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Plant-based food supplement formulation in France
Sophie LAFAY, phDRD, Quality & Regulatory affairs director
FOOD SUPPLEMENTSRecent regulatory concept
Defined by DIRECTIVE 2002/46/EC of the European Parliament and the Council,
Transposed in the French Decree on march 20th, 2006
“Food supplements means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities”
Directive 2002/46/CE
Transposed in national legislation:
Decree 2006-352 of March 20th, 2006
relative to food supplements
✓ Defines registration procedure
✓ Establishes labelling requirements
✓ Specifies vitamins and minerals, and for each of them, the forms that may be used for the manufacture of food supplements (Annexe II – Amended by regulation 1170/2009 of November 30th, 2009)
Order of May 9th, 2006
✓ Min & max levels for vitamins and minerals
FOOD SUPPLEMENTSFrom Europe to France
In France,
✓ Consumer code dependant
✓ Food supplements marketing does not require marketing individual authorizationbased on the assessment by experts of a dossier submitted by the manufacturer.
Regulation compliance of food supplements is under manufacturer responsability
Consumer security and non-misleading must be respected.
FOOD SUPPLEMENTSRecent regulatory concept.
Registration to the General Directorate for Fair Trading, Consumer Affairs and Fraud Control (DGCCRF).
Synadiet, 2019. L’essentiel des complements alimentaires
http://www.synadiet.org/sites/default/files/page/files/lessentiel_des_complements_alimentaires_1.pdf
2 Md€
Independent professional association created in 1950, Synadietbrings together companies in the food supplement sector inFrance, whatever their activity (manufacturers, ingredientsuppliers, marketers, consultants, distributors, etc.)
OpinionWay study for Synadiet, march 2019
50% are sold in pharmacy/drugstore
46% of the French have already consumed food supplements
FOOD SUPPLEMENTSFrom Europe to France
http://www.synadiet.org/sites/default/files/page/files/lessentiel_des_complements_alimentaires_1.pdf
❑ Vitamins❑ Minerals❑ Trace-elements
❑ Fruits or vegetables powders, extracts❑ Plants, plants extracts ❑ Bacteria, yeasts
❑ Traditional oil (vegetal oil, fish oil…)❑ Bees products
❑ Nutritionnal or physiological substances
AromasColoursSweetenersCarrier…
FOOD SUPPLEMENTSComposition.
Communication
Hygiene and safety
Co
nsu
mer
pro
tect
ion
FOOD SUPPLEMENTSAll under control
GALENIC FORM
FOOD SUPPLEMENTSAll under control
CONTAMINANTS
Hygiene and safety
Heavy metals
Mycotoxins PCB
Polycyclic aromatic
hydrocarbons
Regulation (EC)629/2008
Regulation (EC) 396/2005
Regulation (EC)752/2014
& many amendments
Regulation (EC) 1259/2011
Regulation(EC) 2015/1933
Arsenic
Cadmium
Dioxins, furans PCBs
(EU) 2015/1381
(EU) 2014/193
(EU) 2013/711(EU) 2014/663
Pesticides
MicrobiologyRegulation (EC)
2073/2005
FOOD SUPPLEMENTSAll under control
GALENIC FORM
FOOD SUPPLEMENTSAll under control
ADDITIVES
Hygiene and safety
Regulation (EC) 1334/2008
Regulation (EC) 873/2012
Regulation (EC)
1332/2008
Additives(sweeteners,
bulking agent, carrier,
preservatives….)
Enzymes
Regulation (EC) 231/2012
Regulation (EC) 1333/2008
Regulation (EC) 1129/2011
Regulation (EC) 1130/2011
& their many amendments
Approval procedureRegulation
(EC)1331/2008Aroma
FOOD SUPPLEMENTSAll under control
GALENIC FORM
FOOD SUPPLEMENTSAll under control
ACTIVE INGREDIENTS
Vitamins & Minerals
Plants, plant extracts
Physiological & Nutritional substances
Forbidden plants, plant
extracts, substances
Directive 2002/46/ECRegulation (EC) 1170/2009Regulation (EC) 1169/2011 French Order 9th may, 2006
French Order 26th september 2016Regulation (EC) 609/2013European positive lists
French Order 24th june 2014French Decree 2008-841 : positive listBelfrit listEuropean positive lists
Regulation (EC) 1925/2006
FOOD SUPPLEMENTSAll under control
GALENIC FORM
FOOD SUPPLEMENTSPlants, plant extracts
Use of "healthy" plants in France are from a long French tradition
Grandmother’s medicine
An onion for fatigue
“Boil for 20 minutes a liter of water in which you have put the equivalent of a slicedonion. Then drink this preparation regularly for two days, and repeat as soon as youfeel weak again.”
Star anise for digestive disorders
“Prepare a decoction from four star anise stars and a large cup of water, which youwill boil for a few minutes. Once the fire is out, let it steep for another 10 minutes andthen drink, preferably before going to bed. Good to know: star anise can also be usedagainst bronchial irritation.”
NATURAL ≠ SAFE
≠ Phytotherapy
In Europe, > 1000 plants used for medicinal purposes
The French pharmacopoeia lists about 400 of them
200 of which have therapeutic indications.
LIST A OF TRADITIONALLY USED MEDICINAL PLANTS
Food and/or condiment uses
148 escape the pharmacist's monopoly
FOOD SUPPLEMENTSPlants & plant extracts
Main plants in food
supplements
Sleep & stressValerian, hop, lemon balm, rhodiola, saffron, hawthorn
Blood flowHibiscus, ginkgo biloba, horse’s chestnut… Arthrosis
Curcuma, harpagophytum, nettle, blackcurrant…
Digestion & Bowel functionArtichoke, ginger, peppermint, fennel, licorice, psyllium
Immunity & VitalityGinseng, acerola, guarana, maca, guava, echinacea…
SlendernessGreen tea, guarana, fennel, konjac…
Respiratory tractEucalyptus, mint, thyme, pelargonium…
Synadiet, 2019. L’essentiel des complements alimentaires
FOOD SUPPLEMENTSPlants, plant extracts
Powder? Dry extract?Liquid extract?Essential oil? Infusion?
