Selling food supplements in the EU; notification, novel foods, claims, the border

The exclusion is worth being precise about, because it changes who you hire. Article 2(2) of the GPSR states that the Regulation does not apply to food, and food supplements are foodstuffs by definition under Article 2(a) of Directive 2002/46/EC. So there is no GPSR Responsible Person for a supplement, and a service sold on that basis is a service you do not need.

What replaces it is the food business operator. Under Regulation (EC) 178/2002 the operator under whose name the food is marketed is responsible for its compliance, and the importer is a food business operator with duties of traceability one step back and one step forward, and of withdrawal and notification where a food is unsafe. That is the role an EU importer of supplements actually carries, and it is not something a marketplace field asks you for.

The notification is not an authorisation and does not make the product lawful; it puts the authority on notice and gives it the label. That distinction matters when a national authority later objects to an ingredient or a dose: a notification number is not a defence, and a product notified in one member state has no standing in another.

The duty falls on the person placing the product on that national market, which for imports is the importer or the distributor who first makes it available there. Practical planning point: some procedures run weeks, and a few require a national responsible address on the label, so the notification calendar sits on the critical path of a launch and not beside it. Check the mutual-recognition position before assuming that a product lawfully marketed in one member state can simply move.

The form matters as much as the amount. Annex I lists which vitamins and minerals may be used and Annex II which chemical forms of them; a mineral supplied as a salt that is not on Annex II cannot be used, however common it is elsewhere in the world. That is a frequent reason an American or Asian formulation cannot simply be relabelled for Europe.

On top of that sits Regulation (EC) 1925/2006, which governs other substances with a nutritional or physiological effect. Its Article 8 procedure lets the Commission prohibit a substance, restrict it, or place it under Union scrutiny; substances handled that way go into Annex III. That is the mechanism through which specific botanicals and their preparations have been restricted, and it is the list to check before formulating a botanical product for the whole EU rather than for one member state.

Two details decide most cases. First, the authorisation attaches to the specification, not to the plant: a different extraction solvent, a different plant part or a different concentration can put your ingredient outside an existing entry. Second, many entries are protected data authorisations, which means only the applicant may use them for five years; another importer needs his own dossier or an authorisation without data protection.

The alternative route is the traditional food from a third country notification, for foods with a documented safe history of use of at least 25 years in a significant part of the population of a third country. It is faster than a full authorisation but is still a procedure with EFSA and member states in it. The Commission’s novel food catalogue is indicative rather than legally binding, but it is the first place to look and it will tell you quickly whether an ingredient is a problem.

Regulation 1169/2011 is the rule that is most often forgotten on a supplement label, because people treat supplements as a regime of their own. It is not: the mandatory legibility rule applies, with an x-height of at least 1.2 mm (0.9 mm on packs whose largest surface is under 80 cm²), and the fourteen allergen categories in Annex II must be emphasised in the ingredient list by font, style or background colour. The particulars have to be in a language easily understood in the member state of sale.

One genuine difference: the nutrition declaration section of Regulation 1169/2011 does not apply to food supplements, because Article 29(1)(a) excludes foods within the scope of Directive 2002/46/EC. The amounts of vitamins, minerals and other substances are declared instead under Articles 8 and 9 of that Directive, per portion as recommended for daily consumption, with the percentage of the nutrient reference values where they exist. Putting a 1169/2011-style nutrition table on a supplement is a common way to declare the wrong thing.

The botanicals position is the one that trips importers. When the Commission adopted the list of permitted health claims in 2012 it set aside the claims relating to botanical substances pending further consideration, and those claims remain ‘on hold’ under the transitional measures of Article 28. They may still be used, subject to national rules and to the general requirement not to mislead, but they have not been assessed, and member states enforce them very differently.

Practical consequences. A claim that is fine on a German listing can be actionable in France or Italy; that is a genuine legal difference, not a translation issue. Any claim you use has to be substantiated and the substantiation kept, and the burden is on the food business operator. And a claim can move the product out of food law entirely: presenting a supplement as treating a condition makes it a medicinal product by presentation, and the national medicines agency will say so.

This is the rule that physically stops a container, and it is invisible from the product side: the trigger is the combination of commodity and country of origin, and the Commission amends the annexes roughly twice a year on the basis of border-rejection and RASFF data. Botanicals, seeds, spices, nuts and dried fruits move on and off the list; so does the identity and physical check frequency, which can be 10%, 20% or 50%.

The operational duties fall on the operator responsible for the consignment, in practice the importer or his customs agent: submit Part I of the CHED-D at least one working day before arrival, present the consignment at a designated point, and pay for the controls. Customs will not release for free circulation without the finalised CHED. Budget the delay: a physical check with laboratory analysis holds the goods until the result is in, and for a product with a shelf life that is a commercial cost even when the result is clean.