ONE-TIME IMPORTATION OF COSMETIC PRODUCTS FOR

DISTRIBUTION/SALE IN THE PHILIPPINES

I. Limit of Cosmetic Products Without Need of FDA Clearance (before release

by BOC)

Imports of FDA-DOH-regulated cosmetic products may be brought into the

Philippines without prior clearance from the Food and Drugs Administration,
provided such products are:
a. For personal use;
b. In quantities not exceeding the limits:

Cosmetics
Perfumes 5 pieces
Lipsticks 10 pieces
Shampoo 2kg
Lotion 2kg
Bar Soap 2kg
Assorted Cosmetics 1kg

c. Brought into the Philippines in any of the following ways:

- In passenger baggage, whether accompanied or unaccompanied;
- In balikbayan boxes; or
- In parcels sent through mail/delivery services. 1

COMMENT: All of the three instances must be present so the importer need not secure
a clearance.

II. Importation of Cosmetic Products

A company in the Philippines needs to register with the FDA it does any of
the following with FDA-regulated products:

1
https://customs.gov.ph/wp-content/uploads/2015/10/Memorandum-Importation-of-FDA-DOH-Regulated-
Products-For-Personal-Use.pdf;
https://www.fda.gov.ph/wp-content/uploads/2021/03/CHECKLIST-OF-REQUIREMENTS-FOR-COSMETIC-
ESTABLISHMENTS.pdf;
https://www.fda.gov.ph/wp-content/uploads/2021/03/FDA-Circular-No.-2013-002.pdf
 1. Importing
2. Exporting
3. Wholesale trading
4. Distribution
5. Manufacturing2

License to Operate (LTO)

A company is required to obtain an LTO before it can legally import,

distribute, sell wholesale, and/or manufacture cosmetics.3

A company can apply for an FDA certificate with the Center for Food in the
FDA central office. Companies may also apply at the respective FDA regional
field office in their location. The LTO is, at first, valid for one year. Renewed
LTOs will be valid for two years.

Applicants must submit the following documents to the FDA to get an LTO:

a. Petition form. The owner, incorporator, or an authorized representative

must submit a notarized petition form.

b. Joint Affidavit of Undertaking. The owner of the company and an

authorized person must sign an affidavit saying that they understand the
FDA’s regulations for LTO. The authorized person is a pharmacist or
allied health science professional. The authorized person must also
present their professional license or board certificate.

Pertinent documents for authorized person (pharmacist or any allied health

science professional with relevant trainings:

- Notarized Joint Affidavit of Undertaking with 2 x 2 ID picture of

authorized person (see Annex B)(except NCR and CHD IV-A)
- PRC Board Certificate
- Valid PRC ID
- Current Professional Tax Receipt (PTR)
- Duties and responsibilities signed by the authorized person and teh
immediate supervisor
2
https://emerhub.com/philippines/processing-fda-certificate/
3
https://www.dayananconsulting.com/registering-cosmetic-products-in-the-philippines-made-easy/
 - Certificate of Attendance to Qualified Person in Industry Regulatory
Affairs (QPIRA) for CCRR or promissory letter to attend with proof of
scheduled day of attendance and payment4

c. Certificate of Attendance to an FDA-sponsored seminar on licensing of

establishments. The business owner or relevant authorized person must
attend the seminar. It is also possible to submit a promissory letter to
attend.

d. Proof of business registration. Certificate of Registration with the

Securities and Exchange Commission if Corporation/Partnership and
registration with DTI if sole proprietor. You can also submit your business
permit from your local government unit.

e. Proof of occupancy or business address. Applicants must submit

documents related to the business location. For example, the contract of
lease for a rented space.

f. Floor plan and vicinity map. In addition to the proof of occupancy,

applicants must also submit documents about the business location itself.
This includes a floor plan with dimensions.

Notification

Before the product can be released to the market, the FDA must be notified
first using the procedures outlined in the Cosmetic E-Notification v.2.0 User
Manual for Applicants.

You need to provide the following information in your Cosmetic Product

Notification:

a. 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, and the shade name/number if a
single shade is notified (e.g. BRAND ABC PRODUCT XYZ EYSHADOW
SHADE 1). If there are different shades, the shade name/number for each
shade shall be declared.

4
https://www.pntr.gov.ph/other-perfumery-or-cosmetics-including-depilatories/
b. Product Types – the category of the cosmetic product for which you are
applying for notification.

c. Particulars of the Product – The validity of the notification may either be

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

d. 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.

e. Product Presentations – select whether you are applying for (1) a single
product, (2) a range of variants similar in composition for the same use
but differs in colors, flavors, etc., (3) palette(s) in a range of one product
type, or (4) combination products in a single kit.

f. Local Company Responsible for Placing the Cosmetic Product in the

Market – Indicate the local company responsible for placing the cosmetic
products in the market. This company must also have a valid LTO
number. 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.

g. Establishment Information – It refers to the particulars of the

manufacturer and/or supplier of the notified cosmetic product.

h. Person Representing the Local Company – It refers to the company

representative who 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.

i. 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.
 To apply, follow the steps below:

1. Obtain a CCRR User Account by requesting one from info@fda.gov.ph.

You must provide the following information to proceed:
Email address or company email address
Name
Position
Contact No.
Company Name
Company Address
Product Classification: Cosmetics
2. Log in at the FDA e-portal (https://ww2.fda.gov.ph).
3. Click on “New Case” and accomplish the ASEAN Notification Form.
4. Download the “Order of Payment” and assign this task to the FDA
Cashier.
5. Pay the fee either through any Landbank branch or by online Bancnet
payment methods.
6. Wait for the Result of Application.
7. Download and print the notice of acknowledgment once your application
is approved.

Organizations that have submitted correct application documents will then be

issued a Cosmetic Product Notification certificate which is valid for 1-3 years.
Those with insufficient documentation will be given a Notice of Deficiencies
wherein clarification or further explanation of details will be asked. Finally,
anyone who declared misleading information or failed to meet FDA standards
will merit a Letter of Disapproval.

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.

Note that the same process of application for cosmetic e-notification applies for
revalidation. In the e-portal, 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.
 In the event that the notification is desired to be cancelled, the applicant may
choose to cancel the application. This option is available in the Revalidation
Application Task.5

Certificate of Product Registration

After getting your license to operate, you can apply for an FDA certificate of
product registration. The FDA certificate is valid for 1-2 years and is subject to
renewal upon expiration.

To apply for a certificate of product registration, you will need to prepare the
following:

a. Application form
b. Valid license to operate from the FDA
c. Product labels. You must provide copies of the product’s labels in all
packaging sizes. You must also include photos of the product in all
packaging sizes from different angles. You must also include supporting
documentation for logos/seals per labeling regulations. For example,
Halal or Sangkap Pinoy.
d. Product documents. The documents must support any product claims.
You must also include documents detailing physicochemical and
microbiological specifications.
e. Certificate of analysis. This document must contain important details
about the product. The information must be relevant to compliance with
food standards and regulations.
f. Product sample. You must also provide an actual representative product
sample. Your sample must appear as it would commercially and complete
with all labels.

In addition to submitting the above, you must also pay the registration fee. 6

COMMENT: Since the query regarding the one-time importation of cosmetic products
is not for personal use as discussed, the process above should apply because even if the
importation is done once, it must still comply with the rules laid down by the FDA
especially if the products will be sold to the market.

5
https://www.dayananconsulting.com/registering-cosmetic-products-in-the-philippines-made-easy/
6
https://emerhub.com/philippines/processing-fda-certificate/