Jim O'Keeffe (Cork South West, Fine Gael)
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Question 118: To ask the Minister for Health and Children the position in relation to vitamin and mineral supplements; the reason it is proposed to substantially reduce the recommended daily allowance as the maximum dose per tablet; if such proposals are based on detailed research into safety issues; if her attention has been drawn to the fact that such change will result in major cost and hardship; and if she will make a statement on the matter. [23463/07]

Jim O'Keeffe (Cork South West, Fine Gael)
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Question 143: To ask the Minister for Health and Children the extent of the use here of vitamin or mineral supplements; her views on whether they have a considerable contribution to make in health matters; the reason changes are proposed in relation to their sale; and if she will make a statement on the matter. [23842/07]

Pat Gallagher (Donegal South West, Fianna Fail)
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I propose to take Questions Nos. 118 and 143 together.

These questions relate to the Directive on Food Supplements (2002/46/EC) which established harmonised rules for the sale and labelling of vitamins and minerals as dietary supplements and introduced a methodology under which maximum levels for vitamins and minerals in food supplements will be set. Article 5 of the Directive provides that the setting of such levels will be based on scientific risk assessment and data on vitamin and minerals intake from other foods while also taking account of what is considered an adequate vitamin and mineral intake for an average person. The scientific risk assessment will take into account the upper safe levels as determined by the European Food Safety Authority (EFSA). The legislative process in the setting of these levels will follow Standing Committee Procedure i.e. the agreement of Member States to a Commission proposal.

The European Commission consulted widely and the Irish response was formulated following a public consultation which took place during August and September, 2006. That response suggested that the Commission should proceed on a cautious basis, setting maximum limits for as many vitamins and minerals as possible based on scientific evidence. This arises from concern at the possible and, as yet, unknown risks of excessive intake of certain vitamins and minerals from all sources over a period of time. It was considered vital that the safety of the general population and the needs of particular subgroups such as pregnant women, children, older people and those on various specialist diets be taken into account in formulating the final position on this issue.

Examples of known adverse effects associated with over-consumption of some commonly taken vitamins and/or minerals include—

reduction in iron absorption as a result of ingesting calcium;

increase in the risk of cardiovascular disease and cancer as a result of excessive iron intake;

significant risk to unborn children of complications arising from vitamin A toxicity, where the mother ingests large doses of pre-formed vitamin A;

higher cancer mortality rate amongst smokers who ingest large doses of beta-carotene (despite the belief that it may afford some protection against chronic diseases — mainly cancer); and

over-consumption of folic acid leading to masking of vitamin B12 deficiency-related anaemia in older people.

In July of this year the Commission produced an Orientation Paper on the setting of those levels: the paper also addresses a similar provision of the Fortification Regulation (EC) No 1925/2006 in regard to setting maximum levels of vitamins and minerals added to foods. The first meeting of a Working Group of Member States experts to discuss that paper was held on 24 September last: discussions at the Working Group will inform a Commission Proposal for a Directive which must be published by January 2009. My Department will take account of the views of Irish consumers and industry stakeholders, as well as the discussions of the Working Group, and these will influence the final position taken in future discussions on this issue.

To date, EFSA, at the Commission's request, has given an opinion on upper levels for 16 nutrients and a further 19 nutrients have not yet had a level set — due to a lack of data based on oral intake dose-response studies. However, other scientific bodies (in the UK and the US) have established levels for many of those remaining nutrients. The Commission has proposed in the Orientation Paper that in the case of certain nutrients where studies have indicated evidence of no or low toxicity even at high level dosage, that it may be possible to waive the setting of maximum levels. The Commission consider this a proportionate approach which is in line with the principle of better regulation. The Commission has also proposed to refer to the figures from the US and UK bodies in the absence of EFSA figures in order to attempt setting the levels.

My Department does not gather data on the extent of vitamin or mineral supplements usage. In general, healthy people obtain adequate levels of nutrients by eating a variety of foods in moderation rather than by taking supplements. In addition, in Ireland an increasing range of foods are fortified by manufacturers through the addition of vitamins and minerals. As almost any nutrient can be potentially toxic if consumed in large quantities over a long period, the absence of scientifically based maximum levels of vitamins or of minerals could lead to their inadvertent over-consumption. There is also the possibility of interactions between dietary supplements and prescription drugs and among several dietary supplements taken at the same time which underlines the desirability of a cautious and science based approach. Finally, the setting of maximum levels for vitamins and minerals should not, in itself, cause major cost or hardship.