According to África Gallego, director and senior regulatory consultant at LegaleGo Regulatory International, it is all-too-common for supplement firms to expand across borders with the presumption their product is legal across the EU. And the absence of immediate issues gives a false sense of security which causes costly issues later down the line.
“A product is launched, distributed and commercialized for months without any objection. The natural conclusion is that everything is compliant,” Gallego said. “However, enforcement is decentralised and often delayed for several months even for several years.
“In practice, this leads to regulatory requests after commercialisation, relabelling obligations affecting distributed stock, and, in some cases, product withdrawals.”
She added: “The cost is not only regulatory. It is operational and reputational.”
A harmonized framework with different applications
European legislation provides a common foundation for food supplements, particularly through Directive 2002/46/EC and related horizontal rules, Gallego explained.
However, market access depends, to a large extent, on how each Member State interprets and applies that framework in practice. Differences emerge in levels of tolerance, evaluation criteria and, importantly, administrative practice.
“Germany, for instance, may take a more flexible approach in certain formal aspects, while France tends to apply stricter scrutiny, particularly regarding botanical Ingredients,” Gallego said. “Belgium, on the other hand, relies on well-defined positive lists that directly impact product viability.”
She added: “The result is not a lack of legal certainty, but rather a fragmented one.”
According to Gallego, one of the most common mistakes in EU expansion is to assume that the notification process operates uniformly across Member States.
While in some countries, notification is an administrative step; in others, it becomes a de facto validation point, she explained, which has a a direct impact on the time-to-market.
“In countries such as Spain or Germany, companies can typically notify a product and place it into the market almost immediately, assuming responsibility for compliance. In France or Belgium, however, the practical reality is different.
“In France, notification through the DGCCRF is often followed by a review that may lead to subsequent objections. In Belgium, the process can operate, in practice, as a form of pre-market scrutiny, particularly for products containing sensitive ingredients.”
The “European formulation” that does not exist
A common assumption is that a single formulation can be used across all Member States, when in in practice, this is rarely feasible, the expert warned.
“Differences in maximum levels for vitamins and minerals are a clear example. A product with a specific vitamin D dosage may be acceptable in Spain, while requiring adjustments in Germany or France,” said Gallego.
Caffeine will also be subject to stricter thresholds or additional warning requirements in some Member States.
However, the most significant divergence arises in the treatment of botanical Ingredients, Gallego said.
“Italy operates under the BELFRIT list, allowing the use of specific botanicals under defined conditions. France may apply a more restrictive approach to those same ingredients, while Belgium introduces its own criteria.”
Divergence in product categories
In some cases, the regulatory challenge does not lie in the composition, but in the classification of the product itself.
A common example, Gallego explained, is liquid products or functional drinks formulated as food supplements.
Depending on the country and the authority’s interpretation, the same product may be classified as a food supplement or as a beverage.
This will affect applicable compositional limits, permitted additives, labelling requirements, and overall regulatory obligations.
“In practice, this has led to situations where products designed and positioned as supplements had to be completely reconsidered after being reclassified in specific markets. This is not a minor adjustment, it is a structural shift.”
Multi-country labelling
According to Gallego, labelling is often where regulatory differences become most visible.
“A recurring issue concerns mandatory warnings. A product containing botanical ingredients may require specific warnings in France that are not mandatory in Spain. When marketed with multi-language labels, these warnings must be consistently integrated across all versions.”
“When this is not properly managed, inconsistencies appear in labelling and tend to appear during inspections or in response to regulatory requests. And correcting them is not always straightforward.”
