Awg Nur Azim bin Hj Matnor Public Health Officer Cosmetic Unit 11 th May 2018 – DARe Entrepreneur Day Department of Pharmaceutical Services Ministry of Health Brunei Darussalam DEPARTMENT OF PHARMACEUTICAL SERVICES| MINISTRY OF HEALTH | BRUNEI DARUSSALAM Are your SAFE Beauty Products ?
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Awg Nur Azim bin Hj MatnorPublic Health Officer
Cosmetic Unit
11th May 2018 – DARe Entrepreneur Day
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Are your
SAFEBeauty Products
?
CONTENTS
DEFINITION of Cosmetic Products
REGULATION and CONTROL of Cosmetic Products
PROCEDURES of Cosmetic Product Notification
RESPONSIBILTIES of a company placing cosmetic product
SURVEILLANCE and ENFORCEMENT on cosmetic product
ADULTERATION of Cosmetic Products
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Who useCOSMETIC PRODUCTS ?
What do you understand byCOSMETIC PRODUCTS ?
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Facial
Wash
Deodorant
Lotion
Shampoo Hair Gel
Nail
polisher
Lipstick
Toothpaste
Shower
gel
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
PROUCTS REGULATED AS
Creams, emulsions, lotions, gels and oils for skin
Face masks
Tinted bases
Make-up powders
Toilet soaps
Perfumes
Depilatories
Deodorants
Shaving products
Products intended for application to the lips
Products for the care of the teeth and the mouth
Products for nail care and makeup
Hair care products
Products for external intimate hygiene
Sun bathing products
Products for tanning without sun
Skin whitening products
Anti-wrinkle products
Others
C O S M E T I C
P R O D U C T S
DEFINITION
C O S M E T I C
P R O D U C T
any substance / preparation intended to be placed in contact with the EXTERNAL PARTS of the human body / with the teeth and
the mucous membranes of the oral cavity with a view exclusively or
mainly to …Keeping them in good condition
Cleaning them
Perfuming them
Changing their appearance
Correcting body odours
Protecting them
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Cosmetic
Products
are used by
ALL age groups
BOTH genders
1992
2003
IMPLEMENTATION of
the ACD by all ASEAN
Member States by 1st
January 2008
2008
Brunei Darussalam has
transposed the ASEAN
COSMETIC DIRECTIVE
(ACD) into the local
regulations, MEDICINES
(COSMETIC PRODUCTS)
REGULATIONS 2007, and
implemented the
Regulations since June
2008 2011
All cosmetic
products in
Brunei
Darussalam
MUST COMPLY
with the
Regulations by
1 January
2011
A total of 11 SECTORS WERE IDENTIFIED
ASEAN CONSULTATIVE COMMITTEE
ON STANDARDS AND QUALITY
(ACCSQ) was formed by the ASEAN
Economic Ministers to facilitate and
complement the objectives of the
ASEAN Free Trade Area (AFTA)
ASEAN COSMETIC COMMITTEE
(ACC) was formed as one of the
sectoral bodies mandated to
develop a harmonization scheme on
the REGULATORY and TECHNICAL
requirements for the placement of
cosmetic products traded in ASEAN
Agreement on the ASEAN
HARMONISATION COSMETIC
REGULATORY SCHEME (AHCRS)
was signed by the ASEAN Economic
Ministers
REGULATION of COSMETIC PRODUCTS t imelineDepartment of Pharmaceutical Services
Ministry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Cosmetic Products in
Brunei Darussalam are
regulated under the
MEDICINES
(COSMETIC
PRODUCTS)
REGULATIONS, 2007
which is in line with
the ASEAN Cosmetic
Directive (ACD)
CONTROL of Cosmetic Productsin Brunei Darussalam
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY
(BDMCA) through the DIRECTOR OF PHARMACEUTICAL SERVICES
is the Authority for the implementation of the Regulations
Cosmetic products
comply with
QUALITY &
SAFETY criteria
marketed in Brunei
Darussalam
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
involves AN
UPFRONT
DECLARATION OF
COMPLIANCE by
the importer or
manufacturer
before placing the
cosmetic product in
the local market
Any cosmetic
company THAT
FAILS TO
COMPLY with the
regulations shall
be punishable by a
fine not exceeding
B$5,000 or 2
years in prison or
both if convicted
COSMETIC PRODUCT NOTIFICATION
MUST NOTIFY THE
AUTHORITY before
placing the cosmetic
product in the local
market
Cosmetic products can
only be marketed after
receiving the
NOTIFICATION
ACKNOWLEDGEMENT
LETTER from the
Authority
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
“KEDAI RUNCIT”SUPERMARKETS CUBES
BOOTHS
ONLINE / SOCIAL MEDIA
COSMETIC PRODUCTS NOTIFICATIONforMUST be SUBMITTED
and OTHERS
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Acknowledge???
