The European Commission has started to look at the regulations of botanicals in the EU through the so called REFIT process. In the words of the Commission, REFIT is “is a rolling programme to keep the entire stock of EU legislation under review and ensure that it is ‘fit for purpose’; that regulatory burdens are minimised and that all simplification options are identified and applied.”

What is the REFIT process for botanicals?

The European Commission is looking at whether current regulations are fit for purpose in the case of botanicals. This includes the Nutrition and Health Claims Regulation (NHCR) in reference to botanicals, and, in that context, at whether specific EU regulation of botanicals, and their quality, would have a positive effect. The process is ongoing, and it involves consultation with stakeholders. It is projected to end in 2017, but actual outcomes will probably be seen in 2018.

What is the hope of the industry with reference to botanicals?

As customary, there are different views. Most hope that health claims on botanicals may be addressed through a specific process, which would take into account traditional use. Traditional use is taken into account in the case of traditional herbal medicines, but not in the case of botanicals used in food or food supplements. Herbal medicines, however, while having a medicinal purpose, often have a similar composition of food supplements with botanicals.