Which rules apply to a food supplement label
An EU food supplement label answers to two layers of law. Regulation (EU) No 1169/2011 sets the general particulars for all prepacked food. Directive 2002/46/EC adds rules specific to food supplements, including the metric units for declaring vitamins and minerals. That is why converting vitamin D from IU to mcg is one of the first jobs when a formula moves onto EU artwork.
Claims, additives and novel food ingredients bring further acts into play. Member states then add national rules on maximum levels, notification and substances other than vitamins and minerals. This guide sets out what each layer requires and where to check it.
What Directive 2002/46/EC requires on the label
The food supplements directive 2002/46/EC fixes the name of the product and five mandatory particulars. Article 6 requires the product to be sold under the name “food supplement”. It also requires:
- the names of the categories of nutrients or substances that characterise the product, or an indication of their nature;
- the portion of the product recommended for daily consumption;
- a warning not to exceed the stated recommended daily dose;
- a statement that food supplements should not be used as a substitute for a varied diet;
- a statement that the product should be stored out of the reach of young children.
Article 6 also bars attributing to a supplement the property of preventing, treating or curing a human disease. Article 7 bars wording that states or implies a balanced and varied diet cannot provide appropriate quantities of nutrients. Article 8 requires the amount of each nutrient or substance with a nutritional or physiological effect to be declared numerically, per recommended daily portion.
General particulars under Regulation (EU) No 1169/2011
Article 9 of the Regulation lists the mandatory particulars. Food supplements are exempt from the mandatory nutrition declaration under Article 29, so energy, fat and similar values are not required.
| Particular | Point to note for supplements |
|---|---|
| Name of the food | “Food supplement” is the legal name; a descriptive name usually accompanies it |
| List of ingredients | Includes capsule shell and additives in descending order of weight; Article 20 sets the exemptions, such as carriers used in the quantities strictly necessary |
| Allergens | Substances in Annex II are emphasised in the ingredient list, including those in carriers or shells |
| Net quantity | Check how Annex IX applies to products sold by count, such as capsules and tablets |
| Date of minimum durability | Must be supported by stability data for the declared values |
| Storage conditions | Required where the product needs special storage |
| Food business operator | Name and address of the operator under whose name the product is marketed |
| Instructions for use | Required where appropriate use would be difficult without them |
Lot identification is required separately under Directive 2011/91/EU. Particulars must appear in a language easily understood in the member state of sale, and member states may require one or more official languages of the Union (Article 15). Article 13 and Annex IV set a minimum font size. For distance selling, Article 14 requires mandatory particulars, except the date of minimum durability, to be available before the purchase is concluded, and all of them at delivery.
Declaring vitamins and minerals: units and %RI
Annex I of the Directive lists each vitamin and mineral with the unit in which it is declared. Minerals are declared as the element, not the salt. A label states milligrams of magnesium, never milligrams of magnesium citrate. The elemental content calculator handles the salt-to-element arithmetic.
| Nutrient | Annex I unit | What formulators usually convert from |
|---|---|---|
| Vitamin A | µg RE (retinol equivalents) | IU, or mass of retinyl ester |
| Vitamin D | µg | IU |
| Vitamin E | mg α-TE (alpha-tocopherol equivalents) | IU, or mass of tocopherol or its ester |
| Minerals | mg or µg of the element | Mass of the mineral salt |
Article 8 also requires vitamins and minerals to be expressed as a percentage of reference values. Those values now sit in Annex XIII, Part A, of Regulation (EU) No 1169/2011. Substances with no reference value, such as amino acids or botanicals, are declared by amount only.
Converting vitamin D IU to mcg and vitamin E IU to mg
The International Unit measures biological activity and is defined for each vitamin separately. IU to mcg conversion therefore uses a different factor for each vitamin and, for vitamin E, for each form. Every IU figure in a formula must be converted before the label is drafted.
For vitamin D, one fixed factor applies to both cholecalciferol and ergocalciferol. The arithmetic is simple, but the raw material is usually a diluted preparation. Its certificate of analysis states the potency, and that figure drives the weigh-out. The vitamin D forms guide covers the preparations used in each format.
For vitamin E, the factor depends on stereochemistry and esterification. Natural-source RRR-alpha-tocopherol, synthetic all-rac-alpha-tocopherol and their acetate and succinate esters each carry their own factor. Using the wrong one shifts the declared mg α-TE. The vitamin E forms guide sets out the forms.
The vitamin unit converter applies the correct factor for each form. SoleChem sends the specification sheet and certificate of analysis with its quote, which give the form and potency this step needs.
Declared values, overages and tolerances
Article 9 of the Directive states that declared values are averages based on the manufacturer’s analysis of the product. The value must hold to the end of shelf life. Manufacturers therefore add an overage to nutrients that degrade during storage, sized from their own stability data.
The Commission has published guidance on tolerances for nutrient values on labels. It describes how far analytical results may deviate from the declared value. It is guidance rather than law; check the current version and how the competent authority of each market applies it. The overage calculator helps plan the input amount against a declared value.
Novel food ingredients: extra labelling conditions
Under the novel food regulation, Regulation (EU) 2015/2283, a novel food may be placed on the market only once authorised and entered in the Union list. That list sits in Implementing Regulation (EU) 2017/2470. Each entry sets the specification and, where appropriate, conditions of use and specific labelling requirements.
Those requirements can fix the designation used on the label and, for some entries, add statements. Listing of a vitamin or mineral source in Annex II of the Directive does not by itself settle novel food status. Check both, using the permitted forms guide and the novel food guide.
Claims, additives and other substances
Any nutrition or health claim falls under Regulation (EC) No 1924/2006. Only authorised claims may be used, with their conditions of use, as recorded in the EU Register of nutrition and health claims. Trade marks and brand names that could be read as a claim are also covered. The health claims guide explains the Register.
Additives in supplements must be authorised for the food supplement category under Regulation (EC) No 1333/2008. Their purity criteria are set in Regulation (EU) No 231/2012. In the ingredient list, an additive is usually named by its functional class followed by its specific name or E number; check Annex VII of Regulation (EU) No 1169/2011 for the rule and its exceptions.
The Directive’s composition rules harmonise vitamins and minerals only. Amino acids, botanicals and other substances are governed mainly by national rules. Regulation (EC) No 1925/2006 provides an EU procedure to restrict or prohibit certain substances.
National rules and notification
Article 5 of the Directive foresees EU maximum amounts for vitamins and minerals. Until they are set, member states apply their own limits, and these differ. The maximum levels guide explains how to find them.
Article 10 allows member states to require notification, by forwarding a model of the label to the competent authority. Procedures and timing differ between countries. The competent authority of each member state publishes its own requirements, and those are the source to check before launch.