Do I Need Product Registration for Supplements?

• United States: No pre-market approval under DSHEA. New dietary ingredients introduced after 1994 require 75-day notification, but most products can go to market with no approval.
• Germany: No mandatory notification, but BfR assessment is strongly recommended.
• Netherlands: No pre-notification required for standard supplements.
• Sweden: No notification required for most supplements.

• France: DGCCRF notification required before marketing — relatively fast (weeks, not months), online portal.
• Italy: Ministry of Health notification required. Online system with Italian-language dossier.
• Spain: AESAN notification for certain product types. Standard vitamins and minerals are generally exempt.
• Belgium: FASFC notification required before placing supplements on the market.

• Canada: Natural Product Number (NPN) from Health Canada. Timeline: 10–300 days depending on risk class.
• Australia: ARTG listing or registration from TGA. Timeline: weeks (listed) to 24 months (registered).
• UAE: Dubai Municipality or Abu Dhabi Department of Health registration. Timeline: 2–6 months. Arabic label required.
• Saudi Arabia: SFDA registration. Timeline: 6–12 months. Halal certification expected for many ingredients.
• South Korea: Ministry of Food and Drug Safety (MFDS) registration for health functional foods. Complex; local partner strongly recommended.
• Japan: No registration required for standard Foods with Function Claims (FFC), but notification to Consumer Affairs Agency required. 'Foods for Specified Health Uses' (FOSHU) require full approval.

Selling without required registration exposes you to: product seizure at customs, import refusal, retailer de-listing, fines and penalties, and in serious cases criminal liability. Amazon and major retailers in registration-required markets will not list your product without proof of registration.