European manufacturers will likely incur significant costs as a result of the European Commission’s mission to harmonize maximum levels for vitamins and minerals in food supplements.
Product reformulations alone could cost Europe’s food supplements industry up to €212m ($242m) over five years, driven mainly by R&D, marketing and relabeling investment, according to Brussels-based consultancy EPPA.
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The burden would fall disproportionately on small and medium sized enterprises, noted EPPA partner Alexandra Bocquillion, speaking at the Association of the European Self-Care Industry (AESGP) 61st Annual Meeting in Warsaw, Poland.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, Bocquillion warned.
An EPPA survey completed by 6,000 EU consumers found that over half of respondents said they would be negatively affected if their food supplements were no longer available or if the vitamin/mineral levels contained were too low.
A quarter indicated that they would have difficulties maintaining their current level of health or would have to rely more on alternative products, for example fortified foods or medicines.
Slow Progress
Despite being legislatively required to harmonize maximum VMS levels in both food supplements and fortified foods since 2002, the Commission has made slow progress.
The von der Leyen Commission sought to get the ball rolling on the issue in 2021 by asking the European Food Safety Authority to deliver scientific opinions on tolerable upper intake levels (ULs) for eight nutrients, from which MPLs could later be derived.
Delayed by more than a year, EFSA has since delivered its scientific opinions on ULs for the eight nutrients, which seems to have prompted some work on the issue by the new Commission.
At the Annual Meeting, AESGP’s regulatory affairs and policy manager Klavdija Kmetic pointed to a recently leaked draft Commission approach that she said seemed “scientifically flawed” and “could result in unintended consequences for the sector.”
As a result of seeing this draft, AESGP has “become particularly active and advocated for a science-based and pragmatic path forward,” Kmetic revealed.
The association is “quite optimistic” that there will be positive developments in the near future, Kmetic said.
Pragmatic Approach
Bocquillion’s message to the Commission was that there’s “no one size fits all.” Any such crude approach is “simply not realistic” in terms of meeting consumer needs, she said.
Like AESGP, EPPA is calling for a more pragmatic approach and a model that would be “more fit for purpose” depending on different categories, based on age, gender, for example.
European food supplement manufacturers’ association EHPM also recently stressed that any model for harmonizing maximum VMS levels should be “fair and practical” and “scientifically sound” and should “take into account existing national approaches, consumers’ choices and habits, and the impact on the food supplements sector.”
Furthermore, policymakers must “ensure that the development of any new models is informed by a thorough impact assessment and genuine consultation with stakeholders,” EHPM added.
