The Meeting was held in plenary. .vn



24384000SUMMArY REPORTTHE thirtieth meeting of The ASEAN COSMETIC COMMITTEE Nay Pyi Taw, Myanmar, 20-21 June 2019 INTRODUCTIONThe 30th Meeting of the ASEAN Cosmetic Committee (ACC) was held on 20-21 June 2019 in Nay Pyi Taw, Myanmar. The Meeting was preceded by the following events:30th Meeting of the ASEAN Cosmetic Scientific Body (ACSB), held on 18-19 June 2019; 13th Meeting of the ASEAN Cosmetic Testing Laboratories Committee (ACTLC), held on 18-19 June 2019; andMeeting of the Heads of Delegations (HoDs), held on 19 June 2019.The Meeting was chaired by Ms. Vu Thi Hiep, Deputy Head of Legislation and Inspection Division, Drug Administration of Vietnam, Ministry of Health, Viet Nam. The Vice Chair of the Meeting was Ms. Ellys Mohammed, Pharmaceutical Chemist, Department of Pharmaceutical Services, Ministry of Health, Brunei Darussalam.The Meeting was attended by the delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam, representatives from the ASEAN Secretariat and the ASEAN Cosmetic Association (ACA). The list of delegates appears as ANNEX 1.OPENING CEREMONYThe 30th Meeting of the ASEAN Cosmetics Committee (ACC) was officially opened by HE. Dr. Myint Htwe, Union Minister, Ministry of Health and Sports, Myanmar. HE. Dr. Myint Htwe commended ASEAN Member States for their commitment in fully implementing the ASEAN Cosmetic Directive since 2008 up to present and highlighted that the ACD has simplified some steps and procedures without neglecting health and safety aspects. HE. Dr. Myint Htwe also commended the contribution of the ASEAN Cosmetic Committee (ACC) in facilitating trade of cosmetic products within the region, and the effort in strengthening and expanding cooperation with external development partners. Furthermore, HE. Dr. Myint Htwe also appreciated ASEAN Cosmetic Scientific Body (ACSB) for its work in reviewing EU Cosmetic Regulation and ASEAN Cosmetic Testing Laboratory Committee (ACTLC) in establishing inter-laboratory network and new ASEAN Cosmetic Methods. Lastly, Dr HE. Dr. Myint Htwe wished the ACC a fruitful meeting and an enjoyable stay in Nay Pyi Taw. The opening speech of HE. Dr. Myint Htwe appears as ANNEX 2.Agenda Item 1:Adoption of the AgendaThe Meeting adopted the agenda which appears as ANNEX 3.AGENDA ITEM 2:Business ArrangementSThe Meeting was held in plenary. The programme of activity of the Meeting appears as ANNEX 4.AGENDA ITEM 3: HANDOVER OF the acc CHAIRMANSHIPThe Meeting witnessed the handover of the Chairmanship of ACC from Thailand to Viet Nam. The Meeting also witnessed the handover of the Vice-Chairmanship of ACC from Viet Nam to Brunei Darussalam.The Meeting expressed its highest appreciation to Mrs. Narupa Wongpiyarattanakul for her valuable contribution to the work of ACC during her tenure as the Chair of ACC.AGENDA ITEM 4: UPDATES ON THE LATEST DEVELOPMENT IN ASEAN ECONOMIC INTEGRATIONThe ASEAN Secretariat briefed the Meeting on the recent developments in economic integration initiatives in ASEAN as well as the relevant decisions made at higher bodies, as appears in ANNEX 5. The Meeting noted the following:50th ACCSQ MEETINGReview on the 1998 ASEAN Framework Agreement on MRAACCSQ reviewed the draft text, and agreed in principle with the document.?ACCSQ also agreed to target the signing of the document at the 52nd AEM Meeting in 2020.Development of Principles for Harmonisation of Regulatory RegimeACCSQ reviewed the latest draft text and principally agreed to endorse it.? However, the Meeting requested the ASEC to scrub the draft text and re-circulate to ACCSQ for final review by 31st January 2019.? ACCSQ further agreed on the target to submit to SEOM 3/50 for endorsement.Monitoring the ASEAN Standards and Conformance Strategic Plan 2016-2025ACCSQ requested the ASEAN Secretariat to identify prioritisation of KPIs, indicative timeline and responsible WG/PWG for discussion at the next ACCSQ Meeting. The Meeting agreed in principle to the draft M&E Mechanism, which can be used to start tracking the progress of the KPI due 2019. The Meeting