1. Indonesian Cosmetic Regulation and Market Perspectives
Mayagustina Andarini
Deputy Director Cosmetic Product Safety Evaluation
The National Agency for rug and Food Control, the Republic of Indonesia
Korea, October 2 nd ,2014 1

2. Becoming an innovative, credible and internationally recognized drug and food regulatory authority for public protection.
To conduct pre-market evaluation and post-market control based on international standard.
To implement quality management system consistently.
To optimize partnership with stakeholders in various lines.
To empower public in protecting themselves from the risk and harmful drug and food to health.
To build the learning organization.

3. GLOBALIZATION

4. COMPETITION ↑↑ DEMAND ↑↑
GLOBALIZATION
Time
Transportation
Economic and Industrial Community
Increased of Free Trade
Elimination of Tariff
COMPETITION ↑↑ DEMAND ↑↑
FREE TRADE
LOW OF PRODUCTION COST
HIGH PRODUCT QUALITY

5. IMPACT OF GLOBALIZATION FOR REGIONAL (ASEAN)
ASEAN established the ASEAN Community through increased cooperation in the field of economic (ASEAN Economic Community), social culture (ASEAN Socio Culture Community), and security defense (ASEAN Security Community)
Making the ASEAN Charter, which became the basis of legal and institutional framework within the organization and the community of ASEAN

6. ASEAN Economic Community
Mission:
ASEAN Single Market and Production Base
Increased prosperity through economic development in ASEAN
Free trade, services, investment of skilled labor and the free flow of capital

7. Single market and production base
ASEAN Economic Community (AEC) Blueprint ASEAN Integration Strategic Framework (2009 – 2015)
Single market and production base
A.1 Free flow of goods
Provide technical assistance in the harmonization standards and technical regulations primarily in the 12 priority sectors of the AEC
A.2 Free flow of services
Competitive economic region
Equitable economic development
Integration into the global economy

8. 2008: ASEAN TEN NATIONS, ONE COMMUNITY AND ONE STANDARD

9. Why Harmonization is needed ?
World almost without limit (borderless)  towards global community  become regional challenges to strengthen its position in the global level
Improvement in quality, safety and effectiveness in accordance with the accepted of international standards and requirements
 make globally competitive ability
The business community needs certainty and transparency
Consumer has the right to easily access the desired product.

10. ASEAN Harmonization In Cosmetics
KTT Asean
In Singapore (1992)
ASEAN Free Trade Area
(AFTA)
Reduction of Technical Barrier
MRA
Common Effective
Preferential Tariff (CEPT)
11 priority integration sectors in ASEAN economic (including cosmetics)
ASEAN Consultative Committee for Standards Quality (ACCSQ)
ASEAN Harmonized In
Cosmetic Regulatory
ASEAN Agreement of
Economic Ministry
(AEM)
2 Sept’ 03
Cosmetic Product Working
Group (CPWG) (1998)
ASEAN Harmonized Cosmetic
Regulatory Scheme
(AHCRS)

11. Agreement on the AHCRS ASEAN Harmonized Cosmetic Con’t.
Regulatory Scheme (AHCRS)
2 September 2003
Con’t.
Signed by 10 ministerial-level
representatives of the ASEAN
member countries
ACD Implementation
Agreement on the
AHCRS
SCHEDULE A
ASEAN Mutual Recognition
Arrangement (MRA) 2003
SCHEDULE B
ASEAN Cosmetic
Directive (ACD) 2008
Implementation of
ASEAN Harmonization
In Cosmetics
Implementation of Mutual Recognition Arrangement (MRA) on
1st January 2003
Special deal is done by the member
states agreed to apply AHCRS
Through Notification System
PMS/PSE Implementation

12. ASEAN Harmonization of Cosmetic is for :
Enhance cooperation between ASEAN member countries in order to guarantee the quality, safety and claims benefit of the cosmetics marketed in the ASEAN.
Removing trade barriers through harmonization of technical requirements for cosmetics and impose a single standard.
Enhance the competitiveness of ASEAN products.

