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): $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
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)
• Up to 10 different formulations: $4,000.00 per target substance (up to 45 business days)
Formula Essentials Packages (review of entire product formulation)
• Formulation consisting up to 5 different components: $3,850.00 (up to 60 business days)
• Formulation consisting up to 10 different components: $7,580.00 (up to 90 business days)
• (Add-on) $750.00 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.