Natural colours: regulatory momentum grows, but global rules remain fragmented

Different regulatory approaches for new colour substances

The contrasting treatment of Galdieria sulphuraria extract, a microalgae-derived blue pigment, highlights how regulatory priorities can shape market access for innovative colour solutions.

In March 2026, the European Food Safety Authority (EFSA) concluded that the extract does not raise safety concerns at the proposed uses and established an acceptable daily intake (ADI). However, EFSA did not support use under quantum satis conditions due to concerns about high intake in some population groups. The ingredient is therefore still awaiting final approval from the European Commission, with final permitted use levels yet to been set.

The US has taken a different approach. In 2025, the US Food and Drug Administration (FDA) approved the same substance as a colour additive that does not require batch certification, providing a clearer route to commercialisation.

Classification strategy: food additive or food ingredient?

Beyond individual authorisations, a more fundamental divergence is emerging in how regulators classify pigment-rich substances. In the EU, companies are increasingly exploring routes that position these products as foods or food ingredients, rather than food additives. This can allow access via the Novel Food framework instead of the more restrictive food additive route, therefore enabling manufacturers to use intrinsic colouring properties without being regulated as additives.

Yellow tomato extract, which is rich in carotenoids, illustrates this approach. The ingredient, including proprietary formats such as Lumenato™, has received a positive EFSA safety opinion under the Novel Food Regulation; however, it is still awaiting formal authorisation and inclusion in the EU Union list before it can be marketed.

The US takes a different view; similar carotenoid-rich tomato extracts require colour additive approval when used to colour food. The same materials may generally be used as food or dietary ingredients (e.g. under GRAS or supplement frameworks), provided any colour imparted is incidental and clearly unimportant as to appearance, value, marketability, or consumer acceptability.

Pipeline developments highlights new sources of natural colours

The next generation of natural colours is increasingly emerging from microbial and algal derived ingredients, attracting both regulatory and commercial interest.

EFSA is currently reviewing a number of applications for such substances, including Schizochytrium (microalgal oils and extracts) and Kluyveromyces (fermentation derived ingredients).

While not always classified as colour additives, many of these are recognised as ingredients with colouring and additional functional properties. This reflects a broader shift toward biotechnology enabled colour systems, which may blur the line between additives and functional ingredients.

Navigating an increasingly complex natural colours landscape

As natural colour innovation accelerates, regulatory requirements are becoming more difficult to navigate. Differences in authorisation pathways, classification approaches and permitted use conditions can create significant challenges for companies developing products for multiple markets.

Leatherhead Food Research supports food and beverage businesses in navigating these challenges through its membership programme and specialist regulatory consulting services. Whether assessing classification options, planning an EU Novel Food application or exploring routes to market for new colour technologies, businesses can access expert guidance, including support through annual member helpline hours.