Post-Authorisation compliance: how to anticipate a DREAL inspection?

Published 
January 11, 2018

DREAL: what is it?

DREALs are deconcentrated services that fall into the ecology, energy, sustainable development and land use planning ministries. They exercise their mission under the authority of region and departments' prefects for missions dealing with their competencies.

For REACH Authorisation procedures, DREAL inspectors intervene after the process of application for Authorisation. Their goal is to control all the users of a substance that has been granted an Authorisation by the European Commission so as to make sure that their activity complies with the conditions of the Authorisation.

What steps to follow to be ready for a potential inspection?

Two possible Authorisations

An Authorisation can be requested either by a downstream or an upstream user.

Individual Authorisation of a downstream user

For a company covered by an Authorisation specific to its use, here are the elements you should formalise:

  • Translate the summary of RMMs
  • Centralise all justifying elements (monitoring, mostly)
  • Do a follow-up of the substitution

Company covered by an upstream Authorisation

If your use is covered by an upstream Authorisation, you should:

  • Notify your use within three months
  • Translate the summary of RMMs
  • Establish the compliance with the conditions of the Authorisation (activities, operational conditions, risk management measures, monitoring...)
  • Collect supporting data and documents
  • Do a follow-up of the substitution
  • Consolidate date and documents

NB: If you are a downstream user and the Authorisation has not been delivered to the applicant yet, you can keep using the substance, as long as the company providing you with said substance has applied for an Authorisation before the Latest Application Date for this substance.

How do I know if my use is authorised?

In the context of a downstream application, to be sure that your use is authorised, you can:

  • Check the label of the product and the SDS your supplier provides you with
  • Look for a REACH Authorisation number (they look like: REACH/xx/xx/x')

If you cannot find these elements, we encourage you to contact your supplier directly in order to know if your use is authorised.

Wish to know more about the REACH Authorisation process?

For more information, do not hesitate to contact Fang Zhou or one of our experts!

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