Note:  This draft is only intended as a copy for comments during the stakeholder consultation 
period of the proposed guidelines. The content of this draft may change and does not prejudge 
any policy nor decision of the FDA. Citation of any text in this draft, fo r purposes other than the 
submission of comments as indicated in the issued announcement, is not recommended.  
 
 Civic Drive, Filinvest  Corporate  City, Alabang 1781 Muntinlupa, Philippines  
 Trunk Line +63 2 8 857 1900                       Fax +63 2 8 807 0751  
 Website: www.fda.gov.ph                   Email: info@fda.gov.ph  
 
 1 
 2 
 3 
FDA CIRCULAR  4 
No. ____________  5 
 6 
 7 
SUBJECT:  Updated Guidelines on Product Information File (PIF)  for Cosmetic 8 
Products  Repealing FDA Circular No. 2018 -001 “ Reiterating the 9 
Mandatory Implementation of Article 8 of the ASEAN Cosmetic 10 
Directive ‘Product Information ’” 11 
 12 
 13 
I.       BACKGROUND  14 
 15 
In 2005, the ASEAN Cosmetic Directive (ACD), its annexes and appendices, were adopted 16 
and implemented through the issuance of Department of Health (DOH) Administrative 17 
Orders (AO) No. 2005 -0015 and 2005 -0025, respectively, to harmonize the cosmetic 18 
regulatory scheme in the ASEAN region. The harmonization scheme aims to eliminate 19 
restrictions to trade of cosmetic products and enhance cooperation within the ASEAN 20 
Member States (AMS) in ensuring the saf ety, quality and claimed benefits of cosmetic 21 
products. The processes instituted by the Food and Drug Administration (FDA), through the 22 
Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research 23 
(CCHUHSRR), pursuant to the adopti on of the ACD, therein included pre - and post - 24 
marketing regulatory processes, such as the notification of cosmetic products and the audit 25 
of Product Information Files (PIF), among others. Under the ACD, ASEAN Member States 26 
(AMS), through the National Regul atory Authorities (NRA), shall conduct post -marketing 27 
surveillance (PMS) activities, and undertake all necessary measures to ensure that only 28 
cosmetic products that conform to the provisions of the ACD, its Annexes and Appendices 29 
may be placed in the marke t. 30 
 31 
To further enhance the efficiency of the notification application process and promote 32 
transparency of information, in 2015, through FDA Memorandum Circular (FMC) No. 2015 - 33 
011, CCHUHSRR digitized and implemented the Cosmetic Electronic Notification proc ess 34 
using the FDA E -Portal. With the entry of cosmetic products facilitated by the 35 
implementation of the electronic notification, the FDA reiterated the responsibilities of the 36 
Market Authorization Holder (MAH), pursuant to the ACD, including the maintenan ce of a 37 
Product Information File (PIF). Wherein, the PIF is intended to contain evidence that should 38 
be sufficient to review safety, quality and claimed benefits of cosmetic products, it is 39 
incumbent upon the MAH to ensure the accessibility and availabilit y of such documents for 40 
the review and audit of the FDA. To assist MAHs, the FDA issued FDA Circular No. 2018 - 41 
001 and FDA Advisory No. 2022 -0383 providing guidance on the PIF requirement.  42 
 43 
However, in the course of the implementation of the ACD and PIF Aud its, findings of the 44 
FDA showed that a number of MAHs remain to be non -compliant to the PIF requirement. 45 
Violations were found to range from an incomplete PIF to completely without PIF for 46 
cosmetic products already placed in the market. There is thus a nee d to strengthen the 47  
Page 2 of 13 
 implementation and enforcement of the ACD with the end -view of ensuring the safety and 1 
quality of cosmetic products. It is in this light that these updated PIF guidelines are hereby 2 
issued, which is intended to form part of the FDA PMS framework complementing the 3 
cosmetic electronic notification scheme. Further, wherein the COVID -19 pandemic has 4 
introduced mobility restrictions that posed challenges in the conduct of PIF Audits, 5 
alternative audit arrangements and other sustainable mechan isms have been considered in 6 
the design of the PIF Audit.  7 
 8 
 9 
II.       OBJECTIVES  10 
 11 
This Circular aims to : 12 
1. Improve the regulatory compliance to PIF requirements as set forth by the ACD ; and  13 
2. Establish an updated PIF guidelines in the context of evolving digital technology and 14 
pandemic resiliency . 15 
 16 
 17 
III.      SCOPE  18 
 19 
This circular shall cover all cosmetic establishments duly licensed by the CCHUHSRR  who 20 
