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In a thorough update of the bestselling first edition, Pira International has worked again with the Packaging Group at Keller and Heckman LLP to produce the second edition of Food Contact Legislation for US Markets. This brand new edition provides in-depth insights into the Food and Drug Administration's (FDA) implementation of its Food Contact Notification program and its future. The updated volume features expanded coverage of the FDA's 2007 updated Chemistry Recommendations, the FDA's allergen labeling requirements, and practical advice about gaining clearances under the Federal Food, Drug and Cosmetic Act. The volume also tackles the problematic impact that state legislative mandates have on FDA regulation of food contact materials, and how these state initiatives can often impose inappropriate pressures on agency and market behaviors.
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- Explicit FDA sanctions
- Exemptions from the FDA's pre-clearance authority
- Special issues, including the use of recycled material in food packaging
- California's Green Chemistry Initiative
Contents
Introduction
History of FDA Regulation
- The Pure Food and Drug Act of 1906
- The Federal Food, Drug, and Cosmetic Act of 1938
- Amendments
State vs Federal Authority
Setting the Stage
- Definition of food
- Food additive
- Food contact substance
The Adulteration Standard of the Act
- Section 402 - general
- Section 402 and 409
- Safety criteria - reasonable certainty of no harm
Explicit FDA Sanctions of Food Contact Materials
- The food additive regulations
- Threshold of regulation
- Food contact notifications
Examples of Specific Regulations
- Adhesives
- Can coatings
- Paper and paperboard
- Colorants
- Irradiated food packaging
Pre-market Regulatory Authority Exemptions
- No migration/No food additive position
- Functional barrier doctrine
- GRAS substances
- Prior sanctions
- Housewares
- Basic resin doctrine
Special Issues
- Recycled packaging in contact with food
- Printing inks
- Active & intelligent packaging
- Solvents
- Modified atmospheric packaging
- Phthalates
- Allergens
- Nanotechnology
Food Contact Notifications
- Overview
- The FCN process
- Changes to an existing FCN
Filing Food Additive Petition/Food Contact Notification
- FDA's guidance documents
- Composition and method of manufacture
- Intended conditions of use
- Amount of additive in food and entering the diet
- Safety of the additive
- Environmental assessment
- FDA's review of FCNs
Protecting Confidential Information
- Freedom of Information Act
- Structuring FDA submissions to protect CBI
- Food additive master files
- Disclosure of non-confidential information - when and where
- Customer Assurance
- Compliance letters
- Section 303 guarantees
- Liability
- Third-party certifications
When to Go to the FDA
FDA Enforcement Authority
- Strict liability
- Civil and criminal liability
- Prohibitions under the Act
- Judicial & non-judicial options to stop behaviours
Other Laws Bearing on Food Packaging
- Bioterrorism Act
- CONEG heavy metals statutes
- California Safe Drinking Water and Toxic Enforcement Act of 1986
- State recycling laws
- State coding laws
- Toxic Substances Control Act
- Regulation of antimicrobials
Conclusion