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لإمارات للمواصفات والمقاييسهيئة ا Emirates Authority For Standardization & Metrology (ESMA)
النظام الإماراتي للرقابة على مستحضرات التجميل و العناية الشخصية
UAE Scheme for Cosmetics and Personal Care
دةدولة الإمارات العربية المتحUNITED ARAB EMIRATES
حقوق الطبع محفوظة لهيئة الإمارات للمواصفات والمقاييس
ميلادي 1013/ الموافق لـ /
UAE Scheme for Cosmetics and Personal Care Products
Article (1)
Terms and Definitions
1.1 The following terms and phrases shall have the meanings hereby assigned to them unless the context
demands otherwise:
- Country: The United Arab Emirates
- Authority: Emirates Authority for Standardization and Metrology (ESMA)
- Board: Board of the Directors of the Authority
- Director General: Director General, ESMA
- Competent Authorities: All those federal and local governmental authorities of the country who
have been authorized to implement the requirements of this scheme.
- Scheme: UAE Scheme on Cosmetics and Personnel Care.
- Supplier:
o If the product manufacturer is a resident of the country: Any person who provides his identity
as a maker of the product by designating the product on his name or any relevant trade
description, as well as any person who modifies the product.
o If the product manufacturer is not a resident of the country: Manufacturer’s representative in
the country or the importer in the absence of the representative in the country.
o Each professional of the supply chain, and who may have a role that has an impact on the
safety features of the product.
- UAE Standard: A document stating the features, descriptions, properties, quality, dimensions and
specifications or the safety and security requirements of a commodity, material, service. It also
includes the terms, symbols, test methods, sampling, packing, labeling and marks.
- Conformity Assessment: The process that verifies the fulfillment of the approved scheme or
technical regulations or standards. The subject field of conformity assessment includes activities
such as inspection, testing, certification or any other related activities.
- Emirates Conformity Assessment Scheme (ECAS): The UAE scheme that verifies the fulfillment
of the approved standard and includes activities such as inspection, testing and/or calibration,
certification.
- Cosmetics and Personal Care: Any substance or mixture intended for use on external parts of the
human body with a view exclusively or mainly to cleaning them, perfuming them, changing their
appearance, protecting them, keeping them in good condition or correcting body odors.
- Nanomaterial: An insoluble or bio-persistent and intentionally manufactured material with one or
more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
- Date of minimum durability: The date until which the cosmetic product, stored under appropriate
conditions, will continue to fulfill its initial function and, in particular, will remain in conformity
with Article 4 of this scheme.
1.2 For the purpose of this scheme, the terms and definitions of the mentioned national standards shall
apply unless the context indicates otherwise.
Article (2)
Implementation Scope
This scheme is applicable to (1) all types of cosmetics and personal care products including those used in
hotels, spas, fitness centers, saloons, etc. (2) launching, handling, exhibition and selling of cosmetics and
personal care products in the local markets and shops and facilities related to these products. Medicinal
products, medical devices, biocidal products etc. are not covered under this system.
Article (3)
Responsibilities of Implementation
3.1 The Authority
1. Issuing UAE standards for the cosmetics and personal care products.
2. Registration and issue of ECAS certificates for cosmetics and personal care products
3.2 The supplier
1. The supplier shall comply with all the requirements of this system.
2. The supplier shall ensure that the product(s) is (a) complying with requirements specified in Article
(4) and it shall be evidenced by the ECAS certificate.
3. The supplier shall have and retain the all the relevant documents including the test reports in support
of the above and make them available to all those who are implementing this system.
4. The supplier shall immediately inform the authorized bodies and the market surveillance authority in
case it is found that the product(s) released in to the market is unsafe or can pose risk to the end user.
5. The supplier shall extend full cooperation to all the relevant authorities in the implementation of this
system.
3.3 The ports and custom departments in the country
The ports and custom departments shall allow only those products to enter the country which have
ECAS certificates. The ports and customs department shall take appropriate action in collaboration
with the Authority in the case of unregistered products (products without ECAS certificate).