are holder s of a valid Certificate of Product Notification (CPN).  21 
 22 
 23 
IV.     GENERAL GUIDELINES  24 
 25 
A. Only duly notified cosmetic products that conform to the provisions of the ACD, its 26 
Annexes and Appendices, shall be placed in the market.  Cosmetic products that are duly 27 
notified with the FDA shall have a corresponding PIF.  28 
 29 
B. The PIF of a Cosmetic Product must be made readily available and accessible to the FDA 30 
by the MAH upon the issuance of a Certificate of Product Notification (CPN). The PIF 31 
shall be kept, updated and ma intained by the MAH in accordance with the language, 32 
format, retention period, among others, as provided in these Guidelines.  33 
 34 
C. Cosmetic products duly notified with the FDA shall be subjected to a PIF Audit. The 35 
FDA may perform PIF audits as part of routine inspections and audits or in an ad hoc 36 
manner, and may be conducted on -site or off -site. The MAH, through its Qualified 37 
Person , shall coordinate with the FDA to ensure the orderly conduct of the PIF Audit.  38 
 39 
D. The FDA shall ensure the confidentiality of the data and information submitted or 40 
presented during the PIF Audit.  41 
 42 
E. Failure to comply with these guidelines, including but not l imited to, deficiencies in the 43 
PIF content and format, non -submission of documentation necessary to determine the 44 
safety, quality, and claimed benefit of a cosmetic product, refusal of the MAH and/or 45 
Qualified Person to coordinate with the FDA thereby prev enting the orderly conduct of 46 
the PIF Audit, shall be subject to appropriate regulatory action.  47 
 48 
F. The FDA shall not be precluded from conducting other PMS activities, apart from PIF 49 
Audits, to assess the safety, quality, and claimed benefit of cosmetic products and 50 
determine compliance with the ACD and other relevant product standards, in order to 51  
Page 3 of 13 
 ensure consumer protection and public health and safety, pursuant to its mandate 1 
following Republic Act (RA) No. 7394, RA 9711, and other laws, rules and regulations.  2 
 3 
V.     SPECIFIC  GUIDELINES  4 
 5 
A. Responsibilities  of the MAH. The MAH shall have the following responsibilities in 6 
relation to the PIF requirement:  7 
 8 
1. The MAH or the “company responsible for placing the cosmetic product in the 9 
market” shall keep and maintain an updated PIF.   10 
2. The MAH shall be updated on the latest amendments of the ACD, its Annexes 11 
and Appendices. The MAH shall preferably keep a file of all relevant FDA 12 
issuances, rules, regulations and standards for cosmetic products.  13 
3. The MAH shall ensure that the complete PIF is readily available and accessible 14 
at the address of the MAH  as declared in the CPN consistent with the address 15 
indicated on the immediate or secondary packaging of the cosmetic product as 16 
per ACD Appendix II – ASEAN Cosmetic Labeling Requirements. For 17 
Distributors and Micro, Small and Medium Enterprises (MSMEs), c onsiderations 18 
shall be given as to the completeness of the PIF, wherein Part I of the PIF shall 19 
be required, at the minimum, to be available at the address of the MAH for the 20 
purposes of initial PIF Audits.  21 
4. For PIF Audits, accessibility and availability of  information to the FDA shall be 22 
ensured by the MAH. Further, upon specific request of the FDA, other 23 
information required to determine the safety, quality, and claimed benefit of the 24 
cosmetic product shall be provided by the MAH within a reasonable timefr ame.  25 
 26 
B. Language, Content and Format of PIF. The PIF shall be in accordance with the 27 
following language, content and format:  28 
 29 
1. The PIF documents shall be written in English and/or Filipino Language.  30 
2. The PIF shall contain administrative information pertaining to the status of 31 
authorizations of the cosmetic product, its manufacturer and MAH, and technical 32 
information pertaining to the quality and safety data of the raw materials and 33 
finished product, fo llowing the content and format of the ANNEX A . 34 
3. The PIF shall be kept in any suitable media type (i.e. paper, electronic, etc.) 35 
provided that it is easily accessible to the PIF Auditor.  36 
 37 
C. Retention Period and Updating of PIF. The retention period and updating of the PIF 38 
shall be in accordance with the following:  39 
 40 
1. The PIF shall be kept and maintained on a per product basis.  41 
2. The PIF shall be kept for a minimum of three (3) years after the cos metic product 42 
has last been placed in the market (i.e. date when the inventory reaches zero (0) 43 
