CASE STUDY 2:
Product Registration and
- Howard Gilmour
- Adrian Sharpe
- Hendro Harijogi Poedjono
Authorisation of Food Additives
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.
AUTHORIZATION OF FOOD
ADDITIVES & PRODUCT
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
Better resource utilization and cost
Authorisation of JECFA evaluated food additives needs 6-8
years in some countries
ELEMENTS OF RISK ASSESSMENT
To Build A Solid Foundation
in Risk Assessment
Realistic Exposure DataHigh Quality Safety Studies
MULTIPLE STAKEHOLDERS ENGAGED IN
THE SAFETY EVALUATION PROCESS
• Food Regulators
• Food Scientists
• Transparent Process for all
Food and Beverage
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
• Applying risk assessment principles and issuing food safety
regulations based on sound science-based risk assessment.
Product safety is our #1 priority.
Multiple stakeholders are engaged in the safety review
Innovation in our industry helps bring excitement to our
Assessments for new, innovative ingredients are rigorous and
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.
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
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