Substance evaluation contributes to the identification of chemicals of concern requiring further risk management

Substance evaluation aims to verify whether a substance is a risk to human health or the environment. Substances are selected for evaluation according to the criteria set in the Integrated Regulatory Strategy.

The evaluating Member State competent authorities (MSCAs) considered that 224 (70 %) of the 321 substances evaluated between 2012 and 2023 required further information to clarify the suspected concerns. For the rest of the substances, the evaluating authorities found the available information sufficient to conclude the evaluation.

After evaluating the available or requested information, the evaluating MSCAs concluded on whether 235 substances constitute a risk to human health and/or the environment, and how to use the existing and obtained information on these substances, for the purposes of regulatory risk management:

• For 104 substances, the evaluating MSCAs concluded that no further regulatory follow-up action at EU level was warranted.
  • For 90 substances, the evaluating MSCAs concluded that the substance is not hazardous and/or the exposure data demonstrates no risk.
  • For 14 substances, no further regulatory follow-up action at EU level was proposed due to actions by the registrants in their registrations to ensure safety (e.g. changes to supported uses, applied risk management measures, reduction of the aggregated tonnage, cease of manufacture).
• For 131 substances, the evaluating MSCAs assessment concluded a need for further regulatory follow-up action at EU level.
  • 89 substances with proposals for harmonised classification and labelling, either as a new entry in CLP-Annex VI, or an update of an existing harmonised classification.
  • 26 substances with proposals for identification as a substance of very high concern (SVHC).
  • 21 substances with proposals for restriction.
  • 21 substances with proposals for another EU-wide risk management measures (for example, an EU-wide occupational exposure limit).
  • 24 substances where a need for further regulatory actions at EU level was identified but the risk management options analysis was not yet finalised. The evaluating MSCA will prepare a separate risk management option analysis to clarify the appropriate follow-up regulatory actions.

Note that a substance can have more than one regulatory follow-up action at EU level proposed.

Follow-up to substance evaluation

After the deadline for submitting the requested information has passed, the evaluating Member State competent authority assesses whether the submitted information meets the requirements. This may lead to one of the following conclusions:

1. The submitted information clarifies the concern and the risks are controlled to the extent that no further measures are needed.
2. The submitted information clarifies the concern and there is a need for further EU-wide risk management measures to control them.
3. The submitted information does not clarify the concern or it raises further concerns. This may lead to a new information request which would mean that the follow up process would start over.

Follow-up to substance evaluation, 2013-2023