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4 GENERAL SAFETY REQUIREMENTS
5 GENERAL MARKING AND LABELLING REQUIRMENTS
6 SPECIFIC MARKING AND LABELLING REQUIRMENTS
7 PRODUCT CLAIMS
8 PACKAGING
Annex 1 Illustrative List of Cosmetics
Preamble to Annex 2
Annex 2 List of Substances Prohibited in Cosmetic Products
Annex 3 List of Substances Which Cosmetics Products Must Not Contain Except Subject to Specific Restrictions
Annex 4 List of Colorants Allowed in Cosmetics Products
Annex 5 List of Preservatives Allowed in Cosmetics Products
Annex 6 List of UV Filters Allowed in Cosmetic Products
Annex 7 SYMBOLS USED ON PACKAGING/CONTAINER
Annex 8 MODIFICATION
Gulf Technical Regulation GSO 1943:2024
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
1 SCOPE
1.1 This gulf technical regulation is concerned with the general safety requirements and parameters as well as labelling 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 keep in good condition
1.3 The field of application of cosmetics is to one or more of the following:
•
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 external genital organs
2 NORMATIVE REFERENCES
2.1 GSO 2020 “ Cosmetics - 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 “ Cosmetics — 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 16217 “ 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 EC 1233/2009 Regulation of the European Parliament and of the Council*.
* 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.
* The Kingdome of Saudi Arabia has a deviation of item
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.
3 TERMS AND DEFINITIONS
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
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
A mixture or solution composed of two or more substances.
3.4
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
Natural or synthetic substances(s) used solely to impart a pleasant smell to a cosmetic product and/or the body.
3.6
An insoluble or bio-persistent material, intentionally manufactured with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
3.7
Substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product.
3.8
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
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
They are generally minor constituents of a substance or a raw material that can originate from:
•
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
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
Any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark.
3.13
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
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 cosmetic 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
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
Packaging designed to come into direct contact with the contents
3.20
Packaging designed to contain one or more primary packages and including any protective materials, if present
Note 1 to entry: 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
A packaged item containing two or more products sold as a unit.