Progress in evaluation in 2019

ECHA is reporting on the progress made in 2019 in dossier and substance evaluation in line with Article 54 of REACH.

The information received as a result of 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

Under dossier evaluation, ECHA checked 203 substances (covered by 207 follow-up assessments). For 81 substances, registrants complied with the information requested. 17 substances were flagged for harmonised classification and labelling (CLH), one for further clarification on endocrine-disrupting properties and one for further assessment of persistent, bioaccumulative and toxic properties.

In 71 cases, national enforcement authorities had to be involved, and information requirements were fulfilled for 15 of those substances. They are not included in the table below to avoid double counting, as the assessments had to be conducted twice: firstly, when ECHA had to inform national authorities about non-compliance with the decision and secondly, when the information has been provided and considered compliant resulting in those assessments being closed.

Remaining assessments on 54 substances were still open in early 2020.

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

  Outcome
Decision type Substances compliant with decision by the deadline Substances compliant with decision after involving national enforcement authorities1 Substances non-compliant with decision, assessments still open2 Substances non-compliant with the decision, a new decision issued3 Substances proposed as candidates for further regulatory process
Testing proposal decisions 34 17 27 7 8 CLH
Compliance check decisions 47 19 27 10 9 CLH, 1 ED, 1 PBT
Total 81 36 54 17 17 CLH, 1 ED, 1 PBT

CLH: harmonised classification and labelling
1 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.
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 to substance evaluation

19 substances were evaluated. For one substance, Member State competent authorities were invited to consider enforcement actions against registrants because requested information was not adequately submitted by the deadline. For eight substances, the evaluating Member State competent authority requested more information on the basis that the submitted information did not clarify the original concerns, or raised further concerns.

For the remaining 10 substances, the evaluating Member State competent authority considered that the available information was sufficient to clarify the concerns. On the basis of the information provided, the evaluating Member State competent authority was able to conclude on the need for further regulatory action.

Conclusions

In principle, the evaluating Member State competent authority may propose one or more of the following further regulatory actions to address the concerns:

  • A proposal for harmonised classification and labelling for carcinogenic, mutagenic or toxic to reproduction, respiratory sensitisers, or other effects.
  • A proposal to identify the substance as a substance of very high concern (SVHC).
  • A proposal to restrict the substance.
  • Actions outside the scope of REACH such as a proposal for EU-wide occupational exposure limits, national measures or voluntary industry actions.

Of the 22 substance evaluation conclusions published in 2019, 12 concluded that no further risk management measures are currently necessary, and 10 concluded that further risk management measures are necessary.

Summary of concluded substance evaluations where further regulatory actions were proposed

Suspected concern Concluded regulatory follow-up
action at EU level
Concluded substances by EC/List number Evaluating MSCA
Carcinogenicity Restriction 200-001-8 FR
Harmonised C&L 239-701-3 FR
Mutagenicity Restriction 200-001-8 FR
Reproductive toxicity Identification as an SVHC (Authorisation) 701-251-5 NL
Endocrine disruption Identification as an SVHC (Authorisation) 310-154-3 DE
Sensitiser Harmonised classification and labelling 202-908-4
202-653-9
UK
PL
Other hazard-based concern Harmonised classification and labelling 203-584-7
239-701-3
266-733-5
202-653-9
295-835-2
430-050-2
LV
FR
DE
PL
IT
ES
Restriction 266-733-5 DE

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