News Brief

On July 17, 2024, REACH24H successfully assisted a Beijing-based company in obtaining the Final Letter for a Food Contact Notification (FCN) from the U.S. Food and Drug Administration (FDA), covering its PHA (polyhydroxyalkanoate)-based product.

Successful FCN Submission for PHA Product

The notified product, Polyhydroxyalkanoates (PHA), is a bio-based, marine-degradable polymer material approved for contact with all food types except those containing over 15% alcohol, under Condition of Use B-H (suitable for boiling water sterilization).

 For the client, this successful submission marks a critical milestone in accessing the U.S. market, laying a solid foundation for future expansion into American markets with their food contact material products. 

REACH24H Demonstrates Professional Expertise

U.S. FCN applications are notoriously complex, requiring extensive data on substance properties, migration studies, toxicological profiles, and environmental assessments.

 Leveraging the product’s unique characteristics, REACH24H focused on analyzing compositional stability and migration behavior, designing a tailored submission strategy based on prior successful project experience. By addressing key technical challenges early and maintaining efficient communication with the FDA, REACH24H expedited the approval process, securing the FCN swiftly and enabling the client to gain a competitive edge in global markets.

REACH24H Food Contact Materials (FCM) Compliance Team

REACH24H’s FCM team possesses deep expertise in regulatory frameworks across China, the U.S., the EU, Canada, Mercosur (Southern Common Market), and other regions. With proven success in novel substance registrations (China, EU, U.S.), recycled plastics approvals (EU, U.S.), and direct communication channels with regulatory authorities, the team collaborates with top-tier global laboratories to deliver customized compliance solutions and efficient services.

REACH24H FCM Compliance Services

•  Food Contact Material Compliance

•  U.S. FCN (New Substance Submissions)

•  China Novel Food-Related Substance Filings

•  EU EFSA Novel Substance Applications

•  Canada Letter of No Objection (LONO)

•  Mercosur Positive List Inquiries

•  Regulatory Advisory / Customized Product Reports

•  Compliance Analysis / Novel Substance Evaluation

•  Conformance Testing & Declarations

Additional Services

•  Testing Coordination & Supervision

•  Compliance Analysis Reports

•  Tailored Regulatory Updates & Alerts

•  Supply Chain Compliance Training

•  Regulatory Translation Services