Published on 23 February 2026
FAQ – Frequently asked questions
Use equivalence
It is primarily the responsibility of the users of substances and preparations to check in a timely manner (i.e. before the relevant expiration date of the application),
- whether the uses of substances of Annex 1.17 ORRChem cannot be substituted by other substances or alternative processes before the expiry of the transitional period, and
- whether a use in Switzerland corresponds to a use in the EU of the substance for which an authorisation has been requested or granted in the EU or
- whether an application for a temporary exemption for the further use in Switzerland must be submitted to the Notification Authority for Chemicals.
According to Art. 13 ORRChem the cantons are responsible for monitoring compliance with the provisions of this Ordinance in the absence of regulations to the contrary. Consequently, the cantons are responsible for checking whether substances of Annex 1.17 ORRChem are used according to the provisions of this Annex. Manufacturers and cantonal authorities should address their questions to the Notification Authority for Chemicals, which shall give an opinion in consultation with the assessment authorities.
In this regard, the user of the substance shall also assume direct responsibility. Fundamentally, it is unlikely that an authorisation granted by the European Commission would be revoked before the expiry of the defined term. If, contrary to expectations, this situation were nevertheless to occur, the company concerned in Switzerland could, on the basis of Annex 1.17 Number 2 para 6, submit no later than 3 months after an EU-approval had been revoked, an application to the Notification Authority for Chemicals for the grant of an exemption.
Reference to an EU approval also applies to a Swiss company that uses a substance of Annex 1.17 ORRChem for the same purpose as an authorisation holder in the EU for the duration of the EU approval as defined by the European Commission.
The number issued by the European Commission for a particular approval referred to by a user of a substance of Annex 1.17 ORRChem in Switzerland, or the authorisation number awarded by the Notification Authority for an exemption pursuant to Annex 1.17 Number 2 paragraph 4, must be notified to the Notification Authority by the user in the context of its reporting requirement pursuant to Annex 1.17 Number 3 paragraph 1 ORRChem. The information reported by the users is made available by the Notification Authority to the cantons for fulfilling their enforcement tasks.
Exemptions
An exemption from the Swiss authorities is then only required if
- no use according to Annex 1.17 Number 2 paragraph 1 is given or
- for the substance in question and the purpose of use in question, no application for approval has been submitted in the EU (for which a decision has not yet been taken) or
- for which no approval has been granted by the European Commission (cf. Annex 1.17 Number 2 paragraph 2) and
- the company in Switzerland cannot forego using the substance in question after the expiration of the transitional period defined for this substance.
This is correct.
Reporting
If a company in Switzerland concludes that the use of a substance listed in Annex 1.17 Number 5 ORRChem is allowed because the European Commission has granted a company domiciled in the EU an approval for the same use of the substance, then the Swiss company must comply with the reporting requirement in accordance with Annex 1.17 Number 3.
Your assumption is correct. The reporting requirement applies to all companies in Switzerland which after the expiration of the transitional period use a substance listed in Annex 1.17 Number 5 and in regard to the intended use cannot rely on a general exemption in accordance with Annex 1.17 Number 2 paragraph 1.
Socio-economic analysis
If an adequate control route is inapplicable, i.e. the risk arising from further use of the substance is not adequately controlled. This is the case when the estimated exposure exceeds the DNEL (Derived No-Effect Level) for health or exceeds the PNEC (Predicted No-Effect Concentration) for the environment.
An adequate control route is also ruled out when a substance falls under one of the following categories in Annex 1.17 ORRChem:
- CMR (carcinogenic, mutagenic or toxic for reproduction) for which it is not possible to determine a threshold value
- substances of equally very high concern for which it is not possible to determine a threshold value
- PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent, very bioaccumulative) substances and
- as well as substances of high concern having PBT or vPvB properties (e.g. endocrine disruptors).
Here, it is not possible to derive DNEL or PNEC levels.If a suitable alternative for the requested use is available to the applicant then a derogation cannot be granted via the socio-economic route.
Suitable alternative substances or suitable alternative technologies:
- Suitable and available for use
- The modification leads to a reduction in risk for people and the environment
- Technically feasible (the alternative fulfils the specific function under the conditions of use)
- Economically feasible (use of the alternative leads, after switching costs, to a positive gross profit)
- Available to the applicant in adequate quantities and quality
A socio-economic analysis has to demonstrate the extent to which the socio-economic benefits of the notified use of the substance outweigh the risks to health and the environment. Here, possible alternatives should also be considered and shown not to be suitable. For an authorisation in Switzerland the socio-economic analysis must be tailored to Swiss conditions.
1. Socio-economic benefits
- information on the size of the company in question
- Benefits for the company
- Benefits to the whole economy
- Total social benefits
- How could this situation change over time?
- Impacts of a ban (the most probable impacts of a non-availability of the substance):
- Use of an unsuitable alternative
- Changes to the product quality
- Changes to the process quality
- Terminating the offer of certain goods or services
- Costs or savings for manufacturers, importers, dealers and users in the supply chain.
- Relocation of certain production activities to third countries
- Social impacts on workers, users and society, e.g. employment, working conditions, job satisfaction, education of workers and social security.
- Macroeconomic impacts on growth, taxes, etc. (trade, competition and economic development). The more a use is limited to one company, one industry or sector, the sooner an analysis of the impacts can also itself be limited to the company, an industry or sector.
- Information on the reasons for limiting the scope to a specific geographical region or to a specific part of the supply chain.
2. Risks to health and the environment
- Number of exposed workers in the company
- Measures to control the risks
- Possible effects, as well as health and ecological impacts, which may occur in relation to the use of a substance in the supply chain in question as well as in the complete life cycle of the substance.
- Reasons for not considering certain impacts
- State the difference from an existing authorisation in the EU (for another use).
3. Possible alternatives
- Investigated alternative substances
- Investigated alternative technologies (process, product modification)
- Options for switching as well as their feasibility
- How could this situation change over time? Which actions would be required, within which time frame, to switch to a possible alternative substance/technique (substitution plan)?