Philippines Cosmetics Regulations QA

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HLF-ph-10
What are the categories of cosmetics in Philippines? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?

Evershine RD：

In Philippines, the Philippine Food and Drug Administration (FDA) is responsible for cosmetic monitoring, implementing cosmetic notification and preparing product information documents.

Cosmetics are any substances or preparations intended to come into contact with the outside of the human body or the mucous membranes of the teeth and oral cavity to cleanse, perfume, alter the appearance and/or correct body odor and/or protect or maintain the health of the human body.

【參考連結】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2016-0003.pdf

HLF-ph-20
If a foreign company wants to sell cosmetics in Philippines, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.

Cosmetic Institution Business License

1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.

2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

Application documents

1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).

2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).

3. Business registration certificate

．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)

．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.

4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.

．Cooperative Development Authority (CDA) certificates are available for cooperatives.

．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.

5. Proof of housing (office, manufacturing plant and warehouse)

．Certificate of Transferable Title (TCT) as proof of ownership.

．Notarized proof of occupancy, if owned by one of these companies.

．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.

．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.

．A valid notary warehousing agreement for a 3PL.

6. Other requirements

．Floor plan / layout in meters and correctly identified areas (offices and warehouses)

．Manufacturing Plant Blueprint

．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)

7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):

．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)

．China board certificate

．Valid PRC ID card

．Current Professional Tax Return (PTR)

．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors

．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)

．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)

8. Importer specific requirements

．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.

．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate

．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.

．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.

9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).

【參考連結】

https://www.fda.gov.ph/downloadables/

Evershine RD：

DBC

https://www.dayananconsulting.com/

Freyr

https://cosmetics.freyrsolutions.com/

HLF-ph-30
If a foreign company wants to sell cosmetics in Philippines, can it assign a Philippines company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

Yes. Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration in the name of the local company.

Cosmetic Institution Business License

1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.

2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

Application documents

1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).

2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).

3. Business registration certificate

．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)

．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.

4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.

．Cooperative Development Authority (CDA) certificates are available for cooperatives.

．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.

5. Proof of housing (office, manufacturing plant and warehouse)

．Certificate of Transferable Title (TCT) as proof of ownership.

．Notarized proof of occupancy, if owned by one of these companies.

．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.

．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.

．A valid notary warehousing agreement for a 3PL.

6. Other requirements

．Floor plan / layout in meters and correctly identified areas (offices and warehouses)

．Manufacturing Plant Blueprint

．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)

7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):

．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)

．China board certificate

．Valid PRC ID card

．Current Professional Tax Return (PTR)

．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors

．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)

．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)

8. Importer specific requirements

．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.

．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate

．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.

．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.

9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).

Cosmetic Adverse Events

1. Companies responsible for placing cosmetic products on the market should report to the Philippine Food and Drug Administration (FDA) regardless of the source of the report (consumers, healthcare professionals, etc.).

2. Report content

．Per Serious Adverse Event: All serious adverse events should be reported. Reports of non-serious adverse events are not required. It must be reported whenever there is a reasonable suspicion that the cosmetic product may have been the cause of the reaction.

．The term reasonable doubt generally means that there is evidence of causation or association.

．Appropriate medical and scientific judgment should be exercised for each condition with a high incidence of non-serious, single serious adverse reactions before reporting to a regulatory agency.

3. Time of reporting

．Fatal or life-threatening adverse events should be reported to the regulatory agency as soon as possible (e.g. by telephone, fax, email, or in writing) but no later than 7 calendar days, followed by an additional 8 calendar days to complete the Adverse Cosmetic Event Reporting Form, and provide any other information that regulators may require.

．Other Serious Adverse Events: All other non-fatal or non-life-threatening serious adverse events must be reported as soon as possible, but no later than 15 calendar days after first discovery.

4. Cosmetic Adverse Event Report Form

．Company information: name and address, company, name and designated telephone number, fax number, e-mail of the reporting person.

