ACD Guidelines For Product Information File (PIF)
ACD Guidelines For Product Information File (PIF)
ACD Guidelines For Product Information File (PIF)
13 June, 2007
ASEAN
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Table of Content
1.
2.
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2. PIF Organization
2.1 Product Information Required under ACD
Article 8 of the ACD spells out the list of information required in the PIF:
a) The qualitative and quantitative composition of the product, in case of
perfume compositions, the name and code number of the composition and the
identity of the supplier;
b) Specifications of the raw materials and finished product;
c) The method of manufacture complying with the good manufacturing practice
as laid down in the ASEAN Guidelines
d) Assessment of the safety for human health of the finished product, its
ingredients, their chemical structure and level of exposure;
e) Existing data on undesirable effects on human health resulting from use of the
cosmetic product; and
f) Supporting data for claimed benefits of cosmetic products should be made
available; to justify the nature of its effect;
Article 9 of the ACD requires the company to provide information on the method of
analysis to the regulatory authority:
a) The available methods used by the manufacturer to check the ingredients of
cosmetic products corresponding with the Certificate of Analysis; and
b) The criteria used for microbiological control of cosmetic products and
chemical purity of ingredients of cosmetic products and/or methods for
checking compliance with those criteria
2.2 Recommended PIF format
In view of the above ACD requirements, companies placing products in the market
need to organize the PIF in such a way that it meets the requirements and be easily
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The fourth and final part of the PIF provides detailed information on the safety
assessment and data of the finished product and also relevant efficacy data to
support any claims made on the product.
A. Safety Assessment:
- Signed assessment report of the safety for human health of the finished
product based on its ingredients, their chemical structure and level of
exposure;
- Curriculum Vitae of the safety assessor;
B. The latest compiled report on confirmed or recorded adverse events or
undesirable effects on human health resulting from use of the cosmetic product:
- The adverse event report in the PIF is expected to be updated by the
company on a regular basis;
C. On-pack product claim support:
- Full signed report of the Efficacy Assessment of the product, based on its
composition or on tests performed;
- Supporting data including literature review for claimed benefits of cosmetic
products should be made available to justify the nature of its effect;
4. PIF Audits
4.1 Types of audits:
Since the PIF must be at the address specified on the label, Authorities can audit the
PIF at that address. There are 2 possibilities:
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Ad-hoc audits: these may be triggered by results found on samples from the
market, by consumer complaints, etc. It is recommended that the audit be
announced at least 48 hours in advance. Of course, in case of extreme
urgency the auditing can take place without announcement;
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