ANNEX I Part 1
Details of Product Classification
Category I products
Category I products are products that have potential to be
absorbed through the skin mucous membrane. These products include:
-
- products for
application in the area around the eyes (except eye brow
products)
- lip
products
- oral cavity
products
- hair dyes
containing phenylenediamine, toluenediamine, their salts and
derivatives
- sun tanning
products containing topical dyes or tan accelerators, applied over
a large area of the body and remain in contact with the skin
solely for the purpose of browning the skin
Category II products
Category II products are products other than the ones listed
in Category I. They include:
- Hair dyes
not containing phenylenediamine, toluenediamine, their
salts and derivatives
- Sun tanning
products not containing topical dyes or tan
accelerators.
Products for application on the hair, scalp, skin, without
rinsing including but not exclusive to: -
- Deodorants
- Skin
lotion/ creams
- Shaving
preparations
- Oils
- Cheek
colours
- Foundations
- Eyebrow
colours
- Nail
preparations
- Depilatories
- Hair
preparations
- Face
packs
- Face/ body
masks
- Bar
soaps
- Perfumes
- Talcum
powders
Products, which remain in traces after rinsing or use
including but not exclusive, to: -
- Bath oils,
salts and other bath preparations
- Hair
shampoo, conditioner, treatment
- Shaving
foam
- Body/ face
cleanser
Other products not listed here
ANNEX I Part 2
List of
Recognized Bodies for CFS and GMP Certification
Credible
Certificate of Free Sale (or alternatives) and recognized bodies for
CFS (or alternatives)
Listed below but not limited to:
|
Country |
Type of
Certification & Its Recognized
Bodies |
|
Argentina |
Self-issued CFS endorsed by
Argentina Chamber of Commerce |
|
Australia |
CFS by Pharmaceutical Service
Branch (PSB), State Health Department |
|
|
CFS by State and Territory chambers
under ACCI ( Australian Chamber of Commerce and
Industry) |
|
|
Certificate to allow/permit sale by
PSB above |
|
|
CFS by Australian
CTFA |
|
|
CFS by Australian
Industry Group |
|
Austria |
Self issued CFS endorsed by
F.C.I.O. - Fachverband der Chemischen Industrie
Osterreich |
|
Belgium |
CFS by Belgium Commercial &
Industrial Chamber, Ministry of Public Health |
|
|
Self-issued CFS endorsed by
Ministere Des Affaires Sociales De La Sante Et De
D'Environnement
and Inspection des Denrees
Alinmentaires |
|
Canada |
CFS by CCTFA ( Canadian Cosmetic ,
Toiletry and Fragrance Association) |
|
China |
CFS issued
by China Toothpaste Industry Association (CTIA)
|
| CFS by
State Hygiene Bureau |
|
|
Certificate of Health issued by
Provincial Institute of Health Inspection |
|
|
CFS by CAFFCI (China Association of
Fragrance Flavour and Cosmetic Industry) |
|
France |
Self-issued CFS endorsed by the
F.I.P. (Federation des Industries de la
Parfumerie) |
|
Germany |
Self-issued CFS endorsed by I.K.W.
(Industrieverband Koperflege und Waschmittel e.V) – The German
Cosmetic , Toiletry , Perfumery and Detergent
Association |
|
|
CFS by Veterinary
Affairs and Food Inspection Specialist
Department |
|
Greece |
Self-issued CFS endorsed by E.O.F.