．Product Details: Product name (e.g. product notification), ingredient list and package size (please attach a separate list), product type/intended use, manufacturer’s name and country of manufacture, expiry or production date, batch number.

．Adverse event details: name/initial, ID or passport number, age, gender, ethnicity/nationality, date of adverse event.

．Description of adverse events (use and attach a separate report if necessary): Delay between last use of the product and onset of symptoms: How the product was used: Was the person hospitalized for the adverse reaction? Was the person sought medical attention? Results.

【參考連結】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Adverse-Event-Reporting-System.pdf

https://www.fda.gov.ph/downloadables/#

HLF-ph-35

HLF-ph-40
Do foreign companies need to apply for an approval before importing cosmetics sold to Philippines? If yes, which authority is in charge? What documents are required?
What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD：

Local companies responsible for placing cosmetic products on the market should register with the FDA and submit a notification (electronic cosmetic notification) prior to placing the product on the market.

Cosmetics electronic notification

1. Applicant: The local company responsible for placing the cosmetics on the market.

2. Application web page: FDA e-portal https://ww2.fda.gov.ph

3. Process

．Send a request to info@fda.gov.ph with the following information: email address (preferably a company email address), name, contact details, company name, company address, product category: cosmetic.

．Log in to the FDA electronic portal.

．Select a new case and fill out the ASEAN Notification Form.

．Payment.

．If approved, download and print the confirmation notice.

．Get a notification certificate. (Initial submission, notices are valid for up to 1 to 3 years at the applicant’s option. Those with insufficient documentation will receive a notice of deficiencies requesting clarification or further explanation of certain details, any declaration of false or misleading information Companies receive rejection letters.)

4. Application to fill in the content

．A valid LTO number for the company.

．Country of manufacture, supplier details (if applicable).

．Ensure that the information provided is consistent with the company’s current LTO in effect.

．The name and title of the person representing the company.

．Product ingredients: Apply for the complete ingredient list of cosmetic products, the role and percentage of restricted ingredients in the formula.

．Information declared in a product notification: brand, product name, product model, product type, intended use, product description, local company responsible for placing the cosmetic product on the market, agency information, local company representative, list of product ingredients.

．Product Information File (PIF): The Philippines complies with the ASEAN Cosmetics Directive (ACD), which requires individuals or companies placing products on the market to keep product information files easily accessible to regulatory agencies in the relevant member states. This document can be printed or electronic and should be updated every time the company decides to change any aspect of the notification product.

Cosmetic Labels

1. The outer packaging of cosmetics or the direct packaging of cosmetics without outer packaging shall be marked with the following contents:

．The name of the cosmetic and its function, unless it is clear from the description of the product.

．Instructions for use of cosmetic products, unless clearly indicated from the product name or appearance.

．Full ingredient list, ingredients must be declared in descending order of weight when added. Fragrance complete ingredients must be declared in descending order of weight when added, perfumes and fragrance compositions and their raw materials may be replaced by the words perfume, essence, aroma or essence; ingredients with a concentration of less than 1% may be followed by ingredients with a concentration of greater than 1% List in any order; colorants may be listed by color index number or name in any order after other ingredients; for decorative cosmetic products sold in multiple shades, all colorants used in the range may be listed, provided that Added terms may contain or +/-. Ingredients should be specified using the nomenclature in the latest standard; botanicals and botanical extracts should be identified by their genus and species, attributes may be abbreviated, however, the following should not be considered ingredients: impurities in the raw materials used, Auxiliary technical materials that are prepared but not present in the final product, materials used as solvents or carriers for perfume and fragrance compositions, are absolutely necessary in quantities. country of manufacture.

．Name and address of the company responsible for placing the product on the local market.

．Contents expressed in weight or volume in metric or metric and imperial.

．Manufacturing batch number.

