AY06 Regulations in Food Ingredients

Have a look at our PowerPoint Introduction and Brochure describing deliverables, differentiators and case studies. Eight case studies can also be reviewed.

Objective

This report outlines the regulations for food, dietary supplements, medical foods/devices etc. in the EU, US, Japan and China. For each of these, we have outlined information relating to definitions, toxicity, safety, health claims, labelling and enforcement. Where possible, we have included decision trees so that the process can be clearly envisaged. Some information is also provided on timescales.

Additional information has been included in the appendix, including specific formats for applications (e.g. novel foods in EU etc.). Although CPL Business Consultants has collated data for this report and is aware of the regulations regarding food ingredients and related areas, it is not a specialised regulatory consultancy.

Click to see the contents of the study or look below for an outline.

Table of Contents

Introduction

Introduction

  • Contents and Recommendation
  • Regulatory Contacts
    • 8 contacts

Differences between US and EU Regulatory Systems

    • Dietary Supplements
    • Food Additives
    • Novel Foods/GRAS

European Regulations

  • Summary
  • Definitions
    • Food or ‘Foodstuff’
    • Food Supplements
    • Medical Products
    • Additives
  • Toxicity / Safety
    • General Food Law
    • Novel Foods
    • Addition of Vitamins and Minerals and of certain other substances to food
    • Food Additives
    • Food Supplements
  • Health Claims
    • Nutrition and Health Claims made on Foods
    • Regulation No 1924/2006
    • EFSA Health Claim submissions related to BCKAs and Sphingolipids
  • Labelling
    • Proposed New EU Law in Food Information to Consumers
    • Foodstuffs for Particular Nutritional Uses (PARNUTS)
    • New EU Commission Initiative on Specialised food products
  • Enforcement
    • Regulations
    • Directives
    • EFSA

US Regulations

  • Summary
  • Definitions
    • Food or ‘Foodstuff’
    • Food Supplements
    • Medical Food
    • Food Additives
  • Toxicity / Safety
    • Food Additives
    • Generally Regarded As Safe (GRAS)
    • Dietary Supplements
    • Comparison of Regulatory Pathways for a Proposed Food Ingredient
  • Health Claims
  • Labelling
    • Labelling of Dietary Supplements
    • Label Claims for Dietary Supplements
  • Enforcement
    • Food Ingredient Decision Tree

Japanese Regulations

  • Summary
  • Definitions
    • Food or ‘Foodstuff’
    • Functional Foods and Drinks
    • Dietary Supplements
    • Medical Products
    • Additives
  • Food Safety
    • General Food Law
    • Novel Foods
  • Health Claims
    • Nutrition and Health Claims made on Foods
    • Foods with Nutrient Function Claims (FNFC)
    • FOSHU (Foods for Specified Health Uses)
    • “Unregulated” With Respect to Health Claims (So-called health foods)
    • FOSDU (Food for Special Dietary uses)
  • Labelling
  • Enforcement
    • Food Safety Commission (FSC)
    • Ministry of Agriculture, Forestry and Fisheries (MAFF)
    • The Ministry of Health, Labour and Welfare
    • Consumer Affairs Agency

Chinese Regulations

  • Summary
  • Definitions
    • Food or ‘Foodstuff’
    • Functional Food and nutrients supplements
    • Dossier components for preparation of functional food applications in China
    • Additional restrictions on Chinese traditional remedies and medicines
    • Provisions for the Naming of Health Food
    • Special Dietary Foods
    • Food Supplements
    • Food Additives
    • Novel Foods
  • Food Safety
    • General Food Law
    • Food Safety Law of the People’s Republic of China
    • Novel Food Regulation (2007) – Administrative Measures on Novel Food under G/TBT/N/CHN/240
    • Health Food Regulation (1996)
    • Probiotic Health Food Regulation (2005)
    • Medicine Administration Law (2001)
  • Health Claims
    • Differentiating functional foods and drugs
    • Approved Health Claims
    • Substantiation based on product testing
    • Substantiation based on scientific literature
    • Types of health claim
  • Labelling
    • Standard for Nutrition Food Labelling or pre-packaged foods
  • Enforcement
    • Ministry of Health
    • State Food and Drug Administration (SFDA)
    • National drug and food complaints centre

15 Tables

10 Figures

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