The main amendments adopted by the updated Guidance include the new overarching definition of nanomaterials, the key attributes that trigger safety concerns over nanomaterials, and important physicochemical parameters of nanomaterials’ safety assessments.

On June 26, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the updated Guidance on the Safety Assessment of Nanomaterials in Cosmetics (Guidance).¹ Incorporating the latest updates in nanomaterial safety research, the Guidance provides an overview of the key issues and data requirements relating to the safety assessment of nanomaterials in cosmetics.

Management of Nanomaterials under the Cosmetics Regulation

Nanomaterials have various functions as cosmetic ingredients, such as UV filters, preservatives, colorants, etc. While bringing certain benefits to consumers, the nanoscale feature may also pose risks to consumers. As a result, ensuring the safety of nanomaterial ingredients has been an important focus of attention in the Regulation (EC) No 1223/2009 (Cosmetics Regulation).

According to the Cosmetics Regulation, cosmetics containing nanomaterials are subject to pre-market notification, safety assessment, and additional labelling. If the European Commission has concerns regarding the safety of a nanomaterial, it can refer to SCCS for a scientific opinion. In addition to this oversight on risk assessment, SCCS gives cosmetic enterprises and risk assessors instructions on the safety assessment of nanomaterials intended for use in cosmetics, as outlined in the Guidance.

The Guidance is complementary to The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation for specifically addressing the safety aspects of nanomaterials, therefore should be used in conjunction with the latter. Since the last revision of the Guidance in 2019, a number of new developments have been made through nanomaterial safety researches. In view of these developments, SCCS has therefore updated the Guidance.

Important Amendments in the Updated Guidance

Compared to the previous version, the updated Guidance mainly incorporates the following amendments:

1. Introducing the New Overarching Definition of Nanomaterials

To ensure the consistency in regulatory interpretations and practices, the EU Chemicals Strategy for Sustainability (CSS) proposes using coherent terminology to define nanomaterials. Guided by this proposal, in June 2022, the Commission adopted the Commission Recommendation on the Definition of Nanomaterial (the Recommendation) to align legislation across all sectors with each other in terms of new overarching definition of nanomaterials. According to the Recommendation,

"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.

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.

Though the Recommendation has not yet been applied to the Cosmetics Regulation, it is likely that the definition of nanomaterials in the Cosmetics Regulation will be consistent with the one in the Recommendation. Therefore, the updated Guidance introduces the new definition, and advises stakeholders to take it into consideration when assessing the safety of nanomaterial ingredients.

2. Presenting Key Attributes that Trigger Safety Concerns Over Nanomaterials

In 2020, following a mandate by the Commission, SCCS published the scientific advice SCCS/1618/2020, highlighting the key attributes of nanomaterials that should raise safety concerns of a safety assessor. The advice provides the scientific reasoning behind such attributes to help prioritize nanomaterials for further evidence-based safety assessment.

In light of this advice, SCCS considers that in the absence of any hard and fast rules for identifying safety concerns about nanomaterials, as a general principle, the use of nanomaterial should be attached with further concern in terms of each of the following attributes.

3. Detailing Important Physicochemical Parameters of Nanomaterials' Assessments

The properties, behavior, and biological effects of nanomaterials may be influenced by a number of physicochemical parameters. Thorough physicochemical characterization of nanomaterials is therefore critical for safety assessments. The previous version of the Guidance compiled a list of important parameters for nanomaterials' safety assessments, such as chemical identity, chemical composition, production process particles, and number-based particle size distribution. All of these parameters relevant to a given nanomaterial should be measured. Based on this, the updated Guidance further supplements the detailed description of several important physicochemical parameters, including aspect ratio, solubility and dissolution rate, solubility in non-aqueous media, endocrine disruption, uptake into blood cells, etc.

In addition to these updates, based on the literature published after the last revision, the updated Guidance includes the newly proposed frameworks for grouping and read-across approaches, explains when historical/existing data can be used in the assessment, and updates the available replacement methods for toxicological evaluation of nanomaterial ingredient. Details of these changes can be found here.

Further Reading

• EU to Adopt 11 Changes to the Use Requirements for Cosmetic Ingredients
• EU to Amend the Use Requirements for 13 Nanomaterials in Cosmetics
• EU Proposes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics

Reference Links

[1] SCCS—Guidance on the Safety Assessment of Nanomaterials in Cosmetics—2nd Revision

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