The Report of the Sixth Meeting of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) The ASEAN Cosmetic Committee (ACC) THE ASEAN Cosmetic Scientific Body (ACSB) 06 December 2006, Bohol, Republic of Philippines INTRODUCTION The Sixth Meeting of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) ASEAN Cosmetic Committee (ACC) ASEAN Cosmetic Scientific Body (ACSB) was held on the 06 December 2006, at Bohol, Republic of Philippines. ACSB MEMBERS PRESENT Brunei Darussalam Cambodia Mr Chong Chee Kiong Dr Chhieng Phana Ms Nam Nivanna Dr Purwantyastuti Ms Nuning Barwa Mr Vongtavanh Chiemsisourath Mrs Mayphet Phonsima Ms Anis Talib (Co-Chair) Ms Hamida B Minhaj Not present Dr Celia L Ong Ms Esperanza Moya Dr Alain Khaiat Mrs Narupa Wongpiyarattanakul Dr Simon Young (Secretary) Mr Nguyen Van Loi Mr Nguyen Van Vien Mr Apinan Rothanavibhata Mr Tonny Pranatadjaja (Chair) Indonesia Lao PDR Malaysia Myanmar Philippines Singapore Thailand Vietnam ACA Introduction of the Meeting by the Chair The Chairman welcomed the delegates and introduced the objective of the meeting which was to focus on making progress on clarification of borderline products and product labelling. The delegates then introduced themselves. Agenda Item 1 – Adoption of the Minutes and Agenda The Minutes of the previous meeting were adopted without amendment. Page 1 of 7 Agenda Item 2 – Review of Actions from the 6th ACSB Meeting The secretary reviewed key actions from the previous meeting, all of which were either completed or on the agenda for completion at this meeting. Agenda Item 3 – Borderline Products/Claims Guidelines Borderline Products As requested by ACC, six borderline product areas were discussed for inclusion in the ACD Illustrative list. The following proposals to ACC were agreed in the ASEAN spirit. Personal lubricant products Should not be considered to be cosmetics under the ACD as they are normally intended to come into contact with mucous membranes other than those of the oral cavity. Intranasal cleaning products Should not be considered to be cosmetics under the ACD as they are normally intended to come into contact with mucous membranes other than those of the oral cavity. Slimming products Products intended to deliver a slimming benefit i.e. a weight loss benefit should not be considered as cosmetic products. This should be replaced by ‘Body Contouring Products’ to be consistent with ‘Bust Contouring Products’ already approved for addition to the Illustrative list by ACC. Leave-on antimicrobial products Leave-on products making antimicrobial claims should be considered to be cosmetics under the ACD provided that they do not contain ingredients restricted at the levels used or banned. Cosmetic leave-on antimicrobials should not be for use on broken skin e.g. for wound-cleaning. Page 2 of 7 Claim Guidelines All countries present made comments on the discussion document circulated by the Secretary (Attachments 1-6). A number of claims areas were identified and discussed further to ensure common understanding and approach, these were, Antiseptics It was agreed that antiseptic claims could be considered to be cosmetic provided that they were not associated with medical claims e.g. wound cleansing. Action at the cellular level It was agreed that the ‘action at the cellular level’ is a mechanism of action, not an end benefit. It could be included in cosmetic claims provided that the product benefit being delivered is cosmetic. Oil regulation/control It was agreed that claims in this area could be made by a cosmetic product provided that no absolute claim is made e.g. ‘stops oil production’ and that any claimed effect is reversible. Stress reduction It was agreed that certain products e.g. aromatherapy products have been demonstrated to help to reduce stress levels. Although this can be shown empirically through brain activity scans it is not realistic to expect this type of data to be produced as claim support. Claims of blood pressure reduction will not be permitted. Muscle relaxation Massage with massage oil can cause muscle relaxation, however this is primarily due to the massage and such claims should not be permitted for cosmetic products. Singapore proposed a simplification of the Claim Guideline circulated, reducing the number of negative claim categories from one for each entry in the Illustrative list to one for each area of product application e.g. Skin, Hair, Oral etc. ACA then made a presentation including a helpful decision-making process to assist regulators and industry to define whether a product should be classified as a cosmetic under the ACD by considering three factors, 1. The intended target site 2. The intended use 3. The claims Page 3 of 7 Actions to be taken Secretary to produce a draft proposed Claims Guideline based upon the input received from all countries and from ACA. The proposal will include the decision process and an amalgamated and simplified version of the negative claim examples using the Singapore format as a format guide. To be circulated to ACSB members by end of January 2007 and refined by ACSB for presentation to the next ACC meeting. Agenda Item 4 – Product Labelling Singapore presented proposals for changes to the ASEAN Cosmetic Labelling Requirements (Attachment 7). These were discussed and the following proposals agreed for presentation to ACC 1. Ingredient Labelling There are 2 paragraphs labeled ‘B’. It is proposed that the paragraph called ‘Scope and Definition’ will remain as paragraph ‘B’. The second paragraph B ‘Labelling of Cosmetic Products’ should be changed to paragraph C C 1 c) Full ingredient listing: There is currently no provision of the order in which to list. It was agreed to propose the following to ACC (Following the EU/US models) ‘The ingredients must be declared in descending order of weight at the time they are added. Perfume and aromatic compositions and their raw materials shall be referred to by the word “perfume” or “flavour”. Ingredients in concentrations of less than 1% may be listed in any order after those of concentration of more than 1%. Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV’. For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the terms “may contain” be added The ingredients shall be specified using the nomenclature from the latest edition of standard references (Refer to appendix A). Botanicals and extract of botanicals should be identified by its genius and species. The genus may be abbreviated C 1 h) manufacturing date or expiry date without further requirements Current wording of the paragraph requires either manufacturing date or expiry date for products with shelf lives less than 30 months. This causes a possible issue in Vietnam where the Consumer Protection Law requires both. This issue could be addressed either by changing the wording of the paragraph to ‘manufacturing date and/or expiry date, or by keeping the wording as is and Vietnam invoking Article 11 Page 4 of 7 of the ACD. After discussion, Vietnam agreed to keep the wording as is and invoke Article 11. C 1 j) registration number from the country of origin It was proposed and agreed that this section be deleted as products will not be registered under the ACD. Annexe A - List of Standard References It was agreed that two Japanese references which no longer exist be deleted. Actions to be taken All proposals to be presented to 7th ACC for review and acceptance by ACSB Chair. Agenda Item 5 – Hydrogen Peroxide for Tooth-Whitening Singapore presented a review of the use of hydrogen peroxide at >6% under the supervision of dentists in ASEAN countries. Generally dentists use products containing lower levels of H2O2 e.g. Laos 4%, Indonesia 3%. Philippines dentists use products at >6% which are not classified as cosmetics. The Indonesian Dental Association indicated that they did not consider consumer products with levels of H2O2 >0.1 % to be safe. Actions to be taken Singapore to modify current H2O2 tooth whitening entry to include use by dentists at ≤6% by next ACSB. Indonesia to consult with National Dental Association to resolve their concern over use of H2O2 in tooth-whitening products at ≤ 6% and report back to next ACSB. Agenda Item 6 – ASEAN Handbook Entries Summaries of reviews and proposals for each of the 8 ingredients had been precirculated by designated ACSB members as agreed. Each proposal was summarised by the secretary and discussed by ACSB members where required. Proposals were then agreed by unanimous vote in the spirit of ASEAN harmony. All 20 ingredients were reviewed with the following results I II III IV V AHCI Annexe Banned List Restricted List Colourants Preservatives UV Filters Total Proposals Agreed 1 ingredient 2 ingredients 1 ingredient 1 ingredient 5 ingredients Page 5 of 7 Further Review Required 2 ingredients 1 ingredient Complete Complete Complete 3 ingredients The proposals are summarised, with specific actions in Attachment 8. Agenda Item 7 – Workplan for the EU Restricted List A workplan for review of the updates to the EU Cosmetic Directive restricted ingredients list was proposed and agreed. Actions to be taken Secretary to distribute review forms to ACSB members by 15 December 2006 ACSB Members to return completed forms to Secretary by 31 March 2007 Completed forms to be circulated to ACSB by 06 April 2007 Feedback on reviews (Agree/Disagree/Discuss) to Secretary by 18 May 2007 Discussion and preparation of proposals for 8th ACC in June 2007 The ASEAN Ingredient annexes will be updated following endorsement by the ACC. The new versions will be rearranged into alphabetical order by INCI name. EU reference numbers will be retained in the interests of clarity by the Secretary by end January 2007. Agenda Item 8 –Fluoride levels in Oral Care ACSB Members consulted with National Dental Associations and Ministries of Health in all ASEAN countries to assess the status of fluorosis. This was discussed and the following proposal agreed. Thailand and Cambodia will permit fluoride in oral care products to a maximum level of 1100ppm due to National safety concerns under Article 11 of the ACD. All other countries present will adopt the ACD limit of 1500ppm. Actions to be taken Secretary to contact Myanmar to inform them of decision and request their opinion. Agenda Item 9 – AOB Item 1 – ASEAN Microbiological Limits ACA Raised the fact that an error had been present in the previous limits proposed. Actions to be taken A small working group (ACA, Indonesia, Philippines, Thailand & Malaysia) to review the ASEAN and international limits, test methods and reference standards and make a recommendation to the next ACSB Meeting Page 6 of 7 Item 2 – Editorial Process It was agreed that any errors detected in the ACD ingredient lists or technical annexes/appendices will be sent to the Secretary for correction and communication. Editorial process will become a fixed item on the agenda of future ACSB meetings. Corrected versions will be presented to ACC for approval. Agenda Item 10 - Next Meeting The next meeting of the ACSB will be held back to back prior to the next meeting of the ACC. Agenda Item 11 – Close The Chairman then summarised the meeting and thanked the ACSB members, ACA, and observers for their valuable inputs, comments and attention. The Chair and all present expressed their gratitude and appreciation to the host country for their arrangements and warm hospitality before the meeting was closed by the Chair. Page 7 of 7