Current law, Switzerland

Various regulations contain nano-specific amendments. The definition of nanomaterials and the most important current Swiss regulations for nanomaterials are listed below.

Current law

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. The various legal areas and the corresponding definitions are listed below.

Definition according to the Swiss Chemicals and Plant Protection Products Ordinance:
Nanomaterial: A material containing particles in an unbound state or as an aggregate or as an agglomerate, where one or more external dimensions is in the size range 1-100 nm, or a material where the specific surface area by volume is greater than 60 m2/cm3. A material is only considered to be a nanomaterial if it is deliberately produced to utilise the properties arising from the defined external dimensions of the particles it contains, or from the defined surface area by volume of the material. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm are considered to be nanomaterials.

Definition according to the Therapeutic Products Ordinance:
Authorisation or variation applications for medicinal products in Switzerland must state whether the medicinal product contains nanoparticles. The following definition is used in this context: Nanoparticle: at least one dimension in the size range 1-1,000 nm and a function or mode of action based on nanotechnological properties.

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.
  • 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 data requirements 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.

Reporting obligation

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 specific reporting obligation has applied to biopersistent nanofibers and nanotubes longer than 5 micrometres since March 2018 as these can cause lung damage if inhaled.


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.

Although substances may only be used in food and cosmetics if they are safe, a duty to declare nanomaterials in foodstuffs and cosmetics applies. This duty to declare is intended to ensure that consumers have the information they need when buying foodstuffs or utility products.

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, nanospecific 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. This value corresponds to the limit value for respirable asbestos fibres.

Further information can be found under «Links» and «Legislation».

Last modification 17.05.2022

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