FDA Food Contact Compliance Assessment and Testing Support

U.S. FDA food-contact regulatory route assessment, compositional/migration testing, authorization-status review and conditions-of-use documentation for packaging, containers, cookware and food-processing contact parts.

Service overview

U.S. food-contact compliance asks whether each food-contact substance has an appropriate regulatory basis for its intended conditions of use. The basis may be a 21 CFR provision, an effective Food Contact Notification, a Threshold of Regulation exemption, an existing sanction or another lawful basis. SCS Testing supports document and testing assessment based on substance identity, material structure, food type, temperature and contact time. This is not food facility registration.

Applicable products or businesses

• Food packaging, containers, tableware, cookware and food-processing/contact components
• Plastics, coatings, adhesives, paper, metals, rubber, silicone and multilayer materials
• Material producers, finished-product manufacturers, brand owners and U.S. importers

Target market

• U.S. food-contact materials market

Regulatory authority

• U.S. FDA food program

Regulations, directives and standards

• FD&C Act section 409 framework for food additives and food-contact substances
• Applicable food-contact material and component provisions in 21 CFR
• Food Contact Notifications and their manufacturer/use-specific conditions
• Applicable chemistry, toxicology and environmental guidance

Service scope

• Material-layer, substance-identity and regulatory-basis review
• Food type and Conditions of Use assessment
• Migration, residual or compositional restriction testing
• Compilation of supplier declarations, FCN/21 CFR basis and intended-use documentation

Service process

• Confirm materials, layer composition, food types and contact conditions
• Review the regulatory basis and limitations for each relevant substance
• Identify evidence gaps and define migration/composition testing
• Complete testing and conditions-of-use assessment
• Compile the compliance evidence; if no basis exists, separately assess an FCN or another route

Information required

• Material and multilayer description, complete composition and suppliers
• Intended food types, temperature, duration and repeated-use conditions
• 21 CFR, FCN or other authorization basis
• Migration/residual and toxicology data where applicable
• Labels, limitations of use and customer specifications

Sample requirements

• Samples must represent final material structure, thickness and manufacturing process
• Different colours, formulations, coatings or adhesives require risk-based assessment
• Migration-test samples must have defined contact area and actual use conditions

## Reports, certificates or registration outcomes Outputs are test reports, a regulatory-basis matrix and document-gap record for the agreed material and use conditions. They are not FDA certification of the finished product. FCN applicability can be limited by notifier, substance and conditions of use.

Factors affecting timing

Timing is significantly affected by composition transparency, regulatory-basis research, migration conditions, toxicology/environmental data gaps and whether a new FCN route is needed.

Common compliance risks

• Using a food facility registration number as food-contact compliance evidence
• Relying on an FCN that does not cover the current manufacturer or conditions of use
• Testing overall migration while overlooking substance authorization and specific restrictions
• Substituting an EU or other-market report for a U.S. regulatory-basis review

Frequently asked questions

## Do FDA food-contact products require registration?

There is no single finished-product registration. Each material and substance needs a lawful basis for its conditions of use, and an FCN route may be assessed where necessary.

## Does a 21 CFR test report guarantee compliance?

The report must match material identity, method, food type and conditions of use and be considered with compositional authorization evidence.

Is an FCN available to every company?

Not always. An FCN may be limited by notifier and conditions of use and must be checked individually.

Related services

• Multi-market food-contact testing
• FDA food facility registration
• EU food-contact compliance
• Packaging composition and migration testing

Information for an initial assessment

Provide the product name, model, intended use, target market, bill of materials and available reports so that the applicable route and evidence gaps can be assessed.