THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
INTRODUCTION
1.
The Second Meeting of the ASEAN Consultative Committee for Standards and Quality
(ACCSQ) ASEAN Cosmetic Committee (ACC) was held on 7 – 8 June 2004 in Bangkok,
Thailand.
2.
The Meeting was chaired by Mrs. Werawan Tangkeo, Executive Director, Bureau of
Cosmetic and Hazardous Substances Control, Food and Drug Administration, Ministry of
Public Health, Thailand, and co-chaired by Drs. Ruslan Aspan, MM, Deputy, Traditional
Medicine, Cosmetic and Complementary Product Control, National Agency of Drug and Food
Control, Republic of Indonesia.
3.
The Meeting was attended by Mr. Chong Chee Kiong, Scientific Officer, Ministry of
Health, Brunei Darussalam; Dr. Chhieng Phana, Director, Bureau of Drug and Cosmetic,
Ministry of Health, Cambodia; Dr. M. Hayatie Amal, Director, Traditional Medicine,
Cosmetics and Complementary Product Inspection and Certification, National Agency For
Drug and Food Control, Indonesia; Dr. Vilayvang Phimmasone, Director General, Food and
Drug Department, Ministry of Health Food & Drug Department, Lao PDR; Ms. Anis Talib,
Head, Cosmetic Unit, National Pharmaceutical Control Bureau, Ministry of Health, Malaysia;
Prof. Leticia Barbara Gutierrez, Director, Bureau of Food and Drugs, Department of Health,
Philippines; Mrs. Marie Tham, Deputy Director, Centre for Drug Administration, Health
Sciences Authority, Singapore; Mr. Phongpraphan Susonthitaphong, Head of Pre-Marketing of
Cosmetic Control Division, Food and Drug Administration, Ministry of Public Health,
Thailand; Mr. Tonny Pranatadjaja, President, ASEAN Cosmetic Association, and their
respective delegations. Staff Member of the ASEAN Secretariat was also in attendance. The
List of Delegates and Observers appears as ANNEX 1.
Agenda Item 1:
Introduction of the Meeting by the Chair of the ACC
Introduction of the Co-Chair, Country
Delegates/Representatives, the ASEAN Secretariat and
Other Participants
4.
The Chair welcomed the Co-Chair, Member Countries delegates, ASEAN Secretariat,
ACA delegates, invited guests from CEN and observers present at the Second Meeting of the
ASEAN Consultative Committee for Standards and Quality (ACCSQ) ASEAN Cosmetic
Committee (ACC).
5.
The Meeting also noted with satisfaction the presence of representatives of the
industries as part of the delegation of some countries.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
Agenda Item 2:
6.
The Meeting adopted the agenda as amended, which appears as ANNEX 2.
Agenda Item 3:
7.
Adoption of the Agenda
Business Arrangement
The Meeting was held in plenary.
Agenda Item 4:
Highlights of the First ACC Meeting
8.
The Chair presented to the Meeting the main outcomes of the First ACC Meeting held
in Melia Hanoi Hotel, Hanoi, Vietnam on 18 - 19 December 2003.
9.
The Meeting noted, among others, the following:
(i) The role of ACC is to oversee the implementation of the Agreement on ASEAN
Harmonized Cosmetic Regulatory Scheme (AHCRS), and will operate under the
TERMS OF REFERENCE of the ASEAN Cosmetic Committee adopted during the
1st ACC Meeting in Hanoi, Vietnam.
(ii) Member Countries had indicated their participation in the MRA and Directive as
follows:
- Schedule A (MRA) – Lao PDR, Malaysia and the Philippines
- Schedule B (Directive) – Brunei Darussalam, Cambodia, Indonesia,
Singapore, Thailand and Vietnam
(iii) The Meeting adopted the following:
- Guidelines for the implementation of the ASEAN Harmonized Cosmetic
Regulatory Scheme.
- Requirements for Notification under Schedule B, the ASEAN Cosmetic
Directive.
- ASEAN Cosmetic GMP – Program proposed by Malaysia
- Establishment of ASEAN Cosmetic Scientific Body
10.
The highlights of the Chair with the report of the 1st ACC Meeting appear together as
ANNEX 3.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
Agenda Item 5:
Report outcomes of the 23rd ACCSQ Meeting
11.
The ASEAN Secretariat briefed the Meeting on the outcomes of the 23rd ACCSQ
Meeting held on 8-9 March 2004 in Bali, Indonesia. The ASEAN Secretariat’s information
paper and the report of the 23rd ACCSQ Meeting appear together as ANNEX 4.
