ASEAN Cosmetic Directive

Report
Cosmetic Product Notification
WHO Collaborating Centre
for Regulatory Control of
Pharmaceuticals
Member of Pharmaceutical
Inspection Cooperation Scheme
Certified to ISO 9001:2000
Cert. No: AR 2293
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Jalan Universiti,
46730 Petaling Jaya, Selangor
Tel : 603-78835400 Fax : 603-79562924
Website : www.bpfk.gov.my
Email : [email protected]
Presentation Outline
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•
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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
STRENGTHENING REGIONAL REGULATORY
FRAMEWORKS THROUGH PARTNERSHIP
5
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
…….Background
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
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7
Objectives
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
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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
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The ASEAN Cosmetic Directive
(Contents)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
General provisions
Definition and Scope
Safety requirements
Ingredient listings
ASEAN Handbook of Cosmetic Ingredients
Labeling requirements
Product Claims
Product Information
Methods of Analysis
Institutional Arrangements
Special Cases
Implementation
…..ASEAN COSMETIC DIRECTIVE
Comprises:
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•
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•
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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

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
14
…..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.
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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
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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
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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
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PRODUCT SAFETY
 Under normal/reasonable use conditions
- Safety of the ingredients depends on exposure
conditions i.e.:
•
•
•
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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 ingredients
Eg : 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)
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INGREDIENTS
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
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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
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activities.
LABELING REQUIREMENTS
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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 market
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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
Eg :
Importer/manufacturer/notification
holder
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COSMETIC CLAIMS
How to determine ?
5-step decision-making process
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Decision process to identify cosmetic products & claims
Product
Product
Proposition
Proposition
1. Does the product contain only
ingredients permitted by the
ACD and no ingredients
banned by the ACD ?
1.
Composition
Not
Cosmetic
NO
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 ?
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 ?
4. Is the product presented as
treating or preventing disease
in human beings ?
YES
2.
Target Site
Not
Cosmetic
NO
YES
3.
Main Function
Not
Cosmetic
NO
YES
4.
Non-Cosmetic
Presentation
Not
Cosmetic
YES
NO
5. Does the product permanently
restore, correct or modify
physiological function by
exerting a pharmacological,
immunological or metabolic
action ?
5.
Non-Cosmetic
Function
NO
Cosmetic
Cosmetic
Product
Product
YES
Not
Cosmetic
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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 )
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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)
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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
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.
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All NEW cosmetic products must
notify NPCB prior to market the
product in Malaysia
Notification Procedure……
SELF-REGULATION
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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
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Notification procedure
How to notify?
notification template
(online)
Website: www.bpfk.gov.my/Quest2
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National Pharmaceutical Control Bureau MOH Malaysia
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Information required during notification
•
Particulars of Product
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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:
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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 Complaint
6. Advertisement
7. 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 ASEANwide single market
• Can be achieved if we continue to work together in the
traditional spirit of ASEAN cordiality and solidarity.
THANK YOU
‘TERIMA KASIH’

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