．The date of manufacture or expiry date of the product, expressed in an unambiguous manner (eg month/year) and shall consist of month and year or day month and year order. The minimum shelf life should be the date the product will continue to perform its original function after storage under appropriate conditions. For cosmetic products with a minimum shelf life of less than 30 months, an expiration date must be indicated.

．Special precautions to be observed in use, especially those in the columns Conditions of Use and Warnings, must be listed on the attachment, as well as any special precautions on cosmetic products. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin; for ingredients of bovine or porcine origin, the exact animal must be declared.

．If the size, shape or nature of the container or packaging does not allow the display of the specified details, use of leaflets, brochures, hang tags, display boards, shrink wrapping etc. shall be permitted. However, at least the following details should appear on the small direct packaging: cosmetic name, manufacturing lot number.

．Details should be easy to read, clearly understood and indelible.

．Details shall be displayed in English and/or the national language and/or language understood by the consumer in the place where the product is sold, the official languages of the Philippines are Filipino, English.

．Standard reference documents for cosmetic ingredient nomenclature: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstracts Service.

【參考連結】

https://www.fda.gov.ph/wp-content/uploads/2021/07/Appendix-II-Labeling-Requirements.pdf

https://www.fda.gov.ph/downloadables/

HLF-ph-45

HLF-ph-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages ​​are allowed? Website?

Evershine RD：

Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration in the name of the local company.

Cosmetic Institution Business License

1. Applicants: Local businesses engaged in import, export, trade, retail and distribution of cosmetics in the Philippines.

2. Application webpage: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login

Application documents

1. Consolidated application form (with ID photo of owner/registrant/general manager and authorizer).

2. Notary Secretary Certificate/Special Power of Attorney (if the authorized representative is not the owner of the DTI business register or one of the SEC registrants).

3. Business registration certificate

．Valid business name registration certificate with the Department of Trade and Industry (DTI) (for sole proprietorships)

．Be validly registered with the Securities and Exchange Commission (SEC) and the articles of incorporation (for corporations or partnerships) of the corporation or partnership.

4. If the business name is different from the company name, the SEC certificate must do business in the institutional name and style.

．Cooperative Development Authority (CDA) certificates are available for cooperatives.

．Provide a valid mayor’s permit if the business address on the DTI business register and SEC is different from the reported office address.

5. Proof of housing (office, manufacturing plant and warehouse)

．Certificate of Transferable Title (TCT) as proof of ownership.

．Notarized proof of occupancy, if owned by one of these companies.

．Notarized valid lease/sublease agreement if the space/building occupied is not owned by yourself.

．Valid permit from Home Owners Association (HOA)/Condo/Building Authority, if within a residential complex/condo.

．A valid notary warehousing agreement for a 3PL.

6. Other requirements

．Floor plan / layout in meters and correctly identified areas (offices and warehouses)

．Manufacturing Plant Blueprint

．Nearby/location map with landmarks (i.e. Google Maps, sketches of the area)

7. Relevant documents of the authorized person (pharmacist or any relevant trained allied health science professional):

．Notarized Affidavit of Joint Commitment (with 2 x 2 ID photo of authorizer)

．China board certificate

．Valid PRC ID card

．Current Professional Tax Return (PTR)

．Duties and Responsibilities Signed Off by Authorized Persons and Immediate Supervisors

．CCRR’s Qualified Personnel for Industry Regulatory Affairs (QPIRA) Certificate of Attendance or Letter of Commitment of Attendance (with scheduled attendance date and proof of payment)

．Proof of attendance or letter of commitment to attend 13 ASEAN Cosmetics GMP module trainings with scheduled attendance date and proof of payment (for traders and manufacturers only)

8. Importer specific requirements

．Product list: source name and address, manufacturer’s name and address, complete product list by country of origin.

．A valid Foreign Agent Agreement (FAA) or any form of authorization for each source/supplier duly certified by the Philippine Consulate

．If the source/supplier has designated another logistics/billing company, either: A valid supply agreement between the foreign source/supplier and the manufacturer, a valid tripartite agreement duly certified by the Philippine Consulate.