12.
The Meeting noted, among others, the following:
(i)
(ii)
ACCSQ noted the progress made in the area of cosmetics and endorsed the
Reports of the 8th CPWG and the 1st ASEAN Cosmetic Committee (ACC)
together with the Work Programme.
ACCSQ discussed measures to facilitate the integration of 11 priority sectors
and the realization of the ASEAN Economic Community as Single Market and
Production Base by 2020 and the following decisions were made:
ASEAN policy on Standards and Conformance
-
To develop ASEAN policy on standards and conformance based on the WTO TBT
Agreement. The APEC Guideline on Transparency of Standards, APEC Guideline
for Good Regulatory Practice and others could be used as references. Such policy
would commit member countries to ensure their standards and technical regulations
do not hinder intra ASEAN Trade or discriminate against products of other ASEAN
member countries
-
To facilitate member countries to participate more actively in the existing sectoral
MRAs, ACCSQ encouraged member countries who are not yet signatory of the
MRA/ MLA of the International Laboratory Accreditation Cooperation (ILAC),
Asia- Pacific Laboratory Accreditation Cooperation (APLAC), International
Accreditation Forum (IAF), Pacific Accreditation Cooperation (PAC) or who do not
intend to develop their own accreditation in line with MRA/ MLA of the ILAC,
APLAC, IAF, PAC to appoint another ASEAN member countries who are already a
signatory to such MRA/ MLA to undertake accreditation of their national CABs.
-
To encourage active participation of private sector and regulators in the ACCSQ
activities.
Roadmaps for the integration of 11 priority sectors
-
To facilitate the integration of the 11 priority sectors, ACCSQ will develop the
concrete roadmap and action plan in the area of standards and conformance for each
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
sector. The following member countries were assigned to take lead in conducting
the assessment and coming up with the draft roadmaps:
o
o
o
o
o
o
Wood-based product and automotives- led by Indonesia
Healthcare and e-ASEAN Sectors- led by Singapore
Rubber-based products, textiles and apparels- led by Malaysia
Agro-based products and fisheries- led by the ASEAN Secretariat
Electronics- led by Philippines
Air travel and tourism led by Thailand
-
All the roadmap will be finalized to submit for consideration by SEOM end of
August 2004.
13.
The Meeting was informed of the draft roadmap for the integration of healthcare sector,
which covers cosmetic sector. The Meeting considered the recommendation on acceleration of
the implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme by 31 December
2005 and the following concerns were raised:
(i)
(ii)
14.
Since Member Countries are required to transpose the ASEAN Cosmetic
Directive into their national legislation, it would take time for Member
Countries to do so.
Early implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme
would affect a number of small and medium enterprises in ASEAN as they
would need time to put in place the system in compliance with the requirements
of the ASEAN Cosmetic Directive.
The Meeting, however, agreed to discuss this issue further under the Agenda Item 10.
Agenda Item 6:
Report/Discussion on the EC-ASEAN Cosmetic SubProgram
15.
Mr Alain Decharnat, the Team Leader for the EC-ASEAN Regional Economic
Cooperation Program presented to the Meeting on the activities and time frame for the
implementation of the sub-program on Cosmetic. Mr Decharnat’s presentation appears as
ANNEX 5.
16.
The Meeting noted the following activities to be organised in 2004 – 2005:
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
Regional Activities
(i) ASEAN GMP
- To understand, implement and interpret uniformly, among Member States, the
guidelines on ASEAN Cosmetic GMP.
(ii) Post Marketing Surveillance and Product Safety Evaluation
- To provide assistance on Capacity Building for Laboratory Expertise (PMS/PSE
1) to establish testing methods and assess the chemical components of cosmetic
products for safety evaluation.
-
To provide assistance on Capacity Building for Safety and Efficacy Evaluation
(PMS/PSE 2) to perform testing methods to evaluate the safety of the products
to consumers
-
To provide assistance on Capacity Building for Management of Adverse Events
and non-conforming products (PMS/PSE 3) to set up procedures on sampling
methods, adverse cosmetic product reporting, management and dissemination of
this information through electronic networking
(iii) Institutionalising ASEAN Cosmetic Scientific Body
- To set up system, procedures and management of ASEAN Cosmetic Scientific
Body and to review the ingredients listing
National Activities
(i)
(ii)
(iii)
Accreditation for BFAD Philippines, BPOM Indonesia, TFDA Thailand
Laboratories
National Testing Laboratory for indigenous materials (Philippines, Indonesia,
Thailand)
National Assistance Centre (Philippines)
17.
