SFDA Cosmetics Regulations

Update of the list of banned substances (Annex II)

• The use of the ingredient, Diphenylphosphine oxide trimethylbenzoyl to artificial nail products is restricted to 5%
• The product identification label must have the following warnings:
  • For professional use only
  • Avoid Skin Contact
  • Read Direction for use carefully

• Maximum permissible concentration of (Phenylenediamine PPD) and its salts (p-Phenylenediamine HCL) and (p-Phenylenediamine Sulphate) in oxidized hair dyes should not be more than 2%
• The use of (p-Phenylenediamine) and its salts is restricted to only oxidized hair dyes

All Manufacturers are instructed not to use the claim "Tahara" on the label of Cosmetic Products containing musk.

• Prohibition of the use of "Formaldehyde" and "Methylene Glycol" in all Cosmetic Products.
• Prohibition of importation or manufacture of any products that do not comply with this circular from the date of publication. Products already on the market have until 1441/9/1 (23/04/2020) to comply.

• Restriction of the use of "Hydrolyzed Wheat Protein" by limiting its maximum molecular weight to 3.5 KDa for use in a Cosmetic Product.
• Prohibition of importation or manufacture of any products non-compliant with this circular from the date of publication. Products already on the market have until 1442/6/1 (14/01/2021) to comply.

SFDA have decided the following:

• First: ban the use of (HICC) completely in cosmetics, and that ban also cosmetics including below:
  • 4-(4-hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde
  • 3-(4-hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde
• Second: ban import and/or manufacture violated products starting from 1/7/2020 and grace period for available products in market till 1/7/2021

The SFDA has developed a document, "Products Classification Guidelines”, to help the companies as well as the SFDA regulators to easily classify these products.

SFDA have decided to modify the restrictions for usage as below:

• First: restrict the use of MIT individually or in mixture in rinse off products no more that 0.0015% 15PPM
• Second: prohibition of MIT either individually of in mixture for leave on products
• Thirdly: cease the addition of MIT to rinse off products which contains ratio CMIT/MIT 3:1
• Fourthly: ban import and/or manufacture violated products starting from 1/1/2020 and grace period for available products in market till 31/12/2020

Commencing from 11.01.2019 onwards, its allowed to add Triclosan to all cosmetic products.

• The limits stipulated in the regulation should be followed and adhered to.

Extension of exemption from fees for listing cosmetic products

All products circulating in the market with unaccepted representations of microbe or germ control (such as 99.9% elimination of germs, bacteria) or protection will be in violation as of 01.01.1438 AH and treated according to the Cosmetics Code promulgated by the Royal Decree No. M/49 dated 18.06.1436 AH. The companies willing to have their cosmetics representations assessed must apply for registration of such products in the e-registration system of cosmetics (eCosma).

The amendment No. is 10526 /ع says that the manufacturers and importers of the following products are allowed to choose the type of tamper seal for their products in order to ensure the product is only opened by the final consumer:

• cosmetic products of liquid oral hygiene
• care products of external parts of genital organs

exception to products filled in aerosols.

All preparations containing Hydroquinone are subject to registration as pharmaceuticals in any proportion.

Circular No. 3597 dated 12/2/1432 bans all mouth wash and related products which contain alcohol used for rinsing, cleaning or sterilizing of the mouth and teeth. The decision to ban these types of products has been taken due to the existence of permissible and available alcohol free alternatives.

The Authority has set the following terms regarding the trading of cosmetics in form of ampoules:

• Adherence to the Saudi standard specifications for cosmetics;
• No Therapeutic inspirations shall be put on the product or leaflets in this regard.
• The following instructions shall be written with clear Handwriting on the internal and external package:
  • Cosmetic product is for external use only.
  • Care should be taken when opening the package.
  • Avoid eye contact when using the product.