GUIDELINES FOR REGISTRATION OF COSMETICS IN

SRI LANKA
The objective of regulation of cosmetics is to provide safe and quality cosmetics to the people of Sri Lanka, at a
standard equal to that of comparable countries. To achieve this, regulators and industry should work together to
meet common goals. The purpose of this guideline is to provide guidance and inform marketing authorization
holders and consumers on the methods and criteria employed by the regulatory authorities on determining the
suitability for registration as a cosmetic, describes the requirements for registration and how applications should
be made.

The basis for the regulatory control comes from the Cosmetics, Devices and Drugs Act No. 27 of 1980.
All cosmetics marketed in the country whether manufactured here or imported must be registered in compliance
with the regulations published under the authority of these laws (Regulation No 38 of 1984).

OBJECTIVE OF REGISTRATION

• To ensure that cosmetic products in Sri Lanka are safe and not injurious to health.

• To prohibit the use of certain toxic substances as ingredients in cosmetic products.

• To ensure that cosmetic products are properly labelled with batch markings and listing of
ingredients used.
DEFINITIONS

AMENDEMENTS TO THE Definition in the Cosmetics, Devices and Drugs Act No. 27 of 1980
as any substance or preparation or device intended to be applied to the human body for cleansing, improving
or altering the complexion, skin, hair, teeth or mucous membranes of the oral cavity without affecting the
body’s structure or function.
Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, nail polishes, eye and
facial make-up preparations, shampoos, permanent waves, hair colours, tooth pastes, deodorants and any
ingredient intended for use as a component of a cosmetic products and cosmetic devices. Soap products making
no label claim of human use are not considered as cosmetics under the law.
PRODUCT
An ingredient(s) in a cosmetic dosage form having a singular identity, composition characteristic and origin
PRODUCT VARIANT
For the purpose of this guideline product variants shall mean “items in a range of cosmetic products which are
produced by the same manufacturer that are similar in composition and are intended for the same use but are
available in different colours, fragrances or flavours”.
 Colour shall mean a substance used as an ingredient of cosmetic product solely to give colour to the
product
 Fragrance shall mean a substance used as an ingredient of cosmetic product solely to impart odour to
the product and
 Flavour shall mean a substance used as an ingredient of cosmetic product solely to impart taste to the
product.

NATURAL PRODUCT COSMETICS

Products formulated from herbs, animal and mineral must be registered with the CDDA if intended to be used
as a cosmetic.

WHEN DOES A COSMETIC BECOME A DRUG?

Products that are cosmetics but also exert a therapeutic effect (intended to treat or prevent disease, or affect the
structure or functions of the body) will be considered to be a medicine irrespective of whether therapeutic
claims are made on the label or in advertising material. Even if a product is intended for marketing as a
cosmetic it would be determined to be either “cosmetic” or “medicine” depending on;
• Its Ingredients
• Its route of administration
• Therapeutic claims made on its label / or in advertising
One of the main factors in determining whether a product is a cosmetic or a medicine, is on the claims made for
the product There are also several indicators that a cosmetic product has a proposed therapeutic use. Intended
use may be established in a number of ways. Among them are:

 Claims stated on the product labeling, in advertising, on the Internet, or in other promotional
materials. Certain claims may cause a product to be considered a drug, even if the product is marketed
as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat
or prevent disease or otherwise affect the structure or functions of the human body. Some examples are
claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.

 Consumer perception, which may be established through the product's reputation. This means
asking why the consumer is buying it and what the consumer expects it to do.

 Ingredients that may cause a product to be considered a drug because they have a well known (to
the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principal also holds true for essential oils in fragrance products. A fragrance marketed for promoting
attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions
that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its
intended use

Such products must comply with both the drug and cosmetic provisions of the law.
REGULATION OF COSMETIC PRODUCTS
The government of Sri Lanka regulates the manufacture, sale and importation of cosmetic products by requiring
that all cosmetic products be registered before they can be manufactured, supplied, distributed or sold. The
details of the registration procedures can be found under the proceeding topics
WHO SHOULD APPLY FOR A PRODUCT LICENCE

Person(s) who import or manufacture cosmetic products or have products imported or manufactured on their
behalf are responsible for applying to the Drug Regulatory Authority (DRA), to have their products registered.
The applicant shall be responsible for the product and all information supplied in support of his application for
registration of the product
PRODUCTS FROM MULTIPLE SOURCES

