Regulatory Guidance

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The report includes:

• Overview of the substances within the given group
• Justification for the need for regulatory risk management
• Summary of conclusions and actions

How does ECHA assess substances?

• The main source of information is the registration dossier.
• The assessment is based on the examination of hazards, uses and potential for substitution.
• Grouping by ECHA differs from the read across approach in a dossier.
• ARN and their conclusions may change in light of new information or further assessment.

Depending on the results of the dossier screening, further “data generation” (CCH process) or no action can be required. A confirmed assessment leads to CLH and restriction in the future.

Report’s main aims and benefits

• The report clearly states next actions to be done regarding the given group of substances.
• It allows for a better estimation of the substitution potential giving indications whether similar substances are safer.
• It pools information enabling faster action.

What can you do?

• Keep your registration up-to-date
• Regularly follow the updates of the public activities coordination tool (PACT) to check the availability of an assessment of regulatory needs for your substance.