Introduction of ChemO
Although Switzerland is not a member of the European Union, it has several bilateral agreements, including recognizing REACH registrations and the IUCLID dossier.
Swiss chemical legislation is implemented through several Ordinances. The defined Ordinances within the scope of the work are:
- Ordinance on Protection against Dangerous Substances and Preparations (Chemical Ordinance; ChemO; SR 813.11) and
- Chemicals Risk Reduction Ordinance (ChemRRV; SR 814.81).
These Ordinances concern the placing on the market of chemicals, such as notification of new substances and the registration of a named finished product with the Product Registry, which is a specialty for Switzerland.
Several requirements are relevant to the Swiss notification of new substances:
- The notifier (manufacturer, importer, or Only Representative) must have its registered office in Switzerland.
- New substances (not listed in the European Inventory of Existing Chemical Substances (EINECS)) registered in the EU are also subject to notification in Switzerland.
- It is assumed that the substance in scope is not subject to exemption from notification under Article 17 of ChemO.
- The obligation to notify applies to substances with more than 1 tonne per year per importer. It applies to dangerous as well as non-dangerous substances.
- Data requirements are given in Articles 18 and 19 (Technical Dossier) of ChemO. Notifications need to be submitted in quadruplicate. The information and documents may be in English, with a cover letter in a Swiss language (French would be used).
- Physico-chemical, mammalian, and environmental toxicology data required are similar to that in REACH for the various tonnage bands. IUCLID in its electronic form is accepted.
- Substances may be placed on the market after the Swiss authorities have accepted the notification. The authorities have a period of 60 days, after receipt of submission, in which to examine a notification (article 31, ChemO). If the evaluation is completed earlier by the evaluation authorities, then the authorities may issue their decision in less than 60 days.
- It is therefore advisable to start compiling the Swiss dossier well before it has been submitted to ECHA, and submit it to Swiss authorities just after acceptance by ECHA.
Revision of ChemO（Swiss REACH）
In May 2021, the Swiss Federal Office of Public Health notified WTO of its revision to ChemO Regulation. The revised regulation requires all substances (both new and existing substances) that have not registered under EU REACH to be notified before entering the Swiss market.
The revised regulation aims to align with EU REACH. It applies to all substances that have not completed EU REACH registration. That is to say, substances that are registered under EU REACH may not fulfill the requirements under Swiss chemical regulations if the following conditions are met:
- The tonnage band must not exceed the registered volume under EU REACH.
- If substances are used as intermediates registered under strictly controlled conditions under EU REACH, and there is no relevant physiochemical, toxicological as well as eco-toxicological data, then these substances can only be used as intermediates registered under strictly controlled conditions in Switzerland, other uses will be deemed as illegal.
- If the manufacturer or importer is able to prove that the substance has been registered under EU REACH and transacted within the EEA, then the substance can also be transacted in Switzerland. However, related manufacturers or importers must make sure the volume of substances shall not exceed the registered volume, unless these substances fulfill the exemption requirements under EU REACH.
The public consultation for the notification will be closed on July 11, 2021. The revised regulation is expected to be adopted on February 15, 2022, and officially implemented from August 15, 2022, but as of November 2022, there is no update.
- Swiss only representative
- New substance notification under ChemO, SR 813.11;
- Substance registration under EU REACH.