The new information received resulting from an ECHA decision is screened to verify whether the requests were fulfilled and the hazard or concern clarified, and to identify any cases where further regulatory actions may be needed. 

Follow up to dossier evaluation 

In 2021, 307 substances reached the follow-up to dossier evaluation step. The process has been concluded for 210 substances. 

For 148 substances, registrants submitted the required information within the given deadline. 44 substances were identified as needing harmonised classification and labelling. One needed further assessment related to its persistent, bioaccumulative and toxic properties.

136 follow-up assessments covering 132 substances were referred to national enforcement authorities as registrants did not provide the requested information in time. 

After enforcement actions, registrants submitted the necessary information in 56 cases. Assessments carried out after the case was referred to national enforcement authorities are not added to the table below as a separate assessment as they are considered part of the original evaluation. 

Number and outcome on substances subject to follow ups to dossier evaluation

CLH: harmonised classification and labelling
¹No or inadequate information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. This led to a dossier update with sufficient information.
² No or inadequate information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions against the registrant. The requested information has not yet been provided.
³ Information has been provided, but the information requirement was not met.

Follow up on substance evaluation 

In 2021, 6 substances were evaluated. For 1 substance, the evaluating Member State competent authority requested more information as the submitted information did not clarify the original concerns, or raised further concerns. 

For the remaining 5 substances, authorities found the available information to be sufficient to clarify the concerns and were able to conclude on whether there was a need for further regulatory action. 

Conclusions

The evaluating Member State competent authority may propose one or more of the following regulatory actions to address the concerns:

• harmonised classification and labelling for substances that are carcinogenic, mutagenic or toxic to reproduction, respiratory sensitisers, or pose other concerns, e.g. are hazardous for the aquatic environment;
• identification as a substance of very high concern (SVHC);
• restrict the substance; or
• actions outside the scope of REACH such as EU-wide occupational exposure limits, national measures or voluntary industry actions.

Summary of concluded substance evaluations where further regulatory actions were proposed

* A need for further regulatory action(s) 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 action(s).
** PBT: persistent, bioaccumulative and toxic; vPvB: very persistent and very bioaccumulative.