Navigating Europe’s Supplement Laws in 2025

What is a Novel Food?

To understand why it’s important to comply with novel food regulations—and how EffePharm is leading the way—let’s first explore what the EU Novel Food Regulation entails and why it was established.

The regulation was implemented to ensure that any novel or new food ingredients entering the EU market are safe for consumers and are thoroughly evaluated before approval. This is especially important with the progressive food and supplement industry, which witnesses new ingredients being added that have not previously had a history of consumption within the EU.

In accordance with Regulation (EU) 2015/2283, a novel food is any food that had not been significantly consumed in the EU before May 15, 1997. It also addresses foods with a history of consumption outside the EU for at least 25 years, which can utilize a simplified notification process. Chia seeds, cannabidiol (CBD), and, more recently, nicotinamide mononucleotide (NMN) are some examples of novel foods. Before they can be sold, these products must undergo a rigorous safety assessment by the European Food Safety Authority (EFSA) to ascertain whether they meet the EU’s high standards of consumer protection. This type of regulatory framework enables innovation to flourish while preserving the integrity of the EU food market.

Is NMN Approved as a Novel Food in Europe?

Nicotinamide mononucleotide (NMN) exemplifies the impact of the EU Novel Food Regulation on the industry of novel supplement ingredients. NMN is a novel food that is not authorized in the EU at present. EffePharm’s UTHEVER® NMN has made a breakthrough as the first NMN brand to complete the EU Novel Food public consultation and enter the risk assessment phase with the European Food Safety Authority (EFSA), awaiting final approval.
Regarding the Novel Food dossier process, the European Commission and EFSA are open but guarded in their approach to NMN safety. While NMN’s potential is appreciated, the EU requires ample scientific evidence to guarantee consumer safety before approving it for the market. Brands await approval to sell NMN in Europe legally and wish to catch the first market wave.

Liposomal Supplements: Regulatory Considerations

Liposomal supplements—with their enhanced bioavailability—have gained popularity in recent years, but their legal status on the European market is likely to be uncertain.

For the regulatory status of liposomal supplements, there is no single ‘one-size-fits-all’ approach for each liposomal supplement. The EU Commission has indicated that liposomal vitamin C is not considered novel (based on the EU Novel Food Catalogue). This is because vitamin C has been a part of EU consumption since before May 1997.

The EFSA characterizes liposomes as “soft nanomaterials” when their particle size falls within the 0–100 nm range. These novel food-activating engineered nanomaterials are not most liposomal supplements — including those powered by the LipoAvail™ platform, which are calibrated to a 100–250 nm specification, which fall outside the limited nanomaterial definition. LipoAvail™ liposomal supplements are intentionally sized over 100 nm for the EU market and strictly maintain efficacy as actual liposomal transport carriers.

How to Ensure Compliance with EU Novel Food Regulations

The process for obtaining Novel Food authorization in the EU involves several key steps. The applicant submits an exhaustive application to the European Commission, including scientific data on the composition of the novel food, manufacturing process, and intended use. The European Food Safety Authority (EFSA) then conducts a thorough safety assessment, typically within nine months, to determine whether there are any potential risks to consumers. Once EFSA presents a positive opinion, the European Commission drafts an implementing act to include the new food in the Union List, allowing it to be legally distributed throughout the entire EU.

Future of NMN and Novel Foods in Europe

The latest news regarding NMN’s regulatory journey in Europe is promising: EffePharm’s UTHEVER® NMN became the first brand of NMN to navigate the EU Novel Food public consultation hurdle and has now moved on to the EFSA risk assessment stage, edging closer towards potential approval next year in 2025.
This milestone marks a broader trend of increasing authorizations for new ingredients as the EU strives to strike a balance between innovation and consumer protection. UTHEVER® NMN is at the forefront of this work, leveraging its scientific expertise and clinical data to guide the compliance front and be the standard for NMN and other new supplements. With shifting regulatory frameworks, EffePharm’s vision for the future will enable it to shape the development of new foods, bringing innovative, safe, and effective products to the European market.

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