National Pharmaceutical Control BureauMinistry of Health MalaysiaJalan Universiti, 46730 Petaling Jaya, SelangorTel : 603-78835400 Fax : 603-79562924 Website : www.bpfk.gov.myEmail : nik@bpfk.gov.my

WHO Collaborating Centre for Regulatory Control of Pharmaceuticals

Member of Pharmaceutical Inspection Cooperation Scheme

Certified to ISO 9001:2000Cert. No: AR 2293

Cosmetic Product Notification

Presentation Outline

• Background: ASEAN Harmonised Cosmetic Regulatory Scheme

• ASEAN Cosmetic Directive• Achievements: Progress of the implementation of the

ASEAN Cosmetic Directive • Cosmetic Notification – Malaysia Experience• Issues and Challenges• Way forward

2

Definition of Cosmetic• A cosmetic product shall mean “any substance or

preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”

3

ASEAN Harmonised Cosmetic

Regulatory Scheme

Vision: One single Regulatory

Scheme for the Region

4

ASEAN TEN NATIONS, ONE COMMUNITY

AND ONE STANDARD

5

STRENGTHENING REGIONAL REGULATORY FRAMEWORKS THROUGH PARTNERSHIP

Background

• Different regulations in different countries made life for about 3,000 Cosmetic SMEs and MNCs in ASEAN difficult to move their products across the region;

• Unlike other products e.g. pharmaceuticals, cosmetics are low risk consumer driven products “ they want to look good & feel better”. This drives new technologies and innovation by the industry;

• Consumers tend to keep up with new fashions. This drives shorter “life cycle” of products (3-6 months);

• If the registration takes up to 4-6 months, how to promote innovation and satisfy consumer demand and expectation?

• The regulation should look into ensuring essential requirements “safety and quality”. Beyond this, it would prevent innovations, limit choices for consumers and create barriers to Trade;

6

7

In 1997, the ASEAN Cosmetic Association officially requested the ASEAN secretariat to facilitate

harmonisation of regulations

ASEAN Secretariat gathered the RAs from the 10 countries and industry to work on the proposal

beginning of 1998

Vision: One Single Regulatory Scheme for the Region by 1st

January 2008

7

…….Background

Objectives

8

1. To enhance cooperation amongst Member Countries in ensuring the safety, quality and claimed benefits of all cosmetic products marketed in ASEAN;

2. To eliminate restrictions to trade of cosmetic products amongst Member States through adoption and implementation of harmonised technical requirements (ASEAN Cosmetic Directive)

After 6 years of negotiation, the ASEAN Agreement on Harmonisation was agreed and signed by ASEAN

Economic Ministers on 2nd Sept 2003 in Cambodia by all 10 countries

8

ASEAN Harmonized Cosmetic Regulatory Scheme

Agreement between ASEAN nations to

> Work together in ensuring the safety, quality and efficacy of cosmetics

> Eliminate restrictions to trade of cosmetics amongst member nations or in another word, to facilitate free movement of cosmetic in ASEAN region

Signed by ASEAN Economic Ministers on 2nd Sept 2003 in Cambodia

Member nations bound to adopt and implement the ASEAN Cosmetic Directive by 1st January 2008

9

ASEAN Harmonised Cosmetic Regulatory Scheme

Comprises:• Schedule A: ASEAN Mutual Recognition of

Product Registration Approvals for Cosmetics (voluntary & transitional phase)

– no longer applicable

• Schedule B: The ASEAN Cosmetic Directive (all Member Countries obliged to implement by 1 January 2008 ) – Notification Procedure

10

The ASEAN Cosmetic Directive (Contents)

1. General provisions2. Definition and Scope3. Safety requirements4. Ingredient listings5. ASEAN Handbook of Cosmetic Ingredients6. Labeling requirements7. Product Claims8. Product Information9. Methods of Analysis10. Institutional Arrangements11. Special Cases12. Implementation

…..ASEAN COSMETIC DIRECTIVE

Comprises:

