ASEAN Cosmetic Directve
ASEAN Cosmetic Directve
ON
ASEAN HARMONIZED COSMETIC REGULATORY SCHEME
TABLE OF CONTENTS
A. GENERAL
1. What is the ASEAN Harmonized Cosmetic Regulatory Scheme? Who are
affected by this Scheme and when is it effective?
2. Why is ASEAN moving to this scheme? What are the benefits we can derive from
this?
3. How can I make ASEAN Harmonized Cosmetic Regulatory Scheme work for
me? Who can I contact if I have questions? Where can I get help?
4. Where can I get more information about the ASEAN Harmonized Cosmetic
Regulatory Scheme?
SCHEDULE A : Mutual Recognition of Product Registration Approval
5. When do I need to comply with the ASEAN Cosmetic Product Registration
Requirements? What will happen with the local registration requirements/timing?
6. If my country implements Schedule A, what do I need to comply with? What do I
need to do to ensure that I can comply with the requirements?
7. Does change of any packaging materials of an existing product in the market
require new product registration?
8. Does change of brand name of an existing product in the market require new
product registration?
9. How does the ASEAN Cosmetic Product Registration Requirements impact the
current Product Notification or registration system existing in some countries?
SCHEDULE B - ASEAN Cosmetic Directive
10. What is Schedule B - the ASEAN Cosmetic Directive?
11. What are the benefits we can derive from the implementation of the Directive?
12. How will the Directive affect my company? How do I prepare for the
implementation of the Directive?
13. What are my responsibilities under the ASEAN Cosmetic Directive after it has
been implemented?
14. What is Post Marketing Surveillance (PMS)?
15. When the Directive is implemented, will the industry still need to label registration
numbers on the product?
16. What if I change formulation or packaging or claims of an existing product in the
market? What do I need to do under the Directive?
17. What is the role of the cosmetic regulatory authority under the Directive?
B. ILLUSTRATIVE LIST
18. What is the Illustrative List? Is this a restricted list?
19. Is the Illustrative List my basis for determining whether my product is cosmetic or
not?
C. COSMETIC INGREDIENT LISTS
20. What are the ASEAN Cosmetic Ingredient Listings? How do I use them? What is
a restricted List? What is a Negative List? What is a Positive List?
21. What is the ASEAN Handbook of Cosmetic Ingredients?
22. What do I need to follow if my country has existing local Cosmetic ingredient
listings?
23. What if my ingredient is not found in any of the ASEAN Ingredient Listings?
24. What if my ingredient exceeds the allowable maximum level in the ASEAN
Ingredient Listings and I have extensive safety data to support my ingredient
level?
25. What is the ASEAN Cosmetic Scientific Body (ACSB)? How does it work?
26. Who do I contact if I have queries/concerns on Ingredient Listings?
D. GMP
27. What is the ASEAN Cosmetic GMP?
28. What will happen if I am a small company and I cant comply with GMP?
29. How can I comply with the ASEAN Cosmetic GMP? What Should I do?
E. LABELING
30. What are the ASEAN Cosmetic Labeling Requirements? What do I need to
comply with the requirements and when?
1. Appendix A
2. Appendix 1
3. Appendix 2
I. Background
ASEAN is a very important player in the global trade, regardless of product category,
with a market of >500 million people as compared to EUs only >300 million. ASEAN
with its 10 member countries namely; Brunei Darussalam, Cambodia, Indonesia,
Malaysia, Myanmar, Lao PDR, Philippines, Singapore, Thailand and Vietnam, has
always been focused on its economic and social growth. The region has a very strong
economic alliance with ASEAN secretariat in Jakarta, Indonesia that has been working
to meet its key goals of economic integration in the region. The vision of regional
economic integration was conceptualized in recognition of the importance and potential
of trade liberalization and facilitation and in desiring to increase regional
competitiveness.
However, market integration is not just about cutting or removing tariffs on trade.
ASEAN countries have to make sure that non-tariff barriers including technical barriers
created by standards, technical regulations and conformity assessment are removed.
