Europe shows little sign of resolving botanicals

Europe shows little sign of resolving botanicals
The working document will give the next European Commission "some orientations" for its work after 2019, says Alexandra Nikolakopoulou, head of the European Commission’s Unit for Food Information and Composition, Food Waste

12 June 2018 - Deborah Wilkes

The current European Commission will not propose legislation on the controversial issue of health claims for botanical ingredients, according to Alexandra Nikolakopoulou, head of the European Commission’s Unit for Food Information and Composition, Food Waste.

Nikolakopoulou told a recent gathering of the European OTC industry that Commission staff intended to produce a working document on botanicals by the end of 2018.

Speaking at the 54th Annual Meeting of the Association of the European Self-Medication Industry (AESGP) in the Netherlands, Nikolakopoulou said the working document would give the next Commission "some orientations" for its work after 2019.

Seven years have passed

Seven years have now passed since the Commission halted the European Food Safety Authority’s (EFSA’s) evaluation of more than 2,000 health claims for botanical ingredients under Article 13.1 of the Regulation on nutrition and health claims made on foods including food supplements.

Industry wants a solution to the problem. However, the Commission has still not announced a way forward on the controversial issue of health claims for botanical ingredients, which divides opinion in the European Union.

The heart of the problem is that products with botanical ingredients are not defined at the European Union level and may be classified by member states as foods, botanicals or herbal medicines. Different regulatory approaches for the same product by member states leads to distortion in the single market.

As Nikolakopoulou pointed out, evidence of traditional use is accepted for therapeutic indications on Traditional Herbal Medicinal Products (THMPs) but not for claims on food supplements. Furthermore, there are stricter requirements for placing THMPs on the market.

REFIT evaluation

The Commission is in the process of evaluating Regulation 1924/2006 on nutrition and health claims made on foods as part of the European Union’s Regulatory Fitness and Performance Programme (REFIT) (click here to read the News story). At the time this News story went to press, the Commission was awaiting the final report produced by external contractors.

Nikolakopoulou said the Commission had already started "reflecting" on policy orientations.

She told delegates that a study carried out as part of REFIT had concluded that the objectives of the Regulation had not been achieved – given the absence of a decision on health claims for botanicals – but the original objectives were still relevant.

The study, pointed out Nikolakopoulou, said a massive rejection of health claims for botanicals should be prevented. Traditional use to substantiate health claims on botanicals should be explored, according to the study, as should the feasibility of introducing safety and/or quality provisions.

The study did not raise specific safety concerns related to botanicals, she added, but it did point out that the applicable legislative framework created obstacles to the internal market.

Furthermore, continued Nikolakopoulou, the study noted that further harmonisation would have a limited effect, as national authorities would still remain responsible for the classification of botanicals as THMPs or food supplements.

The study concluded that developing a harmonised European Union positive or negative list of botanicals in foods appeared to be a key solution, said Nikolakopoulou, in combination with exploring solutions to the issue of classification.

Nikolakopoulou told delegates that the Commission was not obliged to follow the findings of the study.

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