Saudi Arabia bans syringe-style cosmetic packaging from 2027 with new labelling rules for ampoules, vials

SAUDI ARABIA – Saudi Arabia’s Food and Drug Authority has banned cosmetic products for external use from being sold in syringe-style packaging from 1 January 2027, while requiring clear Arabic and English warnings on ampoules and vials stating the products are for external cosmetic use only.

The SFDA said in a circular to manufacturers and importers that it had identified products intended for external use being marketed in packaging resembling pharmaceutical forms, including syringes, ampoules and vials. 

Under the new rules, cosmetics packaged in syringes will be prohibited from circulation, while cosmetics sold in ampoules and vials will still be permitted but must carry clear warnings in both Arabic and English stating that the product is for external cosmetic use only and must not be injected. 

Packaging and Labelling Requirements for Cosmetics

Labels must also warn users to avoid contact with the eyes and exercise caution when opening the product. 

The SFDA also prohibited advertising, promotional or marketing materials that state or suggest that such products can be administered by injection or through any other device that penetrates the skin. 

Manufacturers, importers and other establishments have been given until December 31, 2026, to withdraw products covered by the circular from the market or make the necessary changes to bring them into compliance with the new requirements. 

The move aims to prevent cosmetics from being mistaken for injectable pharmaceutical products, addressing a growing concern about packaging similarity between cosmetic products and medical devices or injectable medicines.

Compliance Deadline and Enforcement

The authority said legal action would be taken against products and establishments that fail to comply after the deadline, with measures taking effect from January 1, 2027, after the grace period expires. 

The ban follows similar regulatory actions in other markets where syringe-style cosmetic packaging has raised safety concerns due to the potential for misuse or confusion with pharmaceutical injectable products. 

The requirements apply to all cosmetic products intended for external use, with the prohibition on syringe packaging being absolute and the labelling requirements for ampoules and vials being mandatory for both inner and outer packaging. 

The SFDA’s circular is part of broader efforts to strengthen regulatory oversight of cosmetic products and ensure consumer safety across the Kingdom. 

Manufacturers and importers are expected to begin compliance preparations immediately to meet the end-of-year withdrawal deadline.

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