Stems? Leaves?Flowers? Roots? Totum?
The same plant will not be used for the same indications !
The same plant can be safe or toxic
What are we talking about?
EFSA SCIENTIFIC COOPERATION (ESCO) REPORT - 2009Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern
FOOD SUPPLEMENTSPlants, plant extracts
FOOD SUPPLEMENTSPlants, plant extracts
✓ Maximum doses✓ Precautions for use✓ Substances to be monitored
FOOD SUPPLEMENTSPlants, plant extracts
French law of 24 June 2014 establishing the list of plants, other than
fungi, authorized in food supplements and their conditions of use
540 authorized plants
→ Scientific name, family, vernacular names, plant parts used, substances to monitor, restrictions
FOOD SUPPLEMENTSPlants, plant extracts
Plant matter: Geographical Origin, Growing & harvest Conditions Agricultural process
Herbal preparation:Standardization criteria , specifications, purity criteria, storage conditions, stability study
FOOD SUPPLEMENTSPlants, plant extracts
• Plant & herbal preparation consumption forecasts• Potential consumption from other sources• Available consumption data • Toxicological data: Undesirable molecules & associated assay methods• Known and supposed molecular interactions • Manufacturing process evolution versus traditional use • Risk analysis related to safety under the proposed conditions of use
FOOD SUPPLEMENTSPlants, plant extracts
Harmonization of lists: the “BelFrIt List” 1000 plants
FOOD SUPPLEMENTSPlants, plant extractsEuropean Lists
Positive list Positive listNegative list
No legal value Cannot be used as a regulatory justification for the use of a plant
DenmarkCroatia
Lithuania
FOOD SUPPLEMENTSPlants, plant extractsEuropean Lists
AustriaEstonia
Monaco !
FOOD SUPPLEMENTSPlants, plant extracts
Security must be a prerequisite
Legal manufacturer:
✓ has responsibility to ensure consumer safety
✓ must control its finished product
✓ must control its sourcing
✓ must set up all the necessary controls, whether regulated or not
A large number of plants is therefore authorized in Europe
⤷ who is the right supplier (at the best price!) ?
⤷ whoever meets the minimum quality standards imposed by the regulations
Communication
FOOD SUPPLEMENTSAll is under control
Hygiene and safety
GALENIC FORM
Consu
mer
pro
tect
ion
FOOD SUPPLEMENTSAll under control
Consumer protection
Regulation (EC) 1924/2006 : Nutritional & health claimsRegulation (EC) 432/2012 & Regulation (EC) 536/2013 : Approved health claims Regulation (EC) 907/2013 : Generics Descriptor
No misleading communication
Food supplement must not constitute a drug by function
Food supplement must not constitute a drug by presentation
Food supplements are foodstuffswe do not treat with food
we maintain a good healthy statewe prevent risks of diseases
Labelling requirementRegulation 1169/2011
Quality Production Marketing BusinessDevelopment
FOOD SUPPLEMENTSRegulations define the development procedures
Development processSteps that involve all teams
Regulation compliance is under legal manufacturer responsibility
FOOD SUPPLEMENTS
Regulations define Good Development Practices (GDPs)
GDPs facilitate Good Manufacturing Practices (GMPs)
Development Quality
Raw material
suppliers:
1- Raw material selection
2- Samples & Quality documentation
Vitamins,
Minerals,
Herbal extract,
Nutritional
Substances…
3- Raw material regulation conformity.
→ Chemical & quality documentary control
Development
4- Raw material qualification; In-coming control definitions
FOOD SUPPLEMENTSGood development practice (GDP)
CONCEPT/IDEAMarket studyBibliographic researchScientific, regulatory, legal status evaluation
Non exhaustive list of quality documentation for raw material qualification
FOOD SUPPLEMENTSGood development practice (GDP)
Specification sheet (raw material identification; macroscopic, microscopic, rheological, organoleptic; composition; shelf-life)Certificate of analysis example Material Safety Data SheetFood grade statementGMO free statementPackaging compatibility with foodstuff statementFood allergen statementIrradiation or fumigation free statementBSE /TSE free statementProcessProduction site statementRaw material origin statement Analysis methods Analysis method validation reportStability studies
ProductionTechnical
Development
5 – Laboratory assays
Galenic formulation determination
6 - Pilote (intermediate size of machines)
7- Semi-industrial assay
FOOD SUPPLEMENTSRegulations define good development practice (GDP)
Raw material qualification;
In-coming control definitions
ProductionMarketing Business
8 bis – Notification to DGCCRF
8ter – Industrialization
8 – Communication
development (packaging,
leaflet, product sheet,
advertising…)
10 – Market
9 – Finish product conformity statement
FOOD SUPPLEMENTSRegulations define good development practice (GDP)
SecurityNo misleading communication
MarketSuccess
Grower
Manufacturers
In & out
controls
FULL PROCESS
QUALITY
CONTROL
ICH
stability
studies
ISO / GMP
manufacturers
Regulatory
evaluation
Highest quality in-sourcing Ingredient,
process & FP controls
FOOD SUPPLEMENTSConclusion
Regulatory
evaluation
Suppliers
Raw materials
FEED
Thank you for your attention
www.gynov.com www.indigothera.com
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