ToxForum, 9 November 2005 Andr Bergman, Novozymes

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ToxForum, 9 November 2005André Bergman, Novozymes
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European Industry Approach to Safety Evaluation
of Food Enzymes

• Content

• Binding principles
• Guidelines
• Customer safety
• Risk assessment approach elements
• Enzyme safety
• Strain safety
• Manufacturing safety
• Product safety
• Exposure
• Alternatives for future safety assessment

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European Industry Approach to Safety Evaluation
of Food Enzymes

• Guidelines
• - All industries use the same guidelines
• Consumer safety
• - Top priority for all

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• Enzyme identity
• Characterization
• IUB and/ or CAS/EINECS classification

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Strain

• Taxonomy (Genus species) of host strain
• History of safe use
• Non-pathogenic and non-toxigenic
• Genetic modifications of host
• Metabolites
• No unwanted side activities
• Introduced DNA
• Well-characterized
• Description of donor for expressed gene
• Well-known plasmids
• Enzyme expression
• Selectable marker

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• Good Manufacturing Practices (GMP)
• Raw materials and processing aids
• Approved food additives or safe
• Pure culture fermentation
• Quality Management system
• ISO 9001 certified
• HACCP
• Standard Manufacturing Process
• Fermentation
• Purification
• Formulation
• Quality control of the finished product

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Product Safety
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• Characterization of test batch
• Representative for the commercial products
• Ames test
• Human lymphocyte cytogenetic assay
• 13 weeks oral toxicity study in rats
• NOAEL (TOS/kg/day)

Product Safety
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• Purity specifications
• Food Chemicals Codex (FCC)
• Joint FAO/WHO Expert Committee on Food Additives
  (JECFA)
• Processing aid versus Additive
• Regulatory and Labeling requirements
• Dosage of enzyme product in application
• Organic solids from fermentation
• Consumption
• Daily consumption of food per person per kg
• Exposure
• Estimated Daily Intake Dosage x Consumption
• Safety Margin
• NOAEL/EDI

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European Industry Approach to Safety Evaluation
of Food Enzymes
Conclusion

• Enzyme product expressed by the (GMM) production
  strain can be safely applied for its intended use
  in food manufacture

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European Industry Approach to Safety Evaluation
of Food Enzymes
Present

• Enzymes are safe
• Strains have safe history
• Manufacturing process is safe
• Worst case evaluation

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European Industry Approach to Safety Evaluation
of Food Enzymes
Near Future From a consumer safety point of view

• No difference between processing aid and food
  additive
• No difference between non GMO and GMO derived
  enzymes
• No necessity for long term animal studies

More sophisticated legislation

• Simple regarding safety issue
• Taking safe strain lineage concept into account