COSMETIC PRODUCT REGULATION

COSMETIC REGULATION IN THE

PHILIPPINES
In the Philippines, the Food and Drug Administration (FDA), is responsible for
regulating cosmetic products and ensuring the safety, purity, and quality of cosmetics
in Philippines market. Being a prominent member of ASEAN, Philippines formally
adopted the ASEAN Harmonized Regulatory Scheme and the ASEAN Common
Technical Documents into the National Requirements in April 2005 and allowed the
cosmetic industry a transitory period to 31 Dec 2007. Since then, a notification
scheme has been implemented in Philippines.

All cosmetic companies shall obtain a License to Operate (LTO) prior to engaging in
manufacturing, importation, distribution and sale of cosmetics. The LTO is also an
essential requirement to be able to notify cosmetic products. All companies are asked
to ensure that their notified products meet the requirements of the ASEAN Cosmetic
Directive, its annexes and appendices.

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
COSMETIC REGULATION IN THE
PHILIPPINES

Center for Cosmetics and Household

Urban and Hazardous Substances
Regulation and Research
University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
The ASEAN Cosmetics Association, Inc. (ACA) consists of organizations from different
countries that aim to harmonize and maintain cosmetics regulations, upgrade the
standards of technical competence and scientific expertise in the local industries
and expand the cosmetics trade in ASEAN.

In February 2001, the ASEAN Cosmetic Association, Inc. decided to work with
various lead countries in ASEAN to address the infrastructure needs and programs
of the cosmetics industry within the region. This step was taken in order to support
the regional harmonization of cosmetics regulations.

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 ASEAN COSMETIC
DIRECTIVE
GENERAL PROVISIONS
Company or person placing the cosmetic in the market shall NOTIFY the regulatory
authorities of each Member State where the product will be marketed
Company or person responsible for placing the cosmetic in the market shall keep the
product’s technical and safety information readily accessible to the regulatory
authority

BENEFITS:
✓The product to trade cycle will be shortened
✓Research breakthroughs and new product technologies can be made
available to consumer faster
✓Provide consumer with wider choice of cosmetic products
✓Helps in building cosmetic/ingredient safety database for the industry

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 LEGAL BASIS IN THE PHILIPPINES
Administrative Order No. 2005-0015
Adoption of the Association of Southeast Asia Nation (ASEAN) Harmonized Cosmetic
Regulatory Scheme and ASEAN Common Technical Documents

Administrative Order No. 2005-0025

Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN
Common Technical Documents

FDA Memorandum Circular 2015-010

Guidelines on Issuance of Center for Cosmetics Regulation and Research (CCRR) User
Account to Access E-Portal
FDA Memorandum Circular 2015-011
Guidelines for Electronic Notification of Cosmetic Products (Cosmetic E-Notification
Version 2.0) Using the FDA E-Portal

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 ASEAN COSMETIC DIRECTIVE ANNEXES
Annex I Illustrative List By Category of Cosmetic Products
Annex II List Of Substances Which Must Not Form Part of the
Composition of Cosmetic Products
Annex III List of Substances Which Cosmetic Products Must Not
Contain Except Subject to Restrictions and Conditions
Laid Down
Annex IV List of Colouring Agents Allowed For Use in Cosmetic
Products
Annex VI List of Preservatives Which Cosmetic Products May
Contain
Annex VII List of UV Filters Which Cosmetic Products May Contain

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
Positive List vs Negative List

Positive List Negative List

ACD Annex IV ACD Annex II
ACD Annex VI
ACD Annex VII

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 ASEAN COSMETIC DIRECTIVE
APPENDICES

Appendix II ASEAN Cosmetic Labeling Requirements

Appendix III ASEAN Cosmetic Claim Guideline
Appendix VI ASEAN Guidelines for Cosmetic Good
Manufacturing Practice

