There is a legally defined maximum daily dosage for the over-the-counter sale of melatonin (supplements) in the Netherlands. Products that can result in a daily intake of 0.3 milligrams or more of melatonin are considered medicines by the Dutch Health and Youth Care Inspectorate (IGJ). Because these products fall under the Medicines Act, they are not suitable for sale on bol. Melatonin supplements with a maximum daily dosage of up to 0.3 milligrams are still permitted. These are considered food supplements by the IGJ.

Daily Dosage < 0.3 mg Melatonin

• Products containing up to 0.299 mg of melatonin are classified as food supplements.
• Sleep-related claims are not allowed if the product contains only melatonin.
• Claims about other ingredients (if present) are allowed, provided they comply with EU health claim regulations.

Daily Dosage ≥ 0.3 mg Melatonin

• Products with a daily dosage of 0.3 mg or more are classified by IGJ as UAD products (“Uitsluitend Apotheek en Drogist” – Pharmacy and Drugstore Only).
• To sell these products, medicinal sales rights are required.
• These products must be registered in the Medicines Information Bank.