1. Introduction
Nanomaterials are chemical substances. Therefore, in the European Union, nanomaterial-related risks are addressed by existing laws. EU Framework Directive 89/391/EEC (1) on occupational safety and health; Directive 98/24/EC(2) on exposure to chemical agents; Directive 2004/37/EC(3)(4) on carcinogens and mutagens; and EU REACH (see §1.3) and CLP (see §1.4) chemical regulations also apply to nanomaterials.
In France, the Labor Code does contain regulations to prevent chemical-related risks in the workplace (5). These regulations do, of course, apply to nanomaterials, as do all other laws governing the commercialization of chemical substances, drugs, cosmetics, and food.
However, to effectively take into account nanomaterials' unique properties, some of the existing laws and regulations could need to be updated. And, for certain nanomaterials uses, specific regulations could be necessary.
2. The EU's definition of nanomaterials
As a first step towards developing nanomaterials-specific laws and regulations, the European Commission recommended a definition that distinguishes nanomaterials from non-nanomaterials. In October 2011, the EC issued a recommendation(6) intended to serve as a frame of reference in determining whether or not a material should be considered a nanomaterial for regulatory and policy purposes:
A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm –100 nm.
This recommendation is not currently legally binding. Talks are still ongoing to establish a regulatory definition that would be applicable to relevant laws and regulations.
3. Chemical regulations
The EU's main chemical regulations are :
> REACH and CLP
> "use" rules for specific applications or functions
a) REACH regulations
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)(7)(8)(9)(10) is an EU regulation that entered into force on June 1, 2007. REACH, which applies to the manufacturing and commercialization of more than one ton per year of any chemical substance or product, was established to improve the protection of human health and the environment from chemical-related hazards and make the EU's chemical industry more innovative and competitive. REACH applies to all chemical substances manufactured and commercialized, whether for use in industrial processes or in everyday life.
REACH places the burden of proof on companies. To comply with REACH, companies must identify and manage the risks linked to the substances they manufacture and commercialize in the European Union. Companies must demonstrate that their products do not have any negative impacts on human health or the environment, show how the substance can be safely used, and provide users with risk-management information. If the risks cannot be managed, the authorities can restrict the use of a substance.
Manufacturers, importers, and downstream users of chemical substances must register the substances they manufacture, commercialize, and use with ECHA(11). Data on the risks and dangers of the substances being registered must be provided for the registration process to be completed. For registration purposes, a substance is defined by its chemical composition and structure—not by size or shape.
REACH does not yet contain any requirements specific to nanomaterials. However, the potential risks arising from these new types of materials must be assessed and managed. Taking nanomaterials into account will create new challenges in terms of future modifications to REACH. REACH annexes could be revised and ECHA could require companies to provide additional risk-assessment data when registering substances.
b) CLP regulations
The CLP (Classification, Labelling and Packaging) sets forth rules for classifying, labelling, and packaging chemical substances and mixtures (12). The regulation ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals.
CLP entered into force in January 2009 and is based on the United Nations' Globally Harmonized System of Classification and Labelling. CLP gradually replaced two previous EU laws: the Dangerous Substances Directive and the Dangerous Preparations Directive.
Before commercializing a chemical substance or mixture, companies must determine the hazards to human health and the environment and classify the substance or mixture according to the hazards identified.
According to CLP regulations, the labelling and classification of dangerous substances and mixtures must be filed with ECHA, which maintains a Classification and Labelling Inventory of notified and registered substances received from manufacturers.
There are no CLP regulations specific to nanomaterials. However, nanomaterials are within the scope of CLP, so CLP regulations do apply. This means that CLP filing requirements apply to nanomaterials. If a nanomaterial is classified differently than the microscopic or macroscopic form of the material, the nanomaterial must be registered with the required supporting documentation
c) Safety Data Sheets
Safety Data Sheets must be compiled for substances that fall under the REACH regulations. Title IV of REACH establishes the rules that must be followed by suppliers; REACH Annex II sets forth the requirements for compiling Safety Data Sheets.
REACH Article 31 requires Safety Data Sheets for dangerous substances and preparations compiled in accordance with Annex II (13)(14). The Safety Data Sheets are compiled to inform professional and commercial users of the substances or preparations so that they can take the necessary health, occupational safety, and environmental measures.
This requirement also applies to nanomaterials identified as presenting a danger and nanomaterials for which no data on health and environmental impacts is available. The ISO/TR 13329:2012 standard: Nanomaterials -- Preparation of material safety data sheet (MSDS)(15) provides practical recommendations for compiling MSDSs for nanomaterials.
d) Labor laws
EU occupational health and safety directives(1) and directives on chemical agents(2)(3) require employers to ensure the safe use of potentially-dangerous chemicals and to implement workplace risk prevention rules. Nanomaterials are not specifically mentioned in these directives, but do fall within their scope.
Maximum exposure limits (MEL) will also need to be established for occupational health and safety purposes. It is also strongly recommended that employers set up and keep up-to-date exposure and health monitoring logs for concerned employees.
e) Medical products and systems
The European Commission, in its second regulatory review, acknowledged that current laws on medical products do establish a framework for assessing the risks and benefits of nanomaterials. The EC is currently investigating ways to set up measures to manage risks specific to nanomaterials, in particular for drugs that contain nanoparticles and genetically-active material. Registration of these products could be required under Regulation (EC) No. 1394/2007(16).
f) National laws in Europe
Several European countries have or are considering passing specific nanomaterials laws. The goal is to implement registration programs that would allow the authorities to know where nanomaterials are being produced and transformed and to identify the main uses of the materials.
France is the first European country to have passed a law specifically addressing nanomaterials(23). The law, passed under the nation's Grenelle 1 and Grenelle 2 environmental acts, establishes mandatory reporting of the manufacturing, import, and commercialization of "nanoparticulate substances." The provisions(24) of the August 3, 2009 law require manufacturers, importers, and distributors in France to report annually to the French Ministry of the Environment the identity, quantities, and uses of these substances as well as the identities of the commercial users to whom the substances have been sold. Filing requirements apply to 100 grams or more of nanoparticulate substances manufactured, imported, or sold per year.
Other European countries have passed laws similar to France's and now have reporting requirements for certain types of nanomaterials. Belgium(25) and Denmark have passed such laws(26). Similar laws are under discussion in countries like Sweden, Italy, and Germany. Given the variety of national initiatives, the next step forward would be to implement a single common reporting system for the entire EU.
g) Laws outside of Europe
Outside of Europe, the trend is similar, with nanomaterials legislation being passed in a number of countries and regions. In general, national chemical laws are based on an assessment of risk by a government agency prior to commercialization. These laws apply to nanomaterials as well, and are currently being revised to more effectively address nanomaterials.
Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS)(27)(28) defines industrial nanomaterials as materials intentionally produced, manufactured, or engineered for their unique properties. Nanomaterials fall under the Industrial Chemicals Notification and Assessment Act (29), which distinguishes these new materials from traditional materials.
The United States and Canada are working together to implement a unified approach to chemicals, including nanomaterials, through the Toxic Substances Control Act (TSCA) and the US Environmental Protection Agency's premanufacture notice (PMN) filing process(30).
In Asia, countries like China, Japan, and South Korea(31) are also looking at legislation specific to nanomaterials. Singapore is investigating a nanomaterials filing process.