OVERVIEW OF CCRR

&
PROGRESS OF THE IMPLEMENTATION
OF THE ASEAN COSMETIC DIRECTIVE
IN THE PHILIPPINES
I. FOOD AND DRUG ADMINISTRATION
&
CENTER FOR COSMETICS
REGULATION AND RESEARCH
(ORGANOGRAM)
 OFFICE OF THE DIRECTOR
Engr. Ana Trinidad F. Rivera
Director IV

PRODUCT RESEARCH AND LICENSING AND

STANDARDS DEVELOPMENT REGISTRATION
DIVISION (PRSDD)
DIVISION (LRD)

QUALITY AUDIT & POLICY, RESEARCH &

COSMETICS Household
PRODUCT STANDARDS Urban
ASSESSMENT DEVELOPMENT Hazardous
Substances
II. STATUS OF COSMETIC
INDUSTRY
 1. Number of licensed cosmetic establishments
As of 15 May 2016, the total number of licensed cosmetic establishments are as
follow:
Classification No of Licensed
Cosmetic 2013 2014 2015 As of 16 May
Establishment
2013 2014 2015 2016
Cosmetic 1314
Distributor Manufacturer
1488
253 314
845
311 914
Cosmetic Trader Trader
338 324
377 370252 403 274
Distributor 1,000 1,475 1,617
Cosmetic
Manufacturer
262 314 249
256
Total 1,577 2,159 2,331
TOTAL 1914 2179 1346 1444
Table 1. Number of Licensed Cosmetic Establishments from 2013 up to 15 May 2016.
 Background
» In 2005, the Department of Health (DOH) – Food and
Drug Administration (FDA), then called Bureau of Food
and Drugs (BFAD), has adopted and implemented the
ASEAN Harmonized Cosmetic Regulatory Scheme and
the ASEAN Common Technical Documents including
the ASEAN Cosmetic Directive (ACD) by issuing
Administrative Orders No. 2005-0015 and 2005-0025
respectively for the purpose of eliminating trade
barriers and enhancing cooperation within the ASEAN
Member States in ensuring the safety, quality and
claimed benefits of cosmetic products.
» In line with the ASEAN Cosmetic Harmonization, the
ASEAN Cosmetic Committee (ACC) has been
established to ensure that the ACD would be
implemented effectively. It is composed of
representatives from each member state’s regulatory
authority responsible for cosmetic products as well as
representatives from the ASEAN Cosmetic Industry,
namely the ASEAN Cosmetic Association (ACA).
» The ACC meets semi-annually to coordinate, review
and monitor the implementation of the ACD and
review and update the technical documents as
necessary. Updates and amendments that have been
adopted during an ACC meeting shall be formally
cascaded and disseminated to the local cosmetic
industry through the issuance of a circular.
 2. Number of Notified Cosmetic Products
As of 15 May 2016, the total number of cosmetic products with valid notifications is
42,054 (multiple variants per notification) or 70,385 (notification per variant).

Number of Cosmetic Notification Applications

Received
23,641 22,832
19,554 20,172
16,179
14,448 13,735
11,468 10,754

2008 2009 2010 2011 2012 2013 2014 2015 2016 (AS OF
15 MAY
2016)

Graph 1. Trend of Cosmetic e-Notification Applications Received from 2008 – 2016

 2.1 Cosmetic e-Notification version 2.0
With the implementation of the cosmetic e-notification version 2.0, the FDA
Philippines can now monitor the cosmetic products in the market and can generate
data/information more effectively such as:

a. Origin of the Cosmetic Products

Locally Manufactured Cosmetic Products vs.

