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CASE STUDY 2:
Product Registration and Import/Export Certification
- Howard Gilmour - Adrian Sharpe - Hendro Harijogi Poedjono
Authorisation of Food Additives & Flavours
Howard Gilmour
www.foodindustry.asia
WHERE WE ARE TODAY
The Joint Expert Committee on Food Additives (JECFA) has
evaluated more than 2,500 additives
Since 1958 more than 10,000 substances currently allowed in human
food in the United States
FEMA is Flavor and Extract Manufacturers Association.
EFSA is the independent risk assessment body of the European Union
The US and JECFA and EFSA share a system that works by ensuring
the safety of ingredients through rigorous testing and analysis of
all the relevant data and scientific literature. It is a very thorough,
transparent and comprehensive process.
www.foodindustry.asia
AUTHORIZATION OF FOOD
ADDITIVES & PRODUCT
REGISTRATION
Non harmonized authorization process of food additives across ASEAN.
Duplication of effort and lengthy complex approval process (8 years +).
Protracted product registration process.
Consistency & clarity of information.
Increased innovation and investment in ASEAN.
Better resource utilization and cost benefit.
www.foodindustry.asia
Authorisation of JECFA evaluated food additives needs 6-8
years in some countries
www.foodindustry.asia
ELEMENTS OF RISK ASSESSMENT
Hazard
Assessment Dose Response
Analysis Exposure
Assessment Risk Analysis
To Build A Solid Foundation
in Risk Assessment
Realistic Exposure Data High Quality Safety Studies
Sound Science
www.foodindustry.asia
MULTIPLE STAKEHOLDERS ENGAGED IN
THE SAFETY EVALUATION PROCESS
• Food Regulators
• Food Scientists
• NGOs
• Transparent Process for all
Food and Beverage
Industry
Other
Stakeholder
Government
Regulator
www.foodindustry.asia
RELATIONSHIP BETWEEN INDUSTRY
AND REGULATORY AGENCIES
Petitioner is responsible for demonstrating safety
Regulatory authorities are responsible for
• Conducting a full and fair evaluation of the data and
information
• Applying risk assessment principles and issuing food safety
regulations based on sound science-based risk assessment.
Regulatory
Authorities Petitioner
www.foodindustry.asia
CONCLUSIONS
Product safety is our #1 priority.
Multiple stakeholders are engaged in the safety review process.
Innovation in our industry helps bring excitement to our consumers.
Assessments for new, innovative ingredients are rigorous and TRANSPARENT.
Assessments should be conservative, yet realistic; conclusions must be based on sound science.
It is desired that country authorities recognize international risk assessments to support efficient approval process.
AFRIS. AsianFoodRegulationInformationService.
We have the largest database of Asian food regulations in the world and it’s FREE to use.
We publish a range of communication services, list a very large number of food events and online educational webinars and continue to grow our Digital
Library.
We look forward to hearing from you soon!
