The ruling specifically relates to a French case brought to the court in which French authorities took legal action against Noria Distribution for distributing and selling products that exceeded maximum vitamin levels stipulated in French law.
Despite the fact that the products were legal under wider EU legislation and could be legally sold in other Member States, the fact that France has individual laws which stipulated lower maximum allowed levels meant that the case was taken to the ECJ.
The new ruling is the latest in a long line of case law relating to maximum permitted levels of vitamins in Europe, and clarifies some areas, said EU nutrition and food law expert, and managing director of Hylobates Consulting, Luca Bucchini.
The ECJ has now said there needs to be a procedure for products legally sold elsewhere in the EU to be notified and evaluated based on safety in France – even if they exceed France's maximum levels.
Furthermore, the ruling confirms that maximum levels need to be based on risk assessment and intake in the population and that when setting maximum levels, international risk assessments (such as EFSA's) need to be taken into account.
“Overall the ruling is a reminder that, even without harmonisation of maximum levels, Member States do have to follow EU case-law, as Italy has recognised this week raising maximum levels for vitamin D, vitamin B12 and K based on EFSA's assessments and EU law,” said Bucchini.
“Hopefully as Sweden and Germany set their own levels, their risk assessment bodies will provide advice in line with EU case-law,” he added – noting that if Member States complied with EU law, harmonisation of maximum levels “would be almost inevitable.”
Also commenting on the ECJ ruling, Patrick Coppens director of regulatory and scientific affairs at Food Supplements Europe said the ECJ decision is not surprising given previous cases, but that it does highlight specific areas that must now be followed.
For example, Coppens noted that the ruling clearly states that since maximum levels can only be the on the basis of a risk assessment, then in cases where there is no safety risk there should also be no maximum level applied.
Harmonised levels?
Both Bucchini and Coppens suggest that the new ruling, if followed, will mean that all European Member States should eventually harmonise maximum levels to around the levels that EFSA safety data suggests, which is not currently the case.
“We trust that such court judgements will lead in the end to Member States more-or-less levelling out their maximum levels at the safety basis,” said Coppens
Bucchini noted that it is uncertain whether France will apply the resulting case-law to change its legislation or leave to the courts to enforce the ruling – noting that the latter would place a significant onus on businesses.
Coppens said the final decision in the case will now be referred back down to French courts – however given the ECJ ruing, it would be impossible to rule any other way.
“Industry has often quietly accepted decisions which fly in the face of EU law. The ruling reminds firms that it is often worth fighting wrong regulations,” added Bucchini.