Cosmetics Law in Saudi Arabia

The Cosmetics Law in the Kingdom of Saudi Arabia is a set of rules applied to cosmetics, their factories, warehouses, and the trade and circulation of these products within the Kingdom. It clarifies how the provisions are applied to cosmetics, their factories, and warehouses. The law was issued on April 7, 2015, and consists of thirty-eight articles.

Cosmetic product, as defined in Article One of the Cosmetics Law in the Kingdom, refers to any product containing one or more substances designed for use on external parts of the human body. These include the skin, hair, nails, lips, external genitalia, teeth, or the mucous membranes of the oral cavity. The purposes of these products are for cleaning, perfuming, protecting, maintaining in good condition, altering appearance, or improving body odor.

Article Two of the Cosmetics Law in the Kingdom stipulates that the provisions of this law apply to cosmetics, their factories, warehouses, as well as their trade and circulation. The Saudi Food and Drug Authority (SFDA) oversees the cosmetics sector and holds several responsibilities, including issuing technical regulations and standards for cosmetics, factories, and worker requirements. These regulations are based on a set of procedures and controls aligned with international standards. Additionally, the SFDA publishes lists of prohibited substances and restricted-use materials for cosmetics on its website after determining them.

The SFDA ensures that cosmetics comply with the technical regulations, standards, and approved requirements. Cosmetics cannot be imported or traded in the Kingdom unless they are registered with the SFDA and a registration certificate is obtained in accordance with the regulations. The SFDA has the authority to withdraw any cosmetic product and ban its circulation if it is proven to be unsafe or harmful to health.

Manufacturers and production companies are required to submit an application to register the cosmetic product with the SFDA in accordance with the procedures and conditions specified in the regulations. The SFDA will make a decision on the registration request within fifteen days of fulfilling the requirements and will issue a registration certificate. In the case of rejection or failure to make a decision, the SFDA will provide reasons for the rejection or delay.

When registering any cosmetic product in the Saudi market, several key conditions must be met, including: ensuring the product's safety and confirming it is free from any manufacturing defects that could harm users.

The registrant of the cosmetic product must inform the SFDA of any manufacturing errors, product recalls in other countries, or any harm caused by the product. Additionally, the registrant must keep a product information file and submit it to the SFDA upon request, report any modifications to the product or misuse, and document wholesale sales.

According to Article Eleven of the Cosmetics Law in the Kingdom, each cosmetic product must include data or a label according to the requirements specified in the regulations. The SFDA also publishes a list of registered cosmetics on its website. Additionally, a technical license for the factory must be obtained from the SFDA in accordance with the requirements and conditions outlined in the law’s executive regulations.

To obtain a technical license for a factory producing cosmetics, several conditions must be met, including the factory's implementation of Good Manufacturing Practices (GMP) for cosmetics as approved by the SFDA. The factory must also commit to notifying the SFDA of any changes in the factory, its products, or the information it has provided. The factory is prohibited from operating outside the scope of its license and cannot begin marketing any cosmetic product until it has been registered. The license for the factory or warehouse is valid for a specified period, up to five years, and can be renewed.

Article Twenty of the Cosmetics Law in the Kingdom stipulates that the license for a factory or warehouse is valid for five years and is renewable. It also specifies that cosmetics cannot be advertised or promoted before they are registered. Additionally, advertising and promotional activities must comply with the rules and conditions outlined in the regulations.

Without prejudice to the responsibilities of the Ministry of Health as outlined in the Private Health Institutions Law and the Pharmaceutical Establishments and Products Law, the SFDA is responsible for supervising and inspecting cosmetics factories, warehouses, retail outlets, shipments, and consignments. If the SFDA determines that a cosmetic product poses a threat to public health, it must issue a warning through appropriate channels.

If the SFDA determines that a cosmetic product is unsafe, harmful to health, or not registered, it must take one or more of the following actions: cancel its registration, ban its circulation, withdraw or recall the product, or suspend its circulation for a period specified by the SFDA. If the SFDA suspects that a cosmetic product may violate the provisions of this law or its regulations, it may also suspend its circulation for a period determined by the authority.

It is prohibited to circulate any cosmetic product that has been canceled, banned, withdrawn, recalled, or had its circulation suspended by the SFDA. SFDA inspectors may take samples of cosmetics for testing and analysis according to the regulations and conditions specified in the law. Additionally, employees appointed by a decision of the SFDA's Chief Executive Officer are responsible for recording violations of the provisions of this law and its regulations, and they have the authority to exercise criminal investigation powers.

Managers and employees at the locations subject to inspection must allow SFDA inspectors to perform their duties without obstruction, and provide all necessary assistance, information, documents, and required samples.

Article Thirty-One of the Cosmetics Law outlines the violations under this law, deeming anyone who commits or attempts to commit one or more of the following acts in violation of its provisions:

- Deceiving or adulterating a cosmetic product.

- Trading in a counterfeit, spoiled, expired, or mislabeled cosmetic product.

- Using false information to promote the cosmetic product, either on the product itself or in its advertising.

- Importing containers or packaging for a specific cosmetic product into the Kingdom with the intent to deceive.

- Manufacturing, printing, possessing, selling, or displaying containers or packaging for a specific cosmetic product with the intent to deceive.

- Providing the SFDA with false information related to the cosmetic product.

- Imported, exported, re-exported, manufactured, marketed, sold, or stored the cosmetic product for themselves or others in violation of the provisions of this law or its regulations.

- Obstructed the work of SFDA inspectors, whether by preventing them from entering the factory, warehouse, or retail location of the cosmetic product, or by preventing them from obtaining samples.

Non-compliant cosmetics under the Cosmetics Law are subject to the following provisions: spoiled, counterfeit, and unregistered products must be destroyed. The destruction is carried out by one or more committees formed for this purpose, and the products, along with related documents, may be seized when necessary.

Anyone who violates any provision of the Cosmetics Law or its regulations is subject to one or more of the following penalties: closure of the factory or warehouse until the violation is corrected, cancellation of the factory or warehouse license, a fine not exceeding SAR5,000,000, imprisonment for a period not exceeding five years, and the penalty may be doubled in the case of repeated violations.