Botanicals and Health claims

Community pharmacies in EU supply traditional herbal medicines, which have a longstanding tradition in Europe. Their effect is well understood and have been proven to cure and/or relieve symptoms in variety of therapeutic areas. Pharmacists when dispensing or medical doctors when prescribing traditional herbal medicines have to be assured that safety of such products is of the highest standard and have sufficient regulatory guarantees for efficacy of such product.

The Regulation on nutrition and health claims made on foods (Regulation (EC) No 1924/2006), which also affects foods supplement sector) lays down harmonised rules across the European Union for the use of nutrition claims (such as “low fat” or “high fibre”) or health claims (such as “reducing blood cholesterol”). This Regulation foresees implementing measures to ensure that any claim made on foods' labelling, presentation or marketing in the European Union is clear, accurate and based on evidence accepted by the whole scientific community.

In September 2010, the Commission announced its intention to restructure the process of progressive adoption of the list of permitted health claims on food products (also known as "Article 13 claims"). Article 13 claims includes health claims for botanical substances. The list is currently on hold, allowing additional evidence to be submitted to EFSA’s attention before a final decision on them is taken.

In 2016, the European Commission started an evaluation of the nutrition and health claims Regulation in order to assess whether the Regulation is fit for purpose or, on the contrary, the Reglation needs some adjustements. This evaluation exercise focuses on (i) nutrient profiles and (ii) health claims on plants and their preparations added to foods. To conduct such evaluation the Commission has tasked a external consultant the preparation of a study on the current legal framework of health claims on plants or their use in food.

The evaluation is mainly focusing on two options:

  1. Full application of NHCR to health claims on botanicals. This would mean that a majority of health claims put on hold would receive a negative assessment and will be listed as non-authorised health claims for foods.

  2. The inclusion of traditional use as sufficient substantiation to justify a health claim. This would mean that health claims on botanicals in food would be authorised on the basis of established traditional use.

On 16 February 2017, PGEU replied to the stakeholders’ consultation supporting the full application of the Regulation (EC) No 1924/2006 to health claims on plants and their preparations used in foods. In this scenario, traditional use is not sufficient to obtain an authorisation for a health claim.

The staff working document for this evaluation was published on 20 May 2020. Concerning health claims on plants and their preparations, the evaluation states that it could be appropriate to explore the notion of 'traditional use' in the efficacy assessment of health claims on plants and their preparations used in foods together with the effects of the co-existence, on the EU market, of Traditional Herbal Medicinal Products on the same plant substances. The Commission was handed the results of the evaluation and will decide on future steps.