Delivering Fluid Sealing Solutions Since 1972

FDA Regulations

FDA – What is it?

The Food and Drug Administration is the Federal Agency within the U.S. Department of Health and Human Services responsible for overseeing the manufacturing and distribution of consumer products such as food, pharmaceuticals, electronic products that emit radiation, and medical devices together with the development of biological products such as cosmetics, products that treat allergies and vaccines. All FDA-produced materials are handled and packaged in a certified cleanroom environment and subjected to strict testing to meet the requirements of the most demanding food and beverage processing operations. FDA manages a list of materials and chemicals that are approved for contact with foods. They make sure those products are safe to use, effective, and accurately labeled. Materials that meet these requirements are then declared as “FDA Compliant”.


What “FDA Compliant” elastomer materials usually are?

  • Used for food, drink, dairy, meat, or any food-compliant chemicals
  • Dependable service at the broad scope of temperature
  • Inodorous, tasteless, and present essential resistance to bacteria escalation
  • Non-allergenic, non-toxic and non-marking

Which paragraphs describe the FDA’s relevance in the sealing industry?

FDA CFR 21.177.2600 (paragraphs A-D) represents the applicable regulations for ‘Rubber articles intended for repeated use’. These paragraphs list the components and numerical restraints that may be used in rubber compounds for formed products intended for repeated use in all stages of food production, preparation, and freightage.

FDA CFR 21.177.2600 (paragraphs E & F) specifies restraints on extractable products if the FDA rubber seal is intended to be used in contact with water or greasy foods. The regulation details extraction test limits in water and n-hexane. For the FDA rubber material to be compliant with these regulations, this claim must be becked with relevant documentation such as the manufacturer’s FDA Compliance Certificate.

What does it mean FDA-compliant?

FDA does not ‘approve’ products to CFR 21.177.2600. It’s the manufacturer’s responsibility to prove compliance by publishing an FDA Certificate. A component may be produced using an FDA rubber material that is adequate for food contact; this does not imply that the part is technically suitable for its planned application.

Above compounds must consist entirely of the elements recorded in the FDA’s White List situated in the Code of Federal Regulations (title 21) section number 177.2600. O Ring manufacturers must exploit food-grade materials solely from the whitelist of endorsed ingredients.

Types of applications where FDA compliance was required

  • Food portioning processes
  • Water purification
  • Bottle filling
  • Distilled water pumps
  • Label adhesive dispensers
  • Seamers
  • Beverage can manufacture

Which elastomer materials can be compliant?

M Barnwell Services supplies FDA O Rings and other FDA Seals from a huge range of compliant elastomer materials, including:

Class A-D (dry foods)

Class A-E (aqueous foods)

Class A-F (fatty foods)

If you require further information regarding our range of products and/or services, please contact a member of the team.

M Barnwell Services endeavour to make sure that all content is correct. Manufacturing partners assisted with the creation of this page. E & OE. For more detailed information, visit the official FDA website.