ASEAN has recognized the need to conclude Mutual Recognition Arrangements and
harmonize standards and technical regulations in order to facilitate the movement of
goods within the region.
In December 1998, ASEAN decided to meet this problem head-on by signing the
Framework Agreement on Mutual Recognition Arrangements and the ASEAN Cosmetic
Association was the driving force for this. In July 1997, the ASEAN Cosmetic Association
officially asked the ASEAN Secretariat and the ASEAN Consultative Committee on
Standards and Quality for help in removing barriers to cosmetics, specifically by
harmonizing technical regulations governing the cosmetic industry in ASEAN. Since then
ASEAN cosmetic regulators and the cosmetic industry in the ASEAN region have been
working together to address the issues associated with barriers.
As a result of this collaboration, the Agreement on the ASEAN Harmonized
Cosmetic Regulatory Scheme (AHCRS) was signed on 2 September 2003. The AHCRS
lays down the requirements for cosmetic products for all signatory ASEAN Member
Countries starting from 1 January 2008. A product produced or marketed in any
signatory country and meeting the requirements of AHCRS would be able to enter other
signatory countries. The most significant aspect of this harmonized scheme is that all
ASEAN Member Countries will move from the traditional and preferred approach of premarket approval to the new approach of post-market surveillance for cosmetic
products, considered being more effective.
The harmonization of cosmetic regulations in the region will benefit all
stakeholders: the consumers (a wider choice of safe cosmetic products), the regulatory
bodies (one simplified regulatory system) and the cosmetic industry (open ASEAN as
one single market for manufacturers, with more than 500M consumers).
A. Coverage
SCHEDULE A: MUTUAL RECOGNITION ARRANGEMENT OF PRODUCT
REGISTRATION APPROVAL. The product registration approval in an Asean country is
recognized in Member Countries, where a mutual recognition arrangement has been
agreed upon. Schedule A is a preparatory stage for Member Countries to proceed to
Schedule B but a Member Country can opt to proceed directly to Schedule B.
SCHEDULE B: THE ASEAN COSMETIC DIRECTIVE: Product Notification The
manufacturer or the person responsible for placing cosmetic products on the ASEAN
market, shall notify the cosmetic regulatory authority of each Member State where the
product will be marketed of the place of manufacture or of the initial importation of the
cosmetic product before it is placed on the ASEAN market. In most ASEAN countries,
this is a transition from a pre-market approval (registration) system to post -market
surveillance. All ASEAN countries are committed to implement Schedule B The
ASEAN Cosmetic Directive by January 2008.
B. Technical Documents
The following are the highlights of the ASEAN Harmonized Cosmetic Regulatory
Scheme Common Technical Documents. These have been the result of close
collaboration between the ASEAN governments and the cosmetic industry with the
objective to harmonize cosmetic technical requirements among ASEAN Member
Countries for the marketing of safe and quality cosmetic products.
i. Illustrative List by Categories of Cosmetics
The current EUs illustrative list has been adopted with emphasis that this list is not
exhaustive. Products satisfying the definition of cosmetic in the ASEAN Directive
(similar to the EU definition) shall be allowed as a cosmetic.
ii. Cosmetic Ingredient Lists
The ASEAN Cosmetic Directive has the following Annexes:
Annex II: List of Substances which must not form part of the composition of cosmetic
products
Annex III: List of Substances which cosmetic products must not contain except
subject to restriction and conditions laid down
Annex IV: List of Colouring Agents allowed for use in cosmetic products
Annex V: List of Excluded from the scope of the Directive
Annex VI: List of Preservatives which cosmetic products may contain
Annex VII: List of UV filters which cosmetic products may contain
Additionally the Directive contains an ASEAN Handbook of Ingredients which lists
the differences between current regulations and the Cosmetic Directive. The ASEAN
Cosmetic Scientific Body (ACSB) is tasked with making a decision as to the status of
the ingredients contained in the Handbook no later than January 2011.
