REGULATIONS IN FOOD INGREDIENTS

Transcription

1 REGULATIONS IN FOOD INGREDIENTS Prepared by: CPL Business Consultants The Manor House, Howbery Park, Wallingford, Oxfordshire, OX10 8BA Tel: , Catherine Robinson, MSc Jessica Carter, BSc Dr Robert Harwood Dr Esther Hunter Dr Steve Lisansky July 2012

2 Food Regulations - contents - i TABLE OF CONTENTS INTRODUCTION... 1 CONTENTS AND RECOMMENDATION... 1 REGULATORY CONTACTS contacts... 1 DIFFERENCES BETWEEN US AND EU REGULATORY SYSTEMS... 8 Dietary Supplements... 8 Food Additives... 8 Novel Foods/GRAS... 8 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/ 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... 78

3 Food Regulations - contents - ii 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/ 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

4 Food Regulations - contents - iii TABLES TABLE 1 COMPARISON OF DIETARY SUPPLEMENTS LEGISLATION IN THE US AND EU... 8 TABLE 2 COMPARISON OF FOOD ADDITIVES LEGISLATION IN THE US AND EU... 8 TABLE 3 COMPARISON OF NOVEL FOODS/GRAS LEGISLATION IN THE US AND EU... 8 TABLE 4 WHEAT GERM OIL HEALTH CLAIMS TABLE 5 SPHINGOLIPID HEALTH CLAIMS TABLE 6 BRANCHED CHAIN AMINO ACIDS HEALTH CLAIMS TABLE 7 SKIN RELATED HEALTH CLAIMS UNDER ARTICLE TABLE 8 CHOLESTEROL LOWERING HEALTH CLAIMS UNDER ARTICLES 13.1 AND TABLE 9 DEFINITION OF AN NDI AND REQUIREMENT FOR NDI NOTIFICATION TABLE 10 A COMPARISON OF FOSHU RATES OF APPROVAL TABLE 11 PROFILE OF SPECIFIED HEALTH USES APPROVED FOR FOSHU PRODUCTS TABLE 12 DETAILS REQUIRED BY MHLW IN THE APPROVAL OF A FOSHU PRODUCT TABLE 13 MEDICAL FOODS FOR THE ILL TABLE 14 A COMPARISON OF FNFC, FOSHU AND SO-CALLED HEALTH FOODS : TABLE 15 AUTHORISED AND UNAUTHORISED HERBS FOR USE IN FUNCTIONAL FOODS IN CHINA FIGURES FIGURE 1 OVERVIEW OF EU FOOD LEGISLATION FIGURE 2 ORGANISATION OF THE HEALTH CLAIM APPLICATION FIGURE 3 TYPES OF SUBSTANCES FOR WHICH GRAS NOTICES HAVE BEEN SUBMITTED FIGURE 4 NDI NOTIFICATION GUIDANCE DECISION TREE FIGURE 5 FOOD INGREDIENT REGULATORY PATHWAYS FIGURE 6 COMPARISON OF REGULATORY PATHWAYS FIGURE 7 FDA FOOD INGREDIENT DECISION TREE FIGURE 8 FLOW CHART OF FOSHU APPROVAL FIGURE 9 DECISION TREE FOR HEALTH CLAIM PROCEDURE IN JAPAN FIGURE 10 EXAMINATION AND APPROVAL DECISION TREE FOR FUNCTIONAL FOODS IN CHINA

5 Food Regulations - contents - iv CHINA REGULATIONS CONTENTS OF THE APPENDIX FOOD LAW China Food Law GAIN Report China Food Safety Law 2009 LABELLING China Labelling regulation REGULATIONS AND NEWS China Advancing Food Safety China food and agricultural import regulations and standards China Food Standards and Exports China Update on Chinese Regulations EU REGULATIONS FOOD ADDITIVE INFORMATION Data requirements for the evaluation of food additive applications (EFSA) 2009 Guidance on submissions for food additive evaluations 2001 Practical guidance on submission of application on food addtitives, food enzmes & food flavourings UK Food Additive Guidance Notes FOOD SUPPLEMENT INFORMATION Annex I and Annex II of Directive EC EU Report on Food Supplements Food Supplements Directive EC NHS Report on Supplements HEALTH CLAIMS INFORMATION BCAA Health Claims EFSA Consolidated List of Health Claims 13.1 EFSA guidance for preparation of application for authorisation of a health claim EU press release regarding health clams list FSA compliance guide for Regulation Guidance on EFSA Spingomyelin Health Claim Wheat Germ Oil and Immunity Wheat Germ Oil Health Claims LABELLING INFORMATION Directive EC EU Food Labelling Laws Directive EC Foodstuffs Intended for Particular Nutritional Uses Draft regulation regarding specialised food products (repeals Dir EC) SUMMARY TABLE OF DIETETIC FOODS NOTIFIED IN MEMBER STATES NOVEL FOODS INFORMATION Example of novel food application Notification of Novel Foods in EU Regulation EC Information necessary to support application UK guidance to demonstrate substantial equivalence VITAMIN & MINERALS INFORMATION Admin guidance for submission for safety of substances inc vitamins & minerals Guidance on submission for safety evaluation of nutrients or other ingredients for use in food Regulation including Annex I and Annex II General Principles and Requirements of Food Law Regulation EC Guidance on EU Food Controls JAPAN REGULATIONS FOOD LAW Food Safety Basic Law Food sanitation Ordinance for Enforcement of the Food Sanitation Act Relationship between national and local governments FOOD SAFETY INFORMATION Standards for the safety assessment of GMO Foods

6 Food Regulations - contents - v REGULATIONS GUIDANCE Food and agricultural import regulations and standards - narrative tokyo japan Food Regulations FOSHU Presentation Guidebook for Export to Japan (Food Articles) 2011 Handbook for Consumer Products Imports Regulations Newly established regulation in Japan Foods with Health Claims Overview of Administration of Food Safety Japanese and International Regulatory Comparison (2003) SPECIFICATIONS AND FOOD LISTS Compendium of food additive specifications List of products that are being safety evaluated List of products that have undergone safety assessment Specs and Standards for foods, food additives etc Specs Standards and testing Methods for foodstufs implements containers and packaging US REGULATIONS DIETARY SUPPLEMENTS GUIDANCE INFO NDI for Phyto-Derived Ceramides New Dietary Ingredient Notification Draft Guidance for Industry FOOD SAFETY LAWS INFORMATION Food Safety Modernisation Act How to Submit a GRAS notice Sub Chapter B Food for Human Consumption Subchapter B Food for Human Consumption cont HEALTH CLAIMS GUIDANCE INFO Approved Health Claims and Requirements for Labelling Guidance for Industry on Evidence Based Review System for Scientific Evaluation of Health Claims Guidance for Industry on Health Claims based on an Authoritative Statement of a Scientific Body Interim Procedures for Qualified Health Claims in Labelling of Food & Dietary Supplements Structure function claims guidance for industry