Cosmetics

regulation
Understanding cosmetics regulation
1/ Competent authorities
2/ Definition of cosmetics
3/ Cosmetic notification
4/ Safety requirements
5/ Labeling requirements
6/ Advertisement
7/ Ingredient requirements
8/ Product notification
9/ Types of change to notification
10/ Language requirements…
Cosmetics regulation system in Korea
VIETNAM COSMETICS
REGULATION
 Competent Authorities
Vietnam Cosmetic Regulation completely follows the
ASEAN Cosmetic Directive as a member country of
ASEAN.

The cosmetic products are regulated by the Drug

Administration of Vietnam (DAV) under the Vietnam
Ministry of Health (MOH).

To sell your products to the Vietnam market, you first

need to go through a cosmetics registration procedure
of proclamation and obtain a valid proclamation
receipt number for each type of product.
Definition of cosmetic product
A “cosmetic product” shall mean any substance or
preparation intended to be placed in 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
with a view exclusively or mainly to cleaning them,
perfuming them, changing their appearance and/or
correcting body odors and/or protecting them or keeping
them in good condition.
 Cosmetics notification
Cosmetics notification in Vietnam can be done by a
local business entity who is the brand owner or
appointed a company by the brand owner with
the function of the cosmetic business in Vietnam.

For foreign cosmetic brands, it is necessary to set

your local subsidiary or appoint a local partner
who has the permission to trade cosmetic products
in Vietnam.
 Cosmetics notification
Once you have set your local company or appoint a local
partner, you can need to prepare and submit the following
documents to proceed with your product registration in
Vietnam:

1/ Notification report of cosmetics

2/ Company registration certificate (Copy)
3/ The power of attorney of the producer/owner of
the product (original or notarized copy)
4/ Free sales certificate
5/ Product Information File (PIF) for every product
 Cosmetics notification
The PIF includes:

1/ Administrative documents and a summary

of the product

2/ Raw material quality data

3/ Finished product quality data

4/ Safety and efficacy data

Ingredient Listings Cosmetic Products have to be adopt all Annex
Annex II – List of substances which must not form part of
the composition of cosmetic products

Annex III – List of substances which cosmetic products

must not contain except subject to restrictions and
condition laid down

Annex IV - List of coloring agents allowed for use in

cosmetic products

Annex VI – List of preservatives allowed

Annex VII – List of UV filters which cosmetic products

may contain
 Safety Requirements
Cosmetics are necessary to be assessed and evaluated
product safety following the ASEAN safety guideline and
attributes specified in Annex 06-MP.

There are restrictions set out for heavy metals and microbial
parameters in cosmetic products. All other requirements
concerning cosmetic ingredients can be found in the latest
version of ASEAN Cosmetic regulation.

The organization or individuals who are responsible for

putting products on the market are organizations are also
responsible for the safety, effectiveness, and quality of the
product.
 Labeling requirements
The labels must be written in English or Vietnamese
and include the following information:

1/ Name of the product and its functions

2/ Usage instructions
3/ The full formula of ingredients
4/ Country of origin
5/ Name of the distributor
6/ Quantification
7/ Batch number
8/ Manufacturing or expiration date
9/ Warnings and precautions
 Post-Market Surveillance
Authorities has been deploying Post-Market
Surveillance, collaborates with the National Institute
for Drug Quality Control, Health Inspectorate,
Market Control Department to go for audit.

High-risk cosmetic products have been selected for

priority audit.

Authorities coordinates with the customs and other

relevant authorities to prevent cosmetic products
illegally imported into Viet Nam.

Authorities can audit the PIF, product quality,

GMP, labeling…
 Manufacturing

Cosmetic product are consistently manufactured

and controlled to the specified quality, compliance
with CGMP- ASEAN Guidelines.

It is concerned with all aspects of production and

quality control.
Certificate of free sale regulatory
Authority to issue: State management agency.
Legalized by Vietnamese Embassy in local country.