at retail level) or according to the company’s Standard Operating Procedure 44 
(SOP), whichever provides for a longer retention period.   45 
 46 
D. Conduct of PIF Audits.  PIF Audits shall be performed by the FDA in accordance with 47 
the Audit Plan and/or other Notices issued by the FDA in order to determine and ensure 48 
the compliance of the products with the ACD, following these guidelines:  49 
 50  
Page 4 of 13 
 1. Types of PIF Audit. PIF Audits may be conducted according to the following 1 
classifications:   2 
 3 
a. Routine PIF Audit  - are audits conducted by FDA during the validity of 4 
the CPN, which occurs following a Notice of Audit (NOA) sent preferably 5 
one (1) month befor e the date of Audit.  6 
 7 
b. Ad hoc PIF Audit  - audits which are conducted with or without notice, 8 
triggered by any of the following events:  9 
• results from sampling, testing, and verifying products from the 10 
market,  11 
• consumer complaints,  12 
• adverse event reports from healthcare practitioners and other 13 
verifiable sources,  14 
• evaluation of ingredients, formulation, intended use and/or 15 
product claims during notification application,  16 
• post-licensing inspections, monitoring, and investigations,  17 
• advertisements and promotion al articles monitoring,  18 
• post-marketing surveillance (PMS) activities,  19 
• coordination with local enforcement agencies, government 20 
agencies, and international partners, and  21 
• other assessments, reviews, and/or investigations initiated or 22 
referred to the FDA which finds that a cosmetic product has 23 
issues relating to safety, quality, and/or claimed benefits 24 
which necessitate FDA intervention.  25 
 26 
2. Sites of PIF Audit. PIF Audits, whether routine or ad hoc , may be conducted on - 27 
site or off -site based on the urgency of the issue being investigated and the best 28 
use of resources available.  29 
 30 
a. On-site audits - are audits where the PIF Auditors are physically at the 31 
address of the MAH, as declared in the CPN.  32 
 33 
b. Off-site audits  - are audits where the PIF is audited remotely by the PIF 34 
Auditor. Off -site audits may occur in any of the following manner as 35 
determined by the FDA:  36 
 37 
i. Synchronous remote PIF Audit - are audits performed off -site, 38 
where documents are presented by the MAH to the PIF Auditor, and 39 
reviewed, through a live audit session assisted by information and 40 
communication technology platforms.   41 
ii. Desktop PIF Audit – are audits performed remotely by reviewing 42 
the required documents submitted by the MAH.  43 
 44 
The conduct of off-site audits shall take into consideration the following:  45 
i. Synchronous remote PIF audits shall utilize secure virtual 46 
meeting/conferencing platforms hosted by the FDA. Virtual 47 
meetings shall be documented and/or recorded. Recordings shall 48 
only be used for the purposes of accurately documenting the 49 
conduct of the PIF Audit meeting, including the agreements made 50 
therein.  51  
Page 5 of 13 
 ii. The PIF and the specific documents requested for review shall be 1 
transmitted to the PIF Auditor through a secure file-sharing 2 
platform, either hosted by the FDA or the MAH, at the preference 3 
of the MAH. All documents transmitted to the FDA shall be treated 4 
with utmost confidentiality and shall be used for the purposes of 5 
the audit and the regulatory actions that foll ow.  6 
iii. Findings that cannot be verified remotely shall be verified on -site, 7 
if necessary.  8 
iv. Collection of samples, if necessary, shall be coordinated with the 9 
establishment.  10 
 11 
3. Notice of Audit. Except for cases involving emergency investigations or on 12 
issues tha t require urgent resolution, the FDA shall issue a Notice of Audit (NOA) 13 
to the MAH prior the conduct of a PIF Audit. The NOA shall specify the date, 14 
type and site of the audit. In case of off -site audits, the pertinent details for the 15 
arrangements of the remote or desktop audit shall also be provided. 16 
Communication with the establishment shall be done using the contact details 17 
provided in the notification application.  18 
 19 
4. Documents and other materials to be presented during PIF Audits. The 20 
following PIF documents and other materials must be made available to the FDA 21 
to ensure the orderly and timely conduct of the PIF Audit:  22 
 23 
a. In general, the complete PIF must be made available during PIF Audits, 24 
whether routine or ad hoc , onsite or offsite. However, the following 25 
