The FDA (Food and Drug Administration) is an independent U.S. agency responsible for protecting public health in the United States. It oversees the safety and efficacy of human and veterinary drugs, biological products, medical devices, and radiation sources, as well as the safety of food.
Materials and products that come into contact with food in the USA must therefore comply with FDA regulations. These are defined in the so-called CFR paragraphs of the FDA with regard to materials. The specifications regarding composition, additives and properties according to the positive list as well as the material-related requirements must be met.
A product that meets these standards may then be designated as FDA compliant. The person placing the product on the market must be aware that it is his responsibility to use the product in such a way that it complies with the guidelines. These requirements, also for further processing steps, are listed in the respective CFR paragraphs.
Ensinger refers, with a few exceptions, to the confirmation of raw material conformity according to the relevant CFR paragraphs. In some exceptions, direct testing, e.g. of the semi-finished product, may also have taken place. However, all necessary information is disclosed via a valid, usually order-related declaration. Ensinger thus confirms the FDA conformity of the plastics and offers FDA-approved plastics or FDA-compliant plastics.
Ensinger offers a wide range of FDA plastics in the form of compounds, filaments, semi-finished or finished parts that meet FDA requirements and are thus approved for food contact.
So if FDA approved plastics such as FDA PEEK or FDA POM are sought, the Ensinger product can be used.
For other regions, the local corresponding regulations must be observed and complied with (example 10/2011/EU).
