Progress in evaluation in 2018

Under Article 54 of REACH, ECHA is reporting on the progress made in 2018 in dossier and substance evaluation. 

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, 229 registration dossiers were checked. In 70 cases, registrants did not comply with the information requested. 23 substances were flagged for harmonised classification and labelling.

Number and outcome of follow-ups to dossier evaluation

Decision type Outcome
  Compliant cases by the deadline Compliant cases after involving national enforcement authorities* Non-compliant cases still open** Non-compliant cases and a new decision was issued*** Proposal for further regulatory process
Testing proposal decisions 64 20 13 32 17 CLH
Compliance check decisions 59 16 15 10 6 CLH
Total 123 36 28 42 23 CLH

CLH: harmonised classification and labelling
* No or inadequate information was provided by the deadline. ECHA invited Member State competent authorities to consider enforcement actions towards 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 towards the registrant. The requested information has not been provided yet.
*** Information has been provided, but the information requirement was not met.

Follow-up to substance evaluation

Under substance evaluation, 23 substances were evaluated. For one substance, Member State competent authorities were invited to consider enforcement actions towards the registrants because requested information was not adequately submitted by the deadline. For 10 substances, the evaluating Member State competent authority requested more information on the basis that the submitted information did not clarify the concerns, or raised further concerns.

For the remaining 12 substances, the evaluating Member State competent authority considered the available information was sufficient to clarify the concerns and conclude on the need for any further regulatory action. 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.

For 9 of the 12 substance evaluations concluded after follow-up evaluation, further regulatory actions were proposed by the evaluating Member State competent authorities.

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