Cosmetic GMP Regulations to be Fully Implemented in July, Fines up to 5 Million NTD

Central News Agency, Taipei, May 27. Products such as shampoo and antiperspirants are classified as cosmetics. To ensure hygiene and safety, the Food and Drug Administration (FDA) is pushing for nearly 1,000 manufacturing sites across Taiwan to comply with GMP standards, with full implementation starting July 1st. Violators face fines of up to 5 million NTD. Additionally, manufacturers are required to complete Product Information Files (PIF). According to the Ministry of Health and Welfare's FDA regulations, in addition to makeup, products such as shampoo, facial cleanser, body wash, soap, hair oil, toner, talcum powder, antiperspirants, lipstick, foundation, liquid eyeliner, nail polish, mouthwash, and toothpaste fall under the category of cosmetics. The FDA announced at a regular press conference today that starting July 1st, all types of cosmetic manufacturing sites in Taiwan must apply GMP standards. Chi Lan-hui, head of the FDA's Quality Supervision and Management Division, explained that Taiwan amended the 'Cosmetic Hygiene and Safety Management Act' in 2018 and formulated the Good Manufacturing Practice (GMP) for cosmetics by referencing international standards (ISO 22716). To allow the industry to gradually transform and upgrade, a three-stage implementation schedule was planned. The first stage (July 1, 2024) targeted manufacturing sites for specific-use cosmetics such as sunscreen, hair dyes, perms, antiperspirants, and home-use teeth whitening products. The second stage (July 1, 2025) included manufacturing sites for baby products, lip products, eye products, non-medicinal toothpaste, and mouthwash. The third stage (July 1, 2026) will cover all remaining general cosmetic manufacturing sites (excluding solid handmade soap manufacturers exempt from factory registration). Chi Lan-hui stated that the first and second stages combined cover about 450 cosmetic manufacturing sites, and the third stage is expected to cover more than 400 additional sites. Since the beginning, 1,003 factory guidance and inspection visits have been conducted. While areas for improvement were identified, businesses completed improvements within the specified timeframes, so there have been no actual cases of fines imposed yet. Wang De-yuan, Deputy Director-General of the FDA, emphasized that in the future, if a business is notified to make improvements within a time limit and fails to do so, it may be fined between 20,000 and 5 million NTD under the Cosmetic Hygiene and Safety Management Act, and may be subject to repeated fines. In serious cases, the business may be suspended for one month to one year, or have its company, commercial, or factory registration partially or fully revoked, or have its cosmetic registration or permit revoked. Furthermore, Wang pointed out that starting July 1st, in addition to manufacturing sites meeting GMP, they must follow compliant Product Information Files (PIF). Every step, from raw material weighing, feeding, mixing, and stirring during the manufacturing process, to filling, packaging, and finished product inspection, must have clear Standard Operating Procedures (SOP) and detailed records. The FDA emphasized that to assist businesses in introducing internal control processes that meet cosmetic GMP, it will continue to hold relevant briefings, seminars, and factory guidance activities, and provide businesses with self-assessment forms and 26 key document templates. Subsequently, it will continue to work with local health authorities to conduct audits and guidance activities to grasp the implementation status of businesses and ensure that the industry can steadily implement quality management.