Products with the same formulation and the same name but sourced from different manufacturing sites shall be
registered separately.
HOW AND WHERE TO FILE

Application forms are available from the DRA. The duly completed application should be submitted in English
in a hard cover file in duplicate to the DRA, 120
Norris Canal Road, Colombo 10.
If more than one application is submitted, there shall be no cross reference from one application to another, i.e.
information supplied in one application and also
required in other applications shall be repeated in those other applications. .For products classified under the
category “ Product Variant” shall be allowed to
be registered under one application but with separate fees for each variant.
TEST MARKET SAMPLING OR SAMPLES FOR STUDY PURPOSE
The industry maybe allowed manufacturing or importing unregistered products for the sole purpose of a
selective test sampling or clinical studies before its registration. However, prior approval from the DRA must
be obtained for such activities.
RESPONSIBILITY OF REGISTRATION HOLDER
The registration holder either manufacturer or importer must in writing declare that they are responsible for
ensuring safety quality and efficacy of the registered cosmetic product and that the product complies with all
existing regulations. Responsibilities include
 Using raw materials which are safe and at the allowed concentration
 Practicing good manufacturing practices
 Ensuring appropriate packaging material is used to guarantee quality of product
 Executing suitable quality control
 Having effective procedure for handling any adverse effects that may occur with the product when used
VALIDITY OF REGISTRATION

Full Product Registration

Full registration of a cosmetic will be valid for a period of 5 years. Renewal of registration to
be done every five years.
Provisional registration
Under certain circumstances provisional registration may be granted for a period of one year. Provisional
registration will be granted for a
 New cosmetic product
 New manufacturer
 New formulation of an existing product
 Products which have been suspended due to quality problems will be given provisional registration on
reapplication for registration
Applications that do not provide the required documentation as outlined above for registration of a cosmetic
product will not be granted provisional registration pending submission. The registration process will be
stopped at that moment of time till all documents are furnished
AMMENDMENTS OR CHANGE IN A REGISTERED COSMETIC

Following registration of a cosmetic, the holder of the certificate of registration should notify the authorities of
 any material changes that have been made or that are proposed to be made to the relating to the
registered cosmetic product
 any new information regarding the safety of the cosmetic product or active ingredients/ excipients used
in the product.
DOCUMENTS WHICH MUST ACCOMPANY APPLICATION FORMS FOR REGISTRATION OF A COSMETIC

The application should contain all the information detailed below in support of their proposal to
register a cosmetic product

 Name and address of applicant

 Status of applicant : Manufacturer / Importer
 Name and address of manufacturer
 Name and address of person responsible for marketing the cosmetic
 Name of cosmetic : Brand name / Official or Approved name
 Classification of cosmetic : Controlled / General (Refer Annexure 1)
 Product category of cosmetic: Refer Annexure 11
 Formulation and package content:
 Composition:
 Certificate of analysis from a laboratory acceptable to the DRA Sri Lanka (Refer Annexure).
 Certificate of free sales (CFS) - certificate from the health authority or a recognized body of the country
in which the cosmetic is produced confirming that the cosmetic is in use there and the period of use, if
not available state reasons.
 Fully packed sample of the cosmetic in the form that it will be offered for sale
 A sample of the label used in the containers and
 A sample of the package insert
 For controlled cosmetics a certification of observance to Good Manufacturing Practices (GMP) - This
certificate must be from the country of manufacture and issued by the health authority or recognized
body.
All supporting documents in languages other than English must be translated to English.
In addition the company shall
 Submit the smallest possible pack size of the product.
 Submit labels, package inserts and outer carton of each pack size if the label contents and presentations
are different.
Additional details regarding the application shall be submitted if and when requested by the Licensing
Authority.
CLASSIFICATION OF COSMETICS
For the purpose of registration, cosmetic products will be categorised according to their level of risk into two
groups.

Cosmetic

Controlled Cosmetics General cosmetics

CONTROLLED COSMETICS

They are cosmetic products that have the potential to be absorbed through the skin or mucous membrane or
contain substances that maybe harmful or are promoted for use in children. This category is subject to stringent
control.
The Controlled Cosmetics are listed in Annexure 1.

