Arabic
Issued by Saudi Food and Drug Authority Decision 4/44.
Chapter 1
Definitions
Article 1 of the Regulation
In addition to the definitions provided in the Food Law, the following words and phrases have the meaning assigned to each of them, unless the context requires otherwise:
Competent entities:
Government entities directly or indirectly related to food safety and concerned with the application of the provisions of the law and its regulation.
Report (or notification):
Specific information exchanged between focal points in the system regarding unsafe food that may pose a direct or indirect risk to human health.
Food establishment official:
A person licensed or legally authorized by the licensee and responsible for ensuring compliance with implementing the provisions of the law and the decisions issued pursuant to it in the establishment that is under his responsibility.
Good operating practices:
The procedures and precautions issued by government or international entities that must be followed in handling food throughout the food chain to ensure food safety and quality, such as good manufacturing practices, good agricultural practices, and others.
Requirements:
The standards and conditions required by the competent entities related to food handling, and include the protection of public health and consumer protection.
Conformity:
Achieving compliance with legal requirements, technical regulations, and mandatory specifications.
Verification of conformity:
Proving that the product, service, process, system, entity, or person meets the necessary requirements for each of them under the applicable legislation and technical regulations.
Agricultural production inputs:
All that is required for agricultural production, such as feed, pesticides, veterinary medicines, feed supplements, seeds, fertilizers, hormones, and any other supplies except for buildings, equipment, fixed installations, and their accessories.
Food health certificate:
A document (paper or electronic) issued by the competent entity in the country of origin or the country of export, which shows the safety and suitability of the food in accordance with the requirements of the Gulf technical regulations pertaining to it, and may include the food establishment registration number, or in accordance with any adopted equivalent alternative measures.
Seizure:
A procedure taken by the authority to seize any consignment of imported food, domestic food, or part of them in case of doubt that the food does not conform to the requirements imposed by the competent entity.
Cross-contamination:
The transfer of harmful substances or microorganisms to ready-to-eat food through hands, food contact surfaces, and equipment and tools that are dirty and come into contact with raw food and then come into contact with ready-to-eat food. It also includes the contact of raw food or the liquid resulting from it with ready-to-eat food.
Control:
Implementing inspection and measurement operations in a systematic and planned manner that provides a comprehensive view of the extent of the application of food laws in food establishments.
Food harmful to health:
Food that contains hazards in its origin or has been contaminated during any of its handling stages, making it non-conforming to the legislation and technical regulations in force in the country, and negatively affects consumer health.
Unsafe food:
Food that is unfit for human consumption, or that may cause harm to consumer health.
Food is considered unsafe if it is spoiled or contains harmful substances and is not suitable for consumption.
Food that is unfit for human consumption:
Food that is unsuitable and unacceptable for human consumption in accordance with its intended use, due to spoilage or contamination with foreign substances or unintended changes that have occurred in the apparent or sensory properties of the food.
Adulteration:
Any alteration to the food product itself, whether by removing an element from it, adding an element to it, mixing or blending it with other substances, or by any other means that changes its nature or contradicts the information on its food label.
Foods for special nutritional uses:
Products that are prepared or formulated to meet specific nutritional needs arising from particular physical or physiological conditions and/or specific diseases and disorders, and whose composition clearly differs from that of ordinary products similar to it, if they exist.
Foods for special medical purposes:
A category of foods for special nutritional uses, specifically manufactured for the dietary use of patients and intended for use only under medical supervision.
These foods are prepared for the total or partial feeding of patients who suffer from a limited or no capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or a specific component of them, or who have medically prescribed special nutrient requirements that cannot be met by modifying ordinary food, foods for special nutritional uses, or both.
Official training programs:
Food safety training and certification programs officially accredited by the competent entity.
Energy drinks:
Carbonated or non-carbonated beverages primarily prepared from water, natural carbohydrates, caffeine, and certain other ingredients such as vitamins, minerals, amino acids, and permitted food additives. They may also contain natural fruit juices or pulp and plant extracts.
