Data-waiving justifications

As a registrant, you are responsible for ensuring that your registration dossier fulfils all the REACH requirements at your tonnage band. 

Data waiving refers to omitting some of the information required under REACH Annexes VII-X from your registration. If you need to omit any required information, you need to justify your reasons for not submitting required data. 

Possible reasons for not submitting a study in the dossier are indicated in columns 1 and 2 of the relevant requirement in Annexes VII to X of REACH or sections 2 and 3 of Annex XI of REACH.

If your dossier contains data waivers, the following is verified during the completeness check:

  • A justification has been provided in line with columns 1 or 2 of the relevant requirement in REACH Annexes VII to X, or in sections 2 and 3 of REACH Annex XI, and that it has been reported in the appropriate IUCLID field. 
  • If the data waiving justification relies on other information (for example, a classification, a study result or the chemical safety report), this information is also included in the appropriate section of the dossier.

 

Specific advice

Check the specific advice page if you need more information on:

  • Waiving of substances used in the EEA in cosmetic products.
  • Registration obligations of Plant protection products.
Related
Need help?

If you have questions related to technical completeness check, use ECHA’s contact form:

  • ECHA’s contact form
    • In the contact form, select ‘Registration’ under Topic.

      Provide the following details related to your question in the ‘Question’ field:
    • Indicate clearly that your question concerns the technical completeness check.
    • If you are still preparing your dossier and need help to understand how to fill in a particular IUCLID section, provide as many details as possible on your situation and approach to fulfil the information requirement.
    • If you have already submitted your dossier and need help to understand the completeness check outcome, include the submission number assigned to your submission by ECHA.
 

For questions related to the Validation assistant, there is a separate instruction available: