Cosmetic Compliance Advisory
At Lighthouse Selection, our vision extends beyond showcasing the culinary character of Australia. We strive to connect the beauty we discover to another aspect of this remarkable country.
While we are passionate about introducing the world to the diverse flavors and ingredients of Australian cuisine, we also recognize that Australia has much more to offer. From its breathtaking landscapes to its vibrant culture, there is a profound beauty that transcends the culinary realm.
How We Can Assist?
Ideation & Planning
We start by listening. Whether you already have a clear idea or are still exploring, we’re here to help you frame the vision of your product.
→ No prior experience in cosmetics development required.
Documentation Support
We ensure your ingredient list, claims, and usage instructions are properly structured from the start.
→ Don’t worry about paperwork — we guide you through every section required for a compliant PIF.
&
Development
Regulatory-Oriented R&D Collaboration
In partnership with certified OEM/ODM laboratories and academic experts, we assist in testing your formula while ensuring it aligns with TFDA cosmetic guidelines.
- Ingredient traceability
- Preservative system compliance
- Safety & stability testing
- Regulatory-suitable formulation logic
Formula Amendment & Legal Refinement
Based on trial outcomes and TFDA legal standards, we assist in amending the formula and updating all relevant sections in your PIF file, including:
- Label claims
- Usage instructions
- Ingredient percentages
- Allergen and prohibited substance checks
Finalize
Product Finalization & Ownership Transfer
Once your formula complies with Taiwanese law and your desired product effect, we proceed to finalize documentation.
- Full PIF compiled (Chinese＆English)
- Certificate of formula ownership
- NDA & exclusivity agreement (optional)
- Ready for TFDA product registration
What is a PIF?
A Product Information File (PIF) is a comprehensive dossier required by the Taiwan Food and Drug Administration (TFDA) for all cosmetic products marketed in Taiwan. It serves to ensure product safety, quality, and regulatory compliance throughout the product's lifecycle.
When is a PIF Required?
July 1, 2024
Specific-purpose Cosmetics Type I
Applies to specific-purpose cosmetics, including:
- Sunscreens
- Hair dyes and perms
- Antiperspirants and deodorants
- Teeth whitening products containing peroxide
July 1, 2025
Specific-purpose Cosmetics Type II
Applies to:
- Children’s cosmetics
- Lip and eye products
- Non-medicated oral care products (e.g., toothpaste, mouthwash)
⚠️ Why Immediate Action is Crucial
With Phase 3 set to commence on July 1, 2026, encompassing all general cosmetics, the current year serves as the final window for brands to ensure compliance for existing products already on the market.
Key Considerations:
- Comprehensive Testing Requirements
- Regulatory Compliance
- Market Continuity
July 1, 2026
Applies to all other general cosmetics.
Contents of PIF
According to the TFDA's "Cosmetic Product Information File Management Regulations," a complete PIF comprises five main sections encompassing 17 specific items.
- Section 1: Product Description
- Section 2: Quality Data
- Section 3: Functional Claims Support
- Section 4: Safety Assessment
- Section 5: Appendices
Is Compiling a PIF Challenging?
Preparing a PIF can be complex, especially for businesses unfamiliar with TFDA regulations. Challenges may include:
- Data Collection
- Testing Requirements, need to be conducted in Taiwan
- Regulatory Compliance, need to assigned by a TFDAcertificated Safety Assessor（SA）
Consequences of Non-Compliance
Legal Basis: Under Article 23 of Taiwan's Cosmetic Hygiene and Safety Act, cosmetics businesses that fail to establish a PIF as required may face the following penalties:
- Fines: Ranging from NT$10,000 to NT$1,000,000.
- Repeat Offenses: Businesses may be fined successively for continued non-compliance.
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Additional Sanctions: In severe cases, authorities may impose:
- Suspension of business operations for 1 to 12 months.
- Revocation of company, business, or factory registrations.
- Revocation of product notifications or licenses.
Importance of Compliance
Mandatory Requirement: All cosmetic products sold, gifted, displayed, or offered for trial in Taiwan must have an established PIF.
Inspection Readiness: The PIF must be stored at the address listed on the product label and be readily accessible for TFDA inspection.
Market Access: Non-compliance can lead to product removal from the market, affecting brand reputation and sales.
