To ask Her Majesty's Government why no discussions have taken place between officials of the Department of Health and the Directorate General for Enterprise and Industries of the European Commission in relation to the potential impact upon small- and medium-sized enterprises of setting maximum permitted levels for vitamins and minerals in food supplements; and whether they plan to hold such discussions in future. [HL3954]

To ask Her Majesty's Government why no discussions have taken place between Ministers at the Department of Health and the European Commissioner for Health relating to the setting of maximum permitted levels for vitamins and minerals in food supplements. [HL3955]

To ask Her Majesty's Government whether they intend to take further action to encourage the European Commission to ensure that any recommendations it makes for maximum permitted levels for vitamins and minerals in food supplements take into account the impact upon small- and medium-sized retailers and manufacturers; and what is the likely timetable for the process of establishing such levels for nutrients in supplements. [HL3956]

To ask Her Majesty's Government whether the Medicines and Healthcare products Regulatory Agency and the Food Standards Agency have reviewed the implications for free trade in food supplements and herbal remedies of the coming into force of the Mutual Recognition Regulation ((EC) 764/2008). [HL3957]

No discussions have taken place between Department of Health officials and the European Commission Directorate-General for Enterprise and Industry, or Health Ministers and the European Commissioner for Health, on the impact of setting maximum permitted levels for vitamins and minerals in food supplements because no specific levels have yet been proposed by the European Commission, or discussed in Commission-led working group meetings with member states.

Officials of the Food Standards Agency (FSA), the Department for Business, Enterprise and Regulatory Reform and the Department for Environment, Food and Rural Affairs met the Health Food Manufacturers' Association (HFMA) on 25 March 2009 to discuss possible approaches to assessing the potential impact on small- and medium-sized Enterprises (SMEs) of the setting of maximum permitted levels for vitamins and minerals in food supplements. The HFMA is currently working with industry colleagues to assess the potential impact on SMEs against a number of hypothetical scenarios to inform discussions with the European Commission.

A European Commission-sponsored analysis of the economic, social and environmental impact of the policy options for the establishment of maximum levels for vitamins and minerals in food supplements was undertaken in summer 2008. Seven member states were used as case studies, including the United Kingdom. The UK food supplements industry, including organisations representing SMEs, engaged fully in this work and provided relevant data. The European Commission has indicated that this assessment will accompany its proposals on maximum levels when they are issued.

The timing for finalising the proposals on maximum levels for vitamins and minerals in food supplements is uncertain due to European Parliamentary elections during June and European Commission college changes in October. At the last working group meeting with all member states on 4 December 2008, the European Commission advised that draft proposals outlining maximum levels for vitamins and minerals would be discussed at the next full working group meeting, a date for which has not been set.

Regarding Regulation (EC) No 764/2008 on mutual recognition, 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.

The FSA has advised 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 Mutual Recognition 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.