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GCC Standardization Organization (GSO) is a regional Organization which consists of the National Standards Bodies of GCC member States. One of GSO main functions is to issue Gulf Standards and technical regulations through specialized technical committees (TCs).
GSO Ministerial Committee in its meeting number () held on / / H, which corresponds to / / , has approved the update of Gulf Standard GSO 1943:2022 titled "Cosmetic Products : Safety Requirements of Cosmetics and Personal Care Products" in Arabic and English languages which was studied through the technical program of GSO Technical Committee for Cosmetics and Personal Care (TC12) in Kingdom of Saudi Arabia schedule . The Kingdome of Saudi Arabia has a deviation of item No. 2.23 where the Kingdom adopts a list of prohibited and restricted cosmetic ingredients, colorants, preservatives and UV filters published on the SFDA website.
This document will cancel and replace the Gulf Standard GSO 1943:2021.
1.1 This gulf technical regulation is concerned with the general safety requirements and parameters as well as labeling and packaging requirements that should be fulfilled by all cosmetics and personal care products. An illustrative list of these products is given in Annex 1 of this technical regulation.
1.2 The technical regulation specifies 6 main functions or purpose of use for cosmetic and personal care products, namely:
• To clean
• To perfume
• To change the appearance
• To protect
• To keep in good condition
• To correct body odors.
1.3 The field of application of cosmetics is to one or more of the following:
• The epidermis
• The hair system
• The nails
• The lips
• The teeth
• The mucous membranes of the oral cavity
• The external genital organs
1.4 Products intended to come into contact with the mucous membranes include those used:
• In the vicinity of the eyes
• On the lips
• In the oral cavity
• On the external genital organs
2.1- GSO 2020 “Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices”.
2.2- GSO 2528 “Cosmetic products – Technical Regulation of Cosmetic and Personal Care Products Claims”.
2.3- GSO ISO 18416 “Cosmetics - Microbiology - Detection of Candida albicans”.
2.4- GSO ISO 18415 “Cosmetics - Microbiology - Detection of Specified and Non- Specified Microorganisms”.
2.5- GSO ISO 10130 “Cosmetics – Analytical Methods - Nitrosamines: Detection and Determination of N-Nitrosodiethanolamine (NDELA) in cosmetics by HPLC, Post-Column Photolysis and Derivatization”.
2.6- GSO ISO 16212 “Cosmetics - Microbiology - Enumeration of Yeast and Mould”.
2.7- GSO ISO 21149 “Cosmetics — Microbiology — Enumeration and Detection of Aerobic Mesophilic Bacteria".
2.8- GSO ISO 21150 “Cosmetics - Microbiology - Detection of Escherichia Coli”.
2.9- GSO ISO 22717 “Cosmetics - Microbiology - Detection of Pseudomonas Aeruginosa”.
2.10- GSO ISO 22718 “Cosmetics - Microbiology - Detection of Staphylococcus Aureus”.
2.11- GSO ASTM E640 “Standard Test Method for Preservatives in Water-Containing Cosmetics”.
2.12- GSO ISO 17516 “Cosmetics - Microbiology--Microbiological Limits”.
2.13- GSO ISO 24443 “Determination of Sunscreen UVA Photoprotection in vitro”.
2.14- GSO ISO 21148 “Cosmetics - Microbiology - General Instructions for Microbiological Examination”.
2.15- GSO ISO 29621 “Cosmetics - Microbiology - Guidelines for the Risk Assessment and Identification of Microbiologically Low-Risk Products”.
2.16- GSO ISO 11930 “Cosmetics - Microbiology - Evaluation of The Antimicrobial Protection of a Cosmetic Product”.
2.17- GSO ISO 24442 “Cosmetics - Sun Protection Test Methods -In vivo Determination of Sunscreen UVA Protection”.
2.18- GSO ISO 24444 “Cosmetics - Sun Protection Test Methods -In vivo Determination of the Sun Protection Factor (SPF)”.
2.19- GSO 2237 “Cosmetics – Sunscreen Products”.
2.20- GSO ISO 1621 "Cosmetics - Sun Protection Test Methods - Water Immersion Procedure for Determining Water Resistance".
2.21- ISO 18861 “Cosmetics - Sun Protection Test Methods - Percentage of Water Resistance”.
2.22- GSO 917 “Aerosol Dispensers”.
