U.S – The U.S. Food and Drug Administration (FDA) has announced a final rule, amending regulations related to food contact notifications (FCNs) to streamline administrative processes and improve food chemical safety oversight.
The rule aims to enhance the efficiency of the FDA’s FCN program while ensuring continued vigilance in monitoring the safety and use of food contact substances.
It modifies regulations 21 CFR 170.105 and 21 CFR 170.102, empowering the FDA to determine the effectiveness of an FCN for reasons other than safety concerns. Previously, the FDA could only revoke an FCN based on safety issues.
The new changes allow the FDA to consider factors such as abandonment by the manufacturer or duplication of authorization.
By granting the FDA the authority to declare an FCN no longer effective in cases of abandonment or duplicative authorization, the final rule reduces redundancy and enhances regulatory efficiency.
Manufacturers and suppliers now have an opportunity to provide input before the FDA makes a determination, ensuring all relevant information is considered.
While the final rule expands FDA’s scope in evaluating FCN effectiveness, it maintains the agency’s ability to revoke authorizations based on safety concerns. FDA can still take action if necessary data or information is not provided or if safety concerns arise, regardless of abandonment or duplicative authorization.
The regulator will publish notices of its determinations in the Federal Register, marking the date when an FCN becomes ineffective. This process ensures transparency and informs stakeholders of regulatory changes. Additionally, FDA plans to regularly update its list of effective FCNs on the agency’s website to reflect the latest information.
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