GENERAL COSMETICS

All cosmetic products not listed under controlled cosmetics

COSMETIC PRODUCT CATEGORIES

Cosmetics shall be further categorised according to the intended purpose of use.
The “Cosmetic Product Categories” are listed in Annexure 2
EVALUATION PROCEEDURE OF A COSMETIC PRODUCT
COSMETIC EVALUATION SUBCOMMITTEE (CESC)
All properly submitted applications for registration as cosmetics will be reviewed by the Cosmetic Evaluation
Subcommittee (CESC) appointed by the Cosmetics, Devices and Drugs Technical Advisory Committee (TAC).
The CESC will meet regularly on scheduled dates once every 4 - 6 weeks and review the applications according
to a established review procedure. Minutes of each meeting will be maintained. At each meeting the minutes of
the previous meeting will be confirmed and sent to the TAC. The decision of the CESC will be communicated
in writing to the applicant. In case of a negative decision a clearly stated reason (s) for the negative decision
will be communicated to the applicant. In the case of a provisional registration any requirement and suggestions
of the CESC will be communicated to the applicant.
ELEMENTS OF THE REVIEW PROCESS
Basic Criteria for a cosmetic product
A cosmetic product should fulfill at least the following three criteria
1. Active ingredient (s): The active ingredient should have low inherent toxicity (e.g. no carcinogenic
properties, minimal allergenic effects) relevant for human use unless such an hazard can be appropriately
addressed by labelling).
2. Intended use: Should be appropriate for classification as a cosmetic.
3. Product properties: The product should not have an unfavorable adverse event profile that needs
physician’s supervision during use. Claims that indicate the product is a therapeutic agent cannot be made
for a product marketed as a cosmetic.
If the cosmetic meets the three basic criteria it will also need to comply with relevant statutory standards, meet
labelling requirements, and compliance of manufacturing process with the Sri Lanka / WHO code of Good
Manufacturing Practice (GMP).

ASSESSMENT OF QUALITY, SAFETY, STABILITY AND EFFICACY

Different kinds of evidence such as traditional use or epidemiological data and registration in reference
authorities will be taken into account when evaluating for Safety, Quality, Stability and Efficacy.
GENERAL COSMETICS
A cosmetic will be assessed with reference to the following:
1. The list of prohibited / allowable ingredients / preservatives / colourants as specified in the Sri Lanka
Standards (SLS 457 part 1 and 11), European Union (EEC) Cosmetics Directives, or standard reference
texts and the knowledge and experience of the Cosmetic Evaluating Subcommittee (CESC)
2. “Finished Product Specification” as specified in the Sri Lanka Standards Finished Product Specification /
or a Reference Authority (UK, USA, EEC, Australia, India). An analytical certificate from laboratories
 acceptable to the CESC (see annexure 2) should be provided. If the product contains ingredients not
included in official lists their specifications and testing methods should be included
3. Sterility: Cosmetics need not be sterile, however, they must not be contaminated with microorganisms,
which may be pathogenic, and the density of non -pathogenic micro- organisms should be low. In addition,
cosmetics should remain in this condition when used by consumers. The cosmetic will have to conform to
the accepted microbial limits as specified by the Sri Lanka Standards Institute / Reference Authority.
4. Stability data for the cosmetic should be furnished.

CONTROLLED COSMETICS

In addition to the above a controlled cosmetic will be assessed with reference to the following:
5. Adherence to Good Manufacturing Practices (GMP)
6. Cosmetics authority strongly urges controlled cosmetic manufacturers to conduct whatever toxicological or
other tests as appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not
adequately substantiated, it should bear the statement.
“Warning - The safety of this product has not been determined.”

