In the skincare industry, “regulation changes” often mean that brands must quickly adjust their formulas, packaging, labeling, and processes. To help brands navigate these changes smoothly, we have compiled recent key regulatory updates and corresponding recommendations to help you maintain legality and stability throughout the development, manufacturing, and market launch stages.
Key Regulatory Highlights
1. The Cosmetics Hygiene and Safety Management Law (July 1, 2019) officially came into effect.
Taiwan’s cosmetics industry has officially transitioned from the “Cosmetics Hygiene Management Regulations” to the ” Cosmetics Hygiene and Safety Management Act,” strengthening the regulatory framework and aligning with international standards.
Starting July 1, 2021, common toothpaste and mouthwash were added to the cosmetics management system. Also a general registration system and new labeling system for cosmetics were implemented.
2. A landmark change in the “Era of Cosmetics” (2024/2024.07.01)
Starting July 1, 2024, Taiwan’s cosmetics management will enter the ” Era of Cosmetics” no longer distinguishing between “general cosmetics ” and ” cosmetics for specific purposes,” and strengthening product information registration and safety data systems.
3. Latest Subsidiary Laws and Announcements Updated (Starting in 2025)
- Revise “List of Restrictions on the Use of Cosmetic Ingredients” comes effective from October 1, 2025.
- The revised “Administrative Fee Standards for Cosmetics” comes effective from on July 1, 2026.
- Preannouncement: Obligations regarding “Labeling Regulations for Cosmetic Outer Packaging, Containers, Labels, or Instructions” within the system.
The Main Impact on Corresponding Brands/Manufacturing
- Labeling and packaging materials need to be updated: for example, phrases such as “packaged in Taiwan” need to be added.
- Enhanced ingredient review and restrictions: The ingredient usage restriction table has been updated, and formula inspections are more stringent.
- The obligation to register product information has been expanded: Under the new law, the “Product Information File (PIF)” system has been strengthened, and complete data must be prepared.
- Increased penalties and enhanced surveillance : Failure to register products in accordance with the law or inconsistent labeling may result in fines of NT$100,000 or more, or even business suspension.
Brand Recommendation Steps
- Immediately review existing product labeling and packaging : confirm whether they comply with the new labeling obligations.
- Update the formula and ingredient list : Reconfirm the formula’s compliance by referring to the latest “Ingredient Usage Restriction Table ” .
- Establish/strengthen the PIF (Product Information File) preparation process : ensure complete filing of product information, raw material data, and process records.
- Monitor industry regulations : Pay attention to the progress of subsidiary laws, announcements, and draft laws, and be prepared to avoid the risk of sudden changes.
- Integrate OEM/ODM, packaging, and legal collaboration : Manufacturing, packaging, and regulations need to be reviewed simultaneously to ensure a smooth product launch process.
Regulations Quick Report Area
- Effective from 2025-11-06 : Announcement of revisions to the “Table of Restrictions on the Use of Cosmetic Ingredients”.
- Effective from July 1, 2025 : New administrative fees and charges will take effect.
- Preannouncement of : “Regulations on the Labelling of Cosmetic Outer Packaging, Containers, Labels or Instructions” has entered a 60-day public comment time period.
Summary of Key International Regulations
The following are the main market regulatory differences that brands most frequently encounter, summarized in a concise and readable format:
European Union — Cosmetic Regulation (EC) 1223/2009
Features: A rigorous, comprehensive, and globally influential regulatory system.
- A PIF (Product Information File) must be created .
- A safety assessment is required .
- Most complete list of prohibited ingredients
- The world’s most stringent regulations on preservatives, colorants, and fragrances.
- The product must specify the Responsible Person (RP).
- Medical suggestion and exaggerated description are not allowed.
- Efficacy claims must be supported by scientific evidence.
USA — FDA / MoCRA (New Law 2022)
Feature: Shift from voluntary management to stronger regulation
- The MoCRA (Modernization of Cosmetics Regulation Act) has been in effect since 2023.
- Increased requirements for ingredient transparency
- Security data retention is mandatory (similar to PIF, but with greater flexibility).
- The factory must comply with GMP (Good Manufacturing Practices).
- Product launch requires registration.
- Sunscreen is classified as an “OTC drug,” and its regulations are stricter than those for general cosmetics.
- Advertising regulations are governed by FTC (Federal Trade Commission) rules.
Japan —Pharmaceutical Machinery Act (PMD Act)
Unique Feature: Cosmetics and “quasi-pharmaceuticals” operate in parallel.
- Japanese cosmetics are divided into:
Cosmetics / Quasi-drugs - Quasi – drugs have the requirement of “labelable efficacy” but require application.
- Ingredient specifications are regulated according to the “Positive List,” which is stricter than other countries.
- Labelling obligations: ingredients, usage, manufacturer, batch number, precautions
- Claim restrictions: It must not imply therapeutic efficacy.
- Product launch requires notification.
Taiwan — Cosmetics Hygiene and Safety Management Act
Features: Gradually aligning with the EU framework
- A new law came into effect in 2019, comprehensively reforming the management of cosmetics.
- Starting in 2024, the “Era of Cosmetics” will no longer distinguish between specific uses.
- The product must be registered as a cosmetic product.
- Some projects require the establishment for PIF.
- Ingredient usage restrictions table is in line with international standards.
- Claims must be avoided: medical terminology, exaggerated language, and suggestive claims about therapeutic effects.
Brand-Specific Regulatory Checklist
(Applicable to: OEM/ODM development, brand owners, pre-listing review)
🔍A. Basic Product Information
□ Product Name (Chinese/English)
□ Capacity Indication
□ Product Category (Cleansing/Moisturizing/ Sunscreen /General Skincare)
□ Are the Usage Instructions and Precautions Clear?
🧪B. Formula compliance check
□ Does it comply with the latest? “List of Restricted Use of Cosmetic Ingredients”?
□ Prohibited ingredients are not included (e.g., steroids, prohibited preservatives, etc.)
□ Are the ingredient proportions in accordance with regulations? (e.g., fragrances, colorants, acids, etc.)
□ Is additional safety data required? (e.g., acids, standardized plant extracts)
📦C. Packaging materials and outer box labeling
□ Does the labeling comply with the latest regulations of the Ministry of Health and Welfare?
□ Does it includes: manufacturer, address, batch number, and expiration date?
□ If it is an “Imported Product,” does it include the distributor’s information?
□ Does it avoid using prohibited terms (such as: repair, regeneration, desalination, injection, deep penetration, etc. )?
□ Does it include necessary information such as “repackaged in Taiwan” (if applicable)?
🗂D. PIF (Product Information File) Preparation
□ Formulation (including complete ingredient list, INCI)
□ Ingredient Safety Data (SDS/TSD)
□ Manufacturing Batch Records
□ Packaging Material Compatibility Data
□ Product Stability Test Data
□ Safety Assessment (SA) Signed Documents
🚚E. Pre-IPO registration (required)
□ Has the product information been uploaded to the TFDA (Taiwan’s Food and Drug Administration) platform?
□ Are the ingredients correctly matched?
□ Are the packaging photos complete?
□ Have a login code been obtained after logging in?
🌍F. Exports (including imports from China, the United States, ASEAN, etc.)
□ Has a Chinese import certificate been applied for?
□ Does it comply with local packaging and ingredient standards?
□ Have the necessary documents (such as formula, product images, packaging specifications, MSDS) been provided?