Global Oversight: Nanomaterials Regulations in Cosmetic Products

The rapid development of nanotechnology has transformed the cosmetics industry, leading to the growing application of nanomaterials into cosmetic products globally. Renowned for unique physical properties, these materials enhance product performance by improving ingredient dispersibility, providing antimicrobial and antioxidant benefits, and increasing the transparency of sunscreen formulations.

However, the use of nanomaterials in cosmetics has also raised safety concerns. While no evidence currently links nanotechnology in cosmetics to health risks, uncertainties remain in many aspects about its long-term effects on human health and the environment. Due to their microscopic size and high permeability, nanoparticles may penetrate the skin, enter the bloodstream, and potentially affect vital organs such as the brain and lungs.

In response to these potential risks, regulatory authorities worldwide have begun implementing measures to ensure the safe use of nanomaterials in cosmetics. This article explores the regulatory landscape for nanomaterials in cosmetic regulations across key global regions.

1. Overview of Cosmetic Nanomaterial Regulations Across the Globe

2. Detailed Requirements

1) European Union

• Definition

The European Union has established a regulatory framework to govern the use of nanomaterials in cosmetics. Under the Regulations (EC) No 1223/2009, nanomaterial is defined 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”. As revealed by the Guidance on the Safety Assessment of Nanomaterials in Cosmetics from the Scientific Committee on Consumer Safety (SCCS), in line with evolving scientific understanding, the European Commission has proposed a more detailed and inclusive definition of nanomaterials, as follows:

“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:

1. one or more external dimensions of the particle are in the size range 1 nm to 100 nm;

2. 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;

3. 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.

In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered. However, a material with a specific surface area by volume of < 6 m2/cm3 shall not be considered a nanomaterial.

• Pre-market Notification Requirements for Nano-Ingredients

Cosmetic products (including those with approved nanomaterials used as colourants, UV filters, or preservatives) must be notified to the European Commission via the cosmetic products notification portal (CPNP) prior to market placement. The notification must specify whether the product contains nanomaterials, with their identification and the foreseeable exposure conditions. 

For cosmetics containing nanomaterials other than colorants, preservatives and UV-filters and not covered by other restrictions in Regulation (EC) No 1223/2009, the notification must be submitted at least six months before market placement. Required notified information shall at least include the identification, specification, toxicological profile, safety data, the reasonably foreseeable exposure conditions, and estimated annual market quantity of the nanomaterial. If the European Commission has concerns regarding the safety of the nanomaterial, it may request a risk assessment from the SCCS.

• Approved Nano Ingredients

Up until now, the Commission has authorized the following nanomaterials for use in cosmetic products, including:

• Approved UV Filters: MBBT (Methylene bis-benzotriazolyl tetramethylbutylphenol) (nano), titanium dioxide (nano), zinc oxide (nano), tris-biphenyl triazine (nano), and bis-(diethylaminohydroxybenzoyl benzoyl) piperazine (nano).

• Approved Colorants: Carbon black (nano).

Additionally, the use of hydroxyapatite (nano) will be restricted, while the use of 12 nanomaterials, including copper (nano),will be banned in cosmetics.

• Labeling Requirements

All cosmetic ingredients that are in nano form must be clearly labelled with the word "nano" in parentheses following the substance name in the product’s ingredients list.

2) The United States

The U.S. Food and Drug Administration (FDA) oversees the use of nanomaterials in cosmetics but has not established specific regulations or a legal definition for nanotechnology or nanomaterials. Firms and individuals marketing cosmetics, including those containing nanoscale materials, are required to ensure their products are safe for use under labeled or customary conditions and are properly labeled.

In June 2014, the FDA released the Guidance for Industry: Safety of Nanomaterials in Cosmetic Products. This guidance reflects the FDA’s current perspective on the safety assessment of nanomaterials in cosmetics and aims to assist industry and stakeholders in identifying potential safety issues. It also provides a framework for evaluating nanomaterials to ensure their safe use in cosmetic products. While not legally enforceable, this guidance serves as an important reference for understanding the FDA's expectations regarding the safe use of nanotechnology in cosmetics.

Sunscreens, classified as over-the-counter (OTC) drugs in the U.S., are subject to the Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human Use. Although this monograph does not address nanomaterials, the FDA issued a proposed rule in 2019 addressing their evaluation in sunscreens. The FDA emphasized that it does not automatically classify sunscreen products containing nanomaterials as generally recognized as safe and effective (GRASE) or not GRASE. Instead, safety and regulatory compliance are determined on a case-by-case basis, reflecting the unique properties of nanomaterials and their potential impacts on product performance and consumer safety.

