Branch reform
Given the uncertainty surrounding EU regulation of botanical ingredients in foods and food supplements and across the health claims associated with them, you would be forgiven for expecting levels of anarchy of wild west proportions.
In fact, despite the fragmented nature of legislation among the various Member States (MS) when it comes to positive lists or other forms of approval, and despite the lack of any decision from the European Commission (EC) on health claims regulation, the botanicals sector is trying to get on with the job without waiting for regulatory resolve to take hold. On the topic of health claims, regulatory affairs adviser at EAS Strategic Advice, Europe, Claire Lennon explains that, nearly three years ago, the EC decided to suspend botanicals from the Nutrition and Health Claims Regulation process. A year ago, a discussion paper from the EC outlined two options for the future. “Option One was status quo,” says Lennon. “Option Two was to address the specificities of botanicals via a change of the applicable legislation, which would enable ‘tradition of use’ as a factor for health claims, and further include consideration of quality and safety.”
Health claim failures (Return to top)
Vice president of the UK-based Health Foods Manufacturers’ Association (HFMA) Penny Viner is not alone in believing that the first option would result in failure for most – if not all – ‘on hold’ botanical health claims. “The UK would probably prefer this option, even though officially it is sitting on the fence," she states. “Currently, there's no UK pre-assessment authorisation for food supplements, not even label approval, so the infrastructure requirements for Option Two would be a bit daunting.”
Elsewhere, cheerleaders for the second option are less cagey about their preferences. Earlier this year, former chair of the European Food Safety Authority (EFSA) Scientific Committee Dr Vittorio Sillano spoke out in favour of ‘tradition of use’ as a criterion in assessing ingredients and associated claims.
Viner, who spoke at the same event, says: “Sillano is one of those many people who want to see both medicinal and traditional herbal regimes existing sensibly in parallel, and who believe it seems reasonable for 'tradition of use' criteria to be applied.”
For some, the regulatory impasse on health claims can be a positive benefit. “If you are already using a botanical ingredient, then you can carry on using the claim," explains Viner. “Companies can introduce new products with the same extracts and the same claims," she says. "Strictly speaking, they shouldn't be making new claims, but I'm sure many of them do.”
Most of the HFMA’s members produce or market food supplements, while others supply traditional herbal medicinal remedies. “It is the companies only supplying in the herbal remedies area who might be frustrated," Viner explains. “They could argue that, from a health claims perspective, the supplements companies have an advantage.”
Reluctance to launch new products (Return to top)
Not everyone is so upbeat about being stranded in this marketing no-man's land. At Frutarom Health in the Netherlands, the segment manager for dietary supplements, Maider Gutierrez, explains that health claims for all the company’s extracts are ‘on hold’. She explains: “Because of the existing uncertainty, many customers were reluctant to launch new products ... but things are starting to move again now.”
Meanwhile, since April 2011, those supplying non-food remedies in the EU have been subject to the Traditional Herbal Medicinal Products Directive, where each MS operates a registration scheme, which includes the option of traditional herbal registration based on safety, quality and ‘traditional use’.
So could botanicals for use in food supplements also be regulated separately from food ingredients? Many consider this highly unlikely.
When it comes to regulation of the products themselves, rather than associated claims, some in Europe are concerned about the looming spectre of regulation under medicines law.
In April this year, Belgium, France and Italy launched the so-called Belfrit initiative on a harmonised positive list of botanicals for use in foods and supplements.
Hopes (Return to top)
Lennon at EAS says: “It is to be hoped that the impact it will have on the wider effort to harmonise MS regulation and have plant/botanical claims cleared at EU level will be positive, in the sense that other MSs might follow the approach,” she says, adding that Romania has already expressed interest.
But given the emphasis on safety, some see little chance of this process feeding into or supporting health claims. Says Frutarom's Gutierrez: “In our opinion, the link with the claims regulation will be hard to establish, and the possibility of a positive effect on this topic is very small.”
Harmonisation even on the level of positive lists seems tricky enough. On one level, says Gutierrez, there is clarity about which plants are permitted and which are not. “But then, we have extracts that can be sold in Spain but not in Belgium, for example. The leaves may be OK, but the whole plant may not be,” she says.
So why does the EC not regulate the use of botanicals in food supplements? After all, the Food Supplements Directive (which came into force in 2005) foresees the inclusion of herbal extracts along with vitamins, minerals, amino acids, essential fatty acids and fibre as potential ingredients in supplements.
If the levels of other nutrients can be regulated under the Directive, why not botanicals? Viner at the HFMA has a suitably pithy explanation: "The Commission has declined to extend its powers, because it's had problems establishing maximum permitted levels (MPLs), even when it comes to vitamins and minerals.”
These knotty issues can become political as well as legal footballs. In a July review of the 'Balance of Competences' between the EU and itself, the UK's Department of Health suggested there were areas where regulatory harmonisation might not be in the interests of either consumer protection or a more smoothly operating single market. It identified MPLs as an example.
In the absence of harmonised EU provisions regarding botanicals in food supplements, the result is a patchwork of specific MS legislation, positive and/or negative lists, internal guidelines and case-by-case safety risk assessments. Lennon politely characterises this EU market as being “coloured with divergent approaches”.
Some might argue that this multi- coloured variety adds up to little more than one very large grey area. Those in the botanicals business may be wishing for less colour of any sort, and more black and white.
