The European Federation of Associations of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA) welcomed the ruling which they said would strengthen the argument to set levels at higher rather than lower levels across the European Union.
“This will be useful in discussions with member states especially those that have advocated basing USLs on multiples of recommended daily intakes such as Denmark and Belgium,” noted EHPM regulatory affairs director, Lorène Courrège.
Patrick Coppens, the secretary general of ERNA, said the ruling would restrict the capacity of member states to base USLs on “hypothetical calculations” and observed that national courts now had clear guidelines upon which to base USLs.
The ECJ ruling, prompted by a challenge to USLs set in France and led by the supplements manufacturer Solgar, in a sense fills a vacuum created by the fact that USLs have not yet been set at EU level despite member state and European Commission discussions that have gone on since the Food Supplements Directive became law in 2002.
But the Council for Responsible Nutrition International (CRN-I) was more cautious, issuing a statement that acknowledged “logical” aspects of the ruling such as the recognition of the safety principle.
Open to interpretation?
But CRN-I said the ruling was open to interpretation that could see USLs established at low levels or even at zero as France had done in the case of fluoride.
“CRN is highly concerned that maximums for substances with no known adverse effects will be set arbitrarily and unnecessarily low because there is no official risk assessment value.”
It added it was also worried, “that some member states will judge the data on intakes from other sources to be highly unreliable in order to limit the amounts in food supplements to zero without genuine scientific justification.”
The ruling, which can be found here, affirms that member states in setting USLs in the absence of EU wide levels, must respect EU principles of free trade and mutual recognition.
Coppens acknowledged that member state interpretation of such rulings could be unpredictable, but said mutual recognition or a return challenge to the ECJ would serve to moderate any extreme positions.
Labeling
He also welcomed the fact that the ECJ had acknowledged that product labels could serve as an adequate warning measure to inform population segments such as children or pregnant women about potential consumption problems.
“When a member state would opt to set maximum levels for the whole population, based on the risk of sensitive population groups (e.g. children), it must respect the principle of proportionality,” he said.
“This means that it must ascertain that the measure is necessary for the objective pursued and cannot be attained by less restrictive measures. In this respect the ECJ confirms that appropriate labeling to inform particular groups of consumers that may be at risk from excessive consumption of a nutrient, can enable these consumers to decide for themselves to use these products and certainly is a valid less restrictive risk management tool.”
He added: “In this verdict, the ECJ reconfirms the principle that maximum levels should be set on the basis of a scientific risk assessment. This endorses the basic principle of the ERNA/EHPM risk management model that has also been adopted by the EU as the basis for the discussions on maximum levels.”