PACKAGING
Liquid oral hygiene products (e.g. mouthwashes, fresheners) and all cosmetic vaginal products (e.g. pessaries,
tablets) must be packaged in tamper resistant packages when sold at retail .The package is considered tamper
resistant if it has an indicator or barrier to entry which if breached or missing alerts a consumer (e.g. shrink or
tape seal, sealed carton, tube or pouch aerosol container) that tampering has occurred. The tamper resistant
feature may involve the immediate or outer container or both. The package must also bear a prominently placed
statement alerting the consumer to the tamper resistant feature.
ADULTERATED / MISBRANDED / COUNTERFEIT COSMETIC
A cosmetic will be considered adulterated if it contains a substance which may make the product harmful to
consumers under normal conditions of use, if it contains a filthy, putrid or decomposed substance, if it container
is composed of a harmful substance, or if it is manufactured or stored under unsanitary conditions, or contains a
non - permitted colour. Rigorous adherence to Good Manufacturing Practices (GMP) guidelines is expected at
all times of manufacture and storage.
A cosmetic will be considered misbranded if its labelling is false or misleading, if it does not bear the required
labelling information, or if the container is made or filled in a deceptive manner.
A cosmetic will be considered counterfeit if it is deliberately and fraudulently mislabeled with respect to
identity and /or source.
LABELLING REQUIREMENTS
The containers of all cosmetics imported, manufactured, processed or packed locally or sold or exposed for sale
should have labels bearing the following information.
GENERAL COSMETICS
 The brand name, type of product / Botanical names of ingredients will not be permitted as brand names
 Product category
 The weight / volume of contents
 The date of manufacture
 If it is not stable for at least 36 months include “Best used before” / Expiry date - The date should be
clearly stated and shall consist of the month and the year in that order
 The batch number or lot number assigned by the manufacturer
 The product registration number (optional)
 Country of manufacture and the name and address of the manufacturer
 The name and address of the company or person responsible for marketing the product locally.
 The function of the product unless it is clear from the presentation of the product
 Instructions on use unless it is clear from the product type or presentation
 Special precautions to be observed in its use
 Warning statements ( See Annexure 4)

CONTROLLED COSMETICS

In addition to the labelling requirement stipulated above, cosmetics classified as “ controlled cosmetics” are
required to bear
• An ingredient declaration.
Ingredient names used should be specified according to nomenclature in the International Cosmetic Ingredient
Dictionary (INCI), British Pharmacopoeia (BP), United States Pharmacopoeia (USP), Chemical Abstracts
Service (CAS) or such other approved nomenclature. The ingredient declaration must be conspicuous, so that it
is easily read at the time of purchase. It may appear on any information panel of the outer container or if not
packaged in an outer container on the jar, tube or bottle containing the product. The declaration may also appear
on a tag or card that is firmly affixed to the container. The name of each ingredient used should be declared in
descending order of predominance except that fragrances or flavour may be listed as fragrance or flavour. A
cosmetic will be considered to be misbranded if its labelling is false or misleading or does not bear the required
labelling information.
The source of any bovine-derived materials used, as ingredients in cosmetic products must be declared in both
controlled / general cosmetics. The information should include the type of bovine-derived materials used i.e.
type of tissue or organ used and the country of origin of the bovine-derived materials.
LANGUAGE AND LETTER SIZE FOR LABELS
All items should have their labeling at least in the English language, but preferably in all three languages
(English, Sinhala, and Tamil). The letters of which, must not be less than0.75mm high in the case of a small
label, not less than 1.5mm high in any other case of an inch in height.
FORMAT FOR CONSUMER INFORMATION
Consumer product information when deemed necessary by the CESC will be in the following formats.
Directions on use
Warnings e.g.; Do not use this product if you are----------------
Ask the doctor before use ----------------------
Stop using this product if -----------------------
Therapeutic claims either actual or implied are not appropriate in the labelling of cosmetics
Annexure V contains examples of claims that are cosmetic - oriented and will be acceptable the authority.
COSMETIC ADVERTISING
♦ No person should advertise any cosmetic / cosmetic device which is not registered with the Authority
♦ No person shall import into the country advertising material of any cosmetic, which is not registered with
the Authority.
♦ No person shall make any false or exaggerated claim for any cosmetic or misuse research results or
quotations from scientific literature to support such claim
♦ All advertising material should be sent to CESC for approval before advertising on the public media.
♦

REPORTING OF ADVERSE REACTIONS

The registration holder or consumer is requested to inform the DRA any adverse reaction (s) due to the
registered product immediately. Reports should include details of

• The complainants name, address and contact telephone number

• Details of the reaction

 ANNEXURE 1
Cosmetics will be broadly classified as
• Controlled cosmetics
• General cosmetics

