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

USA

Updated SPL Implementation Guide for Cosmetics Registrations

The FDA has released an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, incorporating revisions related to cosmetic product facility registration and product listing requirements.

FDA Delays Enforcement of MoCRA Facility and Product Listing Requirements

The FDA issued guidance announcing a six‑month enforcement delay for cosmetic product facility registration and product listing obligations under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), allowing additional time for industry compliance.

Revised Leafy Green STEC Action Plan

The FDA updated its Leafy Green Shiga toxin–producing E. coli (STEC) Action Plan, adding new details on sampling, method development, and ongoing longitudinal studies in Arizona and California. A new fact sheet was also released highlighting how adjacent land uses affect produce safety.

Small Entity Compliance Guide: Yogurt Standards of Identity

The FDA issued a Small Entity Compliance Guide explaining actions required to comply with amendments to the standards of identity for low-fat and nonfat yogurt and updates to the general yogurt standard. These revisions reflect modern yogurt production practices while preserving essential product characteristics.

Updated Electronic Submission Process for Food Ingredients and Packaging

The FDA has enhanced its CFSAN Online Submission Module (COSM), allowing industry to submit fully electronic regulatory filings related to food ingredients and packaging, replacing paper-based submissions.

EUROPE

New EU Restrictions on Microplastics in Cosmetics

As part of the EU’s green transition, Regulation (EU) 2023/2055 amends REACH to phase out intentionally added microplastics—including those used in cosmetics—due to their persistence and environmental impact.

Restriction Proposal for Certain Chromium (VI) Substances

ECHA has been mandated to prepare an Annex XV restriction dossier targeting certain chromium (VI) substances currently listed in entries 16 and 17 of REACH Annex XIV. If adopted, these substances would be removed from the Authorisation List for the first time.

New Limits for Nitrites and Nitrates in Foods

To advance Europe’s Beating Cancer Plan, the European Commission has set significantly reduced maximum levels for nitrites and nitrates used as food additives, balancing protection against harmful bacteria with minimizing consumer exposure to carcinogenic nitrosamines.

ASIA

INDONESIA

Updated Requirements for Cosmetic Import Certificates

BPOM has amended regulations governing the importation of drugs and food, including cosmetics. Importers must obtain an import certificate (SKI Post Border) before or within seven days after customs release of goods. Products not covered by the certificate may not be imported.

Draft Regulation on Cosmetic Adverse Reaction Reporting

Indonesia released a revised draft regulation for public consultation outlining updated requirements for reporting adverse reactions to cosmetics. The draft clarifies reporting obligations, definitions, and notification procedures.

SOUTH KOREA

Updated Cosmetic Safety Standards

MFDS has amended the Regulation on Safety Standards for Cosmetics, adding changes to seven prohibited ingredients and three restricted ingredients, along with corresponding CAS numbers and chemical names. Most changes took effect on November 30, 2023, except updates related to hair dye substances, which take effect six months later.

CHINA

Finalized Toothpaste Notification Dossier Requirements

NMPA has issued the finalized Provisions for Management of Toothpaste Notification Dossiers, detailing notifier responsibilities, user information documentation, and dossier components. The regulation takes effect December 1, 2023.

Updated Administrative Measures for FSMP Registration

SAMR has released revised Administrative Measures for Foods for Special Medical Purpose (FSMP), including new priority review pathways, clarified non‑approval conditions, updated labeling rules, and optimized registration procedures. The measures take effect January 1, 2024.

THAILAND

Proposed Labeling Requirements for Ampoule, Vial, and Syringe Cosmetics

The Thai FDA has conducted a public consultation on proposed labeling rules for cosmetics in ampoules, vials, and syringes, specifying mandatory content, language, placement, and format.

Public Consultation on Food Contaminant Limits

The Thai FDA is seeking input on proposed amendments to maximum levels for contaminants in food. Stakeholders are asked to assess expected impacts of three different regulatory options.

JAPAN

Updated Policy on Food Contact Materials

Japan’s MHLW issued Notification No. 324, confirming the Positive List (PL) system for food-contact packaging will take effect June 1, 2025. Modifications to substance listings—including eliminations, consolidations, and revised restrictions—will also be implemented on this date.

PHILIPPINES

Proposed Adoption of PNS and RCP for Processed Foods

The Philippines FDA released a draft regulation proposing adoption of the Philippine National Standards (PNS) and Recommended Code of Practices (RCP) for processed food products as binding technical regulations.

REST OF WORLD

TAIWAN

Updated Registration Requirements for Infant Formula and Related Products

TFDA has amended regulations governing registration, review, and permitting for food and related products, including infant formula, disease‑specific formula, and food additives. Most revisions take immediate effect, with a one-year grace period for hygiene analysis requirements.

AUSTRALIA

New Rules for Sports Supplements

Australia’s DAFF has issued new rules requiring certain sports supplements—those marketed for improving or maintaining physical or mental performance and sold in tablet, capsule, or pill form—to be registered as therapeutic goods (medicines) under TGA oversight beginning November 30, 2023. Pure glucose products are exempt.