4. Where can I get more information about the ASEAN Harmonized Cosmetic
Regulatory Scheme?
1. Information about the Asean Harmonized Cosmetic Regulatory Scheme can be
obtained from the following websites:
a.
b.
c.
d.
2.
Information could also be obtained from the contact person in each Member
Countries and local cosmetics associations. (Appendix 2)
13. What are my responsibilities under the ASEAN Cosmetic Directive after it has
been implemented?
A. You and your company will be fully responsible for the safety and quality of cosmetic
products placed in the market. The following is a guide of what you will need to do when
you intend to market a cosmetic product in ASEAN:
i.
Be conversant with the all requirements of the Directive and the Annexes of
ingredient listings (i.e banned, restricted and permitted substances). Seek the help of the
local regulatory authority and industry association.
ii.
Take steps to ensure full compliance with the Directive s requirements and
technical documents, particularly the requirement on the safety and quality of the
cosmetic product.
iii.
File Notification with the cosmetic regulatory authority in the country where you
intend to market the product. Pay the necessary notification fee as required.
iv.
Ensure that the technical and safety information required in Article 8 of the
Directive (Product Information File) is ready anytime for inspection by the cosmetic
regulatory authority.
v.
Monitor products in the market for product quality or adverse cosmetic event.
Report any serious adverse cosmetic event to the regulatory authority.
14. What is Post Marketing Surveillance (PMS)?
A. The Regulatory Authorities will conduct an on-going post-market surveillance
programme on cosmetic products to ensure that they comply with the Directive s
requirements. This may involve any or all of the following activities:
15. When the Directive is implemented, will the industry still need to label
registration numbers on the product?
A. No. Product labels will no longer be required to reflect registration numbers.
16. What if I change formulation or packaging or claims of an existing product in
the market? What do I need to do under the Directive?
A. Check if your formula changes comply with the ASEAN Cosmetic Ingredient Listings,
the ASEAN Cosmetic Labeling Requirements, the ASEAN Cosmetic Claims Guidelines.
You will also need to check if the change would require a new notification or amendment
and file for the change accordingly.
17. What is the role of the cosmetic regulatory authority under the Directive?
A. The cosmetic regulatory authority has the authority to enforce post-marketing
surveillance to ensure compliance with the ASEAN Cosmetic Directive. They can visit
the company anytime, with or without prior notice, to audit the Product Information File
as well as take samples for analytical testings. In the event of non-compliance with
requirements of the ASEAN Cosmetic Directive, the regulatory authority can impose
sanctions for the violation as defined in the local laws and issue a product recall if
deemed necessary to protect public health.
B. ILLUSTRATIVE LIST
18. What is the Illustrative List? Is this a restricted list?
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22. What do I need to follow if my country has existing local Cosmetic ingredient
listings?
A. When the country starts implementing the ASEAN Cosmetic Ingredient Listings, these
will supersede the local ingredient listings. The ASEAN Handbook of Cosmetic
Ingredients will be superseded by the recommendations of the ACSB adopted by the
ASEAN Cosmetics Committee.
23. What if my ingredient is not found in any of the ASEAN Ingredient Listings?
A. If the ingredient is not in the Banned List or Restricted List, the ingredient is allowed
for use without any restrictions or special conditions. However, if the ingredient is
functioning as a colorant or preservative or UV filter and is not in the ASEAN List of
allowed Colorants, Preservatives or UV filters, the ingredient will not be allowed for use.
24. What if my ingredient exceeds the allowable maximum level in the ASEAN
Ingredient Listings and I have extensive safety data to support my ingredient
level?
A. The ingredient is not allowed beyond the maximum limit. The safety data can be
presented to the ACSB through the ACC for modification of the limit. Until a positive
recommendation is made by the ACSB and adopted by the ACC, the limit is to be
complied with.