2.23- Regulation (EC) No 1223/2009 of the European Parliament and of the Council*.
*Note: link below for European directive for cosmetics, which shows all current amendment’s and subsequent updates:
http://eur-lex.europa.eu/eli/reg/2009/1223.
*Note: The Kingdome of Saudi Arabia has a deviation of item No. 2.23 where the Kingdom adopts a list of prohibited and restricted cosmetic ingredients, colorants, preservatives and UV filters published on the SFDA website according to Annex 8.
For purposes of this technical regulation, terms and definitions below shall be applied:
3.1 Cosmetic and Personal Care Products
Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
3.2 Substance
A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
3.3 Mixture
A mixture or solution composed of two or more substances.
3.4 Sunscreen Product
Any preparation as, for example, cream, oil, gel, spray contains UV-filters and intended to be placed in contact with the human skin with a view exclusively or mainly to protecting it from UV radiation through absorbing, scattering or reflecting radiation.
3.5 Fragrance
Natural or synthetic substances(s) used solely to impart a pleasant smell to a cosmetic product and/or the body.
3.6 Nanomaterial
An insoluble or bio-persistent material, inten¬tionally manufactured with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
3.7 Preservative
Substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product.
3.8 Colorant
A Substance which may be added to a cosmetic product for the primary purpose of colouring the cosmetic product, the body as a whole or certain part thereof, by absorption or reflection of visible light. Precursors of oxidative hair colorants shall be deemed colorants.
3.9 UV-Filter
A substance which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation.
3.10 Impurities
They are generally minor constituents of a substance or a raw material that can originate from:
• Constituents themselves.
• The manufacturing processes.
• Chemical synthesis or interaction within the product that could occur under normal storage conditions.
• Potential migration from the final packaging to the product.
• Potential chemical changes caused by instability of the product in contact with the final packaging.
3.11 Contaminants
Unintended substances that can originate from sources outside the chemical pathway, chemical processes, unexpected situations such as bad storage of primary substances or instability of the primary packaging.
3.12 Manufacturer
Any natural or legal person who manu¬factures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark.
3.13 Importer
Any natural or legal person established within the Gulf States, who places a cosmetic product from a country outside the Gulf States into the Gulf market.
3.14 Distributor
A person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Gulf market.
3.15 Making available on the Market
Any supply of a cos¬metic product for distribution, consumption or use on the Gulf market in the course of a commercial activity, whether in return for payment or free of charge.
3.16 Single Application Products
Products intended to be used only once immediately after opening.
3.17 Free Samples
Products which are made freely available to the end user.
3.18 Impracticable Packaging Products
Products that is impossible for practical reasons to label the information on their packaging or container.
3.19 Primary Packaging
Packaging designed to come into direct contact with the contents
3.20 Secondary Packaging
Packaging designed to contain one or more primary packages and including any protective materials, if present
NOTE: For labelling purposes, the outermost packaging is considered to be the secondary packaging that holds or contains the package at the point of sale.
3.21 Multi-pack
A packaged item containing two or more products sold as a unit.
Cosmetic and personal care products shall fulfill the following requirements:
4.1 The products shall be completely free from pork and all its derivatives.
4.2 They shall be safe for human health when used under normal or reasonably foreseeable conditions of use.
4.3 They shall be homogenous, stable and their properties impacting safety, efficacy and quality shall not change during its shelf life when stored and used as per the instructions.
4.4 It should be free from any filthy or decomposed substance.
4.5 It should not contain graphics or images or phrases that are inconsistent with Islamic traditions and prevailing social values in GCC countries.
4.6 Cosmetic and personal care products shall not contain any of the following:
4.6.1 Prohibited substances which are listed in Annex 2.
4.6.2 Restricted substances which are not used in accordance with the restrictions or the limits laid down in Annex 3.
4.6.3 Colouring agents other than those listed in Annex 4 of this technical regulation with the exception of cosmetic products containing colouring agents intended solely to colour the hair.
4.6.4 Colouring agents listed in Annex 4 of this technical regulation used outside the conditions laid down therein, with the exception of cosmetic products containing colouring agents intended solely to colour the hair.
4.6.5 Preservatives other than those listed in Annex 5 of this technical regulation.
4.6.6 Preservatives listed in Annex 5 of this technical regulation, used beyond the limits and outside the conditions laid down therein, unless other concentrations are used for specific purposes apparent from the presentation of the product.
