Cosmetics Control Unit Centre for Drug Administration Health Products Regulation Group Health Sciences Authority Nov 200

1. Cosmetics Control UnitCentre for Drug AdministrationHealth Products Regulation GroupHealth Sciences AuthorityNov 2007 Overview of the ASEAN Cosmetic Directive Implementation and Updates

2. ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) Agreement on AHCRS signed by ASEAN Economic Ministers on 2nd Sep 2003 in Cambodia Comprises • Schedule A: ASEAN Mutual Recognition of ProductRegistration Approvals for Cosmetics (voluntary & transitional phase) • Schedule B : The ASEAN Cosmetic Directive (all Member Countries obliged to implement by 1 January 2008)

3. ASEAN Cosmetic Directive (ACD) • Closely aligned with the European Cosmetic Directive • Provides common definition for cosmetics, details ingredients not permitted in cosmetics and lists approved Preservatives, Colourants and UV filters • Provides Labelling Requirements, Guidelines on Cosmetic Good Manufacturing Practice, and Cosmetic Claims

4. Articles of the ACD • General provisions (Article 1) • Definition and scope (Article 2) • Safety requirements (Article 3) • Ingredient listings (Article 4) • Labelling and Claims (Article 6 & 7) • Product information (Article 8) • Methods of analysis (Article 9) • Institutional arrangements (Article 10) • Special cases (Article 11) • Implementation (Article 12)

5. ASEAN Technical Documents - Appendices Appendix I Definition of Cosmetic Product and Illustrative List by Category of Cosmetic Products Appendix II ASEAN Cosmetic Labelling Requirements Appendix III ASEAN Cosmetic Claims Guidelines Appendix IV ASEAN Cosmetic Product Registration Requirements Appendix V Common Requirements for Import/Export of Cosmetic Products Appendix VI ASEAN Guidelines for Cosmetic Good Manufacturing Practice Appendix VII ASEAN Cosmetic Ingredient Listings http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/cosmetic_products/asean_regulatory.html

6. ASEANCosmetic Ingredient Listings = Annexes Five Annexes • Annex II – Prohibited ingredients list • Annex III – Restricted ingredients list • Annex IV – Colorants positive list • Annex VI – Preservatives positive list • Annex VII – UV Filters positive list • Only ingredients listed on the positive lists may be used • ALL ingredients should not cause damage to human health under normal or reasonably foreseeable conditions (assessed by company marketing the cosmetic product)

7. Implementation of the ACD • Implementation Date: January 1, 2008 • No pre-market approval/licensing • No import and manufacturer licences required • Under the Health Product Act • Responsibility of ensuring product safety and quality is on the company that markets the product – self regulation

8. Determine if product is a cosmetic By: • Definition: Any substance or preparation intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, eyes and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance, and/or correcting body odours and/or protecting or keeping them in good condition. • Composition • Site of application • Function

9. Is the product a cosmetic? • Composition: • Any ingredient from Annex II: if yes, the product is not a cosmetic • Any restricted ingredient? If yes, within the limits and for the required purpose? If no, the product is not a cosmetic • All colors, preservatives or UV filters from Annexes IV, VI or VII, and used within the limits? If no, the product is not a cosmetic

10. Is the product a cosmetic? • Target site of application: • External parts of human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity: if no, the product is not a cosmetic; Note: injectables, intranasal products, personal lubricants are not cosmetics

11. Is the product a cosmetic? • Function: • The product should be applied to the permitted parts of the human body with a view exclusively or mainly for cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition. If not, the product is not a cosmetic; • The product should not be presented as for treating or preventing disease in humans.

12. What is Company’s responsibilities? • Ensure product conforms to all the requirements of the ACD, including • The ASEAN cosmetic GMP guidelines (Appendix VI) • The safety requirements (Article 3) • The ASEAN Cosmetic Labelling requirements (Article 6 & Appendix II) • Notify HSA prior to sale in the local market (Article 1) • Keep Product Information File (PIF) for each product (Article 8) • Report Serious Adverse Event(s)

13. 1 a) Cosmetic Good Manufacturing Practices(Appendix VI) • Guideline for manufacturers to develop internal quality management systems and procedures • Importers must ensure that their overseas manufacturers are compliant with the guidelines in the manufacture of products exported to Singapore

14. 1b) Safety Requirements(Article 3) • A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/cosmetic_products/files_1.Par.91125.File.tmp/Safety%20Assessment.pdf

15. 1c) LabellingRequirements (Appendix II) • Product name & function • Instructions for use • Full ingredient listing • Country of manufacture • Contents (weight / volume) • Batch number • Manufacturing / expiry date (expiry date required for products with <30 months durability) • Name and address of company responsible for placing the product in the market • Special precautions (Annexes III, VI, VII) / country specific warnings)

