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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)