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FDA Regulations for Rubber

Rubber Development, Inc. offers its customers materials for their products that are used in numerous food contact applications. We find that often there is confusion over the definition of “FDA Approved.” We hope this bulletin will clarify that definition and what RDI offers its customers with regards to materials intended to come in contact with food. The United States Food and Drug Administration (FDA) issues guidelines for the manufacture of rubber articles used in the handling of food. These include the guidelines of what ingredients can be used in the production of rubber, in what proportions and what amount can be extracted when tested in relation to the food for which it is intended. The only FDA guideline Rubber Development attempts to comply with is the FDA Title 21, Part 177.2600, “Rubber Articles Intended for Repeated Use.”

Part 177.2600 lists numerous chemicals permitted in the manufacture of rubber articles intended for repeated contact with food. Parts 100 through 199 of the same FDA Title 21 regulate these chemicals. Rubber Development purchases from its suppliers those chemicals that are documented, by those suppliers, to comply with those regulations.

Rubber Development offers three levels of compliance with the FDA Title 21, Part 177.2600 as follows:

1. Formulated with Ingredients Complying with FDA Title 21, Part 177.2600

Certification that the ingredients and proportions used comply with FDA Title 21, Part 177.2600. There is no charge to the customer for this level.

2. Formulated and Tested to Meet the Requirements of FDA Title 21, Part 177.2600

Certification that the ingredients and proportions used comply with FDA Title 21, Part 177.2600 and test results (RDI utilizes an independent laboratory for these tests) that the extractives comply with the same. A quotation is required, but the charges usually run in the hundreds of dollars and can take a few weeks to complete. (Not required for articles intended for use with dry food.)

3. FDA Approved

This involves formal submission to the United States Government Food and Drug Administration, costs $6000 and up and can take from 4 to 18 months to receive approval. A quotation will be supplied upon request.

Formulating to meet the FDA requirements can be accomplished in most elastomers but somewhat restricts the possible physical characteristics of the finished material. This restriction may result in the material not being able to meet some “commercially available” ASTM D2000 line call-outs. It also impacts the cost of the raw materials due to the limitations in ingredients and suppliers. It can also impact the cost of finished articles due to its impact on the “processability” of the material.