4.6.7 UV-filters other than those listed in Annex 6 of this technical regulation.
4.6.8 UV-filters listed in Annex 6 of this technical regulation, used beyond the limits and outside the conditions laid down therein.
4.7 The presences of traces of the substances listed in Annex 2 of this technical regulation shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that in conforms to the article 4.2.
4.8 Sunscreen products shall comply with the articles 5.11 and 9.9 in the standard mentioned in article 2.19 of this technical regulation.
4.9 The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 4.2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonized standards such as GSO ISO 22716.
4.10 Cosmetics and personal care products shall comply with the microbiological limits in the GSO standard in article 2.12.
4.11 The non-intended presence of small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 4.2. But In the case of its presence as an impurity, they should not exceed the following limits:
Lead:
10 ppm
Arsenic:
3 ppm
Cadmium:
Mercury:
1 ppm
Antimony:
5 ppm
1,4 - Dioxane:
10 ppm
4.11.1 The occurrences of heavy metals in the following cases: eye products or mouth products or kids' products or products with limits above these limits will be evaluated on a case-by-case basis. Products with values above these limits may undergo an assessment to determine the level of risk posed by the product, which would then determine the appropriate enforcement action according to the National Standardization Body (NSB).
All cosmetic and personal care products shall bear the fol¬lowing information in indelible, easily legible and visible lettering:
5.1 The name of the product and the name of trade mark.
5.2 The name and address of manufacturer or distributor. The name and the address shall be sufficient to identify the undertaking.
5.3 Country of origin of the product.
If two or more countries are involved in the production of a cosmetic product, the origin is obtained by the country where carried out the economically justified processing. When two or more countries have the equal cost of producing the product, a country achieved the last process of manufacturing a cosmetic product obtains the origin.
5.4 Nominal content of the product. The nominal quantities shall be expressed in UI standards units of weight or volume. The nominal content information is exempted in the following cases: for products containing less than 5ml or 5g, single-application products, free samples.
5.5 The time period, from the date of manufacturing, the cosmetic product shall fulfil its initial requirements and complies with the article 4.2 provided it is stored at the stated conditions. This date should be expressed on the primary or secondary packaging by one of the following options depending on the durability and the expiry of the product:
5.5.1 Product(s) deteriorating within 30 months from the date of manufacturing: In this case, “date of minimum durability” also known as “Expiry date” shall be clearly expressed in the order of month and year (or) the day, month and year. If necessary, this date shall be accompanied by conditions that shall be satisfied in order to guarantee the stated durability. This date shall be preceded either by the phrase “best used before the end of”’ or by the abbreviation “Exp.” or the letter “E” or by the symbol, shown in the Fig (1) of Annex 7 or a validity statement referring to the production date.
5.5.2 Product(s) deteriorating after 30 months from the date of manufacturing: In this case the manufacturer shall declare the minimum durability date as per article 5.5.1 or the time period after opening, in months (or) years in numerical numbers, during which the product is safe and cannot cause harm to the consumer. This time period shall be indicated by the symbol, shown in Fig (2) of Annex 7, and it can occur either inside or outside of the symbol.
5.5.3 The declaration of time period after opening as stated in the article 5.5.2 is not relevant in the following cases:
a) Products presented in containers where there is no need of physical opening and there is no possibility of contact between the product in the container with the external environment (e.g. sealed pressurized containers)
b) Single-application products.
c) Products with a low microbiological contamination risk such as those with pH≥10.0, pH≤3.5, high alcohol content (e.g. perfumes, eau de cologne,…)
d) Products that state Expiry date.
5.6 Conditions of use, Warning Statements and precautionary information shall clearly express on the label and the following should be considered:
5.6.1 Conditions of use and warnings for a range of ingredients listed in Column (i) of the Annexes 3 to 6 of this technical regulation shall be printed on the label of both the primary packaging or the secondary packaging. Additionally, any other information deemed necessary for the safe use or disposal of the product shall also be provided.
5.6.2 These requirements also apply to products intended for professional use, in hairdressing in particular, and careful consideration should be given as to how the product is used and whether there is increased risk due to prolonged exposure or more unusual conditions of use.
