Rubber articles intended for repeated use may be safely used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

The rubber articles are prepared from natural and/or synthetic polymers and adjuvant substances as described in paragraph (c) of this section.

The quantity of any substance employed in the production of rubber articles intended for repeated use shall not exceed the amount reasonably required to accomplish the intended effect in the rubber article and shall not be intended to accomplish any effect in food.

Substances employed in the preparation of rubber articles include the following, subject to any limitations prescribed:

Substances generally recognized as safe for use in food or food packaging.

Substances used in accordance with the provisions of a prior sanction or approval.

Substances that by regulation in parts 170 through 189 of this chapter may be safely used in rubber articles, subject to the provisions of such regulation.

Substances identified in this paragraph (c)(4), provided that any substance that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation.

Elastomers.

Vulcanization materials—(a) Vulcanizing agents.

Accelerators (total not to exceed 1.5 percent by weight of rubber product).

Retarders (total not to exceed 10 percent of weight of rubber product).

Activators (total not to exceed 5 percent by weight of rubber product except magnesium oxide may be used at higher levels).

Antioxidants and antiozonants (total not to exceed 5 percent by weight of rubber product).

Plasticizers (total not to exceed 30 percent by weight of rubber product unless otherwise specified).

Fillers.

Colorants. Colorants used in accordance with § 178.3297 of this chapter.

Lubricants (total not to exceed 2 percent by weight of rubber product).

Emulsifiers.

Miscellaneous (total not to exceed 5 percent by weight of rubber product).

Rubber articles intended for use with dry food are so formulated and cured under conditions of good manufacturing practice as to be suitable for repeated use.

Rubber articles intended for repeated use in contact with aqueous food shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with distilled water at reflux temperature, shall yield total extractives not to exceed 20 milligrams per square inch during the first 7 hours of extraction, nor to exceed 1 milligram per square inch during the succeeding 2 hours of extraction.

Rubber articles intended for repeated use in contact with fatty foods shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with n-hexane at reflux temperature, shall yield total extractives not to exceed 175 milligrams per square inch during the first 7 hours of extraction, nor to exceed 4 milligrams per square inch during the succeeding 2 hours of extraction.

In accordance with good manufacturing practice finished rubber articles intended for repeated use in contact with food shall be thoroughly cleansed prior to their first use in contact with food.

The provisions of this section are not applicable to rubber nursing-bottle nipples.

Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.

For Federal Register citations affecting § 177.2600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.