§ Mr. Laurence Robertson
To ask the Secretary of State for Health if he will make a statement about the incorporation of EU directives on food supplements and herbal medicines into UK law; and what assessment he 1223W has made of the impact on the over the counter availability of food supplements and herbal medicines following the incorporation into UK law of the EU directives. 
§ Ms Blears
[holding answer 22 May 2002]: The food supplements directive must be transposed into UK law by the last day of the month, one year after the date of entry into force of the Directive.
The Directive will not immediately outlaw any products already on the UK market. Lists of permitted vitamin and mineral sources remain open, pending safety assessments for additional substances. The Government welcomes the amendment to Article 4(6)(b) which was recently adopted by the European Parliament and which extends the time for dossier submission from 18 to 36 months after the Directive comes into force. The Directive gives Member States the opportunity to allow continued sale of products containing vitamin and mineral sources not yet on the permitted list for up to seven years after the Directive comes into force, pending safety assessment of these sources. When implementing the Directive, the Government intends to take full advantage of this flexibility.
Incorporation into United Kingdom law of the proposed Directive on Traditional Herbal Medicinal Products will be subject to the outcome of European negotiations. On the basis of the formal proposals published in January 2002 by the European Commission, we anticipate that consumers will have continuing access to a wide range of traditional herbal remedies sold over the counter.
Features of the proposed Directive which might, in principle, inhibit availability are the requirements relating to safety and quality and the definition of traditional use. However, our assessment is that the introduction of the proposed safety and quality standards is necessary for effective public health protection and the maintenance of public confidence in the sector. This in turn will ultimately affect the strength of public demand for herbal remedies. The proposed standards are ones which are already successfully met by many manufacturers in UK and elsewhere of traditional herbal remedies.
As to the definition of traditional use, we take the view that a large number of unlicensed herbal remedies currently on the market, and sold legally under Section 12(2) of the Medicines Act, 1968, have a strong basis in tradition and so should be able to satisfy the requirement to demonstrate traditional usage. This assessment is based, for example, on the extensive herbal literature covering various herbal traditions, on the activities of herbalists over many decades in supplying herbal medicinal products to individual patients following consultation, and on the existence of large numbers of long-standing licensed herbal remedies in the UK and elsewhere.
It will not be possible to predict for some time to come the full extent to which herbal remedies will be sold under this Directive. One important issue is that there are likely to be significant numbers of products with a clear basis in tradition and containing herbal ingredients which, depending on the presentation of the company's specific product, may legally be sold either as medicines or in another regulatory product category such as food, cosmetic or general consumer product. There may 1224W therefore be options for companies in relation to many such products as to which regulatory route would be most advantageous.
The Medicines Control Agency is holding a public consultation on the proposed Directive including its likely regulatory impact. The consultation document (MLX 283) can be viewed on the Agency's website www.mca.gov.uk. The consultation period closes on 21 June 2002.