In this case study, a global speciality chemicals company engaged CPL to assist in its diversification strategy into food ingredients by providing guidance on the relevant regulations in Europe, the US, Japan and China.
Objective
This report outlined the regulations for food, dietary supplements, medical foods/devices etc. in the EU, US, Japan and China. For each of these, we included information relating to definitions, toxicity, safety, health claims, labelling and enforcement. Where possible, we also included decision trees to show how the processes work clearly. Some information was also provided on timescales.
Additional information was included in an appendix, which included specific application formats (e.g. novel foods in the EU etc.). Although CPL Business Consultants has knowledge of the regulations for food ingredients and related areas, it is not a specialised ‘regulatory consultancy’ (i.e. does not prepare and submit dossiers).
Click to see the contents of the study, or look below for an outline.
Food Ingredients Regulations
Introduction
- Contents and Recommendation
- Regulatory Contacts
- 8 contacts
Differences between US and EU Regulatory Systems
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- 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 Food Ingredients 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 Food Ingredients 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 Food Ingredients 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
Have a look at our PowerPoint Introduction and Brochure describing deliverables, differentiators and case studies. You can also review eight case studies.