AESGP Conference

1. 1
R. Anton
Categorisation of herbal products: a point of view
Robert ANTON
Emeritus Professor of the University of Strasbourg
Member of national Academies of Pharmacy and Medicine
robert.anton@unistra.fr
Herbal (medicinal) products, Food supplements and self – care medical devices
Brussels , 7-8 Octobre 2014

2. 2
R. Anton
…Some little background…

3. 3
R. Anton
EMA: Botanical clinical indications for herbal drugs
EMA: two levels of labelling for therapeutical indications, marketing authorisation
- « traditional use » ( history of use, traditional mode of preparation): Syzigium, Curcuma, Melissa, Rosmarinus , Viola, Lavandula….
- « well-established use » (bibliography :pharmaco-clinical data available)
Directive 2004/24/EC

4. 4
R. Anton
EFSA: a scientific strategy for food supplements
Quality and safety well defined:
Advice on the EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as FS, based on real cases studies
EFSA Journal (2009), 7 (9) 280-323
The same logical assessment as for pure substances: vitamines, minerals with a nead of a clinical proof of efficacy !

5. 5
R. Anton
Some important questions
- How to prove a positive health impact on an homeostatic status and on an healthy human body ?
- Why 2 different attitudes and judgments in terms of herbal remedies and food supplements requirements for the same plants and plant preparations ?
Practically no “traditional claims” accepted and issued!
Examples of indications which could be considered as related to physiology
Increasing the elimination of bile and facilitate digestion, appetite stimulation, temporary fatigue, minor sleep problems, elimination of water from the kidneys….

6. 6
R. Anton
EFSA: a logical…but a paradoxal opinion in the european context
Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/20061 (Rheum sp., Cassia sp.,Rhamnus sp., Aloe spp..)
EFSA Journal 2013;11(10):3412
Senna Hypericum

7. 7
R. Anton
Similar imperative criteria for food supplements as for traditional herbal remedies
Imperative criteria
1. Same plant species and plant parts
2. Same quality criteria
3. Same type of traditional preparation
4. Same traditional uses
5. Same safety: history of use more than 30 years in Europe
6. Same type of population

8. 8
R. Anton
Some conclusions
Important european future requirement
-To find a convergent point of view
-To harmonize the different concepts
-Compendium: a third version in preparation
-Belfrit project list of plants
-France: « Arrêté » published on the 17th July 2014 : list of plants (more than 500 species) authorized in the food supplements and their conditions of use considering the substances to supervise

9. 9
R. Anton
Examples of monographs and reference standard texts
European Pharmacopoeia
French Pharmacopeia = Pharmacopée française
German Pharmacopoeia = Deutsches Arzneibuch (DAB)
English Pharmacopoeia = British Pharmacopoeia (BP)
US Pharmacopoeia = United States Pharmacopoeia (USP)
WHO monographs and guidelines
ESCOP = European Scientific Cooperation in Phytotherapy
EMA (EMEA) : HMPWP (Herbal Medicinal Products Working Party)
Other references: AFNOR (France), ISO, ICH….
Data bank: COSING…

10. 10
R. Anton
Some positive propositionals
1. Other hypothesis:
- question of dosage…
- health physiological impact on the human body…
2. Keep the plants with the labeling « well established use » only and strictly for herbal remedies
3. Accept the plants with the « traditional use » concept, or transfer them to the list of plants for food supplements
4. An imperative need for a very specific regulation…..

11. 11
R. Anton
The same traditional plant species
Ambivalent or borderline botanicals
Cynara
Ficaria
Gentiana
Passiflora
Melilotus

12. 12
R. Anton
Some examples of papers… perhaps useful…!
1.The role of Traditional Knowledge in the Safety Assessment of Botanical Food Supplements. Requirements for Manufacturers
R. ANTON, M. SERAFINI, L. DELMULLE
European Food and Feed Law, 241-250 (2012)
2. Project BELFRIT Harmonizing the Use of Plants in Food Supplements in the European Union: Belgium, France and Italy – A first Step
COUSYN Guillaume, DALFRA Stefania, SCARPA Bruno, GEELEN Joris,
ANTON R., SERAFINI M., DELMULLE L.
European Food and Feed Law, 3, 187-196 (2013)
3. The substantiation of claims for botanical food supplements in relation to traditional use
R. ANTON, M. SERAFINI, L. DELMULLE,
European Food and Feed Law, 8, 321-328 (2013)