The Meeting further noted the total budget of 1.3 million Euros has been allocated for
the above activities.
18.
To enable the smooth implementation of the project, the Meeting agreed to the
following course of actions by Member Countries.
(i)
To confirm with the Program Team Leader the Junior Expert and Subcommittee Members by 18 June 2004.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
(ii)
To nominate candidates to participate in the GMP - Action 2, training in EU in
September 2004 and GMP - Action 3, Awareness Workshop in Malaysia in
October 2004 through the ASEAN Officer, Ms Jessica Plana, by 20 August
2004 and 1 October 2004 respectively.
Agenda Item 7:
19.
Report/Discussion on the ASEAN Cosmetic GMP –
Action Plan/Work Program
Malaysia presented to the meeting the following SOPs which appear as ANNEX 6.
(i)
(ii)
Code of Conduct for Assessment Team
Conduct of Assessment
20.
The ACC discussed and agreed that Malaysia will work with the EU experts to revise
the SOPs. The SOPs will be used as guidelines for the Senior ASEAN experts and EU experts
to conduct GMP assessment for cosmetics according to the work schedule mentioned in
ANNEX 6.
21.
Regarding the time frame for GMP Assessment, Malaysia will finalize it in consultation
with the respective Member Countries.
22.
The Meeting discussed the proposal of Malaysia of the use of GMP checklist from
BFAD Philippines in the assessment and agreed that Senior Experts should review the
checklist. Once finalized, Senior Experts will share the checklist with Member Countries.
23.
ACA proposed to review the assessment results after the first round to ensure that the
interpretation of guideline suited the scope of ASEAN GMP and applicable to SMEs.
24.
In order to ensure the successful implementation of GMP, the Meeting agreed that more
funding should be sought. In this context, the Meeting was informed that Australia has
provided assistance for the Committee to develop a project proposal, which would
subsequently submit for consideration of funding, by Australia.
25.
The Meeting agreed that once Member Countries received the project proposal, they
should confirm with the ASEAN Secretariat within 15 days.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
Agenda Item 8:
Report/Discussion on the ASEAN Cosmetic Scientific
Body
26.
Thailand presented to the meeting the list of ACSB members nominated by Member
Countries (except Myanmar and Vietnam) and draft of the Term of Reference of the ACSB.
The list of ACSB members appears as ANNEX 7.
27.
The Meeting considered and endorsed the list of ACSB members. Indonesia, however
informed the Meeting that it would reconsider its nomination, and advise Thailand as soon as
possible.
28.
In considering the TOR of the ACSB, the Meeting discussed measure to ensure
that the conflicts of interest will not occur during the operation of ACSB and agreed that
ACSB members shall declare any conflict of interest in writing to the ACSB Chair. They may
be permitted to continue working on the specific case by consensus of the ACSB members.
29.
The Meeting agreed to adopt the revised TOR of ACSB and submit it for consideration
and endorsement by ACCSQ. The revised TOR of ACSB appears as ANNEX 8.
30.
To enable member countries to participate in the ACSB meeting, the Meeting agreed
that one ACSB meeting be organized per year prior to the ACC meeting. In case there is any
request from cosmetic industry in ASEAN to the ACSB to consider revising the ingredient list,
the ACSB can convene the meeting, and the funding for conducting the meeting should be
shouldered by that industry.
Agenda Item 9:
Report/Discussion on the ASEAN Post Marketing
Surveillance/Safety Evaluation – Action Plan/Work
Program
31.
Singapore presented to the meeting the draft Template for Notification for a Cosmetic
Product and revised guidelines on Post-Marketing Surveillance/ Product Safety Evaluation.
Singapore’s papers appear together as ANNEX 9.
32. The Meeting was of the view that close cooperation between regulators, industries and
consumer associations is necessary to ensure that the Post-Marketing Surveillance/Product
Safety Evaluation functions well in Member Countries,
33. The Meeting exchanged views on information sharing amongst ASEAN Member
Countries on products to be recalled or withdrawn from the market and agreed that such
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
information should be kept confidential by the regulators. Only the respective companies
which market the products should be kept informed and have access to the information.
34. The Meeting agreed that not only unsafe products, but also defective and nonconforming products should be notified.
35. In this regard, the Meeting assigned Singapore to reconsider the draft Template for
Notification for a Cosmetic Product concerning reporting of adverse event, and to draft the
Post-Marketing Surveillance Alert System to circulate for consideration by Member Countries
prior to the next ACC Meeting. The draft should cover definition of defective, unsafe and nonconforming products as well as measures to deal with the defective, unsafe and nonconforming products.
