RD, Quality & Regulatory affairs director€¦ · Sophie LAFAY, phD RD, Quality & Regulatory affairs director. FOOD SUPPLEMENTS Recent regulatory concept Defined by DIRECTIVE 2002/46/EC

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


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) 2015/1933

Arsenic

Cadmium

Dioxins, furans PCBs

(EU) 2015/1381

(EU) 2014/193

(EU) 2013/711(EU) 2014/663

Pesticides

MicrobiologyRegulation (EC)

2073/2005


GALENIC FORM


ADDITIVES

Hygiene and safety



Regulation (EC)

1332/2008

Additives(sweeteners,

bulking agent, carrier,

preservatives….)

Enzymes





& their many amendments

Approval procedureRegulation

(EC)1331/2008Aroma


GALENIC FORM


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



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


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


✓ Maximum doses✓ Precautions for use✓ Substances to be monitored


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


Plant matter: Geographical Origin, Growing & harvest Conditions Agricultural process

Herbal preparation:Standardization criteria , specifications, purity criteria, storage conditions, stability study


• 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


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 !


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


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

Documents

RD, Quality & Regulatory affairs director€¦ · Sophie LAFAY, phD RD, Quality & Regulatory affairs director. FOOD SUPPLEMENTS Recent regulatory concept Defined by DIRECTIVE 2002/46/EC