considerations may be applied by the FDA, as deemed necessary.  26 
i. In all cases, MAHs scheduled for a PIF Audit shall be required to 27 
present Part I “Administrative Documents and Product Summary” 28 
of the PIF, aside from the required documents specified in the 29 
Notice.  30 
ii. For distributors and MSMEs, considerations may be applied for 31 
Parts II to IV of the PIF, provided that  a reasonable and compelling 32 
justification is provided for the absent PIF Parts. The MAH may 33 
thus be given a sufficient amount of time ranging from fifteen to 34 
sixty (15 -60) calendar days, depending on the urgency of the audit, 35 
to make the necessary arrange ments with their suppliers and 36 
submit the required documents and/or pertinent information.  37 
iii. Product Information/documents containing confidential   materials 38 
and/or proprietary information that have been required by the FDA 39 
representatives during audit may b e directly sent to the agency by 40 
the foreign supplier or local manufacturer or source.  41 
 42 
b. For ad hoc  audits, the MAH may be required to present specific documents 43 
to determine the safety, quality, and claimed benefits of the product. This 44 
shall be communicat ed to the MAH through the NOA, if applicable.  45 
 46 
c. MAHs with incomplete PIF shall be given sufficient amount of time 47 
ranging from fifteen to sixty (15 -60) calendar days, depending on the 48 
urgency of the audit and classification of the deficiency/ies , to provide 49 
their corrective action report (CAR) and other documents required by the 50 
PIF auditors. Notwithstanding the provided timeline for compliance to 51  
Page 6 of 13 
 documentary requirements, the FDA may conduct further regulatory 1 
actions and direct further complian ce pursuant to the succeeding 2 
provisions on the resolution of deficiencies.  3 
 4 
E. Deficiencies. For purposes of transparency, clarity and efficiency, non -conformances 5 
found during PIF Audits shall be classified and treated as follows:  6 
 7 
1. Classification of Deficiencies . The classification of deficiencies shall be as 8 
follows. An illustrative, non -exhaustive list of observations is attached as 9 
ANNEX B classified following the foregoing definitions as provided. The FDA 10 
shall endeavour to publi sh an updated list, based on the review of the 11 
implementation of this Circular.  12 
 13 
a. Critical deficiency - a deficiency which has produced, or may lead to, a 14 
significant risk of producing either a product which is harmful to humans. 15 
It also covers findings of the establishment's or its agent's commission of 16 
fraud, misrepresentation or falsification of products, records or data, or 17 
withhold any relevant data contrary to the provisions of law, rules and 18 
regulations or appropriate standards.  19 
 20 
b. Major def iciency - a deficiency which indicates a major deviation from 21 
the terms of the marketing authorization, ASEAN Cosmetic Directive, its 22 
annexes and appendices, and other internationally -accepted standards; or, 23 
a combination of several “other” deficiencies, n one of which on their own 24 
may be major, but which may together represent a major deficiency and 25 
should be explained and reported as such; or, repetitive deviation for at 26 
least two consecutive audits.  27 
 28 
c. Other deficiency  - a deficiency which cannot be classif ied as either 29 
critical or major, but which indicates a departure from the ACD, its 30 
annexes and appendices, and other internationally -accepted standards. A 31 
deficiency may be “other” either because it is judged as minor, or because 32 
there is insufficient info rmation to classify it as major or critical.  33 
 34 
2. Resolution of Deficiencies. Deficiencies shall be treated and resolved as follows:  35 
 36 
a. In case of findings classified as critical deficiency (ies), the PIF auditor is 37 
authorized to direct the establishment to initiate outright, any or all of the 38 
following:  39 
i. Temporarily stop production of affected product line/s and further 40 
importation and/or distribution;  41 
ii. Undertake or cause company -initiated recall of affected batches 42 
following existing FDA rules and procedure for product recall;  43 
iii. Address the deficiencies, including submission of CAPA plan and 44 
objective evidence of compliance, not later than thirty (30) 45 
calendar days reckoned on the day following the receipt of the 46 
audit report.  47 
 48 
Critical find ings may result in the FDA imposing subsequent regulatory 49 
