Requirements for packaging of dietary supplements
A complete set of legal regulations (EU Regulation No. 1169/2011, Food and Nutrition Safety Act) and technical criteria that must be met by the packaging and label of a dietary supplement placed on the market.
Mandatory Labeling
- Legal name "Dietary Supplement": This term must appear on the packaging in close proximity to the trade name and cannot be replaced by other terms (e.g. "preparation", "conditioner").
- Declaration of ingredients and RWS table: List of active substances per recommended daily dose and percentage of the Reference Intake (% RWS) for vitamins and minerals.
-
Three mandatory warning clauses:
- “Do not exceed the recommended daily dose.”
- “A dietary supplement cannot be used as a substitute for a varied diet.”
- “Dietary supplements should be stored out of the reach of small children.”
- Identification data and traceability: Full details of the marketing authorisation holder (name and address of the manufacturer/distributor in the EU), production batch number (LOT) and date of minimum durability ("Best before...").
- List of ingredients and allergens: Full chemical composition in descending order by weight, with clear graphical distinction (e.g. in bold) substances causing allergies or intolerances.
Technical standards and material protection
- Certificate for contact with food (Food Grade): Materials in direct contact with the product (PET/HDPE bottles, foils, cans) must meet the requirements of Regulation (EC) No. 1935/2004 and have the glass and fork symbol and be free of BPA and phthalates.
- Barrier properties (WVTR / OTR / UV): The packaging must protect against the penetration of water vapor, oxygen and light radiation (e.g. use of dark amber glass, HDPE or Alu-Alu foil for substances susceptible to oxidation).
- Tamper-Evidence: Obligation to use mechanisms signaling the first opening (e.g. a plate welded under the cap, a guarantee ring on the cap, a heat-shrink band on the neck).
