Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia Jalan Universiti 46730 Petaling Jaya, Selangor Tel : 603-78835400 Fax : 603-79562924 Website : www.bpfk.gov.my

WHO Collaborating Centre for Regulatory Control of Pharmaceuticals

Member of Pharmaceutical Inspection Cooperation Scheme

Certified to ISO 9001:2008

Cert. No: AR 2293

UPDATES ON ASEAN COSMETIC DIRECTIVE

Presentation Outline

• Regulation of Cosmetics in Malaysia • Updates on the ACD Implementation • Post Market Surveillance • Directives issued by DPS • Quest 3 updates

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Regulation of Cosmetics in

Malaysia

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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)

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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

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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)

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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.

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UPDATES ON ACD IMPLEMENTATION

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Special Meeting of the HODs of the ASEAN Cosmetic Committee (ACC)

• 21-22 February 2012, Petaling Jaya • Issues discussed ;

– Country-specific requirements – Progress of the implementation of ACD in ASEAN

Member States

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Country-specific Requirements (1) The Meeting discussed the country-specific requirements raised by ACA and the clarification provided by the Member States and agreed that: • most cases the claims by ACA were not substantiated • some cases it was just a case of misinterpretation of the national

regulations and procedures. Recommendation: ACA to seek clarification from the relevant regulatory agencies in cases where there is ambiguity in interpretation of the national regulations.

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Country-specific Requirements (2)

• The Meeting discussed the issues raised by ACA, in particular on the requirements for the inclusion of the notification number on labels of cosmetic products by Cambodia and Thailand.

• ACA considered the implications on the consumer perception on cosmetic products that have notification numbers, which could be interpreted as these products have been verified and approved by the regulatory authorities.

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Country-specific Requirements (3) Cambodia • Informed that the requirement for notification number on the

label is for traceability and also to combat counterfeit products.

• Cambodia was requested to raise this matter with the relevant regulatory authorities to consider other options to combat counterfeit cosmetic products and protect the consumers.

HODs noted that the placing of notification numbers on cosmetic products could be considered as a short-term interim measure to address the challenges.

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Country-specific Requirements (4)

Thailand • confirmed the requirement for the notification

number to be placed on products is imposed for monitoring purposes and to support the post market surveillance activities.

• Thailand was requested to raise this matter with the relevant regulatory authorities to consider reverting the recent decision to place notification numbers on labels.

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Country-specific requirements raised by CTFA (1)

• Indonesia Issue : PIF is required prior notification process - Company is only reminded to have the PIF ready for future

audits as stated in the applicable government regulation & it is not required to be available in hand prior notification process

• Singapore Issue : declaration of % of full formulation is mandatory for

high risk product - Declaration of actual % is only required for restricted

ingredients 14

Country-specific requirements raised by CTFA (2)

• Brunei Issue : delay of receipt of notification Note up to 2 months - Issue has been rectified - Sept 2011, 1 week after submission – company will be given

temporary number to release consignment at the custom

• Thailand Issue : requirements for the inclusion of the notification

number on labels of cosmetic - As mentioned above

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Country-specific requirements raised by CTFA (3)

• Vietnam Issue : requirements for CFS during the submission of

notification and should be endorsed by the Viet Nam Embassy of the manufacturing country

- CFS is required as part of the documents for cosmetic

notification - to prevent counterfeit and illegal cosmetic products

- The request for CFS could be considered as a short-term interim measure to address the challenges faced by Viet Nam, in post market surveillance

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Status of the implementation of the notification of cosmetic

products in Malaysia

– As of 14 February 2012 = 118,500 cosmetics notified with NPCB

(Year 2011 = 67,159 )

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Post Market Surveillance Malaysia PMS activities:

Screening of information for notification application PIF auditing Label monitoring of targeted products Handling of product complaints Monitoring of cosmetic advertisement Product sampling and laboratory testing ASEAN Post Marketing Alert system GMP Audit

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Challenges faced with the implementation of ACD : Post Market Surveillance

1. Preparation of the PIF 2. Compliance to the cosmetic GMP

requirements 3. Product claims – Label & advertisement 4. Product sampling and laboratory testing

1. Challenges faced with the preparation of the PIF

• 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 e. Product which possible to make excessive claims (eg; body contour, massage products, anti-acne etc.) f. Product Complaint g. Advertisement

