Nanotechnology has revolutionized various industries, including cosmetics, by offering innovative products with enhanced properties. Nanomaterials have gained significant attention in the cosmetic industry due to their unique characteristics. However, the potential risks associated with nanomaterials have prompted the need for global regulations to ensure their safe use in cosmetics.
As the European Union (EU) and China stand as the two largest economies in the cosmetics industry worldwide, ZMUni has undertaken a comprehensive analysis of the utilization of nanomaterials in cosmetics within these two influential regions. This aims to provide valuable insights for industry stakeholders and policymakers.
Definitions of Nanomaterials in EU and China
Under the EU Cosmetics Regulations (EC) No 1223/2009, nanomaterial means 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 China, nanomaterial is defined as, in the Regulations on the Management of Registration and Notification of Cosmetic Ingredients, an insoluble or biologically non-degradable artificial materials composed of material or material units with at least one dimension ranging from 1 to 100nm in three-dimensional spatial structures
Regulatory Compliance of Nanomaterials in EU
On 26 June 2023, the publication of the Guidance on The Safety Assessment of Nanomaterials (NMs) in Cosmetics by the EU Scientific Committee on Consumer Safety (SCCS) holds significant influence over the cosmetics industry. This guidance serves as a crucial resource for industry professionals, regulators, and stakeholders involved in the production and regulation of cosmetic products containing nanomaterials.
NMs may exhibit certain physicochemical properties, biokinetic behaviour, biological interactions, and/or toxicological effects that are different from the conventional or bulk form of the same ingredients. Thus, the Guidance is structured in separate sections covering requirements for safety assessment, physicochemical characterisation, exposure assessment, hazard identification and dose-response characterisation, and risk assessment of NMs.
For cosmetic products containing NMs, they must be notified at least six months prior to being placed on the market. Certain categories of cosmetic ingredients - e.g. colourants, UV-filters and preservatives, including their nanoforms - can only be used in cosmetic products when ‘authorised’by SCCS.
Additionally, all ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.
Figure 1 demonstrates the schematic outline for the safety assessment of nanomaterials in cosmetics.
Regulatory Compliance of Nanomaterials in China
China has implemented stringent regulations regarding the utilization of nanomaterials in cosmetics, driven by a strong emphasis on safety.
The Regulations on the Management of Registration and Notification of New Ingredients in Cosmetics require that, in addition to providing general physicochemical properties, nanomaterials should also provide specific physicochemical indicators such as particle size and distribution, aggregation and agglomeration characteristics of the materials, surface chemical information, and morphological information.
The regulations also explicitly state that toxicological test (animal testing) data for all items should be provided for nanomaterials, and it is further required to provide explanations of toxicological test methods for nanomaterial detection. Additionally, specific toxicological test requirements are outlined for nanomaterials intended for use on the skin or with potential inhalation exposure.
The Regulations on the Supervision and Administration of Children's Cosmetics clearly stipulate that the use of materials prepared using nanotechnology is not allowed in children's cosmetics. If there is a necessity to use such materials in the absence of alternatives, the reasons must be stated, and a safety evaluation must be conducted specifically for the use of children's cosmetics.
The Technical Guidelines for Cosmetic Safety Assessment also specifically require the selection of cosmetic ingredients with a long history of safe use. The use of new technologies such as genetic engineering and nanotechnology in ingredient preparation is not encouraged. If there is a necessity to use such materials in the absence of alternatives, the reasons must be stated, and a safety evaluation must be conducted specifically for the use of children's cosmetics.
With Regard to The Regulations on the Management of Registration and Notification of Cosmetic Ingredients, cosmetics using nanomaterials should indicate (nano) after the names of such ingredient materials in the formula. Additionally, the quality specifications provided by the manufacturer of the ingredient and safety assessment data based on the quality specifications and formula should be provided.
It is important to note that regulations may vary in their scope and specific requirements. Additionally, regulatory frameworks are continuously evolving as scientific knowledge and understanding of nanomaterials progress. Therefore, it is advisable to consult the relevant regulatory authorities for the most up-to-date information on nanomaterial regulations in specific countries.
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