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.
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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.
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.
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.
Components for hygiene-sensitive areas, conforming to FDA and EU regulations 10/2011