Nanotechnology has changed the development of cosmetic products, improving their performance, stability, and sensory experiences. The use of nanomaterials is now more frequent in sunscreens, colored cosmetics, and some personal care products. Although the use of nanomaterials has brought benefits to the beauty industry, there are also challenges and concerns about safety, which has led countries such as the EU, to implement regulations that restrict the usage in a product type, banning certain types of nanomaterial ingredients, and requiring the registration of nanomaterial ingredients. However, despite their widespread use, some countries or jurisdictions now have their own definition of what defines a nanomaterial, leading to regulatory inconsistencies and challenges in the global cosmetics market. The definition of a nanomaterial varies due to evolving technology, diverse regulatory approaches, and differing safety and risk assessments.

Key Takeaways

  • Learn which countries and jurisdictions around the world currently have definitions of nanomaterials as they apply to cosmetic products
  • Review the details of the criteria of these nanomaterial definitions as well as special considerations and additional requirements such as labeling and registration
  • Follow expert advice in how to address nanomaterial compliance for raw materials and formulated cosmetics through data and documentation

What you need to know

Different Definitions of Nanomaterials Around the World

European Union (EU)

  • In the EU, the definition of a nanomaterial in the European Cosmetic regulation (EC) 1223/2009, defines them as “An insoluble or biopersistent, intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nanometers.
  • The definition was updated in 2022 in Commission Recommendation of 10 June 2022 on the definition of nanomaterial (2022/C229/01), defining a nanomaterial as:
  •  ’Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions:
  • (a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm
  • (b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm
  • (c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm
  • Additionally, cosmetic products containing nanomaterials (other than colorants, preservatives, and UV filters, and not otherwise restricted by Regulation (EC) No 1223/2009) are subject to an additional procedure. These products must be specifically notified through the CPNP at least six months before being placed on the market (Article 16(3)).  It is also important to consider that some ingredients in nano form are prohibited for use in cosmetics.  These prohibitions can be found under Annex II of the EU Cosmetics Regulation.

France

  • In France, the definition of nanomaterials in cosmetics aligns closely with the European Union’s (EU) regulation, as France follows EU guidelines for the regulation of cosmetic products. The French Decree No. 2012-232 defines a nanomaterial as:
  • “Substance as that defined in Article 3 of the Regulation (EC) No 1907/2006, intentionally manufactured to a nanometric scale and containing particles in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion threshold of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm”
  • In 2013, France launched the R-Nano portal as part of its efforts to regulate and monitor the use of nanomaterials in various industries. Under French law, manufacturers, importers, and distributors who handle more than 100 grams per year of substances in nanoparticle form are required to report these materials to the R-Nano portal. The regulation and monitoring of nanomaterials are governed by a national reporting scheme aimed at ensuring the safety of these substances in various sectors, including cosmetics, chemicals, and manufacturing. The R-Nano portal, managed by ANSES (French Agency for Food, Environmental and Occupational Health & Safety), plays an important role in this regulatory framework. It was introduced to facilitate the reporting of nanomaterials by manufacturers, importers, and distributors, providing key data for risk assessments, public safety, and market transparency.

United States

  • In the U.S., the Food and Drug Administration (FDA) does not have a single, clear definition of nanomaterials. The FDA does, however, provide guidance on the use of nanotechnology in cosmetics and requires that cosmetic companies assess the safety of their products, including those containing nanomaterials.

Canada

  • Health Canada considers a substance, product, or component material to be a nanomaterial if it meets one of the following criteria:
  • At or within the nanoscale in at least one external dimension, or has an internal or surface structure at the nanoscale, or;
  • It is smaller or larger than the nanoscale in all dimensions but exhibits one or more nanoscale properties or phenomena

  • Definition:
  • Nanoscale: This refers to the range of 1 to 100 nanometres. Any substance that falls within this size range is considered to be at the nanoscale.
  • Nanoscale Properties/Phenomena: These are properties or effects that are attributable to the material’s size at the nanoscale. These properties are distinct from the chemical or physical properties of individual atoms, molecules, or bulk materials. They may include changes in reactivity, strength, or conductivity, which arise from the material’s nanostructure.
  • Manufactured: In this context, the term “manufactured” encompasses any engineering processes and the control of matter at the nanoscale, meaning that it applies to materials intentionally
  • In Canada, chemical substances, including nanomaterials, are regulated under the Canadian Environmental Protection Act (CEPA) 1999, which grants the authority to collect information, assess risks, and manage potential impacts on the environment and human health. Under CEPA, the Domestic Substances List (DSL) is used to determine whether a substance is already in commerce (existing) or is considered new to the Canadian market. Chemical substances, including nanomaterials, not listed on the DSL are subject to the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999.

Australia

  • In Australia, nanomaterials in cosmetics refer to materials that have been intentionally engineered to have at least one dimension in the nanometer scale (usually between 1 and 100 nanometers) and meet the following:
  • Is introduced as a solid or is in a dispersion
  • Consists of solid particles in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale

Our expert advice

Ithos expert advice
Let Ithos help!

Contact Ithos today to see how you can easily track nanomaterial definitions as part of your raw material library for easy reporting and reference

Here are some important steps to consider:

  • Obtain Nanomaterial Statements for All Raw Materials Used in Your Formulas
  • Request nanomaterial statements from your raw material suppliers. This is especially important for substances that may more commonly be present in your formulas in nano forms.  This includes colorants, sunscreens, and silica.
  • Stay Up to Date with Regulatory Bodies and Their Updates on Nanomaterials, Especially Safety Updates
  • Regularly monitor updates from key regulatory bodies such as the European Commission (EC), FDA, and Australian TGA for any changes in nanomaterial regulations that include:  
  • New scientific findings related to nanomaterial safety.
  • Regulatory revisions, including definitions, labeling requirements, or approval processes.
  • Request Additional Safety Data for Nanomaterials from Suppliers/Manufacturer
  • When sourcing nanomaterials, ask your suppliers and manufacturers for toxicological data and safety assessments specific to the nanomaterial forms of ingredients. 
  • Using the Ithos Screening Tool, Review Formulas for Compliance in the Intended Country of Distribution
  • Establish your companies policy on nanomaterials including the stance on global usage, safety assessment requirements, and documentation storage, review, and recordkeeping

Did you know?

The Ithos platform is constantly updated to reflect the most up-to-date nanomaterials definitions?  With our attribute data, raw materials that meet one or several nano definitions can be recorded and along with their supporting documentation. Contact us today to learn how to simplifying your screening & tracking of nanomaterials.

Reference links

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