Under Article 6 of Directive 2002/46/EC, the legal sales name of these products is "Food Supplement". This wording must appear on the label in addition to (not in place of) any brand or fancy name. Brand names, fancy names and descriptive names cannot replace the legal name.

The legal name must be translated into the language of the target market, e.g.:

Article 13 of Regulation (EU) No 1169/2011 sets minimum legibility rules for all mandatory particulars. Mandatory information must be conspicuous, clearly legible, indelible and not hidden, obscured or interrupted by any other written or pictorial matter.

Important: "x-height" is not the point size of the font. Different fonts at the same point size will produce different x-heights. Always measure the actual lower-case "x" of the chosen font on the production-size proof.

Confirmation required from the vendor / manufacturer

• Largest surface area of the pack (cm²) - determines whether the 1.2 mm or 0.9 mm rule applies.
• Confirmation of x-height of mandatory text on the production-size artwork.

The label must include an ingredients list, introduced by "Ingredients" or the equivalent term in the label language.

Ingredients must be listed from highest to lowest amount used in the product.

The list must also:

• break down mixed ingredients into their individual parts, where required;
• name additives clearly, including what they do, for example "anti-caking agent: silicon dioxide";
• identify the source of vegetable oils or fats, for example "vegetable oil: sunflower";
• mark engineered nanomaterials with "(nano)";
• include capsule shells, coatings, glazing agents, and any processing aids that remain in the final product.

Disclaimer: Digistore24 does not independently verify the product formulation or ingredient composition. The manufacturer is responsible for ensuring that the ingredients list matches the actual food supplement. Digistore24 relies on the manufacturer's product documentation, including the applicable Certificate of Analysis (CoA) and formulation records and in turn checks for the marketability of the product.

Allergens

Any of the 14 EU-regulated allergens that are present in the product must be clearly highlighted within the ingredients list, for example in bold, CAPITALS, underline, or a contrasting colour.

If the label states that allergens are shown in bold, this must be checked carefully against the final artwork. In some label reviews, this statement appears even though the allergens are not actually bolded; this must be corrected before approval.

"May contain" or cross-contamination statements are voluntary, but where used, they must be accurate, not misleading, and supported by the manufacturer's documented risk assessment.

Active Ingredients: How Much Is in the Daily Dose

• For food supplements, the label must clearly state how much of each main active ingredient is included in the recommended daily amount.
• This could include vitamins, minerals, plant extracts, amino acids, or other key ingredients.
• The amounts shown must be based on the final product being sold, not just the supplier's raw ingredient information. Small normal differences from manufacturing are usually acceptable.

Food supplements have their own nutrient labelling regime (Article 8 of Directive 2002/46/EC) - the standard "big-7" nutrition table required for general foods does not apply unless a nutrition or health claim is made.

Example layout

Nutrition Information per daily dose (2 capsules):

Vitamin C 80 mg (100% NRV*)

Vitamin D 10 µg (200% NRV*)

Zinc 5 mg (50% NRV*)

Magnesium 100 mg (27% NRV*)

*NRV = Nutrient Reference Value per Regulation (EU) No 1169/2011, Annex XIII.

• For food supplements sold in dose form (capsules, tablets, gummies, sachets) the net quantity is conventionally expressed by number of units, but the net weight of the contents must also be declared.
• Food supplements are usually expressed by number of units, for example "60 capsules", "90 tablets", or "30 sachets", and this must match the actual fill count.
• The label must also state the net quantity in metric units, such as "60 capsules / 36 g" or, for liquids, "250 ml".
• The net quantity must appear in the same field of vision as the legal name, "Food Supplement."

Article 6(3) of Directive 2002/46/EC requires the following five elements to appear on every food supplement label, in addition to the general FIC requirements:

Standard wording (English baseline - translate for target market)

• Take [X] [capsule(s)/tablet(s)] daily with water, preferably with a meal.
• Do not exceed the recommended daily dose.
• Food supplements should not be used as a substitute for a varied and balanced diet and a healthy lifestyle.
• Keep out of reach of young children.