．Manufacturer’s certificate of GMP compliance (any of the following): Valid manufacturer’s GMP certificate issued by a government agency or recognized business association (WHO, ECC/EU, COLIPA) in the country of origin, if the manufacturer is from an ASEAN member state , the self-declaration of compliance with GMP, a certificate of free sale issued by a government agency in the country of origin (national regulatory agency or chamber of commerce), an ISO certificate in compliance with GMP, and a valid manufacturer’s license.

9. Validity period: LTO is valid for 1 year (extensions must be made 3 months before the expiration date).

Cosmetic Labels

1. The outer packaging of cosmetics or the direct packaging of cosmetics without outer packaging shall be marked with the following contents:

．The name of the cosmetic and its function, unless it is clear from the description of the product.

．Instructions for use of cosmetic products, unless clearly indicated from the product name or appearance.

．Full ingredient list, ingredients must be declared in descending order of weight when added. Fragrance complete ingredients must be declared in descending order of weight when added, perfumes and fragrance compositions and their raw materials may be replaced by the words perfume, essence, aroma or essence; ingredients with a concentration of less than 1% may be followed by ingredients with a concentration of greater than 1% List in any order; colorants may be listed by color index number or name in any order after other ingredients; for decorative cosmetic products sold in multiple shades, all colorants used in the range may be listed, provided that Added terms may contain or +/-. Ingredients should be specified using the nomenclature in the latest standard; botanicals and botanical extracts should be identified by their genus and species, attributes may be abbreviated, however, the following should not be considered ingredients: impurities in the raw materials used, Auxiliary technical materials that are prepared but not present in the final product, materials used as solvents or carriers for perfume and fragrance compositions, are absolutely necessary in quantities. country of manufacture.

．Name and address of the company responsible for placing the product on the local market.

．Contents expressed in weight or volume in metric or metric and imperial.

．Manufacturing batch number.

．The date of manufacture or expiry date of the product, expressed in an unambiguous manner (eg month/year) and shall consist of month and year or day month and year order. The minimum shelf life should be the date the product will continue to perform its original function after storage under appropriate conditions. For cosmetic products with a minimum shelf life of less than 30 months, an expiration date must be indicated.

．Special precautions to be observed in use, especially those in the columns Conditions of Use and Warnings, must be listed on the attachment, as well as any special precautions on cosmetic products. There must be a statement (in any format) on the product label indicating the presence of ingredients of animal origin; for ingredients of bovine or porcine origin, the exact animal must be declared.

．If the size, shape or nature of the container or packaging does not allow the display of the specified details, use of leaflets, brochures, hang tags, display boards, shrink wrapping etc. shall be permitted. However, at least the following details should appear on the small direct packaging: cosmetic name, manufacturing lot number.

．Details should be easy to read, clearly understood and indelible.

．Details shall be displayed in English and/or the national language and/or language understood by the consumer in the place where the product is sold, the official languages of the Philippines are Filipino, English.

．Standard reference documents for cosmetic ingredient nomenclature: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstracts Service.

【參考連結】

https://www.fda.gov.ph/wp-content/uploads/2021/07/Appendix-II-Labeling-Requirements.pdf

https://www.fda.gov.ph/downloadables/

HLF-ph-55

HLF-ph-60
What documents are required when importing approved cosmetics into Philippines? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

Without a sales notification, the local company responsible for placing a cosmetic on the market should register with the FDA and submit a cosmetic electronic notification prior to placing the product on the market.

Customs

1. The importer business first needs to obtain the import clearance certificate from the Internal Revenue Service, and then the importer registers with the Bureau of Customs (BOC) and opens an account on the Customer Data Registration System (CPRS).

2. The import customs clearance certificate is valid for three years, and the customs customer data certification must be updated every year. CPRS certification costs P1000 ($20) and usually takes 15 business days to process.

3. Philippine Customs imposes a 12% Value Added Tax (VAT) on imported goods and no duties or taxes are levied on goods valued below P10,000 (US$200).

4. Enterprises importing into the Philippines must provide the following documents upon arrival of the goods:

．Packing list.

．Bill.

．Bill of lading.

．Import permit.

．Customs Import Declaration.

．Certificate of Origin.

．Product Registration Certificate from FDA.

．Duly notarized Supplemental Statement of Valuation (SDV).

．Free Trade Agreement (FTA) certificate of origin.

．Goods declaration.

．Tax Credit Certificate (TCC) or Tax Debit Notice (TDM) (if applicable).

5. Import Documentation

．Bill of lading/air waybill, or proof of the carrier or agent of the ship or aircraft.

．Commercial Invoice, Letter of Credit or any other commercial document to demonstrate payment.

．Commercial documents indicating the commercial value of the goods.

6. For Letter of Credit (L/C) transactions, a duly completed letter of credit including pro forma invoice and Single Administrative Document (SAD) with pre-customs import duties is required. Non-L/C transactions require pro forma invoices, such as drafts of acceptance (D/A), payment documents (D/P), opening of accounts (OA), or self-funding documents.

7. Documents must be submitted to the Customs Official Entry Division (FED) or its equivalent office or unit together with a signed and notarized SAD printout of the customs broker and the customs broker (if any).

【參考連結】

https://customs.gov.ph/

https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf

HLF-ph-70
What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

Good Manufacturing Practices (GMP) for Cosmetics

1. The documentation system should include the full history of each batch, from starting material to finished product. The system shall record the performance of maintenance, storage, quality control, primary distribution and other specific matters related to GMP.

2. There should be a system to prevent the use of any superseded documents.

3. If an error occurs or is found on the document, it should be corrected in a way that does not lose the original entry, as close to the original entry as possible, initialed and dated.

4. If there is an explanation in the document, it should be stated level by level.

5. Documents should be dated and authorised.

6. Documentation shall be readily available to interested parties.

7. All specifications should be approved by an authorized person.

8. Specifications of original packaging materials shall include:

．Material name

．Material Description

．Testing Parameters and Acceptance Limits

．Technical Drawing (if applicable)

．Special precautions, e.g. storage and safety conditions if necessary.

9. Bulk and finished specifications should include:

．Product name

．Description

．Physical properties

．Chemical and/or microbiological analyses and their acceptance limits (if necessary)

．Storage Conditions and Safety Precautions (If Necessary)

10.Production Documents

Master Recipe: Should be available upon request.

．Product name and product code/number

．Expected Packaging Materials and Storage Conditions

．List of raw materials used

．List of equipment used

．Process controls and their limitations on processing and packaging (where applicable)

Batch Manufacturing Record (BMR): A batch manufacturing record should be prepared for each batch of product

．Product name

．Bulk formula

．Brief description of manufacturing process

．Lot number or code

．Start and end dates for processing and packaging

．Indication of a single major device and the line or location used

．Cleaning records of equipment used for processing (as applicable)

．Process controls and laboratory results, such as pH and temperature test records

．Packaging line customs clearance inspection record

．Any sampling performed during various steps of processing

．Any investigation of a specific fault or discrepancy

．Inspection Results of Packaged and Labeled Products

Quality Control Records: Records should be kept of each test, assay results, and release or rejection of starting materials, intermediates, bulk products, and finished products.

．Test date

．Material recognition

．Supplier name

．Received date

．Original lot number (if available)

．Batch number

．QC number

．Quantity received

．Date of sampling

．QC Results

Product Information File (PIF)

1. The ASEAN Cosmetics Directive (ACD) requires individuals or companies placing products on the market to maintain product information documents.

