Note
This article applies only to products distributed in the EU by the Irish Reseller Digistore24 MSLW Limited.
Purpose & Scope
This document sets out the baseline label requirements that must be met before any white-label food supplement artwork is approved for production. It is intended as a reference for vendors, label designers, and manufacturers involved in preparing or approving the artwork.
These requirements are the regulatory minimums that apply to all products, regardless of formulation, brand, or pack format. This baseline is a living document and is subject to updates. Any change in EU food law, applicable national law in the destination market, or relevant EU Register claim authorisations may trigger an update.
The main legal bases are Regulation (EU) No 1169/2011, Directive 2002/46/EC, and Regulation (EC) No 1924/2006. If this baseline conflicts with applicable law, the law prevails. Product-specific elements - including brand name, formulation, claims, ingredient listing, and artwork design - remain outside the scope of this baseline and are reviewed case by case under the standard artwork approval process.
Language note: All examples are provided in English for clarity. Mandatory label information must appear in a language easily understood by consumers in the Member State where the product is marketed, usually the relevant official language(s). Any artwork supplied by Digistore24 must be accurately translated and adapted for the target market; machine translation alone is not acceptable. Multilingual labels are permitted, provided all mandatory particulars are fully translated and meet the applicable legibility requirements in each language.
Mandatory Particulars - Overview
Every food supplement label sold in the EU must carry the following mandatory particulars. Each is detailed in the sections that follow.
- Legal name of the food: "Food Supplement" (in the relevant language)
- Names/categories of the characterising nutrients or substances
- List of ingredients (including additives, allergens emphasised)
- Net quantity (number of units and/or net weight/volume)
- Recommended daily portion (dosage instructions)
- Warning not to exceed the stated recommended daily dose
- Statement that supplements are not a substitute for a varied diet
- Statement to keep out of reach of young children
- Nutrition declaration with %NRV for vitamins/minerals
- Date of minimum durability ("Best before" / "Best before end")
- Storage conditions and/or conditions of use (where relevant)
- Batch / lot identification
- Name and address of the responsible food business operator (FBO) in the EU (always Digistore24 MSLW Limited)
- Country of origin / place of provenance (where required)
- Any additional mandatory warnings linked to specific ingredients
Detailed Requirements
Expand each section below for the full specification of the relevant mandatory particular.
Mandatory Legal Sales Name: "Food Supplement"
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.:
| EN: Food Supplement |
| DE: Nahrungsergänzungsmittel |
| FR: Complément alimentaire |
| ES: Complemento alimenticio |
| IT: Integratore alimentare |
| NL: Voedingssupplement |
Font Size & Legibility
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.
| Requirement | Specification / What we check |
| Minimum x-height (general) | 1.2 mm - the height of the lower-case "x" of the chosen font must be at least 1.2 mm for all mandatory particulars. |
| Minimum x-height (small packs) | 0.9 mm - applies only where the largest surface area of the pack is less than 80 cm². |
| Nutrition declaration exemption | Packs with a printable surface < 25 cm² are not required to bear the nutrition declaration. Packs < 10 cm² are not required to bear a nutrition declaration or a list of ingredients (other particulars still apply). |
| Contrast & background | Text must be in clear contrast to the background. Avoid overlaying mandatory text on busy imagery. |
| Indelibility | Print/labels must not rub off, smudge or peel under normal handling and shelf conditions. |
| Same field of vision | Legal name and net quantity must be in the same field of vision. |
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.
List of Ingredients
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.
Nutrition Declaration & Nutrient Reference Values (NRV)
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.
| Requirement | Specification / What we check |
| What to declare | The amount of each nutrient or substance with a nutritional/physiological effect that characterises the product, expressed in numerical form, per portion of the product as recommended for daily consumption. |
| Units (vitamins/minerals) | Use the units specified in Annex I of Directive 2002/46/EC (e.g. mg, µg, IU only where allowed). Use mg for zinc - not µg. |
| %NRV | For vitamins and minerals listed in Annex XIII of Regulation (EU) No 1169/2011, the amount must also be expressed as a percentage of the Nutrient Reference Value (NRV) per recommended daily portion. |
| Significant amount rule | A vitamin/mineral may only be the subject of a nutrition or health claim if it is present at ≥ 15% of the NRV per recommended daily portion. |
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.
Net Quantity
- 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."
Recommended Daily Dose & Mandatory Warnings
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:
| Requirement | Specification / What we check |
| (a) Characterising nutrients | Names of the categories of nutrients or substances that characterise the product (e.g. "Vitamin C", "Magnesium and Vitamin B6", "Omega-3"). |
| (b) Recommended daily portion | Clear directions for use stating the amount to be taken per day, e.g. "Take 1 capsule daily with a glass of water" or "Take 2 tablets twice daily". Where the daily intake is split, the total daily intake should be evident. |
| (c) Do-not-exceed warning | A warning not to exceed the stated recommended daily dose. |
| (d) Varied diet statement | A statement that food supplements should not be used as a substitute for a varied and balanced diet. |
| (e) Out-of-reach statement | A statement that the product should be stored out of the reach of young children. |
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.
Date of Minimum Durability (Best Before)
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).
| Requirement | Specification / What we check |
| Wording | "Best before ..." where the date includes the day, month and year. |
| Format | Day/month/year is the standard EU order. Month should be unambiguous (use letters or 3-letter abbreviation where space allows, e.g. "31/12/2027" or "BBE 12/2027"). |
| Location | Must appear on the pack in a clearly legible place, with a main-label cross-reference where needed, e.g. "Best before end: see base of pack." |
| Storage conditions | If the durability date depends on specific storage conditions, these must be stated in the same field of vision. |
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.
Batch / Lot Identification
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.
Responsible Food Business Operator (FBO)
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
Nutrition & Health Claims
- 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.
Pre-Submission Checklist (Vendor / Manufacturer)
Before submitting label for sign-off with Product Compliance, vendors must confirm the following in writing:
- Target Member State(s) and language(s) of the label.
- Largest pack surface area (cm²) and confirmed minimum x-height of mandatory text on the production-size proof.
- Stability data supporting the declared best-before period and storage conditions.
- Best-before date format and exact print location on the pack.
- Batch / lot code format and print method.
- Country of manufacture and origin of the primary ingredient.
Before submitting label for sign-off with Product Compliance, vendors must ensure that the label has:
- List of all claims to be used, with the corresponding EU Register reference for each.
- Recommended daily dose and Net Quantity
- That the Digistore24 EU distributor block has been included verbatim, in the correct language, with vendor entity name inserted.
- Full quantitative formulation of the finished product (per daily dose), including %NRV calculations, supported by analytical / raw-material data and correct % given.
- Allergen status of every ingredient including capsule shell, excipients and processing aids and highlighted as required.