A new SFDA circular introduces specific packaging, labelling, and marketing requirements for cosmetic products presented in pharmaceutical-style forms.
The Saudi Food and Drug Authority (SFDA) has issued Circular No. 6905 introducing new requirements for cosmetic products marketed in pharmaceutical-style forms, including ampoules, vials, and syringes. The measures aim to ensure compliance with the Cosmetic Products Law and prevent confusion between cosmetic and medicinal products.
Under the circular, cosmetic products marketed in syringe form are prohibited, while products presented in ampoules and vials must comply with specific packaging and labelling requirements. The circular also restricts advertising and promotional materials that may imply injectable use.
Affected businesses have until 31 December 2026 to recall non-compliant products and bring them into compliance before regulatory actions take effect. The Authority also confirmed that regulatory measures will be taken against non-compliant products and establishments after the end of the grace period.
Key Requirements
- Cosmetic products must not be marketed in syringe form.
- Cosmetic products marketed in ampoules or vials must display specific warning statements in both
- Arabic and English on the inner and outer packaging.
- Mandatory statements include:
> Cosmetic products for external use only. منتج تجميلي للاستخدام الخارجي فقط
> Do not inject. غير مخصص للحقن
> Avoid contact with eyes. تجنب ملامسته العينين
> Open with caution. افتح بحذر
- Advertising, promotional, and marketing materials must not indicate or imply that the products are intended for injection or use with devices that penetrate the skin.
What Businesses Should Do
Manufacturers, importers, brand owners, and distributors of cosmetic products intended for the Saudi market should review their product portfolios, packaging, labels, and marketing materials to determine whether any products are affected by the new requirements.
Early preparation will help ensure compliance before the deadline and reduce the risk of market disruptions.
Need support with regulatory compliance in Saudi Arabia? Contact Cotecna's team for guidance on market access and regulatory requirements.
About Cotecna
For over 50 years, we have been supporting agriculture, food and pharma, minerals and metals, and consumer products supply chains all over the world. We provide testing, inspection, and certification services to help our clients navigate evolving regulations, ensure product compliance, and support their sustainability journey.