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Completeness check

General questions

Is there any obligation according to Article 21 of REACH to interrupt the manufacture or import of the substance during the technical completeness check (TCC)?

Manufacture or import does not need to be interrupted during the completeness check of a dossier when the dossier is submitted to update an existing registration, which already has a registration number assigned, for the following reasons: (i) when the reason for the update is to respond to an ECHA communication or decision requesting additional information; or (ii) the registrant has new and relevant information about the substance, and its uses and properties. However, if the update is made to increase the scope of the registration (e.g. increase of tonnage band, or change from an Article 17/18 registration to an Article 10 registration), the new scope cannot be applied in the manufacture/import until the dossier has successfully passed the completeness check.

For new dossiers submitted to obtain a registration number, the following scenarios exist:

  • In the case of a non phase-in substance for which the manufacture or import is to be started, the waiting period must be respected as the assignment of the registration number, and the right to manufacture or import the substance, rely on the submission of a complete registration dossier to ECHA and the granting by ECHA of a registration number.
  • In the case of a phase-in substance which was pre-registered, and for which the relevant registration deadline has not yet passed, there is no requirement to interrupt manufacture of import during the completeness check. Such substances may be manufactured and imported until their relevant registration deadline without a registration number. If a dossier for a pre-registered substance is submitted immediately before its relevant registration deadline, but fails the completeness check, ECHA will set a deadline by when the dossier has to be completed. The manufacture or import of the substance may continue during this time even if the registration deadline is passed. However, if the dossier is not completed by the set completeness check deadline, ECHA will issue a decision rejecting the registration. If the relevant registration deadline has passed at this moment, the registrant cannot continue manufacture or import until they successfully submit a new registration dossier and receive a registration number for the substance.

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