– KINGDOM OF SAUDI ARABIA (KSA): COSMETICS AND PERFUMERY PRODUCTS: MARKET ACCESS AND REGULATIONS

Role

Salicylic Acid permitted concentration

Active Ingredient

≤ 3% in rinse-off hair products

≤ 2% in other products

Preservative

< 0.5%

e. Zinc oxide permitted at concentration less than 25% (unless it is used for a medical condition, in which case it will be classified as a drug)

f. Alpha-hydroxy acids (AHAs):

a. Permitted at total concentrations equal to or less than 10%, with a pH equal to or greater than 3.5

b. The inner and outer labels of all leave-on skin products containing AHAs at concentrations equal to or greater than 3% shall carry cautionary statements in Arabic and English to the effect: “Use only as directed,” “Avoid contact with the eyes,” “If irritation persists, discontinue use and consult a physician,” “It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen,” “Contact of the . . . product with the skin must be of limited frequency and duration.”

c. Preparations intended to be diluted in bathwater may contain levels of citric acid exceeding 10%.

Products falling under the above restrictions will generally be classified as low-risk health products and will be subject to listing at SFDA.

3. Product-specific standards

In addition to the general safety standard, some specific product standards still exist in the KSA. Even if these are not mandatory and not sanctioned officially by SFDA, it should be noted that they may be used for local assessment (for samples drawn by customs and tested in local laboratories). Some of these parameters may not be aligned with the SFDA-sanctioned standards. An acquaintance with the parameters included in these standards is therefore highly desirable in order to achieve a reliable risk analysis.

Example of specific parameters requested by a SASO standard:

SASO 1512:2010 (equivalence GSO 1152:2010)

▶ pH value shall be in the range of 5–9,5.
▶ The total content of fatty substance shall be not less than 15% by mass.
▶ The water content shall be not more than 85% by mass.
▶ The utility date shall not be more than three years.

Note: All the SASO standards have equivalence at a GCC level with the GSO standards, which may be applicable in other countries within the GCC.

2.3.2.2 DEFINITION AND SCOPE OF APPLICATION

a. Definition

As per GSO 1943/2009, “Cosmetic Products—Cosmetic Products Safety Requirement,” the written definition of a cosmetic product is identical to the European definition:

“Any substance or preparation intended to be placed in contact with the various external parts of 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 and/or correcting body odors and/or protecting them or keeping them in good condition.”

This standard provides an illustrative list of products considered as cosmetic products, which include but are not limited to the following:

– Creams, emulsions, lotions, gels, and oils for the skin (hands, face, feet, etc.)

– Face masks (with the exception of peeling products)

– Tinted bases (liquids, pastes, powders)

– Makeup powders, after-bath powders, hygienic powders, etc.

– Toilet soaps, deodorant soaps, etc.

– Perfumes, toilet waters, and eau de cologne

– Bath and shower preparations (salts, foams, oils, gels, etc.)

– Depilatories

– Deodorants and antiperspirants

– Hair care products: hair tints and bleaches; products for waving, straightening, and fixing; setting products; cleansing products (lotions, powders, shampoos); conditioning products (lotions, creams, oils); hairdressing products (lotions, lacquers, brilliantines)

– Shaving products (creams, foams, lotions, etc.)

– Products for making up and removing makeup from the face and eyes

– Products intended for application to lips

– Products for care of teeth and mouth (mouthwash products containing alcohol are considered banned products)

– Products for nail care and makeup

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