Verification of Cosmetic Product
Notification Documents
Screening for Completeness
of Cosmetic Product
Notification Documents
Submission of Cosmetic Product
Notification Documents
Payment and
Collection of
Cosmetic Product
Acknowledgement
Letter
Collection of
Cosmetic
Product
Notification
Rejection Letter
YES
NO
1 2 3 4
COSMETIC PRODUCT NOTIFICATION PROCEDURES
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Acknowledge???
Verification of Cosmetic Product
Notification Documents
Screening for Completeness
of Cosmetic Product
Notification Documents
Submission of Cosmetic Product
Notification Documents
Payment and
Collection of
Cosmetic Product
Acknowledgement
Letter
Collection of
Cosmetic
Product
Notification
Rejection Letter
YES
NO
1 2 3 4
COSMETIC PRODUCT NOTIFICATION PROCEDURES
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
TIME
8.00 - 11.45 a.m.
COUNTER OPENING TIMES
DAY
Tuesday & Thursday
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
CHECKLIST
Original Copy(ies) of the Cosmetic Product Notification
Form
Original Copy of the Log for the Notification of Cosmetic
Products
CD which contains:
1. Cosmetic Product Notification Form
2. Log for the Notification of Cosmetic Products
Copy of the Company’s Certificate of Incorporation
Copy of importer’s and representative’s (if applicable)
Brunei Darussalam Smart Identity Card
Letter of Authorisation for the appointed Representative
(if applicable)
FOR COMPANIES SUBMISSION
OF COSMETIC PRODUCT
NOTIFICATION
1
2
3
4
5
6
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
For local manufacturers - Product Sample7
For No. 1,2 & 3 , these
documents will be
submitted EVERYTIME
during submission of
cosmetic product
notification
Original Copy(ies) of the Cosmetic Product
Notification Form
Original Copy of the Log for the Notification of
Cosmetic Products
CD which contains:
1. Cosmetic Product Notification Form
2. Log for the Notification of Cosmetic Products
1
2
3
Copy of the Company’s Certificate of Incorporation
Copy of importer’s and representative’s (if
applicable) Brunei Darussalam Smart Identity Card
Letter of Authorisation for the appointed
Representative (if applicable)
4
5
6
For no. 4, 5 & 6, these
documents will only be
submitted during FIRST
TIME submission of
cosmetic product
notification
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Enter web : www.moh.gov.bn
Click on “Businesses”
Click on “Importing Cosmetics”
1
2
3
4 Click on relevant “Submission of Cosmetic Product
Notification” to download relevant forms
1. Submission of Cosmetic Product Notification
2. Guidelines3. Other Forms4. Infographics5. List of Notified Cosmetic Products6. List of Banned Cosmetic Products7. Regulations8. Technical Documents9. Other Links
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
SCREENING
Forms that are
NOT COMPLETE
during submission
at the counter will
be RETURNED
FOR COMPLETENESS
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Acknowledge???
Verification of Cosmetic Product
Notification Documents
Screening for Completeness
of Cosmetic Product
Notification Documents
Submission of Cosmetic Product
Notification Documents
Payment and
Collection of
Cosmetic Product
Acknowledgement
Letter
Collection of
Cosmetic
Product
Notification
Rejection Letter
YES
NO
1 2 3 4
COSMETIC PRODUCT NOTIFICATION PROCEDURES
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
VERIFICATION COSMETIC PRODUCT NOTIFICATION
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Form will be:
1. Screened
2. Verified
Acknowledge???
Verification of Cosmetic Product
Notification Documents
Screening for Completeness
of Cosmetic Product
Notification Documents
Submission of Cosmetic Product
Notification Documents
Payment and
Collection of
Cosmetic Product
Acknowledgement
Letter
Collection of
Cosmetic
Product
Notification
Rejection Letter
YES
NO
1 2 3 4
COSMETIC PRODUCT NOTIFICATION PROCEDURES
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
ACKNOWLEDGE
???