action, including but not limited to issuance of notice of product recall, 50  
Page 7 of 13 
 disapproval of application, suspension or revocation of the issued 1 
authorization.  2 
 3 
b. In case of major and other deficiencies, the PIF auditor is authorized to 4 
direct the establishment to address the deficiencies, including the 5 
submission of CAPA Plan and objective evidence of compliance, not later 6 
than sixty (60) calendar days reckoned on the day following the recei pt of 7 
the audit report.  8 
 9 
Failure to sufficiently comply and address the deficiencies during the 10 
provided compliance period may result in the FDA imposing subsequent 11 
regulatory action, including but not limited to issuance of notice of product 12 
recall, disap proval of application, suspension or revocation of the issued 13 
authorization.  14 
 15 
 16 
VI.     PENALTY CLAUSE  17 
 18 
Any establishment found to be in violation of the provisions of this issuance shall be deemed 19 
in violation of Republic Act No. 3720 as amended by Republic Act No. 9711 and shall be 20 
penalized accordingly following the Uniform Rules of Procedures laid down under Book III 21 
of the Implementing Rules and Regulations of Republic Act No. 9711.  22 
 23 
 24 
VII.     SEPARABILITY CLAUSE  25 
 26 
The provisions of this Circular are hereby declared separable and in the event that any such 27 
provision is/are declared invalid or unenforceable, the validity or enforceability of the 28 
remaining portions or provisions including other provisions of the ACD which are not 29 
affected by  this update, shall remain in full force and in effect.  30 
 31 
 32 
VIII.      REPEALING CLAUSE  33 
 34 
FDA Circular No. 2018 -001, FDA Advisory No. 2022 -0383 and other previous issuances 35 
inconsistent with this Circular are hereby repealed, rescinded and modified accordingly.  36 
 37 
 38 
IX. EFFECTIVITY  39 
 40 
This Circular shall take effect after fifteen (15) days after its publication in a newspaper of 41 
general circulation and filing with the University of the Philippines, Office of the National 42 
Administrative Register.  43 
 44 
 45 
 46 
 MARIA ROSARIO D. SINGH -VERGEIRE, MD, MPH, CESO II   47 
Officer -In-Charge  48 
        Department of Health   49 
 50 
 51  
Page 8 of 13 
 ANNEX A  1 
 2 
Product Information File (PIF)  3 
 4 
 5 
The PIF shall be composed of the following documents:  6 
 7 
1. Part I: Administrative Documents and Product Summary  8 
 9 
1.1. Administrative Documentation  10 
1.1.1.  Copy of valid License to Operate (LTO) of the MAH  11 
1.1.2.  Copy of valid Distribution Agreement  12 
1.1.2.1.  In case the MAH is a Cosmetic Distributor (Importer) , the documents 13 
must be duly authenticated by the Territorial Philippines Consulate or 14 
Apostilled:  15 
1.1.2.1.1. In case the Foreign Supplier is the manufacturer of the cosmetic 16 
product, Foreign Agency Agreement (FAA) or Letter of Authorization 17 
from the Foreign Supplier.  18 
1.1.2.1.2. In case the Foreign Supplier is not the manufacturer of the cosmetic 19 
product,  20 
1.1.2.1. 2.1. FAA or Letter of Authorization from the Foreign Supplier and 21 
a valid Supply Agreement between the Foreign Supplier and the 22 
manufacturer; or  23 
1.1.2.1.2.2. Valid tripartite agreement between the MAH, Foreign 24 
Supplier, and manufacturer  25 
1.1.3.  Copy of the valid C PN 26 
 27 
1.2. Qualitative and Quantitative Formula of the Cosmetic Product  28 
1.2.1.  Complete ingredient list with their corresponding function and percentage (%) 29 
content. Ingredients shall be named using the nomenclatures from approved 30 
references, namely, (1) International C osmetic Ingredient Dictionary, (2) British 31 
Pharmacopoeia , (3) United States Pharmacopeia, and (4) Chemical Abstract 32 
Service.  33 
1.2.2.  In case the cosmetic product contains fragrance materials, the name and code 34 
number of the composition, and the identity of the sup plier of the fragrance 35 
materials shall be indicated.  36 
 37 
1.3. Product Presentation  38 
1.3.1.  Actual commercial sample of the cosmetic product.  39 
The retention samples for every batch of cosmetic product 40 
manufactured/distributed shall be kept in accordance with the ACD Appendix VI 41 
– ASEAN Guidelines for Cosmetic Good Manufacturing Practice (GMP). 42 
Retention period shall be according to the SOP of the cosmetic establishment.  43 
1.3.2.  In case when the actual commercial sample is unavailable, facsimile samples of 44 
the immediate and/or  secondary packaging and other informative materials that 45 
are used (i.e. leaflets,  hang tags) may be presented provided that the actual 46 
