Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

USA

CANADA

Health Canada Grants Approvals for Three New Food Enzymes

On October 11, 2023, Health Canada announced NOM/ADM-0209, effective immediately, which modifies the List of Permitted Food Enzymes. This update allows the use of Cellulase from Trichoderma reesei RF11412 in Brewers’ and Distillers’ mash with the required maximum level as “Good Manufacturing Practice.”

US

FDA Updates Compliance Program for Infant Formula

The U.S. Food and Drug Administration (FDA) has updated its compliance program for infant formula. This program provides detailed guidelines for FDA investigators, lab analysts, and compliance officers, addressing inspection procedures, sample collection, analysis, and compliance actions to ensure the safety and nutritional standards of infant formula in the U.S.

FDA Issues Warning Regarding Little Oak Infant Formula

The FDA has issued a warning for parents and caregivers about LittleOak infant formulas, which are being voluntarily recalled. These products were sold in the U.S. without the necessary premarket notification required by the FDA.

FDA Consults on New Electronic and Paper Forms for Cosmetic Facility Registration and Product Listing

The FDA introduced a draft for a new electronic submission portal, Cosmetics Direct, as well as paper forms FDA 5066 (Registration of Cosmetic Product Facility) and FDA 5067 (Cosmetic Product Listing), for public consultation until October 18, 2023. The FDA encourages the use of the electronic submission method to improve submission efficiency and allow easier access to prior registrations and listings.

FDA Releases New Structured Product Labeling (SPL) Guidelines for Cosmetics

On October 13, 2023, the FDA launched the Structured Product Labeling (SPL) Implementation Guide and Validation Procedures. This guide establishes requirements for submitting cosmetic product registration and listing data electronically in the SPL format, aligning with drug product submission standards.

EUROPE

EU

EU Tightens Restrictions on Intentionally-Added Microplastics in Cosmetics

The EU has notified the WTO of a new draft regulation aimed at tightening restrictions on products, including cosmetics, containing intentionally-added microplastics. This regulation, adopted under the EU’s REACH chemical legislation (Regulation (EC) No 1907/2006), reflects the EU’s continued efforts to improve environmental protection.

UK

Guidelines Released for Managing CMR Substances in Cosmetics

The UK has published new guidelines for managing CMR substances (carcinogenic, mutagenic, or toxic for reproduction) under its cosmetics regulation. These guidelines apply to England, Scotland, and Wales and outline the procedures for requesting exemptions for the continued use of such substances.

ASIA

CHINA

Shanghai Clarifies Cosmetics Advertising Requirements

The Shanghai Municipal Administration for Market Regulation (AMR) has released a draft of the Shanghai Cosmetics Industry Advertising Compliance Guidelines for public consultation. The guidelines clarify requirements for cosmetics advertising, including permissible efficacy claims and prohibited content.

China Simplifies Notification Process for Marketed Toothpastes

The China National Medical Products Administration (NMPA) announced changes to toothpaste supervision regulations, simplifying the notification requirements for toothpastes already on the market before December 1, 2023.

TAIWAN

Taiwan Releases Updated Guidelines for Product Information Files

The Taiwan Food and Drug Administration (TFDA) has published updated guidelines for establishing the Product Information File (PIF) for cosmetics. These guidelines include revised terminology, document references, and PIF templates. They also provide alternatives to animal testing.

SOUTH KOREA

South Korea Consults on Cosmetic Colorant Testing Methods

The Ministry of Food and Drug Safety (MFDS) in South Korea has published an exposure draft of proposed regulations on the types, standards, and testing methods for cosmetic colorants. The consultation period ended on September 13, 2023, with suggestions to allow companies to independently determine testing methods based on their product characteristics.

ROW

NEW ZEALAND

New Zealand Seeks Further Input on Labelling Fluoride Toothpastes

New Zealand’s Environmental Protection Authority (EPA) has been revising the Cosmetic Products Group Standard. A public hearing held on September 20, 2023, discussed the addition of labeling requirements for fluoride concentrations in fluoride-containing toothpaste.

AUSTRALIA

Australia Adds Seven Cosmetic Ingredients to the AIIC

The Australian Government has added seven industrial chemicals to the Australian Inventory of Industrial Chemicals (AIIC). These chemicals can now be listed on the AIIC without the requirement for a specific period to pass since their assessment certificates were issued.

Australia Seeks Feedback on Draft Evaluation Statements for Industrial Chemicals The Australian Government has initiated a public consultation on 20 draft evaluation statements regarding the safety of industrial chemicals. This consultation period will remain open until November 27, 2023.