Progress in evaluation

Under Article 54 of REACH, ECHA is required to report on the progress made in dossier and substance evaluation by 28 February every year. The reporting contains a quantitative description of the generated outputs. A description of their impact and links to ECHA’s Integrated Regulatory Strategy will be included in the report on the implementation of the strategy to be published in April.

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

Substance evaluation aims to verify whether a substance constitutes a risk to human health or the environment from an EU-wide perspective. The selection of substances originates from the common screening at the basis of the Integrated Regulatory Strategy.

Of the 243 substances evaluated between 2012 and 2018, the evaluating Member State competent authorities considered that 172 (71 %) required further information to clarify the suspected concerns. For the remaining substances, the evaluating Member State competent authorities considered the available information was sufficient to conclude on the concerns.

After evaluating the available or requested information, for 95 substances conclusion documents have been published. For 47 of these substances, the evaluating authorities concluded that further risk management measures such as restrictions, identification of substances of very high concern, harmonised classification or other actions outside the scope of REACH were needed.

Follow-up to substance evaluation

The evaluating Member State competent authority assesses whether the information submitted has addressed the information requests and is sufficient to conclude on the concerns. This may lead to one of the following conclusions:

  1. There is sufficient information to clarify the concerns. The evaluating Member State competent authority may conclude that risks are sufficiently under control with the measures already in place (i.e. no further regulatory action). Otherwise, it may conclude that there is a need for further risk management measures (normally EU wide regulatory measures). 
  2. The concerns are not clarified or the new information raises further concerns. The evaluating Member State competent authority may then request further information and the decision-making process will be repeated.

Follow-up to substance evaluation, 2013-2018

 Outcome of follow-up Number of decisions
All requested information provided and considered sufficient to conclude on the concerns. 24
All requested information provided but further information is required to clarify the concerns. 13
No or inadequate information was provided by the deadline. Member State competent authorities invited to consider enforcement actions towards the registrants. 1
Total 38

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