Since the European Food Safety Authority (EFSA) put about 1,500 botanical health claim evaluations on hold in 2010 while it deliberated how to evaluate them, food business operators in the EU have been forced to develop the botanical sector without access to these or any other newly submitted claims. As long as these applications remain on hold, no approved health claims can be made on botanical substances in food products, be they functional foods or food/dietary supplements.

One way to move forward is to use the on-hold claims that have not yet been evaluated (and rejected) by EFSA. Legally, they can be used, provided certain requirements are met, but they remain in a regulatory limbo, and food business operators wishing to use them are legally on thin ice. As soon as EFSA resumes the evaluation of these pending claims, they could be finally rejected and thus rendered illegal.

Filling a Regulatory Void
In the face of this regulatory void, a growing number of EU Member States are working on building national rules regarding botanicals, among them (jointly) Belgium, France, and Italy (the BELFRIT list). Italy has even gone a step further by developing its own list of botanicals and their corresponding authorized health claims. Just in October 2017, Italy adopted selected parts of the BELFRIT List, adding them into its national positive list.

As a result of this initiative, the Italian botanical market is one of the most prosperous markets in the EU with just under €1 billion (May 2015 to May 2016) while innovation is notably stagnating in other EU markets.

This development is sending a clear signal: innovation in botanical products is possible, but not within the current regulatory environment. How long will it take for other EU countries to adopt their own national rules? Will the EU Commission get its act together before that happens?

And what about other categories like probiotics, which have seen all health claim applications rejected despite overwhelming evidence of numerous health effects in the public domain? The situation for probiotics and prebiotics is at least as dismal, with innovation stagnating in the EU while it is thriving everywhere else.

Upper Limits for Nutrients?
Speaking of national rules in the absence of EU guidance—another area where the same thing is happening is the establishment of upper limits for vitamins and minerals.

Vitamins and minerals are crucial for health, but the detrimental effects of oversupply are also well documented. Therefore, Member States have been urging the EU Commission to come up with upper levels for these nutrients in food supplements and fortified foods for a while, but so far definitive limits as set out by Brussels are still lacking. This has led to an influx of products, mostly food supplements that contain vitamins and minerals in amounts exceeding the Recommended Daily Allowance by 100% and more.

Again, Member States have proceeded to take matters into their own hands. The EU Food Supplement Directive is a directive, not a regulation, which means that translation into national legislation is up to each Member State. Several countries have already set up their own upper levels for vitamins and minerals in supplements. Among these countries are The Netherlands, Norway, Italy, and, most recently, Belgium.

Since these countries incorporated their upper limits into national law, this development makes things complicated for foods business operators wishing to market their products in more than one EU market. Those planning to export their multivitamin products into Europe (e.g., from Asia or the U.S.), need to take the various upper limits into account.

Other countries, while not having gone that far yet, have acknowledged the need for definitive upper limits by devising recommendations. One such country is Germany, which has been working on a discussion paper regarding upper limits since early 2000. Still, it is probably only a matter of time before more EU countries decide on national limits.

Cause for Confusion
Since this development is not in the best interest of free trade within Europe and indeed globally, the onus is on Brussels to act. The regulatory situation is in fact approaching the state it was in before the first harmonization efforts in the EU were made—products that are legal to market in one Member State may receive no marketing authorization in others, even despite the Mutual Recognition procedure.

Unless and until clear guidance from the EU Commission emerges, this situation will continue to cause confusion. As more and more national initiatives serve to make things even more complicated, food business operators are advised to seek guidance from consultancies such as analyze & realize whose network covers insight into national legislations and may be able to bring clarity.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: [email protected]; Website: www.analyze-realize.com.