Food Supplement Registration in Saudi Arabia

Regulatory Authority Saudi Food and Drug Authority Regulatory Website

https://www.sfda.gov.sa/

10 Days

Food supplements containing vitamins and/or minerals are primarily valuable nutritional supplements because of the minerals and/or vitamins they contain. Food supplements containing concentrated forms of vitamins and minerals, either alone or in combination, are available in a variety of forms, such as capsules, tablets, powders, solutions, etc.; their purpose is to supplement the intake of vitamins and/or minerals from a regular diet, and they are not in the form of conventional food. (GSO GSO CAC/GL 55:2015 Guidelines for Vitamin and Minerals Food Supplements).

The product’s classification as a food supplement or a medication will determine which competent authority will evaluate it and process its registration in the Kingdom of Saudi Arabia. The SFDA evaluates both of them. Before being introduced for sale on the local market, all food supplements, whether imported or domestically produced, must first receive approval and registration from the SFDA.

If the product satisfies the GSO or SFDA requirements, a registration certificate will be issued by the Saudi Arabian Food and Drug Authority (SFDA).

• Certificate of free sale certified by the competent authorities in the country of origin (imported products).
• Licence for a food establishment issued by SFDA (locally manufactured products).
• Certificate of Hazard Analysis and Critical Control Point (HACCP) or Good Manufacturing Practice
• Certificate (GMP) or (ISO22000) Certificate.
• Certificate of intelligence analysis issued by an accredited laboratory according to the international standard (ISO17052 “general requirements for the competence of testing and calibration laboratories”) including the main ingredients of the product and its nutrients in their quantities and percentages.

Food supplements containing vitamins and minerals should be labeled in accordance with the General Guidelines on Claims (CAC/GL 1-1979) and the Codex Standard for the Labelling of Prepackaged Foods (Codex-Stan 1-1985, Rev. 1- 1991).

The product will be branded as a “food supplement” and will list the specific nutrient category(ies) or vitamin(s) and/or mineral(s) that it contains, depending on the situation.

The product’s label should list the vitamins and minerals that are included in it in numerical form. Weight units that comply with the Codex Guidelines on Nutrition Labelling (CAC/GL 2-1985 Rev.1-1993) should be used.

The indicated vitamin and mineral contents should correspond to the portions of the product that are advised for daily consumption; if this is not the case, the amounts per unit for a single usage may also be provided.

Additionally, vitamin and mineral information must be expressed as a percentage of the nutrient reference values listed in the Codex Guidelines on Nutrition Labelling, if applicable.

The product’s label should specify how it should be used (amount, frequency, and any unique circumstances).

The consumer is advised not to exceed the maximum amount in one day by the label.

Frequently Asked Questions: Food Supplement Registration in Saudi Arabia

1. What is the process for registering a food supplement in Saudi Arabia?

Food supplement registration in Saudi Arabia involves submitting an application to the Saudi Food and Drug Authority (SFDA). The process includes providing product details, ingredients, labeling, and manufacturing information for evaluation.

2. How long does it take to register a food supplement with the SFDA?

The registration process typically takes 2-6 months, depending on the completeness of the application and the complexity of the product. Ensuring all documents meet SFDA requirements can help avoid delays.

3. What documents are required for food supplement registration in Saudi Arabia?

Required documents include product composition, Certificate of Analysis (COA), Good Manufacturing Practice (GMP) certificate, product labeling in Arabic and English, and proof of safety and efficacy.

4. Are there specific labeling requirements for food supplements in Saudi Arabia?

Yes, the SFDA requires labels to include product name, ingredients, usage instructions, warnings, storage conditions, and expiry date. Labels must also be translated into Arabic.

5. Do I need a local representative to register a food supplement in Saudi Arabia?

Yes, foreign manufacturers are required to appoint a Saudi Authorized Representative (SAR) to handle the registration process and ensure compliance with SFDA regulations.