Nanomaterials have revolutionized the cosmetic industry, offering unique benefits such as enhanced UV protection (in sunscreens), improved color dispersion (in makeup), and better delivery of active ingredients. However, due to their ultra-small size (typically $1 \text{ to } 100 \text{ nanometers}$), these materials present specific safety assessment and regulatory challenges, particularly regarding potential skin penetration and subsequent systemic exposure.
1. Defining and Regulating Nanomaterials
The European Union (EU) takes the most stringent approach to Nanomaterial Cosmetic safety, primarily through the Cosmetic Regulation (EC) No 1223/2009. The regulation explicitly defines a nanomaterial and subjects its use to strict regulatory oversight.
- Definition: A Nanomaterial means an intentionally produced material that has constituent particles, in an unbound state or as an aggregate or as an agglomerate, where 50% or more of the particles in the number size distribution have one or more external dimensions in the range $1 \text{ nm}$ to $100 \text{ nm}$.
- Regulatory Status: Any ingredient used in a cosmetic product in a nano form must be clearly indicated in the ingredient list with the word “nano” in parentheses following its name (e.g., Titanium Dioxide (nano)).
2. The Nanomaterial Notification Process
Unlike standard cosmetic ingredients, Nanomaterials that are not specifically regulated (e.g., as UV filters) require a special Nanomaterial notification and assessment process before they can be placed on the market.
- CPNP Notification: All cosmetic products must be notified via the CPNP (Cosmetic Products Notification Portal). For products containing nanomaterials, the notification must explicitly include this information.
- The Six-Month Rule: The “Responsible Person” (manufacturer or importer) must notify the European Commission of the use of a Nanomaterial six months before placing the product on the market. This gives the Scientific Committee on Consumer Safety (SCCS) time to review the safety data.
- SCCS Assessment: The notification must include robust safety data proving the material’s safety, especially its lack of percutaneous penetration. The SCCS is tasked with evaluating this data and issuing an opinion on whether the use of the specific Nanomaterial is safe in the intended cosmetic application.
3. Case Study: Nanomaterials as UV Filters
The use of mineral UV filters, such as Zinc Oxide and Titanium Dioxide, in Nanomaterial form is a classic example of this regulation in practice.
- Specific Regulation: These nano-sized UV filters are listed in Annex VI (the list of permitted UV filters) and are only authorized if they comply with strict specifications, such as maximum concentration limits and purity criteria.
- Safety Conclusion: Scientific data, rigorously reviewed by the SCCS, has generally confirmed that specific forms of Zinc Oxide (nano) and Titanium Dioxide (nano) are safe for use on healthy skin because they do not penetrate the skin barrier.
In conclusion, the presence of Nanomaterials in cosmetic formulations is a powerful driver of innovation, but it mandates the highest level of regulatory diligence. Compliance requires precise adherence to the Nanomaterial notification process and clear Regulatory Status checks to ensure that technological advancement aligns perfectly with consumer safety.
