How are nitrosamines regulated in cosmetics?

Nitrosamine contamination in cosmetics is regulated under EU Cosmetics Regulation EC 1223/2009. The regulation sets a limit of 50 μg/kg (50 ppb) for total nitrosamine content in finished cosmetic products.

How nitrosamines form in cosmetics

Many cosmetic formulations contain amine-based ingredients. Diethanolamine (DEA), triethanolamine (TEA), and related compounds are widely used as emulsifiers, surfactants, and pH adjusters. Under certain conditions, these amines react with nitrosating agents to form nitrosamines.

Nitrosating agents can be present as trace contaminants in raw materials or can form from other ingredients during production or storage. This means nitrosamines are not always present at the point of manufacture. They can develop over the shelf life of the product, which is why testing at release alone may not be sufficient.

NDELA (N-nitrosodiethanolamine) is one of the most commonly detected nitrosamines in cosmetic products because of the widespread use of DEA-based ingredients.

What the 50 μg/kg limit means

The limit applies to total nitrosamine content, not individual compounds. This means the testing method needs to capture all nitrosamines present in the sample and report a single total value.

The ATNC (Apparent Total Nitrosamine Content) method is the recognised approach for this. It measures total nitric oxide released from all nitrosamines in the sample. The Ellutia ATNA automates this method, processing up to 10 samples per hour with sensitivity below 1 ppb.

If a screening result exceeds the limit and you need to identify which nitrosamines are present, GC-TEA provides speciated analysis to identify and quantify individual compounds.

UK-specific considerations

Following Brexit, the UK has adopted its own cosmetics regulatory framework based on the EU regulation. The 50 μg/kg total nitrosamine limit carries across. Updated SCCS guidance continues to apply, with specific attention to ingredient-level controls and product-level testing.

In-house vs outsourced testing

Many cosmetics manufacturers currently outsource nitrosamine testing. As regulatory pressure increases and testing frequency rises, the economics of in-house testing improve. The Ellutia ATNA is designed for this shift, providing automated screening at a throughput that suits production-level volumes.

Want to discuss nitrosamine compliance testing for your cosmetics products? Get in touch with the team.