Draft guidance will improve botanical safety

By Alex McNally

- Last updated on GMT

Related tags: European union, European food safety authority

Draft guidance on safety assessment of botanicals for use in
supplements and those botanicals that should be prioritised for
safety assessment is expected from EFSA this month.

As a result of a 2004 discussion paper on botanicals and botanical preparations, the European Food Safety Authority (EFSA) asked its scientific committee to prepare the two compendia. Comments will be accepted on both until February 15 2008. Brussels-based European Botanical Forum (EBF) said the move would remove existing grey areas, which gives the potential for some botanicals considered dangerous in one member state to be used in another. The guidance document is another step in the harmonisation of food laws across Europe, and should be ready by mid-December, an EFSA spokesperson told NutraIngredients.com. In an interview with NutraIngredients.com, EBF forum chairman Manfred Ruthsatz said: "You have some prohibited plants in some markets but the same plant can appear on a list in other countries." ​ Ruthsatz said there are some clear examples of botanicals never to appear in food supplements, such as foxglove. He added: "This will establish clearly what can and can't be used, but also to create transparency in the process. "To establish a toxic plant list sounds easy, but there is a lot to gain if we do it in the right way, but there can be a lot to lose." ​ The group has established its own list which includes some 60 plants which should be considered toxic and not be allowed for food supplements. EBF is also pressing for traditional knowledge to be considered in EFSA's evaluation of health claims for botanicals, under the health and nutrition claims regulation. If traditional evidence were to be disregarded, there is a chance that botanicals and botanical-containing products could be left out in the cold by the new regulations. This could create a barrier to the market since botanical companies may not have the budget required to deliver another layer of proof through clinical trials. Harmony ​ The European Commission is in the throes of harmonising food law across the bloc. Steps so far include setting a unified upper level for mineral and vitamins in supplements and fortified foods. This move has caused concern among the industry as countries currently differ radically on what they allow, with some preferring higher levels than others. The rules for marketing botanical products in the European Union are not yet harmonised and complex national rules can make it tough to bring products to the shelves. This also means some botanicals can be classed as a medicinal in one country and as a food supplement in another. Ginkgo biloba​, for example, is classed as medicinal in Germany and Spain, but as a food supplement in Italy and Belgium. Botanical products include herbs and plants, herbal infusions, and herbal extracts used in regular foods and in food supplements. This article has been amended from the original published on December 6 to represent EFSA's role as a risk assessor, and not as a regulator with the authority to impose a ban, as implied. NutraIngredients.com apologises for any misunderstanding caused by the error. A spokesperson for EFSA said: "EFSA is not establishing any list of botanicals that should be banned. EFSA's scientific committee is developing two compendia listing botanicals and botanical preparations that have been used in food and are known to contain undesirable substance. There is no judgement on whehter these botanicals are safe or unsafe for food use. These botanicals contain naturally some pompounds that deserve special attention when looking at the safety aspects."

Related topics: Regulation & Policy, Suppliers, Botanicals

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