PAYMENT AND COLLECTION
OF COSMETIC PRODUCT
ACKNOWLEDGEMENT
LETTER
YES NO
COSMETIC PRODUCT
NOTIFICATION
REJECTION LETTER WILL
BE EMAILED AND MAILED
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Saturday
8.00 ~ 9.00 a.m.
Monday - Thursday
8.00 ~ 11.45 a.m. & 1.30 ~ 2.00 p.m.
TIME & DAY COLLECTION & PAYMENT OF COSMETIC
PRODUCT ACKNOWLEDGEMENT LETTER
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
PAYMENT FOR COSMETIC PRODUCT
NOTIFICATION
FEES FOR NOTIFICATION OF COSMETIC PRODUCTS
(1) (a) New Product Notification $10 / year
(b) Variant $10 / year
(c) Palette(s) in range of one product
type
$10 each (first 5
colours) / year
$5 each (subsequent
colour) / year
(2) Renewal of Cosmetic Product Notification* $10 / year
(3) Application to amend Cosmetic Product
Notification
No charge
*Renewal of Cosmetic Product Notification – Annual renewal fee to maintain the notification of each cosmetic product.
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Once you received the COSMETIC PRODUCT
ACKNOWLEDGEMENT LETTER ……..
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
It doesn’t mean that it has been “APPROVED” by
Ministry of Health
It has only been NOTIFIED to Ministry of Health
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
SOCIAL MEDIA ADVERTISEMENTS
NOTIFIED
DI NOTIFIKASI
RESPONSIBILITIES OF A COMPANY FOR PLACING THE COSMETIC PRODUCT IN THE LOCAL MARKET
it’s the RESPONSIBILITY of ALL IMPORTERS and MANUFACTURERSof cosmetic products to ENSURE that the imported/manufactured products COMPLY with the REGULATIONS as
stipulated in the MEDICINES (COSMETIC PRODUCTS)
REGULATIONS, 2007
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
MEDICINES (COSMETIC PRODUCTS) REGULATIONS, 2007
COMPLY with the
REGULATIONS
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
involves AN
UPFRONT
DECLARATION OF
COMPLIANCE by
the importer or
manufacturer
before placing the
cosmetic product in
the local market
DECLARATION OF COMPLIANCE
I hereby declare on behalf of my company that the cosmetic product in the notification MEETS ALL THE REQUIREMENTS of
the MEDICINES (COSMETIC PRODUCTS) REGULATIONS, 2007 and ASEAN COSMETIC DIRECTIVE with its ANNEXES
and APPENDICES.
I undertake to abide by the following conditions:
• Ensure that the PRODUCT’S TECHNICAL AND SAFETY INFORMATION is MADE READILY AVAILABLE to the Authority
concerned and to keep records of the distribution of the products for product recall purposes;
• NOTIFY the Authority of FATAL OR LIFE THREATENING SERIOUS ADVERSE EVENT6 as soon as possible by
telephone, facsimile transmission, email or in writing, and in any case, no later than 7 calendar days after first knowledge;
• SUBMIT the ADVERSE COSMETIC EVENT REPORT FORM7 within 8 calendar days from the date of my notification to
the Authority in para 2-ii above and to provide any other information as may be requested by the Authority;
• REPORT to the Authority of all OTHER SERIOUS ADVERSE EVENTS that are not fatal or life threatening as soon as
possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report
Form7;
• NOTIFY the Authority of any CHANGE IN THE PARTICULARS submitted in this notification;
• ENSURE THAT if and when directed by the Authority I will RECALL the product from the market, and discontinue selling or supplying the product
I understand that I CANNOT PLACE RELIANCE ON THE ACCEPTANCE OF MY PRODUCT NOTIFICATION BY THE
AUTHORITY in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the
standards or specifications that I had previously declared to the Authority.
I declare that the particulars given in the notification are TRUE, all data, and information of relevance in relation to the
notification have been supplied and that the documents enclosed are authentic or true copies.
I understand that I shall be responsible for ensuring that each consignment of my product continues to MEET ALL THE
LEGAL REQUIREMENTS, and conforms to all the STANDARDS and SPECIFICATIONS of the product that I have declared
to the Authority.