3) Canada

In Canada, Health Canada regulates cosmetics under the authority of the Food and Drugs Act and the Cosmetic Regulations. However, no specific provisions currently address nano ingredients within these regulations.

To support the identification of nanomaterials, Health Canada has developed a policy outlining a working definition. According to this definition, a nanomaterial refers to any manufactured substance or product that meets one of the following criteria:

• It is at or within the nanoscale in at least one external dimension, or has internal or surface structures at the nanoscale.

• It is smaller or larger than the nanoscale in all dimensions but exhibits one or more nanoscale properties or phenomena.

The "nanoscale" is defined as a range of 1 to 100 nanometres, inclusive. "Nanoscale properties/phenomena" refer to unique size-dependent characteristics that differ from the chemical or physical properties of individual atoms, molecules, or bulk materials. "Manufactured" encompasses engineered processes and controlled manipulation of matter.

For sunscreens, which are classified as non-prescription drugs or natural health products depending on their active ingredients, Health Canada applies specific requirements. According to the Primary Sunscreen Monograph, applicants seeking market authorization for products containing nano Zinc Oxide or nano Titanium Dioxide—meeting Health Canada's working definition of nanomaterial—shall collect and retain certain information. This includes data on the nanomaterial's intended use, function, purpose, manufacturing methods, and physical and chemical properties, as outlined in Section 7 of Health Canada's Policy Statement on Nanomaterials. Companies are required to make this information available to Health Canada upon request.

4) Chinese Mainland

China's cosmetics regulations currently include provisions for managing new nanomaterials and labeling requirements for finished products containing nanomaterials. However, detailed safety management requirements for nanomaterials are still underdeveloped.

• Definition and Dossier Requirements for New Nanomaterials

The Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers defines nanomaterials as insoluble or non-biodegradable artificial ingredients with at least one dimension between 1–100 nanometers in the three-dimensional structure or composed of aforesaid dimension as basic units.

For the notification of new nano ingredients, in addition to general physical and chemical properties like color, odor, and state, detailed specificity parameters shall be provided, including particle size distribution, aggregation/agglomeration characteristics, surface chemical properties, and morphology information.

Toxicological safety assessments for new nano ingredients must include all 12 required test items, with explanations on the applicability of the various toxicological test methods to the detection of nanomaterials. Skin absorption/dermal absorption test data shall also be provided for new nano ingredients intended to be used on the skin, while inhalation toxicity test data is required for those with potential inhalation exposure.

• Safety Assessment of Nanomaterials

The Guidelines for Submission of Cosmetics Safety Assessment Dossiers specifies that if products containing nanomaterials, the quality specifications of the nanomaterials should be clarified, including purity, crystal form, initial particle size distribution, and surface coating substances. Based on the quality specifications safety assessments shall be conducted on the nanomaterials under the use amount in the formula. At the same time, an explanation shall be given on whether the toxicological test method adopted in the assessment is suitable for the testing of the nanomaterials.

Given their small particle sizes, nanomaterials pose a higher risk of inhalation exposure, and their use is discouraged in products with such risks.

• Labeling Requirements

The Provisions for Management of Cosmetic Registration and Notification Dossiers requires that "(Nanoscale)" be marked after the name of nano ingredients in the product formula table.

• Restrictions in Children’s Cosmetics

The Supervision and Administration Provisions on Children Cosmetics and the Technical Guidelines for Cosmetic Safety Assessment 2021 prohibit the use of nanomaterials in children’s cosmetics unless no suitable alternatives are available. In such cases, the reasons and safety assessment for use in children must be provided.

 5) Taiwan, China

In Taiwan, the safety of cosmetics containing nanomaterials is regulated by the Taiwan Food and Drug Administration (TFDA) under the Guidelines for Risk Assessment of Cosmetics with Nanomaterials (the Guidelines), which was originally issued in July 2015, and most recently updated on November 8, 2024.

The Guidelines defines "cosmetics containing nano ingredients" as materials that possess an external space or internal structure with one or more dimensions ranging from 1 to 100 nanometers. These materials are artificially manufactured and are characterized as insoluble or biopersistent (non-biodegradable). It also provides a comprehensive list of assessment items required for evaluating the safety of cosmetics containing nanomaterials.

