General Information Booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme

Transcription

1 asean General Information Booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme Ten Nations One Community Association of Southeast Asian Nations

2 General Information Booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme i

3 The Association of Southeast Asian Nations (ASEAN) was established on 8 August The Members of the Association are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam. The ASEAN Secretariat is based in Jakarta, Indonesia. For inquiries, contact: Public Affairs Office The ASEAN Secretariat 70A Jalan Sisingamangaraja Jakarta Indonesia Phone : (62 21) , Fax : (62 21) , public@aseansec.org General information on ASEAN appears on-line at the ASEAN Website: Catalogue-in-Publication Data General Information Booklet on the ASEAN Harmonised Cosmetic Regulatory Scheme Jakarta: ASEAN Secretariat, November 2006 ix,40 p, 15.5 x 21 cm 1. Cosmetic industry, cooperative ASEAN Table of Contents: I. BACKGROUND OF THE ASEAN HARMONISED COSMETIC 1 REGULATORY SCHEME A. Coverage 2 Schedule A - Mutual Recognition Arrangement of Product Registration Approval Schedule B - The ASEAN Cosmetic Directive: 2 Product Notification B. Technical Documents Page i. Illustrative List by Categories of Cosmetics 3 ii. Cosmetic Ingredient Lists 3 iii. ASEAN Guidelines for Cosmetic 4 Good Manufacturing Practice (GMP) iv. ASEAN Cosmetic Labeling Requirements 4 v. ASEAN Cosmetic Claims Guideliness 4 vi. ASEAN Cosmetic Product Registration Requirements/ 4 Procedure (Schedule A) viii. ASEAN Requirements for Import/Export of Cosmetic 5 Products ISBN Printed in Indonesia The text of this publication may be freely quoted or reprinted with proper acknowledgment. Copyright ASEAN Secretariat 2006 All rights reserved ii II. ASEAN COSMETIC REGULATORY HARMONISATION: FREQUENTLY ASKED QUESTIONS A. General 1. What is the ASEAN Harmonised Cosmetic Regulatory 5 Scheme? Who are affected by this Scheme and when is it effective? 2. Why is ASEAN moving to this scheme? 6 What are the benefits we can derive from this? 3. How can I make ASEAN Harmonised Cosmetic 6 Regulatory Scheme work for me? Who can I contact if I have questions? Where can I get help? iii

4 4. Where can I get more information about the ASEAN 7 Harmonised Cosmetic Regulatory Scheme? Schedule A - Mutual Recognition of Product Registration Approval 5. When do I need to comply with the ASEAN Cosmetic 7 Product Registration Requirements? What will happen with the local registration requirements/timing? 6. If my country implements Schedule A, what do I need 7 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 8 product in the market require new product registration? 8. Does change of brand name of an existing product in 8 the market require new product registration? 9. How does the ASEAN Cosmetic Product Registration 9 Requirement 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? What are the benefits we can derive from the 10 implementation of the Directive? 12. How will the Directive affect my company? 10 How do I prepare for the implementation of the Directive? 13. What are my responsibilities under the ASEAN Cosmetic 10 Directive after it has been implemented? 14. What is Post Marketing Surveillance (PMS)? When the Directive is implemented, will the industry still 12 need to label registration numbers on the product? 16. What if I change formulation or packaging or claims of 12 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 12 under the Directive? B. Illustrative List 18. What is the Illustrative List? Is this a restricted list? Is the Illustrative List my basis for determining whether 13 is my product cosmetic or not? C. Cosmetic Ingredient Lists 20. What are the ASEAN Cosmetic Ingredient Listings? 13 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? What do I need to follow if my country has existing local 15 Cosmetic ingredient listings? 23. What if my ingredient is not found in any of the ASEAN 15 Ingredient Listings? 24. What if my ingredient exceeds the allowable maximum 15 level in the ASEAN Ingredient Listings and I have extensive safety data to support my ingredient level? vi v

5 25. What is the ASEAN Cosmetic Scientific Body (ACSB)? 16 How does it work? 26. Who do I contact if I have queries/concerns on Ingredient 16 Listings? D. Good Manufacturing Practice (GMP) 27. What is the ASEAN Cosmetic GMP? What will happen if I am a small company and I can t 16 comply with GMP? 29. How can I comply with the ASEAN Cosmetic GMP? 17 What Should I do? E. Labeling 30. What are the ASEAN Cosmetic Labeling Requirements? 17 What do I need to comply with the requirements and when? 31. Does ASEAN Cosmetic Labeling Requirements require 18 ingredients to be reflected on the packaging? 32. Is the Expiry Date a mandatory labeling requirement under 18 the ASEAN Cosmetic Labeling Requirements? 33. Is there a standard format to be followed for the labeling 18 of the Expiry Date or the Manufacturing Date? 34. Do we need to reflect the Manufacturer s name and 19 address on the label? 35. I have existing inventory of old labels/packaging? 19 What will I do with this inventory? F. Claims 36. How do I determine if my claim is acceptable as cosmetic? Is there a harmonised list of allowed/not allowed claims 20 in ASEAN? G. Frequently Asked Questions in Cosmetic Product Notification 38. What should I do if I intend to import or manufacture a 20 cosmetic product for local sale? 39. After filing a product notification and receiving an 20 acknowledgement (e.g. notification number) from the regulatory authority, does it mean that the product has been approved for sale by the authority? 40. If my product has been notified to an ASEAN Member 21 Country, is it exempted from notification to another ASEAN country in which I intend to market the product? 41. If the cosmetic product is meant solely for export or re- 21 export, must notification be filed with the regulatory authority? 42. Are samples including Hotel s sample, and professionally 22 used cosmetic exempted from notification and the requirements of ACD? 43. Does each individual shade of a range of a cosmetic 22 product or a palette of colours require a separate product notification? 44. Can a company that is not registered to operate business 22 in the ASEAN Member Country where the product will be marketed, file the product notification? vi vii

6 45. What are the supporting documents to be submitted with 23 a product notification? 46. If there are any changes in the information submitted in 23 a product notification, do I have to file a new product notification? H. Guidance Document on Product Notification to the Regulatory Authority Particulars of a product 47. Name of brand and product Product types Intended use Product presentations(s) Particulars of the manufacturer(s)/assembler(s) Particulars of company Particulars of the person representing the local company Who should the industry report to? What should be reported 29 a. Every cases of serious Adverse Event b. High Incidence of Adverse Event (Non-serious/ severe reactions) 59. When to report the Adverse Event 31 a. Fatal or life threatening Adverse Event b. Other serious Adverse Events J. Appendices 1. Annex A Appendix Appendix Appendix 3 39 Product ingredient list if required by regulatory authority 54. Full ingredient listing and nomenclature 27 I. A Guide Manual for the Industry on Adverse Event Reporting 55. Introduction Definitions and terminology 29 a. Adverse Event b. Serious Adverse Event viii ix