Means of transport:
Trucks, containers, tankers, and cars of any type or size used in the transportation of foodstuffs, whether refrigerated, frozen, or at normal room temperature.
Re-export:
The export of imported foods in the same condition in which they were imported, from a free circulation zone, internal processing facilities, or free industrial zones, directly to the rest of the world, and from customs warehouses or free trade zones to the rest of the world.
Halal foods:
Foods that are permitted in accordance with the principles of Islamic Sharia and meet the requirements provided in the technical regulations and standard specifications.
Halal certificate:
A document issued by the competent entity that is accredited by the Kingdom in the country of origin or the country of export, indicating that the meats and their products have been prepared and produced in a manner that conforms to the requirements of Islamic Sharia, or that the products or their ingredients are halal and produced according to the requirements of Islamic Sharia, and that all conditions, ingredients, and preparation tools comply with the requirements of Islamic Sharia and the required conditions provided in the technical regulations and standard specifications.
Consignment:
A quantity of food products covered by a single official certificate.
Batch (lot):
A specific quantity of food produced essentially under the same conditions.
Production batch code:
A code for a quantity of foodstuff that is essentially produced under the same conditions during a specific time period, and is usually from a specific production line or unit.
Store (warehouse):
A building or part of it designated for storing and preserving foodstuffs for a specific period until they are offered.
Release permit:
Permission to allow foodstuffs to enter the Kingdom after inspection and verification that they meet the requirements stipulated in this regulation.
Microbiological contamination:
Contamination with microorganisms or the toxins produced by microorganisms on or within food during its production, manufacturing, preservation, preparation, processing, packaging, wrapping, transportation, or keeping.
Food irradiation:
Exposing food to a sufficient dose of radiation for the purpose of eliminating microbial contaminants in it, in accordance with technological requirements and in an appropriate manner.
Unsanitary conditions:
Situations, means, and conditions that can lead to the exposure or contamination of food with physical, chemical, or biological contaminants, making the food harmful or dangerous to human health or unfit for human consumption.
Novel food:
Food and its ingredients that meet any of the following conditions:
1․ That it contains a new or modified molecular structure.
2․ That it contains bacteria, fungi, or algae, or is derived from any of them.
3․ That it contains plant-based materials or is derived from them, in addition to animal-derived foods, with the exception of food and its ingredients obtained through traditional production and breeding methods that are considered safe for consumption.
4․ That it is obtained through methods not previously used that cause significant changes in composition and structure, affecting its nutritional value, metabolism, or the presence of an inappropriate level of substances as human food.
Mutual recognition agreements:
An agreement between the authority and foreign government entities to recognize the equivalence of food control procedures on both sides for specific procedures.
Focal point:
A person or his delegate who represents the government or private entity concerned with food safety, designated by that entity to facilitate and expedite communication between the authority and the entity.
Rapid food alert system:
A system for collecting, analyzing, and exchanging information related to food safety with the competent entities within and outside the authority, for the purpose of taking appropriate measures to maintain consumer health and safety.
Article 2
The law aims to:
1․ Ensuring food safety and working to improve its quality.
2․ Protecting consumer public health by reducing food-related risks and disseminating sound nutritional awareness.
3․ Protecting consumers from food that is harmful, adulterated, misleading, or unfit for human consumption.
4․ Not hindering food trade.
Article 3
The provisions of this law apply to all stages of the food chain.
Chapter 2
Food Regulations and Specifications
Article 4
The authority shall issue technical regulations and standard specifications for food, its facilities, and employees in them.
Article 2 of the Regulation
The authority shall issue technical regulations and standard specifications for food, its facilities, and employees in them. In the absence of Saudi or Gulf technical regulations or standard specifications, the authority may apply any relevant international legislation, regulations, or specifications relating to food until it issues its own technical regulations or standard specifications, in the following sequence:
1․ International legislation or specifications, or documents issued by the Codex Alimentarius Commission, the Food and Agriculture Organization, the World Health Organization, the World Organisation for Animal Health, the International Plant Protection Convention, or joint committees between them.
