Consumer Health – USA/Europe/Asia/ROW Regulatory News – April 2024

USA

Final Guidance on New Dietary Ingredient Notification Procedures

The FDA has issued final guidance titled “New Dietary Ingredient Notification Procedures and Timeframes,” addressing common questions about the NDIN submission and review process. This document finalizes Section V of the 2016 revised draft guidance and incorporates additional clarifications from other related sections.

Draft Guidance on NDIN Master Files for Dietary Supplements

The FDA released new draft guidance, “New Dietary Ingredient Notification Master Files for Dietary Supplements,” which expands upon and replaces recommendations regarding Master Files from the 2016 revised draft guidance. The update outlines how Master Files can support NDIN submissions by protecting confidential data and streamlining future filings.

EUROPE

Preliminary Opinion on Silver in Cosmetic Products

The SCCS has published a preliminary scientific opinion on the use of silver (CAS No. 7440-22-4) in cosmetic products. Stakeholders may submit comments until May 5, 2024.

ASIA

CHINA

Technical Documents for Cosmetics Safety Assessment Finalized

NIFDC released the complete set of technical documents required for cosmetics safety assessments during the transition period (May 1, 2024 – May 1, 2025). These include: 

• Index of Cosmetics Safety Assessment Data from Authoritative Organizations 
• Ingredient Usage Information of Marketed Cosmetic Products 
• FAQ on Ingredient Usage Information of Marketed Cosmetic Products 

THAILAND

Updated Cosmetic Ingredient Requirements

The Thai FDA has approved updates to cosmetic ingredient lists following public consultation. The changes, effective immediately, align Thailand’s requirements with previous amendments to the ASEAN Cosmetic Directive.

HONG KONG

Implementation of Phase 1 Disposable Plastic Tableware Ban

Hong Kong has enacted the first phase of its disposable plastic tableware ban under the Product Eco-responsibility (Amendment) Bill 2023. The ban restricts the sale and distribution of nine categories of disposable plastic tableware, with a phased implementation schedule for catering establishments.

INDONESIA

Second Amendment to Processed Food Label Regulation

BPOM has issued the Second Amendment to Regulation No. 31/2018 on Processed Food Labels. While effective April 5, 2024, stakeholders have a four-year compliance grace period. Notably, new labeling requirements for bottled drinking water mandate storage instructions: “store in a clean and cool place, keep away from direct sunlight and objects with pungent smell.”

KOREA

New List of Raw Materials Subject to Import Ban

MFDS has published an updated list of raw materials prohibited from import, including diphenhydramine, raspberry, pomegranate seeds, and yellow oleander.

REST OF WORLD

AUSTRALIA

Updated Evidence Guidelines for Assessed Listed Medicines

The TGA has issued version 1.2 of the Assessed Listed Medicines Evidence Guidelines. The pathway allows sponsors of low-risk products with higher-level indications to obtain ARTG listing following pre-market assessment of efficacy evidence.

AICIS Fees and Charges Proposal for 2024–25

AICIS has opened a consultation on its proposed fees and charges for 2024–25, inviting stakeholder feedback before submitting the proposal for government approval.

Industrial Chemicals Categorisation Guidelines Updated

AICIS has published updated guidelines to help introducers determine the appropriate categorization of industrial chemicals under the Industrial Chemicals Act 2019. The update replaces specific biodegradability and sediment transformation testing references with “acceptable test guidelines.”

CANADA

Mandatory Plastic Products Reporting for 2024–2026

Environment Canada has issued a notice under CEPA requiring manufacturers and managers of plastic resins and certain plastic products to report data to the Federal Plastics Registry. Noncompliance may result in enforcement actions.

Amended List of Permitted Supplemental Ingredients

Health Canada has updated its List of Permitted Supplemental Ingredients (M-SIS-24-01), now allowing phosphatidylserine (soy) as an approved supplemental ingredient.