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

USA

Canada

Three New Food Enzymes Granted Approvals

On October 11, 2023, Health Canada unveiled NOM/ADM-0209 with immediate effect, modifying the List of Permitted Food Enzymes to enable the use of Cellulase from Trichoderma reesei RF11412 in Brewers’ mash and Distillers’ mash, with the requested maximum level as “Good Manufacturing Practice”.

US

FDA Issues Updated Compliance Program for Infant Formula

The U.S. Food and Drug Administration has updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious.

FDA Alerts Parents and Caregivers to Concerns Regarding LittleOak Infant Formula

The U.S. Food and Drug Administration (FDA) is alerting parents and caregivers about LittleOak infant formulas that are currently being voluntarily recalled by the company. The products have been sold in the U.S. illegally because the company has not submitted to the FDA the required premarket notification.

US Consults on Electronic Portal and Paper Forms for Cosmetic Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) unveiled its newly developed draft electronic submission portal (Cosmetics Direct), Paper Form FDA 5066-Registration of Cosmetic Product Facility and Paper Form FDA 5067-Cosmetic Product Listing for public consultation. The period for public consultation will last until October 18, 2023. Companies have the option to choose either electronic submission via Cosmetics Direct or paper submission methods. However, the FDA encourages electronic submission to enhance the efficiency and timeliness of data submission. Moreover, by utilizing the electronic submission method, companies can conveniently access their previous registrations and listing submissions as well as view the Submission ID for accepted submissions.

USFDA Unveils Guidelines on Structured Product Labeling (SPL) for Cosmetic Product Facility Registrations and Product Listings

U.S. Food and Drug Administration (FDA) rolled out a comprehensive Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (the Implementation Guide) on October 13, 2023. This development comes on the heels of the recent unveiling of Cosmetics Direct, the electronic submission portal through a draft guidance, which requires cosmetic registration and listing data to be electronically submitted in the SPL format, aligning with the submission format for drug products.

EUROPE

EU

Restrict Intentionally-added Microplastics in Cosmetics

EU notified WTO of a draft regulation aiming at imposing tighter restrictions upon products, including cosmetics, containing intentionally-added microplastics. On September 27, 2023, EU officially adopted these restrictions under EU’s chemical legislation Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), marking another significant stride in environmental protection.

UK

Guidelines on Managing CMR Substances Under the Cosmetics Regulation

UK released a guidance introducing the management of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) within the cosmetics regulatory framework. Applicable to England, Scotland, and Wales, the guidance outlines the regulatory requirements for CMR substances, and describes the exemption application process for their continued use.

ASIA

China

Shanghai Government Clarifies Requirements for Cosmetics Advertising: Permitted Efficacy Claims, Content Requirements, and Prohibited Advertising Contents

Shanghai Municipal Administration for Market Regulation (AMR) released the draft of Shanghai Cosmetics Industry Advertising Compliance Guidelines for public consultation. 1 The Guidelines is applicable to cosmetic manufacturers and operators in Shanghai, including cosmetics registrants, notifiers, production enterprises, operators, and user units, who promote their cosmetics through various media and forms.

China Simplifies Notification Document Requirements for Marketed Toothpastes

China National Medical Products Administration (NMPA) issued an announcement regarding the implementation of toothpastes supervision regulations and the simplification of notification document requirements for toothpastes already available in the market. Acknowledging the current state of the toothpaste industry, the announcement: Highlights the primary responsibility of the toothpaste notifier, introduces simplified notification document requirements for toothpastes that have been on the market before December 1, 2023.

Taiwan

Guidance Documents for Establishing the Product Information File (PIF)

Taiwan Food and Drug Administration (TFDA) released the updated guidance documents for establishing the product information file (PIF) for cosmetics, including the Guidelines on the Establishment of PIF, Manual for the Establishment of PIF, and PIF Checklist. The main revisions made in these documents are related to the terminology of and references for documents, PIF templates, and the alternatives to animal testing, which entered into force upon their release.

South Korea

Cosmetic Colorant Requirement

The Ministry of Food and Drug Safety(MFDS) published an exposure draft of Types, Standards, and Testing Methods for Cosmetic Colorants1 for public opinion. The consultation period is set to end on September 13, 2023.  MFDS mainly proposes deleting the specified testing methods in the regulation to allow companies to autonomously establish the testing methods according to their product characteristics. The competent authority also plans to provide guidelines for cosmetic colorant testing methods2 for enterprises’ references. Other testing methods beyond the guidelines would be allowed if they are scientifically validated.

ROW

New Zealand

New Zealand Cosmetic Product Group Standards: Further Information Around Labelling Fluoride Toothpastes Requested

The revision of New Zealand’s Cosmetic Products Group Standard has drawn the attention of cosmetic industry. After an online webinar on April 12 to introduce the proposed amendments1, the Environmental Protection Authority (EPA) held a public hearing on September 20, 20232. At that hearing, Manatū Hauora (Ministry of Health) spoke to the submitted suggestions about adding labelling requirements for fluoride concentrations in fluoride-containing toothpaste to the Cosmetic Product Group Standard.

Australia

Seven Cosmetic Ingredients added to the Australian Inventory of Industrial Chemicals (AIIC)

The Australian Government announced the addition of seven industrial chemicals to the AIIC under Section 83 of the Industrial Chemicals Act 2019. These chemicals have applied for early listing and their assessment certificates do not include a condition on the period for which the industrial chemicals are permitted to be introduced. They can be listed in the AIIC even if less than 5 years have passed since the issuance of their assessment certificates.

Australia Consults on 20 Draft Evaluation Statements on Industrial Chemicals

The Australian Government initiated a public consultation, seeking feedback on 20 draft evaluation statements. These evaluation statements aim to provide safety information regarding the use, import, and manufacture of industrial chemicals. The consultation will remain open until November 27, 2023.