Contents:
1/ Name of issuer.
2/ Date and reference number.
3/ Name of product.
4/ Kind of product.
5/ Name and address of manufacturer.
6/ Name, signature and seal.
7/ CFS must be show that the product is freely sole in
the market of the manufacturing country.
Import cosmetics
to Vietnam
Types of cosmetics are permitted
to import to Vietnam

Beauty Products

Baby and Child Care Products

Green or Natural Products

The authorization requirements to import
cosmetic products to Vietnam market

1/ Local legal representation: You will need to find

either a reliable local distributor or set up a Wholly-
Foreign Owned Company in order to import your
product. Finding a local distributor with no previous
experience in the Vietnamese market can be challenging
due to common fraudulence and corruption from the
application system.

2/ Product Registration: including product information

file in both English and Vietnamese
The authorization requirements to import
cosmetic products to Vietnam market
3/ Product Specification: requirements to be approved
by the Ministry of Health: including Safety Assessment,
Raw Material Registration and Formula, Preservative
Efficacy, Product Stability, Good Manufacturing Practice,
Proof of Claims

4/ Labelling

5/ Certificate of Free Sale

6/ Regular notification to local authorities: The

responsible agent must notify national authorities.
 Cosmetics product notification
Importers who wish to notify cosmetic products have to
submit the following documents to the Ministry of Health:

Notification of cosmetic product form (hard and soft copies)

Notarized copy of the company’s Business Registration Certificate

in Vietnam

Power of Attorney of the manufacturer indicating that the company

is authorized to import and distribute the product

Certificate of Free Sale or Permit of Circulation from the country of

origin certifying the product to be sold in overseas markets
 HS code of cosmetics
Harmonized System Codes (HS Code) is the legal
identification of a product when entering a country.
The HS code of a product determines the tax rates that
will be applied to the item.

Check the respective HS Codes on the national tariff

database.
 HS code of cosmetics
Examples of HS code of cosmetics:

3303: Perfume

3304: Skin care, body care, facial care

products

3305: Hair care products

3307: Toiletries, shaving and bath

preparations, deodorant
Establish a local business to import to VN

It is mandatory for a business to have a legal

representative in Vietnam to conduct any trading
business.
 Paying taxes
Tax requirements vary depending on the origin of your
product. The general requirement for tax regulations include:

Import Tax

Value-added Tax (VAT)

Special Consumption Tax (SCT)

Environment Protection Tax (EPT)

Customs procedure for importing cosmetics to VN
Normally, customs documents for import commercial
cosmetic product to Vietnam include:

1/ Customs declaration
2/ Contract, commercial invoice, packing list
3/ Bill of lading (B/L), airway bill (AWB)
4/ Valid Template for Notification of cosmetic product
received and numbered by Drug Administration – MOH
5/ Certificate of Origin (C/O) in case of special
preferential import duty under FTA

(Circular 39/2018/TT-BTC dated 20 April 2018 Ministry of

Finance – Vietnam)
 Quality assurance &
Quality control of cosmetics
 Definition
“Planned and systematic activities implemented
within the quality system that can be demonstrated
to provide confidence that a product or service
will fulfill requirements for quality”

Quality Assurance is a system for evaluating

performance, service, of the quality of a product
against system, standard or specified requirement
for customers.
Quality assurance vs. Quality control

Quality assurance is process oriented and

focuses on defect prevention.

Quality assurance is a set of activities for

ensuring quality in the processes by
which products are developed.
Quality Assurance vs. Quality control

Quality control is product oriented and

focuses on defect identification.