2. Product information required by ACD

．Qualitative and quantitative ingredients of the product, in the case of fragrance ingredients, the name and code of the ingredient and the identity of the supplier

．Specifications of raw materials and finished products

．Production methods that comply with the Good Manufacturing Practices set out in the ASEAN Guidelines

．Assess the safety of the finished product, its composition, chemical structure, and exposure levels to human health

．Existing data on adverse effects of cosmetic use on human health

．Supporting data on the claimed benefit of a cosmetic product to demonstrate the nature of the effect, providing information on analytical methods to regulatory authorities

．Available methods for manufacturers to check cosmetic ingredients against certificates of analysis

．Standards and/or methods for checking compliance with these standards for cosmetic microbiological control and chemical purity of cosmetic ingredients

3. Recommended PIF Format: Companies placing products on the market need to organize the PIF in a way that is compliant and easy to consult with the authorities, it is recommended that the PIF be divided into the following 4 parts:

．Part 1: Administrative Documents and Product Summary

．Part 2: Raw material quality data

．Part 3: Finished Product Quality Data

．Part 4: Safety and Efficacy Data

．Each of the 4 sections should provide a table of contents

4. Part 1: Administrative Documents and Product Summary

．Administrative documents: A copy of the notification form with the confirmation receipt from the authorities, including: the identity of the product, the address of the manufacturer, assembler, importer and the company placing the product on the market, a letter of authorization from the owner of the product or a letter of agreement related to the product, Other relevant administrative documents, such as: business license, company registration certificate

．Qualitative and quantitative formulation of the product (INCI or other ACD approved reference name and corresponding ingredient concentration): For fragrances, the name and code of the ingredient and the identity of the supplier must be declared

．Product descriptions and labels: external and internal labels (photos and/or drawings), consumer information leaflets and instructions for use (if part of the product is sold to consumers)

．Manufacturing Declaration: The manufacturer or company declares that the product is manufactured in accordance with the ASEAN GMP Guidelines or any ACC-approved equivalent GMP guidelines, providing the batch coding system/key of the product

．Safety Assessment (Summary) according to ASEAN Guidelines on Cosmetics Safety Assessment: Safety Statement (Signed Statement of Opinion, including Name and Qualifications of Safety Assessor), Adverse Human Health Effects Confirmed (Summary)

．Packaged Product Claim Support (Summary): Summary Report of Product Efficacy Evaluation Based on Product Composition or Testing Conducted

5. Part 2: Raw material quality data

．Specifications and test methods for raw materials/ingredients: Specifications for each ingredient, method of analysis corresponding to the specification for each ingredient, name and code of the specified fragrance, name and address of the supplier, statement of compliance with the latest IFRA guidelines

．Raw material safety data based on supplier data, published data, or reports from scientific committees such as the ASEAN Cosmetic Science Body (ACSB), the European Union’s Scientific Committee on Consumer Products (SCCP) or the US Cosmetic Ingredient Review (CIR)

6. Part 3: Finished Product Quality Data

．Qualitative and quantitative formulation of the product (INCI or other approved ACD reference name and corresponding ingredient concentration)

．The recipe should describe the function of each ingredient/ingredient

．Manufacturer contact details: name, country and address of manufacturer, assembler and packer

．Manufacturing Process Summary

．Further details of the manufacturing process, quality control and related manufacturing documents

．Standard for cosmetic microbiological control and chemical purity of cosmetic ingredients

．Analytical methods for compliance with inspection specifications

．Product stability summary report, product shelf life less than 30 months to provide stability test data and report or stability evaluation supporting the validity period

7. Part 4: Safety and Effectiveness Data

．Signed safety assessment report for human health of finished products based on their composition, chemical structure and exposure levels

．Safety Assessor Resume

．The latest compiled report of confirmed or documented adverse events or adverse effects on human health resulting from the use of the cosmetic

．Adverse event reports in PIF are expected to be regularly updated by the company

．Full signed report of product efficacy evaluation based on its ingredients or tests conducted

．Supporting data, including a literature review of the cosmetic’s claimed benefit, should be provided to demonstrate the nature of its effect

8. The company or individual responsible for placing the cosmetic product on the market should keep the PIF at the address specified on the label for easy access by the regulatory authorities. Be it an importer, manufacturer or distributor. It is recommended to retain PIF for a minimum of 3 years after the product was last placed on the market.