CONTROLLED COSMETICS :
These include products that have the potential to be absorbed through the skin or mucous membranes and baby
products.
- Products for application in the area around the eyes (except eye brow products)
Oral care products -the only benefits claimed to result
from the use of the product must
be consequential on improvements
to oral hygiene, including for the
prevention of tooth decay or the
use of fluoride for the prevention
of tooth decay; and
(b) benefits in relation to other
diseases or ailments, eg gum or
other oral disease or periodontal
condition, must not be claimed to
result from use of the product
-
- Hair dyes contaninig phenylendiamine, toluenediamine, their salts and derivatives
- Hair growth promoters
- Sun - tanning preparations intended to protect against sunburn – not be presented as having a sun
protection factor of more than 15; and not be presented as water-resistant not have a therapeutic
claim ,including any representation about skin cancer, made for it;
- Skin lightener products
Anti - Dandruff agents -The product must be presented as
controlling or preventing dandruff only
through cleansing, moisturising,
exfoliating or drying the scalp
-
- Baby products
- Lip products
- Vitaminised / Hormone / Placenta containing products
- Healthcare antiseptic products
- Pediculocide shampoo
- Anti perspirants / Deodarants
 - Medicated soaps
- Insect repellants

GENERAL COSMETICS :
Cosmetics which are not listed under controlled cosmetics

ANNEXURE 2
Accredited laboratories

ANNEXURE 3: LABEL WARNINGS

EXAMPLES OF WARNING STATEMENTS

 Identifying a product as being intended for use exclusively by adults are :

“Keep out of reach of children or for adult use only.
 Aerosol Products - Cosmetic aerosol products must bear the following label statement
Warning - Avoid spraying in eyes. Contents under-pressure. Do not puncture or incinerate. Do not store at
temperature above 120 degree. F. Keep out of reach of children.
 Feminine Deodorant Sprays
Products whose labelling states or suggests that the product is for use in the female genital area or for use all
over the body must bear the following label statement.
For external use only. Spray at least 8 inches from skin. Do not apply to broken, or irritated, or itching skin.
Persistent, unusual odour or discharge may indicate conditions for which a physician should be consulted.
Discontinue use immediately if rash, irritation, or discomfort develops.
 Bubble Bath Products
A foaming detergent bath product (bubble bath product) is defined as any product intended to be added to the
bath for the purpose of producing foam and containing a surface active agent serving as a detergent or foaming
agent. Children’s bubble bath products, and all foaming detergent bath products, not labelled as intended for
use exclusively by adults, should bear adequate directions for safe use and this caution:
Use only as directed. Excessive use or prolonged exposure may cause irritation to the skin and urinary tract.
Discontinue use if rash, redness, or itching occur. Consult your physician if irritation persists. Keep out of reach
of children.
 Hair dye Products
A hair dye products should bear a statement
This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test
according to accompanying directions should be first be made. This product must not be used for dying the
eyelashes or eyebrows, to do so may cause blindness.
 Depilatories and Hair Straighteners -
Should provide explicit warnings and directions for safe use.
 Products containing Oestrogenic Hormones placental Extract or Vitamins
Products containing estrogen, estrone, estradiol, progesterone, placental extract or vitamins may be considered
drugs, particularly if the label declaration is supplemented with standards implying prevention or treatment of
disease or effect on the structure or any function of the human body.
The oestrogen content of an OTC product be it a drug or a drug as well as a cosmetic may not exceed 10,000 IU
/ ounce. Users must be directed to limit the amount of product applied daily so that no more than 20,000 IU or
equivalent be used per month.
 Suntan Products
They should have the warning statement – If itching, or rash occurs stop using and consult your doctor
 Baby powder
Should have the warning statement “Not for use on newborn baby's naval."
 Body powder / suspension containing boric acid or sodium borate or menthol or camphor
Should carry the warning statement “ Do not use in children under 3 years of age” and “ Do not inhale or
swallow as it maybe harmful “.
 Bleaching preparations containing hydroquinone
Hydroquinone in concentrations of 2.0% for OTC use, while 4% concentrations are allowed for professional
use only.
Should carry the warning statement " avoid contact with eyes"
Test for allergic reactions before use (see PIL for test method)
Avoid sunlight on the area
Stop using if a rash or irritation occurs or if there is no improvement after 1month of continued use
 Anti dandruff preparations containing aluminium pyrithione
Should carry the warning statement
Avoid contact with eyes
Stop using if a rash or irritation occurs.
Do not use in children under 6 years.
 Fluoride toothpastes
Should carry the warning statement "Children under 7 years should use a very small amount (pea size) of
toothpaste and should not swallow"
 Products containing aluminium acetate ( 0.13% - 0.5%)
Should carry the warning statement "For external use only. Avoid contact with the eyes"
 Products containing Hamamelis water
Should carry the warning statement "For external use only. Avoid contact with the eyes"
 Egg Shampoos
A preparation that contains less than one egg per shampoo should not be referred to as an egg shampoo and the
word egg should not be used as part of the name of the preparation.
 Topically applied cosmetic products containing alpha hydroxy acids (AHAs)

