Implementation of the ACD in

MYANMAR 2019

Cosmetic Control Section

Department of Food and Drug Administration
Nay Pyi Taw, Myanmar
 Profile of Myanmar

• Republic of the Union of

Myanmar
• Population - 53,582,855 
• Capital - Nay Pyi Taw
• Urban population - 33%
(percentage of total)
• Population Density - 82 ppl/km2
of land area
Presentation Outline

 Background (Regulation of Cosmetic)

 Cosmetic Notification
 Cosmetic Manufacturing
 Post Market Surveillance
 Public awareness raising
 Intra-inter agency cooperation
 The Way forward
Regulation of Cosmetics in Myanmar (Background)

 New cosmetic regulation order under the Public Health

Law (1972) aligned with ACD has been promulgated on 15
October 2010 by the Ministry of Health

 Food and Drug Administration has fully implemented the

cosmetic notification system since 1st January 2011
 Regulation of Cosmetics in Myanmar

 Company or person placing the cosmetics in the market must

submit the cosmetic notification at the Department of Food &
Drug Administration
 Standard Guidelines by “ASEAN Harmonized Cosmetics
Regulatory Scheme”
 The company or person placing the cosmetic product in the
local market must be responsible for ensuring safety, quality and
claimed benefit and to ensure that the product compliances with
all existing regulations
Regulation of Cosmetics in Myanmar

 The person who desires to manufacture the cosmetic

products shall apply for Certificate of Cosmetic
Manufacturer at the Department of Food & Drug
Administration
 Cosmetic Manufacturers need to ensure: products are
manufactured in facilities that comply with the ASEAN
Guidelines on Good Manufacturing Practices (GMP)
Regulation of Cosmetics

1. Premarket Control

2. Post Market Control

3. Community Awareness
1. Premarket Control of Cosmetics

Imported 1. Notification Certificate

Cosmetics 2. Renewal of Notification

Premarket
Control
1. Manufacturing Certificate
Local 2. Notification Certificate
Manufacturing
of Cosmetics 3. Renewal of Manufacturing
Certificate
Cosmetic Notification in Myanmar

 Notification of products through hard copies with ASEAN

notification template (planning to upgrade the manual system
to electronic online system)
 As of October 2019, a total of 24724 cosmetics notified with
Department of FDA
 Notification process takes about 6-8 weeks
 Notification validity period – 2 years
 Lists of Notified Cosmetic are published at Food and Drug
Administration Website (www.fdamyanmar.gov.mm)
Notification and Renewal of Cosmetics
(2015 to 2019 October)

8000

7000

6000

5000

4000

3000

2000

1000

0
2015 2016 2017 2018 2019
(Jan -Oct)
Notification Process Flow Chart

Document Submission
Notification &
Assessment Fees
Review the ingredients & Payment
label to comply with ACD

Approval/ Reject

Data installation for Notification

Process

Issue for Notification Certificate

Labeling Requirements

 Brand & product name  Manufacture Name &

 Product description Address

 Direction  Distributor Name &

of Use
 Ingredient
Address (parallel)
List
 Warning / Caution
 Net Weight
 Country of Origin
Manufacturing of Cosmetics
 To develop internal quality management system and procedures
 To constantly manufacture and control to specific quality
concerned with all aspects of productions and quality control
 Assessment by GMP Audit
 Pre-audit to ensure whether the new cosmetic manufacturer is
equipped with the appropriate facilities according to the guideline
to manufacture cosmetics
 Routine audit on cosmetic manufacturers to ensure whether the
manufacturer comply with GMP Guideline to standardise
cosmetic manufacturing with other AMS
 Manufacturing validity period – 3 years
Manufacturing Process Flow Chart
Document Submission
Laboratory Fees,
Inspection Fees, Product
Assessment Fees Payment
Documentary Review Sample receive and
to comply with ACD Laboratory Analysis

