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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
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…Some little background…
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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
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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
!
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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….
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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
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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
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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
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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…
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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…..
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The same traditional plant species
Ambivalent or borderline botanicals
Cynara
Ficaria
Gentiana
Passiflora
Melilotus
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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)