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Novotema elastomer sealing materials gain FDA compliance

Novotema elastomer sealing materials gain FDA compliance
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Food contact sealing

Novotema S.p.A. is pleased to announce that it has had five elastomer materials successfully tested to FDA 177.2600 - the United States standard 21 cfr (Code of Federal Regulation) §177.2600.

The extraction tests relate to paragraphs E and F from the standard, which permit the elastomer materials to be used in applications where there is repeated contact with foods.

The five materials successfully tested:

  • NBR, black, Shore A hardness 70
  • EPDM, black, Shore A hardness 60
  • EPDM, black, Shore A hardness 70
  • VMQ, red, Shore A hardness 70
  • VMQ, red Shore A hardness 40

 

R&D Manager Salvatore De Marco commented: “The results of these tests are very encouraging, because they enable Novotema to offer high performance elastomer sealing solutions to food and beverage process applications – offering total consumer confidence in both safety and operational efficiency.”

“Since its acquisition by IDEX Sealing Solutions in June 2015, Novotema has invested consistently in a series of developments focused on innovative sealing materials for food and beverage applications.

Food contact materials must be demonstrably safe, manufactured in accordance with specific regulations, proving that they will not transfer their ingredients to foodstuffs in quantities pre-defined as being potentially hazardous to health. Different international markets have their own standards to cover this. The United States FDA standard 21 cfr §177.2600 is commonly adopted worldwide.

 What is FDA 177.2600?

The Food and Drug Administration (FDA) is the body responsible for controlling and regulating food and pharmaceuticals within the United States Department of Health. The FDA defines susceptible food contact materials, and subdivides them into three categories:

  • dry foods
  • aqueous foods
  • fatty foods

 

These categorised materials are regulated by the Federal Food, Drug and Cosmetic Act – a series of laws declared by the United States Congress to protect food, medicines and cosmetics. This Act concerns "any substance whose use can lead to - or is believed to be capable of – the substance itself to become part of food, in cases where such substance is not considered safe.” The definition specifically refers to those substances that are used to "produce, pack, process, prepare, treat, package, transport or contain food".

Contact our engineering team today to discuss Novotema’s latest test results in more detail, or sealing solutions for the food process industry.

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