1
2
3
4
5
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
DECLARATION OF COMPLIANCE
REGULATED INGREDIENTS OF COSMETIC PRODUCTS
FIRST SCHEDULE
MEDICINES (COSMETIC
PRODUCTS)
REGULATIONS, 2007
ASEAN
COSMETIC
DIRECTIVE
REGULATED INGREDIENTS
Part I Annex IIList of substances which MUST NOT FORM
part of the composition of cosmetic products
Part II Annex III
List of substances which cosmetic products
must not contain except subject to
RESTRICTIONS and CONDITIONS laid down
Part III Annex IVList of COLOURING AGENTS allowed for use
in cosmetic products
Part IV Annex VIList of PRESERVATIVES which cosmetic
products may contain
Part V Annex VIIList of UV FILTERS which cosmetic products
may contain
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
knowing the
BANNED INGREDIENTS ( ANNEX II )
Ingredient CAS Number Reference No.
ISOPROPYLPARABEN 4191-73-5 1374
ISOBUTYLPARABEN 4247-02-3 1375
PHENYLPARABEN 17696-62-7 1376
BENZYLPARABEN 94-18-8 1377
PENTYLPARABEN 6521-29-5 1378
3-BENZYLIDENE CAMPHOR 15087-24-8 1379
KETOCONAZOLE 65277-42-1 1380
Cosmetic Products containing banned
ingredients are NOT ALLOWED to be
sold in the local market
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
PRESERVATIVE ( ANNEX VI )
Only allowed in RINSE OFF
cosmetic products
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
IngredientCAS
Number
Reference
No.
Mixture of
Methylchloroisothiazolinone
(MCIT) &
Methylisothiazolinone (MIT)
26172-55-
4, 2682-20-
4, 55965-
84-9
39
Methyisothiazolinone 2682-20-4 57
LIST OF ANNEXES OF THE ACD
Enter web : www.moh.gov.bn
Click on “Businesses”
Click on “Importing Cosmetics”
1
2
3
4 Click on icon “Technical Documents” to obtain relevan
information
1. Submission of Cosmetic Product Notification
2. Guidelines3. Other Forms4. Infographics5. List of Notified Cosmetic Products6. List of Banned Cosmetic Products7. Regulations8. Technical Documents9. Other Links
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
For external use only. Not for eyes. If contact with
eyes flush with water
IMPORTED BY:ABC Private Limited
1, DEF Lane,Brunei Darussalam
1
4
5
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
PRODUCT LABELLING knowing the requirements
The Ministry of Health also CONDUCTS
SURVEILLANCE on products sold in the
market to ensure that all cosmetic products are
notified and meet the regulatory requirements
The INSPECTION ACTIVITY also ensures that banned
cosmetic products / un-notified products and cosmetic
product notifications that are cancelled or withdrawn
are not available in the market
Samples of cosmetic products particularly for
the WHITENING COSMETIC PRODUCTS are
also SAMPLED and TESTED for banned
ingredients
SURVEILLANCE and
ENFORCEMENT
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
on cosmetic products
Cosmetic products found to be adulterated
with banned ingredients are ANNOUNCED
through the MEDIA and NEWS.
The Ministry of Health is in contact with other
ASEAN Member States through the ASEAN
POST - MARKET ALERT SYSTEM (PMAS)
to EXCHANGE INFORMATION on cosmetic
products that have been withdrawn and
found to contain ingredients that are not
allowed or against the rules in the country
concerned.
