Notification of Cosmetic Products Containing Nanomaterials

Cosmetic products containing nanomaterials are subject to specific obligations under Regulation (EC) No 1223/2009.

In addition to the standard CPNP notification required under Article 13, certain cosmetic products containing nanomaterials must be notified to the European Commission under Article 16, through the dedicated section of the CPNP – Cosmetic Products Notification Portal.

This notification must be submitted six months before the product is placed on the market.

When Article 16 Notification Is Required

The specific notification is required for cosmetic products containing nanomaterials that have not already been subject to a full risk assessment by the SCCS – Scientific Committee on Consumer Safety.

Article 16 notification is not required when the nanomaterial is already regulated under Annexes III, IV, V or VI of Regulation (EC) No 1223/2009, for example as an authorised colorant, preservative or UV filter.

Before developing or launching the product, it is therefore important to verify:

• whether the ingredient falls within the definition of nanomaterial;
• whether the nanomaterial is already regulated under the annexes of the Cosmetics Regulation;
• whether a specific Article 16 notification is required.

Who Submits the Notification

The notification of cosmetic products containing nanomaterials must be submitted by the Responsible Person.

The Responsible Person may appoint a delegate, by written mandate, to prepare part of the notification. However, the delegate cannot submit the notification directly to the Commission.

The final submission through the CPNP remains the responsibility of the Responsible Person. Certain information, such as the estimated annual quantity of nanomaterial contained in the products intended to be placed on the market, can only be entered by the Responsible Person.

One Notification for Each Nanomaterial

If a product contains more than one nanomaterial, a separate notification must be prepared for each nanomaterial.

The same applies to products available in several variants or shades: if each variant contains a different nanomaterial, each one must be assessed separately.

This is particularly relevant for make-up products, coloured cosmetics, sunscreens and cosmetic lines with multiple references.

Information Required

Article 16 notification requires detailed technical information on both the product and the nanomaterial.

The main information includes:

• identification of the cosmetic product;
• identification of the nanomaterial;
• IUPAC name and other available identifiers;
• product category;
• Responsible Person details;
• physicochemical specifications of the nanomaterial;
• particle size;
• morphology;
• surface characteristics;
• solubility;
• estimated annual quantity;
• toxicological profile;
• safety data;
• exposure conditions.

Technical files may also be uploaded in PDF or ZIP format, for example for specifications, toxicological profile, safety data and exposure conditions.

Exposure Conditions

Exposure conditions are a key part of the notification.

The following information must be provided:

• whether the product is rinse-off or leave-on;
• route of exposure: dermal, oral or inhalation;
• concentration of the nanomaterial in the product;
• reasonably foreseeable conditions of use.

These data are especially important for spray products or cosmetics that may involve inhalation exposure.

Notification, PIF and Safety Assessment

Nanomaterial notification does not replace the PIF – Product Information File and does not replace the cosmetic safety assessment.

The product must still be supported by complete and consistent technical documentation, including the formula, CPSR, PIF, label, raw material documentation, toxicological data and safety information.

Article 16 notification must therefore be aligned with the full regulatory documentation of the cosmetic product.

Common Mistakes to Avoid

Common mistakes include:

• failing to verify whether a raw material is a nanomaterial;
• confusing Article 13 notification with Article 16 notification;
• missing the six-month deadline;
• failing to submit separate notifications for multiple nanomaterials;
• entering data inconsistent with the formula, PIF or label;
• underestimating inhalation exposure in spray products;
• lacking adequate technical, toxicological and safety data.

Plan the Notification Before Launch

The notification of cosmetic products containing nanomaterials should be assessed from the early stages of product development.

The six-month period before market placement makes it essential to plan technical data collection, documentation review and notification submission in advance.

Proper management helps avoid launch delays, incomplete documentation requests and regulatory issues during market surveillance.