Nanomaterials regulations


Nanotech’s benefits need to be weighed against any potential environmental or public health danger these materials pose.


Nanomaterials offer a huge range of potential benefits to society resulting from their continued development and deployment in science, engineering and technology. However, these benefits need to be weighed against any potential environmental or public health danger these materials pose. The relatively unknown health effects and risks associated with nanomaterials has been the focus of increasing attention from researchers, consumers, environmental organizations, pressure groups and regulatory bodies. However this does not necessarily paint a gloomy picture for nanomaterials. As yet, no reports have identified adverse effects on the human body from nanomaterials. Although research on the effects of nanomaterials has been conducted worldwide and recently some recent academic papers suggest certain harmful effects on mice under certain conditions, the data necessary to assess the effects of nanomaterials on human health remains insufficient.

Regulatory bodies worldwide have sought to develop risk assessment processes to study the potential detrimental impacts of producing nanomaterials as well as the impact of their incorporation in products. At present, nanotechnology products are regulated mainly through existing regulations. However, this is viewed as not being effective in taking into consideration the unique properties of nanomaterials. New regulatory provisions have been advocated by a number of groups, but up to now most authorities have sought to extend current regulation schemes as well as ensuring nanomaterials meet current requirements. Voluntary schemes to ensure compliance have also been endorsed by public bodies and industry. However, these have met with varying degrees of success.

These bodies have been working on a variety of frameworks to deal with the presence of nanomaterials in the market place. Examples of regulation of nanomaterials worldwide are outlined below:


• In 2009, the European Parliament asked for tighter controls on nanotechnology in chemicals and materials; cosmetics; foods; occupational health and worker safety; and environmental safety and waste.

• In October 2011, the European Commission (EC) announced that it will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle. The statement represented the first response to MEPs’ call for a clear regulatory and policy framework on nanomaterials. The parliament also called for amendments to the EU chemicals legislation REACH.

• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulates the use of chemical substances in Europe. Nanomaterials must comply with the reach regulations as “substances”.

• In October 2011, the EC issued a definition of a nanomaterial. It describes a nanomaterial as “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.”

• In November 2011, the EU’s Council’s committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for ‘problematic’ substances. The proposed legislation states that there is ‘scientific uncertainty’ about the safety of nanomaterials, and ‘to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.’ The proposed legislation calls on the European Commission (EC) to ‘regularly review the provisions on nanomaterials in the light of scientific progress. The proposed legislation incorporates the EC’s recommendation on the definition of a nanomaterial, stating: ‘nanomaterial’ means a natural or manufactured active substance or non-active substance 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. Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows: ‘particle’ means a minute piece of matter with defined physical boundaries; ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; [and]’aggregate’ means a particle comprising of strongly bound or fused particles. The EC would have the authority to determine, at the request of a member state, whether a substance is a nanomaterial. It would also have the authority to adopt delegated acts to adapt the definition of nanomaterial ‘in view of technical and scientific progress and taking into account the Commission Recommendation.’ Under the proposed legislation, where nanomaterials are used in a product, the risk to the environment and to health must be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word ‘nano’ in brackets. Every five years, member states would be required to submit to the EC a report on the implementation of the biocides regulation in their respective territories. The report must address several topics, including information on the use of nanomaterials in biocidal products and the potential risks.

• In January 2012 the European Parliament adopted a final legislative agreement revising EU rules on biocides dealing with product approvals and active substances in the products. The adopted rules mention that consumers will get information about the biocidal treatment of articles either via labelling or via information from suppliers and nanomaterials will now be regulated comprehensively, including specific approval of the active substance, separate assessment (based on adequate test methods) and labelling.

• Requirements concerning cosmetics are currently laid down at EU level in Directive 76/768/EEC on cosmetic products. The regulation states that all ingredients present in the product in the form of nanomaterials should be clearly indicated in the list of ingredients, by inserting the word ‘nano’ in brackets after the ingredient listing. The ruling defines nanomaterial as ‘an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm’. In future the requirements concerning cosmetics will be governed by the Regulation (EC) No 1223/2009 on cosmetic products, which will repeal Directive 76/768/EEC. Under this Regulation, most provisions of which only come into effect from 2013, 32 safety assessment of such products will be more stringent and market surveillance more rigorous.

