The update comes as the European Commission prepares to open a call for evidence and a public consultation designed to set EU-wide MPLs for vitamins and minerals—an initiative that has been in the works for two decades.
While the process is moving forward again, market-wide enforcement is expected to take several years, leading some member states to continue revising and implementing their own national limits.
Luxembourg is among several countries, including Belgium and France, to set its own MPLs, contributing to a fragmented European supplement market in which products may be compliant in some countries and prohibited in others.
Commenting on the new updates, Gaëlle Donaghy, head of regulatory consulting at Nutraveris, noted that they are unlikely to have a negative impact on supplement brands and manufacturers operating in Luxembourg, given that most maximum levels have increased or stayed the same.
“Overall, the revision is likely to be positive or neutral for much of the food supplement industry,” she said. “Indeed, the higher maximum levels for vitamins C and D, together with the removal of numerical maximum levels for several B vitamins and chloride, provide manufacturers with greater formulation flexibility.”
Key updates to MPLs
The updated regulation has made several key changes, including an increase to MPLs for vitamin C and D. Supplement manufacturers can now include up to 1,000 mg in once-daily vitamin C products (up from 240 mg), while maximum levels for vitamin D have increased from 7.5 µg to 50 µg per day.
Donaghy said these changes will allow for greater flexibility in some formulations but that several sports nutrition products— such as electrolytes and energy gels—may be prohibited.
“The main restrictive change concerns sodium, for which the maximum daily amount has been reduced from 5,100 mg to 2,000 mg,” she said. “Products exceeding the new limit will need to be reviewed and may require a reduction in the recommended daily dose, reformulation or, if compliance cannot otherwise be achieved, withdrawal from the Luxembourg market.
“However, widespread product withdrawals appear unlikely. The change is more likely to affect a limited number of high-sodium products, particularly certain electrolyte and sports nutrition formulations.”
For the majority of other vitamins and minerals, MPLs have stayed the same. For example, the UL for vitamin A will remain at 1,200 μg per day, vitamin E 18 mg, calcium 1,600 mg and iron 28 mg.
Other ingredients, including vitamins B1, B2, B5 and B12, biotin and chloride, have not been given a maximum limit. This is likely due to insufficient evidence rather than these ingredients remaining safe at high doses, Donaghy noted.
“[This suggests] the available evidence was considered insufficient to derive a tolerable upper intake level, or UL,” she said. “This should not be interpreted as meaning that unlimited intakes are necessarily safe; it means that the available data were not sufficient to establish a numerical UL. Luxembourg’s position is in line with EFSA.”
The new law also provides additional powers to the Minister Responsible for Food, who will be permitted to impose fines ranging from €250 to €10,000 for non-compliant food business operators.
Is more change on the horizon?
The revised annex has also updated the list of permitted vitamin and mineral sources. Of note, nicotinamide riboside chloride (the salt form of NR) has been added to the approved list, reflecting changes made at the wider EU level.
However, Luxembourg’s updated guidance is at risk of being overturned in the near future, given that the European Commission could soon set out its own EU-wide MPLs, which would override existing legislation held by individual member states.
“Once an EU maximum level is established for a particular nutrient, Luxembourg will have to apply that harmonized level,” Donaghy said. “Any conflicting national limit for the same nutrient would therefore have to be amended. National provisions may, however, remain relevant for nutrients not covered by the EU measure.”
