Item by item, against Article 3 of the regulation
Taiwan PIF Self-Check: How Many of the 16 Items Do You Have?
The 16 items are not 16 equal boxes. Three are gating items — miss any one and the file does not hold up legally, however complete the other fifteen are. Three others may be waived, provided a qualified Safety Assessor evaluates the product and states the reason. So a score out of 16 tells you very little; what matters is which kind you are missing.
The 16 items below follow the wording of the regulation. Answer each one and you get a result with next steps. Everything is calculated in your own browser and nothing is uploaded — a company's compliance gaps should not be sent to someone else's website.
This is an unofficial translation provided for reference. The authoritative text is the Chinese original.
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1
Basic product information
Product name, product category, dosage form, purpose, manufacturer name and address, and information on the manufacturing or importing business.
How this item is usually closed
Most of this was already filled in during product registration — copy it across and check it. For split manufacturing, list every manufacturing site and the process it performs (Article 3, paragraph 3).
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2
Proof of completed product registration
GatingDocumentation evidencing completed product registration.
How this item is usually closed
Download it after completing registration on the TFDA cosmetic product registration platform. Without registration the other fifteen items have nothing to attach to — this is the starting point, not just one item among sixteen.
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3
Full ingredient list with individual concentrations
GatingNames of all ingredients and their individual concentrations.
How this item is usually closed
Only the manufacturer can produce this, and it is the one document you genuinely cannot obtain elsewhere. Where the maker is concerned about formula confidentiality, a non-disclosure agreement, or supply on the condition that it is used only for compliance assessment, usually resolves it.
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4
Product label, insert, outer packaging or container
Product label, package insert, outer packaging or container.
How this item is usually closed
It must be the version actually on the market, and the Chinese labelling must comply with Article 7 of the Cosmetic Hygiene and Safety Act. Design files or photographs of the product both work.
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5
Proof or declaration that the manufacturing site meets cosmetic GMP
Documentation or a declaration that the manufacturing site complies with the Cosmetic Good Manufacturing Practice regulations.
How this item is usually closed
Note the wording: proof or a declaration. A third-party GMP certificate is not the only route — a compliant declaration also satisfies this item. People often assume a factory audit is unavoidable here.
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6
Manufacturing method and process
Manufacturing method and process flow.
How this item is usually closed
The maker's process description. It does not need formula-level detail, but the manufacturing steps must be visible.
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7
Directions, area of application, amount, frequency and target population
Method of use, area of application, quantity, frequency and target population.
How this item is usually closed
This item directly determines how item 16 is calculated — the exposure figure for a product used around the eyes differs from one used on the limbs. Written vaguely, the safety assessment cannot proceed.
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8
Adverse reaction data
Data on adverse reactions from use of the product.
How this item is usually closed
If none have occurred, record "none". What matters is whether a mechanism exists to collect and record them, not whether you have cases.
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9
Physicochemical properties of the product and each ingredient
Physical and chemical properties of the product and of each individual ingredient.
How this item is usually closed
One of the three items most often "filed but not valid". Maker specification sheets usually cover the finished product only; the properties of each individual ingredient have to be compiled separately.
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10
Toxicological data on ingredients
Toxicological data on the ingredients.
How this item is usually closed
One of the three items most often "filed but not valid". In most cases animal testing does not need to be repeated — existing toxicological databases and published literature will support it. What can be cited, and to what depth, is a judgement for the Safety Assessor.
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11
Product stability test report
May be waivedProduct stability test report.
How this item is usually closed
May be waived under Article 3, paragraph 5.
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12
Microbiological test report
May be waivedMicrobiological test report.
How this item is usually closed
May be waived under Article 3, paragraph 5.
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13
Preservative efficacy test report
May be waivedPreservative efficacy test report.
How this item is usually closed
May be waived under Article 3, paragraph 5.
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14
Substantiation for functional claims
Supporting data substantiating functional claims.
How this item is usually closed
Only required where a claim is made. Whatever effect the packaging or advertising states needs matching substantiation. The reverse is also an option: dropping a claim you cannot support is often cheaper than substantiating it.
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15
Material data for packaging in contact with the product
Material data for packaging that comes into contact with the product.
How this item is usually closed
Material certification from the packaging supplier. Note the scope: packaging in contact with the product. The outer carton does not count.
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16
Product safety data
Gating(1) Safety assessment conclusions and recommendations, signed and dated by the Safety Assessor. (2) Documentation that the Safety Assessor meets the qualifications in Articles 4 to 6.
How this item is usually closed
This item decides whether the PIF is merely "filed" or actually valid. Without the signature and date of a qualified Safety Assessor (安全資料簽署人員), the entire file has no legal effect. The qualifications are set out in Articles 4 to 6: a degree in medicine, pharmacy, cosmetic science, toxicology or a related field, completion of cosmetic safety assessment training (4 hours regulation + 8 hours ingredient application and risk + 36 hours assessment methods + 6 hours writing conclusions), and at least 8 hours of continuing education each year.
About items 11 to 13
Items 11 to 13 may be waived under Article 3, paragraph 5 — but that does not mean "skip them". A qualified Safety Assessor must evaluate the product's properties and state the reason inside item 16. This is usually the easiest cost to avoid, and also the easiest to get wrong: skipping the tests with nobody signing off on why leaves you three items short.
This checklist follows Article 3 of the Regulations Governing Cosmetic Product Information Files and is offered for self-assessment only. It is not a determination by the competent authority. Whether a specific case complies remains subject to TFDA announcements and individual assessment.