agreed to consider the report on the progress of the KPIs during the 2nd Meeting of ACCSQ every year.S&C Strategic Plan 2016-2025 Identification of New SectorsACCSQ agreed that the following will be considered as potential new areas:Chemicals, to consider transportation fuels and bio-fuels.To draft Terms of Reference in consultation with ACIC with focused/clearer scope.Smart Cities (taking into consideration Smart Manufacturing and IR 4.0).WG1 to continue its studies on smart cities as new area to support in harmonization. WG1 to collaborate with respective PWGs in identifying the standards required to be scoped under this study group.Relevant PWG to consider smart cities in their Term of References (ToR).Progress in Cosmetic SectorACCSQ noted, among others, the following:HOD of ACC agreed to consolidate their response to the feedback of ASEAN Cosmetic Association (ACA) corresponding to each of the country specific requirement for comparison and consideration for further actions, so as to improve the implementation of the ACD.ACTLC will follow-up the comments of Korea on ACTLC’s project on “Strengthening Post-Market Surveillance Activities to Support ACD through Laboratory Testing” and refine the project proposal for submission to Korea, together with the budget for the project proposal.Progress in Rubber-Based Products Sector ACCSQ noted the outcome of the “ASEAN Proficiency Testing (PT) Training Workshop on ISO/IEC 17043:2010 (E)” under JAIF 2.0. the Workshop was attended by the representatives from; Rubber Based Product Working Group;ASEAN Cosmetic Committee; ASEAN Medical Device CommitteeJoint Sectoral Committee for Electrical and Electronic Equipment; Prepared Foodstuff Product Working Group; Traditional Medicine and Health Supplements Product Working Group; ASEAN-Australia/New Zealand FTA Sub-committee on Standards, Technical Regulations and Conformity Assessment Procedures (AANZFTA SC-STRACAP)The ASEAN Secretariat reported the progress of the AANZFTA SC-STRACAP projects on:Stream 1 (Good Regulatory Practice)ACCSQ noted that this will be combined with the workshop/forum in Stream 2 and Australia is coordinating with Malaysia for the finalisation of the project proposal.Stream 2 (International Standards Engagement)ACCSQ noted that Australia is in the process of revising the project proposal noting the comments received from the AANZFTA Support Unit (ASU).Stream 3 (Technical Capacity Building projects for food and beverage cosmetics)ACCSQ noted the following:the project proposal on Technical Capacity Building is being revised by Australia considering the comments from ASU;the “Capacity Building Programme on International Prepared Food Standards (for MSMEs), has been endorsed by the AANZFTA Joint Committee (FJC).Proposed ACCSQ-Korea DialogueACCSQ noted the updates from Ministry of Food and Drugs Safety (MFDS), Korea, as follows:MFDS has announced its intention to promote regulatory cooperation with AMS in the field of cosmetics through setting up of Regulatory Cooperation Bodies (RCB) with each AMS counterpart by 2019. MFDS has held working-level meetings to discuss regulatory issues in the field of cosmetics between Korea and Viet Nam in the Korea-Viet Nam director-level consultation meeting;MFDS have planned to discuss ways to promote regulatory cooperation in the field of cosmetics with AMS through the on-going cosmetic ODA projects. ACCSQ agreed to seek further clarification with Korea on her plan to set up RCB in the field of cosmetics and the “ASEAN-Korea Cosmetic Council” during the 1st ACCSQ-Korea Dialogue on Standards and Conformance (ACCSQ-Korea Dialogue)ACCSQ also discussed the progress of the Concept Note on Cosmetics – “Strengthening Post-Market Surveillance Activities to Support ASEAN Cosmetic Directive (ACD) through Laboratory Testing” developed by ACTLC, under ACC, as follows:To invite MFDS’s experts for a dialogue session at the next ACTLC Meeting (scheduled to be held on 18th June 2019, Myanmar) to develop training modules together;To seek clarification on MFDS’s intention in requesting for participation