Saudi Arabia

I. FOOD SUPPLEMENTS IN SAUDI

Vitamin and mineral food supplements derive their nutritional relevance primarily from the minerals and/or vitamins they contain. Vitamin and mineral food supplements are sources in concentrated forms of those nutrients alone or in combinations, marketed in forms such as capsules, tablets, powders, solutions etc., that are designed to be taken in measured small-unit quantities but are not in a conventional food form and whose purpose is to supplement the intake of vitamins and/or minerals from the normal diet (GSO GSO CAC/GL 55:2015 Guidelines for Vitamin and Minerals Food Supplements).

II. REGISTRATION OF FOOD SUPPLEMENTS IN SAUDI

All companies must be registered in the Electronic Food Registration System and have a valid License, in order to be able to sell their products in the Saudi market.

The competent authority that assesses and registers the products is the Saudi Food and Drug Authoriy (SFDA). All imported and locally manufactured food supplements are required to be registered in the electronic food registration system and obtain a a registration certificate  prior to being launched in the local market for sale.

The expected time for product registration and order completion is 10 working days.

III. VITAMINS AND MINERALS

(i) Vitamin and mineral food supplements should contain vitamins /provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO.

The sources of vitamins and minerals may be either natural or synthetic and their selection should be based on considerations such as safety and bioavailability. In addition, purity criteria should take into account FAO/WHO standards, or if FAO/WHO standards are not available, international Pharmacopoeias or recognized international standards. In the absence of criteria from these sources, national legislation may be used.

Vitamin and mineral food supplements may contain all vitamins and minerals that comply with the given criteria, a single vitamin and/or mineral or an appropriate combination of vitamins and/or minerals.

(ii) The minimum level of each vitamin and/or mineral contained in a vitamin and mineral food supplement per daily portion of consumption as suggested by the manufacturer should be 15% of the recommended daily intake as determined by FAO/WHO. Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the safe dosage into account and minerals and vitamin intake from other food sources.

IV. MANDATORY LABELLING REQUIREMENTS OF FOOD SUPPLEMENTS IN SAUDI

Labels of food products must conform with the requirements laid down in the SFDA.FD/GSO 9 “Labeling of prepackaged food stuffs” and in the SFDA.FD/GSO 2233 “Requirements of nutritional labeling”.

Moreover, vitamin and mineral food supplements should be labelled according to the Codex Standard for the Labelling of Prepackaged Foods (Codex-Stan 1-1985, Rev. 1-1991) as well as according to the General Guidelines on Claims (CAC/GL 1-1979). 

The name of the product shall be “food supplement” with an indication of the category (ies) of nutrients or of the individual vitamin(s) and/or mineral(s) contained in the product as the case may be.

The amount of the vitamins and minerals present in the product should be declared in the labelling in numerical form. The units to be used should be units of weight consistent with the Codex Guidelines on Nutrition Labelling (CAC/ GL 2-1985 Rev.1-1993).

The amounts of the vitamins and minerals declared should be those per portion of the product as recommended for daily consumption and if different, the amount per unit for single use may also be given.

Information on vitamins and minerals should also be expressed as a percentage of the nutrient reference values mentioned, as the case may be, in the Codex Guidelines on Nutrition Labelling.

The label should indicate how the product should be used (quantity, frequency, special conditions).

The label shall contain advice to the consumer not to exceed the maximum one-day amount.

The label should not state or imply that supplements can be used for the replacement of meals or a varied diet.

The label shall contain a statement that the product should be stored out of reach of young children.

V. CLAIMS

Health and nutrition claims are regulated under the SFDA.FD 2333 “Requirements for Health and Nutrition Claims”. Only health and nutrition claim that meet the requirements set by the regulation are allowed to made. 

Approved health claims and related conditions of use , restrictions and warnings are listed in Table No. 1. Moreover, the following claims are prohibited: claims on weight loss, endorsements by individual health professionals, disease prevention or cure claims, unsubstantiated statements, and misleading or fear-inducing claims. Terms like “wholesome” or “healthful,” are also not allowed.