13. CHANGE OF PARADIGM BEFORE ASEAN HARMONIZATION AFTER
1. Registration System
1. Notification System
2. Pre Market Evaluation
2. Post Market Control
3. Post Marketing Vigillance
3. Product Safety Evaluation (PSE)

14. Product Information File
Cosmetic Control System
Post-Market
Control
Pre-Market
Control
Post-Market
Control
Product
database
NOTIFICATION
SYSTEM
Sampling
Product testing
Inspection
PMS/PSE
Product Information File
(PIF)
Cosmeto-
Vigilance
Product Notification
To NADFC
PIF Audit
Notification
Number
Quality
Safety
Efficacy

15. ACDTransposition of ACD into Indonesian National Regulation(
Decree of Minister of Health No. 1175/Menkes/Per/VIII/2010 concerning License of Cosmetic Production
Decree of Minister of Health No. 1176/Menkes/Per/VIII/2010 concerning Notification of Cosmetic
Decree of the Head of National Agency for Drug and Food Control No. HK year 2010 concerning Criteria and Procedure of Cosmetic Notification Submission.
Decree of the Head of National Agency for Drug and Food Control No. HK year 2010 concerning Guidelines of Product Information File
Decree of the Head of National Agency for Drug and Food Control No. HK year 2010 concerning Technical Requirements of Cosmetic.
Decree of the Head of National Agency for Drug and Food Control No. HK year 2011 concerning Technical Requirements of Cosmetic Ingredients.
etc

16. Implementation of ASEAN Cosmetic Directive
Pre-market evaluation (Registration) to Notification (1st January 2011), caused a greater responsibility to the manufacturers / importers on cosmetic safety, quality and claim benefit.
Cosmetics should be notified by the manufacturer / importer to the NADFC and guaranteed its quality and safety by:
Complying the regulation
Providing the Product Information File
Reporting serious adverse events
Cosmetic notification applicable for all cosmetics categories that will be circulated in Indonesia

17. Implementation of ACD (con’t)
Strengthening of Post-Market Surveillance (PMS) :
Inspection of production/distribution facilities
Inspection of Cosmetic GMP
Sampling and laboratory testing
Product Information File Audit and Product Safety Evaluation
Advertisement and Promotion Control
Consumer Empowerment and Awareness
by increasing the understanding on cosmetic in order to protect themselves from harmful cosmetic

18. Con’t Efforts to raise consumer awareness:
Information dissemination, through:
Leaflet, brochure, NADFC website.
Public Advertisement Services on Electronic Media
Talkshow
Direct consultation at exhibition
NADFC Consumer Complain Service Unit
Province Offices engagement (involving some government institutions)
NGO engagement

19. Cosmetic Notification
Implementation of
Cosmetic Notification

20. Technical Data for Import Cosmetic
Taxpayer Registration Number
Trading Business Permit
Importer Identification Number
Letter of Authorization
Certificate of Free Sales and Certificate of Good Manufacturing issued by Authorized Government and must be legalized by Indonesian Embassy in the country where the principle is

21. Number of Applicants

22. Cosmetics that meant to be marketed in Indonesia must be notified to NADFC and its Product Information File must be prepared

23. Notified Cosmetic Product

24. MARKET PERSPECTIVES
Numbers of Company: mei 2014 TOTAL
IMPORTERS
LOCAL Manufacturer
CONTRACT
824 (Sum of )

25. INDONESIA Population: 237.641.326
Wide : km2 (land), 93000km2 (sea)
Ratio Male and Female: ( : 986)
Cosmetics industry is one of the priority sectors in the enhancement industry today because it still requires the availability of specialty chemical raw materials (specialty chemicals).

26. Gross Domestic Product of Indonesia

27. Indonesia’s Cosmetics Market
Figures of Nationwide sales of cosmetics by Ministry of Industry :
* 2011 : 667 Million USD
* 2012 : 815 Million USD
Ministry of Industry stated sales of the cosmetics industry in Indonesia grew 15 percent in the year Export cosmetics this year expected to reach $ 406 million, increasing up to 20 percent.
Beauty trends in Indonesia :
* Basic skincare and make-up products
* Sales growth in men skincare product

28. Notified Cosmetic Based On their Product’s Category

29. Prospects for cosmetics industry are looking good in Indonesia

30. Beauty and Personal Care in Indonesia (Euromonitor 2013)
Significant price increase leads to accelerating value growth in 2013
Products targeting Muslim female consumers are on the rise
Multinationals continue to lead despite intensified competition from locals
Increasing role of health and beauty retailers
Healthy prospects for beauty and personal care

31. Change of Cosmetic Control Paradigm from registration to notification system
Provide a Strengthening in Post Market Surveillance and Consumer Awareness

32. 감사합니다
TERIMAKASIH