5.6.3 Where it is impossible for practical reasons to print this information on the label, the information shall be mentioned on an enclosed or attached leaflet, label tape, tag or card. This shall be referred to either by abbreviated information or by the “hand-in-book” symbol, shown in Fig (3) of Annex 7, which shall appear on the primary packaging or secondary packaging.
5.7 Batch Number or Lot Code. A code which enables the manufacturer or supplier to identify the batch in which the product was manufactured shall be marked on both the primary packaging and the secondary packaging. If the product is not made in a batch, then the code should enable the date and place of manufacture to be identified. Where it is impossible for reasons of size for the lot code to appear on both the primary packaging and the secondary packaging, it may appear on the secondary packaging alone.
5.8 Product Function. The function of the cosmetic product should be clearly printed on the primary packaging or the secondary packaging, unless it can be spontaneously and obviously deducted from a combination of:
• The product presentation (shape, size and volume) e.g. lipstick
• Its name (e.g. cream) or trademarks
• Its function claims
• Pictures, logos and figurative or other signs (e.g. the picture of an eye on an eye-shadow).
5.9 List of Ingredients shall be printed on either both primary packaging and the secondary packaging or only secondary packaging of the product or tag, cards…etc. as in article 5.9.6. The list shall be preceded by the term “ingredients”. For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing. The following shall not, however, be regarded as ingredients:
• Impurities in the raw materials used
• Subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product.
• Materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.
5.9.1 Perfume and aromatic compositions and their raw materials shall be referred to by the term ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex 3 of this technical regulation, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.
5.9.2 The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.
5.9.3 All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.
5.9.4 Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.
5.9.5 An ingredient should be identified by its common name that is its INCI name, as listed in the common ingredient’s nomenclature of the European Union.
5.9.6 Where it is impossible for practical reasons to print this information on the label, the information shall be mentioned on an enclosed or attached leaflet, label tape, tag or card. This shall be referred to either by abbreviated information or by the “hand-in-book” symbol, shown in Fig (3) of Annex 7, which shall appear on the primary packaging or secondary packaging. Where it is impracticable to label that abbreviated information or the symbol, they may be omitted.
5.9.7 For cosmetics and personal care that are supplied in neither a primary packaging nor secondary packaging and whose size, shape or texture makes it impractical to provide ingredient information as detailed above, the information may be given on a notice or leaflet in close proximity to the product offered for sale. In this case, the hand-in-book symbol (Fig (3) of Annex 7) is not needed on the package.
5.10 The requirements in article (5.1, 5.2, 5.3, 5.4, 5.5, 5.7 and 5.9) shall be in Arabic and/or English Languages. However, the following requirements shall be presented in both Arabic and English Languages on either primary or secondary packaging of the products:
• Name of the product.
• Product function and/or use instructions unless clear from product form.
• Warnings instructions and precautionary information.
• Necessary storage instructions for safe use if needed.
6.1 For toilet soap that are supplied neither in a primary packaging or secondary packaging, the name and address of the manufacturer or supplier and the batch code are required to be given on in any of the following means:
• The soap itself (but only required to be indelible until it has been put into use).
• The secondary packaging in which it is exposed for supply.
• The primary packaging in which it was packed before being exposed for supply.
6.2 Hotel Amenities are subject to all of the requirements of this technical regulation. Where labelling as per article 5.9 is impossible for practical reasons or impracticable for reasons of size or shape, the provisions detailed in (articles 5.9.6 and 5.9.7) shall apply. For example, it is acceptable for the ingredient information to be given on a leaflet or card which can be placed close to the product where the standard allows this.
6.3 Cosmetic and personal care products that are supplied as Multi-packs, ingredient labelling can be dealt with as follows:
• Where the ingredient labelling is on the secondary packaging, the ingredients for each product may be separately listed or combined into one list.
• Where labelling on the secondary packaging is impossible for practical reasons or impracticable for reasons of size or shape, the provisions detailed in (articles 5.9.6 and 5.9.7) shall apply.
• In the case of transparent packaging where the ingredient labelling of the individual products is clearly visible, secondary labelling is not required.
6.4 Cosmetic and personal care products that come in glass ampule and vials should contain the following instructions in Arabic and English:
• For external use only.
• Avoid contact with eyes.
• Open with caution.
7.1 Claims on cosmetic and personal care products shall fall under the scope in Article 1 and within the Cosmetics definition in Article 3.1 of this technical regulation.
