Dietary Supplement Regulations – Part 2

Overview – European Regulations

A wide variety of botanical and other substances have been sold as dietary supplement ingredients, including many that are considered to be medicinal substances under most regulatory regimes in EU countries. The report published by the European Association of Self-Medication Industry, titled ‘Herbal Medicinal Products in the European Union’ has found that there was no consistency between the member states in the interpretation of the medicines Directive with respect to herbs. The criteria used to differentiate between medicinal and food herbs varied widely.

The EU food safety regulatory system needed a centralized regulatory power that would bring a more homogeneous type of regulation where member states would let European institutions oversee both risk assessment and risk management. Recognizing the need to harmonize laws, the EC issued compositional directives in the 1970’s. These directives created standards of composition for certain foodstuffs. The standards allowed some ingredients and prohibited others that did not meet the requirements set by the commission. Pertinently, the goal of those directives at that time was to guarantee the free movement of food within the European Common Market, rather than to advance consumer health. The directives applied only to particular ingredients, including sugars, jams, chocolate products, and preserved milks. Ultimately, however, this formula failed because the differing culinary cultures of the member states prevented them from agreeing on the adoption of those ingredients’ requirements. In 1985, the EU came up with a new approach. Instead of trying to harmonize all of the food regulations, it decided to use labeling to indicate the differences in composition and production methods, allowing consumers to make an informed decision. It adopted the principle of mutual recognition, requiring a member state to allow the free circulation of goods produced in conformity to equivalent standards of other member states.

In 2002, the Council of the EU and the European Parliament adopted regulation and created the principles of food law and creating the European Food Safety Authority (EFSA). Each member state had regulated its own foodstuffs. In contrast, the EFSA is an independent agency that provides scientific advice to member states and EU institutions. It gathers data to help anticipate risks and issues opinions on matters and provides scientific assessments but does not handle any of the risk management.

Instead, the EU institutions and the member states themselves are responsible for risk management, a division of authority that poses an obstacle to greater centralization. Under the European system the authority is not only divided among various countries, but those countries also have flexibility both in the way they control their food safety regulations and in the way they implement EU regulations and directives. Traceability and labeling are probably the biggest part of the harmonization of standards and principles that the EU has undertaken in the realm of food safety regulation.

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