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Regulations and Certification of Contact Substances for the United States: Make sure that all indirect food additives have FDA clearance for import and sale in the United States

Indirect food additives, substances in contact, and their components, must comply with the provisions of the Food Contact Substance Act

All substances that come into contact with food (directly or indirectly) are considered by the FDA to be an indirect food additive

FDA requirements on the use of indirect food additives in products for export to the US are covered by the Food Contact Substance (FCS) Act

FDA regulatory authorization concerning the use of contact substances, United States of America

Examples of cases regulated by the FCS are:

Examples of products that typically need to comply with the FCS for import into the United States are:

For import into the United States, the FDA requires that all indirect food additives be demonstrably safe before they are authorized for sale in the United States

The safety of an additive is determined on the basis of the classification of each component within the FCS. A premarket notification is required from the FDA in order to import new FCS components into the US, or to propose new uses of products already approved by the FDA.

The rules regarding an FCS depend on its chemical composition. It is the responsibility of the FCS manufacturer to ensure that the materials in contact with food comply with the specifications and limitations required by US standards.

The identity, specifications, and limitations of the individual FCS components are governed by the US provisions contained in:

ExportUSA Services for FDA clearance to import indirect food additives to the US

Eligibility check according to US law and requests for permits and authorizations for import and sale issued by the FDA

Many businesses need a written assessment that determines the eligibility status of their product under the provisions of the Food Contact Substance Act.

Generally, they are requests that come from the US importer or the US customs declarant, who want to be sure that the product to be imported, such as plastic containers for ice cream, as an example, has been produced with materials and procedures accepted by the FDA.

ExportUSA offers an eligibility analysis of components and materials pursuant to the Food Contact Substance Act [FCS], which includes:

The regulatory references for the European market and for Italy concern:

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