Nanomaterials in Cosmetics and Regulatory Duties

Nanomaterials are increasingly used in cosmetic formulations to improve texture, stability, and performance. In products such as sunscreens or skincare treatments, these microscopic ingredients can enhance UV protection, transparency, or product consistency. 

However, their use also brings specific regulatory obligations in the European Union. Cosmetic products containing nanomaterials are subject to additional requirements, including pre-market notification and specific labeling rules. 

Definition and common examples of Nanomaterials 

In the EU context, nanomaterials are generally defined as insoluble or bio-persistent substances intentionally manufactured with one or more external dimensions between 1 and 100 nanometres. Their small size can influence how ingredients behave within a formulation. 

Common examples include titanium dioxide and zinc oxide used in sunscreens, as well as silica nanoparticles that help improve texture or stability. Scientific evaluations published by the Scientific Committee on Consumer Safety provide guidance on how these materials are assessed for safety in cosmetic products. 

Regulatory requirements in the EU 

When nanomaterials are present in a cosmetic product, additional regulatory steps apply. These typically include notification to authorities before placing the product on the market and specific labeling requirements to indicate the presence of nano ingredients. 

Such measures are intended to ensure transparency and allow authorities to monitor the use and safety of nanomaterials in cosmetics. 

Challenges for cosmetic companies 

Identifying which formulations contain nanomaterials is often the first challenge, especially for companies managing large product portfolios or working with multiple suppliers. 

Maintaining accurate documentation, tracking safety data, and ensuring that all required steps are completed can increase operational complexity. This becomes more demanding when products are distributed across different markets or frequently reformulated. 

How software supports compliance management 

Digital tools can help structure and centralize information related to nanomaterials. A centralized ingredient database can highlight formulations containing nano ingredients and provide visibility across all affected products. 

Software platforms can also support documentation management, preparation of product dossiers, and overall oversight of formulations and related data. 

References:

Regulation (EC) No 1223/2009 on cosmetic products

SCCS, Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 13th revision, 2023