in cosmetic regulatory meetings under ASEAN bodies, and confirm if Korea is able to be the supporter and donor to fund the five (5) activities under its proposed Concept Note ? given that MFDS has expressed interest to collaborate on cosmetic regulations in its responses, whereas the ACTLC’s Concept Note proposal focuses more on cosmetic testing to complement the implementation of the ACD;submit the responded Concept Note that has incorporated above points, along with a draft budget, to Korea/MFDS for further consideration and clarification; andACCSQ noted and agreed to seek feedback and clarification with Korea regarding (a) and (b) and also to seek its response toward the submitted budget during the 1st ACCSQ-Korea Dialogue.Senior Economic Official Meeting (SEOM) 1/50SEOM endorsed the TOR for the Building and Construction Working Group (BCWG), while noting the need to ensure that this be in sync with the TOR on the ASEAN Smart Cities Network that is currently being developed.SEOM endorsed the ASEAN Guidelines on Good Regulatory Practice.The Meeting noted that while the discussion between ACCSQ and Korea on the ASEAN-Korea ToR is yet to be finalised, Korea is still able to recommend its expertise and provide assistance to ACTLC in developing training module. In this relation, Chair of ACTLC informed the Meeting that the 13th ACTLC Meeting agreed to explore the support of Korea, through the ASEAN Secretariat, for the development of training modules on 1,4-Dioxane and other possible cosmetic testing methods offered by Korea.The Meeting noted that ACTLC, through the ASEAN Secretariat will liaise with Korea regarding the development of the training modules and will update the progress at the next HoD Meeting. Action by: ASEAN Secretariat, ACTLCAGENDA ITEM 5:FOLLOW-UP FROM THE 29th ASEAN COSMETICCOMMITTEE MEETINGThe ASEAN Secretariat informed the Meeting on the actions taken on matters arising from the 29th ACC Meeting held on 25-26 October 2018 in Kuala Lumpur, Malaysia, as appears in ANNEX 6. On the development of national cosmetic law, the Meeting noted that Myanmar is at the stage of engaging with the general attorney’s office, the cosmetic law is expected to be completed in 2020. The Meeting also noted Viet Nam is in the early process of developing its national cosmetic law and the timeline for its passage is however yet decided.The Meeting agreed to discuss pending issues under the corresponding agenda items.AGENDA ITEM 6:PROGRESS OF THE IMPLEMENTATION OF THE ASEAN COSMETIC DIRECTIVE (ACD)6.1Member States’ Updates on the Implementation of the ACD in their Respective TerritoriesThe Meeting noted the progress of the implementation of the ACD including information on country specific requirements related to notification by all Member States as appear together in ANNEX 7. 6.2Update from the Industry Following the Implementation of the ACDA representative from ACA updated the Meeting on their activities related to support for SMEs and external affairs, as appears in ANNEX 8. Indonesia sought information on ACA’s effort to increase the competitiveness of ASEAN cosmetic industry at global level. Indonesia noted that cosmetics imported into ASEAN countries are subject to notification whereas ASEAN cosmetics exported outside ASEAN may be subject to more stringent requirements.In relation to this, ACA shared its active participation in conducting trainings and participating in conferences outside ASEAN region. ACA actively supports SME’s participation in international beauty exhibition as an opportunity for networking and integrating ASEAN cosmetic products into global market. ACA shared its efforts in providing inputs to regulatory changes in countries outside ASEAN to enable ASEAN cosmetic industries ease of market access.6.3Information on Country Specific Requirements The Chair of the ACC HoDs shared the outcome of the 30th ACC HoDs Meeting held on 19 June 2019 on the country specific requirements for (i) product notification, (ii) labeling, and (iii) pre-market control as appears in ANNEX 9. The Meeting noted the outcome