– NANOMATERIALS IN COSMETICS: REGULATORY AND SAFETY CONSIDERATIONS

Senior Program Manager, Toxicology
Pharmaceuticals & Healthcare
Intertek Cantox

2233 Argentia Road, Suite 308
Mississauga, Ontario, CANADA L5N 2X7

ABSTRACT

Nanomaterials are present as ingredients in numerous types of cosmetic products that are marketed worldwide. Regulatory and safety evaluations of nanomaterials and nanomaterial-containing cosmetic products continue to evolve with the accumulation of knowledge on the physicochemical and toxicological properties of particles at the nanoscale. This chapter provides an overview of the current state of regulation of nanomaterial-containing cosmetic products in Europe, the United States (U.S.), and Canada. It also outlines some considerations for the design and conduct of evaluations of nanomaterial toxicity that can support cosmetic product safety.

TABLE OF CONTENTS

2.3.4.1 Regulation of Cosmetics Containing Nanomaterials

a. Definition of Nanomaterial

b. Regulation in Europe

c. Regulation in the United States

d. Regulation in Canada

2.3.4.2 Safety Assessment Considerations for Nanomaterials

a. Study Design Aspects

b. Nanomaterial Characterization

c. Dose Metrics

d. Assay Interference

Conclusion

References

2.3.4.1 REGULATION OF COSMETICS CONTAINING NANOMATERIALS

a. Definition of Nanomaterial

The regulation of cosmetics containing nanomaterial ingredients depends, in part, on the definition of a nanomaterial, which in and of itself varies among jurisdictions. For reference, Table 1 presents a summary of the current definition of a nanomaterial for cosmetic regulation purposes in Europe, the U.S., and Canada.

Table 1 Nanomaterial Definition in Different Jurisdictions

Jurisdiction	Definition of Nanomaterial	Reference
Europe	● “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.	1
United States	● FDA has not adopted a formal definition of “nanotechnology,” “nanoscale,” or related terms.	2
	● Although there are numerous definitions of “nanotechnology,” the term is perhaps most commonly used to refer to the intentional manipulation, manufacture, or selection of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.
	● While one definition for “nanotechnology,” “nanoscale material,” or a related term or concept may offer meaningful guidance in one context, that definition may be too narrow or broad to be of use in another.
Canada	Any manufactured substance is a nanomaterial if: ● It is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; or ● It is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena. For the purposes of this definition: ● The term “nanoscale” means 1 to 100 nanometers, inclusive; ● The term “nanoscale properties/phenomena” means properties that are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules, and bulk material; and, ● The term “manufactured” includes engineering processes and the control of matter.	3

b. Regulation in Europe

The European Commission was the first regulatory body to formally regulate the use of nanomaterials in cosmetics. As of July 11, 2013, cosmetic products placed on the European market must conform to the procedures and data requirements contained in Regulation (EC) No. 1223/2009 of the European Parliament and of the Council 1. As of this date, a Product Information File (PIF) for each cosmetic product marketed in Europe must be maintained by a “Responsible Person” within the Community (defined as “a legal or natural person established within the Community”). Each PIF contains a cosmetic product safety report and other pertinent information for a given cosmetic product and must be made available to regulatory authorities if requested. Moreover, the Responsible Person must notify the Commission prior to the introduction of a cosmetic product to the European market. While notification for cosmetic products that do not contain nanomaterials can be made immediately prior to placement on the market, notification for cosmetic products containing nanomaterials must be made six months prior to placement on the market 1. In the latter case, the notified information must contain the following:

1. The identification of the nanomaterial including its chemical name (IUPAC) and other descriptors
2. The specification of the nanomaterial including size of particles and physical and chemical properties
3. An estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year
4. The toxicological profile of the nanomaterial
5. The safety data of the nanomaterial relating to the category of cosmetic product, as used in such products
6. The reasonably foreseeable exposure conditions

The Regulation does not provide specific guidance on how to address some of the items listed above (e.g., the specific types of toxicological data required), but such guidance is available from the European Commission’s Scientific Committee on Consumer Safety (SCCS). Specifically, guidance is available that assists with understanding what needs to be considered when evaluating the safety of cosmetic ingredients in general 4 and when conducting physicochemical characterization, exposure assessment, hazard identification and dose response, and overall risk assessment evaluations for nanomaterials in cosmetics 5. Based on SCCS guidance, the following parameters are considered important for identification and characterization of nanomaterials in cosmetic products 5:

1. Chemical identity
2. Chemical composition and purity
3. Size and size distribution
4. Morphology
5. Surface characteristics (charge, modifications, etc.)
6. Solubility
7. Surface area
8. Catalytic activity
9. Concentration
10. Dustiness (for dry powder products)
11. Density and pore density
12. Redox potential
13. pH
14. Viscosity
15. Stability
16. Other aspects (e.g., ultraviolet absorption, light reflection)

In the event that information supplied for a given nanomaterial raises concerns about its safety, the Commission may request the SCCS to issue a formal opinion. These opinions focus on the safety of the nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. Timelines have been established for the SCCS to request additional information to assist with its evaluation of a given nanomaterial, for such information to be provided, and for a final opinion to be issued, all of which is made publicly available.

Unlike in other regions, special labeling requirements have been established for nanomaterial-containing cosmetics in Europe. Specifically, all nanomaterial ingredients present in a cosmetic product marketed in Europe must be clearly indicated in the list of ingredients and be followed by the word “nano” in brackets. Moreover, the Regulation calls for the creation and maintenance of a publically available catalogue of all nanomaterials that are used in cosmetic products placed on the market. This catalogue will be made available by January 11, 2014 and will indicate categories of cosmetic products that contain nanomaterials and the reasonably foreseeable exposure conditions. In recognizing that understanding nanomaterial safety is a pragmatic process, the Commission has set a deadline of July 11, 2018 for undertaking the first review of the provisions of the Regulation that concern nanomaterials, and will propose suitable amendments to the provisions where it is deemed necessary.

c. Regulation in the United States

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