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
COMPILATION OF PRODUCT INFORMATION FILE (PIF)
① Administrative
documents and product
summary
② Quality data of raw
materials
③ Quality data of finished
products
④ Safety and Efficacy Data
! WARNING !It is an OFFENCE under the Medicines (Cosmetic Products), Regulations 2007 to DISPLAY, IMPORT, DISTRIBUTE, SELL or SUPPLY any types of cosmetic product in the market:
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
D E PA R T M E N T O F P H A R M A C E U T I C A L S E R V I C E S | M I N I S T RY O F H E A L T H | B R U N E I DA R U S S A L A M
WITHOUT
ACKNOWLEDGEMENT
LETTER (Sec 5) issued
by the Authority (ALL
cosmetic product has to
be NOTIFIED before
placing into the market)
INCOMPLIANCE
WITH THE LABELLING
REQUIREMENTS
(Sec 8) (Make sure
ALL labelling
requirement is
complete)
DISPLAY OF BANNED/
PROHIBITED COSMETIC
PRODUCT (Sec 7)
(NEVER import of display
ANY banned product in
the market)
PROHIBITED COSMETICS
Products believe to be
Un Notified
Deeja Cosmetic adulterated with
Hydroquinone & Mercury
Red Cap Cream adulterated with
Mercury
Moleek Plus adulterated with
Hydroquinone & Tretinoin
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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SOLD IN CUBE BOXES IN THE COUNTRY
MEDICINES (COSMETIC PRODUCTS)
REGULATIONS, 2007
Any person who CONTRAVENES
any provision of the Regulations,
if found GUILTY, is liable on
conviction to a fine of not
exceeding $5000,
IMPRISONMENT term of not
more than 2 YEARS or BOTH
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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PENALTY
COMPOUND
Section 77 (Medicines Order, 2007)
The Authority may compound any offence against this Order or under
any rules made thereunder by collecting from the person
reasonably suspected of having committed the offence a sum not
exceeding $2,000
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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DISPOSAL OF SEIZED COSMETIC PRODUCTS
SEC 60(4) – May SEIZE and DETAIN any substance or article (including documents) which he has reasonable cause to believe to be a substance or article in relation to which or by means of which an offence under this order
SEC 63 – FORFEITURE OF GOOD SEIZED
SEC 63(3) – If there is no prosecution with regard to any goods seized under the order, the goods shall be forfeited at the expiration of ONE MONTH from the date of the seizure thereof unless a claim thereto has been made before the date.
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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JASTRE SG. PAKUDepartment of Pharmaceutical Services
Ministry of HealthBrunei Darussalam
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DISPOSAL OF SEIZED COSMETIC PRODUCTS
Cosmetic Products
B e w a r eof ADULTERATED
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Testimonials of Whitening Products
HYDROQUINONE
Prolonged use can
lead to a condition
called
OCHRONOSIS,
which is a BLUE-
BLACK
PERMANENT
PIGMENTATION
on the skin
Products containing
hydroquinone
usually have a
YELLOWISH TINGE
to its colour.
Upon application, it
would cause
STINGING and
BURNING
SENSATIONS
Hydroquinone
cannot be
applied to the
skin (except the
nail surface) and
can only be used
under a
PHYSICIAN'S
CARE in the
treatment of skin
diseases
May be found in SKIN
WHITENING PRODUCTS
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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MERCURY
May be found in SKIN
WHITENING PRODUCTS
Common symptoms
of mercury poisoning
include
PERIPHERAL
NEUROPATHY
(presenting as tingling
sensation or itching,
burning or pain),
SKIN
DISCOLOURATION
(pink cheeks,
fingertips and toes),
SWELLING, and
DESQUAMATION
(shedding of skin)
Mercury is POTENT
INGREDIENT and is
READILY
ABSORBED through
the skin on topical
application and
tends to accumulate
in the body
Exposure to mercury
can cause SKIN
RASHES, UNEVEN
SKIN
PIGMENTATION,
SKIN IRRITATION,
MEMORY LOSS and
MUSCLE
WEAKNESS while
high exposures may
result in DAMAGE to
the BRAIN and
KIDNEYS
It is also extremely
toxic to unborn
children
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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TRETINOIN
It can only be used
under a
PHYSICIAN'S
CARE in the
treatment of acne
Tretinoin is also known as
RETINOIC ACID and may be
found in ANTI-ACNE
PRODUCTS
Upon application, it
may cause STINGING
and WARM FEELING
ON THE SKIN, and in
normal use it produces
some REDNESS,
DRYNESS, ITCHING
and PEELING similar
to that of mild sunburn
Tretinoin is NOT to be
used by PREGNANT
WOMEN because it is
harmful to the
UNBORN CHILD
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Shared to public through MOH website
www.moh.gov.bn
COMPILATION OF BANNED PRODUCTS
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Ministry of Health
ENSURING cosmetic products marketed in Brunei Darussalam is
SAFE and of QUALITY
with your ASSISTANCE and
COOPERATION
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Any enquiries on cosmetic products, please do contact :
COSMETIC UNIT
Drug Administration Section,
2nd Floor, Department of Pharmaceutical Services Building,
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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Enter web : www.moh.gov.bn
Click on “Businesses”
Click on “Importing Cosmetics”
1
2
3
4 Click on relevant icons to obtain information1. Submission of Cosmetic Product
Notification2. Guidelines3. Other Forms4. Infographics5. List of Notified Cosmetic Products6. List of Banned Cosmetic Products7. Regulations8. Technical Documents9. Other Links
Department of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
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