Comprehensive Guide to PIF Content: Essential Items All in One Place, Missing No Details!

Posted by Jolab on May 09, 2025

The 16 data points that must be included in a PIF are as follows:

Item	Document Name	Description
1	Basic Product Information	Includes product name, category, dosage form, purpose, manufacturer name and address, manufacturer or importer information, etc.
2	Proof of Product Registration	Provide relevant proof of product registration on the cosmetic registration platform.
3	Full Ingredient List and Individual Concentrations	Detailed list of all formulation ingredients and their percentage concentrations.
4	Label, Insert, Outer Packaging or Container	Attach images or design drafts of the actual product packaging.
5	GMP Certificate or Declaration	Proof of the manufacturer's compliance with "Cosmetic Good Manufacturing Practice (GMP)" or a legally binding declaration.
6	Manufacturing Method, Process Flow	Description of the actual manufacturing steps and process flow diagram for the product.
7	Instructions for Use	Includes method of use, area of application, dosage, frequency, and target demographic.
8	Adverse Reaction Data	Records of adverse reactions from historical or market feedback after product use.
9	Ingredient Physicochemical Properties	Basic physical and chemical property data for each ingredient (e.g., appearance, solubility, pH).
10	Ingredient Toxicological Data	Includes toxicological safety data such as acute toxicity, skin irritation, and sensitization.
11	Stability Test Report	Tests the product's stability under different conditions and provides a basis for shelf life.
12	Microbiological Test Report	Verification of test results demonstrating product compliance with microbial limit regulations.
13	Preservative Efficacy Test Report	For products containing preservatives, it verifies the inhibitory effect of the preservative system on microorganisms.
14	Functional Efficacy Supporting Data	If efficacy is claimed, clinical or laboratory test data must be provided as supporting evidence.
15	Packaging Material Data	Description of the container/packaging material in contact with the product and stability evaluation data.
16	Product Safety Data	(1) Safety assessment conclusions and recommendations issued by the signatory. (2) Proof of qualification of the safety assessor.

FQA:

Q1: Do brands that commission manufacturing also need to prepare a PIF?

Yes, even if manufactured by a contract manufacturer, the brand remains the responsible party for placing the product on the market. According to Taiwan's "Cosmetic Hygiene and Safety Act," brands must establish and maintain a PIF for each product. Even when produced by an OEM, the brand must actively ensure the completeness and compliance of product information. To efficiently meet regulatory requirements, many brands choose to include PIF preparation in their collaboration with OEM manufacturers, requesting the OEM to provide complete technical documents and raw data to expedite the regulatory data compilation process.

Q2: Are different colors or scents considered different products?

According to the practical standards of the competent authority, if there are differences in product formulation, packaging labels, or intended use, it is recommended to treat them as different product items and establish separate PIFs accordingly. When conducting customized development with cosmetic contract manufacturers, brands often fine-tune products for scent, color, or active ingredients. Therefore, it is advisable to plan for multi-item PIF documentation from the early stages of development to reduce the risk of needing to submit additional documents later.

Q3: If a compound fragrance is used, do all components need to be provided?

Yes, according to regulatory requirements, compound fragrances must list their detailed composition information. Typically, the fragrance supplier provides a complete composition list (e.g., IFRA Certificate or fragrance ingredient analysis report), and the brand should include this information in the PIF.

Q4: Can the PIF be written in English?

While some original source materials may be in English (e.g., foreign literature, SDS), it is recommended that the entire PIF document be primarily written in Chinese for ease of inspection by the competent authority and internal communication. English documents can be provided as attachments, but they should be accompanied by a Chinese summary or key translations. If a PIF outsourcing service is used, most providers are already familiar with these bilingual format requirements and can assist in consolidating the information to ensure document completeness.

Q5: Can the product safety report in the PIF be issued by a foreign safety assessor? Does it need to have specific certification or be registered in Taiwan?

It can be issued by a qualified foreign safety assessor, but their qualifications must meet Taiwan's regulatory standards. This includes: having relevant academic qualifications in medicine, pharmacy, toxicology, cosmetic science, etc., and having completed sufficient hours of professional safety assessment training. Additionally, the report must include the signatory's basic personal information, academic and professional background, and supporting documents. The report content should clearly list the basis for the safety assessment, toxicological data, and risk analysis results, and must be written in Chinese or include a Chinese abstract.

Q6: If the product is for salon or professional use only, does the PIF still need to include consumer-oriented labels and inserts?

Yes, as long as the product is sold or used in Taiwan, regardless of whether it is labeled for "professional use," it is considered a commercially available cosmetic and must comply with general labeling regulations, including target users, methods of use, shelf life, precautions, etc. An additional statement such as "for professional use only" can be added, but important consumer information cannot be omitted. This is also part of how many cosmetic contract manufacturers ensure compliance by simultaneously providing inserts and label designs upon shipment.

Q7: Does Taiwan's regulation accept PIF storage in electronic form? Is a physical copy required for inspection?

Taiwan's Ministry of Health and Welfare accepts PIF storage in electronic files, with PDF being the recommended format. It must retain signing traces, editing records, and links to original data sources. If PIF outsourcing is used, electronic systems are typically employed for management and archiving. It is recommended that brands keep a printed version for unforeseen needs.

Q8: The manufacturing method and process in the PIF are trade secrets. Is there a possibility of them being disclosed to consumers for review? Could this lead to the risk of trade secret leakage?

No. The PIF is a legally required document kept by the business for inspection and is not actively disclosed to the public. The competent authorities will adhere to relevant confidentiality regulations when conducting inspections and will only access relevant information when performing their duties.

Q9: If a startup brand only has a single product for sale, does it still need to create a complete PIF document?

Yes. Even with a single product, a complete PIF document must still be created and maintained as required. Startup brands often have limited understanding of regulations, so it is recommended to collaborate with experienced cosmetic contract manufacturers or OEM manufacturers. They can provide basic data, test reports, and guidance for documentation, speeding up the establishment process and reducing the risk of non-compliance.

Q10: If unfamiliar with regulations and data compilation processes, can a PIF be outsourced to a contract manufacturer for assistance?

Yes. Many PIF outsourcing providers or OEM manufacturers with regulatory experience have established standard operating procedures and document templates. They can assist brands with data collection, document creation, and final compilation, especially in situations involving multiple product items or cross-border raw material sources. This ensures data accuracy and timeliness, allowing brands to focus on marketing and business expansion.