Each month European Advisory Services advisers will offer readers insight into the European and international regulatory arena for the marketing and approval of products, including food supplement legislation requirements in various countries, EU Fortification Regulation and ASEAN regulatory developments.
Since the European Union's Food Supplement Directive was introduced in 2002, the regulatory situation across Europe has become clearer and more consistent. Those companies under the impression that they can now enter all 27 Member State markets using one single formulation however, are still too optimistic. It's true, the regulatory landscape for food supplements has evolved over the last five years, with the harmonisation of aspects such as vitamin and mineral sources and labelling statements, but a number of regulatory issues — such as the use of herbal ingredients and other bioactive substances — are still governed by vastly differing national rules while an EU-wide compromise is hammered out.
Of course, all Member States have an invested interest in getting the best deal for themselves, but in terms of setting and introducing innovative legislation, one front runner is clear. Belgium is no stranger to implementing progressive legislation. Its detailed and comprehensive food supplements legislation did not need much adapting to comply with the provisions of the EU Food Supplement Directive.
Now, as the issue of herbals comes up for discussion, Belgium's existing legislation is one of the most advanced and detailed in the EU. It's 1997 Royal Decree on plants and plant preparations includes around 500 permitted plants, often with conditions of use in food supplements, and a shorter list of plants prohibited for use in all foodstuffs due to toxicity, medicinal effects or a lack of safety data. The herbal lists are well-appreciated by the industry, and are accessible via http://portal.health.fgov.be/. Entering the herbal market is relatively easy for industry — provided your herb is on the positive list. The process of getting a herb onto this list however, can be difficult and depends on the opinion of the Commission for Advice on Plant Preparations. These different lists provide the Belgian authorities with a legal document for refusing herbs, and help them to easily check notifications. They have also been used as a model for similar lists in other Member States and at a global level.
Another step forward is the soon expected Belgian decree of rules for other bioactive substances with a nutritional or physiological effect. These include coenzyme Q10, lutein and lactic acid bacteria, and there is currently no specific decree on the issue existing in any EU Member State. Belgium currently allows the use of bioactive substances other than vitamins, minerals and herbal preparations in food supplements, provided there are no toxicological effects. The upcoming Belgian decree will allow ?other' bioactive substances to be used only under certain conditions, following notification with the Belgian Ministry of Health.
It is difficult at this stage to estimate the effect the new decree will have on the Belgian marketplace or its impact on the other EU countries, but it will certainly be a step forward for clarifying the legal status of specific substances. It could also position Belgium at the forefront of food supplement regulation, by once again setting an example for other EU Member States and guiding them through the process.
EAS' latest guide for companies on the vastly different national approaches to food supplements, fortified and functional foods in the EU's 27 Member States is available next month. To order the report 'Marketing Food Supplements, Fortified and Functional Foods in Europe: Legislation and Practice 2008' visit www.eas.eu.
Article by Pieter Lagae, Regulatory and Marketing Adviser, EAS, 50 Rue de l'Asssociation, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit www.eas.eu.