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?