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National Pharmaceutical Control BureauMinistry of Health MalaysiaJalan Universiti, 46730 Petaling Jaya, SelangorTel : 603-78835400 Fax : 603-79562924 Website : www.bpfk.gov.myEmail : [email protected]
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’