PRODUCT INFORMATION FILE (PIF)

PART I: ADMINISTRATIVE DOCUMENTS AND PRODUCT SUMMARY

A. Administrative Documentation (c/o zienac)
• License To Operate (LTO) of the MAH
• Certificate of Product Notification (CPN)
• Distribution Agreement

B. Qualitative and Quantitative Formula of the product

• Complete ingredient list of the cosmetic product with their corresponding function and
percentage content
• INCI name and CAS number for each RM
• Fragrance identification (name, code number of the composition, and identity of the supplier
of the fragrance material shall be indicated.)

C. Product presentation and labels

• Actual commercial sample of the cosmetic product
• Outer and inner labels
• Consumer information leaflet and instruction for use if part of the product sold

D. Manufacturing statement
• ASEAN Membered State Products: self-declaration in compliance to the ASEAN Cosmetic Good
or ACC approved equivalents
• Non-ASEAN Membered State Products: ASEAN Cosmetics GMP Compliance Certificate or its
equivalent issued by the regulatory agency.
The following GMP guidelines requirements are equivalent to the ASEAN Cosmetic GMP Guideline
- WHO GMP for Pharmaceuticals
- PIC/S/ GMP for Pharmaceuticals
- ISO 22716 2007
• Batch coding system/key

E. Safety Assessment summary as per ASEAN Safety Assessment Guidelines

• Signed summary of the safety assessment ( i e health related consumer complaints)
• Name and qualifications of the safety assessor of his/her curriculum vitae

F. Summary of the confirmed undesirable effects on human health

• Signed Confirmed Undesirable effects on human health
• Standard Operating Procedure (Receiving and processing of consumer complaints)

G. Efficacy Assessment summary based on composition or tests performed.

• Literature review of published data
(1) on the properties of the ingredients contained in the cosmetic product
(2) on the benefits of a product with similar formulation
• Actual tests performed (Either be in vitro or in vivo)
PART II: QUALITY DATA OF RAW MATERIALS
A. Specification and Test Methods of each Raw Materials
• Technical Specification of each RM, including water
• Method of analysis used (corresponds to the technical specifications for each ingredient
including identification test for each ingredient)
• If applicable, Fragrances name and address of supplier, declaration of compliance with latest
IFRA Guidelines (International Fragrance Assoc.)
• Certificate of Analysis (COA) for each ingredient (Should be signed and corresponds to its
technical specifications)

B. Data on the safety of raw materials

• Supplier’s data or safety data sheets
• Published data (i e Toxline Medline) of ingredient
• Report from Scientific Committees like ACSB, SCCP, CIR, etc.
• Not needed for ingredients from the Annexes III, IV, VI or VI (if used accordingly)

C. In cases when the cosmetic products contain placental protein or any other animal extracts
• Certificate of origin (indicating the specie where the placental protein are extracted)
• Technical specification for physical, chemical, and microbiological purity
• Signed COA reflecting the composition of the placental protein
• Certificate issued by the health authority (animal source is free From Transmissible Spongiform
Encephalopathy (TSE))

PART III: QUALITY DATA OF FINISHED PRODUCTS

A. Manufacturing Details
• Manufacturer contact details (Name, country and address of manufacturer, assembler, and packager)
• Manufacturing Process or Batch Manufacturing Method Summary

B. Specifications and test methods of the finished product

• Technical Specifications of the finished cosmetic product
• Method of analysis used (corresponds to the technical specifications for each ingredient
including identification test for each ingredient)
• If applicable, Fragrances name and address of supplier, declaration of compliance with latest
IFRA Guidelines (International Fragrance Assoc.)
• Certificate of Analysis (COA) of the finished product (Should be signed and corresponds to its
technical specifications)

C. Product Stability Summary Report

• accelerated stability study
• long term stability study
PART IV: SAFETY AND EFFICACY OF DATA
A. Safety Assessment
• Signed assessment report on the safety for human health of the finished product, based on its
ingredients, their chemical structure, and the level of exposure
• Curriculum Vitae of safety assessor

B. Report on undesirable effects

•Latest compiled report on health-related consumer complaints

C. On pack product claim supports

• Full signed report on the efficacy assessment of the product based on its composition or on
tests performed
• Supporting data, including literature review, for claimed benefits