cosmetics definition by saudi arabia

Cosmetics in the Kingdom of Saudi Arabia (KSA) are regulated by the Ministry of Health
and the Ministry of Commerce and Industry whereas the Saudi Arabian Standards
Organization (SASO) is responsible for establishing standards, labelling and testing.
Based on the definition of the EU Cosmetics Directive, perfumes and cosmetics are
defined as “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 a view
exclusively or mainly to cleaning them, perfuming them, changing their appearance
and/or correcting body odours and/or protecting them or keeping them in good condition”.
Products that possess a therapeutic effect and claim medical properties or contain
pharmaceutical substances are not considered as cosmetics.
Basically, the KSA authorities consider Annex 1 to the EU Cosmetics Directive an illustrative
list of cosmetics. Conversely to the EU law, perfumery products based on ethanol
are classified according to the essential oil content as follows:
20 1. General Concepts and Cosmetic Legislation
Category A: essential oil content is between 2–2.999% by volume
Category B: essential oil content is between 3–7.999% by volume
Category C: essential oil content is 8% or greater by volume
Cosmetics are not subject to registration or notification, there are pre-shipment testing
procedures in force, based on mandatory SASO standards applied equally to both imported
and domestically produced products. These encompass the protection of health, safety,
national security, public morals, the environment and prevention of deceptive practices. For
imported cosmetics, procedures to ensure conformity to the applicable Saudi standards are
enforced by the Ministry of Commerce and Industry, which implements the International
Conformity Certification Program (ICCP) as a combined conformity assessment, inspection
and certification scheme, on the basis of which goods are allowed entry into the KSA.
Compliance with the relevant Saudi standards, or approved equivalent international alternatives,
leads to the issue of a Certificate of Conformity (CoC) prior to shipment by
Country Offices or Regional Licensing Centres. The ICCP applies to all consumer products
exported to the KSA (KSA, 2004). Samples may be selected for minimum verification tests
as a part of annual routine inspections. Periodic pre-shipment inspection will be performed.
Banned, restricted and regulated ingredient lists are based on the relevant annexes to the
EU Cosmetics Directive. In compliance with Islamic law, cosmetics shall contain no pork,
pork fat or pork derivatives, ethanol must be denatured and should not exceed 90%, containers
containing ethanol should not exceed 250 ml and a non-removable pump is mandatory.
Labelling requirements may differ by product type according to each applicable standard,
however the following information should be legibly and indelibly marked: description
name or function of the product; name of the manufacturer or registered trademark; name
and address of the person (company) responsible for marketing the product if different from
the manufacturer; date of production or batch number; expiry date (applicable to these cosmetics
only: hair creams, shampoos and oils; liquid oxidative hair dyes; chemical depilatories;
toothpastes; lipsticks; deodorants; talcum powders; skin creams or if minimum
durability is less than 30 months); net content in volume or weight; country of origin; ingredients
list (using INCI names); instructions for use and storage (if needed); warnings concerning
restricted substances or voluntary ones.
All products shall be marked in either Arabic or English, but instructions for use and
storage, voluntary and mandatory warnings must be in Arabic.
Manufacturers or exporters are requested to provide evidence that their finished products
are safe for consumer’s use based upon the toxicological profile of the ingredients,
their chemical structure and exposure level. The toxicological evaluation needs to be
signed by an authorised/recognised safety assessor and should contain a series of data similar
to that included in the EU product information.

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