In 2003, a Guidance Level of 25 µg/day for long-term vitamin D supplementation was set by the UK Expert Group on Vitamins and Minerals (EVM) [1], to which industry has worked since the publication of the report.
The EVM Guidance Level has since been superseded by risk assessments undertaken by the European Food Safety Authority (EFSA) and the Institute of Medicine (IOM). A Safe Upper Level (UL) of 100 µg/day from all sources was set by the IOM in 2010 [2] and by EFSA in 2012 [3].
These new ULs for vitamin D doubled the previous IOM and EFSA ULs based on more recent evidence of the safety of vitamin D.
In view of the increase in the EU UL set by EFSA, CRNUK, HFMA and PAGB have agreed a common industry position of 75 µg/day as the maximum level for vitamin D in a food supplement.
The proposed value is based on the risk management methodology developed by the European Association of Health Products Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA) in 2004 [4] (which refers to the 50 µg/day UL from all sources previously set by the Scientific Committee on Food (SCF)/EFSA [5] and the IOM [6]). This model was updated by Food Supplements Europe (FSE) in 2014 [7] (referring to the revised 100 µg/day UL from all sources set by the IOM and by EFSA).
The rationale for the 75 µg/day level takes into account:
A maximum level of 75 µg/day in a food supplement is consistent with the EHPM/ERNA and FSE risk management model (see Annex for calculations).
The upper limit of 75 µg/day for vitamin D is also consistent with the amount in the Belgium Royal Decree on maximum levels in food supplements published in the Belgium Official Journal on 31st October 2017.
In December 2017, the Dutch authorities notified the European Commission and EU Member States of their intention to change the Commodities Act Order on food supplements. For vitamin D, the draft order states in Article 4.3: “Food supplements shall contain an upper daily intake of 75 µg vitamin D, as per instructions”.
Hence the UK industry position is consistent with the position adopted in various other EU Member States.
In the past few years there has been a renewed scientific interest in the functions of vitamin D and more certainty about the safety of supplementary use of vitamin D. Total intakes, therefore, are likely to increase.