Cosmetic Safety Assessment

1. The cosmetic category that uses the ingredient.

2. Method of use (eg smear, spray, smear and wash off, etc.).

3. Concentration of ingredients in the product.

4. The number of products used for each application.

5. Frequency of application.

6. Total area of skin contact.

7. Contact sites (eg mucous membranes, sunburned skin).

8. Contact time (eg, rinse-off products, leave-on products).

9. Reasonably foreseeable abuse that may increase exposure.

10. Type of consumer (eg children, people with sensitive skin).

11. Estimated number of consumers.

12. Apply to sun-exposed skin areas.

13. Quantity that may enter the human body.

【參考連結】

https://www.fda.gov.ph/wp-content/uploads/2021/03/Guidelines-for-the-Safety-Assessment.pdf

https://www.fda.gov.ph/downloadables/

HLF-ph-75

HLF-ph-77

HLF-ph-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Philippines to sell it, does the distributor need a cosmetics business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

Companies engaged in the import, export, trade, retail and distribution of cosmetics in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.

Cosmetic Adverse Events

1. Companies responsible for placing cosmetic products on the market should report to the Philippine Food and Drug Administration (FDA) regardless of the source of the report (consumers, healthcare professionals, etc.).

2. Report content

．Per Serious Adverse Event: All serious adverse events should be reported. Reports of non-serious adverse events are not required. It must be reported whenever there is a reasonable suspicion that the cosmetic product may have been the cause of the reaction.

．The term reasonable doubt generally means that there is evidence of causation or association.

．Appropriate medical and scientific judgment should be exercised for each condition with a high incidence of non-serious, single serious adverse reactions before reporting to a regulatory agency.

3. Time of reporting

．Fatal or life-threatening adverse events should be reported to the regulatory agency as soon as possible (e.g. by telephone, fax, email, or in writing) but no later than 7 calendar days, followed by an additional 8 calendar days to complete the Adverse Cosmetic Event Reporting Form, and provide any other information that regulators may require.

．Other Serious Adverse Events: All other non-fatal or non-life-threatening serious adverse events must be reported as soon as possible, but no later than 15 calendar days after first discovery.

4. Cosmetic Adverse Event Report Form

．Company information: name and address, company, name and designated telephone number, fax number, e-mail of the reporting person.

．Product Details: Product name (e.g. product notification), ingredient list and package size (please attach a separate list), product type/intended use, manufacturer’s name and country of manufacture, expiry or production date, batch number.

．Adverse event details: name/initial, ID or passport number, age, gender, ethnicity/nationality, date of adverse event.

．Description of adverse events (use and attach a separate report if necessary): Delay between last use of the product and onset of symptoms: How the product was used: Was the person hospitalized for the adverse reaction? Was the person sought medical attention? Results.

URL:

https://www.fda.gov.ph/wp-content/uploads/2021/03/Adverse-Event-Reporting-System.pdf

【參考連結】

https://www.fda.gov.ph/downloadables/

https://www.fda.gov.ph/downloadables/#

HLF-ph-85

Contact Us

Manila Evershine BPO Service Limited Corp.
E-mail: mnl4ww@evershinecpa.com
or
Contact by Viber or Skype in working hours of Philippines time zone.
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Viber: +886966173105
Skype: wumeiling25

or
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Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
Linkedin address:Dale Chen

Additional Information

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Email: kerrychen@evershinecpa.com
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Evershine Potential Serviceable City (2 months preparatory period):
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Evershine CPAs Firm is a LEA member headquartered in Chicago, USA, it has 600 member offices worldwide and employs approximately 28,000 people.
Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)
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