• In May 2011, the European Food Safety Authority published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides. To assist with the practical use of the guidance, six scenarios are presented which outline different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required.

• The European Parliament (EP) and European Union (EU) Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labelling food from cloned animals and their descendants, as well as nanotechnology.

• Regarding occupational health and workers safety, most efforts are devoted to evaluating and adapting the existing risk management methods, and to develop appropriate guidance for the handling and disposal of engineered nanoparticles/nanomaterials.

• In the case of medical devices and pharmaceuticals products, the existing provisions, due to the detailed authorisation procedures required, are generally considered adequate for nano-related products, but a case by case approach in the evaluation and authorisation procedures is envisaged to take into account the peculiar properties of nanotechnologies.


• The German Advisory Council on the Environment (SRU) released on September 1, 2011, a report entitled Precautionary Strategies for Managing Nanomaterials, which makes recommendations for a “responsible and precautionary development” of nanotechnology. According to SRU, its objective is to allow for innovation while also identifying and reducing risks at an early stage. SRU concludes that while chemical, product, and environmental regulations are “generally applicable” to nanomaterials, the specific characteristics of nanomaterials could impede the application of the regulations. Closing the regulatory gaps “would require a uniform definition for nanomaterials, their treatment as separate substances in chemicals risk assessments and the obligation for manufacturers to submit data sets specifically adapted to nanomaterials.” SRU states that activities that it believes pose “a certain cause of concern are, in particular, the use of nanomaterials in consumer sprays, the growing sales of consumer products containing silver nanoparticles and the production and processing of carbon nanotubes, which are suspected to be carcinogenic — especially those with a high aspect ratio.” To increase transparency regarding the presence of nanomaterials in consumer products, SRU recommends a register for products containing nanomaterials and an extension of existing labelling requirements. The SRU was founded in 1971 to advise the German government and consists of seven university professors from a range of different environment-related disciplines.  SRU’s advice is independent from external instructions.

• In December 2011, the Social Democratic party forward a motion to the national parliament requesting action on the regulation of nanomaterials, including the implementation of an EU nano-product register alongside the development of a national product register by 2013. In addition, the measures proposed include better verification and the application of the precautionary principle for nano labelling on consumer products, the resumption of EU-wide negotiations concerning the novel food act, and an admission procedure and labelling of nano food products.

• In the same month, The Federal Institute for Occupational Safety and Health (BAuA) of Germany published the policy report ‘Safety and health at work with nanomaterials in research, development, policy advice and transfer of the Federal Institute for Occupational Safety and Health (BAuA)’ The BAuA report discusses the health and safety effects of nanomaterials in the workplace based on recent research. Also discussed are risk analysis, regulation and policy advances, and their relevance for occupational health and safety.

• The Federal Ministry of Food, Agriculture and Consumer Protection is working on a regulation, ‘banning’ (i.e. mandating the re- authorisation) of nanomaterials in inks used on food-contact materials

• EU legislation on cosmetics and food is implemented in Germany by the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch – LFGB) and the German Cosmetics Ordinance (Kosmetik-Verordnung). In accordance with these only products that are safe may be placed on the market. Prior to being placed on the market every cosmetic product must therefore undergo a safety assessment carried out by a suitably qualified person. These provisions also apply to cosmetics containing nanoparticulate ingredients. and mattress covers.


• Belgium has commissioned a project to create an inventory of products containing nanomaterials on the market in Belgium


• The French Article 523-1 of the Environmental Code makes it mandatory to report substances in nano form. This makes France the first country to set up this type of mandatory reporting scheme enabling both substances and their use to be identified. In January 2011, the Ministry for Ecology, Sustainable Development, Transport and Housing issued regulations for public consultation to define procedures for implementing the statutory provisions on application of the annual electronic return of nano form substances put on the market.


