OUR LADY OF FATIMA UNIVERSITY

College of Pharmacy
COSMETIC PRODUCT DEVELOPMENT (COSMETIC
PRODUCT DEVELOPMENT, REGULATION AND
SAFETY)
PCOS311

Worksheet 1

Cosmetic Product Notification

 Objective
At the end of the module, the students are expected to:
◎ Determine the Guidelines On The Unified Licensing
requirements and Procedures of the Food and Drug
Administration (FDA AO No. 2016-0003)
◎ Identify FDA Circular No. 2013-002 “Revised Guidelines in
Licensing of Cosmetic Establishments as stated in:
○ ANNEX A - Checklist of Requirements for Initial, Renewal
and Amendments Applications
○ ANNEX B - Site Master File Format
○ ANNEX C - Petition Form
○ ANNEX D – Joint Affidavit Undertaking
◎ Familiarized with the CAPA Plan (Corrective Action and
Protective Plan)
 Checklist
◎ Read course outline
◎ Read course guide prior to class attendance
◎ Proactively participate in discussion
◎ Answer and Submit Course Unit Tasks
 Cosmetic Product Development

◎ The definition of Cosmetic product in the ASEAN Cosmetic

Directive is “Any substance or preparation intended to be
place in contact with the external parts of the body, or
with the teeth and the mucous membrane of the oral
cavity with a view exclusively or mainly for cleaning
them, perfuming them, changing their appearance and/
or correcting body odors and /or protecting or keeping
them in good condition.”

◎ Cosmetic manufacturers must ensure that their

manufacturing condition in respect with conditions comply
with the GMP set by the ASEAN Guideline on Good
Manufacturing Practice.
 Cosmetic Product Development

◎ Aiming to streamline the process by updating the

submission of application requirements from the
previously manual form to online submissions, the
Food and Drug Administration (FDA) allowed
online application process.

◎ This modernization was kickstarted in March 2013

through FDA Memorandum Circular No. 2013-
011.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Brand Name/Product Name/Product Variants –

○ The complete name of the product should be given, in the
following sequence: brand name, line name (if
applicable), product name, if a single shade is notified,
the shade name/number (e.g. BRAND ABC PRODUCT
XYZ EYSHADOW SHADE 1).

○ If there are different shades, the shade name/number for

each shade shall be declared.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Product Types, or the type/s of the cosmetic product that

you are applying for notification.

◎ Particulars of the Product – The validity of the notification

may either be 1, 2, or 3 years at the option of the applicant.

◎ Intended Use – This refers to the function or use of the

product and not the directions for use e.g. to moisturize the
face, hand, etc.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Product Presentations – A Single Product exists in a single presentation

form.
○ A range of variants similar in composition for the same use but differs in
colors, flavors, etc. is a range of cosmetic products, which are similar in
composition and produced by the same manufacturer, and are intended
for the same use but are available in different shades of color (e.g.
lipsticks, eye shadows or nail polish but not composite packs of different
types).
○ Palette(s) in a Range of One Product Type refers to a range of colors
as defined above, which may be presented in a series of palettes.
○ Combination Products in a Single Kit refer to similar and/ or different
product types packed and sold in a single kit.
○ They cannot be sold separately (e.g. a make-up kit of eye and lip
colors; a set of skin-care products sold in a single kit). Please note that
components of such kits must be notified separately.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Local Company Responsible for Placing the Cosmetic Product in the

Market – It refers to the local company responsible for placing the cosmetic
products in the market, which may be a local manufacturer or an agent
appointed by a manufacturer to market the product or the company that is
responsible for bringing in the product for sale in the country, etc.
○ The applicant for notification must have a valid License to Operate
(LTO) and must state in the notification application the LTO number of
the company responsible for placing the cosmetic product in the
market.
○ If the company responsible for placing the cosmetic product in the
market is a distributor, then the applicant must also declare the details
of the direct supplier or manufacturer of the cosmetic product, namely
Country of Manufacture, Address, and others.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Establishment Information – It refers to the particulars of

the manufacturer and/or supplier of the notified cosmetic
product.
◎ Person Representing the Local Company – It refers to the
person representing the local company responsible. The
representative of the Company, and his or her details must
be stated in the application.
○ This person may be contacted by the FDA in case there
are questions on the cosmetic product, or if additional
documents are needed to substantiate the application.
 What Information should be Declared in the
Product Notification?

The following information shall be declared in the Cosmetic

Product Notification:

◎ Product Ingredient List – All the ingredients in the product

must be specified by using the nomenclature from the latest
edition of standard references (International Cosmetic
Ingredient Dictionary, British Pharmacopoeia, United States
Pharmacopoeia, Chemical Abstract Services).
○ Botanicals and extract of botanicals should be identified
by its genus and species. The genus may be
abbreviated. The functions and percentages of
ingredients must be declared if they are substances with
restrictions for use as specified in the annexes of the
ASEAN Cosmetic Directive.
 What are the Procedures in the Application for
Cosmetic Product Notification in the Philippines?

The application process has four (4) main parts:

Submission, Payment, Download Result, and
Revalidation.

◎ The First Step is the Submission. This is now

done through the FDA’s portal
at https://www.fda.gov.ph.
○ Once you have filled up the necessary details
of the cosmetic product to be notified, you can
submit the application with the FDA through
their portal.
 What are the Procedures in the Application for
Cosmetic Product Notification in the Philippines?

The application process has four (4) main parts:

Submission, Payment, Download Result, and
Revalidation.

◎ The Second Step is Payment.

○ The application for notification has a filing fee, depending
on the number of years applied for, or the number of
years that you want the registration with the FDA to be
valid.
○ The best option for payment is always paying at the
Cashier’s office of the FDA.
○ However, to facilitate applications, the FDA provided
alternative payment options, without need to going
physically to the FDA’s offices.
 What are the Procedures in the Application for
Cosmetic Product Notification in the Philippines?

The application process has four (4) main parts:

Submission, Payment, Download Result, and
Revalidation.

◎ The Final Step is to await the results of the FDA’s evaluation.

○ The time frame depends largely on the circumstances, and the
submission of complete information with the FDA.
○ There are instances when the FDA will send an email requiring
additional documents or information concerning the application.
○ Compliance with the email by submitting the required
documents or supplying the needed information is a requisite to
the FDAs approval of the notification.
○ On the other hand, the failure to comply with the additional
documents or information required will lead to the rejection of
the application for notification.
 Revalidation

◎ Acknowledged cosmetic notifications may be revalidated for a

new validity date, where the new validity date will be based
on the date of submission of the revalidation application.

◎ The same process of application for cosmetic notification

applies for revalidation. Using the previous application and
information, the previously acknowledged case must be
selected to continue with the task for Revalidation
Application.
◎ There must be no modifications from the information provided
during the previous application to avail of revalidation. Hence,
any changes to the information will constitute a new
notification application.
 Reference
1. Turner, Dawn M. "Understanding EC Regulation 1223/2009 on
cosmetics". Desjardin. Retrieved 19 December 2016.
2. Mildau, G.; Huber, B. "The New EC Cosmetics Regulation
1223/2009 – Contents and First Explanations" (PDF).
International Journal for Applied Science - Personal Care -
Detergents - Specialties. Retrieved 19 December 2016.
3. https://ww2.fda.gov.ph/index.php/consumers-corner/cosmetic-
product-notification
4. https://www.fda.gov.ph/category/cosmetic-advisories/
End of
Discussion
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