A A practical vie iew on im implementing a good quality system for food supplements production Michel Horn – President EHPM Brussels, March 14 th 2018
EHPM • European Federation of National Associations of Health Product Manufacturers • Established 1975 • 14 members, from 14 Member States • Manufacturers and distributors of food supplements
EHPM • 1,750+ companies, 98% SMEs • 100,000+ jobs • A growing market: TURNOVER TOTAL BOTANICALS 10,3 to 13,0 billion € 6,05 billion € EUROPE 3,0 billion € 450 million € ITALY biggest market
EHPM Vision In a modern health maintenance system, there is a legitimate place for physiologically active health enhancing products National health systems reduce costs by preventing diseases thanks to the consumption of food supplements Health supplements deserve an appropriate legal environment to deliver well-informed access for consumers to safe and efficient products EHPM will back and help to build any feasible legislation project which offers coherence and legal security for serious & responsible operators
EHPM Missions Monitor legal initiatives and inspire law makers in order to achieve our vision Contribute with scientific and technical expertise whenever needed
Example EFSA safety report on HAD’s COORDINATION ROLE: • Relay of market data from operators • Participation to EFSA conference on results • Help to operators to build valid argumentation • Sending of position on the process to the commission • Participation to debriefing on process by TC with EFSA (with operators and academics) • Information of influential MEP’s on the subject
Example EFSA safety report on RYRMK COORDINATION ROLE: • Explain article 8 reg 1925/2006 to industry stakeholders • Relay position of most concerned national association • Include RYRMK in critical position paper about process art 8
EHPM Priorities 2014 - 2019 • Botanicals: protect Europe’s heritage (history of use -based claims) • Probiotics: secure approval for the use of the term probiotic on labelling with appropriate conditions of use • Innovation: - Foster appropriate and proportionate assessment methodology for health claims - Ensure European Food Safety Authority (EFSA) pre-submission meetings with applicants
EHPM Priorities 2014 - 2019 Governance at EU level: - Achieve greater application of the mutual recognition principle - Ensure appropriate guidance by European Commission to avoid distortions caused by different national interpretations of EU law - Enforce safety and consumer protection standards for internet sales
Why Quality ? • Growing interest of consumers for alternative health- maintenance products • Growing market share of Food Supplements • Opponents arguments: 1) Useless 2) Safety Quality is therefore of extreme importance!
Quality in Food Supplements 2 missions only : 1. Safety of use 2. Truthfulness in communication: - Efficient to deliver the promise - Either excessive nor misleading
Quality guidelines Sector quality guide Legal Industry response Legal monitoring obligations 2002/46 directive + national STATUS Dedicated REGULATING implementation Notification Quality Federal Public Service (FPS) Health, Management Regulation Food Chain Safety and Environment nutritional & CLAIMS System health claims + « traditional » on approved and hold list CONTROLLING used by Federal Agency for the Safety of the 852/2004 & authorities 853/2004 EC QUALITY Food Chain (FASFC) regulation on Hygiene foodstuff
A vir irtual tour of f the application of f the EHPM guid ide in in a food supplement facility Qu Quality Process ss enables Achievement of 2 main goals SAFE TRUTHFUL FUNDAMENTALS: Doesn’t harm Deliver promise = What is needed to develop and sell quality = 1. Manufacturing: appropriate & validated For a FS, QUALITY means 2. Scientific knowledge it is SAFE & TRUTHFUL 3. Regulatory/legal knowledge 4. Being able to identify precisely consumer need
Quality Process enables Achievement of 2 main goals FUNDAMENTALS SAFE TRUTHFUL doesn’t harm deliver promise IDENTIFIED Step 1 Consumer Need Assessed physiological Safe ingredients effects Step 2 Product Idea Legality of ingredients Theoretical formula Goals: Step 3 - Ingredients Formula provides offering a product - Form of intake efficient dosages - Labelling providing highest safety & efficiency criteria Final formula Active ingredients ▪ Step 4 Laboratory assays Stability of TRACABILITY must be present ▪ formula is tested Pilot production until end of shelf life Validated formula/form HACCP Authorities can Authorities verify: Interaction with • verify: correspondence competent authority Step 5 • legality between Either notification/ • dosage of ingredients & authorization ingredients claims or information • Claims (notification) Consumer has a Marketable Production Step 6 guarantee of product samples are stability/ effect reviewed in real during product’s time lifetime Consumer Need Step 7 FULFILLED Controls by authorities at market level Step 8 Post Marketing prevent illegal products being sold Surveillance
Product development process Product Product Production Pos ost-marketing Development & De Concept & Controls monitoring val alidation • Standardize • Assess formulation • Identify consumer production need • AUTHORITIES • Confirm ingredients • Control: • COMPANY: • Understand - Production • Determine SAFE & - Customer Q&A physiological - Process EFFECTIVE dosages - complaints process - Quality - Internal audits • Check interactions • Propose SAFE & TRUTHFUL concept • Pilot Production & validation Mar arket Lau Launch • Stability tests INFORM authorities to get permission (or not)
Product Concept Scientific research
Product Concept Target Product Profile (TPP) ✓ Safe ingredients Ensure Safety ✓ Assessed physiological Based on Ensure Scientific effects Efficacy studies
Product Concept
Product development & validation Sc Scien ientif ific ic evid vidence
Product development & validation Sa Safety studie ies
Product development & validation Tri rials ls & Pil ilot Productio ion
Product development & validation Analy lytic ical l & s stabil ilit ity stu tudie ies
Production & controls Hygie iene controls ls: GMP = HACCP Meth thod
Production & controls In In-process controls ls (crit ritic ical l poin ints)
Production & controls In In-process controls ls (crit ritic ical l poin ints)
Production & controls Quali lity contr trols ls
Production & controls Traceabil ilit ity via via ERP
Compulsory: labelling
Final positive answer
Post-marketing monitoring On sit site sa sample le takin ing by FASF SFC
Post-marketing monitoring Th The Foodweb database
Food Chai ain Se Security Agency au audit its: In Insp spir ired by y NA NAREDI ch check lis lists Check-lists = Naredi quality guidelines
Post-marketing monitoring CRM for r customers Co Compla lain ints/ questions « With my other treatments?» « More than 3/day ?» « Do you have a solution for…? » « I don’t like the taste of… » « Fantastic !» Recorded in internal database
Post-marketing monitoring Traceabil ilit ity all llows tracin ing b back of proble lems
Post-marketing monitoring Monit itorin ing in in in internal l database
Safe & truthful products 39
Conclusions A dedicated Quality Management System: • guarantees consumer protection & satisfaction • avoids any foreseeable accident • is SME compatible (eg. 2,5% of T.O.)
« This category of products deserves a dedicated status. » Commissionner Vytenis Andriukaitis visting a Belgian Food Supplements Manufacture, Sept 01 2015
EHPM Quality Guid ide lished 2007 Revis NEW se NE sections: Publis ised 2014 ✓ Introduction to EU and national regulatory requirements for food supplements ✓ Botanicals ✓ General labelling requirements + + Check-li lists: ✓ Manufacturers ✓ Sub-contractors ✓ Raw material suppliers + Questionnaire for Bot + otanical preparations. http://www.ehpm.org/ehpm-standards/quality.html
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