The demarcation between herbal medicinal products and supplements containing botanicals will be the subject of the “European Herbal Health Products Summit: Which Way Forward?” taking place in Brussels on February 20. Stakeholders from the nutritional and pharmaceutical industries will discuss possible solutions together with food and drug authorities and policymakers. a&r as a leading consultancy and service provider in the field will be represented by our expert Dr. Heike Stier, Head of Consulting & Strategic Innovation.
In the recent resolution*, published by EU Parliament the European Council and the Commission is urged to take action and address the longstanding challenges in current guidelines and policies, namely:
- finalizing the establishment of long-overdue nutrient profiles;
- harmonization within the member states regarding the classification of herbal substances (botanicals) as foodstuffs or herbal medicinal products;
- promptly evaluating on-hold claims and rejecting those already assessed negatively, and
- immediate creation of an EU-wide negative list of botanicals not to be used in food, to
- close gaps in interpretation between the Member States and to eliminate differences in enforcement;
- challenge the use of claims for nutrients not deficient in the EU;
- pursue guidance to better enforce the Claims Regulation in Internet and social media platforms;
- initiating pre-submission consultations between applicants and EFSA.
