant tests.
REACH requires manufacturers and importers of chemical substances (>1 tonne/year) to obtain information on the chemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the ECHA.
Communication in the supply chain
Suppliers of substances must pass on information on the health, safety and environmental properties and safe use of their chemicals to their downstream users via a GHS-compliant Safety Data Sheet (SDS).
Methods and Tools
A Chemical Safety Assessment has to be performed for all substances manufactured and imported in quantities ≥ 10 tonnes/year to determine and demonstrate the safe use of a substance. The Chemical Safety Assessment has to be included in the Chemical Safety Report of the registration dossier. Exposure scenarios are used to assess the exposure of humans and the environment to chemicals and to identify the appropriate risk management measures. Classification and Labeling of substances involves an evaluation of the hazard of a substance or preparation and a communication of that hazard via a label.
Globally Harmonized System (GHS)
OSHA’s final rule conforming the Hazard Communication Standard (HCS) to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was published on March 26, 2012. Modifications to the HCS include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets.