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Authorization requirements (Switzerland)
The safety of nanomaterials is reviewed within existing procedures:
In Switzerland, medicinal products, plant protection products and biocidal products are subject to an authorization procedure. As part of the approval procedure for plant protection products, identification information on the nanomaterials contained has been required since December 2012. In addition, since October 1, 2012, information on whether the medicinal product contains nanoparticles must be provided on the form for a marketing authorization application or variation application for medicinal products.
The use of various additives and ingredients in food, cosmetics and articles of daily use is regulated on the one hand by lists that provide information on whether a substance may be used or not (positive and negative lists), and on the other hand by lists with quantity restrictions. Novel nanomaterials must be approved by the Federal Food Safety and Veterinary Office (FSVO) before being placed on the market. In the case of approval, it must be shown that the substance poses no risk to human health and that there is no violation of the ban on deception. The same applies to applications for packaging materials that contain nanomaterials and are in contact with food. Although only safe substances may be used in food and cosmetics, a declaration obligation for nanomaterials in food and cosmetics will apply from May 2017 with a 4-year transition period.
New chemicals are subject to a notification procedure according to the Chemicals Ordinance (ChemO). Nanomaterials that meet the new substance definition of the ChemO are subject to notification. Since December 2012, information on the identification of nanomaterials has been part of the data set for new substance notifications.
In the case of existing substances and preparations, manufacturers are obliged under the Chemicals Ordinance to check the safety for humans and the environment themselves as part of self-monitoring.
Medical devices are assessed by the manufacturers on their own responsibility. For products with higher risks, a conformity assessment body must be involved. If all conformity requirements are met, the manufacturer issues a
declaration of conformity and, if necessary, the conformity assessment body issues
an EC certificate. The conforming product may be sold CE-marked in Switzerland as well as in all member states of the EU.
Nanomaterial: At present, various international definitions of the term nanomaterial exist. In most definitions, the size of the primary particles plays a decisive role, whereby external dimensions of less than 100 nm in at least one dimension have become accepted as a criterion.
However, the use of the 100 nm limit does not represent a scientifically justifiable size. Thus, nanospecific effects in cells and organisms can also occur with particles whose external mass is larger than 100 nm, since particles up to approx. 500 nm can be taken up particularly easily by cells.
EU definition proposal: In 2011, the EU Commission presented an initial recommendation for a framework definition of nanomaterials: Targeted materials are defined as those that contain particles in an unbound state, as aggregates or agglomerates, and in which at least 50 percent of the particles in at least one dimension have a size of between 1 and 100 nanometers. If the number size distribution is not known, specifically manufactured materials with a specific surface area/volume of more than 60 m2 /cm3 are considered to be nano-relevant. Fullerenes, graphene flakes and single-walled carbon nanotubes are considered nanomaterials even if they have dimensions smaller than 1 nm.
Precautionary approach: Specifically manufactured materials are considered to be nano-relevant if they contain particles in an unbound state, as aggregates or agglomerates, and if one or more external masses are between 1 and 500 nm. Respirable materials up to 10 μm with nanoscale side branches can also trigger nanospecific effects and are therefore also considered nanorelevant. Fullerenes, graphene flakes and single-walled carbon nanotubes are considered nanomaterials even if they have dimensions smaller than 1 nm.
Definition of the Swiss Chemicals and Plant Protection Products Ordinance: Material containing particles in an unbound state, as an aggregate or as an agglomerate, in which one or more external masses lie in the range from 1 to 100 nm, or a material which has a specific surface-to-volume ratio of more than 60 m2/cm3. A material is considered to be a nanomaterial only if it is specifically manufactured to take advantage of the properties resulting from said external masses of the contained particles or said surface-to-volume ratio of the material. Fullerenes, graphene flakes and single-walled carbon nanotubes with one or more external masses below 1 nm are considered nanomaterials.
Definition for marketing authorization or variation applications for medicinal products in Switzerland: Nanoparticles have at least one dimension in the size range 1-1000 nm and a function/mode of action based on nanotechnological properties.
European Cosmetics Regulation: “Nanomaterial” means an insoluble or biologically stable and intentionally manufactured material with one or more external dimensions or an internal structure on the order of 1 to 100 nanometers.
European Regulation on Food Information to Consumers: “Engineered nanomaterial” means any intentionally manufactured material that has a dimension on the order of 100 nm or less in one or more dimensions, or whose internal structure or surface consists of functional compartments, many of which have a dimension on the order of 100 nm or less in one or more dimensions, including structures, agglomerates, and aggregates that may be larger than 100 nm but whose properties due to nanoscale are retained.
Properties due to nanoscale include:
i) those properties that are related to the large specific surface area of the material in question; and/or
ii) special physicochemical properties that differ from the properties of the same material in non-nanoscale form.
The Labor Act and the Accident Insurance Act oblige employers to take all necessary measures to protect the health of their employees. This obligation applies generally, but has not yet been further specified with regard to nanomaterials, either at the level of the law or at the level of ordinances.
To date, there are no binding occupational exposure limits or maximum workplace concentrations for nanomaterials. However, Suva has formulated guideline values for carbon nanotubes in the limit value list.
EU regulations (nano-relevant)
Various regulations contain nano-specific additions. The most important regulations applicable in the EU for nanomaterials are listed below.
Chemicals (which include nanomaterials) are subject to the Chemicals Act in the EU, and the safety and health protection of employees in the workplace is subject to the Occupational Health and Safety Act. In addition, since July 1, 2008, the European chemicals legislation REACH provides a framework for the registration of nanomaterials
The CLP (Classification, Labelling and Packaging) Regulation governs the classification and packaging of substances and mixtures in the EU. An obligation for self-classification according to CLP exists for chemicals since 2010 and for mixtures since 2015. Although the CLP Regulation does not contain explicit requirements for nanomaterials, these materials correspond to the definition for substances established in the regulations, so that the provisions also apply to them.
