are your beauty products safe - dare.gov.bn your beauty products safe.pdf · products for the care...

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





Who useCOSMETIC PRODUCTS ?

What do you understand byCOSMETIC PRODUCTS ?



Facial

Wash

Deodorant

Lotion

Shampoo Hair Gel

Nail

polisher

Lipstick

Toothpaste

Shower

gel



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





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


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



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



“KEDAI RUNCIT”SUPERMARKETS CUBES

BOOTHS

ONLINE / SOCIAL MEDIA

COSMETIC PRODUCTS NOTIFICATIONforMUST be SUBMITTED

and OTHERS



Acknowledge???

Verification of Cosmetic Product

Notification Documents

Screening for Completeness

of Cosmetic Product


Submission of Cosmetic Product


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



TIME

8.00 - 11.45 a.m.

COUNTER OPENING TIMES

DAY

Tuesday & Thursday



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



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



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



http://www.moh.gov.bn/

Acknowledge???




of Cosmetic Product




Payment and

Collection of

Cosmetic Product

Acknowledgement

Letter

Collection of

Cosmetic

Product

Notification

Rejection Letter

YES

NO

1 2 3 4




SCREENING

Forms that are

NOT COMPLETE

during submission

at the counter will

be RETURNED

FOR COMPLETENESS



Acknowledge???




of Cosmetic Product




Payment and

Collection of

Cosmetic Product

Acknowledgement

Letter

Collection of

Cosmetic

Product

Notification

Rejection Letter

YES

NO

1 2 3 4




VERIFICATION COSMETIC PRODUCT NOTIFICATION



Form will be:

1. Screened

2. Verified

Acknowledge???




of Cosmetic Product




Payment and

Collection of

Cosmetic Product

Acknowledgement

Letter

Collection of

Cosmetic

Product

Notification

Rejection Letter

YES

NO

1 2 3 4




ACKNOWLEDGE

???

PAYMENT AND COLLECTION

OF COSMETIC PRODUCT

ACKNOWLEDGEMENT

LETTER

YES NO

COSMETIC PRODUCT

NOTIFICATION

REJECTION LETTER WILL

BE EMAILED AND MAILED



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



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.



Once you received the COSMETIC PRODUCT

ACKNOWLEDGEMENT LETTER ……..



It doesn’t mean that it has been “APPROVED” by

Ministry of Health

It has only been NOTIFIED to Ministry of Health



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



MEDICINES (COSMETIC PRODUCTS) REGULATIONS, 2007

COMPLY with the

REGULATIONS





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



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



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



PRESERVATIVE ( ANNEX VI )

Only allowed in RINSE OFF

cosmetic products



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




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




All claims must COMPLY with the Regulations and the

“ASEAN COSMETIC CLAIM GUIDELINES” :

i. Labelling and advertising of cosmetic products, text

names, trademarks, pictures and figurative or other

must not imply that these cosmetic products have

characteristics which they do not have;

ii. Claims with therapeutic benefit or can be used for a

therapeutic purpose or which is likely to create and

erroneous impression regarding the formulation,

composition quality or safety of the cosmetic product

are not permitted.

For example:

“ to treat ezcema”

“removes scar”

“burn fat”



knowing the CLAIM GUIDELINES

Claims can be SOFTENED

“helps to moisturize skin with eczema problems”

“firms the skin”

“helps in reducing the appearance of scars”




ABCLavender Facial

Cleanser

100ml

Manufactured on: 04/2011Best Before: 04/2015

Made in Malaysia

Brand and Product Name

of the cosmetic product

and its function

Batch No. : BH012011

Product Content (in

weight/volume)

Batch Number

Manufacturing or Expiry

Date of the Product in

clear terms (e.g.

month/year)

Country of Manufacture

Directions for use

Full Ingredient List

Special Precautions

Name and Address of the

Company or Person

responsible for placing

the product in the market

2

3

6

7

8

9

Directions: Apply on a small amount to clean fingertips and gently massage into deep facial areas. Rinse thoroughly.

Ingredients:Aqua, Glycerin, Sodium Chloride, Sodium Laureth Sulfate, Glycol Distearate, Lanadula Angustifoliaextract, Coco Betaine, Sodium Hydroxide, Propylene Glycol, Sodium Benzoate, AcrylateCopolymer

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



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



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.





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:



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



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



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



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.



JASTRE SG. PAKUDepartment of Pharmaceutical Services

Ministry of HealthBrunei Darussalam


DISPOSAL OF SEIZED COSMETIC PRODUCTS

Cosmetic Products

B e w a r eof ADULTERATED





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



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



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



Shared to public through MOH website

www.moh.gov.bn

COMPILATION OF BANNED PRODUCTS



Ministry of Health

ENSURING cosmetic products marketed in Brunei Darussalam is

SAFE and of QUALITY

with your ASSISTANCE and

COOPERATION



Any enquiries on cosmetic products, please do contact :

COSMETIC UNIT

Drug Administration Section,

2nd Floor, Department of Pharmaceutical Services Building,

Spg 433, Rimba Highway, Kg Madaras,

Mukim Gadong ‘A’, BB1514, Brunei Darussalam

Tel: +673 2393298 / 2393301 / 2393230 (Ext 218 / 219/ 225)

Fax: +673 2393297

Email: [email protected]






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




THANK YOUDepartment of Pharmaceutical ServicesMinistry of HealthBrunei Darussalam
