A A practical vie iew on im implementing a good quality system - - PowerPoint PPT Presentation

A A practical vie iew on im implementing a good quality system for food supplements production

Michel Horn – President EHPM

Brussels, March 14th 2018

• European Federation of National Associations of Health

Product Manufacturers

• Established 1975
• 14 members, from 14 Member States
• Manufacturers and distributors of food supplements

EHPM

TURNOVER TOTAL BOTANICALS EUROPE

10,3 to 13,0 billion € 6,05 billion €

ITALY biggest market

3,0 billion € 450 million €

• 1,750+ companies, 98% SMEs
• 100,000+ jobs
• A growing market:

EHPM

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

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

EHPM Priorities 2014 - 2019

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

Dedicated Quality Management System approved and used by authorities STATUS

QUALITY

CLAIMS

2002/46 directive + national implementation Notification 852/2004 & 853/2004 EC regulation on Hygiene foodstuff Regulation nutritional & health claims + « traditional » on hold list

Legal

• bligations

Quality guidelines

Legal monitoring

REGULATING Federal Public Service (FPS) Health, Food Chain Safety and Environment CONTROLLING Federal Agency for the Safety of the Food Chain (FASFC)

Industry response

Sector quality guide

A vir irtual tour of f the application of f the EHPM guid ide in in a food supplement facility

Qu Quality Process ss Achievement of 2 main goals enables

SAFE

Doesn’t harm

TRUTHFUL

Deliver promise

FUNDAMENTALS:

= What is needed to develop and sell quality

• 1. Manufacturing: appropriate & validated
• 2. Scientific knowledge
• 3. Regulatory/legal knowledge
• 4. Being able to identify precisely consumer need

= For a FS, QUALITY means it is SAFE & TRUTHFUL

Achievement of 2 main goals enables

Step 1 Step 2 IDENTIFIED Consumer Need Product Idea Step 8 Step 3 Theoretical formula

• Ingredients
• Form of intake
• Labelling

Final formula

▪ Laboratory assays ▪ Pilot production

Step 4  Validated formula/form Interaction with competent authority

Either notification/ authorization

• r information

Step 5

Marketable product

Step 6

Consumer Need FULFILLED

Step 7 Post Marketing Surveillance

SAFE

doesn’t harm

TRUTHFUL

deliver promise

Safe ingredients Assessed physiological effects Formula provides efficient dosages Legality of ingredients Goals:

• ffering a product

providing highest safety & efficiency criteria Stability of formula is tested Active ingredients must be present until end of shelf life Authorities can verify:

• legality
• dosage of

ingredients

• Claims

Authorities verify:

• correspondence

between ingredients & claims (notification) Production samples are reviewed in real time Consumer has a guarantee of stability/ effect during product’s lifetime Controls by authorities at market level prevent illegal products being sold

FUNDAMENTALS

Quality Process

TRACABILITY HACCP

• Identify consumer

need

• Understand

physiological process

• Propose SAFE &

TRUTHFUL concept

• Assess formulation
• Confirm ingredients
• Determine SAFE &

EFFECTIVE dosages

• Check interactions
• Pilot Production &

validation

• Stability tests

Product De Development & val alidation

• Standardize

production

• Control:
• Production
• Process
• Quality

Production & Controls

• AUTHORITIES
• COMPANY:
• Customer Q&A
• complaints
• Internal audits

Pos

• st-marketing

monitoring Product Concept INFORM authorities to get permission (or not) Mar arket Lau Launch

Product development process

Scientific research

Product Concept

Target Product Profile (TPP)

Ensure Safety Ensure Efficacy Based on Scientific studies ✓ Assessed physiological effects ✓ Safe ingredients

Product Concept

Product Concept

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 Product development & validation

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 Production & controls

Compulsory: labelling

Final positive answer

Post-marketing monitoring On sit site sa sample le takin ing by FASF SFC

Th The Foodweb database Post-marketing monitoring

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

 « 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

CRM for r customers Co Compla lain ints/ questions 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 Post-marketing monitoring

39

 Safe & truthful products

A dedicated Quality Management System:

• guarantees consumer protection & satisfaction
• avoids any foreseeable accident
• is SME compatible

(eg. 2,5% of T.O.)

Conclusions

« This category of products deserves a dedicated status. »

Commissionner Vytenis Andriukaitis visting a Belgian Food Supplements Manufacture, Sept 01 2015

NE NEW se sections:

✓ 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

• tanical preparations.

EHPM Quality Guid ide Publis lished 2007  Revis ised 2014

http://www.ehpm.org/ehpm-standards/quality.html