Some specific ordinances (ChemO, OBP) of the chemical regulation were changed on July 1st, 2015. The information on this web page (or in this document) are under review. Thank you for your understanding.
The registrant (manufacturer or importer) must be domiciled in Switzerland or with a registered office or branch in Switzerland.
Substances must be reported within 3 months after first placing them on the market.
The manufacturer or importer must report the following substances placed on the market (art. 61 ChemO), if the assessment under the self-regulation has shown that they fall into one of the following categories:
- dangerous substances;(Art. 3 ChemO);
- PBT or vPvB substances (Art. 6a ChemO);
- substances listed in Annex 7 ChemO
The ChemO has provided some exemptions from the obligation to report the substances (art. 1 para. 5 and art. 69 ChemO):
- the transport of substances by road, rail, water, air or pipelines;
- the transit of substances under customs supervision, provided that this does not involve any processing or transformation;
- substances in the form of finished products ready for supply to the final user that fall into the following categories:
- foodstuffs as defined by Article 3 of the Foodstuffs Act of 9 October 1992,
- medicinal products as defined by Article 4 paragraph 1 letter a and medical devices as defined by Article 4 paragraph 1 letter b of the Therapeutic Products Act of 15 December 2000,
- animal feedingstuffs as defined by Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 May 1999;
- weapons as defined by Article 4 paragraph 1 and ammunition as defined by Article 4 paragraph 5 of the Weapons Act of 20 June 1997;
- substances, preparations and objects which are waste according to Article 7 paragraph 6 of the Environmental Protection Act, EPA;
- cosmetic products (with exception of the components)
- product import for private purpose;
- intermediates that:
- 1.are not given to third parties,
- 2.do not leave the manufacturing site, or
- 3.are placed on the market in quantities less than 100kg per year
- substances which are placed on the market solely for purposes of analysis, research or education, or which are subject to research and development;
- substances used exclusively for foodstuffs, therapeutic products or animal feedingstuffs;
- gas mixtures consisting exclusively of reported gases;
- substances obtained in Switzerland, because they are already reported;
- chemicals subject to authorization / notification: Plant protection products ; Biocidal products; fertilisers; explosives and pyrotechnic devices;
- only Article 34d applies to dangerous substances that are imported,relabelled and then exported.
The registration application of a substance must contain the following data (art. 64 ChemO):
- the manufacturer's name and address;
- the name of the person responsible for placing the substance or preparation on the market in the EEA in accordance with Article 10 point 2.2 of Directive 1999/45/EC2 or Article 17 paragraph 1 letter a of the CLP Regulation3, if the manufacturer's identity is not mentioned on the label;
- the chemical name according to Article 18 paragraph 2 letters a-d of the CLP Regulation;
- the CAS number;
- the EC number;
- the classification and labelling;
- the intended uses;
- in the case of substances dangerous to the environment: the quantity likely to be placed on the market annually according to one of the following categories: less than 1 tonne, 1-10 tonnes, 10-100 tonnes, more than 100 tonnes;
- in the case of nanomaterials: the composition, particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation;
- an indication of whether the substance is considered to be PBT or vPvB;
- the chemical safety report available in the EEA, provided the manufacturer can reasonably be expected to obtain it.
Any modifications to the data referred to in Articles 64 and 65 must be reported within 3 months (Art. 67 ChemO).
If the quantity of substances and preparations dangerous to the environment actually supplied in a year is outside the reported category of quantities placed on the market, the quantity placed on the market in the previous year must be reported by 31 March of the following year in accordance with the categories specified less than 1 tonne, 1-10 tonnes, 10-100 tonnes, more than 100 tonnes.
Substances that were not subject to registration requirements and before 1 December 2012 placed on the market must be reported within three months.