Produced in consultation with IADSA (International Alliance of Dietary Food Supplement Associations)
This is the second installment of an ongoing column on the global environment for dietary food supplements. In this column we will provide updates on critical issues, emerging dialogue, international focal areas impacting or potentially impacting the regulation and trade of these products.
WHO/FAO (World Health Organization / Food and Agriculture Organization)
Current key dialogue deals with excipients with serious debate on getting several excipients currently on the ‘delete’ list to be approved. Some with potential impact on the food supplements industry include Erythrosine, Castor Oil, Iron Oxides and Chlorophylls, Copper Complexes, and some have global implication, especially in the United States. The group making recommendations to remove these products from the list is under the direction of the Electronic Working Group of the Codex Committee on Food Additives and Contaminants, led by the USA. Removal of these four products through the delete list would lead to market confusion and barriers to trade.
Maximum Levels of Vitamins and Minerals
2002 legislation on vitamins and minerals in the EU took effect in 2005, and this year’s dialogue is focusing seriously on the determination of the maximum levels in Europe, subject of course, to agreement of the 25 member states. This dialogue in Europe could have global impact. The first stages will be a discussion paper issued prior to the European summer break, (early July) with all sides then weighing in. France will most likely take a restrictive position, with the UK likely adopting a far more liberal approach. Over subsequent months, we can expect to see a lot of positioning, influencing and maneuvering with a draft directive to follow, approximately six to twelve months out.
“The adoption of EU levels is key for the food supplement industry, which has actively advocated the setting of science based levels. It will certainly be used as a reference in the current context of the development of non EU countries legislation on food supplements,” says Lorène Courrège, Director of Regulatory Affairs of the EU Federation of Associations of Health Product Manufacturers (EHPM).
Adopts its Food Supplements Legislation
The 2002 EU Food Supplement Directive (FSD) has now officially been implemented in all 25 EU member states thanks to the adoption of the long awaited French implementation Decree at the end of March.
This Decree provides the framework for the marketing of food supplements, and notably regulates the use of Vitamins & Minerals (V&M), but also the use of plants and other ingredients in food supplements (which are not yet regulated under the FSD). Application Orders still need to be issued to detail notably the precise lists of V & M, specifications and levels authorized. Notification is required for placing food supplements on the French Market.
This Decree is the first stone in the legislative framework intended to provide more legal certainty to operators on the French market. It ends the legal vacuum and lack of clarity on compositional and procedural requirements that had previously existed.
In a state of flux
Turkey is currently in an evolving state as it moves towards EU membership. It is in the process of implementing new regulations, and has published a positive list of botanicals that can be used in food supplements. Most conspicuously, the list does not include products such widely used products as Aloe vera or evening primrose oil, but curiously it does include some botanicals, such as valerian, that are often classified as medicines.
There is a conference to be held April 12th and 13th in Ankara, which will bring together high level officials from various ministries, providing them with the opportunity to work with local and national industry to debate the future legislative environment.