• ASEAN Guidelines for Product Information File (PIF)• ASEAN Guidelines for Safety Assessment of Cosmetic Product• ASEAN Cosmetic Labeling Requirements• ASEAN Cosmetic Claims Guidelines• ASEAN Guidelines on Good Manufacturing Practice (GMP) for Cosmetic• A Guide Manual for Adverse Event Reporting• ASEAN Sunscreen Labeling Guidelines

12

…..ASEAN COSMETIC DIRECTIVE

Annexes:

Annex II : List of Substances Which Must Not Form Part of The Composition of Cosmetic Products

Annex III : List of Substances that Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions

Laid Down

Annex IV : List of Colouring Agents Allowed for Use in Cosmetic Products

Annex VI : List of Preservatives Allowed for Use in Cosmetic Products

Annex VII : List of UV Filters which Cosmetic Products May Contain 

…..ASEAN COSMETIC DIRECTIVE

14

Benefit: The product to trade cycle will be shortened Research breakthroughs and new product

technologies can be made available to consumer faster

Provide consumer with wider choice of cosmetic products

Helps in building cosmetic/ingredient safety database for the industry

…..ASEAN COSMETIC DIRECTIVE

Article 1. General provisions

- Company or person placing the cosmetic in the

market shall NOTIFY the regulatory authorities

of each Member State where the product will be

marketed

- Company or person responsible for placing the

cosmetic in the market shall keep the product’s

technical and safety information readily

accessible to the regulatory authority

Principles• Manufacturer

– responsible to guarantee product safety to ensure cosmetic products are safe and do not

contain prohibited substance

• Government – maintain a vigorous program of enforcement &

post market surveillance to allow for an efficient control and withdrawal from

the market of products having undesirable effects.

• Consumer – adequate information – “informed choice” to allow consumer to make an informed choice.

16

ASEAN Cosmetic Committee (ACC)

• The ACC was established, in accordance with Article 10 “Institutional Arrangements” of ASEAN Cosmetic Directive (ACD) to oversee and monitor the implementation of this Directive

17

ASEAN Cosmetic Scientific Body (ACSB)

• ACSB was established to assist the ACC with the effective implementation of the ACD

Objectives To support the effective implementation of the ASEAN Cosmetic

Directive To provide technical support to the ACC based on scientific

justifications and make recommendations to the ACC To support the technical decisions on the cosmetic ingredients and

matters related to the safety of the cosmetic products.

18

ASEAN COSMETIC TESTING LABORATORY COMMITTEE (ACTLC)

• ACTLC was established as a post market surveillance initiative to support the implementation of ACD

Objectives

Provide technical support to laboratory on testing for PMS activities of cosmetic products.

Strengthen competency of national cosmetic testing laboratories of ASEAN Member States.

Establish and maintain an efficient quality assurance system in line with international practices and guidelines.

Promote laboratory conformity assessment and accreditation towards international standards.

19

ACC & ACSB & ACTLC

• The ACSB & ACTLC meets prior to ACC meeting & report its recommendations and proceedings to the ACC

• Meet twice a year (Jun & Dec)• Members – Regulators & Representatives

from 10 ASEAN countries

20

Notification Procedure: ASEAN

• Submission through manual application or online or both (Online notification : Indonesia, Malaysia, Singapore, Thailand, Vietnam)

• Notification Fee, validity period & Notification Number - varies among Member States

• Processing time: 1-3 days• Information required for submission- Share the

Notification template

21

Status of Implementation of Notification Procedure in the ASEAN Countries • Malaysia, Philippines and Singapore

– 1 January 2008• Viet Nam - 10 March 2008• Thailand – 1 March 2008• Brunei Darussalam - 3 June 2008• Cambodia - 1 March 2009• Lao PDR - 1 August 2008• Indonesia - 1 January 2011 • Myanmar - no update on its progress

Article 3 ASEAN Cosmetic Directive- Safety requirements

Basic of safety requirement• Must not cause damage to human health when applied

under normal or reasonably foreseeable condition of use• Manufacturer has to gather the necessary technical

information• Component & finished product evaluated for aspect of

safety• Products produced under GMP• Safety data available• Labeling meets requirement

23

PRODUCT SAFETY Under normal/reasonable use conditions

- Safety of the ingredients depends on exposure conditions i.e.:

• Type of formulation• Concentration• Frequency • Duration of contact• Body area involved• Effect of the sun• Foreseeable misuse

SAFETY ASSESSOR Must have relevant competency

-Qualification, example, diploma in the field of pharmacy, toxicology, dermatology,

medicine or a similar discipline and be suitably trained in the safety assessment of cosmetics

Knowledgeable in safety evaluation on cosmetics

Responsible and ethical

Need not be an employee of the company -i.e. Can belong to an external organisation or institution

SAFETY ASSESSOR RESPONSIBILITIES

Ensure product’s compliance to ACD -e.g. Ingredients

Data available Ingredients safety data Relevant Sufficient

Interactions of toxicological relevance

Penetration is likely to occur

Complementary data are needed On-pack product claims Ingredients Finished product

INGREDIENTS

• Cosmetics – a mixture of ingredientsEg : colorants, preservatives, UV Filters, fragrance & etc

Adopt EU Directives + ASEAN list

Negative list• Prohibited list (Annex II)• Restricted list

Annex III part 1

Annex III part 2

Positive list

Annex IV (Colorants)

Annex VI (Preservatives)

Annex VII (UV Filters)

27

To be avoided:• Ingredients prohibited under Annex II• Ingredients from Annex III when used beyond

permissible limit• Ingredients with toxicological data incompatible with

the intended concentration and use• Ingredients which do not have sufficient toxicological

data and/or safety in-use experience• Ingredients which are not properly characterized

either chemically or through the extraction process for naturals

28

INGREDIENTS

LABELING • Label :

• Information– Written, printed or graphic matter on the

immediate or outer packaging and any form of leaflets.

• Objectives:

• To provide information for the consumers to make an informed choice &

• To assist the regulators for carrying out surveillance activities. 29

LABELING REQUIREMENTS

• Product name & its function• Use instruction • Ingredients listing• Country of manufacturer

Eg : Made in Malaysia Manufactured in USA Country of origin:

Thailand

• Name & address of company responsible for placing the product on the local marketEg : Importer/manufacturer/notification holder

• Content (mg or ml)• Batch number• Mfg. or expiry date• Additional statement

– Declaration of porcine and bovine origin.Eg :This product contains ingredient of pork origin / beef origin

30

How to determine ?

5-step decision-making process

31

COSMETIC CLAIMS

ProductProposition

CosmeticProduct

1. Does the product contain only ingredients permitted by the ACD and no ingredients banned by the ACD ?

5. Does the product permanently restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action ?

4. Is the product presented as treating or preventing disease in human beings ?

3. Is the product intended exclusively or mainly to clean, perfume, change the appearance and/or correct body odours and/or protect or keep the defined parts of the human body in good condition ?

2. Is the product intended for contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity ?

Decision process to identify cosmetic products & claims

ProductProposition

1.Composition

2.Target Site

3.Main Function

4.Non-CosmeticPresentation

5.Non-Cosmetic

Function

CosmeticProduct

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

YES

YES

YES

YES

YES

NO

NO

NO

NO

NO

ProductProposition

CosmeticProduct

ProductProposition

CosmeticProduct

1. Does the product contain only ingredients permitted by the ACD and no ingredients banned by the ACD ?

5. Does the product permanently restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action ?

4. Is the product presented as treating or preventing disease in human beings ?

3. Is the product intended exclusively or mainly to clean, perfume, change the appearance and/or correct body odours and/or protect or keep the defined parts of the human body in good condition ?

2. Is the product intended for contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity ?

Decision process to identify cosmetic products & claims

ProductProposition

1.Composition

2.Target Site

3.Main Function

4.Non-CosmeticPresentation

5.Non-Cosmetic

Function

CosmeticProduct

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

NotCosmetic

YES

YES

YES

YES

YES

NO

NO

NO

NO

NO

32

PRODUCT INFORMATION FILE (PIF)

• Part I : Administrative documents and product summary (As defined in ACD Guidelines for Product Information File)

• Part II (Quality Data of Raw Material)

• Part III (Quality Data of Finished Product)

• Part IV ( Safety and Efficacy Data )33

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

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

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

Cosmetic Notification:MALAYSIA Experience

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)

38

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

39

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)

40

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.

