Standard & approval

FDA

U.S. Food and Drug Administration

Suitability of materials and products for use in the food industry.

Request approval All standards

Field

Food & pharma

Origin

USA

Reference

CFR

Applies to

product-contact materials

Overview

The FDA (U.S. Food and Drug Administration) ensures that materials and products are suitable for use in the food industry. For seals, this means that only materials with sufficient purity and without ingredients of concern are used in product-contact applications.

FAQ

The key questions

What does the abbreviation FDA stand for?

FDA stands for Food and Drug Administration, a US authority responsible for approvals in the field of food and pharmaceutical products. Its regulations are published in the CFR (Code of Federal Regulations), a compilation of all specifications and requirements, including those specific to elastomers and plastics.

Which requirements must be met?

According to FDA regulations, only materials and raw materials that have a certain degree of purity, contain no ingredients of concern in this field and are correspondingly durable are permitted in the food and pharmaceutical sectors.

Which products require FDA approval or conformity?

All product-contact materials used in the food and pharmaceutical industries and in medical technology. This applies to all sealing materials.

How do products obtain FDA approval?

Some materials already hold an official FDA approval or are FDA compliant, both for sheet material (punched parts, flat seals) and for compounds (moulded articles, sealing rings, hose rings, O-rings).

What are the benefits of FDA approval or conformity?

FDA approval or conformity is a decisive factor for end users in the food and pharmaceutical sectors when bringing products to market. The process confirms safety, harmlessness and compliance with FDA quality standards.

Applications