Note: The label must not suggest that a balanced and varied diet is insufficient to provide adequate nutrients.

Additional mandatory warnings (where applicable)

Depending on the formulation, additional warnings may be triggered, including (non-exhaustive):

• Pregnancy / breastfeeding warnings (e.g. high-dose Vitamin A, certain botanicals);
• age restrictions;
• high caffeine content; or
• specific national rules for certain ingredients such as botanicals or probiotics.

These must be checked case by case against the final formulation and the target market before approval.

Article 9(1)(f) and Annex X of Regulation (EU) No 1169/2011 require a date of minimum durability for food supplements (these products are not subject to a "use by" date).

Confirmation required before label sign-off

• Stability/shelf-life data justifying the declared best-before period.
• Exact location of the printed date on the finished pack (photo or mock-up).
• Format that will be applied at filling (DD/MM/YYYY, MM/YYYY, etc.).
• Storage conditions wording matched to the stability data.

Note: These should be provided when the label is being submitted to Product Compliance for approval.

Required by Directive 2011/91/EU. Every pack must carry an identifier of the batch/lot to which the foodstuff belongs, to ensure traceability and recall capability.

• The batch/lot number should be clearly identified, usually with "L" or "Lot", for example "L 24A1234".
• It must be legible, permanent, and not easy to remove or alter.
• Even where a separate batch code is not strictly required, a distinct batch/lot number is expected as best practice for traceability.
• The manufacturer must also have a documented batch numbering system.

Note: Confirmation of the batch/lot number and its exact placement on the label or packaging must be provided when the artwork is submitted to Product Compliance for approval.

Article 8 of Regulation (EU) No 1169/2011 requires the name and address of the EU-based food business operator under whose name or business name the food is marketed.

Digistore24 is the EU distributor for all white-label food supplement products. The wording below must appear on every label intended for the EU market. This wording is supplied by Digistore24 and must not be amended by the vendor.

Standard EU distributor block:

Product of [INSERT VENDOR NAME / ENTITY], distributed in the EU by Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Ireland

RETURNS: Kleine Esch 669, 2841 MK Moordrecht, Netherlands | helpdesk@digistore24.ie

Examples - baseline translations

DE: Produkt von [INSERT VENDOR NAME / ENTITY], vertrieben in der EU durch Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Irland. RÜCKSENDUNGEN: Kleine Esch 669, 2841 MK Moordrecht, Niederlande • helpdesk@digistore24.ie

FR: Produit de [INSERT VENDOR NAME / ENTITY], distribué dans l'UE par Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Irlande.
RETOURS: Kleine Esch 669, 2841 MK Moordrecht, Pays-Bas • helpdesk@digistore24.ie

ES: Producto de [INSERT VENDOR NAME / ENTITY], distribuido en la UE por Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Irlanda. DEVOLUCIONES: Kleine Esch 669, 2841 MK Moordrecht, Países Bajos • helpdesk@digistore24.ie

IT: Prodotto di [INSERT VENDOR NAME / ENTITY], distribuito nell'UE da Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Irlanda.
RESI: Kleine Esch 669, 2841 MK Moordrecht, Paesi Bassi • helpdesk@digistore24.ie

NL: Product van [INSERT VENDOR NAME / ENTITY], in de EU gedistribueerd door Digistore24 MSLW Limited, Ormond Building, 31-36 Ormond Quay Upper, Dublin 7, D07 EE37, Ierland. RETOUREN: Kleine Esch 669, 2841 MK Moordrecht, Nederland • helpdesk@digistore24.ie

• Any nutrition or health claim used on the supplement label must be permitted under applicable EU law, including Regulation (EC) No 1924/2006, and must be approved for use in the relevant product-specific label review. A health claim must be EU-authorised and supported by the product's ingredient list and formulation.
• As a baseline, the label must not state or imply that the product prevents, treats, or cures disease, or otherwise presents the product as having medicinal properties.
• All claim wording, including general wellness wording, botanical references, and any implied claims, is subject to separate review by Product Compliance as part of the product-specific artwork approval process and is outside the scope of this baseline.