41

All NEW cosmetic products must notify NPCB prior to market the

product in Malaysia

42

Notification Procedure……SELF-REGULATION

Who should notify ?• The company (incorporated in Malaysia)

or person responsible for placing cosmetic products in the market is responsible for notifying the NPCB prior to manufacture, import, supply or sale of the products.

NOTIFICATION HOLDER

43

Notification procedure

How to notify?

notification template

(online)Website: www.bpfk.gov.my/Quest2

44

45National Pharmaceutical Control Bureau MOH Malaysia

46

47

Information required during notification

• Particulars of Product– Name & brand name, product type,

intended use, product presentation & list of variant or shades

• Particulars of Manufacturer/Assembler• Particulars of Local Company

Responsible for Placing the Products in the Market

• Particulars of Person Representing the Local Company

• Particulars of Importer (s)• Full Ingredient List (% of restricted

ingredients )• Letter of Authorisation (country specific

requirement)

• Declaration & Confirmation– Product meets all requirement of ACD

which has been transposed into local legislation

– Company undertake to :• Ensure PIF readily accessible to

the authority• Keep distribution records for recall

purposes• Report any serious adverse event • Notify changes made to submitted

particulars– Information supplied is truthful– Each consignment continues to meet

all the legal requirements and conforms to all the standard and specification of the product previously declared

– Cannot place reliance on the acceptance of product notification in any legal proceedings in the event that product failed to conform to any of the standards or specifications previously declared

Cosmetic Notification in Malaysia

• Notification of products through online system the system is equipped with the ‘smart system’ to auto-screen

prohibited and restricted substances in the formulation

– As of October 2012, a total of 127,058 cosmetics notified with NPCB

• Notification validity period – 2 years

• Notified Cosmetics are made available at NPCB website : www.bpfk.gov.my

Post Market Surveillance in Malaysia

Activities:• Screening of formulation for notified cosmetics • 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

Criteria for PIF Audit & Product Sampling

• Priority:1. High risk products -e.g. baby products, products to be used around the eyes & mucous

membranes

2. Whitening products 3. Products with misleading name & intended use

4. Product which possible to make excessive claims (eg; body contour, massage products, anti-acne etc.)

5. Product Complaint6. Advertisement7. Notification holders & manufacturers with history of product cancellation and poor GMP status

ISSUES AND CHALLENGES (1)

• Free movement of cosmetic products in ASEAN – Possibility of exposure of consumers to substandard products

and product with baseless claims

• Compliance to Post Market Surveillance requirements– The need for regulators to develop competency and capability

for Post Marketing Surveillance (PMS)– Lack of infrastructure and services for product testing and safety

assessments.– Lack of training infrastructure and services to develop competent

internal personnel in product testing and assessments

ISSUES AND CHALLENGES (2)

• Product Information File (PIF)– Lack of understanding of some players (especially SMEs) in

complying to the PIF requirements:

Example:

- Safety assessment

- Efficacy support

- Product claims & advertisement

- Labeling requirement

– Difficulty in preparing documents for PIF – imported product– Lack of competent personnel for both regulators and industry to

conduct PIF auditing

ISSUES AND CHALLENGES (3)

• Non-compliance to the ACD of manufacturers not based in ASEAN

WAY FORWARD

• ASEAN Cosmetic Testing Laboratory Network (ACTLN ) – workshop

• infrastructure and services for product testing (include development of common regional testing methods for product classes or substances that present significant risk) and safety assessments including capacity building

• Botanical Safety Assessment Guidelines• Pool of Safety Experts• Development of the ASEAN database for notified

products

…..WAY FORWARD

• Efforts towards harmonisation of the cosmetic sector in ASEAN as well as industry’s participation in providing inputs from the industry perspective will continue, to ensure smooth implementation

• Much work has to be done in order to realise an ASEAN-wide single market

• Can be achieved if we continue to work together in the traditional spirit of ASEAN cordiality and solidarity.

THANK YOU‘TERIMA KASIH’