Compliance testing of food contact materials EU FDA
FDA testing
Testing of food contact materials to check for compliance with the regulations as is described in the Code of Federal regulations (21 CFR 170-190), is mainly focused on the starting materials in most cases. Combined articles must be tested according and met with their specific paragraphs. The text below is a short description. Please review the relevant section(s) very carefully and use the text below as a general introduction.
175 Adhesives
No special analytical testing is required in most cases for adhesives. For some components a maximum amount that may be used or the use for a specific goal is described. If
component described in other sections are used they must comply with the
requirements and limitations as described in the section(s).
175.300 Coatings on metal
Coatings on metal must meet the extraction test requirements of 21 CFR 175.300 (d) table 1 and 2.
In most cases no additional testing is required. Some limitations may apply for
the use of residual content present of the some ingredients.
21 CFR 175.300 (d) table 1—types of food
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsion, high- or low-fat.
B. Oil-in-water emulsion, high- or low-fat.
V. Low moisture fats and oils.
VI. Beverages:
A. Containing alcohol.
B. Nonalcoholic.
VII. Bakery products.
21 CFR 175.300 (d) table 1—types of food
176 Paper
The testing of paper consist in most cases
of extraction tests of the paper using the 21 CFR 176.170 table 1 and 2 as mentioned below.
Sometimes testing is described for the residual content of certain components
added to paper.
21 CFR 176.170(c), Table 1 (Types of Raw and Processed Foods)
I. Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types
VIII or IX of this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end test required).
IX. Dry solids with the surface containing free fat or oil.
177 Polymers and rubber articles
The testing consist in most cases of extraction tests or migration of the
granulate material or sheet form of the base polymer. Sometimes some additional
requirement such as viscosity of the base polymer is present that may need to be
checked for compliance. Sometimes testing is described for the residual content
of a monomer (for example styrene or acrylonitril) or the solubility of the
polymer is mentioned (nylon for example). Each polymer type has his own set of
testing and limitations that must be met. If the final product consist of
mixtures of polymers (blends) each polymer type must met its own section.
Additional requirements could be present for the maximum amount for some
additives, which compliance should be checked (could be done by administrative
or experimental compliance).