Imported Cosmetic Products
21.19%
(8,910)

78.81%
(33,144)
Local Imported

Graph 2. Number of Locally Manufactured Cosmetic Products as Compared to the Number of Imported Cosmetic
Products
b. Country where Most of the Cosmetic Products Originated (Top 10)

Top 10 Countries Where Most of the Notified Cosmetic Products

Originate
3000
2638
2500
1745
2000 1460

1500 1242 1221

1000 623 615 422 406 398

500

0
Philippines U.S.A. China France Korea Italy Thailand U.K. Singapore Japan
No. of Notified Cosmetic Products

Graph 3. Top 10 Countries Where Most of the Notified Cosmetic Products Originate
c. Top 5 Product Type

Top 5 Product Types of the Notified Cosmetic

Products in the Market

3141
2602

1620
1361
677
CREAMS, HAIR CARE MAKE-UP AND PERFUMES/EDT LIP PRODUCTS
EMULSIONS, PRODUCTS MAKE-UP
GELS REMOVERS

No. of Cosmetic Products

Graph 4. Top 5 Product Types of the Cosmetic Products in the Market

d. Performance of Cosmetic e-Notification version 2.0

Performance of Cosmetic e-Notification version 2.0

3000

2500 No. of Applications

Received

2000 No. of Applications

Evaluated
1500 No. of Applications
2331
2322
2215

2194
2176
2066

2571
2531
2362

2292
2244
2077
Acknowledged
106

110

162

139
1000 No. of Applications Not
Acknowledged
500

0
January February March April

Graph 5. Performance of Cosmetic e-Notificetion version 2.0 for January – April 2016
3. Certificate of Good Manufacturing Practices (GMP)
As of 15 May 2016, there are fifteen (15) local cosmetic
manufacturers that have been issued with a Certificate of Good
Manufacturing Practices (GMP)

4. Certificate of Free Sale

As of 15 May 2016, FDA-CCRR has issued six hundred seventy-nine
(679) Certificate of Free Sale to thirty (30) cosmetic establishments.
III. FDA PHILIPPINES’
POST-MARKETING
SURVEILLANCE
(PMS)
1. Product Verification
As part of the Post-Market Surveillance (PMS) system of the FDA Philippines, the
FDA inspectorate are instructed to collect (purchase) random samples of cosmetic
products from the market. These cosmetic products are then checked and verified
for compliance to ACD, its annexes and appendices and other existing national
rules and regulations.

Notified Unnotified Total

Product 15 50 65
Verification
Table 2. Findings of the Product Verification Conducted in the 1st Quarter of 2016

A common finding in all the notified cosmetic products is their non-compliance

to ACD Appendix II – ASEAN Cosmetic Labeling Requirements. A warning
letter/notice is sent to the market authorization holder.
In cases wherein the cosmetic product is found to be unnotified, a public
advisory shall be issued to inform the consumers.
2. Post-Evaluation for Notified cosmetics
Another integral part of the PMS system of FDA Philippines is the post-evaluation
of cosmetic notification. This process comprehensively reviews a cosmetic product
notification application after its acknowledgement and checks its compliance to
ACD, its annexes and appendices and other existing national rules and regulations.

Recommendations of No.
Post-Evaluation Majority of the findings
from the post-
Approved 713
evaluation of cosmetic
For PIF Audit 264
notification are non-
For Product Recall 39 disclosure of the
Market Monitoring 7 function and percentage
content of restricted
TOTAL 1023
ingredients.
Table 3. Number of Cosmetic Products that were Post-Evaluated in
the 1st Quarter of 2016
3. Product Recall
A Notice of Product Recall are issued to all cosmetic companies that have placed
products in the market that are found to be non-compliant to ACD, its annexes and
appendices and other existing national rules and regulations.
Status No.

Voluntary Product Recall 1

Notice lifted 7
For Verification of Compliance 5
Awaiting Compliance 3
For investigation and monitoring 71

Company Moved-Out 4
TOTAL 91

Table 4. Number of Notice of Product Recall Issued and their Status as of 15 May 2016
4. Consumer Complaints
As of 15 May 2016, FDA Philippines has received eight (8) consumer complaints
connected to cosmetic products. Most of these complaints involve the
distribution/selling of cosmetic products without market auhtorizations.