3.4 The competent authority
They shall ensure that only registered products are sold in the market and take appropriate action in
case of violation in collaboration with the authority.
Article (4)
Technical Requirements of the Product(s)
4.1 Safety and Quality Requirements:
1. They shall be completely free from substances or derivatives which are prohibited by Islam. Ex.
Pork, lard.
2. They shall be safe for human health when used under normal or reasonably foreseeable conditions of
use.
3. The product(s) shall comply with the requirements of UAE.S GSO 1943 (Annex 1).
4. The product(s) shall pass the applicable safety tests as mentioned in Annex 1.
5. The product(s) shall be accompanied by Cosmetic Product Safety Report in accordance with
Annex3.
6. The product(s) should be homogenous, stable and their properties shall not change during its shelf
life when stored and used as per the instructions.
7. The presentation of a cosmetic product, particularly its form, odor, color, appearance, packaging,
labeling, volume or size should not be confused for food products as it may result in unintended use
(consumption) which may be dangerous.
4.2 Manufacturing Requirements
The manufacturing organization shall comply with the requirements of ISO 9001 and GSO.ISO
22716.
4.3 Metrological Requirements
The product(s) shall comply with the metrological requirements of UAE.S GSO OIML R 87.
4.4 Packaging Requirements
1. The containers used for cosmetics and personal care products shall comply with article 3 of
UAE.S/GSO ISO 22715 (packaging and labeling). In the case of glass containers they shall also meet
the requirements of UAE.S/GSO 2093.
2. The cosmetic product shall be packed in appropriate containers which are clean, do not interact with
the cosmetic product or vice versa, and it shall be ensured that containers are properly closed.
4.5 Labeling Requirements:
1. All the information (textual and non-textual) appearing on the label shall be truthful and accurate and
shall not be misleading.
2. The product labeling shall comply with the requirements of UAE.S GSO 1943.
3. All the information appearing on the label shall be in both English and/or Arabic.
4. The expiry date of the cosmetic product shall be, expressed by ‘date of minimum durability’ or
‘period after opening’, to be indicated clearly and precisely. The term date of minimum durability is
used in the case of expiry date is equal to or less than thirty months while the term ‘period after
opening’ is used in the case of more than thirty months.
a. The date of minimum durability shall be indicated by the month and year or the day, month and
year, in that order. In any case it shall be preceded by either the symbol 1 of Annex 4 or by the
phrase “best used before the end of”. If necessary this information shall be supplemented by an
indication of the conditions which must be satisfied to guarantee the stated durability.
b. The period after opening shall be indicated by month and/or years preceded by the symbol 2 of
Annex 4.
c. The above requirements are not applicable in the cases where the concept of the durability after
opening is not relevant, that is to say for single-use products, products not at risk of deterioration
or products which do not open.
5. All the ingredients present in the form of nano-materials shall be clearly indicated in the list of
ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.
6. The following shall not appear on the labeling:
a. Pictures and illustrations those are inconsistent with the prevailing social customs and values of
the UAE.
b. Medical claims without authentic evidence
Article 5
Surveillance and Market Monitoring
5.1 ESMA and /or the competent authorities have the right to take the samples from the market for testing to
check the compliance of the product(s). In case of non-compliance, necessary measures shall be taken
against the supplier and supervise to withdraw and /or recall the non-compliance product(s).
5.2 All the fees of market sampling and testing shall be paid by the supplier, if the product sample failed to
meet the applicable requirements of this scheme.
ticle 6Ar
Violations and Penalties
6.1 When any violation is committed against any provision(s)/rule(s) of this scheme, all measures, actions
and penalties shall be taken against perpetrator or the responsible person as stipulated in Federal Law no.
(28) for the year 2001 (for establishing ESMA) and its amendments.
