With the publication of its annexes, the Health Claims Regulation came into full effect in 2012. However, despite the publication of a positive list, not all health claim applications have been evaluated yet. Most notably, botanical claim evaluations are still on hold. This is due to a number of reasons.

A Traditional Herbal Medicinal product (note the “medicinal”) only needs to prove traditional use (i.e., a continuous use of the product for 15 years on the European market and 30 years on the worldwide market, respectively) in order to carry disease-related claims reflecting the traditional usage of the product.

However, if the same ingredients are to be used in a dietary supplement, which is part of the food category, the European Food Safety Authority (EFSA) currently requires no less than gold standard clinical trials as proof of efficacy in order to carry a product-specific health claim. It seems that the requirements for the proof of efficacy for a medicinal product are actually lower than those for a food product. The discrepancies here have led to the assessments being put on hold while the authorities try to resolve this conflict and decide on a way to go forward with the botanical claims.

Drugs or Food?
There are a number of issues to be considered; chief among them, what is the regulatory status of botanicals? Are they to be treated as drug ingredients, which would effectively remove them from being included in food products, or are they food ingredients, in which case the same efficacy requirements should apply to them as to any other food ingredient.

Of course, arguments can be made for both positions. Many botanicals have a long tradition as foods, if only as herbs. On the other hand, in many cases, foods that are consumed in large quantities are being discovered to have health effects. Where is the threshold that makes such a health effect a drug effect? Is it even possible to define a demarcation that will apply to all botanicals equally?

As a result of these questions, none of which will be answered overnight, another consideration in the discussion is this: Can botanicals co-exist in both categories, food and drug? And if so, how?

The Health Claim Regulation, again, was drawn up to harmonize the European regulatory landscape, traditionally a region of widely diverging approaches to health claims. Especially for botanicals, the situation was confusing and added problems for manufacturers wishing to market a product in more than one EU country.

But since the botanical claim evaluations have been put on hold, this situation is set to continue indefinitely, or at least until the evaluation issues are resolved.

Meanwhile, some EU countries, lacking EU guidance, have taken care of the problem in ways that are unlikely to be affected by the HC regulation or by whatever the European Commission may eventually decide. For example, Italy, Belgium and France have drawn up positive lists of botanicals that are allowed as food product ingredients and established these lists as part of their national laws by decree. Italy has even gone a step further, circumventing the HC regulation entirely; each functional ingredient that can be part of a dietary supplement comes with its own functional purpose in the form of health-related label statements, which are considered mandatory label information.

In contrast to the situation in Italy, Belgium and France (where botanicals can easily be food product ingredients), Germany, U.K. and Scandinavia have a long tradition and an established market of herbal medicines. In these countries, botanicals skew medicinal, which also results in a certain resistance by the drug industry toward botanicals in foods. Understandably, pharmaceutical companies are not interested in too many health foods on the market. All this will probably further delay decisions for botanicals.

Meanwhile, as the European Commission delays its decisions, Belgium, France and Italy have founded BELFRIT, which is aiming to consolidate their national situation with the EU legal framework for botanicals in the absence of guidance. Germany and other countries are beginning to look at this approach. In the U.K., the European Botanical Forum (EBF) has compiled a guidance paper for botanical preparations with a focus on safety and characterization standards in an effort to anticipate European developments.

An EU-founded project called “Libra” is looking for a solution to the dilemma of the classification of botanicals either as drugs or as food ingredients.

Positive Progress
All in all, while the Health Claim Regulation and its practical implementation still have a way to go toward unifying all of the EU as far as health claims are concerned, the outcome has been basically positive so far. Generic health claims have been defined that can be widely used. The possibility of applying for product-specific, proprietary health claims is not as obscure as it was five years ago. Experienced consultancies and CROs such as analyze & realize ag can give informed assistance to manufacturers wishing to file such an application, which improves the chances of the claim being accepted considerably.

While some inherent weaknesses of the evaluation process have become apparent, as evidenced by the botanical claims, the problems are being identified and worked on, and have given rise to national initiatives which may, in turn, give feedback to the EU Commission. In the long run, national solutions may thus benefit the entire community.