Strengthening the Compliance to the Malaysia Cosmetic Regulation & Requirements

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1 Strengthening the Compliance to the Malaysia Cosmetic Regulation & Requirements 1

2 Presentation Outline Introduction Post Market Surveillance : Challenges New updates : directives, circular & guidelines 2

3 Regulation of Cosmetics in Malaysia (1) Cosmetics are regulated under the Sale of Drugs Act 1952 (Revised 1989) and the Control of Drugs and Cosmetics Regulations 1984 (amendment 2009) No person shall manufacture, sell, supply, import or possess any cosmetic unless the cosmetic is a notified cosmetic. The person responsible for placing the notified cosmetic in the market shall comply to any directives or guidelines issued under regulation 29 and any conditions imposed by the Director of Pharmaceutical Services (DPS) 3

4 Regulation of Cosmetics in Malaysia (2) The company or person placing the product in the market must be responsible for ensuring safety, quality and claimed benefit of the cosmetic product placed in the local market and to ensure that the product complies with all existing regulations 4

5 Regulation of Cosmetics in Malaysia (3) Cosmetic Manufacturers need to ensure: - products are manufactured in facilities that comply with the ASEAN Guidelines on Good Manufacturing Practice (GMP) 5

6 Regulation of Cosmetics in Malaysia (4) No person shall possess or publish any label, information, pictorial, statement or document which describes the claim of the cosmetics otherwise than in the manner as determined in the directives or guidelines issued by the DPS. 6

7 NOTIFICATION HOLDER RESPONSIBILITIES To ensure that manufacturer manufactures safe product -has good system in place to ensure product safety -comply to ASEAN Cosmetic GMP requirements Collect information on post marketing experience and transfer such information to the manufacturer on a timely basis, determine trends and keep adequate records Competent personnel to handle product complaint and recall Keep the PIF for each product Report any Serious Adverse Event to the authorities 7

8 MANUFACTURER RESPONSIBILITIES Comply to ASEAN Cosmetic GMP Quality control chemical microbiological Appropriate labeling presentation of the product instruction for use, warnings (if relevant) Adequate complaint/ae handling procedure Ensures corrective action, follow-up if visible product change or adulteration is advised from the market place Proper selection of the Safety Assessor 8

9 REGULATOR RESPONSIBILITIES To ensure public health and safety; -PMS activities; product sampling, PIF audit Good collaboration with industry -to investigate complaint/serious adverse events & take proper action To remove unsafe products from the market -product recalls, notification cancellation, media announcement 9

10 CONSUMERS EXPECTATIONS (1) The cosmetics placed on the market are safe and free from banned substances/harmful ingredients i.e. Hydroquinone, Tretinoin, Theophylline, Azelaic Acid & Steroid To provide with adequate information on cosmetics for an informed choice and correct usage - Obtained from: Good labeled product Appropriate/substantiated cosmetic claims Proper packaging vs product packed in ampoule, vial, eye dropper bottle 10

11 CONSUMERS EXPECTATIONS (2) Product complaint Competent personnel to handle and entertain product compliant Provide a platform for them to lodge complaint Regulators & company to be proactive and responsive towards complaint 11

12 CONSUMERS EXPECTATIONS (3) Advertising - To provide them with reliable, accurate, truthful, informative, balanced, up to date information as well as capable of substantiated - Keep away from misleading or unverifiable statements/claims 12

13 Cosmetic Notification in Malaysia As of Feb 2013, a total of 128,720 cosmetics notified with NPCB List of Notified Cosmetics are made available at NPCB website : 13

14 Post Market Surveillance in Malaysia Activities: Screening of information/formulation Auditing the Product Information File (PIF) Sample collection and testing Auditing premises to ensure compliance with ASEAN Guidelines for Cosmetic GMP Handling product complaints Initiating warning and information sharing system between ASEAN countries (ASEAN Post Market Alert System (PMAS)) Monitoring of adverse reactions Monitoring cosmetic advertisement 14

15 Post Market Surveillance : Challenges 1. Compliance to the PIF requirements 2. Compliance to the Labeling requirements 3. Product claims label & advertisement 4. Complaince to the cosmetic GMP requirements 15

16 1. Compliance to the PIF Requirements Criteria for audit (priority) a. High risk products -e.g. baby products, products to be used around the eyes & mucous membranes b. Whitening products c. Notification holders & manufacturers with history of product cancellation and poor GMP status d. Products with misleading name & intended use (eg: ampoule, vial or odd name) e. Product which possible to make excessive claims (eg; body contour, massage products, anti-acne, antibacteria,etc.) f. Product Complaint g. Advertisement 16

17 PIF audited in 2012 No. of PIF audited Targeted : 1098 products & 60 companies 335 No. of companies audited Only 6 companies are able to provide a complete PIF 17 No. of local product 41 (12%) No. of imported product 294 (88%) 17

18 Findings from PIF Audit (1) 1. Unable to provide the part II, III & IV documents - information on raw materials & finished product - safety assessment - efficacy support - unable to engage the qualified safety assessor - Claims substantiation 18

