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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 DataHigh 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!
www.asianfoodreg.com
adrienna@asianfoodreg.com

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Authorisations - Food Additives

  • 1.
  • 2. CASE STUDY 2: Product Registration and Import/Export Certification - Howard Gilmour - Adrian Sharpe - Hendro Harijogi Poedjono
  • 3. Authorisation of Food Additives & Flavours Howard Gilmour
  • 4. 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.
  • 5. 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.
  • 6. www.foodindustry.asia Authorisation of JECFA evaluated food additives needs 6-8 years in some countries
  • 7. 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 DataHigh Quality Safety Studies Sound Science
  • 8. 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
  • 9. 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
  • 10. 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.
  • 11.
  • 12. 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! www.asianfoodreg.com adrienna@asianfoodreg.com