6.2 In case of finding any violation(s) to this scheme, necessary immediate action(s) shall be taken to
resolve the issue and remove its traces from market which includes:
i. Instructing the responsible party to withdraw the product from market with the aim of
rectification or sending it back to the country of origin or destroying it with in the
defined period of time.
ii. Implement all the required actions to withdraw and /or recall the product(s) or any
other necessary corrective actions. The violated party shall bear all the related fees.
7 Any un-authorized use of ECAS certificate and / or Emirates Quality Mark by any person or
organization shall be subjected to punishment as per the above mentioned law without violation to
any other punishment law.
8 Retailor is responsible if he fails to identify the source of the supply of the non-complying product.
Article 7
General Rules
1. It is prohibited to import, manufacture, sell, store, promote or distribute freely any product that
contradicts the articles of this scheme.
2. ESMA is responsible to implement this scheme.
3. ESMA is in charge to prepare the appropriate procedures, in coordination with the competent
authorities, that are necessary to implement this scheme.
4. All those who are connected with this scheme, private and / or public sectors, shall extend full
support to ESMA and the competent authorities to smoothly execute the implementation of this
scheme.
Annexes
Annex (1) Details of Applicable Standards
Annex (2) List of applicable tests for various cosmetic product categories
Annex (3) Cosmetic Product Safety Report
Annex (4) Symbols used on packages and containers
Annex 1
Details of Applicable Standards
# Standard Number Standard Title
1. UAE.S GSO 1943 Cosmetic products – cosmetic Products safety requirements
2. GSO UAE OIML R 87/200 Quantity of Product in Prepackages
3. UAE.S GSO ISO 22715 Cosmetics -Packaging And Labelling
4. UAE.S GSO ISO 22716 Cosmetics - Good Manufacturing Practices (GMP) - Guidelines On Good
Manufacturing Practices
5. UAE.S ISO 10130
Cosmetics -- Analytical methods -- Nitrosamines: Detection and
determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC,
post-column photolysis and derivatization
6. UAE.S ISO 16212 Cosmetics -- Microbiology -- Enumeration of yeast and mould
7. GSO ISO 18416 Cosmetics - Microbiology - Detection of Candida albicans
8. GSO ISO 18415 Cosmetics -Microbiology -Detection Of Specified And Non- Specified
Microorganisms
9. ISO 21149 Cosmetics -- Microbiology -- Enumeration and detection of aerobic
mesophilic bacteria
10. ISO 21150 Cosmetics -- Microbiology -- Detection of Escherichia coli
11. ISO 22717 Cosmetics -- Microbiology -- Detection of Pseudomonas aeruginosa
12. ISO 22718 Cosmetics -- Microbiology -- Detection of Staphylococcus aureus
13. UAE.S GSO 917 Metal Aerosol Dispensers
14. UAE.S GSO 918 Methods of testing Metal Aerosol Dispensers
15. UAE.S/GSO ASTM 640 06 Standard Test Method for Preservatives in Water-Containing Cosmetics
16. UAE.S/GSO 2093 Glass containers used for cosmetics
17. 80/1335/EEC Methods of analysis for checking the composition of cosmetic products
18. 82/434/EEC Methods of analysis for checking the composition of cosmetic products
19. 83/514/EEC Methods of analysis for checking the composition of cosmetic products
20. 93/73/EEC Methods of analysis for checking the composition of cosmetic products
21. 95/32/EEC Methods of analysis for checking the composition of cosmetic products
22. 96/45/EEC Methods of analysis for checking the composition of cosmetic products
Annex 2
List of applicable tests for various cosmetic product categories
Cosmetics Category Required Tests Test Standards
1. Creams, emulsion, lotions,
gels and oils for the skin
(hands, face, feet, etc.)
Toxic Metals
Preservatives
Hydroquinone
Zinc
Ammonia
salicylic acid
80/1335/EEC
83/514/EEC
95/32/EC
96/45/EC
2. Face masks (with the
exception of peeling
products).