7.2 Claims on cosmetic products shall conform to the following common criteria and shall comply with the regulation mentioned in Article 2.2:
• Legal compliance
• Truthfulness
• Evidential support
• Honesty
• Fairness
• Informed decision-making
8.1 The packaging of cosmetics and personal care products shall be designed so that, under conditions specified by the manufacturer for storage, transport and handling, it protects against damage and deterioration and it does not adversely affect the product.
8.2 Metal aerosol dispensers used for packing cosmetics and personal care products shall comply with the requirements in the standard in the article 2.22.
The following list is not exhaustive but is provided by way of example. The definition of cosmetics and personal care products provided in article 3.1 shall be used for other products:
- Creams, emulsions, lotions, gels & oils for the skin (hands, face, feet etc.)
- Face masks (with the exception of peeling products)
- Tinted bases (liquids, pastes, powders)
- Make-up powders, after-bath powders, hygienic powders etc.
- Toilet soaps, deodorant soaps, etc.
- Perfumes, toilet waters and eau de Cologne.
- Bath & shower preparations: salts, foams, oils, gels etc.
- Depilatories.
- Deodorants and anti-perspirants.
- Hair care products:
o Hair tints and bleaches
o Products for waving
o Straightening and fixing
o Setting products
o Cleansing products (lotions, powders, shampoos including anti-dandruff shampoos)
o Conditioning products (lotions, creams, oils)
o Hairdressing products (lotions, lacquers, brilliantines).
- Eye decorative cosmetic products (Eye shadow, mascara, brows and lids pencils, lashes cream,
eye-pencil (Al-Kohl)).
- Shaving products (creams, foams, lotions).
- Products for making up and removing make-up from the face and eyes.
- Products intended for application to the lips.
- Products for care of the teeth and mouth (including teeth whitening).
- Products for nail care and make-up.
- Products for external intimate hygiene.
- Sunbathing products.
- Products for tanning without sun.
- Skin-whitening products.
- Anti-wrinkle products.
Preamble to Annex 2
For the purposes of the Annex 2, the following shall be applied:
a. Rinse-off product: A cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes.
b. Leave-on product: means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes.
c. Skin product: A cosmetic product which is intended to be applied on the skin.
d. Face product: A cosmetic product which is intended to be applied on the skin of the face.
e. Hair product: A cosmetic product which is intended to be applied on the hair of head or face, except eyelashes.
f. Lip product: A cosmetic product which is intended to be applied on the lips.
g. Product applied on mucous membranes: A cosmetic product which is intended to be applied on the mucous membranes of:
- of the oral cavity.
- on the rim of the eyes.
- or of the external genital organs.
h. Nail product: A cosmetic product which is intended to be applied on nails including products for nails protection and preventing nails biting.
i. Oral product: A cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity.
j. Eye product: A cosmetic product which is intended to be applied in the vicinity of the eyes.
k. Professional use: the application and use of cosmetic products by persons in the exercise of their professional activity, product can be sold in retail but is advised to consult professional before and during usage.
l. Salts are taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines: salts of the anions chloride, bromide, sulphate, acetate.
m. Esters are taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl.
Ingredients and substances listed in Annex II of the regulation mentioned in Article 2.23 and its subsequent updates are prohibited for use in Cosmetics Products.
Ingredients and substances listed in Annex III of the regulation mentioned in Article 2.23 and its subsequent updates shall be only used in line with the mentioned restrictions.
Colorants listed in Annex IV of the regulation mentioned in Article 2.23 and its subsequent updates are allowed for use in Cosmetic Products.
Preservatives listed in Annex V of the regulation mentioned in Article 2.23 and its subsequent updates are allowed for use in Cosmetic Products.
UV Filters listed in Annex VI of the regulation mentioned in Article 2.23 and its subsequent updates are allowed for use in Cosmetic Products.
Fig (1) Date of minimum durability
Fig (2) Period- after opening
Fig (3) Reference to enclosed or attached information
Page No.
Clause/ Subclause No.
Line No.
Comment Type
Modification
1
6
2.23
16
TE
The Saudi Food and Drug Authority (SFDA) adopts a list of prohibited and restricted cosmetic ingredients, colorants, preservatives and UV filters published on the SFDA website as following:
https://sfda.gov.sa/en
Comment Type: GE= General TE= Technical ED= Editorial
Last update: 30 January 2025
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