National Drug Organization - Department of
Cosmetics |
|
Hong Kong |
Certificate of Origin issued by
Federation of Hong Kong Industries |
|
India |
CFS by State Licensing
Authorities |
|
Indonesia |
CFS by NADFC ( National Agency For
Drug and Food Control )/Badan Pengawas Obat &
Makanan |
|
Ireland |
CFS by Department of Health and
Children |
|
Italy |
Self-issued CFS endorsed by UNIPRO
(Unione Nazionale delle Industrie di Profumeria, cosmesi,
saponi da toeletta e affini) |
|
Japan |
CFS by Ministry of Health , Labour
& Welfare (MHW) |
|
|
Certificate to allow/permit sale by
MHW |
|
|
CFS by JCIA (Japan Cosmetic
Industry Association) |
|
Korea |
CFS by Korea Food & Drug
Administration |
|
|
CFS by Korea Cosmetic Industry
Association |
|
Luxembourg |
Self-issued CFS endorsed by
Laboratoire de Controle des Desress
Alimentaires |
|
Mexico |
CFS by Mexico Ministry of
Health |
|
Netherlands |
CFS by Health Inspectorate
|
|
|
Self-issued CFS endorsed by Chamber
of Commerce |
|
Philippines |
CFS by Bureau of Food and Drugs
(BFAD) |
|
|
Certificate of product registration
by BFAD |
|
|
Certificate of Export by
BFAD |
|
Poland |
Self-issued CFS endorsed by Polish
Chamber of Foreign Trade |
|
Portugal |
Self-issued CFS endosed by FIOVDE -
Federacao das Industrias de Oleos Vegetais, Derivados e
Equiparados |
|
Singapore |
CFS Issued by Trade Development
Board of Singapore |
|
Spain |
CFS by Ministerio de Sanidad y
Consumo - Dirrecion General de Farmacia y Productos
Sanitarios |
|
|
CFS by STANPA ( Asociacion Nacional
de Fabricantes De Perfumeria Y Afines) |
|
Sweden |
Self-issued CFS endorsed by
Lakemedelfverket (Ministry of Health) |
|
Switzerland |
CFS by Kantonales Laboratorium
Aargau ( KLA) |
|
|
CFS by Swiss Cosmetic and Detergent
Association |
|
|
Self-issued CFS endorsed by Chamber
of Commerce |
|
Taiwan |
CFS by Bureau of Pharmaceutical
Affairs, Department of Health (DOH) |
|
|
Certificate to allow/permit sale by
DOH |
|
Thailand |
CFS by FDA, Ministry of Health
|
|
|
Certificate of Origin by FDA,
Ministry of Health. |
|
UK |
CFS by Department of Trade &
Industry (DTI) - Import Licensing Board |
|
|
Certificate to allow/permit sale by
DTI |
|
|
Self-issued CFS endorsed by the
Department of Trade Industry (DTI) |
|
USA |
CFS by City/State Health
Department |
|
|
Certificate to allow/permit sale by
the City/State Health Department |
|
|
CFS statement by US CTFA
|
|
|
Export Certificate by Department of
Health Services |
| UAE (United Arab
Emirates) |
CFS issued by
Chamber of Commerce |
|
Vietnam |
CFS by Department of Drug
Management (Ministry of Health) |
|
|
Certificate of Health issued by
Directorate for Standards and
Quality |
Credible
Certificate of Good Manufacturing Practice (or its alternative) and
recognized bodies for GMP (or alternative)
Listed below but not
limited to:
|
Countries |
Types of
Certification & Its Recognized Bodies |
|
Australia |
GMP (for anti-perspirant and
sunscreen only) by TGA ( Therapeutic Goods Administration
) |
|
|
License to Manufacture by TGA (
Therapeutic Goods Administration ) |
|
GMP by State and Territory chambers
under ACCI ( Australian Chamber of Commerce and
Industry) |
|
|
GMP by Australian
CTFA |
|
|
CFS by Australian
Industry Group |
|
Austria |
Self-issued CFS endorsed by
F.C.I.O. - Fachverband der Chemischen Industrie
Osterreich |
|
Belgium |
GMP by Belgium Ministry of Public
Health |
|
|
Self-issued GMP endorsed by
Ministere Des Affaires Sociales De La Sante Et De
D'Environnement
and Inspection des Denrees
Alinmentaires |
|
Canada |
GMP by CCTFA ( Canadian Cosmetic ,
Toiletry and Fragrance Association) |
|
China |
GMP issued
by China Toothpaste Industry Association
(CTIA)
|
| Hygiene & Production License by Province
authority |
|
|
Health License for Enterprises of
Cosmetic Products by Public Health Department |
|
|
Certificate of Health issued by
Provincial Institute of Health Inspection |
|
|
GMP issued by CAFFCI ( China
Association of Fragrance Flavour and Cosmetic
Industry) |
|
France |
Self-issued GMP endorsed by the
F.I.P. (Federation des Industries de la
Parfumerie) |
|
Germany |
Self-issued GMP endorsed by I.K.W.
(Industrieverband Koperflege und Waschmittel e.V) – The German
Cosmetic , Toiletry , Perfumery and Detergent
Association |
|
Greece |
Self-issued GMP endorsed by E.O.F.