Toxic Metals
Preservatives
80/1335/EEC
96/45/EC
3. Peeling products Toxic Metals
Preservatives
sorbic acid
salicylic acid
propionic acid
hydroquinone
80/1335/EEC
96/45/EC
95/32/EC
4. Tinted bases (Liquids, pastes,
powders).
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
5. Make-up powders, after-bath
powders, hygienic powders,
etc.
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
6. Toilet Soaps, deodorant
soaps, etc.
Toxic Metals
Preservatives
Zinc
1,4 Dioxane
80/1335/EEC
96/45/EC
7. Bath and shower
preparations (salts, foams,
oils, gels, etc.)
Toxic Metals
Preservatives
Zinc
1,4 Dioxane
80/1335/EEC
96/45/EC
8. Depilatories Toxic Metals
Preservatives
Thioglycolic acid
80/1335/EEC
83/514/EEC
96/45/EC
9. Deodrants and anti-
perspirants
Toxic Metals
Preservatives
Zinc
Zinc 4-Hydroxybenzene sulphonate
In non-aerosol antiperspirants:
zirconium
zirconium
aluminium and chlorine
93/73/EEC
96/45/EC
80/1335/EEC
95/32/EC
93/73/EEC
10. Hair Care Products
Hair Tents and bleaches Toxic Metals
Preservatives
Hydrogen peroxide
Resorcinol
Oxidation Colourants
Alpha Naphthol
Oxalic Acid
80/1335/EEC
82/434/EEC
96/45/EC
Products for waving,
straightening and fixing
Toxic Metals
Preservatives
Free sodium and Potasium
Hydroxide
Oxalic Acid
Free formaldehyde
quinolin-8-ol and bis(8-
hydroxyquinolinium) sulphate
nitromethane
Thioglycolic acid
80/1335/EEC
82/434/EEC
83/514/EEC
96/45/EC
Setting products Toxic Metals
Preservatives
Oxalic Acid
80/1335/EEC
96/45/EC
Cleansing products (lotions,
powders, shampoos)
Toxic Metals
Preservatives
Resorcinol
Zinc
1,4 Dioxane
80/1335/EEC
82/434/EEC
96/45/EC
Conditioning products
(lotions, creams, oils).
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
Hairdressing products
(lotions, lacquers,
brilliantine’s).
Toxic Metals
Preservatives
Zinc
80/1335/EEC
Anti-dandruff Shampoos Toxic Metals
Preservatives
Resorcinol
Zinc
1,4 Dioxane
silver nitrate
93/73/EEC
80/1335/EEC
82/434/EEC
93/ 73/EEC
96/45/EC
selenium disulphide
11. Shaving Products (Creams,
Foams, Lotions, etc.)
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
12. Products for making up and
removing makeup from the
face and the eyes.
Toxic Metals
Preservatives
Zinc
Zinc 4-Hydroxybenzene sulphonate
80/1335/EEC
96/45/EC
13. Products intended for
application to the lips.
Toxic Metals
Preservatives
Zinc
93/73/EEC
96/45/EC
14. Products foe care of the teeth
and the mouth.
Toxic Metals
Preservatives
Zinc
chloroform
Fluoride
Diethylene glycol
Hydrogen peroxide
80/1335/EEC
83/514/EEC
96/45/EC
15. Products for nail care and
make-up
Toxic Metals
Preservatives
Zinc
Free sodium and potassium
hydroxide
Hydrogen peroxide
soluble barium and soluble strontium
in the form of salts or lakes
93/73/EEC
96/45/EC
16. Products for external intimate
hygiene.
