It is possible for a company to keep using a substance which appears on REACH’s Annex XIV after its expiration date, provided it has acquired an Authorisation for its use. Said company will then have to be able to substantiate its compliance with all the conditions entailed by an Authorisation dossier. The company could potentially be subject to controls aiming at determining the compliance of its activity to the Authorisation request. In this article, EcoMundo gives you key elements on how to prepare for a control.

Conformité post-Autorisation REACH: comment anticiper une inspection DREAL ?

Controls for Authorisation to be toughened in 2019

A third wave of controls on REACH Authorisation dossiers is expected to be led by national authorities in 2019. To add to this, projects to toughen the controls on REACH Registration and Authorisation dossiers are also expected to happen in 2019; these will be led by the Forum.

The scope of this control is yet to be defined but it could very well focus on all the chromates listed on Annex XIV or only the substances whose sunset date has expired.

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.

Want to know more about REACH Authorisation procedures?

 

For more information on post REACH-Authorisation compliance, do not hesitate to contact our expert Ms Lucie Echaniz by phone at +33 1 83 64 20 54 for Europe and, for North America, please dial +1 (778) 234 1607 or send and email to [email protected]

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