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Q 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 do not need to be interrupted during the completeness check of a registration update 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 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.

  • In the case of a substance for which the manufacture or import is to be started, the waiting period must be respected.  The assignment of the registration number, and the right to manufacture or import the substance, rely on the completeness of the registration dossier after which a registration number is granted by ECHA.
Data modyfikacji: 28/02/2019
Topic: REACH
Scope: Completeness check
Chapter: General questions
ID: 0061
Wersja: 1.1
This answer has been agreed with national helpdesks.

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