commercial sample shall be submitted to FDA as compliance to the audit.  47 
1.3.3.  For consistency, the actual sample and/or facsim ile presented during the audit 48 
shall be treated as the actual commercial product.  49 
 50 
1.4. Manufacturing Statement  51  
Page 9 of 13 
 1.4.1.  For cosmetic products manufactured in an AMS, a self -declaration of compliance 1 
to the ASEAN Cosmetic Good Manufacturing Practice (GMP) by the cosmeti c 2 
manufacturer is accepted.  3 
1.4.2.  For cosmetic products manufactured in countries other than the AMS, 4 
certifications of ASEAN Cosmetic GMP compliance or its equivalent issued by 5 
the regulatory agency or any accredited business association in the country of 6 
origi n shall be presented. The following are the accepted equivalents of the 7 
ASEAN Cosmetic GMP:  8 
● World Health Organization (WHO) Guide to Good Manufacturing 9 
Practices (GPM) for Pharmaceutical Products  10 
● Pharmaceutical Inspection Convention and Pharmaceutical Insp ection 11 
Co-operation Scheme (PIC/S) Guide to GMP for Medicinal Products/ 12 
Australian Code of GMP for Therapeutic Goods  13 
● International Standard ISO 22716: 2007 Cosmetics – Good 14 
Manufacturing Practices (GMP) – Guidelines on Good Manufacturing 15 
Practices  16 
1.4.3.  SOP for Batch Coding System/ Numbering/key of the cosmetic product  17 
 18 
1.5. Summary of the Safety Assessment of the Cosmetic Product as per the ASEAN 19 
Guidelines for the Safety Assessment of a Cosmetic Product  20 
1.5.1.  Signed summary of the safety assessment  21 
1.5.2.  Name and qualifications of the safety assessor of his/her curriculum vitae  22 
 23 
1.6. Summary of the Confirmed Undesirable Effects on Human Health  24 
1.6.1.  The summary of confirmed undesirable effects on human health shall be updated 25 
monthly or according to the SOP of the cosmetic establishment. The summary 26 
may be in any format easily understandable by the users.  27 
1.6.2.  SOP for Handling  of Consumer Complaints and Adverse Event  Reports  28 
 29 
1.7. On-pack Product Claim Support  30 
Summary of the claim substantiation/ justification may be based on  the following:  31 
1.7.1.  Literature review of published data on the properties of the ingredients contained 32 
in the cosmetic product  33 
1.7.2.  Literature review of published data on the benefits of a product with similar 34 
formulation  35 
1.7.3.  Actual tests performed which can either be in vitro or in vivo . 36 
 37 
 38 
2. Part II: Quality Data of Raw Materials  39 
 40 
2.1. Specifications and Test Methods of Raw Materials  41 
2.1.1.  Technical Specifications of each ingredient including water  42 
2.1.2.  Method of Analysis corresponding to the technical specifications for each 43 
ingredient , including the identification test for each ingredient  44 
2.1.3.  Signed Certificate of Analysis (COA) for each ingredient corresponding to its 45 
technical specifications  46 
2.1.4.  In case of fragrance materials, the name and code number of the fragrance, name 47 
and address of the supplier, certificate of compliance with the latest International 48 
Fragrance Association (IFRA) guidelines  49 
 50 
2.2. Safety data of the ingredients which are taken from any of the following:  51  
Page 10 of 13 
 2.2.1.  Ingredient safety data provided by the supplier or Safety Da ta Sheets  1 
2.2.2.  Published literature and databases (i.e. Toxline, Medline) of ingredients  2 
2.2.3.  Reports from Scientific Committees like the ASEAN Cosmetic Scientific Body 3 
(ACSB), the Scientific Committee on Consumer Safety (SCC S) of the European 4 
Union (EU) or the Unit ed States (US) Cosmetic Ingredient Review Board (CIR)  5 
 6 
2.3. In cases when the cosmetic product contains placental protein or any other animal 7 
extracts, the following shall be part of the PIF Part II:  8 
2.3.1.  Certificate of origin indicating the specie where the connect ive tissue, embryo and 9 
placental protein are extracted  10 
2.3.2.  Technical specifications for physical, chemical and microbiological purity  11 
2.3.3.  Signed COA reflecting the composition of the placental protein  12 
2.3.4.  Certificate issued by the health authority of the country of or igin that the animal 13 
source is free from Transmissible Spongiform Encephalopathy (TSE)  14 
 15 
 16 
3. Part III: Quality Data of Finished Product  17 
 18 
3.1. Complete ingredient list of the cosmetic product with their corresponding function and 19 
percentage (%) content. Ingredients shall be named using the nomenclatures from 20 
