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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






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.

Annex 4

SYMBOLS USED ON PACKAGING/CONTAINER

1. Date of minimum durability

2. Period-after-opening

: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





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





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:

http://www.dm.gov.ae/





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





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)

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