National Drug Organization - Department of
Cosmetics |
|
India |
GMP by State Licensing
Authority |
|
|
GMP by Bureau of Indian Standards
|
|
Italy |
Self-issued GMP endorsed by UNIPRO
(Unione Nazionale delle Industrie di Profumeria, cosmesi,
saponi da toeletta e affini) |
|
Indonesia |
GMP by NADFC ( National Agency For
Drug and Food Control )/Badan Pengawas Obat &
Makanan |
|
Japan |
Manufacturing License by the
Prefectural Government |
|
|
GMP by JCIA (Japan Cosmetic
Industry Association) |
|
Korea |
GMP by Korea Food & Drug
Administration |
|
|
GMP by Korea Cosmetic Industry
Association. |
|
Luxembourg |
Self-issued GMP endorsed by
Laboratoire de Controle des Desress
Alimentaires |
|
Mexico |
GMP by Mexico Ministry of
Health |
|
Monaco |
GMP by Sanitary and Social Action
Direction |
|
Netherlands |
GMP by Health
Inspectorate |
|
New Zealand |
GMP by CTFA |
|
Philippines |
GMP by Bureau of Food and Drugs
(BFAD) |
|
|
License to Operate by
BFAD |
|
Poland |
Self-issued GMP endorsed by Polish
Chamber of Foreign Trade |
|
Portugal |
Self-issued GMP endorsed by FIOVDE
- Federacao das Industrias de Oleos Vegetais, Derivados e
Equiparados |
|
Singapore |
License to Manufacture issued by
Health Science Authority |
|
Spain |
GMP by Ministerio de Sanidad y
Consumo - Dirrecion General de Farmacia y Productos
Sanitarios |
|
|
GMP by STANPA ( Asociacion Nacional
de Fabricantes De Perfumeria Y Afines) |
|
Sweden |
Self-issued GMP endorsed by
Lakemedelfverket (Ministry of Health) |
|
Switzerland |
Self-issued GMP endorsed by
Intercartonal Office For the Control of
Medicines |
|
|
Self-issued GMP endorsed by
Kantonales Laboratorium Aargau |
|
|
GMP by Swiss Agency for Therapeutic
Products |
|
Taiwan |
Manufacturing License by the Bureau
of Pharmaceutical Affairs, Department of
Health |
|
Thailand |
GMP by FDA, Ministry of Health
|
|
United Kingdom |
Self-issued GMP endorsed by the
Department of Trade Industry (DTI) |
|
USA |
GMP by US CTFA |
|
|
Export Certificate by Department of
Health Services |
|
|
General GMP statement by City/State
Health Department |
| UAE (United Arab
Emirates) |
GMP issued by
Chamber of Commerce |
|
Vietnam |
Certificate of Health issued by
Directorate for Standards and
Quality |
ANNEX I Part 3
Non-Permissible Claims For Cosmetic
Products
Cosmetic products should not make claims that are regarded as
medicinal in nature.
This list is not
an exclusive or exhaustive listing.
The examples in
the table should be used as a guide. However, it is prudent for
applicant to seek legal or expert advice to ensure that the proposed
claims are not in breach of existing Acts or
Regulations.
| Subject |
Non-Permissible Claims for Cosmetic
Products |
| Active
Ingredient |
medicinal
(therapeutic) ingredients |
| Ageing |
- eliminate age spots
- de-pigmentation
- bleaching of the skin
- eliminate aging
- eliminate aging process
- stop
aging
- stop
aging process
- reverse
aging
- reverse
aging process
- prevent
aging
- prevent
aging process
|
| Astringent |
|
| Acne, pimple,
blackheads, comedones |
- stop
acne
- heal
acne
- prevent
acne
- stop
pimple
- heal
pimple
- prevent
pimple
- stop
blackhead
- heal
blackhead
- prevent
blackhead
- stop
comedone
- heal
comedone
- prevent
comedone
|
| Contour
creams |
- weight
loss
- removal
of cellulite
- removes
fat
- reduce
swelling (oedema)
- control
swelling (oedema)
|
| Dentifrice |
- abscess
- antiseptic action
- gumboil
- gingivitis
- inflammation of gums
- mouth
ulcers
- periodontitis
- pyorrhoea
- periodontal disease
- sensitivity
- stomatitis
- thrush
|
| Hair |
- eliminate dandruff
- control
dandruff
- eliminate seborrheic dermatitis
- alopecia
- stop
hair loss
- cure
hair loss
- stop
baldness
- cure
baldness
- replace
hair
- restore
hair cells
|
| Healthy |
- restores health (refers to general health)
|
| Mouthwash |
- antiviral
- antiseptic
- germicide
- kills
pathogens
- antibacterial
- antimicrobial
|
| Nails |
|
| Perfumes
(fragrances, colognes, toilet water) |
- any
implication of hormonal attraction
|
| Relax |
- relax
muscles (muscle relaxant)
|
| Skin-(Cleansers,
Soap) |
- antibacterial
- antimicrobial
- antiseptic
- disinfectant
- germicide
- fungicide
- virucide
- kills
pathogens
- heal
cuts
- heal
wounds
- treat
infection
- treat
jock itch
|
| Skin - (Facial
Peels) |
- remove
scars
- remove
permanent markings
|
| Skin -
(Moisturisers) |
- numbing
- pain
- analgesic effect
- abrasions
- bites
- insect
bites
- cuts
- nicks
- inflammed skin
- rashes
|
| Sun, suntan
products, after-sun treatments, sun protection, tanning
