What Are Novel Foods? Understanding EFSA’s Approach to New Ingredients in the EU

The European food and supplement market is one of the most tightly regulated in the world. If you’re formulating or launching a product in the EU, you’ve likely heard the term “novel foods.” But what exactly does that mean and why does it matter for supplement companies?

In this post, we’ll explore the European Food Safety Authority (EFSA)’s definition of novel foods, how the approval process works, and what it means for businesses bringing new ingredients to market.

What Are Novel Foods?

According to Regulation (EU) 2015/2283, a novel food is defined as any food that was not consumed to a significant degree in the EU before 15 May 1997.

Novel foods can include:

• New sources of nutrients (e.g., krill oil for Omega-3s)

• Foods from new production processes (e.g., UV-treated milk enriched with vitamin D)

• Ingredients derived from microorganisms, fungi, or algae

• Extracts from plants or animals not traditionally used in Europe

• Engineered or reformulated ingredients (e.g., nano-forms of existing nutrients)

In short: if it’s “new” to the European food market, it probably falls under the novel food umbrella.

Examples of Novel Foods in Supplements

Some novel foods relevant to supplements include:

• Chia seeds (considered novel until authorisation in 2009)

• Astaxanthin-rich extracts from algae

• CBD (cannabidiol) and hemp-derived extracts (under assessment and legal debate)

• Insect proteins (e.g., cricket powder)

• Plant sterol esters

• Krill oil and algal oils (for Omega-3s)

• Synthetic or fermented alternatives to vitamins and minerals

Why Does EFSA Regulate Novel Foods?

EFSA’s role is to ensure that any new ingredient is:

• Safe for human consumption

• Properly labelled (no misleading health claims)

• Nutritionally beneficial (or at least not disadvantageous compared to existing foods)

This is particularly important in the supplement industry, where new ingredients appear rapidly, often riding the wave of consumer health trends.

The Novel Food Approval Process

Before a novel food can be marketed in the EU, it must undergo an authorisation process that involves:

1. Application Submission A company submits a dossier to the European Commission. The dossier must include safety studies, toxicology data, and proposed uses.

2. EFSA Risk Assessment EFSA reviews the scientific evidence. They assess safety, bioavailability, allergenicity, and interactions.

3. Authorisation & Union List If approved, the ingredient is added to the Union List of Novel Foods. Products can then be marketed across the EU, provided they meet any specified conditions (e.g., max dosage, form, target population).

This process ensures both consumer protection and a level playing field for companies.

Challenges for Supplement Brands

For companies in the supplement space, the novel food framework can feel like a double-edged sword:

Challenges:

• Time-Consuming: Approval can take 18 – 24 months or longer.

• Costly: Safety studies and dossiers require significant investment.

• Market Delay: Brands may lose first-mover advantage while waiting for authorisation.

Opportunities:

• Exclusivity: Novel food approvals can include a 5-year data protection period for the applicant.

• Credibility: EFSA approval provides a strong safety signal to retailers and consumers.

• Innovation: The framework encourages rigorous science-based product development.

Why Novel Foods Matter for the Future of Nutrition

As consumer demand for plant-based, sustainable, and functional nutrition grows, novel foods will play a central role in innovation. Ingredients like fermented proteins, microalgae, and even insects could become mainstream, but only if they pass EFSA’s rigorous standards.

For supplement companies, understanding the novel food framework isn’t just about compliance, it’s about staying ahead of market trends and ensuring long-term credibility.

Conclusion

Novel foods represent the cutting edge of nutrition innovation in Europe, but also one of the most regulated categories. EFSA’s framework ensures safety, transparency, and consumer trust, which ultimately benefits the industry as a whole.

If you’re a supplement brand exploring new ingredients, partnering with an experienced formulation and compliance team can help you navigate the complex novel food landscape and bring innovative products to market successfully.