ECHA reports on the progress made in 2020 in dossier and substance evaluation in line with Article 54 of REACH. 

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 2020, 265 substances reached the follow-up to dossier evaluation step. The process has been concluded for 129 substances.

For 87 substances, registrants submitted the required information within the given deadline. 16 substances were identified as needing harmonised classification and labelling. One substance needed further clarification related to its endocrine-disrupting properties and two other ones needed further assessment related to its persistent, bioaccumulative and toxic properties.

96 follow-up assessments covering 94 substances were referred to national enforcement authorities as registrants did not provide the requested information in time. As the number of cases that needed to be referred to national enforcement authorities increased compared to the year before, the Agency collected, where possible, the reasons for delays (ECHA only started to collect this information systematically from September 2020. In addition, some registrants justified their delays providing multiple reasons or the same reason became applicable for more than one case, e.g. case of a category). The most common reported reasons, among others, were delays due to the lack of laboratory capacity and testing difficulties (ca ~ 30 %), following an impact of CoVID-19 (ca ~ 25 %). ECHA will further investigate how the delays in data generation could be eliminated so that registrants will be able to meet the information requirements in time.

After enforcement actions, registrants submitted the necessary information in 28 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
^* No 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.
^** 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.
^*** Information has been provided, but the information requirement was not met.

Follow up on substance evaluation

In 2020, 17 substances were evaluated. For 5 substances, 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 12 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

CLH: harmonised classification and labelling
^* 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.