of the initial review by the HoDs, as follows:The issues raised by ACA mainly belong to five (5) categories as follows:GMP Certificate or equivalent documents; GMP Inspection required for domestic cosmetics before product notification; Certification of Free Sale (CFS); Product Artwork; and Labeling requirements specifically on the manufacturer’s name and address.The HoDs Meeting noted that not all country specific requirements raised by ACA apply to Product Notification; some apply only for the new manufacturers, while others are required for the purposes of Product Information File (PIF) auditing, licensing of manufacturers and/or supporting of Post Market Surveillance (PMS) activities only.The HoDs Meeting also noted that some country requirements are not required by the ACD but are parts of the national regulation which is imposed to ensure consumer safety, health and quality of all cosmetic products marketed in ASEAN. With the intention to provide clarity on the different practices at national level, the HoDs Meeting agreed that the concerned Member States to provide information on the basis for imposing additional requirements.The HoDs Meeting noted that the ASEAN Secretariat will circulate the updated inputs by 26 June 2019 to the HoDs for feedback on information and the concerned member states will respond to ASEAN Secretariat for compilation by 30 September 2019.Noting the on-going process of providing responses on the country specific requirements, Philippines requested ACA to share background information and results of the survey conducted with its members as a reference for AMS in providing more inputs on the country specific requirements. In relation to this request, ACA informed the Meeting that information was gathered from members of the national industry associations. The Meeting noted that ASEAN Secretariat will share the latest survey template to ACA by 26 June 2019. ACA will clarify with its member whether the issues are still faced by the industry and ACA will subsequently prepare the clarification of these issues by 15 August 2019 for consideration of the HoDs.Action by: ASEAN Secretariat, Member States, HoDs, ACAPost Market Alert SystemBrunei Darussalam briefed the Meeting on the progress report of the ASEAN Post Market Alert System (PMAS) as appears in ANNEX 10. The Meeting noted there were a total of 1,553 alerts raised in year 2018 for cosmetics, pharmaceuticals/biologics, health supplements, traditional medicines and others with 153 of the alerts are for cosmetics. While as of June 2019, there were 644 alerts raised for all product types, 66 of the alerts are for cosmetics.With regard to the revision of PMAS Alert Form, Brunei Darussalam updated the Meeting that the revised PMAS Alert Form has been endorsed by the 26th Pharmaceutical Product Working Group (PPWG) held last November 2018 and Member States have started using the revised PMAS Alert Form since November 2018.The Meeting encouraged PMAS Members to share information on the focal points/coordinators list to Brunei Darussalam.The Meeting noted that higher number of alerts reported by Malaysia was due to active post market surveillance activity conducted to ensure product safety and quality. Number of alerts by Lao PDR remains low due to the limitations of budget and knowledge in conducting post market surveillance. In this relation, Lao PDR sought support from AMS to provide training/workshop for capacity building programme for this purpose.AGENDA ITEM 7:ACC SUB-SECTOR WORKPLAN 2016-2025 7.1ACC Sub-Sector Work Plan 2016-2025The ASEAN Secretariat presented the updated ACC Sub-Sector Work Plan 2016-2025 which was discussed at the HoD Meeting of the 30th ACC, held on 19 June 2019. The latest version of the Work Plan appears as ANNEX 11.AGENDA ITEM 8:REPORT OF THE 13th MEETING OF THE ASEAN COSMETIC TESTING LABORATORIES COMMITTEE The Chair of the ASEAN Cosmetic Testing Laboratories Committee (ACTLC) reported the outcome of the 13th Meeting of the ACTLC held on 18-19 June 2019 in Nay Pyi Taw, Myanmar. The Meeting noted the progress made by