Food supplements and fortified foods

• Directive 2002/46/EC — Food supplements
• Regulation (EU) No 1169/2011 — Food information to consumers
• Regulation (EC) No 1924/2006 — Nutrition and health claims
• Regulation (EC) No 178/2002 — General food law
• Regulation (EU) 2015/2283 — Novel foods

Who has to appoint one

Anyone placing food supplements on the EU market. Article 8 of Regulation 1169/2011 makes the operator under whose name or business name the food is marketed responsible for the food information, and that operator must be established in the Union. An importer is a food business operator in its own right. There is no 'representative' shortcut here: the entity on the label carries food law duties including traceability, withdrawal and notification.

Thresholds and exemptions

None. Each member state also operates its own notification or registration procedure before first sale, and the procedures differ: Italy and France require a dossier, Germany a notification, Spain a registration, and several states charge fees.

What must appear on the label

The name of the food, the list of ingredients, quantitative declaration where relevant, net quantity, date of minimum durability, storage conditions, the name and EU address of the responsible operator, country of origin where its absence would mislead, and instructions for use. Specific to supplements: the names of the nutrient categories or substances, the portion recommended for daily consumption, a warning not to exceed it, a statement that supplements should not replace a varied diet, and a statement to keep out of reach of young children. Allergens must be emphasised in the ingredient list.

Marketplace fields

Marketplaces require the EU operator details and, in several countries, the national notification reference. Listings making unauthorised health claims are removed rather than corrected, and claims about immunity, weight loss, sleep or anxiety attract the most scrutiny.

Documentation you must hold

Product specification and formulation. Notification or registration file per member state. Evidence for every claim used, drawn from the authorised list. HACCP-based procedures and traceability one step back and one step forward. Stability data supporting the shelf life. Certificates of analysis for each batch of active ingredient. Where a botanical or ingredient has no significant history of consumption in the Union before 15 May 1997, a novel food authorisation.

Standards and testing

Heavy metals, microbiological limits, pesticide residues for botanical ingredients, and contaminant testing specific to the material — pyrrolizidine alkaloids in certain herbs, mycotoxins in seeds and nuts. Assay testing to verify the declared quantity of each nutrient, since a declared vitamin content that the analysis does not support is a labelling infringement.

Language requirements

The entire mandatory label must be in the official language of each member state where the food is sold. This is enforced strictly for food, and a sticker translation is acceptable only if durable and complete. Ireland and Malta accept English; nowhere else does.

When it applies

Notification before the first sale in each member state, with lead times ranging from days to several months. Maximum permitted levels for vitamins and minerals are set nationally in the absence of EU harmonisation, so a formulation legal in one state can be illegal in the next.

How long records are kept

Traceability and batch records per national food law, generally the shelf life plus a defined period, and at least five years for the notification file.

What happens if you do not comply

Withdrawal, seizure and destruction, and fines. Unauthorised health claims are among the most sanctioned areas in EU food law, and enforcement is often through consumer protection authorities as well as food safety ones. Products containing unauthorised novel ingredients — certain botanicals, CBD in some presentations — are removed and can lead to criminal proceedings in several member states.

Who enforces it

National food safety authorities and health ministries, customs at import, and consumer protection authorities for claims.

Where the boundary lies

This role cannot be filled by an Article 16 GPSR responsible person: food law requires a food business operator that takes on the substantive duties. Two further traps. Maximum vitamin and mineral levels are national, not harmonised, so a single EU-wide label rarely works. And a claim that a product treats, prevents or cures disease makes it a medicinal product requiring a marketing authorisation, whatever the label says.

Questions we are asked

Can we use the claims from our US label?

Almost never. The EU works from a closed list of authorised claims with prescribed wording; anything outside it is prohibited, including most immunity, detox and weight-loss claims.

Is one notification enough for the EU?

No. Notification is per member state, with different procedures and fees, and permitted maximum levels differ between them.

Is CBD allowed?

CBD extracts are treated as novel foods requiring authorisation, and no authorisation has yet been granted for oral CBD supplements. Several member states seize such products.