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Introduction to Food Contact Regulations
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Introduction to Food Contact Regulations
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Today’s Moderator
Madison AdamsAssent ComplianceCompliance Specialist
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Introduction
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Assent Product SuitesOur Market Leading Platform
Corporate Social Responsibility Product Compliance
Vendor Management Inspections
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Today’s Presenter
Bruce JarnotAssent ComplianceSenior Manager, Product Compliance
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Agenda
1 What Are Food Contact Materials?
2 How Are Food Contact Materials Regulated?
3 Good Manufacturing Practice (GMP)
4 Statutory vs. Migration Regulations
5 Demonstrating Compliance
6 Questions
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Feature Presentation
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It’s all about CONSUMER HEALTH!
Introduction to Food Contact Regulations
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Food contact materials include:
■ Any materials that have foreseeable contact with food■ Food packaging■ Kitchen utensils■ Domestic and commercial food processing equipment
What Are Food Contact Materials?
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Food contact materials are indirect food additives. For example:
■ Metals, alloys, glass and ceramics■ Polymers■ Paper and paperboard■ Coatings■ Adjuvants and production aids■ Adhesives■ Lubricants, wax and grease
What Are Food Contact Materials?
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Global food contact regulations are extremely complex. ■ North America■ Latin America■ Europe, the Middle East and Africa■ Northern and Southern Asia
How Are Food Contact Materials Regulated?
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■ Good Manufacturing Practice■ Statutory Regulations■ Migration Testing■ Risk Assessment
How Are Food Contact Materials Regulated?
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Good manufacturing practices for food contact materials:
■ Required for food contact materials throughout the world□ U.S. FDA 21 CFR 174.5□ EU Commission Regulation (EC) 2023/2006□ Etc.
Good Manufacturing Practice (GMP)
GMP includes:
■ Preventing contamination and cross-contamination■ Clearly defined and controlled manufacturing processes■ Clean manufacturing, packaging and storage facilities■ Operator training■ Corrective action plans■ Collection and retention of appropriate documentation■ Auditing, as needed
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Statutory regulations…
■ Primarily apply to North American compliance■ Are industry self-enforced, but open to government inspection■ Require statute-based compliance
□ U.S. FDA 21 CFR & GRAS substances “generally recognized as safe”□ Canada Safe Food for Canadians Act (SFCA)□ USDA & National Sanitation Foundation (NSF)
■ Based on positive (acceptable) and negative (unacceptable) substance lists■ Require GMP ■ Require documentation
Statutory vs. Migration-Based Regulations
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Migration-based regulations…
■ Primarily apply to European compliance■ Include positive (acceptable) and negative
(unacceptable) substance lists■ Require specific total and specific migration
testing
Statutory vs. Migration-Based Regulations
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Migration evaluates inertness…■ Migration tests the transfer of substances into food
Overall (total) vs. specific migration testing…■ Overall migration looks at total weight of extracted
substances■ Specific migration looks at material-specific restricted
substances□ Example: BPA extracted from polycarbonate
plastic□ Example: PAHs extracted from carbon black
Statutory vs. Migration-Based Regulations
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Migration testing conditions…
■ Based on intended and foreseeable product use conditions
□ Specified temperature□ Specified time□ Specified food simulant (Water,
Oil, 50% Alcohol…)
Statutory vs. Migration-Based Regulations
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Other regions/countries ■ Include elements of both statute- and migration-based compliance
Migration test conditions may vary from EU standards…■ China■ Japan■ Latin America (e.g. Mercosur countries)■ Others
Statutory vs. Migration-Based Regulations
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Food contact compliance cannot be demonstrated through a DSL. ■ The same CAS number may have different grades of purity
◻ Example: Salt (NaCl)◻ Example: Carbon black
■ Food contact materials require GMP, statutory and/or migration testing requirements■ Food contact Materials require documentation
Demonstrating Compliance
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Demonstrating Compliance
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Suppliers may offer food grade materials and formulants.■ Polymers■ Coatings■ Greases and waxes■ Other materials
Food grade is often a marketing claim.■ Sales literature, tech data sheets, etc.■ Should specify regulation(s) and section(s)
Religious certifications.■ Kosher■ Halal
Demonstrating Compliance
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Demonstrating Compliance
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How should I manage migration testing?■ Engage a third-party lab to assist with:
◻ Protocol design (important!)◻ Overall and specific migration testing
Consider testing the finished product or assembly…■ Provides most realistic use scenario■ Provides appropriate component exposure to
food simulant
Demonstrating Compliance
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What if the material is not specified as being food grade?
■ Ask the vendor if they have a food grade alternative■ Ask the vendor whether they have previously investigated food use■ Ask the vendor for a full formulation disclosure for third-party review
When should I consider a risk assessment?
■ If the material (e.g. ink) contains proprietary substances■ If the material is questionable for food safety ■ Should be performed by a competent third-party service
Demonstrating Compliance
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Questions/DiscussionConclusion
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