36. The Meeting considered and adopted the revised guideline for Post-Marketing
Surveillance/Product Safety evaluation, which appear as ANNEX 9. The Meeting further
agreed that Member Countries would provide Singapore with comments within one month to
enable Singapore to finalize the template and submit for adoption at the next ACC meeting.
Agenda Item 10:
Report country progress in preparation for the
implementation of the ASEAN Harmonized Cosmetic
Regulatory Scheme
37.
Member Countries except Myanmar and Vietnam reported to the Meeting on the status
of the implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme. Countries’
reports appear altogether as ANNEX 10.
38. The Meeting noted the following major progresses and concerns by Member Countries:
Progresses Made
(i)
Dissemination of information on the AHCRS to stakeholders has been carried
out in most countries.
(ii)
Working groups comprising of authorities and industries were formed to
prepare for the implementation of the AHCRS.
(iii) Singapore has introduced an e-system to support the Notification of Cosmetic
Product.
Concerns
(i)
Of major concerns are the resources required in transposing ASEAN Cosmetic
Directive into National Laws and Regulations.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
(ii)
(iii)
SMEs need more time to prepare for the implementation of the ASEAN
Cosmetic GMP and PMS/PSE.
Cambodia and Laos PDR have expressed concern of the lack of expertise and
resources to implement the AHCRS.
39.
With the above concerns, Member Countries, namely Brunei Darussalam, Cambodia,
Indonesia, Laos PDR, Malaysia, Philippines, Singapore and Thailand confirmed their readiness
of full compliances with the AHCRS by 2008. The Meeting, however, encouraged Member
Countries to put extra efforts to accelerate the implementation of the AHCRS.
40. The Meeting further expressed the concern about the accurate transposition of the ASEAN
Cosmetic Directive into national legislation. The Meeting suggested that regulators in Member
Countries should work closely with industries, consumer associations and government legal
officers to ensure accuracy and consistency.
41. The Meeting further discussed the recommendation of the draft road map for integration
of Healthcare sector in relation to cosmetics, the Meeting agreed to submit the following inputs
for consideration by ACCSQ.
(i)
(ii)
(iii)
Majority of Member Countries will only be ready for the implementation of the
AHCRS by 2008 as mentioned in article 2 of the Agreement on the AHCRS.
PMS Alert System can be operated by 31 December 2005.
Seven technical documents had been developed to support the implementation
of the AHCRS. Such documents already established common technical
requirements for cosmetics in ASEAN.
42.
Indonesia reported to the Meeting that the Philippines indicated its intention to have a
bilateral MRA on cosmetic product registration with Indonesia. Since Indonesia and
Philippines have the different categories of cosmetic products subject to registration, the
Meeting suggested that a common list of products subject to registration between the two
countries should be identified before entering to MRA, and in negotiating such bilateral MRA,
Philippines and Indonesia should observe carefully the requirements of the AHCRS.
Agenda Item 11:
The Action Plan/Work Programme for the ASEAN
Harmonization of the ASEAN Cosmetic Regulation
43.
The Meeting discussed and adopted the Action/Work Programme as revised, which
appears as ANNEX 11.
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THE REPORT OF THE SECOND MEETING OF THE ACCSQ
ASEAN COSMETIC COMMITTEE (ACC)
7 – 8 June 2004, Bangkok, Thailand
Agenda Item 12:
Other Matters
44.
The Meeting requested Thailand as the Chair of ACC to follow up with Myanmar and
Vietnam on their indication and preparations to participate in the AHCRS.
Agenda Item 13:
Date and Venue of the Next Meeting
45.
The Meeting agreed that the third ACC Meeting be held in Indonesia in late November
/early December 2004. Indonesia will inform all Member Countries on the arrangements at
least one month prior to the Meeting.
Agenda Item 14:
Adoption of the Minutes of the Meeting
46.
The Meeting considered and adopted the Report of the Second Meeting of the ACC
held on 7 – 8 June 2004 in Bangkok, Thailand.
47.
The Meeting agreed to forward the Report to Member Countries, which were not in
attendance to this Meeting for their consideration and confirmation.
ACKNOWLEDGMENT:
48.
The delegates of Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, the
Philippines, Singapore, the ASEAN Secretariat, and the ACA expressed their appreciation to
the Food and Drug Administration of Thailand for the warm hospitality extended and the
arrangements made for the Meeting.
The Meeting was held in the traditional spirit of ASEAN cordiality and solidarity.
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