FDA and EU compliant products

FDA and EU-10/2011-compliant for the medical, food and packaging industry.

To remain FDA and EU-10/2011 compliant you are required to meet strict requirements for food hygiene and food safety in both manufacturing and packaging. igus® has a developed a range of FDA and EU compliant products that conform to the specific guidelines. The FDA and EU compliant product materials have been specially developed for moving applications where there is either direct food contact or a possibility of food contact. As with all igus® materials, they do not require any lubrication therefore product contamination is ruled out completely.

Would you like more information about FDA and EU compliant products? Our experts will be happy to get in touch with you.

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FDA and EU compliant products for moving applications

Plain Bearings

Large range of FDA bearings
Sleeve and flanged options
High temperature and high chemical options.

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Linear

Material: iglidur® A160
Compliant with FDA and EU regulations related to chemicals and food

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Knife Edge Rollers

Available in various FDA materials
Tight deflection radii
Long serive life

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TH3 Chain

First hygienic design e-chain®
Operating temperature -40°C/ +70°C
Resistant to aggressive cleaning agents & chemicals

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3D print

High temperature material
Complies with the fire prevention requirements of the Federal Aviation Administration of the USA (FAA)

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iglidur® plastic rod

Various FDA materials available.
For medium to high loads
Comply with FDA requirements
range from 10mm-100mm dia

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igubal®

FDA inserts with stainless steel housing
Detectable material options
Various igubal® options available.

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Tribo Tape

FDA-compliant
Low coefficient of friction
Optional with adhesive tapes

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xiros®

Different FDA cages available.
Smooth running
Low moisture absorption

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Dryspin

Different sizes, threads & pitches available.
Various nut material options
Suitable with multiple lead screw materials.

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Powder Coating

Good mechanical properties
Protects parts against wear
Excellent wear and sliding properties

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Other the-chain® products for the food industry

Although these are not FDA approved, they are used in food applications where direct food contact is not applicable. With small bend radii, these cost-effective cables are both hydrolysis and micro resistant and offer a long service life.

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readycable® products for the food industry

Despite not being FDA certified, the igus® readycables® are used in applications within the food industry where direct food contact is not made. These pre-harnessed cables can be dispatched within 24 hours and can be produced according to the manufacturers specifications.

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FDA and EU compliant products

FDA approval is achieved through a review of safety and effectiveness of products that go into the marketplace where it has been determined that the "benefits of the product outweigh the known risks for the intended use.". The body is responsible for protecting public health by regulating human & animal drugs and biologics, medical devices, tobacco products and cosmetics

The EU 10/2011 legislation is different. This is a set of rules and regulations for plastic materials with intended contact with food products. It is a challenge for companies developing and manufacturing plastic food contact materials to demonstrate compliance with this regulation due to the complexity surrounding this intricate relationship of being able to understand the obligations and be able to demonstrate compliance.

Only after each individual product has been approved by the PMA does it become an FDA & EU compliant product and will receive FDA certification.