Vol. 150 - Gulf Cooperation Council Proposes Draft GCC Technical Regulation for Cosmetic Products

The Gulf Cooperation Council Standardization Organization (GSO) recently proposed a draft GCC Technical Regulation GSO 1943:2015 “Cosmetic Products -Safety Requirements of Cosmetics and Personal Care Products,” which specifies the definitions of the product, safety requirements, labelling, product claims, packaging and rules for acceptance and rejection.

Safety Requirements

Cosmetic and personal care products shall fulfill the following requirements:

1.The product shall be completely free from pork and all its derivatives.

2.It shall be safe for human health when used under normal or reasonably foreseeable conditions of use.

3.It shall be homogenous, stable and the properties shall not change during its shelf life when stored and used as per the instructions.

4.It shall be free from any filthy or decomposed substance.

5.It shall not contain graphics or images or phrases that are inconsistent with Islamic traditions and prevailing social values in GCC countries.

6.Cosmetic and personal care products shall not contain substances listed in the annexes with conditions.

7.The presence of traces of the substances listed in annex 2 shall be allowed provided that such presence is technically unavoidable in good manufacturing practice.

8.Sunscreen products shall comply with the articles 5.11 and 9.9 in GSO 2237:2012 “Cosmetics-Sunscreen products.”

9.The manufacture of cosmetic products shall comply with good manufacturing practices. Compliance with good manufacturing practices shall be presumed where the manufacture is in accordance with the relevant harmonized standards such as GSO ISO 22716.

10.Cosmetics and personal care products shall comply with the microbiological limits in GSO ISO 17516 “Microbiology-Microbiological limits.”

11.The pH of cosmetic products should be in the range (4-8) excluding the ranges in Annex 3 that are specific to certain ingredients. Certain products formulated with pH values outside this range shall be acceptable if they have evidence to demonstrate that the pH is necessary to achieve the required efficacy and also have a demonstrable safety report.

12.The non-intended presence of small quantity of a prohibited substance, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with point 2.

In the case of its presence as an impurity, cosmetic and personal care products should not exceed the following limits:

 Substance

Lead

Arsenic

Cadmium

Mercury

Antimony

Dioxane

Limits

10 ppm

3 ppm

3 ppm

3 ppm

5 ppm

10 ppm

 

Labelling Requirements 
1. All cosmetic and personal care products shall bear the following information in indelible, easily legible and visible lettering: 
a) The name of the product and the name of trademark 
b) The name and address of manufacturer or distributor 
c) Country of origin of the product 
d) Nominal content of the product 
e) The time period labelling and marking requirements for product deteriorating within and after 30 months from the date of manufacturing 
f) Conditions of use, warning statements and precautionary information 
g) Batch number or lot code 
h) Product function 
i) List of Ingredients shall be printed on either both primary container and packaging or only packaging of the product or tag, cards 

 

2.The information required by items 1) to 8) above must appear on the label of both the container and the packaging of each individual cosmetic product. 
 
3.The information required by items 1) to 5) above shall be at least in Arabic or English. However the following information must be presented in both Arabic and English on the products: 
• Name of the product
• Product function and/or use instructions
• Warnings instructions and precautionary information
• Necessary storage instructions for safe use
4. There are specific labelling requirements for the following products: 
• Toilet soap that are supplied neither in a container or packaging
• Gift sets and kits that contain multiple cosmetics and personal care products
• Hotel amenities
• Cosmetic and personal care products that are supplied as multi-packs
• Cosmetic and personal care products that come in ampule and vials (should contain the following instructions in Arabic and English): 
For external use only
Avoid contact with eyes
Open with caution

Packaging
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 does not adversely affect the product.
2. Metal aerosol dispensers used for packing cosmetics and personal care products shall comply with GSO 917 “Metal Aerosol Dispensers.”

Annexes
The contents of the following Annexes align with Annexes of EU Cosmetic Regulation No.1223/2009 updated to Regulation No.866/2014, except 3 substances suggested by GSO (Ref. Nos. 288 to 290) are added in Annex 3:
Annex 1: Illustrative List of Cosmetics
Annex 2: List of Substances Prohibited in Cosmetic Products
Annex 3: List of Substances which cosmetic products must not contain except subject to the restrictions laid down
Annex 4: List of Colourants Allowed in Cosmetic Products
Annex 5: List of Preservatives Allowed in Cosmetic Products
Annex 6: List of Filters Allowed in Cosmetic Products
Annex 7: Symbols used on packing/container
 
 

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