How to place chemical products on the market in Switzerland

Switzerland is not a member of the European Union but maintains access to the European Single Market through a series of bilateral agreements and treaties between Switzerland and the EU. Switzerland is a member of the European Free Trade Association (EFTA) and as such chemical regulations including EU REACH and CLP do not apply. Instead, Switzerland has a series of national regulations closely aligned with the recognised EU Chemical Regulation Framework with some key differences.

For organisations who are placing products on the market in Switzerland, it is essential to be aware of the national requirements and variations when placing on the market. Ricardo’s chemical risk experts have provided the below overview of how Switzerland’s national laws place regulatory obligations on your SDS, Poison Centre Notifications, REACH registrations and Emergency Response provisions.

SDS

Switzerland’s Chemicals Ordinance (ChemO) covers the requirements for Safety Data Sheets (SDS) within the country. At a high level this is aligned with the principles of an EU REACH SDS, however Switzerland incorporates national elements in Sections 1, 7, 8, 13 and 15.

To facilitate easier trade, organisations have the option to either produce a dedicated SDS for Switzerland or to provide an EU SDS, in an appropriate language, with a Switzerland cover sheet which advises of the national elements users should be aware of. Ricardo’s SDS Authors can support organisations with handling the requirements for Switzerland.

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Poison Centre Notifications

Switzerland has not formally adopted measures to meet the requirement of Article 45 of CLP. Instead, Switzerland has a national register for chemical products and a poison centre (Tox InfoSuisse).

The requirement to notify in Switzerland is governed by the Swiss Ordinance on Protection against Dangerous Substances and Preparations, also known as The Chemicals Ordinance or ChemO, which came into effect in July 2015, and outlines when the extra requirements must be fulfilled and the information required. Much like EU CLP, all information must be kept up to date; making changes to the information regarding your product may require an update to your notification to the Swiss Appointed Body.

Therefore, companies placing on the market are required to have a different approach to their notifications for Switzerland. Ricardo can support businesses with navigating the Swiss regulations and submission requirements.

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Chemical Registration

The Swiss Chemicals Ordinance (commonly called ChemO) is largely harmonised with the EU REACH regulation and has very similar requirements. Some articles of the ChemO legislation make direct reference to the EU REACH regulations (1907/2006). For example, chemicals manufactured or imported in Switzerland at 1 tonne or more per year must be registered under ChemO in the same way that they are for EU REACH. ChemO also includes a list of Substances of Very High Concern (SVHC), but this is a separate list and this should be reviewed separately to the EU REACH list.

The Swiss Food Contact Materials (FCM) list is the go-to inventory for substances used in products which will come in contact with food. Adding a new substance to the list is a relatively simple but long process, as the waiting list for processing applications can be up to four years. Migration data (the amount of the substance expected to migrate from food packaging to the food itself) must be included in the application for inclusion into the Annexes. The list is run jointly between the Swiss and German Competent Authorities with decision meetings on inclusion of new substances being held once every six months.

Switzerland also has separate regulations for biocides under the Ordinance on Biocidal Products (OBP) this is also largely harmonised with the EU Biocidal Products Regulation (BPR). Approved active substances are listed on Annex 1 and 2 of the OBP. The process for approving Active Substances and issuing authorisations for Biocidal Products is similar to the EU. There is also a system for Mutual Recognition of products already authorised in the EU to avoid duplication of work in Switzerland.

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Emergency Response

The requirement for an Emergency Response Telephone number in Section 1 of the SDS is closely aligned with EU requirements. Whilst it is important to include a Poison Centre telephone number, best practice is to consider the full range of potential incidents, including spillages and fires and include an emergency response telephone number that can support these also. Hours of operation for the emergency line should be stated and a response must be available in German, French or Italian.

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SCIP

Substances of Concern in Products for products placed only on the market in Switzerland are not required to be notified to the ECHA database or the authorities.

Switzerland does have a comparable provision to EU REACH Article 33 under Article 71 of The Swiss Chemicals Ordinance (commonly called ChemO) to  communicate the presence of SVHCs down the supply chain when present over 0.1% by weight. Ricardo’s Experts are able to provide more advice on the obligation for communication.

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