On July 11, 2013, European Cosmetics Regulation EC No. 1223/2009 will be fully enforced across the Member States of the European Union (EU). This regulation is directly applicable and does not require national implementation, unlike the Cosmetics Directive 76/768/EEC that it replaces. As explained in the March 2013 edition of this column, the main purpose of the regulation is unchanged: to provide high level protection to human health and a single-functioning internal European market for goods and services.
Although originally presented as a consolidation and simplification of the Cosmetics Directive and its complex amendments, the recasting of the directive into a regulation for cosmetic products was used as an opportunity to extend the scope in several areas. One of these concerned the use of nanomaterial in cosmetic products, now defined in Article 2(k) of the regulation. It states, “‘Nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”
Although this definition sounds useful in the context of cosmetic ingredients, in practice, almost all of the elements need further clarification and agreement, including: insoluble, biopersistent, intentional, manufactured and internal structure. There are also difficulties for ingredient suppliers, product manufacturers and enforcement authorities in measuring materials in a consistent fashion when some of the particles have one or more dimensions, whether internal or external, on the 1 to 100 nm scale. Nevertheless, manufacturers or, more accurately, Responsible Persons (RP), are required to comply with specific requirements as laid out in Article 16 for nanomaterials and for cosmetic products containing nanomaterials. There are three nano-related requirements for industry: notification to the European Commission (EC) six months prior to placing the product on the market; safety assessment of the cosmetic product with particular attention to nanomaterials; and the labeling of ingredients that are nanomaterials.
EC Notification
Unless the nanomaterial is used as a colorant, a UV filter or a preservative and is listed in the appropriate annex to the regulation; or unless the nanomaterial is being used in conformity with any requirement set out in Annex III, the RP must notify the EC of cosmetic products containing nanomaterials six months before placing the product on the market. However, it is not necessary to wait for permission or approval before proceeding to market after the notification has taken place. During this period of time, the EC may request the opinion of the Scientific Committee for Consumer Safety (SCCS) regarding the safety of the nanomaterial in question and, as a result of that opinion, may amend Annexes II or III. Note that the entries in the annexes for colors, UV filters and preservatives do not automatically cover those substances in the nano form unless expressly mentioned.
Safety Assessment
Safety assessment is a specialized area that is the province of experts who must possess specific qualifications as laid out in the regulation. Annex I to the regulation outlines the expected content of the Cosmetic Product Safety Report that must be prepared for each cosmetic product prior to its placement on the market. When referencing the toxicological profile of the substances or ingredients, the annex states, “Particular consideration shall be given to any possible impacts on the toxicological profile due to particle sizes, including nanomaterials.”
Although it is outside the scope of this short column to detail the safety assessment, the safety assessor must ensure the data under review for a particular substance relates to the exact form being used in the product, or that any “read across” performed is based on a scientifically robust rationale.
Labeling
The third element is one of labeling, and Article 19(g) says that any ingredient present in the form of a nanomaterial should be indicated by placing “(nano)” after the ingredient’s INCI name in the list of ingredients. This has led to some concern that the labeling may be misinterpreted or even misrepresented as some form of warning, but this is certainly not the case. All cosmetics, whether or not they contain nanomaterials, must be safe. It should also be mentioned that the shape of the brackets around “nano” is not specified.
This nano-labeling requirement is effective as of July 11, 2013, so the first products to appear on the shelves with “(nano)” in the ingredient listing are likely to be sun protection products due to the presence of micronized titanium dioxide (TiO2). The Cosmetic, Toiletry and Perfumery Association also anticipates that zinc oxide (ZnO), in both nano and non-nano forms, will be added to Annex VI positive list of UV filters of the regulation, allowing for the use of ZnO as a UV filter in the EU. TiO2 and ZnO are efficient UV filters, but using them in the form of small particles greatly increases their filtering efficacy and contributes strongly to the ability of companies to produce sun protection products with much higher SPF values than before. Safety is assured by both the companies manufacturing the products, and because these ingredients have been repeatedly reviewed for safety by the SCCS.
Discussion
It is important to put the issue of size into context, as many doubters question whether nanomaterials can penetrate the skin and whether that is a safety concern. Do not forget that the skin is not a sieve but rather an effective barrier, keeping in what ought to be kept in and keeping out what ought to be kept out. The barrier is so effective that few medicines can be delivered effectively by dermal patches and therefore must be given orally or by injection.
One of the smallest molecules is water, and it does not penetrate the skin. A water molecule is about one third of a nanometer in diameter; in fact, perhaps a slightly ridiculous example, a thirsty person can sit in a bath of water a long time and yet remain thirsty. Sugar glucose is another molecule essential to the life of cells, and it cannot penetrate the skin, even though cells within the skin need glucose for their respiration. A molecule of glucose is approximately one nanometer in diameter. By comparison, some of the smallest particles of micronized TiO2 are 100 nm in diameter, and many are much larger.
If skin is perfectly able to keep out water and glucose, so how much harder would it be for a particle as large as TiO2 to penetrate? After all, a small particle of TiO2 is one million times larger than a glucose molecule, and 27 million times larger than a water molecule. To worry about that huge chunk of material somehow getting through the same skin that effectively prevents the entry of substances so much smaller seems groundless.
Industry must promote the advantages that the safe use of specific nanomaterials in cosmetic products bring to the consumer, and resist any attempt by the misinformed to suggest that “(nano)” labeling should be thought of as a warning.
