Various regulations contain nano-specific amendments. The currently most important Swiss regulations for nanomaterials are listed below.
In Switzerland the Chemicals Ordinance, the Ordinance on Biocidal Products, the Plant Protection Products Ordinance and the legislation on foodstuffs and cosmetics include specific requirements for nanomaterials. Further nano-specific legislative changes are being drawn up as part of the implementation of the "Action plan for synthetic nanomaterials".
The existing requirements are listed below:
Authorisation and registration procedures, self-monitoring
The safety of nanomaterials is reviewed as part of existing procedures:
- Medicinal products, plant protection products and biocidal products are subject to an authorisation procedure. As part of the authorisation procedure for plant protection products, identifying details of any nanomaterials such products contain have been required since December 2012. Furthermore, since 1 October 2012, the authorisation procedures for new or variations of existing medicinal products require from the applicants to state whether the product contains nanoparticles.
- The use of various additives and ingredients in foodstuffs, cosmetics and utility articles is regulated by lists that state whether a substance may be used or not (positive and negative lists, respectively), and by lists containing quantity restrictions. New nanomaterials must be licensed by the Federal Food Safety and Veterinary Office (FSVO) before being placed on the market. It must be shown that the substance neither poses a risk to human health nor gives rise to deception for authorisation to be given. The same applies to applications made in relation to packaging materials that contain nanomaterials and which come into contact with foods. Although substances may only be used in food and cosmetics if they are safe, a duty to declare nanomaterials in foodstuffs and cosmetics applies from May 2017, with a transitional period of 4 years. The duty to declare should ensure that consumers are provided with the required information when buying foodstuffs or utility products.
- New chemicals are subject to a registration procedure in accordance with the Chemicals Ordinance (ChemO). Nanomaterials that meet the ChemO definition for new substances must be registered. Information on the identification of nanomaterials has formed part of the dataset for new substance registrations since December 2012.
- As regards old substances and preparations, the Chemicals Ordinance obliges manufacturers to review their safety for humans and the environment as part of the self-monitoring process.
- Manufacturers have sole responsibility for assessing medical devices. In the case of high-risk products, a conformity assessment body must be involved. If all conformity requirements are met, the manufacturer issues a declaration of conformity and the conformity assessment body issues an EC certificate if applicable. The conforming product can be sold bearing the CE mark in Switzerland and all EU member states.
The Chemicals Ordinance includes a reporting obligation for substances and preparations. The statement of the identity, classification and labelling of hazardous substances and ingredients is mandatory. This also applies to nanomaterials that have been classified as hazardous. Since December 2012, additional information must be provided regarding their identity. A special reporting obligation applies to biopersistent nanotubes and nanofibers longer than 5 micrometers since March 2018. These materials can cause damage in the lungs after inhalation.
Foodstuffs, cosmetics, medicinal products, plant protection products, biocides and chemicals are subject to various labelling and declaration requirements. The purpose of the declaration regulations for foodstuffs, cosmetics and medicinal products is to inform consumers on side-effects, ingredients, the country of origin, etc.
With the exception of biocidal products, foodstuffs and cosmetics current Swiss law does not include any special declaration regulations for nanomaterials. In the case of chemicals and plant protection products, labelling depends on their classification. Hazardous substances and preparations are labelled and provide information about hazards and protective measures. The hazardous substance is also named on the label. These labelling regulations also apply to nanomaterials and preparations that contain nanomaterials.
Emission and immission thresholds, quantity thresholds
Air pollution control, water pollution control, waste disposal, the transportation of hazardous goods and accident prevention are covered by protection regulations that are geared towards the goal of protection. They specify thresholds for emissions and immissions, or provide schemes to classify substances into specific risk categories.
There are currently no such threshold values for nanomaterials, nor are there any nano-specific risk categories.
Employee protection (thresholds and recommended levels)
The Employment Act (EmpA, Art. 6) and the Federal Act on Accident Insurance (AIA, Art. 82) oblige employers to take all measures necessary to protect the health of their employees. This obligation is applicable in general. However, nano-specific threshold levels remain indicative until the amount of data allows their measurement and implementation on a regulatory level.
Therefore, there are no binding workplace thresholds or maximum workplace concentrations for nanomaterials. However, Suva has formulated guidelines for carbon nanotubes in its threshold lists.
Further information can be found under ‘Links’ and ‘Documents’.
Suva - Grenzwerte am Arbeitsplatz 2016 (PDF, 657 kB, 01.01.2016)available in German and French
Last modification 09.08.2018