Food grade rubber – A guide to recent changes in FDA status of FKM & FFKM polymers

In this blog…

Recent changes in FDA standards now mean that certain food-grade rubbers are no longer available. In this article, we discuss these recent changes in further depth. We also highlight our range of food-safe O-rings and food-grade rubber products designed for food processing and contact applications. But, what is food-grade rubber and how do our products meet the new standards? Read on to find out.

What is food-grade rubber?

Food-grade rubber is specifically formulated to be safe for use in food processing and packaging and is used for food-grade O-rings. This encompasses compliance with stringent standards set by regulatory bodies like the U.S. Food and Drug Administration (FDA).

It is vital in applications where rubber will be in direct contact with food products that these types of polymers will not affect the food or taint it in any way. Food-grade means food safe, and the rubber poses no hazard to humans. Most importantly, it will not change the taste or appearance of food and will maintain the quality and integrity of food products.

Changes in the industry and FFKM’s status

If you are using FFKM within food processing, you must ensure that the material is compliant with FDA guidelines. In recent times, as regulations have changed, SYENSQO (Solvay Speciality Polymers) have ended the food contact status of their FFKM grades.

Whilst components that are manufactured with polymer produced before 1st October 2023 will still hold certification, replacement parts may no longer hold FDA certification. If you are unsure, it may be appropriate to contact your FFKM O-ring or seal supplier and request information. Typical food contact approvals affected for these materials are:

• 21 CFR 177.2600(e)&(f) 
• EC 1935/2004

However, there are some standards that have not been affected, such as USP Class 6. This is due to the fact that this standard only determines the toxicity of materials and is not specific to food contact.

Which TRP grades are affected?

If you are using TRP FFKM materials in your applications, the following grades will be affected by this new change in regulations:

• 641FDA
• 642FDA
• 643USP
• 643USPHT

If you are using any of the rubber grades listed above, you should aim to substitute these as soon as possible. If you are looking for suitable replacement rubber grades, we advise converting to these materials:

• 639FDA
• 640USP

These materials are not associated with the Kalrez® brand, and remain unaffected by the termination of the FDA status by Solvay Speciality Polymers. We can also offer custom rubber grades to suit your specific requirements with our TRPlast® products.

Changes to the FDA approvals of FKM Bisphenol Rubber

Another recent FDA-related change worth noting is that as of 31 July 2022, the manufacturers of Bisphenol FKM have withdrawn FDA approval for their materials, which applies to all polymer manufacturers and requires large changes resultantly. Therefore, rubber manufacturers now have to use peroxide curing for applications that involve food and drink contact.

TRP Polymer have developed four materials to service the food industries that require fluorinated sealing products and are manufactured without bisphenol curatives.

You can continue reading about the changes to FKM Bisphenol Rubber FDA approvals on our blog, which includes test data for extraction testing, SIP and CIP test results for the materials. You can also view our technical report on TRP’s FDA compliance.

TRPlast® and its benefits

If you have been affected by this recent regulation change and are searching for replacement food-grade rubber, TRP Polymer are pleased to help. Our new TRPlast® FFKM grades offer equivalent performance to the affected grades mentioned above, making for the ideal seamless substitute for your current materials. 

TRPlast® FFKM offers exceptional performance and dependability for our high-temperature O-rings, boasting the best thermal and chemical resistance.

All materials are designed and formulated by TRP Polymer Solutions, allowing us to offer a wide portfolio of materials to meet most service conditions, and to design customer-specific materials to suit individual applications. 

We can provide customised FFKM materials that meet your specific requirements while being fully compliant with FDA regulations. This means that if you require unique attributes from your custom rubber mouldings or custom O-rings, such as specific colours, hardness, physical properties, metal detectability or any other attributes, we can formulate materials to meet your requirements.

Food safe and future-proof rubber

At TRP, we test food-safe rubber products, evaluating their reaction to moisture, temperature, acids, cleaning solutions, CIP and SIP media. We can carry out extraction testing, compatibility testing and other customer-specific tests to ensure we continue to offer our customers the safest, best-performing materials available.

In addition to the food industry, we manufacture O-rings, rubber seals and gaskets for many different sectors. Just some of these include rubber mouldings for the nuclear, chemical processing, pharmaceutical, motorsport and many other industries.

We specialise in developing materials and products to meet customer-specific requirements, no challenge is too big for us. So, be sure to get in touch to see how we can produce your ideal custom rubber moulding.

For more information on food-grade rubber solutions and how TRP can assist your business, please contact us. Our technical team is ready to provide expert advice and solutions tailored to your needs.