Food Supplements.

I thank the Cathaoirleach for the opportunity to table this motion which concerns the food supplements directive 2002/46/EC.

A decision by the European Commission is imminent on the setting of maximum permitted levels of food supplements available for open sale. When I speak of food supplements, currently it is the setting of maximum permitted levels of vitamins and minerals for sale on the open market but in time the scope of this directive will extend to other food supplements, including probiotics and other such supplements. The proposed setting of maximum levels will remove higher level supplements from open sale and will mean members of the public who wish to avail of the higher level supplements will be able to do so only by means of prescription.

The Irish Association of Health Stores, which has lobbied me and other public representatives intensely on this issue, believes the rationale behind this is about facilitating the Internal Market without examining the impact on both the restriction of consumer choice and on many retailers, manufacturers and distributors, including health food shops which will be negatively impacted by the setting of maximum levels. It argues that in Ireland's case the use of food supplements has continued for the past 40 years and that there has not been one single documented incident of any adverse impact from the use of the higher levels of these supplements. The Irish Association of Health Stores has collated information on 1,000 peer reviewed studies demonstrating clear benefits from the use of food supplements. It argues that the Commission's reasoning is based on the false premise that higher levels of these nutritional supplements are a greater risk to consumers than lower levels. The association would make the opposite argument that nutrients are essential for our health and well-being, particularly given that the nutrient content of food is lower now because of the lower mineral content of soil and, as people are eating much more processed convenience food, there is a greater need than ever for these higher levels of food supplements.

The potential impact of the introduction of permitted levels will mean a serious restriction of consumer choice and any legislation we pass must balance consumer protection with consumer choice. In this instance it would appear consumer choice is being sacrificed and that there is a false sense of a risk being posed in some way by the current availability of food supplements in our health food stores and through other means, for example, nutritional therapists who recommend these higher levels of food supplements to their patients.

In New Zealand and the United States it is pointed out that much higher levels of food supplements are available to members of the public on the open market. There is concern that if these maximum permitted levels are introduced, which will allow consumers access to only low level food supplements in health food stores and so on, it will lead to consumers turning to more unregulated sources such as ordering them via the Internet and there are real concerns about the safety and quality of supplements sourced in that way.

The purpose of raising this issue is to ask the Minister of State to respond and clarify Ireland's position on this area. I understand the Minister has been lobbied intensively by alternative health practitioners and so on. They have pointed out the likely impacts of this and have asked that Ireland seek a derogation to this part of the directive, namely, the setting of maximum levels. They make the argument that while other member states have not traditionally had high levels of food supplements available to their public, in Ireland and the United Kingdom these food supplements have been available and in the past 40 years not one adverse impact has been documented.

I hope the Minister will give some consideration to the request that Ireland should seek a derogation on these maximum permitted levels, recognising the concern of those involved in alternative medicine that such a move would restrict their businesses and the rights of their consumers to avail of the food supplements, which are in the interests of promoting their overall health and well-being.

I welcome the Minister of State, Deputy Brendan Smith, to the House and wish him well in his new Department.

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.