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
OTHER ASEAN COSMETIC DIRECTIVE
DOCUMENTS
❑ ASEAN Cosmetic Directive - Guidelines for Product Information
File (PIF)
❑ ASEAN Guidelines for the Safety Assessment of a Cosmetic
Product
❑ Guidance Format of the Safety Assessment
❑ ASEAN Botanical Safety Assessment Guidance Document
❑ ASEAN Sunscreen Guidelines
❑ ASEAN Microbial Limit
❑ ASEAN Heavy Metal Limit
❑ A Guide Manual for the Industry: Adverse Event Reporting for
Cosmetic Products
University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 Common Banned Ingredients
1. Azelaic Acid
2. Hydroquinone
3. Papaver rhoeas and Cannabis sativa (RA 9165)
4. O-aminophenol
5. Cells, tissues or products of human origin
(e.g. rh-oligopeptide)
6. Stem cell (DOH Administrative Order No. 2013-
012)

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
Updates to the ACD Ingredient List
The Food and Drug Administration (FDA) disseminates
amendments and new regulations adopted as part of
the ASEAN Cosmetic Directive through the issuance of
FDA circulars.

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 APPENDIX II
LABELING REQUIREMENTS

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 APPENDIX II
LABELING REQUIREMENTS

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
Where to find the Special Precautions?

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 Decision process to identify cosmetic products & claims

Product
Product
Proposition
Proposition

1. Does the product contain only

ingredients permitted by the 1. Not
ACD and no ingredients
Composition Cosmetic
banned by the ACD ?

APPENDIX III
NO
2. Is the product intended for
contact with the various YES
external parts of the human
body (epidermis, hair system, 2. Not

COSMETIC nails, lips and external genital

organs) or with the teeth and
the mucous membranes of the
oral cavity ?
Target Site

YES
NO
Cosmetic

CLAIM 3. Is the product intended

exclusively or mainly to clean,
perfume, change the
appearance and/or correct
3.
Main Function
NO
Not
Cosmetic

GUIDELINES
body odours and/or protect or
keep the defined parts of the YES
human body in good
condition ? 4.
Non-Cosmetic Not
4. Is the product presented as
Presentation Cosmetic
treating or preventing disease YES
in human beings ?
NO
5. Does the product permanently
restore, correct or modify 4. Not
physiological function by Non-Cosmetic Cosmetic
exerting a pharmacological, Function YES
immunological or metabolic NO
action ?

Cosmetic
Cosmetic
Product
Product

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 Physiological Effects
Every product that has an effect on the functioning of
the body also has an effect on its metabolism

Cosmetic products typically have effects that are not

permanent, and have to be used regularly to maintain
their effects

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 Examples of
Unacceptable
Claims

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 How to soften claims?
Note that claims can be softened - i.e. made less functional and
more cosmetic in nature by the use of modifiers. An example
of this would be a claim for removing all oil from skin. This
claim could be softened as follows:

✓ Helps to remove oil from skin

✓ Reduces the shine of oily skin
✓ Suitable for oily skin types
✓ Makes your skin feel less oily

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 Secondary claim
Products may have a secondary, minor function that is outside
the above scope. Some examples of acceptable secondary
claim areas are given to the following:

❑ Dandruff ❑ Bust contouring

❑ Caries ❑ Acne
❑ Cellulite ❑ Anti-bacterial
❑ Hair loss

“Note that this is NOT an exhaustive list”

University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 APPENDIX VI
COSMETIC GMP GUIDELINES
✓ Quality Management System ✓ Documentation
✓ Personnel ✓ Internal Audit
✓ Premises ✓ Storage
✓ Equipment ✓ Contract Manufacturing and
✓ Sanitation and Hygiene Analysis
✓ Production ✓ Complaints
✓ Quality Control ✓ Product Recall

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
e-NOTIFICATION PROCESS

University of San Agustin

COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY
 END
University of San Agustin
COLLEGE OF HEALTH AND ALLIED MEDICAL PROFESSIONS
DEPARTMENT OF PHARMACY