accelerators |
- reference to allowing you to stay out in the sun x
times longer
|
| Therapy,
treatment |
- reference to disease control (treatment)
(healing)
- medicated (therapeutic)
- treatment for infections (burns)
|
| Vitamins |
- any
reference to the therapeutic effects of vitamins
|
| Wrinkles |
- eliminate wrinkles
- stop
wrinkles
- reverse
wrinkles
- prevent
wrinkles
|
| Anti-perspiration |
- stop
sweating
- eliminate sweating
- stop
perpiration
- eliminate perpiration
|
ANNEX I Part 4
Format
for CFS and GMP Certificate
The following
certificate is not the required format but is provided by way of
example:
CERTIFICATE OF FREE SALE
Product name:
_______________
Manufacturer:
_______________
This product has been authorized to be *sold / placed in the
market place / can be freely sold / may be sold / may lawfully be
sold / is legal for distribution / for circulation / we have no
objection to the sale / distribution / circulation of this product
in this country _____________
(* The terms to be
allowed for use in a CFS format shall be as listed but not
restricted to it.)
CERTIFICATE OF GOOD MANUFACTURING PRACTICE
Manufacturer:
_________________
The manufacturer conforms to the - *current good
manufacturing practices / current good manufacturing guidelines /
code of good manufacturing practice for cosmetics / COLIPA
guidelines for good manufacturing practice / COLIPA cosmetic GMP
recommendations / principles of good manufacturing practice /
requirements of good manufacturing and quality control to ensure
that they meet the requirements of the country
or, the
manufacturer holds a valid manufacturing license according to the
regulations stipulated in the country
or, the products
manufactured in this facility in the country is in conformity
with the rules and hygiene regulations of the
country
or, this facility is subjected to inspection
by the country authority at suitable intervals according to
the regulations in the country.
(* The terms to
be allowed for use in a GMP format shall be as listed but not
restricted to it.)
ANNEX I Part 5
Guide on ‘How
to List the Ingredients’:
A
full list of ingredients must be given on the outer packaging headed
or preceded by the word INGREDIENTS. Where there is no outer
packaging the list must appear on the immediate packaging. This list
must:
- Show all
ingredients added to the product;
- Use the name
given in the Common Ingredients Nomenclature known as the INCI
name (International Nomenclature for Cosmetic Ingredients)
- In absence of
an INCIa name, use an alternative as listed in Annex I
Part 6 of this guide.
- Show
ingredients in descending order of weight, the weight determined
at the time the ingredients are added to the product.
- Ingredients
in concentrations of less than 1% may be listed in any order after
those in concentrations of 1 % or more.
- Colorants may
be listed in any order, after all the other ingredients using the
Colour Index Number or denominations (however this is not
applicable for hair dyes)
- For
decorative cosmeticsb, marketed in several colour
shades, all colouring agents used in the range may be listed
preceded by the word "may contain"
For the purposes
of labelling, the following are not regarded as cosmetic ingredients
and do not need to be shown:
- Impurities in
raw materials;
- Subsidiary
technical materials used in the preparation of the cosmetic
products but not present in the final product. For example,
alkalis used to adjust the pH at any stage of preparation would
not be declared. Similarly, solvents used for extraction purposes
but subsequently ‘driven off’ would not be listed;
- Materials
used in strictly necessary quantities as solvents or as carriers
for perfumes and aromatic compositions.
Note:
- In cases
where an ingredient does not have an INCI name or is in the
process of getting the INCI registered into the standard
references, a temporary name may be used in the Full Ingredient
Listing.
- Decorative
cosmetics are taken to be cosmetic products intended to modify the
appearance of the area to which they are applied, usually by the
use of colour. Examples are; lipstick, eye shadow, blusher, eye
pencil, liquid foundation, powder, mascara, nail polish, hair
tints and dyes, etc.
ANNEX I Part 6
List of
Standard References to be used for Cosmetic Ingredient
Nomenclature
- International
Cosmetic Ingredient Dictionary
- British
Pharmacopoeia
- United States
Pharmacopoeia
- Chemical
Abstract Services
- Japanese
Standard Cosmetic Ingredient
- Japanese
Cosmetic Ingredients Codex
