MALAYSIA
PROGRESS OF THE IMPLEMENTATION OF
WHO Collaborating Centre
for Regulatory Control of
Pharmaceuticals
Member of Pharmaceutical
Inspection Cooperation Scheme
Certified to ISO 9001:2000
Cert. No: AR 2293
THE ASEAN COSMETIC DIRECTIVE
14th ASEAN Cosmetic Committee Meeting
10 – 11 June 2010
Jakarta, Indonesia
National Pharmaceutical Control Bureau
Ministry of Health Malaysia MALAYSIA
Jalan Universiti
46730 Petaling Jaya, Selangor
MALAYSIA
Tel : 603-78835400 Fax : 603-79562924
Website : www.bpfk.gov.my 1
 Content
5.1 - Status of implementation of notification system for placement of
cosmetic products

5.2 - Efforts taken to ensure common interpretation of ACD and raising

consumer awareness on the implication of ACD

5.3 - Enhancing the capability of SMEs

5.4 - Post Market Surveillance

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 5.1 Status of implementation of notification
system for placement of cosmetic products
• Implementation date : since 1st January 2008

• Notification process
– Submission of product particular via Quest 2 online
www.bpfk.gov.my
– Fee: RM50.00 for each product
– Validity : 2 years

• Development of new online system- Quest3

– Additional Feature: ingredients database & smart system
• To better facilitate and assist regulator for systematic & active PMS
• User friendly –industries to manage product information & effective
monitoring of product notification & product status

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 Product Notification
• From January 2008 – April 2010
Total No. of Notified Cosmetics:
Year Total product Total Notified Notes
received for Cosmetics
notification
2008 30, 351 20,052 - Notification expired
- Voluntary withdrawal
2009 37,466 37,092 - Cancelled

2010 15,276 15,210

(Jan – Apr)
TOTAL 83, 093 72,354

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 • From January 2008 – April 2010
 Percentage of notified cosmetics
– ASEAN originated
Country Total No
Malaysia 29,372
Thailand 5,271
Indonesia 2,842
Philippines 1,806
Singapore 1,448
Vietnam 32
Myanmar 4
Brunei 0
Cambodia 0
PDR Loa 0

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 5.2 Efforts taken to ensure common interpretation of ACD and
raising consumer awareness on the implication of ACD
• Plan for 2010
– Seminar on the updates of the ACD & hands-on session for PIF
• in collaboration the CTFA & MCTIG
– Target group : SMEs, MNC & enforcements
– Tentative date : Sept 2010

• Activities : Jan- May 2010

1. Speaker & panel in the Dialogue with Beauty Saloon Operator – April 2010
• Sharing information on the Notification Procedure & requirements , PMS
activity
• Responsibilities as retailers

2. Speaker in the Consumer Awareness Programme – Cosmetic & You – May 2010
• To increase consumers understanding on how to access the safe cosmetics
• Encourage to read label & warning statement
• To lodge complaint & report any Serious Adverse Event on cosmetics

3. Partnership with the MOH for Consumer Protection & Education – on-going
• Work closely to plan the Consumer Awareness Programme
14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA
5.2 Efforts take to ensure common interpretation of ACD and
raising consumer awareness on the implication of ACD - cont
4. Collaboration with the Consumer Association to produce brochure on the safe
use of cosmetic – on-going
• Sharing information and furnish them with the technical knowledge on the
ingredients concern
• Get together to discuss matters related to cosmetics
• Collaboration to produce brochure on cosmetics subject -ingredients

5. Public/media announcement
• Issued press release to inform public to stop using cosmetics
• Cosmetics cancellation - adulterated with poison items
• Product notified as cosmetic but used beyond cosmetic scope
• Info published in NPCB website

6. Monitoring of Media Advertisement

• Collaboration with Pharmacy Enforcement Division
• Cosmetics with medical claimed/ non cosmetics claims

7. NPCB website – product search function

• Consumer may verify notification status of cosmetics
– only notified cosmetics will appear
14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA
 5.3 Enhancing the capability of SMEs
• Plan for 2010
– Regular workshops for SME
• Topics:
– Updates on the ACD
– PIF requirements
– Safety Assessment requirements
• Small group – less 10 companies ( max 12-15 paxs)
• Time : half-day / monthly
• Tentative date: July 2010
• Target group:
– new company – identified during the PMS - screening of
formulation & product information
– company with lack of knowledge /understanding on the ACD
– Finding from PIF audit

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 5.3 Enhancing the capability of SMEs -cont
• Activities : Jan- May 2010

1. PIF Auditing
• Provide consultation & guidance on the PIF requirements & how to compile the
file during the PIF Audit

2. Contribute expertise in the TWG on product promotion and packaging

organized by SME Corp, MATRADE (Malaysia External Trade
Development Corporation)
• Provide an expert opinion and comment on packaging and promotion materials
for cosmetics

3. Invited as a speaker for International Beauty Expo – May 2010

• Sharing experiences on the Notification Procedure as well as the Control of
Cosmetics in Malaysia

4. Participate in the Seminar by Ministry of  Domestic Trade, Co-operatives

And Consumerism–May 2010
• Panel for a dialogue

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 5.3 Enhancing the capability of SMEs -cont

• Activities : Jan- May 2010

5. GMP audit
– For cosmetic manufacturer – new manufacturer
– Action taken:
» Notification cancellation – no proper facilities for cosmetic
manufacturing
» Allow the manufacturer to take necessary corrective
actions, if the manufacturing facility found not satisfactory
6. Help desk
– Officer in-charge to assist new company to submit notification
– Entertain walk-in customer & assist them to submit the
product notification at the NPCB, MOH

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 5.4 Post Market Surveillance
• Various mechanisms are employed on PMS program to
establish an active and systematic monitoring on notified
cosmetics.

