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
Examples of cases regulated by the FCS are:
Products for the wrapping and packaging of food, dishes, tableware, etc.
Food processing machinery, and parts of machinery that come into contact with food.
Chemicals used as adhesives, lubricants, disinfectants, coatings, etc.
Examples of products that typically need to comply with the FCS for import into the United States are:
Machinery for food processing and preparation;
Plates and crockery;
Food containers;
Flatware and knives;
Coating for refrigerators, ovens or similar appliances;
Plastic film for food packaging.
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:
Code of Federal Regulations
Effective Food Contact Notifications
Prior Sanctioned Letters
GRAS Notices
Threshold of Regulations Exemptions
and, finally, also in the sanctioning actions of the FDA, such as the refusal to import, the import notices, letters of formal notice, etc.
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:
A detailed report prepared by our team of specialists, who determine the legal status of each element of your product/additive, including intended uses [maximum temperatures, microwave use, composition, release parameters, and the need for notification prior to marketing.
A detailed overview of the US testing procedures required by the FDA for some specific FCS products, if applicable.
The regulatory references for the European market and for Italy concern:
The Machinery Directive (Dir 2006/42/EC) with a specific section and,
As it pertains to technical standards, first and foremost, all the UNI EN ISO 14159 standards of 2008, "Machinery Safety: Requirements relating to Hygiene for the Design of Machinery" (a standard that bridges Machinery Directive 42/2006)
Finally, the UNI EN 1672-2 standard of 2009 "Machinery for the Food Industry, Basic Concepts, Hygiene Requirements"
The production principles known as MOCA [Materials or Objects in Contact with Food], with particular reference to the HACCP and FMEA methodology, are an additional technical reference.
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