Attention cosmetic producers! Have you heard of PIF (Product Information Files)?
What is PIF (Product Information Files)?
Product Information Files (PIF) are complete cosmetic documents.
Documents containing information on the quality, safety and functionality of cosmetic products.
To strengthen the industry's self-management capabilities and product quality, thereby ensuring the safety of consumers using cosmetics.
The current international practice has already been implemented by the EU and ASEAN, and will completely replace the "specific use license" after it is implemented for all products in the future.
Cosmetics manufacturers are now required to complete the Product Information Files (PIF) before the product is launched on the market.
It can only be sold, given away, publicly displayed or tried out after being signed by a "safety signing officer" (SA officer).
Who should execute PIF (Product Information Files)?
- Cosmetics manufacturers (cosmetics brands, cosmetics owners)
- Cosmetics importers (cosmetics importers)
- Cosmetics outsourcing manufacturers (OEM, ODM factories) are not obligated
Except for solid handmade soap businesses which are exempted from factory registration.
What does the PIF include?
File information that should be created | File information description and preparation documents |
1. Basic information of the product | Basic information such as product name, category, dosage form, use, manufacturing, filling, packaging location, and manufacturer/importer information |
2. Documents proving product registration | The product has completed the registration information, and the registration content is consistent with PIF |
3. Name of all ingredients and their contents | All ingredients should be named using INCI and their content should be indicated. |
4. Product labels, leaflets, outer packaging or containers | Photos or pictures of the physical appearance of the product and the front and back of the inner and outer packaging, as well as Chinese labels or leaflets that comply with regulations |
5. Documents or declarations proving that the manufacturing site complies with the Good Manufacturing Practices for Cosmetics | Certification or declaration that the manufacturing site complies with ISO 22716 |
6. Manufacturing methods and processes | Briefly describe the product manufacturing process, either as a diagram or in text |
VII. Usage, Part, Dosage, Frequency and Ethnic Groups | Product type, application site, usage amount, usage duration, usage frequency, user group, etc. |
8. Product adverse reaction information | If there are no adverse reactions during normal use of the product, a statement can be used instead. If adverse reactions have occurred, the incident must be recorded and corrective and preventive measures must be taken; serious adverse reactions must be reported to the competent authority |
IX. Physical and chemical properties of the product and its individual components | Describe the physical and chemical properties of the product and its components. You can attach documents such as COA, SDS, TDS, etc. of the finished product and individual components. |
10. Toxicological data of ingredients | Research data on acute toxicity, skin and eye irritation, sensitization, etc. of each ingredient. |
11. Product stability test report | Can be used as evidence to determine product storage conditions and validity period: stability test, accelerated test, shelf life test |
12. Microbiological test report | 5 microorganisms: bacterial count, Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans |
13. Anticorrosion Efficacy Test Report | Anticorrosion performance test (challenge test) |
14. Supporting information for functional evaluation (provide appropriate documents based on product efficacy and claims) | 【Sunscreen products】 ● Identification and content testing of sunscreen ingredients ● Efficacy test: SPF/Star Rating, UVB irradiation B16 melanoma cell inhibition of tyrosinase synthesis test |
【Hair products: shampoo, conditioner, hair dye, perm, etc.】 ● Identification and content testing of effective ingredients for hair dyeing, bleaching and perming ● Efficacy test: hair dyeing/color protection/perming efficacy test, dandruff inhibition test (anti-dandruff) test, anti-inflammatory (anti-dandruff) test, hair strength increase test, etc. | |
【Body/Face Care Products】 ● Active ingredient detection: Salicylic acid, Allantoin, Sulfur, Ascorbyl Tetraisopalmitate ● Whitening ingredient testing: Vitamin C tetraisopalmitate, vitamin C magnesium phosphate, vitamin C glucoside, tranexamic acid, retinol, arbutin, etc. ● Efficacy tests: Propionibacterium acnes inhibition (anti-acne) test, cell anti-inflammatory (anti-acne) test, tyrosinase activity inhibition (whitening) test, free radical scavenging (anti-aging/wrinkle) test, cell test (anti-aging/wrinkle) test, cell oil secretion/anti-inflammatory (oil control) test, hyaluronic acid (moisturizing) test, irritation test, etc. | |
【Body/Face Cleansing Products】 ● Active ingredient detection: salicylic acid, etc. ● Efficacy test: Propionibacterium acnes inhibition (anti-acne) test, cell anti-inflammatory (anti-acne) test, hyaluronic acid (moisturizing) test, irritation test, etc. | |
【Antiperspirant and deodorizing products】 ● Identification and content detection of antiperspirant and deodorizing ingredients ● Efficacy test: body odor improvement test | |
【Tooth/Oral Products】 ● Identification and content testing of teeth whitening ingredients ● Efficacy test: tissue replacement (whitening) test, Streptococcus mutans inhibition (antibacterial) test (dental plaque), Helicobacter pylori inhibition (halitosis improvement), etc. | |
● Other advertising claims | |
15. Information on packaging materials in contact with the product | Heavy metal, plasticizer, material test, dissolution test, heat resistance test |
16. Product Safety Information | The safety assessment conclusions, recommendations, qualification documents, signatures and date of the SA personnel are made by the person who signed the safety document. |
Taiwan PIF official implementation schedule
According to Taiwan regulations, the product information file (PIF) of each cosmetic product should be established and maintained by the manufacturer or importer (brand side).
After the implementation of the first phase, the licensing system for specific-purpose cosmetics was officially terminated on July 1, 2024 and was fully replaced by the PIF system.
The implementation of PIF will be divided into three phases and the scope of application will be gradually expanded. The detailed schedule is as follows:
Officially on the road | Applicable product categories |
July 01, 2024 | Specific purpose cosmetics (such as sunscreen, hair dye, perm, antiperspirant, teeth whitening) |
July 1, 2025 | General cosmetics for eyes and lips, babies, non-medicated toothpaste, mouthwash |
July 1, 2026 | Comprehensively applicable to all general cosmetics (such as facial cleansers, lotions, perfumes) |