Latest edition (the twelfth edition) FCC 12 has over 80 new and updated monographs compared to FCC 11. More than 1,250 monographs including: •
Probiotics &
prebiotics •
Flavors •
Preservatives •
Sweeteners • Fats and oils •
Nutrients •
Colorants •
Infant formula ingredients 18 appendices, providing clear, step-by-step guidance for more than 150 tests and assays including: • Lead limit test • Food Fraud Mitigation Guidance • Guidance on Developing and Validating Non-Targeted Testing
Third edition The specifications in this edition of FCC were officially recognized not only by the FDA but also, under certain conditions, by the Canadian, Australian, New Zealand and UK authorities. This edition shows substantial differences in format from its 9-year-old predecessor, including much larger pages and two-column layout. The addition of 113 new monographs brings the total number to 776, covering over 800 substances. For the first time these include materials such as
dextrose and
fructose, more generally regarded as foods than as additives. Only one monograph, for
aluminium sulphate solution, has been deleted because it appears to be no longer used in foods. The monograph section previously entitled 'Specifications' has been changed to 'Requirements', and this also includes any identification tests that previously appeared under a 'Description' section. Other changes in this edition are the inclusion for the first time of general
Good Manufacturing Practices (GMP) guidelines for food chemicals, and the abandonment of a previous policy whereby the specifications for individual substances applied also to mixtures of the primary substance with additives such as
anticaking agents,
antioxidants and
emulsifiers.
Fourth edition Fifty-two new monographs are added to the third edition, making a total of 967 monographs. In the course of the four editions, FCC has been expanded to include not only food additives, but also substances that come into contact with food and substances that are food (e.g.
fructose and
dextrose). However, three previous monographs have now been deleted (i.e.
carrageenan, cinnamyl antranilate and
methyl formate) due to altered circumstances and special emphasis is now placed on reducing contaminants, particularly lead.
Sixth edition This edition was the first under USP's direction. This edition contains more than 1,000 monograph standards and tests to assure the identity, quality and purity of food ingredients.
Eighth edition This authoritative edition provides: • More than 1,100 monographs, which include chemical formula and structure, chemical weight, function, definition, packaging and storage, labelling requirements, test procedures and more. • Fourteen appendices, which detail more than 150 tests and
assays, with step-by-step guidance for the analysis of
enzymes,
impurities such as metals and pesticides and markers for authenticity testing, among others. • General information, which includes relevant information on a variety of topics including GMP Guidelines for Food Chemicals, a compare-and-contrast table of food and drug GMPs, a table of citations where the FCC has been incorporated by reference in the U.S. Code of Federal Regulations, AOAC International/
International Organization for Standardization (ISO)/
International Union of Pure and Applied Chemistry (IUPAC) method validation guidelines, and helpful introductions into a variety of different analytical test methods. This edition also features for the first time the complete contents of USP's upcoming Food Fraud Database. The database features more than 1,300 entries on adulterants reported for specific ingredients and the corresponding analytical detection method. Based on scholarly manuscripts and media articles from 1980-2010, it serves as a baseline on fraud issues and can be a useful risk management tool for industry, regulators and other stakeholders.
Ninth edition The ninth edition includes latest specifications for the identity and purity of about 1,200 food ingredients, including test methods and key guidance on critical issues. Among the new monographs in the FCC is
spirulina, a food ingredient that was just recently approved as a natural source of blue colour for candy and chewing gum by the US FDA. Formulators also use spirulina in specialty food bars, powdered nutritional drinks, among other products due to its non-animal protein content. Another monograph included in this edition of FCC is brilliant
black PN, a synthetic food colour used in products requiring the colour black in their formulation (jams, chocolate syrup and candy are common examples). Even though the FDA has not approved brilliant black PN as a food colour in the USA, its use in food is currently approved in many other countries.
Fourteenth edition As of mid-2024, the latest edition is the 14th. ==Applications==