Quality, Certifications & Documentation

PRIMEBLEND INGREDIENTS LLC operates under a documented, audit-ready compliance framework that combines internationally recognized food-safety certifications, full U.S. federal and state regulatory registrations, and per-shipment quality verification. As a U.S.-based importer of premium Ukrainian-origin sunflower lecithin, every container we deliver to a customer is backed by a transparent, traceable documentation package — available on request.

Ukrainian Origin — A Heritage of Quality

Ukraine is the world's leading producer of sunflower seeds and the global benchmark for sunflower-derived ingredients. Our flagship sunflower lecithin is sourced exclusively from established Ukrainian production facilities operating under FSSC 22000 Version 6.0 certification — the highest internationally recognized food-safety standard.

This origin matters. Ukrainian sunflower lecithin is produced from non-GMO sunflower seed cultivated across the country's traditional black-earth agricultural belt, processed using mechanical cold-press extraction (no hexane or chemical solvents), and delivered in food-grade IBC totes with full lot traceability from field to finished product. The combination of native non-GMO seed stock, cold-press processing, and globally audited food-safety systems is what positions Ukrainian sunflower lecithin as the clean-label emulsifier of choice for premium U.S. food, beverage, and nutraceutical formulators.

International Food-Safety Certifications

Every shipment is produced and documented under internationally recognized food-safety management systems. PRIMEBLEND maintains and provides on request the current certification package covering each lot delivered.

FSSC 22000 Version 6.0 — Global Food Safety Initiative (GFSI)-recognized scheme; the highest tier acknowledged by the U.S. Food and Drug Administration (FDA) under the Foreign Supplier Verification Program. Mandatory across the food industry since April 1, 2024, and held by our production partners as a condition of our supply agreement.

ISO 22000:2018 — international standard for food-safety management systems, providing a framework that integrates Hazard Analysis and Critical Control Points (HACCP) principles with the prerequisite programs required for safe food production from agricultural input through finished-goods dispatch.

HACCP (Hazard Analysis and Critical Control Points) — the preventive food-safety control system mandated by the FDA, USDA, and global regulators for all food manufacturers and importers; documented hazard analyses on file for every product line.

Halal Certification — confirming compliance with Islamic dietary requirements, supporting access to the global halal food market.

Kosher Certification — confirming compliance with Jewish dietary requirements, supporting access to specialty and religious-dietary segments in the United States and internationally.

Product Compliance & Status

Sunflower lecithin (and our launch-ready non-GMO soy lecithin alternative) carries U.S. regulatory clearances that allow direct, frictionless use across virtually every food-application category — bakery, confectionery, dairy alternatives, plant-based formulations, nutraceuticals, infant nutrition, and beyond.

Generally Recognized as Safe (GRAS) — under 21 Code of Federal Regulations (CFR) §184.1400, sunflower lecithin is a Direct Food Substance pre-approved across all food categories under current Good Manufacturing Practice (GMP). No food-additive petition or GRAS notice is required from the formulator.

Non-GMO by Origin — sunflower lecithin is inherently non-genetically-modified worldwide; no commercial genetically modified sunflower variety exists. This eliminates the need for costly identity-preservation systems and supports clean-label and USDA Organic-compatible product positioning.

Allergen Profile — sunflower lecithin is not designated as a major allergen under the Food Allergen Labeling and Consumer Protection Act (FALCPA, 2004) or the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act, 2021). No "Contains:" label disclosure is required, simplifying both packaging compliance and consumer-facing labeling.

Tariff Classification — Harmonized Tariff Schedule of the United States (HTS) 2923.20.20.00 (food-grade lecithin), filed by our licensed U.S. Customs House Broker on every entry at the Port of New York/New Jersey.

Extraction Method — mechanical cold-press extraction; no hexane or other chemical-solvent residues. Suitable for clean-label, organic-trajectory, and allergen-sensitive formulations.

U.S. Regulatory Registrations

PRIMEBLEND INGREDIENTS LLC maintains the full set of U.S. federal and state registrations required to operate as a licensed food-importer of record.