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
17. Sunbathing products Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
18. Products for tanning without
sun
Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
19. Skin-whitening products Toxic Metals
Preservatives
Zinc
Hydroquinone
mercury
80/1335/EEC
83/514/EEC
96/45/EC
20. Anti-wrinkle products Toxic Metals
Preservatives
Zinc
80/1335/EEC
96/45/EC
21. Test for any cosmetic coming
in metallic packs
Nitrite 82/434/EEC
22. Finger Paints and kids face
painting
Free Formaldehyde
Preservatives
Benzoic acid
pH
toxic metals
82/434/EEC
96/45/EC
23. All the above categories of
cosmetics except deodorant
and after shave lotion
Enumeration of yeast and mould
Detection of Candida albicans
Enumeration and detection of
aerobic mesophilic bacteria
Detection of Escherichia coli
Detection of Pseudomonas
aeruginosa
Detection of Staphylococcus aureus
Nitrosamines
Secondary alkyl- and alkanolamines
and their salts
Annex 3
Cosmetic Product Safety Report
The cosmetic product safety report shall contain the following:
PART A- Cosmetic product safety information
1. Quantitative and qualitative composition of the cosmetic product
The qualitative and quantitative composition of the cosmetic product, including chemical
identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where
possible) and their intended function. In the case of perfume and aromatic compositions,
description of the name and code number of the composition and the identity of the
supplier.
2. Physical/chemical characteristics and stability of the cosmetic product
The physical and chemical characteristics of the substances or mixtures, as well as the
cosmetic product. The stability of the cosmetics product under reasonably foreseeable
storage conditions.
3. Microbiological quality
The microbiological specifications of the substance or mixture and the cosmetic product.
Particular attention shall be paid to cosmetics used around the eyes, on mucous
membranes in general, on damaged skin, on children under three years of age, on elderly
people and persons showing compromised immune responses.
4. Impurities, traces, information about the packaging material
The purity of the substances and mixtures.
In the case of traces of prohibited substances, evidence for their technical unavoidability.
The relevant characteristics of packaging material, in particular purity and stability.
5. Normal and reasonably foreseeable use
The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.
6. Exposure to the cosmetic product
Data on the exposure to cosmetic product taking into consideration the findings
under Section 5 in relation to
1) The site(s) of application;
2) The surface area(s) of application;
3) The amount of product applied;
4) The duration and frequency of use;
5) The normal and reasonably foreseeable exposure route(s);
6) The targeted (or exposed) population(s). Potential exposure of a specific population
shall also be taken into account.
The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. expo sure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary expo sure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).
Particular consideration shall be given to any possible impacts on exposure due to particle
sizes.
7. Toxicological profile of the substances
Shall contain the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.
All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.
Particular consideration shall be given to any possible impacts on the toxicological profile
due to
— particle sizes, including nanomaterials,
— impurities of the substances and raw material used, and
— interaction of substances.
9. Undesirable effects and serious undesirable effects
All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.
10. Information on the cosmetic product
Other relevant information, e.g. existing studies from human volunteers or the duly
confirmed and substantiated findings of risk assessments carried out in other relevant
areas.
:Public Health & Safety Department Organization Unit : الوحدة التنظيمية
Form sheet title: Cosmetics, Personal Care, and Perfumes
Label Assessment Application Procedures :اسم النموذج
Doc Ref. DM-PH&SD-P5-TG3 رقم النموذج:
1/5 2012 1
Cosmetics, Personal Care, and Perfumes Label Assessment
Application Procedures
:Public Health & Safety Department Organization Unit : الوحدة التنظيمية
Form sheet title: Cosmetics, Personal Care, and Perfumes
Label Assessment Application Procedures :اسم النموذج
Doc Ref. DM-PH&SD-P5-TG3 رقم النموذج:
2/5 2012 1
1. The purpose of the procedures
To ensure the conformity of cosmetics, personal care products, and perfumes to
the conditions and specifications of the implemented standards, and thus allowing
importers, producers and traders of cosmetics, personal care products, and
perfumes to avoid the rejection of their shipments that arrive to Dubai’s ports or
avoid withdrawal of their products from the domestic market
2. Field of application
All importers, manufacturers and traders of cosmetics, personal care products, and
perfumes or who want to import, manufacture, and trade these products.
