The European Food Safety Authority (EFSA) has determined that a daily intake of 300 mg of Nicotinamide Mononucleotide (NMN) is safe for the general population, excluding pregnant and breastfeeding women. Following this positive assessment, the European Commission and its Member States will conduct a review to formalize the authorization and publish the conditions for approved use.
Typically, the EU grants authorization for such products within a time frame of five to seven months after receiving a favorable opinion from EFSA.
Should approval be granted, NMN is anticipated to see extensive adoption in dietary supplements across the EU, according to Jerome Le Bloch, the head of scientific affairs at FoodChain ID.
At this juncture, only the applicant, the biotech firm EffePharm, is permitted to share the positive EFSA opinion, as producers of NMN other than EffePharm remain bound by Novel Food regulations.
Le Bloch described the positive opinion as a “major milestone” for the company.
“The market demands NMN, and it is poised to become a bestseller,” he remarked.
NMN in Europe and Regulatory Context
NMN is a naturally occurring compound that the body utilizes to produce NAD⁺, an essential molecule vital for cellular energy production and metabolism. In 2025, EFSA issued a favorable scientific opinion acknowledging NMN as a source of nicotinamide (vitamin B3), which represents a significant step toward potential approval in Europe.
Despite not being inherently more complex than other vitamin B3 derivatives such as nicotinamide riboside (NR), several key factors influence NMN’s regulatory context and market relevance, as noted by Le Bloch.
Firstly, NMN has garnered substantial commercial traction in the United States and Asia, establishing itself as a primary ingredient in products targeting healthy aging and longevity.
“The market has been eagerly awaiting NMN’s introduction, and this positive opinion paves the way for the development of new products,” Le Bloch stated.
Secondly, from both scientific and regulatory perspectives, NMN has undergone evaluation under the latest EFSA guidelines for nutrient sources, in contrast to NR, which was assessed based on earlier standards, Le Bloch explained.
“While NMN is not more complicated than NR, the updated EFSA requirements have heightened scrutiny, and this positive opinion is indicative of the exceptional quality of the data,” he added.
Although EFSA concluded that NMN is safe for use, Le Bloch emphasized that the long-term effects of supplementation may need further evaluation.
The 90-day toxicity study included in the application revealed several side effects, such as alterations in hematology, blood chemistry, and organ weight, which typically warrant additional review.
“It seems that EFSA has adopted a less stringent approach this time, as experts believe these changes are not significant and are not related to the treatment,” he concluded.
