What does FDA compliance mean for molded rubber parts?

23.02.2023

Molded rubber parts are used in many sensitive applications, and as such potentially could have a direct effect on the health of humans.

Customers with business in the food sector have special requirements both for the molded rubber parts and the materials that go into making them. FDA compliance is important in this sector. It is also mandatory.

The Food and Drug Administration (FDA) is the USA’s federal agency responsible for protecting public health. Its provisions function to ensure the safety of products intended for the American market. However, its regulations are also recognised globally.

In this blog post, we will take a closer look at the FDA and examine the significance of FDA compliance in the manufacture of molded rubber parts.

Molded rubber parts in the food sector

There are umpteen examples of end uses for molded rubber parts with food contact. Packaging seals protect food by allowing it to be stored under conditions that prevent decay. Conveyor belts transport food. Diaphragms and valves are employed in the transport of food and for measuring quantities of foodstuffs.

Manufacturers have to be certain that the materials they use have the mechanical properties and durability to make them suitable for purpose. In the food sector, it is additionally vital that materials are food safe.

The Food and Drug Administration (FDA) is a particularly important agency as its regulations detail the requirements rubber parts have to fulfil to be FDA compliant and food safe.

FDA (Food and Drug Administration)

The Food and Drug Administration (FDA) is a United States of America federal agency headquartered in Silver Spring, Maryland. It has a large number of field offices and laboratories, and posts employees around the world.

It is subject to the authority of the United States Department of Health & Human Services (HHS), in short, the Health Department.

The main task of the Food and Drug Administration (FDA) is protecting the public health of the United States.

It is responsible for monitoring the food and drugs sold in the USA. The FDA controls the safety, efficacy and quality of

human medicines
animal medicines
biological products
medical products
food
cosmetics
products that emit radiation

This applies to products that are manufactured in the USA as well as imported products.

For example, the production workshops of all the manufacturers of approved medicines or medical products are inspected regularly to check whether they conform to the standards and regulations of the FDA.

It is also the mission of the Food and Drug Administration to promote and improve public health in the USA. This includes encouraging innovation. The FDA runs accelerated approval procedures to ensure that new medicines get to patients faster so patients with diseases that in the past could not be treated can be treated. In addition, the FDA publishes on a regular basis scientific information and trial results on the efficacy, safety and use of foodstuffs and medicines.

The FDA is also responsible for the regulation of tobacco products. This pertains to both manufacture and marketing. In this instance, the aim is to protect public health and, in particular, reduce the number of underage smokers.

Although the regulations and guidelines laid down by the Food and Drug Administration (FDA) were intended only for the United States, they have been adopted by many countries. Many regulations are globally recognised.

Manufacturers of molded rubber parts for the food industry, no matter what phase the parts are intended for in the production, preparation or transport of food, must ensure that their products conform to FDA standards.

Code of Federal Regulation Title 21 (FDA 21 CFR 177.2600)

Of particular relevance to manufacturers of molded rubber parts is the Code of Federal Regulation Title 21 – Food and Drugs, Section 177.2600 Rubber articles intended for repeated use. Paragraphs A to I cover the requirements for rubber items in repeated use.

Paragraphs A to D of the FDA 21 CFR 177.2600 list all the ingredients and quantitative restrictions that apply to the manufacture of molded rubber parts for them to be FDA compliant. A manufacturer who intends making molded rubber parts for products in repeated use in any phase of production, preparation or transport has to ensure that the contents of the rubber compound are on the white list. This is a mandatory precondition for a manufacturer’s molded rubber parts to be FDA compliant.

If the goods traded are not dry foods then paragraphs E to F apply also.

Paragraph E of the FDA 21 CFR 177.2600 deals with finished rubber articles that come into contact with liquid foodstuffs. Limits are defined for extractables that the rubber parts may not exceed.

Paragraph F of the FDA 21 CFR 177.2600 is similar to paragraph E, but covers fatty foods, unlike E that deals with contact with liquid foods. There are extractables limits defined for rubber items that come into contact with fatty foods.

Basically, FDA regulations along with good manufacturing practice require all molded rubber parts intended for repeated use in contact with food to be cleaned thoroughly before first use (paragraph G of the FDA 21 CFR 177.2600).

In addition, it states that the regulations of the section do not apply to feeding bottle teats made from rubber (paragraph H of the FDA 21 CFR 177.2600).

Scope of application

The strict regulations for FDA compliance mean the rubber materials frequently used by the food sector are also used in the cosmetic and pharmacy industries. Nonetheless, rubber materials approved by the FDA should not be mistaken for rubber materials of medical or pharmaceutical grade.

Commonly used rubber materials in the food industry

The food industry commonly uses products such as molded seals, O-rings, end caps, diaphragms or valves that have direct food contact. The manufacturers of these rubber parts have to meet the specialist specifications of the user sector.

First, the materials have to be durable enough to withstand contact with the chemicals in use in the end product and must also meet the mechanical requirements. The materials often have to perform in a broad thermal spectrum.

Besides, there are special requirements for materials to be odourless and without taste or resistant to bacterial build-up.

For the manufacture of a rubber component or rubber compound, FDA material approval requires all ingredients to be on the white list (see the paragraph Code of Federal Regulation Title 21 (FDA 21 CFR 177.2600)).

Materials that are particularly suitable for use with food and can be formulated to be FDA compliant are:

EPDM:

EPDM is especially suitable for dynamic applications or as sealing material. It has good chemical resistance to acids and alkalis. More on the properties of EPDM can be found here.

FKM:

FKM is primarily used in high-performance applications. Its high heat resistance makes it an excellent choice for both static and dynamic applications. More on the properties of FKM can be found here.

NBR/HNBR:

NBR and HNBR are characterised by their outstanding dynamic properties. In addition, they have excellent resistance to fatty foods such as milk products, and for that reason are often used in the food sector. HNBR is used principally when an application requires high thermal resistance due to higher application temperature. More on the properties of NBR can be found here, more on HNBR here.

Silicone:

Owing to its chemical composition, silicone is frequently used in the food sector and is the material of choice for medical applications. Its purity and the exceptionally broad thermal spectrum (cold as well as heat) covered by silicone means it has an important role to play in the food industry. More on the properties of silicon can be found here.

To conclude, moulded rubber parts contribute significantly to the food industry. In response to the special requirements of the food sector, the Food and Drug Administration (FDA) has provided a framework for the manufactures of moulder rubber parts. The FDA has set a global standard with its regulations intended for the US market as defined in the Code of Federal Regulation Title 21 – Food and Drugs, Section 177.2600 Rubber articles intended for repeated use.

For more details about properties or chemical resistance, or if you have a query about a particular application, please do not hesitate to contact us.

If you have a question about this blog post or would like us to discuss a particular aspect of elastomers in an upcoming blog, please email us on info@hepako.de