This chapter establishes the regulatory context of PIF AI: from the legislative history of Taiwan’s Cosmetic Hygiene and Safety Act, to the substance of the Article 8 PIF obligation, the phased implementation schedule, penalties, and an international comparison with the EU CPR and US MoCRA. After reading, you should be able to answer: what is a PIF, why is July 2026 critical, and what happens if you don’t comply.
Before 2018, cosmetics in Taiwan were governed by the Cosmetic Hygiene Administration Statute (enacted 1972; revised multiple times)1. That statute centered on “pre-market licensing”: special-use cosmetics required registration before sale; general cosmetics were on notification.
Problems:
In 2018 Taiwan’s Legislative Yuan passed the Cosmetic Hygiene and Safety Act (the “Act”)2. Core changes:
Article 8 of the Cosmetic Hygiene and Safety Act:
- Businesses that manufacture or import cosmetics shall establish a Product Information File (PIF) before the cosmetic is supplied, sold, gifted, publicly displayed, or offered as samples to consumers.
- The PIF shall be retained at the business’s premises for inspection. The central competent authority (TFDA) shall prescribe the retention method, content, period, and other implementation details.
- The central competent authority may, by product category, dosage form, or business scale, announce the mandatory implementation schedule of the PIF obligation.
| Obligation | Subject | Timing |
|---|---|---|
| Establish | Manufacturer / importer | Before any supply / sale / gift / display / sample |
| Retain | Manufacturer / importer themselves | Product lifecycle + 10 years post-discontinuation (per implementation rules) |
| Produce on demand | Cooperate with TFDA inspection | TFDA may inspect at any time |
[!IMPORTANT] A key point: the PIF is not submitted to TFDA. Businesses retain it themselves for inspection. This means TFDA does not routinely read each business’s PIF; but upon inspection, inability to produce a complete PIF immediately is non-compliance.
This design directly maps to PIF AI’s product positioning: a self-service tool for businesses, not a submission portal.
The implementation rule Regulations on Management of Cosmetic Product Information Files specifies 16 items3, detailed in §3. Here are the titles for reference:
gantt
title Taiwan Cosmetic PIF Implementation Schedule
dateFormat YYYY-MM-DD
axisFormat %Y/%m
section Phase 1
Special-use cosmetics (sunscreen, hair dye) :a1, 2021-07-01, 2026-07-01
section Phase 2
General cosmetics (large enterprise) :a2, 2022-07-01, 2026-07-01
section Phase 3
General cosmetics (SME) :a3, 2024-07-01, 2026-07-01
section Full mandate
All cosmetics :crit, 2026-07-01, 2030-12-31
Figure 2.1: TFDA announced a three-phase gradual rollout, prioritizing higher-risk products and larger businesses. The full mandate activates on 2026-07-01, giving the industry roughly five years to build capacity.
[!WARNING] After July 1, 2026, all cosmetics manufactured or imported in Taiwan (regardless of category or business size) must hold a complete PIF. As of this whitepaper (April 2026), the remaining preparation window is about 2–3 months.
Articles 23–24 of the Act govern penalties for PIF non-compliance:
| Violation | Fine | Additional consequence |
|---|---|---|
| No PIF before supply | NT$10,000 – NT$1,000,000 | Order to rectify within a period |
| Established but incomplete PIF | NT$10,000 – NT$300,000 | Same |
| Obstructing inspection | NT$100,000 – NT$1,000,000 | Same |
| Failure to rectify by deadline | Aggravated (up to NT$5,000,000) | May order suspension / revoke registration |
| Fraudulent SA signature | Criminal liability (forgery) | Civil liability separately |
[!CAUTION] Fines are per-SKU. For multi-SKU businesses, a single inspection uncovering 10 non-compliant products could, in principle, lead to NT$10,000,000 in fines.
EU Regulation (EC) No 1223/2009 has been in force since 20134. Core mechanism:
The US passed MoCRA in 20225, imposing federal recordkeeping obligations on cosmetics for the first time:
| Dimension | Taiwan Act | EU CPR | US MoCRA |
|---|---|---|---|
| Pre-market obligation | Product registration | CPNP notification | Product listing |
| Integrated PIF | ✅ Article 8 | ✅ CPSR | ❌ (distributed) |
| SA sign-off | Required | Required | Not required |
| Inspecting authority | TFDA | Member-state authorities | FDA |
| Full-mandate date | 2026-07-01 | 2013-07-11 | 2023-12 (facility reg) / 2024-07 (adverse events) |
| Max fine | NT$5M | €10M or 10% of turnover | Civil penalty + recall |
[!TIP] PIF AI prioritizes Taiwan’s Act, but the design (flexible 16-item mapping, multilingual schema) leaves room to extend to EU CPNP and MoCRA. See §12 Roadmap.
This chapter’s regulatory facts map directly to PIF AI’s design:
| Regulatory element | PIF AI design | Chapter |
|---|---|---|
| Article 8 — 16 items | pif_documents table + 16 processing modules |
§3, §8 |
| SA qualification | users.role = 'sa' + sa_qualified_until |
§11 (SA section) |
| In-house retention | Multi-tenant SaaS + AES-256 formulation encryption | §11 |
| Any-time inspection | Complete audit_logs table |
§11 |
| High penalties | UI explicitly marks AI output as “reference draft” to avoid misleading compliance status | §1.3.2 |
| Phased rollout | SaaS pricing tiers (Free / Pro / Enterprise) mapped to business size | §12 |
| Version | Date | Summary |
|---|---|---|
| v0.1 | 2026-04-19 | First draft. Covers Article 8, phased schedule, penalties, EU/US comparison |
© 2026 Baiyuan Tech. Licensed under CC BY-NC 4.0.
Nav ← Chapter 1: Abstract · Chapter 3: PIF 16 Items →
Cosmetic Hygiene Administration Statute (1972; last revised 2016), superseded by the 2018 Act. ↩
Cosmetic Hygiene and Safety Act (promulgated 2018-05-02; phased effect 2019-07-01; fully mandatory 2026-07-01). MOHW/TFDA. ↩
Regulations on Management of Cosmetic Product Information Files (promulgated 2019-06-10). ↩
European Union. Regulation (EC) No 1223/2009 on cosmetic products. Official Journal, 2009. ↩
U.S. Congress. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Public Law 117-328, 2022. ↩