Consumer Health USA/Asia/ROW Regulatory News – Jan 2024

EUROPE

FDA Introduces New Tools for Cosmetic Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) has rolled out additional submission tools designed to give stakeholders greater flexibility when completing cosmetic facility registrations and product listings. These include:

– SPL Xforms: An SPL authoring tool that helps create SPL files containing information required for cosmetic facility registration and product listing.

– Form FDA 5066 and Form FDA 5067: Paper submission options available for online editing. Form 5066 is used for facility registration, while Form 5067 is designated for product listing.

ASIA

CHINA

Requirements for Exporting Cosmetics with Triethanolamine

China’s Ministry of Industry and Information Technology (MIIT), the Ministry of Commerce (MOFCOM), and the General Administration of Customs (GACC) jointly announced the removal of the import license requirement for products containing low concentrations of Triethanolamine (CAS No. 102‑71‑6), including cosmetics.

Definition and Notification Requirements for Essential Oil Cosmetics

The Guangzhou Administration for Market Regulation (AMR) issued a series of FAQs to help standardize the classification and notification process for essential oil products. These clarifications aim to reduce common misunderstandings and prevent notification errors.

JAPAN

Proposed Amendments to Dairy Product Regulations

Japan’s Ministry of Health, Labour and Welfare (MHLW) proposed revisions to the Ministerial Ordinance concerning compositional standards for milk and milk products. The public may provide comments on the draft until February 17, 2024. The updated standards are expected to take effect in mid‑March 2024.

MALAYSIA

Updated Drug Registration Guidance Document for 2024

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the third edition, seventh revision of the Drug Registration Guidance Document (DRGD) on January 19, 2024. Most revisions become effective January 31, 2024, except four directives issued on January 18, 2024, which took effect immediately upon inclusion in the DRGD.

PHILIPPINES

Draft Guidelines on Health Product Recalls

The Philippines Food and Drug Administration (FDA) published a draft of the Guidelines on the Recall of Health Products, including cosmetics. The proposed framework aims to modernize and strengthen recall procedures to safeguard public health. Comments may be submitted to pfpid@fda.gov.ph until January 24, 2024.

TAIWAN

Revisions to the Act Governing Food Safety and Sanitation

Taiwan’s Food and Drug Administration (TFDA) announced amendments to the food advertisement provisions under the Act Governing Food Safety and Sanitation. The revisions increase penalties for violations and integrate advertising infractions into a weighted penalty system, with clearer criteria for evaluating the degree of harm.

ROW

AUSTRALIA

New Standard Import Permit Requirements for Fish Oil

Australia’s Department of Agriculture, Fisheries and Forestry (DAFF) introduced updated import conditions for fish oil products. Key requirements include:

• A valid standard import permit must be obtained before goods enter Australia.
• Products not meeting standard criteria require a non‑standard permit and individual assessment.
• Fish oil (excluding gelatin) must be the only animal-derived ingredient.
• Fish oil must be heat-treated before arrival or processed at an approved site.
• All consignments must comply with biosecurity conditions and be packaged in clean containers.

NEW ZEALAND

EPA Prohibits PFAS in Cosmetic Products

New Zealand’s Environmental Protection Authority (EPA) announced a ban on per‑ and polyfluoroalkyl substances (PFAS) in cosmetics by amending the Cosmetic Products Group Standard on January 30, 2024. The prohibition aligns with European regulations and aims to mitigate potential risks linked to PFAS. Additional updates to the standard were also introduced to enhance cosmetic product safety oversight.

SOUTH KOREA

New Use-By Date Labeling Requirements for Foods

South Korea launched an online platform in January 2024 to help enterprises verify use‑by date requirements for various product categories. As part of efforts to reduce food waste, the Ministry of Food and Drug Safety (MFDS) introduced the “use-by date” system, offering consumers clearer guidance on safe food consumption.