16. 1c) LabellingRequirements (Appendix II) • For very small containers: • Leaflets,pamphlets, hang tags,shrinkwrap, display panel (put in prominent place near product) • Immediate packaging : Name of cosmetic product and batch number • Standard References for IngredientNames • International Cosmetic IngredientDictionary • British Pharmacopoeia • Chemical Abstract Services • United States Pharmacopoeia

17. 2. Product Notification • Online notification system will begin from 2 Jan 2008. • ALL NEW cosmetic products must notify HSA before placing the products in the market. • Existingcosmetic products (marketed before 1 Jan 2008) will now require notifications in 4 phases according to product types in the year 2008. Please note: As the current licensing system will be suspended with effect from 1st Dec 2007, no submission of product licence application for both new/amendments will be possible in the month of Dec 2007.

18. Phases of Notification Phases of existing products to notify New Products subject to notification Phase I: New products subject to notification Phase II: Skin-whitening, anti-wrinkle, face-masks, tinted bases, sun bathing and sun tanning products, make-up and make-up removal pdts Phase III: Creams, emulsions, lotions, gels, oils for skincare, make-up powders, after bath & hygiene powders, perfumes, toilet waters, cologne, deodorants & anti-perspirants Phase IV: Depilatories, hair-care, nail-care and make-up, soaps, bath & shower preparations

19. Acknowledgement of Notification • Immediate – upon successful submission • Company name and address • Brand name and product name • Product notification numbers with expiry dates • Note: As part of post marketing activity, submission of full formulae within 2 weeks maybe required

20. Types of Changes to Notification • New Submission • Global Updates • Amendment

21. New Submission If changes are to be made to: • Brand name • Product name • Product type • Intended use • Formulation • Company change due to change of distribution rights

22. Global Updates ONE New submission to effect change affecting more than 1 product notification : • Change in Manufacturer • Change in Assembler • Change in Importer • Change in Store

23. Amendments If changes are made to: • Name and/or address of company without change of distribution rights (no change in RCB number ) • Amend company info • Person representing the company • Amend CRIS@hsa • Product presentation without change in brand and product name (singe product, palettes in a range, etc) • Email CCU • Packaging materials, labels - not applicable if the information was not submitted in Product Notification Form • Email CCU

24. Exemptions to Product Notification • Cosmetic products that are imported solely for direct re-export or locally manufactured solely for export are exempted from notification but the company should maintain proper records and documentation. • Free Samples in connection with advertising, sponsorship or promotional activity. (Note: Compliance with all other ACD reqmnts necessary: labelling, claims, ingredient safety.)

25. 3. Product Information File (PIF)(Article 8) • Company that places the product in market is responsible for PIF • Mandatory requirement in English for each product • Readily accessible upon request by authority • Maintain all updates on latest product changes to packaging/formulation. HSA may conduct audit of Product Information File or take samples for testing with or without prior notice

26. How to organize a PIF? • PIF Guidelines recommendations: • Part I: Administrative documents and product summary • Part II: Quality data of Raw Materials • Part III: Quality data of finished product • Part IV: Safety and Efficacy data http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/cosmetic_products/files_1.Par.33087.File.tmp/PIF%20Guidelines.pdf

27. 4. Report Serious Adverse Event Adverse Event: any harmful or unintended event reasonably attributable to the normal or foreseeable use of a given cosmetic product Non-serious adverse event • not required to be reported Serious Adverse Event: • Results in death • Life threatening (at risk of death at the time of event) • Requires in-patient hospitalisation, or • Results in persistent or significant disability/ incapacity

28. 4. Report Serious Adverse Event • Fatal or life threatening • As soon as possible (phone, fax, email) after first knowledge, no later than 7 calendar days • Within next 8 days, to complete Report Form • Other serious adverse event that is not fatal or life threatening (hospitalisation, suffer disability) • To report as soon as possible but no later than 15 calendar days after first knowledge • Complete the Report Form • Report to: • Health Sciences Authority, Pharmacovigilance Unit • 11, Biopolis Way #11-03, Helios, Singapore 138667 • Tel: 68663530/ 68663531

29. Implementation(Article 12) • Existing products which do not conform to the requirements of the ACD, will be allowed 36 months grace period to comply • New products (marketed after 31 December 2007) must comply with all requirements of the ACD • Post Marketing Surveillance will be in place and legal action can be taken under the Health Products Act

30. Notification Fees No change in product fees for 2008 • Current category 1 cosmetic products New notification - $15 Re-notification (renewal) - $10 • Current Category II products - $0 New fees in 2009 will be announced in early 2008

31. Summary • Product notification for all cosmetic products • Commitment via self-declaration in the assurance of product safety and quality • Compliance with all requirements of Directive: • Ingredient listings (Annexes II to VII) • Labelling • Cosmetic GMP • Serious Adverse Event Reporting • Product information file

32. Thank You http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/cosmetic_products.html