Regulatory compliance
for food supplements
Food Supplement Regulatory Consulting EU
Food supplement regulation is fragmented across jurisdictions, and the cost of getting it wrong ranges from labelling corrections to full market withdrawal. AML Global handles AESAN and national authority notifications, EFSA health claims dossier support, and novel food ingredient assessments for EU market entry. For US and GCC markets, our team covers DSHEA labelling compliance and Saudi SFDA registration, running all compliance workstreams in parallel so you can move into multiple markets without sequential delays.
Frequently asked questions
Can you handle food supplement notification and label compliance across multiple EU countries?
Yes. Food supplements are notified nationally in each EU country where they are sold, and label requirements still differ between markets: language, mandatory statements, maximum vitamin and mineral levels and the use of certain botanicals. We run the notifications in parallel with the competent authority of each target country (AESAN in Spain, for example) and review your labels against the rules of every market, so your launch is not delayed country by country.
Do you review food supplement labels and health claims?
Yes. We check nutrition labelling, mandatory warnings and nutrition and health claims against Regulation (EC) No 1924/2006 and the EU Register of authorised claims. Where a claim is not yet authorised, we support the preparation of the EFSA health claim dossier.
What does notifying a food supplement to AESAN involve in 2026?
The product must be notified to AESAN before it is placed on the Spanish market, with its label and composition. In 2026 a fee of €328 per marketing notification applies and official controls have been reinforced. See our guide to the 2026 AESAN changes.
Can you assess novel food ingredients?
Yes. We assess whether your ingredients fall under the Novel Food Regulation (EU) 2015/2283 before you launch, and support the authorisation process when an ingredient needs it.