AHAs may increase the sensitivity of skin to the sun while the products are used and for up to a week after use
is stopped, and that this increased skin sensitivity to the sun may increase the possibility of sunburn. Alpha
hydroxy acids are organic acids with a hydroxyl group on the carbon adjacent to the carboxylic acid group. The
predominant AHAs present in cosmetic products are glycolic acid and lactic acid. Other AHAs used in
cosmetic products include citric acid, -hydroxyoctanoic acid, and -hydroxydecanoic acid.

Labeling of a cosmetic product that contains an AHA as an ingredient and is intended for topical application to
the skin or mucous membrane should bear a statement that conveys the following information.
Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to
the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this
product and for a week afterwards.
Antibacterail products: Skin care Antibacterial skin products The product must:
(a) be presented as being active only
against bacteria; and
(b) not be presented as being:
(i) active against viruses, fungi or
other microbial organisms
(other than bacteria); or
(ii) for use in connection with
disease, disorders or medical
conditions; or
(iii) active against a named
bacterium that is known to be
associated with a disease,
disorder or medical condition;
or

(iv) for use in connection with

piercing of the skin or mucous
membrane, for cosmetic or any
other purpose; or
(v) for use in connection with any
procedure associated with the
risk of transmission of disease
from contact with blood or
other bodily fluids; or
(vi) for use before physical contact
with a person who is accessing
medical or health services, or
who is undergoing any
medical or health care
procedure; or
(vii) for use in connection with a
procedure involving
venipuncture or delivery of an
injection

Anti-acne products (including

spot treatments, cleansers, face
scrubs and masks)
The product must be presented as
controlling or preventing acne only
through cleansing, moisturising,
exfoliating or drying the skin
 CHECK LIST FOR ACCEPTING A NEW COSMETIC APPLICATION

Heading P * x Comments
Administrative data
Free sales certificate
Classification of cosmetic
Product category of cosmetic
Methods of preparation
Formulation and package content
Analytical report
Lead, arsenic content where
applicable
List of active Ingredients
List of colouring agents, pigments
and colour additives
Toxicity tests where applicable
Product information leaflet
Clinical experience where
applicable

Labelling assessment check list

Requirement P * x Comment
Label written in
English
Sinhalese
Tamil
Lettering is clear, distinct and legible
Label is firmly and securely attached to the
container
Lettering on the label is;
not be less than0.75mm high in the case of a small
label, not less than 1.5mm high in any other case

Any written or pictorial or descriptive matter on or

attached to or supplied or displayed with the
product
• does not contradict or modify any statement or
label required by the regulations
• is not false or misleading in any way
Contains a description that indicates the nature of
the product eg. toothpaste, shampoo
The name and address of the manufacturer / local
agent
List of ingredients where applicable
Weight / volume of the contents
The batch number
The best use before / expiry date
Warning statement / special precautions if
applicable
Instructions on use
P data available * send data x data not required
References
1. Subchapter G Cosmetics in Code of Federal Regulations. National Archives and Records Administration,
USA. 1995; Part 700: 175 - 203
2. Cosmetics Act 1992 Ministry of Health, Thailand
3. Cosmetic Claims Guidelines. National Coordinating Committee on Therapeutic Goods, Therapeutic goods
Administration. Australia
4. Cosmetic Registration Scheme, Malaysia httpp:/www.serve.com/bpfk/html/cosmetic/registration products
guidelines.htm

Compiled and edited by Dr BMR Fernandopulle,

Secretary Cosmetics Evaluation Subcommittee,
Senior Lecturer Faculty of Medicine Colombo.

The views all members of the Cosmetics Evaluation Subcommittee listed below contributed to the document.
Mrs S Tennekoon
Mr RLA Warakagoda
Mr P Madarasingha
Mr W Pathirana
Ms TPM de Silva
 ANNEXURE 4 COSMETIC CLAIMS GUIDELINES

ACCEPTABLE VERSUS UNACCEPTABLE LABEL CLAIMS

A claim can be a word, a sentence, a paragraph, or simply an implication. The following tables show examples
of acceptable and unacceptable claims. Column A contains claims that are clearly acceptable for a cosmetic
while column C contains claims that are clearly unacceptable for a cosmetic. Column b is in between and the
choice of words could make it acceptable or not. These examples should be taken only as a guide and are not to
be taken as the final authority.

