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Food supplement labeling requirements in the EU: all mandatory information on the label
A food supplement label carries two groups of mandatory information: the general particulars for all prepacked foods under Article 9 of Regulation (EU) No 1169/2011 and the specific particulars under Articles 6 and 8 of Directive 2002/46/EC – such as the name “food supplement”, the recommended daily portion, warnings and the nutrient amounts per daily portion. A nutrition facts table is not required. Statements about preventing, treating or curing a disease are prohibited.
Which rules apply to the label
Food supplement labeling requirements in the EU come from several sets of rules that work together:
- General food law: Regulation (EU) No 1169/2011 on the provision of food information to consumers (FIC Regulation) applies to all prepacked foods – including food supplements.
- Specific rules: Directive 2002/46/EC sets out additional particulars for food supplements. It is implemented in Germany by the Food Supplements Regulation (NemV) and in Austria by the Food Supplements Regulation (NEMV).
- Marketing claims: health claims are governed by Regulation (EC) No 1924/2006.
The food business operator under whose name or business name the food is marketed is responsible for all of this information (Article 8(1) of the FIC Regulation). In contract manufacturing under your brand, that is you.
The general mandatory particulars under Article 9
Article 9(1) of the FIC Regulation lists the particulars that, as a rule, belong on every prepacked food. For food supplements, this means:
| Mandatory particular (Article 9(1)) | What it means for your food supplement |
|---|---|
| (a) Name of the food | “Food supplement” – as laid down in Article 6(1) of Directive 2002/46/EC. Your brand name is added, but it does not replace this name. |
| (b) List of ingredients | All ingredients that are present in the finished product. |
| (c) Allergens | Substances listed in Annex II, emphasized in the list of ingredients, for example by font or style (Article 21). |
| (d) Quantity of certain ingredients | Required where an ingredient appears in the name or is emphasized on the label in words, pictures or graphics (Article 22). |
| (e) Net quantity | The contents of the pack. |
| (f) Date of minimum durability | Introduced by “Best before …” (Annex X). |
| (g) Storage and conditions of use | Any special instructions where needed, such as storing in a dry place. |
| (h) Name and address | Of the company referred to in Article 8(1) – that is, your brand. |
| (i) Country of origin | Only mandatory where Article 26 provides for it – for example, where consumers could otherwise be misled as to the true origin. |
| (j) Instructions for use | Where it would be difficult to use the product appropriately without them. |
| (l) Nutrition declaration | Not required: the nutrition declaration rules do not apply to food supplements (Article 29(1)(a)). The nutrient information under Directive 2002/46/EC takes its place. |
Point (k), the alcoholic strength, concerns beverages only. Not part of Article 9, but mandatory nonetheless, is the lot number: a food may only be marketed if it bears an indication that makes it possible to identify the lot it belongs to (Directive 2011/91/EU).
The additional particulars for food supplements
On top of the general rules, Article 6(3) of Directive 2002/46/EC – in Germany § 4(2) NemV, in Austria the NEMV – requires these particulars on food supplements:
- Nutrient categories: the names of the categories of nutrients or substances that characterize the product, or an indication of their nature – for example “with vitamins and minerals”.
- Daily portion: the portion of the product recommended for daily consumption, for example “one stick pack daily”.
- Warning: a warning not to exceed the stated recommended daily dose. For German labels, the NemV specifies a fixed wording and also allows a warning with the same meaning.
- Diet statement: a statement to the effect that food supplements should not be used as a substitute for a varied diet.
- Children statement: a statement to the effect that the products should be stored out of the reach of young children.
Declaring nutrient amounts and reference values correctly
The heart of the label is the nutrient table. Article 8 of Directive 2002/46/EC sets three rules for it:
- In numbers: the amount of the nutrients or substances with a nutritional or physiological effect is declared in numerical form. For vitamins and minerals, the units in Annex I of the directive apply.
- Per daily portion: the amounts refer to the portion recommended for daily consumption on the label.
- As a percentage of the reference value: information on vitamins and minerals is also expressed as a percentage of the reference values. The directive refers to the former Directive 90/496/EEC; that reference is now read as a reference to FIC Regulation (Article 53(2)). So the nutrient reference values (NRVs) in Part A of Annex XIII apply – according to § 4(3) NemV, wherever a reference value has been set for the substance.
The declared values are average values based on the manufacturer’s analysis of the product (Article 9(1) of the directive). The percentage may also be given in graphical form (Article 9(2)). This is what the structure looks like:
| Per daily portion (one stick pack) | Amount | % NRV* |
|---|---|---|
| Vitamin D | … µg | … % |
| Magnesium | … mg | … % |
| Coenzyme Q10 | … mg | – (no reference value set) |
* Nutrient reference values under Annex XIII of the FIC Regulation. How Novogenia sets minimum and maximum doses is explained in Dosing limits for micronutrients.
What must not appear on the label
- Disease claims: labeling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties (Article 6(2) of Directive 2002/46/EC; for all foods, Article 7(3) of the FIC Regulation). Wording such as “prevents the flu” or “cures inflammation” is therefore off limits.