Inspection Audit

Approval/ Reject

Data installation for Manufacturing Process

Issue the Manufacturing Certificate

 Cosmetic Manufacturing in Myanmar

New Renewal Extension Export

Factory Products Factory Products Factory Products Factory Products

2017 2 - 3 - 13 - - -

2018 10 28 15 150 7 44 - -

2019 3 8 3 44 34 144 1 2
(Jan to
Oct)
2. Post Market Surveillance (PMS)

 (3179)samples are collected & test done from 2014 to till now
(2019 October)
 (151) samples were contained prohibited substances
 They were announced in media and recall action taken by
relative State/Region Food & Drug Supervisory Committee
 Published at the FDA website & FDA Facebook Page
PMS Activities

• taken by participation of State and

Region level to cover the whole
population
• Screening of cosmetics in local
markets
• Screening of information for notified Nay Pyi
Taw
cosmetics
• Monitoring of label for indented
cosmetics
• Handling of product complaints
• Product sampling and laboratory
testing
• Monitoring of cosmetic advertisement
• Evaluation of the documents for claim
substantiation
Cosmetics products taken by PMS

 Anti-acne products
 Anti-melasma products
 UV Protection products
 Skin Whitening products
 Lipstick (Orange color, violet color etc.)
 Overclaimed Cosmetics
 Report from Cosmetic Adverse Reaction
 Complaint to FDA Webpage
 Current Post Market Survey
Year Samples Taken Samples Containing
Prohibited Substances

2014 301
13
2015 225
2016 279 24
2017 518 42
2018 641 34
2019 1061 38
(Jan to Oct)
Total 3025 151
Post Market Surveillance Activity and Findings
of Prohibited Substances
Samples contining pprohibited substances
No of samples tested

2019_x000d_(Jan to Oct) 38
1061

2018 34 641

2017 42
518

2016 24 279

2015 13 225

2014 0 301
Post Market Surveillance Activity
Laboratory Analysis of cosmetics from the
market
Prohibited Substances Commonly Found in
Myanmar

1. Ammoniated Mercury

2. Hydroquinone

3. Steroids

4. Lead

5. Rhodamine-B

6. Retinoic Acid / Tretinoin

3. Public Awareness Raising Activities
 Providing knowledge and health education to public through
FDA States & Regions divisions – 53 times in 2018 & 2019
 Create public awareness on cosmetics to check the sufficient
information of labels
 Promoting exchange knowledge & experiences among ASEAN
countries regarding the ASEAN harmonized cosmetics
regulatory scheme
 Exchange knowledge & information with the related
ministries, non-government organization, other national and
international organization
Public Awareness Raising Activities
 Intra-inter agency cooperation (1)
Emphasis on inter-ministerial cooperation to safeguard public health

1. Ministry of Commerce – Department of Consumer Affairs

2. Ministry of Planning and Finance – Department of Customs

3. Ministry of Home Affairs – Myanmar Police Force

4. City Development Committees

- involve as committee members of FDA Network to regulate
the cosmetics and strengthen the enforcement
- mutual collaboration established between these Ministries at the
entry point helps to monitor the status of imported products
Intra-inter agency cooperation (2)

Collaboration with Department of Public Health, Ministry of

Health and Sports
- to monitor the status of imported products at the entry points
- to monitor and remove known unsafe & suspicious cosmetic
products from local market
- to assist regulator to monitor the compliance with ASEAN
GMP requirements & capabilities of industries
Implementation Research Programs

1. Study on Consumption Behavior and Awareness of

Cosmetic Usage on Women from four selected townships in
Nay Pyi Taw Territory
(2017 – 2018)

2. Assessing the Challenges of Safety Standards in

Manufacturing of Cosmetics and Personal Care Products in
Myanmar
(2019 Jan – today)
Drafting the Cosmetic Law

 already approved from General Attorney Office

 Awaiting finalized approval from Parliament

Data to Policy workshop

 Toxic Beauty Interventions to increase cosmetic safety in

Myanmar (October, 2018)
The Way Forward
Plan for upgrading online notification system from manual
system
Auditing Product Information File (PIF) of imported
cosmetics
 On going process of drafting the cosmetic law
 Competence Human Resource
Systematic Reviews of documents & Post-market Alert
System
 Promoting Community Awareness Raising
Thanks for your attention!