ACTLC, among others:Technical Assistance for Cosmetic Testing LaboratoriesDuring the 1st ASEAN Consultative Committee for Standards and Quality (ACCSQ) and Korea Dialogue on Standards and Conformance which was held last December 2018, Korea expressed, that for the time being, it is unable to support the concept note project proposal on “Strengthening Post-Market Surveillance Activities to Support ASEAN Cosmetic Directive (ACD) through Laboratory Testing”. Korea, however, still able to recommend its experts and provide assistance to ACTLC in developing the training modules;Korea requested that further actions should be taken only after the ToR for ASEAN-Korea (A-K) Dialogue has been finalised;TOR for A-K Dialogue is currently put on hold as the 17th Meeting of the ASEAN-Korea Free Trade Area Implementing Committee (AKFTA-IC) which was held in February 2019 has decided to reactivate its Working Group on Technical Barriers to Trade (TBT) and Sanitary and Phyto-sanitary (SPS), which may have implication to the TOR for A-K Dialogue;Noting that Korea still able to recommend its experts in training modules development, ACTLC agreed to explore support from Korea on the development of training modules on 1,4-Dioxane and other cosmetic testing methods offered by Korea.ACTLC requested the ASEAN Secretariat to liaise with Korea and follow-up the future plan of ACTLC in developing training modules and requested the ASEAN Secretariat to update ACTLC on the progress of the on-going discussion between ASEAN and Korea on the initiative to formalize the sectoral dialogue on Standards and Conformance. The ASEAN Secretariat will update the ACTLC at the next Meeting.Inter-Laboratory Comparison of the Proposed New ACMsThe on-going inter-laboratory comparison conducted by the ACTLC includes (i) Determination of Diethylene Glycol (DEG) by Gas Chromatography–Mass Spectrometry (GC-MS), led by Philippines; (ii) Determination of p-Phenylenediamine (PPD) in hair dyes by HPLC, led by Singapore; and the new inter-laboratory comparison Determination of 1,4-Diaxone by GC-MS, led by Indonesia. ACTLC has completed inter-laboratory comparison on the Determination of Glycolic Acid and Lactic Acid (AHA) by HPLC and agreed to adopt and to propose this to ACC Meeting as the new ACM, namely ACM 010.The Meeting noted the progress made by ACTLC and agreed to endorse Determination of Glycolic Acid and Lactic Acid (AHA) by HPLC as the new ACM, ACM 010, which appears as ANNEX 12.With regard to the new inter-laboratory comparison on Determination of 1,4-Dioxane by GC-MS, the Meeting noted that ACA will share any other existing methods from the industry on the determination of 1,4-Dioxane to ACTLC for reference, through the ASEAN Secretariat, by 28 June 2019. The ASEAN Secretariat will circulate the method shared by ACA to Indonesia, Malaysia, Philippines, Singapore and Thailand by 1 July 2019. Action by: ACA, ASEAN SecretariatThe Meeting endorsed the report of the 13th ACTLC Meeting and its Annexes as appear together in ANNEX 13.AGENDA ITEM 9:REPORT OF THE 30th MEETING OF THE ASEAN COSMETIC SCIENTIFIC BODY The Chair of the ASEAN Cosmetic Scientific Body (ACSB) reported the outcomes of the 30th ACSB Meeting held on 18-19 June 2019 in Nay Pyi Taw, Myanmar. The Meeting noted progresses made by the ACSB and further endorsed Report of the 30th ACSB Meeting and its Appendices, which appear together as ANNEX 14. AGENDA ITEM 10:EU ARISE PLUS PROGRAMMEThe ASEAN Secretariat updated the status of the submission of the revised project proposal on “Cyber Post Market Surveillance” to EU ARISE Plus, as appears in ANNEX 15. The Meeting noted that EU ARISE Plus is unable to support the initiative on the Cyber Post Market Surveillance for Cosmetics since the issue is not part of EU ARISE Plus work plan and does not have resources required under the project proposal.The Meeting discussed and further agreed for the ASEAN Secretariat to explore possible support from other Dialogue Partners and update the ACC the outcome in the next meeting. Action by: ASEAN SecretariatAGENDA ITEM 11:OTHER