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FSAI Scientific Committee Report Advocates New Upper Limits for Vitamins and Minerals to Safeguard Health

Tuesday, 5 June 2018

The Food Safety Authority of Ireland’s (FSAI) Scientific Committee today published a report outlining the process that the food supplement industry can use to establish maximum safe levels for 21 of the 30 vitamins and minerals permitted in food supplements in Ireland. The report sets out tolerable upper intake levels of these nutrients for the population of Ireland which can be used by the food supplement industry as a guide to ensure that the daily dose provided by supplements containing vitamins and minerals is safe when placed on the Irish market. Whilst the setting of maximum safe levels of vitamins and minerals in food supplements is provided for in EU law, the precise levels have not been established yet. The FSAI will be working with the food supplement industry to establish guidance for the marketing of safe vitamin and mineral supplements in Ireland.  The Safety of Vitamins and Minerals in Food Supplements report is available from the FSAI website.

The FSAI’s Scientific Committee recommendations include a new risk assessment approach to aid the industry in ensuring the levels of the nutrients they use in food supplements are safe. It sets out the highest dietary intakes of these micronutrients that are safe for people of different ages and gender. This information will be very helpful for consumers and assist better understanding of the amounts of vitamins and minerals that are excessive. The report also clearly outlines how safe levels of vitamins and minerals vary according to age and gender.

Dr Pamela Byrne, CEO, FSAI states that under food law, all food supplements marketed in Ireland for the first time must be notified to the FSAI. The number of food supplements notified to the FSAI as being on the Irish market has been increasing year on year and it is incumbent on the food supplement industry to take on board this new guidance, reformulate their products accordingly and provide labels that are easy for consumers to understand.

    “The numbers of food supplements that have been notified to us has risen from 700 in 2007 to over 2,500 in 2017 – an increase of over 300%. Of those notified, the number of products that require more detailed examination to assess if they pose a risk to consumer safety is also continuing to rise, with over 95% of food supplements requiring this due to high vitamin or mineral content. We are concerned about the growing number of these products and, in particular, the safety of vulnerable groups of the population in Ireland including children, pregnant women and older people. This comprehensive report enables us to provide robust advice and guidance to the industry on the levels of nutrients for their products by age and gender groupings.”

    “Our advice for the general public regarding taking food supplements is that it is not necessary to take food supplements to maintain a healthy lifestyle. The FSAI recommends a well-balanced diet with plenty of fruit and vegetables and, plenty of exercise. The only food supplements that the FSAI recommends are 400µg folic acid per day for women who are sexually active and a 5µg vitamin D3 only supplement per day for all infants from birth to 12 months”, added Dr Byrne.

According to Prof. Albert Flynn, Chair of the FSAI Scientific Committee, the safe amounts for a person taking any vitamin and mineral varies according to their age and gender.

    “People in Ireland are becoming more aware of the importance of a varied and balanced diet for good health which is positive; however, some are using food supplements in their diet and there can be a mistaken belief that ‘more is better’. There can be adverse health effects when people take too much of some vitamins or minerals. This is particularly true when it comes to children and adolescents who may be taking the same amounts of vitamins and minerals from food supplements as adults, despite having different needs and smaller body sizes. We know from recent surveys of dietary practices in Ireland that most people are getting more than enough vitamins and minerals from their diet alone”, Prof. Flynn concludes.

The FSAI states that this report reviews all of the 30 vitamins and minerals permitted in food supplements in the EU. For those 21 nutrients that have an established tolerable upper level, the adverse effects of excessive intakes are also outlined. For example, continuous excessive vitamin D intakes results in vitamin D toxicity (hypervitaminosis D), which leads to hypercalcemia (high levels of calcium in the blood) which in turn can lead to complications, especially involving the kidneys. The FSAI will continue to monitor the market including assessing the amounts of vitamins and minerals in foods supplements, in order to assess product safety and compliance with legislation that all food placed on the market must be safe.

The FSAI will be developing a guidance document, in conjunction with food supplement industry representatives, to assist the industry in understanding the implications and findings of this report and the actions they should take in relation to their products.

The FSAI Scientific Committee’s research and deliberations for the report included reviewing the outcomes of expert scientific committees in Europe, such as those from the European Food Safety Authority and from the Institute of Medicine in North America who have provided guidance on upper intake levels for nutrients. The FSAI’s Working Group, which undertook the report, comprised expert Irish and UK scientists in the field of vitamins and minerals.


Notes to the Editor:
Food supplements are concentrated sources of micronutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet (Directive 2002/46/EC).

In 2002, EU food law was introduced to regulate food supplements. Although the setting of maximum safe levels of vitamins and minerals in food supplements was provided for in this law, such levels have never been established. Some EU Member States have implemented legislation or developed guidance at national level to set maximum safe levels for some vitamins and minerals in food supplements marketed in their jurisdictions.

Assessment of the safety of vitamins and minerals in food supplements for different population groups is carried out using the relevant maximum safe level referred to as the tolerable upper intake level (UL) for the population group(s) for whom the food supplement is intended. The UL has been established by international scientific bodies including the European Food Safety Authority and is described as the highest level of long-term daily intake of a nutrient, from all sources, judged to be unlikely to pose a risk of adverse health effects to humans.