State of Florida — Limited Liability Company Registration
Document Number L26000164481, registered with the Florida Division of Corporations.

U.S. Internal Revenue Service — Employer Identification Number (EIN)
EIN 41-5219041.

Dun & Bradstreet — D-U-N-S Number
D-U-N-S 144993088 — active and certified, supporting supplier verification, customs filings, FDA Prior Notice submissions, and international trade-credit references.

U.S. Food and Drug Administration (FDA) — Food Facility Registration
Voluntary biennial registration under 21 CFR Part 1, Subpart H (Food Facility Registration).

U.S. Customs and Border Protection (CBP) — Continuous Import Bond
Maintained per CBP Form 301; supporting every entry filed by our licensed U.S. Customs House Broker at the Port of New York/New Jersey.

Foreign Supplier Verification Program

As the U.S. Importer of Record under 21 CFR Part 1, Subpart L — the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals — PRIMEBLEND maintains a complete supplier-verification file for each production source, including:

•  Documented hazard analysis under 21 CFR §1.504, covering biological, chemical (including mycotoxins, heavy metals, and residual solvents), physical, and economic-adulteration hazards.
•  Foreign supplier evaluation and approval per 21 CFR §1.505, with annual re-qualification.
•  Reliance on third-party food-safety certification (FSSC 22000 V6.0) under 21 CFR §1.506(d)(1) where applicable.
•  Annual review of supplier certifications and FDA Import Alert status.
•  Records retained for a minimum of two years and available to FDA within twenty-four (24) hours of request.
•  A Qualified Individual trained under the Food Safety Preventive Controls Alliance (FSPCA) curriculum, as recognized by FDA per 21 CFR §1.500.

Per-Shipment Documentation Package

Every shipment delivered to a PRIMEBLEND customer is accompanied by a complete documentation package that satisfies QA, regulatory, and supplier-qualification requirements at the receiving formulator's facility — eliminating onboarding friction and audit risk.

•  Certificate of Analysis (CoA) — issued by an accredited laboratory, traced to lot number and production date. Full panel: phospholipid profile, acid value, peroxide value, moisture, heavy metals (lead, arsenic, cadmium, mercury), mycotoxins (aflatoxin, deoxynivalenol), microbiology (Salmonella, total plate count, yeast and mould, E. coli, coliforms), and residual solvents.
•  Independent Third-Party Laboratory Verification — every shipment in the first two operational years is independently verified through an ISO/IEC 17025-accredited U.S. food-testing laboratory; risk-based sampling thereafter.
•  Production-Source Food-Safety Certification — current FSSC 22000 Version 6.0 certificate (or equivalent), reviewed annually.
•  Halal and Kosher Certificates — provided on request for products requiring religious-dietary certification at the formulator level.
•  Country of Origin and Production-Facility Identification — origin country (Ukraine), production-facility address, and FDA Food Facility Registration status (where applicable).
•  U.S. Customs Documentation — entry summary, FDA Prior Notice confirmation number, and inland bill of lading.
•  Material Safety Documentation — Safety Data Sheet (SDS) and detailed product specification sheet, formatted for direct ingestion into customer QA systems.

Request Documents & Free Samples

We are happy to share our complete certification package with prospective customers — and to send free product samples for evaluation in your formulation laboratory.

To request supplier certificates, the per-shipment documentation package, technical specifications, allergen statements, kosher or halal certificates, country-of-origin documentation, or free product samples for laboratory evaluation, please contact us. We respond to most inquiries within one business day; certification packages and sample shipments are typically dispatched within three to five business days of confirmation.

Email: office@pbingredients.com
Phone: +1 (855) 564-0777
Office: Urban Coast Workspace, 4240 S. Ridgewood Ave., Suite 3, Port Orange, FL 32127, USA
Web: www.pbingredients.com

We look forward to supporting your formulation, regulatory, and quality-assurance teams with documentation that meets the highest standards of the U.S. food and beverage industry — and with the heritage of premium Ukrainian sunflower lecithin behind every shipment.