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

USA

FDA announces availability of Additional Submission Tools for Cosmetic Facility Registration and Product Listing

The U.S. Food and Drug Administration (FDA) officially launched additional submission tools providing stakeholders with more flexibility for meeting their specific needs in cosmetic facility registration and product listing. These tools include: Structured Product Labeling (SPL) Xforms: This tool serves as an SPL authoring tool, facilitating the creation of SPL file containing information on cosmetic product facility registration and product listing. Form FDA 5066 and Form FDA 5067: These forms are designated for paper submissions. Form FDA 5066 is used for cosmetic facility registration, while Form FDA 5067 directs at cosmetic product listing. These forms are editable online.

ASIA

China

Requirements for Exporting Cosmetics Containing Triethanolamine

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

Essential Oil Cosmetics Definition and Notification Requirements

The Guangzhou Administration for Market Regulation (AMR) issued a set of FAQs aimed at standardizing the classification and notification process for essential oil products. These clarifications can help stakeholders differentiate between commonly confused concepts and avoid notification failures.

Japan

MHLW Proposes Amendments to Regulations for Dairy Products

Japan Ministry of Health, Labor and Welfare (MHLW) revealed an amendment for the Ministerial Ordinance Concerning Compositional Standards, Etc. for Milk and Milk Products. Stakeholders and the public have the opportunity to provide comments on the proposed changes until February 17, 2024. The revised standards are expected to come into effect in mid-March 2024.

Malaysia

Revision of Drug Registration Guidance Document in 2024, Affecting Health Supplement Registration

According to National Pharmaceutical Regulatory Agency (NPRA), Malaysia released the third edition, seventh revision of Drug Registration Guidance Document (DRGD) on Jan 19, 2024. The Revisions will take effect on Jan 31, 2024, except for four directives issued on Jan 18, 2024, which have been incorporated into the DRGD upon its release.

Philippines

Cosmetics Recall Guidelines

Philippines Food and Drug Administration (FDA) released a draft of Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration (the Guidelines). This Guidelines is drafted to develop an updated framework for the recall of health products, including cosmetics, in pursuit of public health and safety. Any comments can be sent to pfpid@fda.gov.ph no later than January 24, 2024.

Taiwan

Revision of act governing food safety and sanitation

Taiwan Food and Drug Administration (TFDA) released the amendment to the food advertisement provisions in Act Governing Food Safety and Sanitation, which increases the severity of penalties with immediate effect. TFDA incorporates the cases of advertising violations into the weighted penalty system. It clarifies one of the weighted factors, (C) degree of harm caused, defining the cases of advertising violations.

ROW

Australia

New Standard Import Permit for Fish Oil

The Department of Agriculture, Fisheries and Forestry (DAFF) of Australia introduced import changes for fish oils. The conditions are: A valid standard import permit issued by the DAFF is required prior to the importation of goods into the Australian territory. If the goods cannot meet the standard conditions, importers must apply for a non-standard permit, and the goods will be subject to individual assessments, with the corresponding product names listed on the permit. The only animal-derived material in the goods (other than gelatine) must be fish oil. In addition, the fish oil must be heat-treated prior to arrival in Australia, or directed to a class 3.0 approved arrangements site for further processing or re-packaging. The goods must meet biosecurity conditions. Each consignment must be packed in clean packaging/containers.

New Zealand

EPA Bans PFAS in Cosmetics

The Environmental Protection Authority (EPA) of New Zealand released a ban on the use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products by changing the Cosmetic Products Group Standard on January 30, 2024.The decision to ban PFAS in cosmetics is part of New Zealand’s precautionary approach to mitigating potential risks associated with these chemicals. To ensure the safety of cosmetic products, regulate non-hazardous cosmetic products containing hazardous ingredients, and align with the rules in Europe, in addition to the PFAS ban, standard has some updates.

South Korea

New Use-By Date Labeling Requirements for Foods

South Korea launched an online platform  to check the use-by date for each product category in January 2024 for enterprises’ references.  To address the issue of food waste, the Ministry of Food and Drug Safety (MFDS) introduced the “use-by date” labeling to provide consumers with clear information on safe food consumption.