What is FDA CFR 21 177.2600 and Why is it Important for Your Food Processing Business ?
What is FDA CFR 21 177.2600 and Why is it Important for Your Food Processing Business ?

What is FDA CFR 21 177.2600 and Why is it Important for Your Food Processing Business ?

Jun 24, 2016 Gaskets | Materials | FDA O-Rings

Food product manufacturers are very particular about standards put in place by the FDA and other governing agencies. These standards define the purity and reliability of a product or process, and prioritize public wellbeing.

USP Class VI approval tests are one of the important standards set by the FDA for products and processes in the food processing industry. This post discusses FDA CFR 21 177.2600, which is an important aspect of these USP Class VI approval tests.

Brief Description on FDA CFR 21 177.2600

According to the FDA, the food additives are differentiated as:

  • Direct: This refers to components that are directly added to food items to improve their characteristics. Some of these may include flavors, food dyes, etc.
  • Secondary Direct: These components are added to food items during processing or treatment, and are removed before packaging.
  • Indirect: These substances are not directly added to the food, but may indirectly come in contact with the food during processing. Rubber components and rubber products used in food processing are termed as indirect substances, and are mainly governed by USP Class VI CFR 21 177.2600 standards.

Important Highlights of CFR 21 FDA 177.2600

Following are two important highlights of CFR 21 177.2600, which will help you understand the standard better.

  • There is a pre-defined list of permitted rubber components, accelerators, vulcanization materials, antioxidants, fillers, and emulsifiers used in food processing. Approved rubber components include silicone rubber, polytetrafluoroethylene (PTFE), Buna, as well as Ethylene, Propylene, Diene Monomer (EPDM).
  • Rubber products that are repeatedly used in the food processing should be thoroughly cleaned before the first use.

How is FDA 21 CFR 177.2600 applicable for your food processing business?

Rubber gaskets and O-rings are integral parts of any food processing equipment. In order to be used, these rubber products should meet the above mentioned CFR 177.2600 requirements.

So, the next time, when ordering elastomer gaskets and O-rings for your food processing equipment, ensure that they adhere to CFR 177.2600 requirements. You can always check the same with the supplier before ordering the product. Also, you can take an expert’s help to confirm if the chosen gasket or O-ring is made from CFR 177.2600 defined elastomer.

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