FAQ – Frequently asked questions

Use equivalence

• Who evaluates whether the application carried out by a Swiss user is covered by the EU authorisation?
• If an EU authorisation, referenced in Switzerland in the context of Annex 1.17 Number 2 para 2, were revoked by ECHA, how would Swiss users be informed of this?
  
• Is the use of an EU authorisation in Switzerland subject to the same expiration date of the EU authorisation or is there a “Swiss” expiration date?
  

Exemptions

• In the case of an exemption in accordance with Number 2 does the company concerned (which e.g. uses these substances professionally or commercially) still need an authorisation (exemption) or can it use these substances without an authorisation?
• In case no exemption in accordance with Number 2 applies: do we understand correctly that the prohibition is also not applicable if there exists an approval by the European Commission (Number 2 para. 2 Annex 1.17)?

 

Reporting

• Should the company transmit the approval by the European Commission to the Notification Authority?
• On the reporting requirement in accordance with Number 3 of Annex 1.17: are we correct in assuming that this reporting requirement is in addition to the authorisation requirement? Or is this reporting requirement intended for the exemptions in accordance with Number 2 Annex 1.17?

 

Socio-economic analysis

• When does the socio-economic route come into consideration?
  
• What are suitable alternatives?
• What must a socio-economic analysis contain at least?

 

Documents

ECHA Guidance on the preparation of socio-economic analysis as part of an application for authorisation

ECHA Guidance on the preparation of an application for authorisation

ECHA Checklist for preparing an application for authorisation or a review report

baua REACH-Info10: Authorisation under REACH

Last modification 18.07.2019