What is FDA compliance?
FDA conformity refers to compliance with the requirements of the U.S. Food and Drug Administration (FDA) for materials and products that come into contact with food, drinking water, pharmaceutical products or the human body. For many plastics, Elastomers and additives, there are clear guidelines as to which ingredients are permitted and under which conditions they may be used safely.
FDA compliance requirements
FDA compliance is not based on a single certificate, but on compliance with specific regulations in the Code of Federal Regulations (CFR).
Essential requirements are:
- Authorised ingredients: Only raw materials and additives listed in the FDA positive lists may be used.
- Migration limits: Materials must not release any substances relevant to health into food or human tissue.
- Production safety: Manufacturing processes must ensure that no unauthorised substances are introduced.
- Verification: The manufacturer must be able to document that the materials used comply with the applicable CFR sections.
- Batch and raw material control: Consistent quality and clear traceability are essential.
One Rubber compound is FDA-compliant if all components - polymers, fillers, crosslinkers, additives - are explicitly approved and have been used correctly.
Application of FDA conformity
FDA conformity is required for products that come into direct or indirect contact with food, drinking water or pharmaceutical substances. Typical examples are Seals, hoses, membranes, moulded parts, pump elements or packaging materials. FDA compliance also plays a role in medical technology when materials interact with the human body or medical devices. For manufacturers and suppliers, this means Only materials and formulations that comply with the relevant FDA regulations may be used for corresponding applications. This is a prerequisite for being allowed to supply components for the US market in sensitive applications.