Enhancing the regulatory decision-making approval process for direct food ingredient technologies : workshop summary

Enhancing the regulatory decision-making approval process for direct food ingredient technologies workshop summary

Detalles Bibliográficos
Autor Corporativo: Institute of Medicine (U.S.). Food Forum (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1999.
Edición:1st ed
Materias:
Food additives > United States > Congresses.
Food additives > Safety regulations > United States > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820328606719
Tabla de Contenidos:
  • Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies
  • Copyright
  • PREFACE
  • Contents
  • WORKSHOP SUMMARY
  • INTRODUCTION AND BACKGROUND
  • OVERVIEW OF THE APPROVAL PROCESS FOR FOOD USE SUBSTANCES
  • Food Additives
  • GRAS SUBSTANCES
  • Interim Additives
  • LEGAL FRAMEWORK OF THE INGREDIENT APPROVAL PROCESS
  • Flaws of the Current Review Process
  • Proposed Changes in the Approval Process
  • Change or Enforce Deadlines for Petition Reviews
  • Implement User Fees
  • Grant a Period of Market Exclusivity
  • Re-evaluate GRAS Affirmation Process
  • Eliminate Notice-and-Comment Procedures
  • Abbreviate Review for Supplemental Uses
  • Evaluate Use of Extramural Petition Review
  • Prioritize Reviews
  • Implement Safeguards to Prevent Sham Petitioning
  • Establish a Sunset Period for Interim Additives
  • Foster Improved Communication between Industry and FDA
  • Improve Quality of Petitions Submitted to FDA
  • SCIENTIFIC INTERPRETATION AND THE APPROVAL PROCESS
  • CRITERIA TO EVALUATE FOOD ADDITIVE SAFETY
  • CURRENT EFFORTS
  • International Efforts
  • IMPROVING THE REGULATORY REVIEW PROCESS
  • Government Perspective
  • Industry Perspective
  • Consumer Perspective
  • SUMMARY
  • APPENDIX A Legal Aspects of the Food Additive Approval Process
  • HISTORY
  • The Food, Drug, and Cosmetic Act of 1938
  • The Food Additives Amendment of 1958
  • DEFINITION OF FOOD ADDITIVE
  • Components of Food
  • Indirect Additives
  • Dietary Supplements
  • Generally Recognized as Safe
  • APPROVAL PROCEDURES
  • Food Additive Petitions
  • GRAS Affirmation Petitions
  • Interim Food Additives
  • SAFETY STANDARDS
  • General Safety Standard
  • Carcinogenicity and the Delaney Clause
  • Special Restrictions: Labeling
  • CASE STUDIES
  • Artificial Sweeteners: Aspartame
  • Biotechnology: Calgene's Tomato
  • Novel Macroingredients: Olestra.
  • THE COMPOSITE PICTURE
  • Track Records Compared
  • A Catalogue of Proposed Solutions
  • Internal Management Initiatives
  • Statutory Hammers
  • Prioritizing Reviews
  • Imposing User Fees
  • Extramural Reviews
  • Combatting Sham Petitioning
  • CONCLUSION
  • APPENDIX: INTERNATIONAL COMPARISONS
  • Canada
  • The United Kingdom
  • The European Union
  • Japan
  • REFERENCES
  • APPENDIX B Case Studies of the Implementation of the Direct Food and Color Additives Amendments to the Federal Food, Drug,…
  • TECHNOLOGICAL AND SOCIAL FACTORS THAT HAVE AFFECTED INTRODUCTION OF NEW DIRECT FOOD INGREDIENTS AND PROCESSES
  • Introduction
  • Developments in Analytical Chemistry
  • Developments in Toxicology
  • The Emerging Understanding of Mechanisms
  • Changes in Risk and Safety Assessment
  • Changes in Agriculture
  • Environmental Concerns
  • Consumer Activity
  • Changes in Food Marketing and Consumption Trends
  • The Impact on FDA
  • Provisions That Continue to Work Well after Six Decades
  • Conclusion
  • CYCLAMATE
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • IRRADIATED POULTRY
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • OLESTRA
  • Overview
  • Chronology
  • Lessons Learned
  • FD&amp
  • C RED NO. 2 (AMARANTH)
  • Overview
  • Chronology
  • Comment
  • Lessons Learned
  • FD&amp
  • C RED NO. 3 (ERYTHROSINE)
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • TCE AND DCM
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • D-LIMONENE
  • Overview
  • Chronology
  • Lessons Learned
  • BENZYL ACETATE
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • ISO-AMYL ACETATE
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • FURFURAL
  • Overview
  • Chronology
  • Comments
  • Lessons Learned
  • PULSED LIGHT
  • Overview
  • Chronology
  • Lessons Learned
  • CHYMOSIN
  • Overview
  • Chronology
  • Comment
  • Lessons Learned.
  • APPENDIX C Enhancing the Regulatory Approval Process for Food Ingredient Technologies A Workshop
  • WORKSHOP AGENDA
  • APPENDIX D Enhancing the Regulatory Approval Process for Food Ingredient Technologies
  • PARTICIPANTS LIST
  • ACRONYMS.

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