EFSA considers a daily intake of 300 mg of NMN to be safe for the general population, excluding pregnant and lactating women. The European Commission and Member States will now review EFSA’s opinion and proceed toward formal authorization and publication of approved use conditions.
The EU typically authorizes products within five to seven months after a positive EFSA opinion.
If approved, NMN will be widely adopted in EU supplements, predicted Jerome Le Bloch, head of scientific affairs at FoodChain ID.
At this stage, only the applicant, biotech company EffePharm, can communicate the positive EFSA opinion, as other NMN producers are still subject to Novel Food restrictions.
Le Bloch said the positive opinion is a ‘major milestone’ for the company.
“The market is asking for NMN, and this will be a best seller,” he said.
NMN in Europe and regulatory context
NMN is a naturally occurring compound that the body uses to produce NAD⁺, a vital molecule involved in cellular energy production and metabolism. In 2025, EFSA issued a positive scientific opinion recognizing NMN as a source of nicotinamide (vitamin B3), marking an important step toward potential authorisation in Europe.
NMN is not inherently more complex than other vitamin B3 derivatives such as nicotinamide riboside (NR). However, a couple of key factors shape its regulatory context and market significance, Le Bloch said.
First, NMN has already established strong commercial momentum in the United States and Asia and is widely positioned as a core ingredient in healthy aging and longevity products.
“NMN had been long-awaited by the market, and this positive opinion will open the possibility to develop new products,” Le Bloch said.
Second, from a scientific and regulatory standpoint, NMN has been assessed under the updated EFSA guidance on nutrient sources, unlike NR, which was evaluated under earlier requirements, Le Bloch explained.
“NMN is not more complex than NR, but the EFSA requirements have increased, and so this positive opinion reflects the high quality of data,” he said.
Although EFSA concluded that the ingredient is safe, LeBloch noted the effects of long-term supplementation could still require further assessment.
The 90-day toxicity study submitted in the application identified several side effects, including changes in hematology, blood chemistry, and organ weight, which would normally trigger additional review, he said.
“I think that EFSA has been less strict than usual, since despite significant changes in this toxicity study, experts consider that effects are not important and not related to the treatment.”