Subject Column A Column B Column C

Acceptable wording for a Maybe acceptable if modified Unacceptable wording for a
cosmetic to provide a cosmetic cosmetic (but not necessarily
implication acceptable for a drug)

• medicinal (therapeutic)
Active ingredient • cosmetic active ingredient
ingredient
Ageing, anti-wrinkle • cover up (hide) age spots • any references to fading age
(blemishes, dark spots (depigmentation leaching
pigmented areas) of the skin)
• feel (look) younger • temporarily reduces depth
(youthful) of wrinkles by • eliminates (prevents. Stops.
• helps prevent (reduce, moisturisation Reduces, slows, reverses)
slow) the signs ageing (wrinkles, premature
(appearance) of ageing • anti-ageing (anti-wrinkle) ageing, ageing process)
(age lines, premature
ageing)
• moisturize ageing skin
• smoothes wrinkles
Astringent • refreshes * (warms, cools, • energizes (stimulates, • decongests skin
tightens, tones) skin invigorates) skin ** • removes toxins
• stimulates circulation
Bio, biological • bio (biological) • action (mechanism) due to
biological/physiological activity
• bio active (cellular)
• biological performance
(function)
• growth (repair) (metabolism)
(structural change)
Comedomes, acne, • cleaner for acne-prone • prevent (stop) (heal0
pimples, blackheads skin comedones (pimples) (acne)
• cover (hide) comedones (blemishes)
(acne, blemishes)
• removes oil
Counter creams *** • any reference to treatment
reduction) of cellulite (orange
peel skin)
• enhances (smoothes) (contours)
 your silhouette
• lose inches, removes fat,
• reduces (controls) puffiness
(swelling0 (oedema)
• restructures skin
• slimming
• tighten (firm) sagging skin
(eyelids) (chin) (muscles)

* Usually contains alcohol or equivalent

** Cosmetic sense of astringent by means of physical surface effect (eg. aftershave lotion)
*** See also - Astringent, skin

Subject Column A Column B Column C

Acceptable wording for a Maybe acceptable if Unacceptable wording for a
cosmetic modified to provide a cosmetic (but not necessarily
cosmetic implication acceptable for a drug)

Dentifrice - • cleans (whitens, brightens • any implication of effect

toothpastes polishes) teeth below the gumline
• removes stain • references to abscess,
• prevent (reduce) plaque antiseptic action, gumboil,
(tartar) build-up (deposit) gingivitis, inflammation of
by brushing (other gums, mouth ulcers,
mechanical means) periodontitis, pyorrhoea,
• helps maintain healthy periodontal disease,
teeth and gums sensitivity, stomatitis,
• tooth decay - fluoride thrush
protects against, reduces
cavities
Deodorant • absorbent that helps keep • helps keep you dry • antiperspirant *
you dry • controls moisture (sweat)
• anti-odorant (deodorant) (perspiration)
• fights bad odour
• kills odour-causing
bacteria
Hair • removes (washes) (cleans) • makes your hair • control (eliminate)
loose dandruff (flakes) stronger dandruff
from the hair. • dandruff (anti-dandruff)
• Add body to (colour) (after shampoo (formula)
shape of ) hair • alopecia
• Help make hair look • prevent (stop) (cure) hair
thicker (fuller) loss, hair thinning
• Revitalise appearance (baldness)
(look) of hair, restore • replace thinning hair
beauty (luster) (sheen) tot • restore hair cells
he hair • stimulate hair follicles
• Promotion luster (growth)
 Subject Column A Column B Column C
Acceptable wording for a Maybe acceptable if Unacceptable wording for a
cosmetic modified to provide a cosmetic (but not necessarily
cosmetic implication acceptable for a drug)

Healthy • healthy ** looking • healthy (healthy tan)