- Downplaying a normal diet: no statement may state or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general (Article 7 of the directive; § 4(4) NemV).
- Misleading information: food information must not mislead – for example, by attributing effects or properties to the product that it does not possess (Article 7(1) of the FIC Regulation).
- Unauthorized health claims: health claims are prohibited unless they are authorized and included in the lists of authorized claims (Article 10(1) of Regulation (EC) No 1924/2006). If you use authorized claims, Article 10(2) requires further information, such as a statement on the importance of a varied and balanced diet and a healthy lifestyle. Details are in Health claims: what you may advertise.
These prohibitions also apply to your website, social media and web shop.
Language, font size and web shop
- Language: mandatory information appears in a language easily understood by consumers in the country of sale; member states may require one or more official EU languages (Article 15 of the FIC Regulation). In Germany, German is mandatory (§ 2 of the German Food Information Implementing Regulation, LMIDV). Several languages on one pack are allowed.
- Font size: the mandatory particulars under Article 9(1) are printed with an x-height of at least 1.2 mm. If the largest surface of the packaging is smaller than 80 cm², 0.9 mm is sufficient (Article 13(2) and (3)).
- Field of vision: the name of the food and the net quantity must appear in the same field of vision (Article 13(5)).
- Web shop: in distance selling, the mandatory information – except the date of minimum durability – must be available before the purchase is concluded, and all mandatory particulars at the moment of delivery (Article 14).
In practice: stick pack, box and small surfaces
With daily servings in stick packs, space is tight: at Novogenia, the stick pack has a window and two lines of text of up to 25 characters each. Here is how to split the information:
- The box as the sales unit: for prepacked food, mandatory information appears directly on the package or on a label attached to it (Article 12(2) of the FIC Regulation). Prepacked food is the single item presented as such to the final consumer (Article 2(2)(e)). If you only sell the stick packs in the box, the complete mandatory information therefore belongs on the box.
- The stick pack for orientation: use the two lines for what helps in everyday use, for example “YOUR BRAND Focus” and “One daily serving”.
- Individual handout: if stick packs are also to go to consumers individually, for example as samples, clarify before printing which information then has to appear on the stick pack itself.
- White box with a sticker: the sticker then carries all mandatory information. Size it so that the minimum font size is met.
- Personalized formulas: if every person receives an individual formula, the nutrient amounts differ from pack to pack. Clarify early with your manufacturer how the individual amounts get onto the packaging.
Checklist for your label
| Item | Legal basis | Typical place |
|---|---|---|
| Name “food supplement” | Article 6(1) Directive 2002/46/EC; § 4(1) NemV | Box, in the same field of vision as the net quantity |
| Categories of characterizing nutrients | Article 6(3)(a) Directive 2002/46/EC | Box |
| Recommended daily portion | Article 6(3)(b) | Box |
| Warning not to exceed the daily dose | Article 6(3)(c) | Box |
| Varied diet statement | Article 6(3)(d) | Box |
| Store out of the reach of young children | Article 6(3)(e) | Box |
| Nutrient amounts per daily portion | Article 8(1) and (2) Directive 2002/46/EC | Box |
| % of reference values (vitamins, minerals) | Article 8(3) Directive 2002/46/EC; Annex XIII FIC Regulation | Box |
| List of ingredients with emphasized allergens | Article 9(1)(b) and (c), Article 21 FIC Regulation | Box |
| Net quantity | Article 9(1)(e) | Box |
| Date of minimum durability | Article 9(1)(f), Annex X | Box |
| Name and address of your company | Article 9(1)(h), Article 8(1) | Box |
| Lot number | Directive 2011/91/EU | Box |
| Storage and use instructions, where needed | Article 9(1)(g) and (j) | Box |
| Language of the country of sale | Article 15 FIC Regulation; in Germany § 2 LMIDV | Box and stick pack |
| Minimum font size | Article 13 FIC Regulation | All surfaces with mandatory information |
| No disease claims, only authorized health claims | Article 6(2) Directive 2002/46/EC; Article 7 FIC Regulation; Regulation (EC) No 1924/2006 | Everywhere, including web shop and advertising |
Practical tips
- Finalize the label before notification: in Germany, a model of the label is part of the notification to the BVL – more in How to register a food supplement in the EU.
- Freeze the copy before printing: every change after printing costs material and time. Compare all mandatory information against the checklist before the print files go out.
- Choose the origin statement deliberately: a country of origin is only mandatory where Article 26 of the FIC Regulation provides for it. If you give one voluntarily, for example “Made in Austria”, and the primary ingredient comes from another country, you also state the origin of that ingredient or indicate that it comes from a different country (Article 26(3); Implementing Regulation (EU) 2018/775).
- Keep shop and label in sync: the mandatory information in your web shop must match the label – update both together.
Frequently asked questions
What has to be on a food supplement label?
Does a food supplement need a nutrition facts table?
How should the warning be worded?
What goes on the stick pack and what goes on the box?
Can my label say what the product helps against?
Related: Notifying food supplements in the EU · Health claims: what you may advertise · Dosing limits for micronutrients
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