25. What is the ASEAN Cosmetic Scientific Body (ACSB)? How does it work?
A. The ACSB has been established to assist ACC in reviewing the safety and technical
data of ingredients and making recommendations on other technical and safety issues
for adoption by the ACC. The ACSB consists of representatives from the regulatory
authorities, the industry and the academe. At present, the ACSB is reviewing the ASEAN
Handbook of Cosmetic Ingredients as well as additions to the annexes of the Directive.
26. Who do I contact if I have queries/concerns on Ingredient Listings?
A. You can contact your local cosmetic regulatory authorities or industry associations.
You can also access the following websites: (ASEAN website: www.ecasean.com, ACA
Website: www.ASEANcosmetics.org (Please refer to Appendix 2)
D. GMP
27. What is the ASEAN Cosmetic GMP?
A. The ASEAN Cosmetic GMP is a set of guidelines published in accordance with the
ASEAN Cosmetic Directive to facilitate the development of a quality management
system by manufacturers producing cosmetic products that are intended for the ASEAN
market.
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28. What will happen if I am a small company and I cant comply with GMP?
A. The Directive does not make any distinction between small, medium or big
companies. All cosmetic products put on the ASEAN market must be manufactured
according to the ASEAN GMP Guidelines.
29. How can I comply with the ASEAN Cosmetic GMP? What Should I do ?
A. With the joint effort of the regulatory authority and the industry,13 training modules on
the ASEAN cosmetic GMP have been developed to provide a consistent interpretation
and implementation of the GMP Guidelines in ASEAN.
It contains minimum
requirements to ensure safe and quality products. You may obtain this information from
your local regulatory authority and the following websites ,www.aseansec.org/4951.htm ,
www.ecasean.com and www.aca.org. You may also contact your local cosmetic
association for information on the training of the 13 modules. (Please refer to Appendix
2)
E. LABELING
30. What are the ASEAN Cosmetic Labeling Requirements? What do I need to do
to comply with the requirements and when?
A. The ASEAN Cosmetic Labeling Requirements define the information that has to
appear on the label. Please see the ASEAN Cosmetic Labeling Requirements Technical
Document for detailed requirements.
All cosmetic products marketed in the ASEAN must comply with the ASEAN Cosmetic
Labeling Requirements by January 2008, when the ASEAN Cosmetic Directive is
implemented. The industry should therefore start revising the labels in accordance to the
ASEAN requirements and work on the transition so existing inventory can be exhausted
and all labels on marketed products can be compliant by year 2008.
If an ASEAN member country chooses to implement the ASEAN Cosmetic Labeling
Requirements before January 2008, the cosmetic product marketed in this country
should comply with the requirements by the date stipulated by the regulatory authority.
31. Does ASEAN Cosmetic Labeling Requirements require ingredients to be
reflected on the packaging?
A. Yes. Full Ingredient Listing using International Nomenclature of Cosmetic Ingredients
(INCI) names needs to be reflected in packaging/label of cosmetic products under the
ASEAN Cosmetic Product Labeling Requirements. However, botanicals and extracts of
botanicals should be identified by genus and species as specified by the INCI lists. The
genus may be abbreviated.
32. Is Expiry Date a mandatory labeling requirement under the ASEAN Cosmetic
Labeling Requirements?
A. The cosmetic product can reflect either the Expiry Date or the Manufacturing Date on
the label under the ASEAN Cosmetic Labeling Requirements.
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33. Is there a standard format to be followed for the labeling of the Expiry Date or
the Manufacturing Date?
A. No, the common technical document does not dictate any standard format for Exp
Date or Mfg Date. Any format can be used (eg month/year), provided it is presented
clearly and legibly, without causing any confusion among consumers
34. Do we need to reflect the Manufacturers name and address on the label?
A. The ASEAN Cosmetic Labeling Requirement requires the name and address of the
company or person responsible for placing the product in the local market on the label.
Therefore, if the manufacturer is the one responsible for placing the product on the local
market, then its name and address should be reflected on the label. However, the
country of manufacture should be reflected at all times.
35. I have existing inventory of old labels/packaging? What will I do with this
inventory?
