FDA Food Contact Substance (FCS) Regulatory Review and Compliance Affirmation

Empowering your global trade with FDA-compliant assurance

This service supports manufacturers and exporters of food-contact materials in preparing a formal FDA Compliance Declaration to demonstrate that their products meet the requirements of the U.S. Food and Drug Administration under Title 21 of the Code of Federal Regulations (21 CFR). It is specifically designed to validate that components used in food contact substance formulations are compliant with FDA provisions for indirect food additives. The declaration serves as documented assurance for downstream customers, importers, or brand owners that the materials are safe and suitable for food-contact applications under U.S. law.

Who This Service Is For

• Manufacturers of food-contact materials, such as plastics, coatings, adhesives, colorants, resins, and rubbers • Exporters supplying component substances intended for use in food packaging or processing equipment • Companies whose buyers or regulators request an FDA Compliance Certificate or Statement • Organizations looking to demonstrate compliance with specific CFR provisions or respond to customer regulatory documentation requirements

Scope of Work

Assess the intended use of the target substance and identify the applicable regulation(s)

From 21 CFR Parts 170–199, which may include but are not limited to: • Subpart B (Indirect Food Additives: Polymers – e.g., §177.1520, §177.2600) • Subpart C (Adhesives and coatings – e.g., §175.105) • Subpart D (Colorants – e.g., §73.XXX) • General GMP requirements under 21 CFR §174.5

Request and review the following:

• Technical data sheets (TDS), including CAS number/s • Safety Data Sheets (SDS) • Functional use and concentration of substance(s) in the finished article • Any supplier declarations or food contact compliance letters from raw material suppliers (if any)

Cross-reference component with:

• Permitted substances and use limitations listed under applicable CFR citations (such as 21 CFR Parts 170–199 i.e., for Additives, Adhesives, Coatings, and Colorants) • Any relevant food-contact notifications (FCNs), threshold of regulation exemptions, or GRAS listings, if applicable

Prepare a formal technical document that substantiates the review of the following:

• Manufacturer’s legal name and address • Substance identification and intended use • Applicable FDA regulation/s cited and bases of compliance • Related technical data (scientific, regulatory, client-provided) • Statement of rationale in case of audit (if applicable) • Conditions of use (temperature, food types, usage limits, etc.)

Deliverables

Finalized FDA Compliance Declaration (PDF) with regulatory justifications and/or recommendations

Pricing and Timeline

Base Package

1 target substance for use in 1 formulation

Price: $900.00

10 to 15 business days upon receipt of full technical data

Add-on: $350.00 per 1 additional formulation for the same substance

Subscribe

Multi-Use Packages

1 substance used in multiple formulations

Up to 5 different formulations:
$2,300.00 per target substance (up to 25 business days)
Subscribe - 5 Formulations

Up to 10 different formulations:
$4,000.00 per target substance (up to 45 business days)
Subscribe - 10 Formulations

Formula Essentials Packages

Review of entire product formulation

Formulation with up to 5 different components:
$3,850.00 (up to 60 business days)
Subscribe - 5 Components

Formulation with up to 10 different components:
$7,580.00 (up to 90 business days)
Subscribe - 10 Components

Add-on: $750.00 per additional component in 1 formulation

Package	Details	Price & Timeline	Action
Base Package	1 target substance for use in 1 formulation Add-on: $350 per additional formulation	$900.00 10–15 business days	Subscribe
Multi-Use Packages	1 substance used in up to 5 formulations	$2,300.00 Up to 25 business days	Subscribe
Multi-Use Packages	1 substance used in up to 10 formulations	$4,000.00 Up to 45 business days	Subscribe
Formula Essentials	Review of entire product formulation Up to 5 components	$3,850.00 Up to 60 business days	Subscribe
	Review of entire product formulation Up to 10 components	$7,580.00 Up to 90 business days	Subscribe
	Add-on: $750 per additional component in 1 formulation

Your compliance, our commitment — bridging borders with trusted documentation.

Services provide assessment based on the available documentation to facilitate compliance per applicable regulations, but does not constitute assured regulatory approval, nor does it guarantee market acceptance, regulatory clearance, or product sales in the target market.