PMS Activities:
1. Screening of information/formulation of notified cosmetics
2. Auditing the PIF
3. Product sampling & testing
4. Monitoring of label of targeted products
5. Handling of product complaints
6. GMP Audit
7. ASEAN Alert

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 Screening of information/formulation of
notified cosmetics
 All the product’s information and details are
screened – for compliance to ACD.

 Any non conformances to the requirements

--Notification will be cancelled
contain prohibited substances,
ingredients exceed the maximum allowable limit,
 inappropriate usage conditions- non cosmetics
non-compliance to GMP requirement.

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA
 To avoid MISUSE of notification system
 PRE-SCREENING mechanism has been
implemented early 2010
– prior to generation of NOTIFICATION Number

 Product with indication/packaging of:

 Moisturizer for men/women sexual performance
 Eye products in eye drop bottle/eye spray packaging
 Vial/ampoule – to be injected
NOT ALLOWED to be notified as cosmetic product

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 PIF Audit
• Priority and criteria for PIF audit:
 whitening products
 high risks products (eye and baby products)
 manufacturers or companies with history of products recalls,
product complaints, failed the laboratory testing
 GMP status
 inputs gathered during initial products screening.

• Total No. of PIF audited (until April 2010):

Year No PIF audited
2009 285
2010 ( Jan- April) 146
TOTAL 431

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

Findings from PIF Audit:

- Most notification holders understand the need of PIF and its

requirements as stated in the ACD.

• However, they still having difficulties to complete the PART II -

Part IV of the PIF requirements :
 Imported product
- lack of cooperation from the manufacturers.
- Manufacturers from oversea are reluctant to disclose the information.

 Local manufacturers/ SMEs:

Difficulties to provide safety assessment – safety assessor,
efficacy support, product claims & advertisement, labeling
requirements
Plan of Action :
The relevant companies will be advised to attend training in NPCB
- to improve their understanding and ensuring the compliance to the ACD.
14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA
 Product Sampling & Testing

• Plan for 2010

Targeted samples:
 Body Contour / product for slimming - screening for Theophylline
 Whitening product - screening for Hydroquinone and Tretinoin
 Acne product - screening for antibiotic/steroid
 Eye care product / to be used around the eyes : Microbial Limit
Test
 Hair Dyes : Heavy metals

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

Product No of product
categories requested (samples)
(Jan – April 2010)

WHITENING 550

ACNE 20

EYE AREA 85

HAIR 23

BODY CONTOUR 56
MAN & WOMEN
PRODUCT 110

OTHERS 46

TOTAL 927

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

• From Jan – April 2010
 a total of 144 results (COA) received
 14 products failed the laboratory testing
Lab Testing Total no failed
MLT 7
Heavy Metals 4
Hydroquinone 2

Tretinoin 1

• Products found to contain Hydroquinone and Tretinoin

 Notification were cancelled
 The failed products were instructed to be recalled from the local market and
eventually being disposed/exported back to the manufacturer.

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 Monitoring of Label & Advertisement

• Labels obtained from products taken through PMS

activities were be screened for compliance to ASEAN
Labeling Requirements and Cosmetic Advertising Code.
• Common non compliance issue on product’s labeling:
 Non-cosmetic claims
 Misleading & inappropriate claims
 Unclear instruction of use
 Inappropriate graphics

• Mutual collaboration with Pharmacy Enforcement

Division in monitoring and investigating the
advertisements on cosmetic products – misleading /
beyond the cosmetic scope

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

• From January – April 2010:

 A total of 127 labels were screened:

 60 products labels required further clarifications and
amendments
 3 products found as non-cosmetic products

 14 cosmetics complaints received due non-compliance to

the Cosmetic Advertising Code:
 8 products found to be advertised with excessive
/unallowable/misleading claims.
 5 products were advertised as sex stimulants.
 1 products was advertised as eye treatment medication
– to be instilled into the eyes.

14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA

 Enforcement Activities
• A mutual collaboration between NPCB and Pharmacy
Enforcement Division has been established to actively
monitor the cosmetic products in the local market.

• Attention has been drawn for the issues:

 Advertisement of cosmetic products – especially for
the products for sex stimulants, instilled into the eyes,
and products used as injection.
 Parallel importers particularly on unauthorized
importations
 Monitoring the status of the products being imported
into the country.
14th ASEAN COSMETIC COMMITTEE MEETING, JAKARTA