EU Botanical Health Claims in Limbo

EU Botanical health claims are stalled, but for how long?

In Europe, botanicals and plant-based extracts, often labeled as “natural food,” are widely available for purchase in pharmacies, supermarkets, herbalist shops, health food stores, and via the Internet. But does this broad access to botanical products stand to change under the EU’s Nutrition and Health Claims Regulation?

As most industry folk know, the EU’s evolving health claims process has been fraught with controversy-and no less so when it comes to the category of botanical ingredients. For reasons discussed ahead, figuring out how to handle botanical health claims under one unified regulatory framework has proven difficult.

As such, on August 1, ministries of health across Europe sent out open letters alerting stakeholders that the European Commission (EC) has put the assessment of health claims for botanicals “on hold.” The letter from the UK Department of Health, for example, noted: “During this pause, the Commission has carried out an internal reflection and consultations on the approach for assessment of health claims for botanicals.”

Later, on September 25, the UK Department of Health released another update letter, this time describing how, at a September 17 EC working group meeting, EU member states were for the first time invited to comment on a new discussion paper that the Commission has drafted talking about different ways in which botanical health claims might be handled. (More on this discussion paper ahead.)

EU Botanical Claims on Hold: Roots of the Problem

Just one of the complications involved with developing a regulatory scheme for botanicals is the fact that botanical ingredients are often classified differently among member states.

“Today, there is no harmonization on the use of botanicals in food in Europe; in other words, it is possible for the same [herbal] product [to be] classified as a foodstuff in one member state and as a medicinal product in another,” explains Cynthia Rousselot, the EHPM Secretariat. (EHPM is the Brussels-based European Federation of Associations of Health Product Manufacturers). For instance, EHPM says, whereas herbal medicinal products must often be premarket-authorized first, botanical food supplements in many EU member states require only notifying a member state’s food authority before entering the market.

In trying to figure out how botanical health claim assessments should be handled under the unified EU Nutrition and Health Claims Regulation, the EU’s European Food Safety Authority (EFSA) has made efforts along the way to lay the groundwork for a best approach. After issuing a safety-focused discussion paper on botanicals in June 2004, in August 2005 EFSA charged its Scientific Committee to develop a “science-based toolkit for the safety assessment of botanicals and botanical preparations.” From 2007 to 2008, EFSA launched a public consultation on a proposed approach for assessing the safety of botanicals. Following publication of its updated guidance document on assessing botanical safety in 2008, EFSA held two other stakeholder meetings on botanicals in 2009 and, the same year, issued four other guidances relating to botanical safety.

Even as regulators continue discussing how to handle botanical claims, in the meantime the January 2008 deadline came and went for manufacturers to submit health claim proposals to their national regulator under the EC’s Article 13 health claims regulation.

Obviously,  given EFSA’s indecision on how to handle botanical assessments, the process for botanical health claims has stalled. Estimates are that thousands of health claims for hundreds of botanical products have been submitted and are still, as of September 2012, in regulatory limbo until the Commission comes out of its new group think.

Moving Forward: Discussion Points

Now back to the EC’s discussion paper, which proposes two approaches to how botanical health claims could be handled. Nutritional Outlook was able to obtain a copy of this document for review. The verdict? While the discussion paper is pretty light on specifics, it does raise some points regarding what is known as “traditional-use data.”

A large proportion of herbal product health claims in the EU is based on the historic and traditional use of a botanical. As the EC states in its discussion paper, regulators could either allow this type of traditional-use data to serve as substantiation for health claims, or, alternatively, regulators could handle botanical health claims with the same requirements they have applied to other health claim submissions-that is, EFSA has required clinical trial data to demonstrate health benefits.

If EFSA does not permit the use of traditional-use data in botanical assessments, it would mean that most health claims would be disallowed because they are not supported by human intervention study data. As the UK-based Health Food Manufacturers Association (HFMA) comments, the types of gold-standard human intervention studies that EFSA has tended to seek in health claims assessments are often not feasible when it comes to botanicals. As HFMA says, it would be “difficult, if not impossible” for herbal companies to be able to offer the sort of evidence EFSA wants to support botanical food supplement claims, mainly because it would require carrying out clinical studies on healthy people and populations.

For those in the botanicals industry, traditional-use data would be a preferred route. Also, as HFMA points out, most of the existing evidence of effects of botanicals can be found in traditional herbal monographs. “Were this readily accepted as part of the substantiation ‘package,’ the [current controversial] situation would be erased,” it states.

The UK Department of Health explained in its September 25 letter to stakeholders that while “adopting this [traditional-use] approach could lead to development of new, specific legislation for botanicals in foods…,” this option would take years to develop. But for many in the botanicals business, taking the time to develop the best possible framework for botanicals would be well worth it. As EHPM’s Rousselot remarks, “Over 95% of herbal manufacturers are small- and medium-sized businesses. An inappropriate decision on the future legal framework will have huge consequences for the products and these companies.”

So, are we facing a potential for massive disapprovals of botanical food supplement claims in Europe? Europe is at a crossroads.

Rousselot says, “If EFSA proceeds with [botanical health claim] assessments without a change of approach, it is expected that most, if not all, claims for botanicals will receive negative opinions and therefore will be rejected for further use.”

Rousselot says that traditional-use data will allow EFSA to not only address safety and quality but to also enhance the free movement of botanical food supplements in the EU market and to “provide legal certainty on the status of these products that are now often considered in different ways” by member state authorities.

And, of course, “This will enable consumers to have access to a wide variety of affordable, safe, and well-controlled products in all member states alike,” Rousselot concludes.