Quality control is a set of activities for

ensuring quality in products. The activities
focus on identifying defects in the actual
products produced.
General principles of quality assurance

Fit for purpose: The product should be

suitable for the intended purpose

Right first time: Mistakes should be

eliminated
Quality control testing for cosmetics
Raw material control

Packaging material control

Intermediate product control

Finished product control

Shelf life and stability control

Analysis of cosmetics
 Analysis of cosmetics

Physical Evaluation

Chemical evaluation

Microbiological evaluation
 Physical evaluation
General test

pH value
Appearance, color, odor
Density
Viscosity
Melting point
Flash point
Fatty acid composition
Foam test…
 Physical Evaluation
Compression test
 Physical evaluation
Spreadability test
 Physical evaluation
Firmness test
 Physical Evaluation
Compactability test
 Physical evaluation
Extrusion test
 Physical evaluation
Lipstick strength and bend test
 Physical evaluation
Nail polish drying test
 Physical evaluation
Tensile test
 Physical evaluation
Force test
 Physical evaluation
Packaging property test
 Chemical evaluation
Active ingredients
Anti-oxidants
Whitening agents
Conditioning agents
Vitamins
UV filters
Humectants
Essential oils
Anti-wrinkle agents
Anti-septic agents
Anti-bacterial and anti-fungal agents…
 Chemical evaluation
Restricted components
• Allergens
• Preservatives (e.g. paraben)
• Contaminants and impurities
– Heavy metals (Hg, As, Pb)
– Pesticides
– Formaldehyde
– Nitrosamines
– Phthalates
– Diethylene glycol
– 1,4-dioxane
– Polycyclic aromatic hydrocarbons (PAHs)
– Volatile organic compounds…
Microbiological evaluation
Microbiological testing of cosmetics
identifies microbial contamination,
including:

1/ Total plate count

2/ Yeast and mold
3/ Pathogens
4/ Preservative challenge test…
Common types of microbes affecting cosmetics

Pseudomonas aeruginosa – Bacteria

Staphylococcus aureus – Bacteria

Escherichia coli – Bacteria

Candida albicans – Fungus-yeast

Aspergillus brasiliensis – Fungus-mold

 Shelf life and stability
Cosmetic product expiration dates should be
established as determined by shelf-life and stability
testing

The purpose of stability testing cosmetic products is

to ensure that a new or modified product meets the
intended physical, chemical and microbiological
quality standards as well as functionality and
aesthetics when stored under appropriate
conditions.
Stability testing for cosmetic shelf life
Cosmetics naturally degrade over time, and stability
testing via the manipulation of storage temperature
and other factors can reveal the extent to which they
degrade by measuring factors such as:

Product response to heat,

humidity, and light
Stability testing for cosmetic shelf life

The natural degradation

rate of key ingredients

A product’s ability to resist

microbial intrusion
Stability testing for cosmetic shelf life

The product’s reactivity to

packaging materials

Impurities exacerbated by
the manufacturing process
 Stability testing for cosmetic shelf life
Whether conducted in real time or under accelerated
conditions, tests should be done in order to assure:

1/ Stability and physical integrity of cosmetic products

under appropriate conditions of storage, transport and use

2/ Chemical stability,

3/ Microbiological stability,

4/ The compatibility between the contents and the container

 Parameter variability during product shelf life

1/ Color, odor and appearance

2/ Changes in the container
3/ pH
4/ Viscosity
5/ Weight changes
6/ Microbial tests demonstrating the ability of the products
to prohibit microbial growth during normal use and other
specific tests if necessary
7/ Analytical data in relation to other parameters for
specific product types
 Stability tests
Physical and chemical integrity tests: evaluate
color, odor / fragrance, pH value, viscosity, texture,
flow, and emulsion stability (signs of separation)

Microbiological stability tests: evaluate the degree

of contamination with bacteria, mold, and yeast.

Packaging stability tests: evaluate the impact of

packaging on the contained product.
Typical physical and chemical integrity tests

Temperature variations tests

Centrifuge tests

Cycle tests

Lighting tests

Mechanical shock tests

Microbiological stability tests

Screening tests

Quantitative tests
 Packaging stability tests

Glass tests

Leaking tests

Weight loss tests

Stability testing for cosmetics is typically performed when:

A new product is developed;

An existing on-market product has been reformulated;

The production method has been modified, or production

has moved to a new facility or vendor; and/or
packaging has changed.