STATISTICS on PIF audited (from Sept 2008 – Dec 2011)

No. of PIF audited 1,223

No. of companies audited 71

STATISTICS on PIF audited (Year 2011)

No. of PIF audited 657

Local products 121

Imported products

536

No. of companies audited

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Findings from PIF Audit (1)

1. Lack of understanding to prepare PIF especially SME

- safety assessment - efficacy support - excessive product claims & advertisement - labeling requirement -unable to engage the qualified safety assessor

- difficulties to obtain the part II, III & IV documents (most of the companies can only provide Part I) BPFK has identify companies for training (including PIF

preparation)

Findings from PIF Audit (2)

2. Information in the PIF differs from information submitted for notification (Quest) Eg: a. Formulation - differ from the formulation submitted to Quest

b. Product name - Change of product name without notification to NPCB

Cancellation of product notification - consider as different product

Findings from PIF Audit (3)

3. Product label ◦ Incompliance to the labeling requirements Failure to comply with the labeling requirements

Eg; - full ingredients listing - warning statement - name and address of notification holder

Product claims

Claimed beyond the scope of cosmetic product

Findings from PIF Audit (4) 4. Claims substantiation

– Unable to provide supportive documents to justify product claims

• antiwrinkle / antiageing • Dermatological tested • Hypoallergenic • Noncomedogenic • Whitening

– Unreliable documents for claims substantiation

5. Documents in foreign language (imported product) 6. Company unable to provide PIF due to:

– product is no longer in the market – never import (notified only)

2. Compliance to the Cosmetic GMP requirements

– Local manufacturer: Total no. of local manufacturer authorize to manufacture

cosmetic : 302 • Existing manufacturer is subjected to routine audit - Poor : Withhold new notification • New manufacturer : pre- audit to ensure that they comply

with the GMP requirement – Unable to comply to GMP requirement – notified product will

be cancelled until compliance

– Overseas manufacturer & non-ASEAN: • the approach may be different in different country, hence

its important to minimize the differences to ensure product quality.

• Compliance to ASEAN GMP for cosmetic???

3. Product claims – Label & advertisement

• Excessive and insubstantial claim - body contour products - product notified as cosmetic but used for internal application (e.g. injectable products, mesotherapy - product use beyond the scope of cosmetic (e.g. massage oil for joint pain, sprains & etc) - Aromatherapy products

• Advertisement with medicinal claims

4. Product sampling and laboratory testing

• Difficulties to obtain sample due to various reason :

-product not marketed/imported etc - product is expensive – company reluctant to provide samples

when requested during the PIF audits for further investigation

DIRECTIVES – DPS 2011

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Date : 31 October 2011

O-Aminophenol (CI 76520) and its salts (CAS No 95-55-6/67845-79-8/51-19-4)

European Cosmetic Directive 2011/59/EC – Hair Dyes - 25 Hair ingredients currently in Annexe III Part 2 has been moved to Annexe III Part 1

O-Aminophenol (CI 76520) and its salts were previously listed in Annexe III, Part 2 Ref No 34

Moved to Annexe II Ref No 1372 Effective implementation date : 3 January 2012

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O-Aminophenol (CI 76520) and its salts

• In the latest review on the data submitted to the Scientific Committee on Consumer Safety (SCCS) in the EU, no final conclusion on the safety of o-aminophenol can be drawn.

• This is due to the insufficient data on physicochemical properties, inadequate information on skin sensitising potential, unsuitable studies on dermal absorption and inadequate studies to exclude the mutagenic potential.

• Based on that opinion o-aminophenol cannot be considered safe when used in hair dye products and should therefore be listed in Annex II: List of substances which must not form part of the composition of cosmetic products.

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Date : 4 April 2011

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Date : 31 March 2011

Updates on Quest 3 System - BPFK has terminated contract for Quest 3 system due to failure

of current Vendor to complete the project according to timeline.

- As a consequence, maintenance of system is now fully dependent on Section ICT in BPFK.

- Rectification of technical IT problems reported by applicants can only be done with limited ability.

- BPFK is in the process of developing new Quest 3+ system to replace the current Quest 3 system.

- Estimated date of completion for Quest 3+ system is by end of year 2013 or early of year 2014.

Thank you for attention…

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