Food supplement label requirements in the EU: mandatory particulars and checklist

Which rules decide what goes on a food supplement label?

Three layers of rules: general EU rules for all prepacked food, EU rules specific to food supplements, and the national rules of the country where you sell.

Each country transposes Directive 2002/46/EC into its own law and language. The EU rules set the content; the exact national wording comes from the law of the country of sale.

A food supplement does not need a nutrition declaration (energy, fat, carbohydrate): Art. 29(1)(a) of Regulation 1169/2011 excludes it.

What must the product be called?

The name under which the product is sold is ‘food supplement’ (Art. 6(1) of Directive 2002/46/EC), in the language of the country of sale. Use the term from the national law of that country.

• Slovakia: ‘výživový doplnok’, the term required by the national decree.
• Czechia: ‘doplněk stravy’ (Decree No 58/2018 Coll.).
• Germany: ‘Nahrungsergänzungsmittel’; France: ‘complément alimentaire’.

Your brand or a fancy name does not replace the name of the food (Art. 17 of Regulation 1169/2011). A descriptive name works well, for example ‘food supplement with magnesium’. The name of the food and the net quantity must be in the same field of vision (Art. 13(5)).

Which particulars are specific to food supplements?

Compared with an ordinary prepacked food, a food supplement label must also show seven particulars under Art. 6(3) and Art. 8 of Directive 2002/46/EC:

1. the names of the categories of nutrients or substances that characterise the product, or an indication of their nature (for example ‘vitamins and minerals’, ‘plant extract’),
2. the portion recommended for daily consumption (for example ‘1 capsule a day’),
3. a warning not to exceed the stated recommended daily dose,
4. a statement that food supplements should not be used as a substitute for a varied diet,
5. a statement that the product should be stored out of the reach of young children,
6. the amount of each nutrient or substance with a nutritional or physiological effect, in numerical form, per recommended daily dose,
7. for vitamins and minerals, also the percentage of the nutrient reference value (% NRV).

The Directive prescribes the meaning of the warnings, not their exact wording. Staying close to the wording of the national rules in your country is the safest approach.

How do you declare amounts per daily dose and % NRV?

Amounts are declared per recommended daily dose, not per 100 g or 100 ml (Art. 8(2) of Directive 2002/46/EC). They are average values based on the manufacturer’s analysis of the product (Art. 9(1)). The dose in the amounts table must match the dose in the directions.

The % NRV is given only for vitamins and minerals that have a nutrient reference value in Annex XIII, Part A of Regulation 1169/2011. It may also be shown graphically (Art. 9(2) of the Directive). Selected values for adults:

Example: 150 mg of magnesium per daily dose is 150 ÷ 375 = 40% NRV. For plant extracts, amino acids and other substances without an NRV, give the amount only, for example with a note that no NRV has been established.

When checking labels, authorities use the European Commission’s guidance on tolerances of December 2012. For food supplements it allows, including measurement uncertainty, +50% / −20% for vitamins and +45% / −20% for minerals. The guidance is not legally binding. In practice, the actual content should not fall more than 20% below the declared value, even at the end of shelf life.

What goes into the ingredients list, and how do you show allergens?

The ingredients list starts with a heading that includes the word ‘ingredients’ and lists all ingredients in descending order of weight at the time they were used (Art. 18 of Regulation 1169/2011).

• Additives are named by their category followed by the specific name or E number, for example ‘preservative: potassium sorbate’ (Annex VII, Part C).
• Capsule shells are ingredients too, for example ‘capsule shell: hydroxypropyl methylcellulose’.
• Engineered nanomaterials are followed by the word ‘nano’ in brackets (Art. 18(3)).
• Allergens from the 14 groups in Annex II are highlighted in the ingredients list itself, using a different font, style or background colour (Art. 21).
• Quantity of an ingredient (QUID): if an ingredient appears in the name or is emphasised in words or pictures, state its quantity (Art. 22, Annex VIII).

Net quantity, best-before date, lot, storage and directions: what exactly?

These follow the general rules for prepacked food:

• Net quantity in ml for liquids and in g for other products (Art. 23). For tablets and capsules, state the net weight; adding the number of tablets or capsules is common and useful. Annex IX, point 1(c) exempts foods normally sold by number if the number can be seen from the outside or is stated on the label; whether authorities apply this to supplements varies, so giving the weight as well is the safe option.
• Best-before date: ‘Best before …’ when the day is given, otherwise ‘Best before end …’. For a shelf life of more than 18 months, the year is enough; for 3 to 18 months, the month and year (Annex X).
• Storage conditions and the period of use after opening, where needed (Art. 25).
• Lot, usually preceded by the letter ‘L’ (Directive 2011/91/EU).
• Directions for use, where it would be difficult to use the product correctly without them, for example ‘add to a glass of water’ (Art. 9(1)(j)).

