Decisions on whether products should be classified as herbal medicinal products, and on the authorisation of herbal medicinal products, are the subject of harmonisation measures at Community level and so are not subject to the requirements of Mutual Recognition Regulation (EC) No 764/2008. The Medicines and Healthcare products Regulatory Agency does not therefore expect the regulation to have a significant impact on the trade in herbal remedies.
We are advised by the Food Standards Agency that measures taken by the authorities of member states pursuant to provisions of food law of general application are explicitly exempted from the requirements of the regulation. These exemptions relate to measures taken under Regulation (EC) No 178/2002 (General Food Law) in relation to risks to health arising from food, and measures taken under Regulation (EC) No 882/2004 (official feed and food controls) in ensuring that food business operators remedy non-compliance with food law. The European Commission is producing guidance on the application of the Mutual Recognition Regulation to different foodstuffs, including food supplements.
(2) what recent progress has been made in discussions on the implementation of the EU Food Supplements Directive; and if he will make a statement.
I met with representatives of the Health Food Manufacturers Association on 22 January 2009 and with the Proprietary Association of Great Britain on 1 April 2009 to discuss matters relating to the Food Supplements Directive 2002/46/EC.
A meeting of the ad hoc technical group of member states, established to undertake scientific modelling on the setting of maximum levels for vitamins and minerals in food supplements, was held on 24 April 2009. At the meeting, member states presented the results of work they had carried out using the scientific models proposed by the European Commission and their respective national data on the intake of vitamins and minerals from the diet.
(2) what information his Department holds on the outcome of the recent consultation by the European Commission on the possible extension of the scope of the EU Food Supplements Directive to include substances other than vitamins and minerals; what discussions (a) Ministers and officials and (b) the Food Standards Agency have had at EU level on such an extension; what his Department's policy is on such an extension; and if he will make a statement;
(3) what assessment has been made of the implications for manufacturers of supplements containing (a) botanical ingredients, (b) glucosamine, (c) creatine and (d) other ingredients of the implementation of proposals to extend the scope of the EU Food Supplements Directive.
There are no current plans for Health Ministers to raise the issues of the setting of maximum permitted levels for vitamins and minerals in food supplements or the extension of the Food Supplements Directive 2002/46/EC to substances other than vitamins and minerals with the European Health Commissioner.
Article 4(8) of the Food Supplements Directive placed an obligation on the European Commission to submit a report to the European Parliament and the Council on the necessity for specific rules in relation to the use of substances in food supplements other than vitamins and minerals. This report was published in December 2008 and the Commission's conclusion was that the current legislative framework is sufficient to regulate the use of substances other than vitamins and minerals in food supplements and that additional legislation in this area is not justified at this stage. No additional information is held by the Department or the Food Standards Agency in relation to the report.
The Commission's report was placed on the agenda for an exchange of views at a meeting of the General Food Law Section of the Standing Committee on Food Chain and Animal Health held on 27 March 2009. At the meeting, the United Kingdom, represented by the Food Standards Agency, supported the position the Commission had expressed in its report and the Commission reiterated its position. Health Ministers and Departmental officials have had no discussions at European level on this issue.
There are therefore no proposals currently under consideration to extend the scope of the Food Supplements Directive to substances other than vitamins and minerals. No assessment has been made of the implications of such an extension for manufacturers of supplements containing botanical ingredients, glucosamine, creatine or other ingredients.