approved references, namely, (1) International Cosmetic Ingredient Dictionary, (2) 21 
British Pharmacopoeia , (3) United States Pharmacopoeia , and (4) Chemical Abstract 22 
Service.  23 
 24 
3.2. Manufacturing details  25 
3.2.1.  Details of cosmetic manufacturer including the company name, complete address 26 
and contact information  27 
3.2.2.  Details of the secondary assembler / repacker of the cosmetic product including 28 
the company name, complete address and contact information, if applicable  29 
3.2.3.  Summary of the Manufacturing Process or Batch Manufacturing Record (BMR)  30 
 31 
3.3. Technical Specifications of the finished product and their corresponding test methods  32 
3.3.1.  Technical specifications of the finished product  33 
3.3.2.  Test methods used  corresponding to the technical specifica tions of the finished 34 
product. The ASEAN Cosmetic Harmonized Testing Methods shall be preferably 35 
used in the quality control procedures of the cosmetic product.  36 
3.3.3.  Signed COA of the finished product corresponding to its technical specifications  37 
 38 
3.4. Product Stabi lity 39 
3.4.1.  The stability study shall be part of the PIF to support the cosmetic product’s 40 
claimed shelf -life. The stability study conducted on the cosmetic product may be 41 
accelerated or long -term.  42 
3.4.1.1.  Accelerated stability study shall be provided for the cosmetic pr oduct less 43 
than one (1) year in the market.  44 
3.4.1.2.  Long -term stability study shall be provided for cosmetic products which 45 
have been in the market for more than one (1) year. In cases when the long - 46 
term stability study has not been concluded, proof of the on -going study 47 
shall be provided.  48 
 49 
 50 
 51  
Page 11 of 13 
 4. Part IV: Safety and Efficacy Data  1 
 2 
4.1. Safety Assessment  3 
The ASEAN Guidelines for the Safety Assessment of a Cosmetic Product shall 4 
preferably be used as a guidance  document when preparing the safety assessment to 5 
ensure that all relevant  aspects of the cosmetic product are evaluated  and assessed.  6 
4.1.1.  Signed safety assessment report of the cosmetic product in terms of potential 7 
effects to human health. The safety assessor shall determine the safety of the 8 
cosmetic product based on the following minimum factors:  9 
4.1.1.1.  Ingredients used in the formulation of the cosmetic prod uct and their 10 
chemical structures.  11 
4.1.1.2.  Potential hazardous by -products of an interaction between ingredients 12 
(i.e. nitrosamines) and/or its impurities  13 
4.1.1.3.  The specific population who will use the product  14 
4.1.1.4.  The area of the body where the product will be used  15 
4.1.1.5.  Duration  and frequency of exposure to the cosmetic product  16 
4.1.2.  Curriculum vitae of the safety assessor. The safety assessor shall possess 17 
qualifications in the field of toxicology, medicine (dermatology), pharmacy and 18 
other related fields and shall be suitably trained  in the safety assessment of 19 
cosmetics.  20 
4.1.3.  In cases when the safety assessor is deemed to have no sufficient technical 21 
background required to assess/evaluate the product safety, FDA reserves the right 22 
to request for additional safety assessment of the product . 23 
 24 
4.2. Record of Confirmed Adverse Events or Undesirable Effects on Human Health  25 
4.2.1.  Compilation of reports of confirmed adverse events or undesirable effects on 26 
human health resulting from the use of the cosmetic product which must be duly 27 
investigated by the MAH . The compilation shall be updated monthly or according 28 
to the SOP of the cosmetic establishment.  29 
4.2.2.  SOP for Handling of Consumer Complaints and Adverse Event Reports  30 
4.2.3.  Serious adverse effects shall be reported to the FDA using the ASEAN Cosmetic 31 
Directive (ACD) Adverse Event Report Form.  32 
 33 
4.3. On-pack Product Claim Support:  34 
4.3.1.  In cases when cosmetic products have made a claim, the substantiation of the 35 
same shall be part of the PIF. The claim substantiation may be from the following 36 
sources:  37 
4.3.1.1.  Literature re view of published data on the properties of the ingredients 38 
contained in the cosmetic product  39 
4.3.1.2.  Literature review of published data on the benefits of a product with 40 
similar formulation  41 
4.3.1.3.  Actual tests performed which can either be in vitro or in vivo . 42 
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Page 12 of 13 
 ANNEX B  1 
 2 
List of Product Information File (PIF) Audit Deficiencies  3 
 4 
 5 
