Regulatory framework
Food establishments (which include all entities involved in the nutritional cycle) and the introduction of food products into commerce are governed by the Food Act and the Food Act Implementing Regulations. Cosmetics are mainly regulated by the Cosmetics Law and the Cosmetics Law Implementing Regulations.
The primary regulatory body governing the implementation of the Food Act and the Cosmetics Law is the SFDA. Both laws provide the SFDA with sweeping supervisory authority to regulate both sectors. Below we discuss some of the key elements of the Food Act and the Cosmetics Law.
The Food Act and Food Act Implementing RegulationsObjective and scope
Article 2 of the Food Act sets out the main objectives of the law. It states that the purpose of the law is, among other things, to ensure food safety and quality; protect consumers from harmful, adulterated or otherwise implicated foodstuff; and prevent any barriers to food trade.
Article 3 of the Food Act states that the Food Act applies to all the stages of the food chain. The Food Act defines the food chain as all stages in which food passes from primary production until it reaches the consumer, including importing, exporting, production , sale, resale and distribution.15
Technical regulations and standards.
Article 4 of the Food Act empowers the SFDA to issue technical regulations and standards for food products. In general, the SFDA will implement national technical regulations and standards that are based primarily on those of the GCC Standardization Organization (GSO). In the absence of local standards addressing a specific point, the GSO standards apply directly in Saudi Arabia as a member of the Gulf Cooperation Councill (GCC)
If such regulations and standards are absent at the national or GCC level or are still in the draft stages, the SFDA will generally adopt equivalent international food standards and regulations from the Codex Alimentarius Commission, Food and Agriculture Organization, World Health Organization, World Organization for Animal Health, International Plant Protection Convention or International Organization for Standardization.16
Registration
All food establishments must register with the SFDA. The Food Act defines ‘food establishments’ as all persons in the food supply chain, including manufacturers, sellers, distributors, importers and exporters.17 All food establishments must also register their food products with the SFDA.18
Article 3 of the Implementing Regulations provides that registration is not required if the product meets SFDA standards and if the food samples are used for promotional purposes or used in fairs or festivals.
Licensing
All food establishments must obtain a licence to handle any food product. The Food Act defines ‘food handling’ as any operations occurring in the food supply chain, including manufacturing, selling, distributing, importing and exporting.19 The SFDA also requires all food establishments to obtain a licence for advertising any food products.
Importation
Article 7 of the Food Act provides that ‘imported food shall only be released [for circulation] after obtaining the approval of the SFDA as prescribed under’ the Food Act. The SFDA has published various guidelines on the procedures for importing food products,20 including specific procedures for specialised categories of food products such as meat products, fruits and vegetables, and honey.twenty one
The Cosmetics Law and Cosmetics Law Implementing RegulationsScope
The Cosmetics Law applies to cosmetic products, including their factories and warehouses, as well as the circulation and trading of such products.twenty two
Technical regulations and standards
Article 2 of the Cosmetics Law provides that the SFDA shall issue the technical regulations and standard specifications for cosmetic products and their factories.
Similar to the Food Act, the Cosmetics Law Implementing Regulations provide that in the absence of Saudi technical regulations or standards, the SFDA shall apply any legislation, regulations or specifications relating to cosmetic products with the following priorities: GSO standards, international standards, regional standards , and standards and technical regulations in other countries.twenty three
The SFDA is also empowered to determine the conformity of cosmetic products with the technical regulations and standards and may use specialised companies to verify such compliance.twenty four
Listing
The Cosmetics Law provides that a cosmetic product may not be imported into or circulated in Saudi Arabia unless it is listed with, and a listing certificate is obtained from, the SFDA. The application for listing a cosmetic product must be submitted by the local factory or the manufacturing company of the product or their representatives.25
Under the law, the lister bears the responsibility for the safety of the product and that the product does not cause any harm to consumers’ health if, under normal circumstances, the product is used in accordance with the usage and disposal instructions indicated on the identification label.26
Licensing
The Cosmetics Law requires all local factories and warehouses to obtain licences from the SFDA.27
ii Food additives and contaminants
The SFDA implements various technical regulations and standards relating to food additives and contaminants. Additionally, as a member of the GCC, the technical regulations and standards issued by the GSO also apply. Both bodies have issued extensive standards addressing food additives and contaminants that food manufacturers must adhere to.
The primary technical regulation addressing contaminants in food in Saudi Arabia is the Contaminants and Toxins in Food and Feed Technical Regulation (SFDA.FD GSO 193:2021).28 The technical regulation contains the maximum levels of contaminants and toxicants in food and feed. Other GSO technical regulations also apply, such as the Additives Permitted for Use in Food Stuffs (GSO 2500:2022). The regulation lists the only food additives that are recognised as suitable for use in foods.
The SFDA and GSO have also implemented other, more specific technical regulations and standards relating to specific food additives, such as standards on limits on salt (eg, Salt Limits Guidelines in Food Products (SFDA.FD 2612:2022))29 and the type of sweeteners permitted in foods (Sweeteners Permitted in Food (GSO 995:2021)).30
In relation to cosmetics, the primary technical regulation addressing additives and contaminants is the Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products (GSO 1943:2021).31 The regulation includes the list of substances prohibited in cosmetic products and the maximum amounts of certain other substances.
iii Recalls
Recall procedures for food and cosmetic products are set out in the Food Act and the Cosmetics Law and their Implementing Regulations. Both regulations contemplate voluntary and involuntary recalls.
Food establishments must have in place a food recall system as per SFDA regulatory guidance for recalling and withdrawing food and feed or packing and packaging materials.32 The Food Act requires voluntary recall of products if food operators have doubts or reasonable belief that food is incompliant with the SFDA requirements and conditions.33 In such circumstances, the food operator must immediately notify the SFDA and commence the recall process all the way to the end consumer. If the SFDA deems it necessary, the operator must also publish the recall announcement in at least two official newspapers.34
In relation to involuntary recall, Article 22 of the Food Act empowers the SFDA to inspect food establishments and facilities and, if necessary, may seek assistance from security agencies. Article 27 of the law also empowers the SFDA to withdraw food samples free of charge to ensure the extent of compliance of the product with the applicable regulations and standards. If the SFDA investigators determine that the food products are in violation of the Food Act, the SFDA may seize the food and take the necessary actions, including mandatory confiscation of unsafe food .35 SFDA inspectors may also order shutting down the business, disposal of the violating products at the expense of the establishment or the re-export of violating products.36
In respect of cosmetics, the Cosmetics Law requires listers to immediately and voluntarily report to the SFDA if there is any damage caused by an unsafe cosmetic product.37 The SFDA also has the right to inspect factories, warehouses, sale locations, consignments and shipments of cosmetic products and to determine whether a product is detrimental to public health.38
If the SFDA proves that the cosmetic product is unsafe, unhealthy or not listed, the SFDA may take any of the following actions: cancel the listing of the product, ban its trading, withdraw it involuntarily, request the operator to recall it or suspend its trading for a period of time.39 If the SFDA decides to withdraw or recall the cosmetic product, the lister is obligated to do so, and if the lister does not comply within the period specified by the SFDA, the lister will be obligated to withdraw and destroy it at the lister’s expense.40