3. Responsibility
3-1 Head of the Consumer Safety Products Section
3-2 Head of the Evaluation and Registration Team
3-3 Senior Consumer Safety Products Officer
3-4 Consumer Safety Products Officer
4. Definitions
4-1 Cosmetic, personal care, or perfume product: is 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 an intention of exclusively or mainly to clean, perfume, change
appearance, correct body odors, protect and/or keep these parts in good
condition
4-2 Cosmetic, personal care, and/or perfume companies: are trading
companies licensed in the UAE and have an activity that is related to
importing and/or manufacturing of cosmetics, personal care, or perfumes
5. Inputs
:Public Health & Safety Department Organization Unit : الوحدة التنظيمية
Form sheet title: Cosmetics, Personal Care, and Perfumes
Label Assessment Application Procedures :اسم النموذج
Doc Ref. DM-PH&SD-P5-TG3 رقم النموذج:
3/5 2012 1
5-1 Authenticated free sale certificate from the country of origin stating that
the product is sold freely in the country of origin
5-2 Product composition and ingredients concentrations report issued by the
manufacturer
5-3 Safety assessment for the nano products
5-4 Product chemical and physical analysis report
5-5 Clinical studies of the product efficacy and proven effectiveness
5-6 Certificate of the animal or non-animal source of some ingredients (stearic
acid, magnesium stearate, sodium stearate, gelatin…)
5-7 Good manufacturing practice (GMP)
5-8 Clinical studies of some non-medical claims indicated on the product label
5-9 Lab test report (see Technical Guidelines 7)
5-10 Organic certificate
6. Details of Procedures
6-1 The company representative must register the company using the e-form
through Dubai Municipality website http://www.dm.gov.ae and then
he/she must choose “register” from the user login field
6-2 The company representative must fill in the form that is available in the
consumer product safety section service site to apply and pay the fees.
6-3 The company representative must submit an artwork* of the cosmetics,
personal care, and perfumes product through the e-form while making
sure that the product label carries information identical to that on the
application form of the cosmetics, personal care, and perfumes and the
representative must submit copy of all required documents (see inputs 5)
6-4 After the completion of all of the requirements a label assessment
certificate ** of the cosmetics, personal care, and perfumes product is
already made for applying company indicating the following:
:Public Health & Safety Department Organization Unit : الوحدة التنظيمية
Form sheet title: Cosmetics, Personal Care, and Perfumes
Label Assessment Application Procedures :اسم النموذج
Doc Ref. DM-PH&SD-P5-TG3 رقم النموذج:
4/5 2012 1
In case there is no missing information or no need for modification
“no remarks” must be written in the remarks field
In case there is missing information and there is a need for
modification all the required amendment must be indicated in the
remarks field, and the product must not be traded until the
amendment is done and the product is reassessed
If the product is found to be medicated or with medical purposes and
not cosmetics, personal care, or perfumes or needs to be classified it
will be referred to the Ministry of Health
6-5 The company representative can check the application status through the
e-form application and once it is finished the company representative can
get a scanned copy of the label assessment certificate or can visit the
section counter to receive the label assessment certificate.
*Artwork Specification:
The artwork must have the following specification including:
The artwork must be clear and in six dimension covering all the
product
The artwork must be colored with light color background
The artwork must be in JPEG format
The artwork must be in high definition
**:
The cosmetics, personal care, and perfumes label assessment is
valid for two years from the date of issuing if it does not carry any
remarks
:Public Health & Safety Department Organization Unit : الوحدة التنظيمية
Form sheet title: Cosmetics, Personal Care, and Perfumes
Label Assessment Application Procedures :اسم النموذج
Doc Ref. DM-PH&SD-P5-TG3 رقم النموذج:
5/5 2012 1
The cosmetics, personal care, and perfumes label assessment is
valid for six months from the date of issuing if it carries remarks
7. References
7-1 Local Circular No. (11/2003) for the year 2003
7-2 Cosmetics, Personal Care, and Perfumes circular 15/02/2010
7-3 Cosmetics, Personal Care, and Perfumes technical guidelines (European
regulation (EC) 1223)