The classification of deficiencies are as follows. The list is non -exhaustive and other 6 
observations may be added, removed, or re -classified as appropriate.  7 
 8 
Non-inclusion of a non-conformance against the ASEAN Cosmetic Directive, any standard, rule 9 
and regulation, shall not preclude the PIF Auditor to assign a classification in this list. In the 10 
assignment of classifications for such observations/findings, the PIF Auditor shall be guided by 11 
the definitions provided for Critical, Major, and Other Deficiencies in this Circular. The FDA 12 
shall endeavour to publish an updated list, based on the review of the implementation of this 13 
Circular.  14 
 15 
1. Critical  16 
● Lack of or incomplete PIF Document  (i.e. technical documents which may affect the 17 
product quality and safety).  18 
● The MAH and/or the manufacturer has no valid License to Operate.  19 
● Deviation from the approved LTO authorization for manufacturer (e.g. product line).  20 
● The product contains a banned ingredient based on ACD.  21 
● The restricted ingredient declared on the CPN and/or qualitative and quantitative 22 
formula of the product has exceeded the maximum allowable concentration based on 23 
ACD Annexes.  24 
● The use of the ingredient is not allowed for its produc t type.  25 
● Lack of or incomplete Technical Specifications for each ingredient.  26 
● Lack of or incomplete COA for each ingredient.  27 
● Unsigned Certificate of Analysis (COA) for each ingredient.  28 
● The ingredients indicated on the actual commercial sample are inconsisten t with the 29 
CPN and/or the qualitative and quantitative formula of the product.  30 
● Lack of Technical Specifications for finished product.  31 
● Lack of Test Method for finished product.  32 
● Lack of COA for finished product.  33 
● Unsigned Certificate of Analysis (COA) of finished product.  34 
● Out-of-specification test results not properly investigated and documented according 35 
to SOP.  36 
● Evidence of falsification or misrepresentation of analytical results.  37 
● The manufacturer from non -ASEAN Member States (non -AMS) has no GMP 38 
Certific ate or its equivalent.  39 
● No Batch Manufacturing/Packaging Records.  40 
● Evidence of falsification or misrepresentation of Batch Manufacturing Record.  41 
● There is no Summary of Safety Assessment for the product.  42 
● No data available to establish the shelf -life of the pr oduct.  43 
 44 
2. Major  45 
● Incomplete PIF Document (i.e. administrative documents)  46 
● Deviation from the approved LTO authorization for Market Authorization Holder 47 
(e.g. LTO activity).  48 
● Lack of or incomplete tests/substantiation/justification for ingredients with specific 49 
requirements as laid down in the ACD Annexes and/or FDA issuances (e.g. 50 
Petrolatum, Triethanolamine, Talc).  51  
Page 13 of 13 
 ● The required labelling information as per ACD Appendix II is not declared on the 1 
label.1 2 
● The conditions of use and warnings and other limitations a nd requirements laid down 3 
in the ACD Annexes are not printed on the label. ¹ 4 
● Lack of SOP for Batch Coding/Numbering.  5 
● Deviations from batch manufacturing instructions during production.  6 
● Unsigned Summary of Safety Assessment.  7 
● Insufficient data to establish th e shelf -life of the product  8 
● Lack of SOP for Handling of Consumer Complaints and Adverse Event Reports.  9 
● The intended and/or direction for use/ target area/ product claim is not appropriate 10 
for a cosmetic product. ¹ 11 
● Lack of or incomplete tests/substantiation/ justification for on -pack claims.  12 
 13 
3. Others  14 
● The PIF is not written in English or Filipino Language.  15 
● Lack of or incomplete safety data for each ingredient.  16 
● The ingredients are not specified using the nomenclature from the latest edition of 17 
standard references, the botanical ingredients and extracts of botanicals are not 18 
identified by its genus and species.  19 
● There is no actual commercial sample presented.  20 
● The address of the MAH reflected on the label is inconsistent with the LTO and/or 21 
CPN.  22 
● The country  of manufacture reflected on the label is inconsistent with the information 23 
declared in the CPN.  24 
● The qualifications/curriculum vitae of the safety assessor is not provided.  25 
● Lack of certificate of compliance to latest IFRA guidelines (for fragrance material s) 26 
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1 For these findings, the PIF Auditor may impose additional regulatory actions (i.e. Issuance of Notice of 
Product Recall) if circumstances re quire.