Regarding permitted nano ingredients, Taiwan allows CI 77266 (nano) as a colorant and Zinc Oxide (nano) as a UV filter in cosmetics.

6) Japan

In Japan, cosmetics are regulated by the Ministry of Health, Labour, and Welfare (MHLW)under the Pharmaceutical and Medical Devices Law. At present, there are no specific regulations governing the management of cosmetics containing nanomaterials

7) ASEAN

During the 16^th ASEAN Cosmetic Scientific Body (ACSB) meeting in July 2012, ASEAN discussed the updates to the EU Cosmetics Regulation regarding nanomaterials. The ASEAN Cosmetic Association (ACA) was assigned the task of drafting a working definition and guidelines for the safe use of nanomaterials in cosmetics for future ACSB meetings. However, as of now, ASEAN has not established formal regulations concerning cosmetics that contain nanomaterials.

Despite the lack of specific regulations, ASEAN has included certain nanomaterials in its cosmetic ingredient annexes, aligning its standards with those of the European Union. The following nanomaterials have been approved for use in cosmetics:

• Approved Colorants: CI 77266 (nano).

• Approved UV Filters: Zinc Oxide (nano), MBBT (nano), Titanium dioxide (nano), Tris-biphenyl triazine Tris-biphenyl triazine (nano), Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano)

8) India

The primary regulatory framework for cosmetics in India is established under the Drugs and Cosmetics Act 1940 and the Cosmetics Rules 2020. However, these regulations do not explicitly address nanomaterials. 

The only relevant standard concerning nanomaterials is IS 4707 (Part 4), which pertains to permitted UV filters in cosmetics. This standard aligns closely with EU cosmetic ingredient standards and includes a substance that involves nano-specific requirements:

9) Australia

• Cosmetics

In Australia, beauty products are classified into two distinct categories: cosmetics and therapeutic goods. Nanomaterials used in cosmetics are regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS). AICIS defines chemicals at the nanoscale as those introduced as solids or in dispersions, consisting of solid particles in an unbound state or as aggregates or agglomerates, where at least 50% of the particles have at least one external dimension in the nanoscale (1 to 100 nm).

The introduction of new chemicals at the nanoscale is considered a "specified class of introduction," which may entail additional requirements and record-keeping obligations. For detailed requirements regarding each introduction category (listed, exempted, reported, assessed), refer to the Categorisation of chemicals at the nanoscale.

• Therapeutic Goods

The Therapeutic Goods Administration (TGA) regulates nanomaterials in therapeutic goods, especially therapeutic sunscreen products. According to the Australian Regulatory Guidelines for Sunscreens (ARGS), nanoparticles are defined as particles ranging from 1 to 100 nanometers in size, which are invisible to the human eye. Ingredients such as nanoparticulate titanium dioxide and zinc oxide are commonly used in sunscreens. Other ingredients may also be utilized in nanoparticle form if they have been specifically evaluated and approved by the TGA. Notably, the particle size of active ingredients does not need to be declared on sunscreen labels.

The TGA actively monitors research on nanoparticles in sunscreens, with a literature review on the safety of titanium dioxide and zinc oxide nanoparticles first published in 2006 and regularly updated.

10) New Zealand

In New Zealand, the Cosmetic Products Group Standard 2020 defines nanomaterials as insoluble or biopersistent materials that are intentionally manufactured with one or more external dimensions or an internal structure on the scale of 1 to 100 nm.

Any individual or entity intending to import or manufacture a cosmetic product containing nanomaterials (excluding colorants, preservatives, and UV filters) must notify the Environmental Protection Agency (EPA) in writing at the time of the first import or manufacture. The notification must include the following information:

• The name of the substance;

• The HSNO approval number and/or title of the group standard under which the substance has a deemed approval;

• The nature of the nanomaterials contained in the substance.

Additionally, the applicant must maintain a record of this notification. All ingredients present in the form of nanomaterials must be clearly indicated in the ingredient list, with the names of such ingredients followed by the word "nano" in brackets.

New Zealand has approved the following nanomaterials for use in cosmetics:

• Approved Colorants: CI 77266 (nano).

• Approved UV Filters: MBBT (nano), Titanium dioxide (nano), Tris-biphenyl triazine Tris-biphenyl triazine (nano), Zinc Oxide (nano), and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano)

With extensive compliance experience and expertise in cosmetics, ChemLinked provides comprehensive global ingredient regulatory research service. For more information and further support, please contact us at [email protected].

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