EFSA changes vitamin B6 and selenium safety limits but critics question the science

01 Mar 2023 --- The European Food Safety Authority (EFSA) has reduced the upper safe limit (UL) of vitamin B6 from 25 mg/day to 12 mg/day and the UL for selenium for adults from 300 µg/day to 255 µg/day. 

The European Commission has requested the EFSA to review previous opinions of the Scientific Committee or the Nutrition, Novel Foods and Food Allergens (NDA) panel on the ULs for several vitamins and minerals.

NutritionInsight speaks with Dr. Annegret Nielsen, senior consultant at Analyze & Realize, a consultancy and clinical research provider for natural health products, about the proposed changes. 

She hopes that the EFSA will reconsider its conclusion as the “proposed UL for vitamin B6 differs significantly from ULs in other markets such as the US, or those proposed by the World Health Organization (WHO), while the scientific data used for the EFSA’s assessment has been criticized.”

However, it is unclear if the EFSA will change its recommendation after the recently closed public consultation. Nielsen adds that the food safety authority is not responsible for the legal implementation or enforcement of the ULs. 

In the US, ULs are assessed by the Food and Nutrition Board, part of the National Academies of Sciences, Engineering and Medicine. 

In reviewing ULs for vitamins and minerals, the EFSA has halved the limit for vitamin B6. Implications for industry 
Nielsen says that “ensuring the safety of the product placed on the market is the principal responsibility of the food business operator and surpassing the UL requirements might render the product unsafe.”

She adds that severe breaches of ULs have resulted in issues with authorities. Several of these reports are included in the EU’s Rapid Alert System for Food and Feed – a notification system for concerns about food and drinks in response to food safety threats. 

“In light of this development and the ongoing discussion on the UL, some manufacturers might need to re-formulate their products to comply with the updated safety requirements.” 

New limits for selenium and vitamin B6 
In a draft scientific opinion, the responsible EFSA panel lowered the UL for vitamin B6 in food supplements and fortified foods. 

The new UL is over eight times lower than the set limit at 100 mg/day from both WHO and scientific bodies in the US. Analyze & Realize adds that the EFSA has received criticism as it used a study from 1987 as a basis for the new levels. 

The consultancy further explains that based on available data, consumers will likely stay within the new UL for selenium via natural dietary intake unless they regularly consume food supplements with high daily doses. 

Reviewing ULs vitamins and minerals
Vitamin B6 was recently hailed as a potential nutrition-based intervention for depression and anxiety, while selenium plays a critical role in thyroid function.

In addition to the ULs for vitamin B6 and selenium, the EFSA has also been asked to review the ULs for vitamin A, D and E, folic acid, folate, iron manganese and β-carotene to take into account recent scientific developments and evidence. 

The ULs need to consider generally accepted scientific data and varying degrees of sensitivity of different groups of consumers. 

“EFSA is currently working on re-evaluating the ULs of all remaining vitamins and minerals,” adds Nielsen. She expects folic acid to be next, as it is currently under discussion in the NDA panel. 

Role of EFSANielsen warns some manufacturers might need to re-formulate their products to comply with the new safety requirements.
Nielsen goes on to explain that the European Commission implements ULs in EU law. 

“The European Commission has mandated EFSA to review the ULs to establish a firm legal basis for the ULs prescribed in Regulation No 1925/2006 concerning the addition of vitamins and minerals and certain other substances to foods and Directive 2002/46/EC concerning UL for food supplements,” she says. 

She adds that the EFSA is only responsible for conducting risk assessments. The authority’s opinions are not legally binding, but EU legislators often use these outcomes as a basis for regulations. 

“We cannot foresee how long these formal procedures will take,” Nielsen concludes. 

By Jolanda van Hal