MATTERSAANZFTA SC-STRACAP Program The ASEAN Secretariat presented to the Meeting progress of the projects under the AANZFTA SC-STRACAP as appears in ANNEX 16.The Meeting noted progress of the revised AANZFTA SC-STRACAP project proposals, as follows:The revised project proposals on: GRP on Cosmetics (Stream 1); International Standards Engagement on Cosmetics and Health Supplements (Stream 2); and technical capacity building on Cosmetics and Food & Beverage (Stream 3) had been endorsed in principle by the 6th AANZFTA-SC STRACAP Meeting (1-2 May 2019 in Melbourne, Australia), subject to the satisfactory review of relevant ACCSQ Product Working Groups, including ACC, TMHS PWG and WG3ASEAN Secretariat circulated all three revised project proposals to ACC for final review with the deadline set by 14 May 2019 for Stream 1 and Stream 2 and by the end of May 2019 for Stream 3. By the said timelines, ACC-Malaysia had submitted her feedback on the revised project proposals Stream 2 and Stream 3. ASEAN Secretariat circulated Australia’s response pertaining to the ACC-Malaysia’s feedback on Stream 2 and Stream 3 for final consideration of the ACC, with the deadline set by 18 June 2019. Following the timeline given, there was no further feedback received from ACC.In connection to above, the Meeting noted that the project proposals Stream 1, 2 and 3 have been satisfactorily concurred by ACC and ready to proceed to the next step. The Meeting further agreed for ASEAN Secretariat to follow up on the implementation of the project proposals and update to the ACC Meeting. Action by: ASEAN SecretariatTerms of Reference (ToR) of the ACCThe Meeting noted that ACC had agreed to make the necessary amendment to the ToR of ACC considering the current arrangement for term of office of Chairmanship and Vice-Chairmanship (ANNEX 17), which is on a yearly rotation basis and on alphabetical order.The Meeting noted and endorsed the revised ToR of ACC as appears in ANNEX 18.Agenda Item 12:DATE AND VENUE OF THE 31st, 32nd AND 33rd ASEAN COSMETIC COMMITTEE MEETINGSThe Meeting appreciated the confirmation of Philippines on the hosting of the 31st ACC Meeting to be held tentatively on 19-22 November 2019 in Manila, Philippines. The Meeting noted that two months prior to the event, Philippines will provide the official invitation including a separate invitation letter for the ACTLC so as to support ASEAN Member States’ internal arrangement.The Meeting also noted the one (1) day Safety Assessment Workshop will be conducted on 18 November 2019 by ACA.Action by: Philippines, ASEAN Secretariat The Meeting proposed Singapore to host the 32nd ACC Meeting to be held tentatively in second week of June 2020. Singapore will confirm the exact date of the Meeting in due course.Action by: SingaporeThe Meeting proposed Thailand to host the 33rd ACC Meeting to be held tentatively in the 3rd week of November 2020. Thailand will confirm the exact date of the Meeting at the 32nd ACC Meeting.Action by: ThailandThe Meeting noted the updated list of ACC Meetings’ schedule as appears in ANNEX 19.ISSUES TO BE FOLLOWED UP The Meeting noted that the list of issues to be followed up from the 30th ACC Meeting will be prepared by the ASEAN Secretariat and will be circulated to ACC Members within two (2) weeks after the Meeting. Agenda Item 13:ADOPTION OF THE REPORTThe Meeting considered and adopted the report of the 30th ASEAN Cosmetic Committee Meeting.ACKNOWLEDGEMENTThe delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Philippines, Singapore, Thailand, Viet Nam, the ASEAN Secretariat and the ASEAN Cosmetics Association (ACA) expressed their appreciation to the Department of Food and Drug Administration, Ministry of Health and Sports, Myanmar, for the warm hospitality extended and the excellent arrangements made for the Meeting. The Meeting also expressed their appreciation to the ASEAN Secretariat for the assistance provided.The Meeting was held in the traditional spirit ofASEAN cordiality and solidarity??ooo0oo?? ................
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