In the case of cosmetics, “Nano” has had to be stated on them in the EU since July 2013, and in the case of food and food packaging since December 2014, if “Nano” is in them (i.e. the word “Nano” must follow the name of the ingredients in brackets. From May 2021, manufacturers of food and cosmetics must also declare in Switzerland whether their products
The EU Biocides Regulation contains specific provisions for nanomaterials. It does not matter whether the nanomaterial is the active ingredient or merely an adjuvant. If a nanoform of an already authorized pesticide is used, the authorization for this product must be reapplied for, summarizing all necessary data.
For medical devices and in vitro diagnostics, the EU enacted a new regulation in 2017. As Switzerland is integrated into the European single market for medical devices, Swiss law will be adapted analogously. The new Medical Device Regulation (MDR) has also created new regulations for nanomaterials in medical devices, which can involve considerable effort. For the risk assessment, a scientific guideline of the EU is available.
Guideline for synthetic nanomaterials
The guideline is intended to show which information is necessary to ensure the safe handling of nanomaterials and products containing nanomaterials. It is also intended to provide assistance on how the relevant information can be identified and in which form and at which position in the safety data sheet (SDS) it should be listed.
Food, cosmetics, pharmaceuticals, plant protection products, biocides and chemicals are subject to different labeling and declaration requirements. The declaration requirements for food, cosmetics and medicinal products aim to inform consumers about side effects, ingredients, country of origin, etc.nt soumis à différentes obligations d’étiquetage et de déclaration. Les prescriptions de déclaration s’appliquant aux denrées alimentaires, cosmétiques et médicaments ont pour but d’informer les consommateurs des effets secondaires, des ingrédients entrant dans la composition, du pays d’origine, etc.
With the exception of biocidal products, foodstuffs and cosmetics, current Swiss law does not contain any specific declaration requirements for nanomaterials. For chemicals and plant protection products, the labeling depends on the classification. Dangerous substances and preparations are labeled and provided with information on hazards and protective measures. In addition, the hazardous substance is named on the label. These labeling requirements also apply to nanomaterials and preparations containing them.
From May 2021, manufacturers of food and cosmetics in Switzerland will have to declare whether their products contain nanomaterials, i.e. add “nano” to the product labels. For the industry, this means that it must test all its products for the presence of nanomaterials. This requires special instruments and analytical methods, which are only available in a few research laboratories. The analyses are extremely complex, as the physicochemical properties of man-made nanomaterials can vary greatly depending on the material and the product. The newly founded service platform Swiss NanoAnalytics at the Adolphe Merkle Institute of the University of Fribourg, which cooperates closely with contactpointnano.ch, can help here.
In order to be able to determine the actual impact of a product on the environment, the entire life cycle would have to be considered, from research and development, production of the starting materials, further and final processing, storage, packaging processes, transport, use, through to recycling and disposal at the end of the product’s life. The precautionary matrix can be used to estimate the precautionary needs at various points in the entire life cycle of nanomaterials for worker and consumer health and for the environment.
Knowledge of how nanoscale matter can be manipulated and controlled to exploit its properties, which arise from the special size- and structure-dependent properties of individual atoms, molecules and which differ from larger-scale macroscopic materials (definition according to the International Organization for Standardization ISO).
Obligation to report
The Chemicals Ordinance contains reporting obligations for substances and preparations. For hazardous substances or ingredients, information on identity as well as classification and labeling is mandatory. This also applies to nanomaterials classified as hazardous. Since December 2012, additional information on identification must be provided for nanomaterials. A specific notification requirement has applied since March 2018 to biopersistent fibrous and tubular nanomaterials with a length of more than 5 micrometers. These can cause damage in the lungs when inhaled.
The precautionary matrix can be used to estimate precautionary needs at various points throughout the life cycle of nanomaterials for worker and consumer health and for the environment.
The EU’s REACH regulation aims to improve the protection of human health and the environment risks that can arise from chemicals. It also proposes alternative methods for assessing the hazards of substances in order to reduce the number of animal tests. In principle, REACH applies to all chemical substances, i.e. not only those used in industrial processes, but also those found in everyday life, for example in cleaning agents, paints/lacquers, and products such as clothing, furniture and electrical appliances.
Even though the REACH regulation does not contain explicit requirements for nanomaterials, these materials meet the definition of substances established in the regulations, so the provisions also apply to them. Under REACH, companies bear the burden of proof. They must identify relevant substances they manufacture, must show how they can be used safely, and must inform users about risk management measures. Since Jan. 1, 2020, REACH regulation requires companies to provide additional information on nanomaterials in the EU market. The new nano-specific guidance from ECHA (European chemical agency) helps them do this.
Read-accross (Références croisées)
The category and analogue approach is one of the most commonly used alternative approaches for addressing data gaps in registrations submitted under REACH. This approach uses relevant information on analogous substances (source substances) to predict the properties of the target substance. If the grouping and analogy approach is applied correctly, experimental testing can be reduced as there is no need to test every target substance.
Nanomaterials enable novel functions in products and technologies. However, nanomaterials may only be marketed and used if their intended use does not endanger humans and the environment. The responsibility for the safe handling of synthetic nanomaterials lies with the manufacturer or importer.
The essential characteristic of nanomaterials is that, due to their extremely small particle size, they can have very different properties than the same substances in the form of larger particles behave differently when interacting with biological systems or uptake mechanisms in humans, animals and plants. An important basis for hazard and risk assessment is therefore data on the physical and toxic properties of these materials.