• Regulatory policy principles released by the Executive Office of the President in 2011 emphasize heavily the need for science-based regulation with respect to engineered nanomaterials. This is an important move in the right direction, and one that has already been taken up by the US FDA in draft guidance on how the agency is thinking about nanomaterials.

• In the United States, the Environmental Protection Agency (EPA) has moved from a voluntary to a mandatory approach to regulating and collecting information on the potentially novel risks from nanomaterials. The EPA has proposed mandatory reporting rules for nanomaterials under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and is developing comprehensive regulations under the Toxic Substances Control Act (TSCA). The TSCA regulations would include four areas: premanufacture notification, a Significant New Use Rule (SNUR), an information gathering rule, and a test rule. Under the Toxic Substances Control Act (TSCA), the EPA has reviewed more than 100 premanufacture notices for nanomaterials and has imposed restrictions on many of them. In December 2011, the EPA proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). Seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT)

• The Food and Drug Administration (FDA) regulates drugs, drug delivery systems, cosmetics, medical devices, vaccines and food products on a “product-by-product” basis and, as such, does not regulate nanotechnology or nanomaterials per se.  Rather, the stage at which FDA becomes involved in the regulation of nanotechnology-derived products depends on the actual product as opposed to its component materials or method of manufacture. In December 2011, the FDA opened a dialogue on nanotechnology by publishing proposed guidelines on how the agency will identify whether nanomaterials have been used in FDA-regulated products. The guidelines are entitled “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”

• The U.S. Consumer Product Safety Commission (CPSC) has stated that potential safety and health risks of nanomaterials can be assessed under existing CPSC statutes, regulations and guidelines (U.S. CPSC, 2005). Neither the Consumer Product Safety Act (CPSA) nor the Federal Hazardous Substances Act (FHSA) requires the pre-market registration or approval of products.

• In 2010 the U.S. Department of Agriculture’s National Organic Standards Board passed a recommendation directing the USDA National Organic Program to prohibit engineered nanomaterials from certified organic products as expeditiously as possible.


• The UK Government response to the Science and Technology Committee report published in January 2010 was to recommend that the Food Standards Agency work with other government departments to develop a scheme to collect information on nanomaterials in general


• The Ministry of Economy, Trade and Industry (METI) published the results of its voluntary information gathering on nanotechnology industry activities in 2010. METI established a Committee on Safety Management for Nanomaterials in December, 2011. METI states that it established the Committee “on the basis of the results obtained from the project ‘Research and Development of Nanoparticle Characterization Methods’ commissioned by the New Energy and Industrial Technology Development Organization (NEDO) and the latest scientific knowledge.”  The Committee will focus on risks caused by nanomaterials, and study appropriate management procedures for nanomaterials considering the actual usage and life cycles. Research and Development of Nanoparticle Characterization Methods (P06041), a research project under the New Energy and Industrial Technology Development Organization (NEDO), was launched in June 2006 to drive research into risk assessment of manufactured nanomaterials in Japan, and was completed on February 28, 2011.

• The Ministry of Health, Labour, and Welfare (MHLW) launched a six-year (2009- 2014) research program on the potential hazards of nanomaterials, focusing on carcinogenicity.

• MHLW and the Ministry of the Environment (MOE) have both instituted a number of other important reports and surveys on nanomaterials safety research and best practices.

• The National Institute of Advanced Industrial Science and Technology (AIST) published interim risk assessment reports on nanomaterials generally and on fullerenes, CNTs, and titanium dioxides in products.


• In cooperation with seven ministries, the Ministry of Environment set a master plan for chemicals management, which will be implemented until 2020. Nanomaterials are a key part of the plan.


• The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) introduced the first regulatory program for “industrial nanomaterials” as of January 1, 2011.


• The OECD founded its Working Party on Manufactured Nanomaterials ocuses on monitoring nanotechnology developments and promoting nanotechnology cooperation and innovation and ons on health-related and environmental safety-related aspects of manufactured nanomaterials.


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