19 Findings from PIF Audit (2) 2. Information in the PIF differs from information submitted for notification (Quest) Eg: a. Formulation & product name - differ from the information submitted to Quest b. Product name - Change of product name without notification to NPCB Cancellation of product notification - consider as different product 19

20 2. Compliance to the Labeling Requirements Label checked in 2012 No. of Label Checked 2237 No. of label warning issued to the notification holders audited 1858 (83%) Non cosmetics 127 (5.6%) 20

21 Findings from label checked Failure to comply with the labeling requirements Eg; - name differs from Quest3 - full ingredients listing/differs from Quest3 - warning statement - name and address of notification holder Product claims Claimed beyond the scope of cosmetic product Non cosmetic product 21

22 3. Product claims Label & advertisement Excessive and insubstantial claim - body contour products - product use beyond the scope of cosmetic (e.g. massage oil for joint pain, sprains & etc) - Aromatherapy products Essential oil (for mind, physiological function) Advertisement with medicinal claims 22

23 Cosmetic Advertising Code Objective : To ensure the marketing and advertising of cosmetics to the public is conducted in a manner that promotes the quality of use of cosmetics, is socially responsible and does not mislead or deceive the consumer 23 23

24 Principles: Advertising To provide reliable, accurate, truthful, informative, balanced, and up to date information that can be substantiated Keep away from misleading or unverifiable statements/claims 24 24

25 4. Compliance to the Cosmetic GMP requirements Manufacturer from Non-ASEAN Countries: the GMP approach may be different in different country ACD : Manufacturing Statement * is required to be kept in the PIF self-declaration * A statement by the manufacturer or company that the product was manufactured according to the ASEAN GMP Guidelines or any ACC approved equivalent GMP Guidelines; Issues: How to verify the GMP compliance? How to determine whether the declared manufacturer is an actual manufacturing premise or only trading company? Do the company really declare the actual manufacturer? Does the manufacturer exist? Action: Prior approval is required for new manufacturer to provide Letter of GMP Conformance or document related to Cosmetic GMP compliance issued by the authority or responsible body in the country of manufacturer Letter of contract giver & contract acceptance is required to be attached during the notification application 25

26 New updates 26

27 1. New Directives by the DPS a. The notification holder to provide info on the list of notified cosmetics to the retailers b. Punitive action on manufacturer who manufactured product detected positive to contain adulteration c. Punitive action on products/notification holders : - Failure to provide PIF documents - Incompliance to the labeling requirements - Advertisement with medicinal claim / non cosmetics claims/ misleading claim - False declaration - Failure to provide response product recall/ complaints Proposed implementation date : May

28 2. Circular - Circular to request the notification holders to udpate their contact info in the Quest system - Circular to instruct the notification holder to state the phone no. on the product label consumer 3. Revision of the current Guidelines for Control of Cosmetic Products in Malaysia Awaiting feedback from the Cosmetic Associations (deadline : 15 March 2013) Proposed date to be published : April/may

29 15 th ACSB Meeting (21 June 2011, Brunei) Annex II : New listing of o-aminophenol (CI 76520) and its salts (CAS No / / ) in Annex II (Ref No 1372). The substance was previously listed as provisionally used substance in Annex III Part 2 Ref No.34. Annex III Part 1 : Ref No 3 6, 11, 12, 16, 19 22, 25, 27, 31-39, 44, 48, 49, 55 and 56 in Annex III Part 2 has been moved to Annex III Part 1 as Ref No , , 225, 227,230, 232, 234, , and The implementation date was on the 3 January Annex III Part 2 : The provisional use of the 2 remaining substances in this Annex i.e HC Red No 10 + HC Red No 11 (CAS No ) and its salts (Ref No 50) and Hydroxyethyl-2-nitro-p-toluidine (CAS No ) and its salts (Ref No 10) was extended from 31 December 2010 to 31 December The date was extended further i.e to 31 June 2013 in the subsequent ACSB Meeting. 29

30 17th ACSB Meeting (Nov,2012- Solo, Jakarta) Annex II Because of its low margin of safety, N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts (CAS No ) will be listed in Annex II, Ref No Annex III Part 1 24 new substances have been added as Ref No Annex III Part 1 1-Naphthol (CAS No ) (Ref No 16) and Resorcinol (CAS No ) (Ref No 22) have set the authorized maximum concentration limits on application to 2.0% and 1.25% respectively. ( 1-Naphtol 2%, Resorcinol 5% in the finished product) Annex III Part 2 The provisional use of Hydroxyethyl-2-nitro-p-toluidine (CAS No ) (Ref No 10) and HC Red No 10 + HC Red No 11 (CAS No ) (Ref No 50) will be moved to Annex III Part 1 Ref No 277 and Ref No 278 respectively. ASEAN had agreed to adopt the changes by 1 st December 2013 or earlier. The implementation date for existing products containing these ingredients would be subjected to Member States decision. 30

31 Latest Update on System Quest 3+ - Project Quest 3+ was approved by MOH in December 2012 ; - Granted approval by MAMPU (Malaysian Administrative Modernization and Management Planning Unit) on the 11 Mac Tentatively system development will kick-start in year Target completion date will be end of 2015 (1 year system development)

32 Thank you for your attention 32

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