A. You would need to work with your regulatory authorities/cosmetic industry on the
transition to the ASEAN compliant labels. It is ideal that exhaustion of old labels be
worked out to avoid scrapping. Meanwhile, you would need to plan how to ensure that
your product labels comply with the ASEAN Cosmetic Labeling requirements by January
2008.
F. CLAIMS
36. How do I determine if my claim is acceptable as cosmetic?
A. If the claim is promising cosmetic benefit and not medicinal or therapeutic benefit, it is
acceptable as long as it can be substantiated. Any cosmetic claimed benefits made shall
be aligned with what is accepted internationally and shall be justified either by technical
data and/or cosmetic formulation or preparation itself. Refer to the ASEAN Cosmetic
Claims for Guidelines for further information.
37. Is there a harmonized list of allowed/not allowed claims in ASEAN?
A. No. ASEAN does not have a harmonized list of claims. Claims/claims assessment will
be subjected to national control.
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Thus, agreed definitions and terminology, as well as procedures, will not only ensure
uniform standards in the adverse event reporting process but will also facilitate product
safety information sharing among ASEAN Regulatory Authorities.
There are two issues within the broad subject of safety data management that are
appropriate for harmonization at this time:
This Guide shall be revised as necessary, to take into account technical progress and
regulatory developments.
39. Definitions and terminologies
a. Adverse Event:
Any genuine harmful or unintended event reasonably attributable to the normal or
foreseeable use of a given cosmetic product.
b. Serious Adverse Event:
A serious event is any untoward medical occurrence that:
Results in death,
Is life threatening (the term life threatening refers to an event in which the
person was at risk of death at the time of the event;
Requires in-patient hospitalization, or
Results in persistent or significant disability/incapacity
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H. APPENDICES
Appendix A
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APPENDIX 1
To:
FOR OFFICIAL
USE ONLY
Date received:
Product Notification No
I. Company Particulars
Name and address of
Company
Name & designation of
person reporting
Tel No.:
Fax No.:
Email:
Yes
No
Yes
No
Outcome
Source of report
Recovered (Date:_______ )
Not yet recovered
Healthcare professional
Consumer
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Others (specify)
APPENDIX 2
CONTACTS: LIST OF ACC MEMBERS , ASEAN Secretariat, CEN Team
Dr.Chhieng Phana
Bureau of Drugs and Cosmetic Registration,
Dept. of Drugs & Food,
#8 St. Ung Pokun (109), Sangkat Mittapheap,
Khan 7 Makara, Phnom Penh,
Cambodia
Tel: 855-23880247 Fax:855-23880247
E-mail: [email protected],
Mr.Vongtavanh Chiemsisourath
Food and Drug Department,
MoH,Vientiane,
Lao P D R
Tel: & Fax 856 21 214014
Email: [email protected]
Ms Anis Talib
Cosmetic Unit
Malaysia
Tel: 603-79573611
Fax:603-79556772
E-mail: [email protected],
Mrs.Marie Tham
Cosmetics Control Unit, Health Sciences Authority
Centre for Drug Administration
11 Biopolois Way #11-03 Helios,
Singapore 138667
Tel: 65 6866 3450; Fax:65 6478 9039
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Email: [email protected],
Mr.Phongpraphan Susonthitaphong
Director of Cosmetic Control Division
Food and Drug Administration
Ministry of Public Health
Thailand
Tel: 66-2-590-7273-4 Fax: 66-2-591-8468
Email:
Ms Le Chau Giang
The ASEAN Secretariat A Jl.
Sisingamangaraja, Jakarta 12110
Indonesia
Tel: (62 21) 724 3372; Fax: (6221) 7262991
Email: [email protected]
Mr.Alain Decharnat
CEN
The ASEAN Secretariat A Jl.
Sisingamangaraja, Jakarta 12110
Indonesia
Tel: 62 0 817 9848599/ Fax: 62 21 7398234
Email: [email protected]
THAILAND
INDONESIA
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MALAYSIA
PHILIPPINES
SINGAPORE
THAILAND
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