(healthy rowing) • promotes (restores) health
appearance
• feels healthy
Mouthwash • fight (reduce) (end) bad • references to plaque • antiseptic (antiviral)
breath (mouth odours) or tartar (see under germicide
• helps eliminate (kill) Dentifrice) • kills pathogens (germs)
odour causing bacteria (odour-causing germs)
(bacteria that cause bad • antibacterial
breath) (antimicrobial)
Nails • repair fingernails • reference to growth • reference to growth
resulting from resulting from nourishing
protection of fingernails
fingernails (eg. by a
nail hardener)
Nourish • nurture (take care of) • nourish (in the sense of
promoting growth) (skin)
(hair) (fingernails) (tissue)
• any implication of
Perfumes hormonal attraction
(fragrances, • reference to relieving
colognes, toilet stress or improving
water) physical well being (i.e
health)
Relax • relax (moisturize) skin • reference to relaxing • relax muscles
(taut skin) the body (unless this • promotes skin respiration
is in the sense of bath
oil a warm bath)
Repair • repair beauty (appearance)
Respiration • reference to non-clogging , • cellular respiratory factor
letting skin breath • promotes skin respiration
Revitalize • moisturize the skin so that • revitalize (skin) • rejuvenate, revitalize living
complexion looks radiant (scalp) (hair) tissue (eg hair follicles)
• revitalize the appearance living cells
(the look) of skin, hair,
scalp, face
Skin - ( Cleansers, • helps eliminate odour • purify • antibacterial
soap) caused by bacteria (antimicrobial)
• cleanse oily skin • antiseptic/disinfectant
• removes top layer of dead (fungicide) (germicide)
skin (virucide)
• cleans all types of skin • reference to disease-
(not just oily) causing organisms, kills
• cleans skin pathogens
• clarify, purity • anti-blemish cream
 • cleans cuts (wounds)
• helps control (treat)
infection (jock itch)
Skin (Facial Peels) • facial scrub • keratolytic • remove (reduce) scars
• smooths (retextures) skin (permanent markings)
• removes top layer of dead
skin
Skin - • moisten (hydrate) • chapped skin
(Moisturizers) (lubricate)(soften) skin • feel (look) young
dried (chapped) by the (youthful)
elements
• long lasting protection
• promotes elasticity
(suppleness) • reference to numbering
• cools skin • desensitize (makes (pain) (analgesic effects)
• desensitize razor-burned less sensitive)
skin (eg .after shave • reduce (prevent)
lotion) irritation
• prevent (protect) skin (dry • prevent (protect) • relieves (soothes) abrasions (bites) (insect b
skin) (lips) chapped damage (drying) (inflamed skin) (rashes)
(dried) against the abuse • relieves (soothes)
of the elements (solvents)* itching (due to dry
• relieves (soothes) (softens) skin)
skin (dry skin) (lips) • soothing agent**
chapped (dried) by wind
(cold) (elements)
• soothes skin, makes skin
feel fresher, smoother
• firms top layer of skin
(temporary effect only)
* Barrier creams, for example
** Soothes wind-burned skin, for example
 Subject Column A Column B Column C
Acceptable wording for a Maybe acceptable if Unacceptable wording for a
cosmetic modified to provide a cosmetic (but not necessarily
cosmetic implication acceptable for a drug)

Sun, suntan • gives skin a bronze • reference to • Helps protect (prevent) the skin
products, (suntanned) colour achieving your against burning (harmful effects
after -sun (appearance) (ie dyes)* darkest tan with less of UV rays0 (sunburn) (photo
treatments, • prevent (protects) against time in the sun. ageing)
sun drying effects of the sun • Tan enhancer • SPF number or sunscreen
protection, • moisturizer-type claims for (magnifier) category description
tanning after-sun moisturizing • Accelerates (speeds up)
acceleration creams (e.g. soothes (activates) suntan
moisturizes) skin after • Pre-tan (tanning) accelerator
tanning • reference to allowing you to
stay out in the x times longer
• screens (blocks) (filters) out
some of the sun's UV
(UVA/UVB/UVC) (harmful
rays)

Therapy, • care • bath (beauty) (dry • reference to disease control

treatment skin) treatment (treatment) (healing)
(therapy) • medicated (therapeutic)
• treatment on surface • treatment for infections (burns)
of skin
Vitamininis • Any reference to the nutriet
ed cosmetics (therapeutic) effects of vitamins
[NB: orals
vitamin
supplements
are
regulated as
medicines ,
as are
topical
products
containing
vitamins
(e.g.
creams) if
intended for
a therapeutic
effect].
• Dyes, some barrier creams, self tanners, sunless tanners for example. (This type of product should include a
warning that it does not provide sun protection.)