EU Directives (Food Supplements) (Hansard, 16 December 2002)

§ Ms Blears

Directive 2002/46/EC on Food Supplements was published in the Official Journal of the European Communities on 12 July 2002 and must be implemented into Member States' national legislation by 31 July 2003. The Food Standards Agency is currently consulting on draft implementing Regulations.

In the short-term the EU food Supplements Directive is unlikely to have any effect upon employment, profit, the number of small firms or sales in the health food industry.

In the longer-term, the impact of the directive will depend upon progress in adding vitamin and minerals and their sources to the lists of permitted nutrients in the Directive and upon developments in the setting of maximum limits for vitamins and minerals in food supplements. The Food Standards Agency is arguing the case for these maximum limits to be based on thorough scientific risk assessments so that there is no unnecessary restriction on the range of products that can be marketed.

We have received a substantial number of representations from the National Association of Health Stores, Consumers for Health Choice, Holland and Barrett and General Nutrition Centres about the proposed Directive on Traditional Herbal Medicinal Products. The main thrust of the representations is to express strong opposition to, or serious concerns about, the proposed Directive on Traditional Herbal Medicinal Products and to express the view that the proposals would threaten viability, profits and jobs in the health food sector, particularly among independent stores. They fear that the Directive will lead to a substantial reduction in consumer choice and have expressed the view that the proposals are over-regulatory in terms of the scope of the Directive and the likely costs of meeting the various requirements. They indicate their belief that there is no evidence that products in question are unsafe or dangerous.

Ministers have met representatives of the natural health specialist retail sector on a number of occasions. Most recently, my noble Friend, the Parliamentary Under-Secretary of State (the Lord Hunt of Kingsheath) met a representative from the National Association of Health Stores on 21 November and representatives of Consumers for Health Choice, Holland and Barrett and General Nutrition Centres on 28 November. He also attended a Consumers for Health Choice Parliamentary reception on 4 December.

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The main regulatory burdens arising from the Directive, for example in relation to the cost of preparing dossiers and applying for registrations, would fall on manufacturers. At meetings with Ministers representatives from a wide range of United Kingdom trade associations representing manufacturers of herbal remedies and health foods have told us that that they believe the Directive will lead to greater consumer confidence and greater stability in the market and have requested that the Government should support the initiative while seeking to achieve maximum flexibility. The Herbal Forum which represents ten UK manufacturers' trade associations, covering the health food, herbal remedies, ethnic medicines and aromatherapy sectors wrote to my noble Friend on 18 November to support the case for appropriate regulation in order to ensure that the public is properly protected against inferior quality products which the current system can allow onto the market. The forum indicates that it appreciates the need for the Directive while identifying a number of areas of concern that it wishes to see addressed in European negotiations or in implementation at national level.

The proposals remain under negotiation, and there are wide differences of view within the herbal sector about the possible impact of the Directive. It is therefore problematic to make reliable estimates of the kind requested in relation to the health food sector. However, our overall assessment remains that it will be possible for a very wide range of herbal remedies to be brought to the market under the Directive as currently drafted. We also share the view put to us by many people in the sector that the proposed systematic approach to standards of quality, safety and information are likely to enhance public confidence and the future prosperity of the sector. Moreover, if in negotiations we achieve the ability to extend the principle of simplified registration to an additional range of products which currently require a full marketing authorisation, in particular traditional herbal remedies with added nutrients, this is likely to lead to increased opportunities for both manufacturers and retailers and a significant expansion in consumer choice as compared with the current position in the UK.

We intend to continue to engage positively in the ongoing European negotiations on the Directive, seeking to ensure the maximum flexibility, consistent with the protection of public health. In negotiations on the Directive, and in any subsequent implementation, we will also seek to contain the regulatory impact, and we welcome the stated intention of the Herbal Forum to work constructively and closely with the Medicines Control Agency to achieve this objective.

At this stage of negotiations on the Directive it is not yet possible to make estimates of costs of registering products. The cost of testing finished products before release onto the market is a matter for the relevant licence holders and, if they choose to purchase the service from a third party, this is for negotiation between the user and supplier of such services.