While EU food legislation is the most stable it has been for years, the European Commission recently introduced a series of changes in the General Food Law which affect the sports and active nutrition sector.
Perhaps one of the most impactful regulatory changes is the upcoming legislation on the setting of harmonised, EU-wide maximum permitted levels (MPLs) for vitamins and minerals included in foods and food supplements.
The topic of setting MPLs has been dormant for many years, demonstrating the difficulty of finding an agreement at EU level. Despite this standstill, in 2021, the Commission
moved this issue back to the top of the political agenda, creating important changes and potential challenges for the industry. With the political debates now progressing rapidly, here is an overview of the existing legal and policy landscape of MPLs and the key issues the industry should be focusing on.
Latest policy developments on MPLs
For almost 20 years, the Commission and EU Member States have tried to reach an agreement on the setting of MPLs, as stipulated by Article 5 of the Food Supplements Directive, which in 2002 set out that “Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set”.
However, due to diverging views across Member States, no real progress was made until 2021, when the Commission set up an ad-hoc task force and gave the mandate to the European Food Safety Authority (EFSA) to update its scientific advice on Tolerable Upper Intake Levels (UL). In particular, the Commission tasked EFSA with the revision of its scientific opinions on the ULs for vitamins A, D, E, B6, folic acid/folate, iron, manganese and β-carotene.
The revised scientific opinions will inform the Commission’s ongoing work on the setting of EU-wide, harmonised MPLs. The corresponding legislative proposal is envisaged for Q1 2024. In this context, the sports and active nutrition sector needs to closely follow and participate in the discussions on MPLs to make sure that the suggested ULs are not set too low and that the industry can continue to cater for the dietary needs of sportspeople.
Vitamin B6 – what businesses need to know
In January 2023, EFSA published its draft scientific opinion on the ULs for vitamin B6. In the new scientific opinion EFSA proposes to lower the current UL of 25mg/day for adults to 12mg/day. EFSA’s recommendation was based on the Dalton and Dalton study which claimed that excess exposure to vitamin B6 can cause adverse health effects, such as peripheral neuropathy.
The European Specialist Sports Nutrition Alliance (ESSNA), the leading trade body for the sports and active nutrition sector in Europe, responded to EFSA’s consultation on the draft scientific opinion, emphasising that, while the suggested UL for Vitamin B6 may be sufficient for the general population, it is regarded as too low for active consumers. ESSNA stressed that the key role of vitamin B6 in catering for the specific dietary needs of sportspeople is well-documented in scientific literature and recognised in existing EU legislation. ESSNA highlighted numerous relevant EFSA-approved health claims, including on the contribution of Vitamin B6 to normal energy-yielding, homocysteine and protein and glycogen metabolism as well as psychological function.
In its contribution to the consultation, ESSNA cited several scientific studies showing that vitamin B6 intake levels among athletes are inadequate. ESSNA’s response also noted that the Scientific Committee on Food (SCF) has recommended the addition of vitamin B6 to protein products, further demonstrating its key role in supporting the specific nutritional needs of sportspeople.
The UL for Vitamin B6 suggested by EFSA would result in the setting of MPL of 5mg/day for food supplements and 2-3 mg/day in other sports and active nutrition products. As a result, these products may need to be reformulated or discarded, incurring additional costs for the industry, causing consumer confusion, and potentially creating unjustified barriers to global trade when products are destined for markets allowing levels of 25mg/day.
Informing the EU-wide model on MPLs to safeguard sports foods
EFSA’s draft opinion on Vitamin B6 is yet another example of the crucial need to help policy makers gain a better understanding of the special role and purpose of sports and active nutrition products, which is to help physically active consumers and athletes supplement their intake.
EFSA is expected to publish its updated opinions on the ULs for vitamins A, D, E, folic acid/folate, iron, manganese and β-carotene in the coming weeks. In this context, proactive engagement with decision makers is key to ensure that any upcoming food legislation covering sports foods is fit for purpose and takes into account the specificities of these products. With the European Commission set to consult stakeholders on the setting of an EU-wide level for MPLs in Q2 2023 and ahead of the publication of the legislative proposal in early 2024, there is an urgent need and opportunity for sports and active nutrition businesses to work together to address regulatory challenges and secure appropriate and proportionate legislation.
Stakeholders affected by or interested in the regulatory dossier of MPLs or any other upcoming legislative changes related to food and nutrition policy can get in touch with the ESSNA Secretariat via info@essna.com