The CJEU recently ruled that the Czech Republic cannot require companies to provide advance notice each time a shipment of food supplements arrives from another EU country.
The ruling calls into question the extent to which Member States can impose additional administrative requirements on products already circulating within the Single Market, said Luca Bucchini, managing director at food supplement regulatory consultancy Hylobates Consulting.
However, the ruling also exposes a widening enforcement gap, with businesses increasingly relying on national courts rather than the European Commission to defend their Single Market rights.
What was the Pragon judgement?
Since 2015, companies have been required to notify authorities of shipments from other EU Member States 24 hours before they arrived in the Czech Republic.
That requirement was overturned by the Pragon judgement, named after Czech company that challenged the rule. The court confirmed that EU contries cannot introduce broad notification systems unless they are strictly necessary for safety in exceptional cases to protect public safety.
“Food supplement businesses in Czechia no longer have to notify authorities of shipments of food supplements from other Member States prior to arrival,” Bucchini said, adding that supplements lawfully marketed in one EU member state should be automatically accepted across the EU.
“Food supplements from other Member States should be assumed to be safe, or they should not be on the EU market at all,” he said.
Single Market enforcement gap
While the judgment removes one barrier, it also highlights how fragmented supplement regulation remains across the EU.
“The Czech regulation was an oddity, but Member States are particularly fond of creating obstacles to the free movement of food supplements for a variety of reasons,” Bucchini said.
Several Member States, including Bulgaria, Hungary and Cyprus, continue to impose barriers to market access, such as requiring businesses to establish a local presence or use a local importer.
He noted that the ruling could encourage other EU countries to review similar administrative requirements; however, any changes are likely to depend on companies challenging those measures or on more proactive enforcement by the European Commission.
“Member States, despite their enormous benefits and the calls for making Europe more competitive, do not see the Single Market as something they should help function,” he said. “More specifically, the ruling challenges the creative use of EU law, in this case the regulation on official controls, to impose barriers to trade.”
Dario Dongo, founder of Italian food law consultancy Fare, commented that the Pragon judgment highlights a wider enforcement gap in the EU Single Market. While the ruling confirms that companies have legal avenues to challenge unjustified restrictions, he said it also exposes the limits of relying solely on EU institutions to remove trade barriers.
“I’m afraid industries will have to rely on proceedings before national courts, as the European Commission hasn’t been very active in monitoring Member States’ compliance over the last decade,” he added.
National supplement notification systems remain
Dongo stressed that the Pragon judgment does not abolish national notification systems for food supplements. Instead, it addresses a specific Czech requirement and does not prevent EU Member States from maintaining notification systems permitted under the Food Supplements Directive.
The wider challenge, he noted, is that those notification systems have been implemented differently across the EU, creating unnecessary administrative burdens and additional costs for companies marketing products across multiple countries.
“This lack of consistency undermines the effective functioning of the Single Market and may make certain national systems more vulnerable to legal challenges,” he said. “At the very least, a uniform digital notification system should be introduced.”
Will Pragon lead to wider reform?
Although the judgment removes one obstacle to cross-border trade, it is unlikely to transform the regulatory landscape on its own, Dongo noted, adding that little change should be expected without reform of the Food Supplements Directive.
“Without a harmonized EU framework, divergent national approaches are likely to persist,” he said. “I expect Pragon to be remembered as a relatively narrow ruling, unless the European Commission uses it as a catalyst for a Single Market-compliant reform of the Food Supplements Directive.”
Bucchini noted that the greater challenge is the lack of a shared EU vision for making the Single Market function effectively for food supplements, whether through further harmonization or by ensuring that the principle of mutual recognition is applied consistently.
“The judgment undoes a barrier and reminds stakeholders, and hopefully the Commission, how to make the Single Market work,” he said.