Year Total No. of Complaints Received

2014 4

2015 9

2016 (as of 16 May 2016) 8

Table 5. Number of Consumer Complaints Received in 2014, 2015 and 2016 (as of 16 May 2016).
5. Public Health Issuances (Advisories)
To ensure the public safety and health, the FDA Philippines issues health advisories
to disseminate new information and increase the level of awareness of consumers.
Beginning 01 January 2016, here are the FDA advisories released for cosmetic
products:

FDA Advisory Subject

FDA Advisory No. 2016-032 Selected Parabens Declared as

Banned Ingredients that may be
Contained in Cosmetic Products

FDA Advisory No. 2016-035 Unnotified Cosmetic Products

Being Sold Over the Internet

Table 6. FDA Advisories Issued Since January 2016.

IV. ADVOCACY PROGRAMS
1. Consumer Manual and Poster on Online
Shopping
The consumer manual and poster on online shopping provide the public key
reminders when purchasing cosmetic products using online shopping websites to
ensure that what they buy are safe and of quality.
2. Consumer Manual on Sunscreen Products
The consumer manual on sunscreen products educates the public on how to
properly choose and use sunscreen products to get its maximum claimed benefits.
3. Conduct of Technical Capability Building for
CCRR Personnel
CCRR Staff with Selected FDA Personnel during the conduct of the training entitled
“Cosmetic Product Trends 2016 and Skin Care – Safety Considerations”
V. INITIATIVES
1. Continuous improvement of Notification process under Version 2.

2. Revised Licensing System in place (e-LTO) FDA Circular 2016-003 & 2016-
004

The FDA streamlined the requirements for the issuance of licenses to all
health product establishments including cosmetics to assist the MSMEs. The
FDA Philippines will now go paperless for ease of process.

3. Intensified Annual Monitoring Plan for 2016

FDA inspectorate are more aggressive in collecting cosmetic products from

the market for product verification and laboratory testing.

4. The FDA was certified for ISO 9001:2008 certification from TUV Rheinland
last March 24, 2016

5. Continuous capacity building of FDA Inspectorate in the conduct of PIF audit

which will now be a part of their post-licensing monitoring program.
VI. The Way Forward
1. FDA-CCRR plans to conduct oversight audit of our regional field offices to
assess/monitor their efficiency and effectiveness in performing inspection and
licensing of cosmetic establishments in compliance with existing FDA rules and
regulations.

2. FDA-CCRR plans to have regular dialogues with its different stakeholders (i.e. Derma
Societies; Spa and Salon owners; MSME/SMEs) to assist them in their compliance with
the ACD and the FDA’s revised Licensing system (e-LTO)

3. Promotion of One town One province cosmetic products for notification and export in
coordination with local government units and Department of Trade and Industry.

4. Continuous capacity building of technical officers/evaluators

5. Development of test methods for the identification of banned ingredients (e.g.

isobutyl paraben)
24th ASEAN Cosmetic
Committee meeting
26-27 May 2016
HaNoi, Viet Nam
Updates and Amendments of the
ASEAN Cosmetic Directive as
Adopted During the 24th ASEAN
Cosmetic Committee Meeting and
Its Related Events
24th ASEAN Cosmetic Scientific Body (ACSB) and
7th ASEAN Cosmetic Testing Laboratory
Committee (ACTLC) Meetings in Hanoi, Vietnam.
 24th ASEAN Cosmetic Scientific Body
(ACSB) Meeting
» Issuance of the final versions of ACD Annexes II,
IV, VI and VII.
» The use of Thioglycolic acid and its salts in
products intended for eyelash-waving is not
authorized. ACD Annex III Ref. No. 2a will remain
unchanged.
» Agreement on the format of the ASEAN
Guidelines on Limits of Contaminants for
Cosmetics.
7th ASEAN Cosmetic Testing Laboratory
Committee (ACTLC) Meeting
» The list of accredited testing laboratories in
the Philippines is found in the Department of
Trade and Industry – Philippine Accreditation
Bureau (DTI-PAB) website.
(http://www.pabaccreditation.dti.gov.ph/publi
c/public_test.php)
» Proposal for the development and publishing
of ASEAN joint opinion statements for certain
ingredients that is of media interest or public
concern.
» Formation of a pilot task force comprising of
Singapore, Philippines and Thailand to work on
talc.
M araming Salamat po!

Thank you for your

attention
www.fda.gov.ph
02-8571984
atfrivera@fda.gov.ph
rldmanaloto@fda.gov.ph