News Brief
In March 10, 2025, two U.S. Food Contact Notification (FCN) submitted by REACH24H successively received Final Letters from the U.S. Food and Drug Administration (FDA).
REACH24H Breaks Through Technical Barriers Again
Leveraging its profound professional expertise, REACH24H successfully assisted a single company in completing FCN submissions for two food contact material additive products and received the Final Letters on the same day.
At the initial stage of the projects, REACH24H’s team engaged in in-depth communication with FDA experts, customized a rigorous submission strategy based on product characteristics, and synchronized the planning of relevant testing procedures, effectively shortening the document preparation period.
During the submission process, REACH24H conducted thorough research on the migration behavior of food contact substances based on the chemical structures and properties of the two products. Dietary exposure was assessed through model evaluations.
Additionally, through a series of rigorous arguments, the team fully demonstrated the safety of the products under intended use conditions, resolving key technical challenges.
The Importance of FCN Application Success on Enterprises
A defining feature of FCNs is that the notified substance is exclusive to the applicant. Other manufacturers must submit separate FCNs to the FDA if they wish to use the same substance. Therefore, a successful FCN submission enhances a company’s market competitiveness and drives economic benefits.
Both newly approved FCNs will officially take effect in April, marking REACH24H’s breakthrough in overcoming technical barriers for its client’s products to enter the U.S. market, enabling smooth exportation to the United States.
REACH24H Expert Food Contact Materials (FCM) Team
REACH24H’s FCM team has an in-depth understanding of regulatory requirements in China, the U.S., the EU, Canada, Mercosur (Southern Common Market), and other regions. With multiple successful cases in novel substance submissions (China, EU, U.S.), recycled plastic applications (EU, U.S.), and familiarity with submission requirements for diverse product uses, the team maintains direct communication channels with regulatory authorities and collaborates with high-quality laboratories worldwide. REACH24H offers tailored compliance solutions and efficient services to enterprises.
REACH24H FCM Compliance Services
Food Contact Material Compliance
U.S. FCN (new substance submissions)
China Novel Food-Related Substance Submissions
EU EFSA Novel Substance Submissions
Canada Letter of No Objection (LONO) Applications
Mercosur Positive List Queries
Regulatory Consulting / Customized Product Advisory Reports
Product Compliance Analysis / Novel Substance Determination
Compliance Testing & Declarations
Additional Services
Testing Coordination & Supervision
Compliance Analysis Reports
Customized Regulatory Updates & Alerts
Supply Chain Compliance Training
Regulatory Translation Services