These are worrying times for suppliers of functional botanical ingredients. Though they have been used safely for years, the European Nutrition & Health Claims Regulation threatens to blow away decades — even centuries — of traditional wisdom.
Of particular concern is how botanicals will fare in terms of the regulation's 'Community List' of generic health claims for widely used, nonproprietary ingredients. Not surprisingly, in light of their long history of use, many commonly marketed botanical ingredients were submitted for inclusion on the list.
But in June, the European Botanicals Forum (EBF) sounded a warning about the approach taken by the European Food Safety Authority (EFSA) to assess health claims for botanicals under the regulation. Botanicals manufacturers feared that if the authority refused to "accept criteria that are sufficient for pharmaceutical herbal products, based on traditional knowledge, it could lead to the eradication of their products."
The EBF's concern was, and remains, that the EFSA will only approve claims for botanicals backed by 'gold-standard' clinical scientific studies. Evidence of traditional use alone will not be enough. As a result, in theory it could become virtually impossible to market a number of well-known botanical ingredients within the EU.
But there may be a partial solution to this conundrum. Naturex, the France-based supplier of about 300 active botanicals, revealed it is using EU pharmaceutical laws as a means to circumnavigate the stringent requirements of the Nutrition & Health Claims Regulation.
The company told Functional Ingredients it is already in the process of compiling European 'Drug Master Files' (DMFs) for approximately 30 of its botanical ingredients. These DMFs will enable it to obtain permission to continue marketing the botanicals in question in nonmedicinal products such as supplements, with recognised health claims — even if the EFSA has refused to approve those claims for use on food products.
The procedure is not without its own demands. For a start, the ingredients must have a recognised history of use in herbal medicine — as alluded to above by the EBF. They must also be manufactured to a specific pharmaceutical grade. In addition, the DMFs have to be compiled and registered with an appropriate authority.
Naturex, for its part, is undertaking all of this work out of the pharmaceutical-grade plant operated by Italian botanicals supplier Hammer Pharma, which Naturex acquired in January 2007. Its DMFs will be registered locally with the Italian Ministry of Health, but they will be automatically applicable throughout the EU.
"We see a very big future in Europe for selling botanical extracts with DMFs — as traditional botanical extracts manufactured to a pharmaceutical grade," said Jacques Dikansky, CEO and president of Naturex. "That was the reason we acquired Hammer Pharma. Today we are working on having about 30 botanical ingredients registered as pharmaceutical extracts. That will be our first group. We should reach 40 or 50 within two years. We will keep going — but there is a limitation because we can only do it for herbs or extracts which have been used in traditional medicine, and you have to demonstrate that traditional use."
The extra cost associated with the DMFs is minimal, Dikansky said. "It adds a little to the price as you have to follow the pharmaceutical procedures, but it's not too bad." And the extra effort required to compile the DMFs is worth it because the alternative could be to stop selling some botanicals altogether in Europe once the health-claims Community List is finalised. "It would be hard for our customers \[in Europe\] to keep selling products without claims," he added.
In general, Dikansky is cautiously optimistic about the Nutrition & Health Claims Regulation. He believes many botanicals will make it on to the Community List but accepts some won't. The biggest issue for the industry right now is not knowing how things will turn out.
"There are still a lot of question marks surrounding the regulation," he said. "Nobody knows how many botanical products will be approved for the Community List. We think, and hope, that a significant number will be approved. Some products have good science behind them. Unfortunately some of the 300 products we sell will not be approved in Europe, though we'll still be able to sell them in the US and Asia."
Naturex recently merged with Spain's Natraceutical to create the world's largest independent speciality-ingredients supplier, and is also working on four dossiers for approval under Article 13.5, which covers proprietary science. For more details on this merger, click here.