Introduction to FDA legislation

It is very difficult to present a complete introduction of the FDA legislation and the practical use for the clearance of a food contact material. This page must be considered as a short introduction to get familiar with the vocabulary.  If you are not experienced with handling the FDA regulations, please be careful to avoid misinterpretations.

The FDA considers three different types of food additives:

- Direct food additives Components added directly to the food
- Secondary direct food additives Components that are added to the food due to food treatment like treating food with ionic resins, solvent extraction
- Indirect food additives Substances that may come into contact with food as part of packaging or processing equipment, but are not intended to be added directly to food

The food contact materials are described in the Code of Federal Legislation (CFR): 21 CFR 174 - 21 CFR 190. Important starting points are:
  21 CFR 175 Indirect food additives: Adhesives and components of coatings
  21 CFR 176 Indirect food additives: Paper and paperboard components
  21 CFR 177 Indirect food additives: Polymers

To this materials additives may be added. Which additives depend on the additive and on the material in which it is intended to be used. There must be a reference to the paragraph in which the additive is mentioned and the restrictions (for example only to be used in polyolefines) and limitations (max 0.5% in the final product) must be respected. See below for part in which additives are described:
  21 CFR 170 Food additives
  21 CFR 171 Food additive petitions
  21 CFR 172 Food additives permitted for direct addition to food for human consumption
  21 CFR 173 Secondary direct food additives permitted in food for human consumption
  21 CFR 178 Indirect food additives: Adjuvants, production aids, and sanitizers
  21 CFR 180 Food additives permitted in food or in contact with food on an interim basis pending additional study

A more detailed overview of the legislation can be found under the header 'legislation'.

Polymers or additives can also be regulation in other ways, the exemptions, like:
- Threshold of regulation
- Food contact notification
- Private letters
- Prior sanctioned food ingredient
- Gras

Special issues:
No-migration TO BE ADDED
Housewares Housewares, like kitchen utensils, beverage dispensers, glasses used in households and restaurant are not covered by the CFR. However, when an unsafe situation does occur the FDA can react.
Basic resin doctrine Unless a specification is given in the relevant paragraph, if components do have to be used during the production process of the polymer (components like catalysts, chain transfer agents, initiators etc) and they are bound into the polymer or washed out, they need not to be listed separately, because they considered as a part of the regulated polymer

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