Whose name and address must be on the label?

The name or business name and address of the business under whose name the product is marketed (Art. 8(1) and Art. 9(1)(h) of Regulation 1169/2011). For private label, that is the brand owner, not the contract manufacturer. If the brand owner is not established in the EU, the importer is named instead.

The manufacturer does not have to be named. You may add ‘Made for…’ voluntarily.

The country of origin is mandatory only where leaving it out could mislead consumers (Art. 26(2)(a)). If you state it and the primary ingredient comes from elsewhere, the rules in Art. 26(3) apply.

Which language must the label be in?

Mandatory information must be in a language easily understood by consumers in the member state where the product is sold (Art. 15(1) of Regulation 1169/2011). Each member state may require one or more of the official EU languages on its territory (Art. 15(2)), and in practice that means the national language. A label may carry several languages (Art. 15(3)).

• Slovakia: Slovak (Act No 152/1995 Coll., § 9(1)).
• Czechia: Czech (Act No 110/1997 Coll., § 3(1)(e)). A Slovak label alone is not enough; a bilingual Slovak/Czech label is allowed.
• Several countries on one pack: each language version must be complete, including the national term for ‘food supplement’ and all warnings.

For online sales, the same language rules apply to the product page.

What font size and layout are required?

The mandatory particulars must have an x-height of at least 1.2 mm, or 0.9 mm if the largest surface of the pack is less than 80 cm² (Art. 13(2) and (3), Annex IV of Regulation 1169/2011).

• The information must be in a conspicuous place, easily visible, clearly legible and, where appropriate, indelible (Art. 13(1)).
• It must not be hidden, obscured or interrupted by other text or images.
• The name of the food and the net quantity must be in the same field of vision (Art. 13(5)).

Which ingredients need extra warnings?

Some ingredients trigger additional statements under EU law, and some countries add their own.

What must an online shop show?

For prepacked food sold online, all mandatory information except the best-before date must be available before the purchase is concluded, on the product page or by other clearly identified means, at no extra cost to the consumer. All mandatory particulars must be available at the moment of delivery (Art. 14 of Regulation 1169/2011).

For food supplements, this includes the supplement particulars: categories of nutrients, daily dose, warnings, amounts per daily dose and % NRV. In practice, publish the full label text on the product page, ideally with a photo of the label, in the language of the market.

Where do national rules add requirements?

EU law sets the content of the label; national law adds details. Before printing, check the rules of each country where you sell.

How notification works across the EU is explained in Food supplement notification in the EU. If you buy from a manufacturer in another member state, see Sourcing supplements from another EU country.

Pre-print checklist

Go through the label line by line before printing:

What do label texts look like for a real product?

The texts below are an example from our catalogue for Liposomal Magnesium Chelate in a 200 ml bottle. They are shown in English for illustration only; on the pack, they must be in the language required where you sell. They show the structure of a label, are not a finished label for your product and contain no health claims.

Which label mistakes are common?

These mistakes follow from the rules above and are easy to miss:

• the national term for ‘food supplement’ missing in one of the language versions,
• amounts given per 100 ml instead of per daily dose, or % NRV missing,
• the amount of the active substance not matching the dose in the directions,
• allergens not highlighted in the ingredients list itself,
• additives listed without their category,
• the manufacturer named instead of the brand owner as the responsible business,
• the name and net quantity not in the same field of vision,
• text smaller than 1.2 mm (0.9 mm on small packs),
• medicinal wording (‘treats’, ‘helps with a disease’), prohibited by Art. 6(2) of Directive 2002/46/EC and Art. 7(3) of Regulation 1169/2011,
• statements implying that a varied diet cannot provide enough nutrients (Art. 7 of Directive 2002/46/EC),
• ‘better absorption’ or ‘higher bioavailability’, which are not authorised health claims. More in Health claims on food supplements and Liposomal supplements explained.

How can we help with your label?

We prepare the label content and, if you wish, print and apply the labels:

• label texts in selected languages (ingredients, amounts per daily dose, directions, warnings, storage),
• a 1:1 size template and a guide for your designer; you supply the artwork, as we do not do graphic design,
• a check of the finished PDF and a proof before printing,
• optional printing and application at €0.30 per unit, with no setup fee; we also supply products without a label, and you receive the label texts and template either way.

We usually dispatch finished products with your label within 3–5 working days of receiving the label artwork, if the product is in stock. In most EU countries, a food supplement must be notified to the competent national authority before it is placed on the market (Directive 2002/46/EC, Art. 10). Requirements differ by country. We’ll advise you and prepare the documents.

The choice of health claims is yours. See the Labels page for details, or send us a label enquiry.