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Food and Drug Administration of United States (US FDA) – Materials that are used in contact with food products

The Food and Drug Administration (FDA) is the regulatory agency of the United States government that is responsible for determining how materials may be used in contact with food products. The FDA participates in publication of The Federal Register, which contains The Code of Federal Regulations (CFR), a codification of the general rules established by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent a broad subject matter.

Definitions for proper use of food contact materials are found in a series of regulations published annually under The Code of Federal Regulations (CFR) Title 21. Title 21 - Food and Drugs is composed of nine volumes, which are subdivided into Parts. Part 177 - Indirect Food Additives: Polymers lists standards for polymers acceptable for use in components of single and repeat use food contact surfaces. Part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers includes standards for certain polymer additives. Parts are divided into Sections identified by chemical family which indicate physical, chemical, and compositional requirements, as well as acceptable service conditions for food contact. Regulations generally limit the extractable substance when exposed to selected solvents.

Within the FDA, there is no government-operated process of inspection of plastics produced for food contact use. Rather, the FDA in their regulations provides certain specifications regarding composition, additives, and properties. A material which meets these standards can then be stated as FDA COMPLIANT. End users should note that it is their responsibility to use the product in a manner compatible with FDA guidelines.

Ceramicware

U.S. Compliance Policy Guides / California Safe Tableware Law and California Proposition 65

Leachable Lead and Cadmium Contents are determined. The requirements are listed as below:

Lead Cadmium

(mcg/ml) (mcg/ml)

Internal Surface (Flatware)

FDA and California Safe Tableware Law :

3.0

0.5

California Proposition 65 :

0.226

3.164

Internal Surface(Small Hollowware)

Any one of six of FDA and California Safe Tableware Law:

2.0

0.5

California Proposition 65 (Average) :

0.1(0.023)

0.332

Internal Surface(Large Hollowware)

Any one of six of FDA and California Safe Tableware Law:

1.0

0.25

California Proposition 65 (Average) :

0.1

(0.023/0.006)

0.084

Internal Surface(Cup and Mug)

Any one of six of FDA and California Safe Tableware Law:

0.5

California Proposition 65 (Average) :

0.1

(0.023)

0.332

Internal Surface(Pitchers)

Any one of six of FDA and California Safe Tableware Law:

0.5

0.25

California Proposition 65 (Average) :

0.1

(0.023/0.006)

0.084

At Rim Surface

Limit of SGCD and CSC :

4.0

0.4

Canada -- Canada AG

Agriculture & Agrifood Canada (Food Production and Inspection Branch) and Health Canada (Health Protection Branch) are the Canadian government agency equivalents to the United States' USDA and FDA, respectively. These Canadian counterparts both conduct evaluations on material formulations, issuing "no objection letter(s)" on an application specific basis. Unlike current FDA and USDA policies, materials cannot be self-certified by manufacturers without prior Agency review and approval.