Ionomeric resins manufactured from either ethylene-methacrylic acid copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl acetate copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts,), or methacrylic acid polymers with ethylene and isobutyl acrylate (and/or their potassium, sodium and/or zinc partial salts) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions:
Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.
Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.
Solvent | Time | Temperature |
n-Heptane | 1 2 | 120 °F (49 °C). |
Water, 3% acetic acid, or 8%/50% ethanol | 1 48 | 120 °F (49 °C). |
1 Hours
Solvent | Minimum extraction times (hours) |
n-Heptane | 8, 10, 12 |
Water, 3% acetic acid, or 8%/50% ethanol | 72, 96, 120 |
The results from a series of extraction times demonstrate equilibrium when the net chloroform-soluble extractives are unchanging within experimental error appropriate to the method as described in paragraphs (d)(1)(i) and (2)(i) of this section. Should equilibrium not be demonstrated over the above time series, extraction times must be extended until three successive unchanging values for extractives are obtained. In the case where intended uses involve temporary food contact above 120 °F, the food-simulating solvent is to be contacted with the food-contact article under conditions of time and temperature that duplicate the actual conditions in the intended use. Subsequently the extraction is to be continued for the time period and under the conditions specified in the above table.
where:
e = Milligrams extractives per sample tested.
s = Surface area tested, in square inches.
F = Five, the ratio of the amount of extractives removed by heptane under exaggerated time-temperature test conditions compared to the amount extracted by a fat or oil under exaggerated conditions of thermal sterilization and use.
e' = Acidified chloroform-soluble extractives residue. e' is substituted for e in the above equations when necessary (See paragraph (e)(6)(ii) of this section for method to obtain e').
If when calculated by the equations in paragraphs (e)(6)(i)(a) and (b) of this section, the extractives in milligrams per square inch exceed the limitations prescribed in paragraphs (c) or (d) of this section, proceed to paragraph (e)(6)(ii) of this section (method for determining the amount of acidified chloroform-soluble extractives residue).
Table 1
Types of food | Appropriate solvent |
1. 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 | Water, n-heptane. |
2. 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 | n-heptane, water, 3% acetic acid. |
3. 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 | Water, n-heptane, 3% acetic acid. |
4. Dairy products and modifications: | |
Water, n-heptane | |
i. Water-in-oil emulsions, high or low fat | |
ii. Oil-in-water emulsions, high or low fat | |
5. Low moisture fats and oils | n-heptane. |
6. Beverages: | |
i. Containing up to 8% alcohol | 8% ethanol/water. |
ii. Nonalcoholic | 3% acetic acid. |
iii. Containing more than 8% alcohol | 50% ethanol/water. |
7. Bakery products | Water, n-heptane. |
8. Dry solids (without free fat or oil) | No extraction test required. |
9. Dry solids (with free fat or oil) | n-heptane. |
21 C.F.R. §177.1330