Brendan Smith (Cavan-Monaghan, Fianna Fail)

Thank you, a Chathaoirligh. I take this opportunity to congratulate you on your election to the office. Everybody in the Oireachtas will be proud of the work of Senator Pat Moylan as Cathaoirleach of the Upper House.

I thank Senator de Búrca for raising this matter on the Adjournment. I take the opportunity also to congratulate her on her nomination by the Taoiseach to Seanad Éireann. I wish her every success here in the coming five years.

The Food Supplements Directive 2002/46/EC was transposed into Irish law in November 2003. The directive established harmonised rules for the labelling of food supplements and introduced specific rules on vitamins and minerals in those products with the aim of ensuring those products are safe to use and appropriately labelled in order that consumers can make informed choices.

The directive had foreseen the setting of maximum and minimum levels of vitamins and minerals in food supplements by regulatory committee procedure. To this end, the European Commission consulted widely in 2006 and produced an orientation paper on the setting of those levels in July of this year. The first meeting of a working group of member states experts to discuss that paper was held in Brussels on Monday last.

It should be noted that the paper also sets out to address a similar provision of the Fortification Regulation (EC) No. 1925/2006 in terms of setting maximum levels of vitamins and minerals added to foods. Discussions at working party level will inform a Commission proposal for a directive which must be brought to the European Parliament and the Council by January 2009.

To date, the European Food Safety Authority, EPSA, at the Commission's request, has set upper levels for 16 nutrients using appropriate scientific data. This means a further 19 nutrients have not yet had a level set, due particularly to a lack of data based on oral intake dose-response studies. However other scientific bodies in the United Kingdom and the United States have established levels for many of those remaining nutrients. The Commission proposes to refer to these in the absence of the EPSA figures.

The Commission has proposed in the orientation paper that in the case of certain nutrients, where studies have indicated there is evidence of no or low toxicity even at high level dosage, it may be possible to waive the setting of maximum levels. The Commission considers this a proportionate approach which is in line with the principle of better regulation.

During the Commission's community-wide consultation which has informed the paper under discussion, a public consultation on this issue to inform the Irish position was facilitated by the Food Safety Authority of Ireland and took place in August and September of 2006.

The Irish position, submitted by the Department of Health and Children to the Commission, indicated that the Commission should proceed on a cautious basis, setting maximum limits for as many vitamins and minerals as possible based on scientific evidence. 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 Ireland's final position on this issue.

This precautionary position was determined by concern at the possible and, as yet, unknown risks of excessive intake of certain minerals and vitamins from all sources over a period of time. In Ireland, an increasing range of foods fortified by manufacturers through the addition of vitamins and minerals are on the market. It is also recognised that Ireland is considered to have a mature market for food supplements. In this case, the absence of scientifically based maximum levels could lead to inadvertent over-consumption of vitamins or of minerals.

The Department of Health and Children has met representatives of the Irish Association of Health Stores and the Irish Health Trade Association to listen to their views. The Department is taking account of the views of the Irish consumer and industry stakeholders and of the discussions in Europe, and these will influence the final position taken.

I compliment Senator de Búrca on raising this important issue.