Product Information File or

PIF
 Requirements for Industry
The Company or Person placing a cosmetic
product in the market shall:
– Notify the regulatory authorities before the product is
put in the market (article 1-3)
– Ensure that they will not cause damage to human
health under normal or reasonably foreseeable
conditions of use (article 3)
– Keep the product information file readily accessible to
the regulatory authorities (article 8)
– Must have adequate knowledge or experience (article
8-d)
 PIF
• Must be at the address of the Company
responsible for placing the product in the market
(as specified on the label): manufacturer,
importer or distributor
• PIF must be in the local language or English
• Must be “readily accessible”. What does that
mean? 1 day, 1 week? Depends if the audit is
unannounced or not
• Must be kept updated of all modifications
 PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure
 PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria
 PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure
 Example
Raw Supplier INCI name Trade Function Conc
Material Name (% w/w)
code
1. abcd Company 1 Acrylic acid xxxx Film former 0.50%
Company 2
Company 3

2. efgh Company 4 Monoethanola yyyy pH adjuster 0.50%

mine

3. ijkl Company 5 Propylene zzzz Solvant 2.00%

Glycol

4. In-house Water Solvant 90.00%

5. mnop Company 6 45100 wwww Colorant 0.20%

6. qrst Company 7 perfume A1234 Fragrance 0.30%

7. etc. Qsp.
100%
 PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure
 Raw Material Specification
• Physico Chemical:
• Colour
• Odour
• Appearance
Obtained from supplier • IR Spectrum
Methods must be available
• Refractive index
Manufacturer must check compliance
• Saponification index
• Heavy Metals content
• Microbiological:
• Bacteria
• Fungi and Yeast
 Raw Material Specification
Special attention should be taken to:
• Water
• Impurities
• Interactions between impurities
• RM manufacturing process
• GMP of supplier
• Ingredients of natural origin:
– Which plant-animal
– Which part is used
– Consistency of supply
 Finished Product Specification
• Physico Chemical:
• Colour
• Odour
Developed by manufacturer
• Appearance
Must be relevant
• pH
Must have the test methods
• Water content
Must check compliance
• Viscosity
• Microbiological:
• Bacteria
• Fungus & Yeast
• Stability
 PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure
 Manufacturing Method
• Pre-mix ingredients 1 to 5 in a SS tank
and bring to 70°C while mixing
• In a secondary SS tank mix ingredients 6
to 8 and bring to 70°C
• Mix contents of tank 2 into tank 1 while
stirring at high speed for 30 min.
• Cool to 40°C stirring gently and add
perfume. Mix for 15 min.
 PIF
1. Qualitative and quantitative composition of the
product: name and percentage of ingredients
(for perfumes name of supplier, code of
perfume and percentage)
2. Specifications of the raw materials and finished
product (physico-chemical and microbiological)
3. Manufacturing method complying with ASEAN
GMP Guidelines
4. Assessment of the safety for human health of
the finished product, its ingredients, its
chemical structure and its level of exposure
 Article 3 ASEAN Cosmetic
Directive
A cosmetic product placed on the market must not
cause damage to human health when applied
under normal or reasonably foreseeable
conditions of use, taking account, in particular, of
the product’s presentation, its labeling,
instructions for its use and disposal, warning
statements as well as any other indication or
information provided by the manufacturer or his
authorised agent or by any other person
responsible for placing the product on the
market
Safety Assessment of Ingredients
Inherent toxicity of
ingredient

Exposure,
Chemical Safety concentration of the
Structure assessment ingredient

Implications for the finished product

 Safety Assessment
• Raw Material • Finished Product
• SCCP opinion • RM concentrations
• ACSB opinion • Use quantity and
• CIR opinion frequency
• Public Scientific • Safety tests done
Literature • In-market data
• Supplier’s data file (complaint level)
 PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria
 Undesirable Effects on Human
Health
• Need to have a complaint management
system
• Personnel must be trained in data
collection, data analysis and reporting
• Results of investigations must be
documented
• Analysis of trends
 PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria
 Claimed Benefits
• Based on ingredient properties (from
literature, from supplier’s files, etc.)
• Based on test performed on the finished
product

All claims must be substantiated

If not, claims should be changed

 PIF
5. Existing data on undesirable effects on human
health resulting form the use of the product
6. Supporting data for claimed benefits (efficacy
assessment)
7. Available methods used to check the
ingredients corresponding with the certificate
of analysis (Article 9)
8. Criteria used for microbiological control;
chemical purity of ingredients and/or methods
for checking compliance with those criteria
 Article 9: test methods
As these are common to many
ingredients/products they can form part of
a separate file
 PIF: suggestions
1. Specific part:
• Product name and function
• Formulation
• Method of Manufacturing
• Product specification
• Safety Assessment
• Efficacy Assessment
• Packaging and labeling
• Complaint analysis
 PIF: Suggestions
2. Ingredient File:
• RM specification
• Supplier data
• Toxicity data – Safety assessment
• First Aid measures (MSDS)
 PIF
A dynamic set of data influenced by:
– New ingredients
– New RM suppliers
– New production process
– New information available
– New manufacturer
– Etc.

Must be readily available

Thank You