Legislation

Prepared by Dr Robert Verkerk, Executive Director, Alliance for Natural Health

January 2005 — EU Food Supplements Directive (Directive 2002/46/EC)
This framework Directive, passed into EU law in 2002, is the first of several to impact on natural healthcare sector. Its primary objective is to assist trade in food supplements between EU Member States by harmonising laws for food supplements across the European Union, although it is supposedly also meant to protect consumers from unsafe products. Its main advantage is that it considers food supplements as a category of food (concentrated sources of nutrients) as distinct from medicines. It has three main problems: 1) only food supplement ingredients that are included on a narrow positive list (initially only for vitamin and minerals) are allowed, so that excluded nutrients are at risk of only being allowed as medicines; 2) a derogation system is provided to allow existing nutrient sources (again, initially only vitamins and mineral forms) which are excluded from the positive lists to be allowed if technical dossiers are prepared and accepted by the European Food Safety Authority, but this is very costly for most ingredients, and; 3) maximum doses of nutrients will be set in due course and these levels are likely to be unnecessarily low.

If the ban in Directive is not overturned by legal challenge, the Directive will result in a ban on around 75% of vitamin and mineral forms currently on the EU market as of 1 August 2005.

Current ANH initiatives

• ANH has initiated a landmark legal challenge against the ban on non-positive list ingredients which is to be heard in the European Court of Justice on 25 January 2005.

• The ANH has submitted a ground-breaking report to the United Nations' Food & Agricultural Organization (FAO) and World Health Organization (WHO) which have been tasked with developing nutrient-appropriate risk assessment methods which will be used for setting 'upper levels' for the Food Supplements Directive as well as global guidelines under Codex Alimentarius. The ANH report recommends a new paradigm in risk assessment which will not result in overly restrictive 'upper levels'.

The Human Medicines (Pharmaceuticals) Directive (Directive 2004/27/EC)
This is the key Directive controlling the use and sale of pharmaceutical products across the EU. It was first enacted in 1965 and has been amended on several occasions, most recently in 2004. Its main problem for natural health products is that it contains an extremely broad definition of "medicinal products", meaning it can entrap a very wide range of products at the will of the Regulator. The function limb of the definition states that any substance or combinations of substances "which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis" should be classified as a medicinal product.

This definition is so broad it technically includes all therapeutic substances, as well as all foods, water, coffee and more or less everything that is consumed by or applied to humans. In an attempt to reduce legal uncertainty, the Directive purportedly provides exclusion for "food, food supplements, medical devices, biocides or cosmetics", but since this exclusion is contained in a Recital rather than an Article, it has little legal weight, especially as this Recital applies to the amending Directive (2001/83/EC) rather than the base Directive of 1965.

Moreover, the Directive has the ability to 'trump' other Directives via its Article 2, which states, "In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply." Therefore, there is a real risk that leading-edge, practitioner-type food supplements are at risk of being classified as medicines, to be controlled by this Directive rather than the Food Supplements Directive. The full drugs regime provided by this Directive is so costly that it would be prohibitive for most food supplement manufacturers.

Apart from regulating conventional pharmaceutical products, the Directive also regulates homoeopathic products and traditional herbal medicinal products (see below), allowing specific dispensations over a normal drugs regime for each category.

Current ANH initiatives

• Lobbying to ensure that Member States' interpretations are such that they exclude all foods and food supplements in all cases.

• Lobbying to ensure that Member States consider most plant products as food supplements rather than as "medicinal products" or "traditional herbal medicinal products."

Traditional Herbal Medicinal Products Directive (Directive 2004/24/EC, amending Directive 2001/83/EC)
This is actually a sub-Directive, being part of the Human Medicines (Pharmaceuticals) Directive. It is intended only for those herbal products that are considered as "medicinal" and which have a history of traditional use. It comes in to force in Member States in late 2005, although provides a transition period up to 2011 before it is fully implemented. Products regulated by this Directive benefit from a fast-track drugs regime where the need to supply costly safety studies can be avoided if it can be demonstrated that the product in question has been used safely over a period of 30 years, of which 15 must be in an EU Member State. The key difficulty here is that many products from non-EU cultures have yet to be used in the European Union and would thereby be excluded. They would then only be permitted if they were able to successfully pass through a full drugs regime, likely to be prohibitively expensive for most non-pharmaceutical manufacturers or suppliers. There is also a risk that herbal products which should rightly be considered as food supplements will be considered by competent authorities in individual Member States as "herbal medicinal products." Particular combinations of herbal products may be disallowed and complex mixtures with significant levels of nutrients will be prohibited. Combinations with vitamins and minerals will only be allowed if the action of the nutrients is considered "ancillary" to that of the herbal ingredients. Significant compliance costs will apply, which will need to be passed on to consumers.

Current ANH initiatives

• Lobbying to ensure a minimum number of herbal products are considered as "herbal medicinal products."

• Facilitate data collation for non-EU herbal products.

Nutrition & Health Claims Regulation (COM(2003) 424 final - 2003/0165 (COD)
As a proposed Regulation, rather than a Directive, the Nutrition and Health Claims Regulation will come into force across the EU immediately it is finalised, rather than needing to be transposed into Member State laws. It was rejected by the European Parliament in April 2004 given the extraordinary number of suggested amendments to the Commission's initial proposal. In its proposed form, it could dramatically restrict the ability of companies and practitioners to communicate effectively with consumers and patients. Its primary purpose is to offer a framework for food manufacturers so that consumers can be provided with substantiated health claims, the purpose of this being to supposedly help them to be both informed and protected. However, the data requirements for claim substantiation, as proposed, are so great that only the largest food companies will be able to afford them. Ironically, given the enormity of the obesity problem in European society, all weight loss claims will be disallowed, as will any claims relating to "psychological or behavioural functions."

Current ANH initiatives

• Lobbying of Member States to ensure that amendments to the new proposal will empower consumers with the potential to make the best possible choices with regard to food and food supplement choice.

• Lobbying to ensure that weight control and slimming product claims can be made.

• Lobbying to ensure that claims relating to psychological and behavioural functions can be made.