United States Food and Drug Administration

Perhaps the best-known regulatory agency is the FDA - the Food and Drug Administration. The FDA is an agency within the United States Department of Health and Human Services.

The FDA has established a list of rubber compounding ingredients that tests indicate are neither toxic nor carcinogenic. Rubber compounds that are produced entirely from these ingredients and also pass the FDA extraction tests are said to “meet FDA requirements”.

The FDA does not approve rubber compounds - it is the responsibility of rubber manufacturers to compound Food Grade materials from the FDA list of ingredients and to establish that the compound passes the necessary extraction requirements.

Regulations

The regulations pertaining to rubber used in contact with foodstuffs are stipulated in a Code of Federal Regulations called CFR Title 21 Chapter 1, Subchapter B, Section 177.2600.

Observant scientistUnder this regulation there are two significant sub-classes - Class 1 for rubber compounds including up to 10% carbon black filler for aqueous media, edible oils and greasy media and Class 2 up to 50% carbon black filler for aqueous media only.

These regulations define which rubber polymers and compounding ingredients can be used and the proportions in which they may be used in rubber articles intended for repeated contact with food and prevent the use of dangerous substances that may be carcinogenic.

CFR Title 21 Section177.2600 lists numerous chemicals permitted in the manufacture of rubber articles intended for repeated use in contact with food. Parts 100 through 199 of the CFR Title 21 go on to regulate these chemicals. The regulations are revised once each year with the new regulations being released around April 1st and they can be searched at http://www.fda.gov/

Rubber Articles

Benefits vs. Risk The critical aspect of these regulations is for rubber articles that are used in repeated aqueous food contact must meet the following requirement - “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 not yield total extractives more than 20 milligrams per square inch during the first seven hours of extraction nor to exceed 1 milligram per square inch in the succeeding 2 hours of extraction.”

For rubber articles intended for repeated use in contact with fatty foods the requirement is “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 not yield total extractives more than 175 milligrams per square inch during the first seven hours of extraction nor to exceed milligrams per square inch in the succeeding 2 hours of extraction.”

In general “FDA compliance” means that the rubber polymer is made from compound ingredients that are listed by the FDA and used in proportions within the FDA guidelines.

Fluid Seals supplies O-rings and other seal components that are certified to be FDA compliant in Kalrez®, Viton®, EPDM, Nitrile and Silicone compounds.