Currently, little published research exists to support

specific methods for predicting cosmetic shelf life.
 7 steps for stability testing
1/ Batch Production

2/ Product Container Filling

3/ Initial Test (Time Point Zero)

4/ Product Storage

5/ Product Evaluation

6/ Determine Stability

7/ Conclusion Report
Efficacy testing of
cosmetics
Efficacy testing of cosmetics
Common efficacy testing of cosmetics
Patch tests with sensitive skin
Rejuvenating tests
Smoothing tests
Cleansing tests
Anti-acne tests
Anti-wrinkle tests
Skin whitening test cách làm ra các
Anti-aging tests loại anti này
Anti-oxidative tests
Skin moisturizing tests
Skin protection tests…
 Tools for efficacy
testing of cosmetics
 pH meter
Ions movement principles
For evaluation of shampoo & cleansers
 TEWA meter
Transepidermal water loss(TEWL)
Measurement of the quantity of water that passes through
the epidermal layer
Usual use in the integrity & health of skin
For evaluation of moisturizers & cleaners
 Corneometer
Measurement of hydration in the stratum corneum

For evaluation of moisturizers & cleaners

 Sebumeter
Determine the sebum level of the skin surface, as well as
on scalp and hair

The measurement is based on grease spot photometry

For evaluation of anti acne & cleaners

 Mexameter
Two components, mainly responsible for the color of the
skin: melanin and hemoglobin(erythema)
The measurement is based on absorption/reflection
Emits 3 specific light wavelengths. A receiver measures the
light reflected by the skin
For evaluation of lightening & anti inflamatory
 VisioLine
Analyze the deeper lines and macro wrinkles
Oblique lighting at an angle of 35°
The mountains in the replica representing the wrinkles of
the skin produce measurable shadows
For formulation and efficacy testing of anti-wrinkle
products, especially suitable for the large wrinkles
 Frictiometer
Measure the friction values on the skin
A constant rotational speed is applied onto the skin by the
friction head. The torque is measured and the result is
displayed as Frictiometer units
The measurement is suitable for comparison measurements,
rather than absolute measurements
 Cutometer
Measurement of skin elasticity

Measure elasticity of the upper skin layer using negative

pressure which deforms the skin mechanically

For the evaluation of moisturizers, anti wrinkles, anti

ageing & stiffening products
Study design
Study design
Study design
Study design
Safety assessment
of cosmetics
Difference between hazard & risk
Hazard
Potential to cause injury
Intrinsic properties of compound
No relationship with dose or exposure

Risk
Calculated probability of harm
Related to exposure in a specific situation
It concerns you
Risk = Hazard x Exposure
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
Safety evaluation of cosmetics
 Types of risks
Local toxicity

System toxicity

Microbiological contamination
 Types of risks
Local toxicity

Skin irritation

Eye irritation

Skin sensitization

Phototoxicity…
 Types of risks
System toxicity

Organ toxicity

Carcinogenicity

Genotoxicity

Mutagenicity

Reproductive toxicity…
 Types of risks
Microbiological contamination
Bacteria

Mold

Yeast

Fungi
 Sources of risk
Unsuitable ingredients

Inadequate microbial quality control

Presence of banned/restricted substances

Unexpected interaction between ingredients…

 Chemicals of concern
Parabens
1,4-Dioxane
Heavy metals (As, Pb, Hg…)
Triclosan
Fragrance
Phthalates
Coal tar
Formaldehyde
Benzalkonium chloride
Toluene
Hydroquinone
Diethanolamine
SLS
Nitrosamines…
Chemicals of concern
 Safety testing in cosmetics
1/ Acute toxicity
2/ Subchronic toxicity
3/ Skin sensitization
4/ Skin absorption
5/ Skin irritation
6/ Mucous membrane irritation
7/ Phototoxicity and photomutagenicity (in
case of UV-light absorbing substances
Safety testing in cosmetics
8/ Mutagenicity
9/ Toxicokinetics
10/ Teratogenicity,
11/ Reproduction toxicity,
12/ Carcinogenicity,
13/ Genotoxicity
14/ Metabolism studies
15/ Human data (if available)…
Good luck…