2․ The International Organization for Standardization (ISO).
3․ Legislation or specifications issued by competent regional entities.
4․ Technical regulations, standard specifications, or requirements adopted in any other country.
The authority may also issue an amendment annex to the adopted technical regulations or standard specifications when necessary.
Article 5
The authority shall—when issuing and updating technical regulations and standard specifications for food—take into account international standard specifications for food.
Article 6
The authority shall—in approving and updating technical regulations and standard specifications for food—adopt the principle of risk analysis.
Article 7
It is not permitted to release imported food except after the approval of the authority, in accordance with the conditions, requirements, and procedures specified by the regulation. The authority shall issue the regulations governing the procedures for granting the permit to release imported food into the Kingdom.
Article 3 of the Regulation
To release imported food, the approval of the authority must be obtained in accordance with the following permit conditions, requirements, and procedures:
1․ That the imported food conforms to the provisions of this law, its executive regulation, the adopted technical regulations, and any decisions, conditions, or requirements stated in circulars issued by the authority or in any agreement or memorandum of understanding between the Kingdom and the exporting countries.
2․ That the food establishment is licensed and registered with the authority.
3․ That the imported food is registered with the authority.
4․ That the consignment of imported food is accompanied by the official documents and certificates stipulated in the adopted technical regulations and the decisions and circulars issued by the authority.
5․ That the imported food is not banned by the authority.
Food imported for non-commercial purposes is excluded from this article, and they are the following:
1․ Food for personal use as specified in the technical regulations.
2․ Samples of imported food for the purpose of conducting scientific studies and research that will not be used for human consumption.
3․ Display and marketing samples not intended for sale, accompanied by health documents and labeled on their information label as: “Free sample”.
4․ Food samples used in exhibitions and festivals, provided that:
(a) They conform to the technical requirements and regulations pertaining to them.
(b) The importer guarantees the suitability of those foods for their intended purpose.
(c) They are not sold or distributed outside the venue of the exhibition or after its end.
Chapter 3
Registration and Licenses
Article 8
Food establishments shall register with the authority, including primary production facilities, and the regulation must specify the registration conditions and procedures.
Article 4 of the Regulation
Food establishments shall register with the authority, in accordance with the following conditions and procedures:
1․ Submitting a registration application and filling out the relevant forms.
2․ That the establishment is licensed with the authority to handle food.
3․ Determining the food establishment official and his representative in the case of his absence.
4․ Fulfilling the requirements and documents relating to the food establishment and its employees, provided in the Food Establishment Registration Manual.
5․ Fulfilling any other requirements specified by the authority that it publishes on its website.
Article 5 of the Regulation
A food establishment shall update its information registered with the authority upon any change to it, including stopping the practice of the activity.
Article 6 of the Regulation
The registration period of a food establishment is five years, renewable.
Article 7 of the Regulation
The authority may suspend the registration of a food establishment in the event that the license is not renewed.
Article 8 of the Regulation
A food establishment shall not start operating and practicing the food activity before registering with the authority.
Article 9 of the Regulation
The authority shall establish a register for registered food establishments, including primary production facilities.
Article 9
A food establishment shall register its food products with the authority, and the regulation must specify the conditions for registration, its procedures, and the materials that are excluded from registration.
Article 10 of the Regulation
Producing, manufacturing, and importing food establishments shall register their local and imported food products with the authority, in accordance with the following conditions and procedures:
1․ Submitting a registration application and filling out the relevant forms.
2․ That the food establishment is licensed and registered.
3․ That the food to be registered is compliant with the law and its regulation, and the technical regulations or standard specifications adopted by the authority, except for those prepared for export if they are compliant with the specifications of the country exported to.
4․ Providing detailed information for food products, including ingredients, nutritional facts, and a copy of the food label.
5․ That there is no decision issued to ban or suspend the manufacture of food that the food establishment wishes to register.
6․ Fulfilling any other requirements specified by the authority that it publishes on its website.
Article 11 of the Regulation
A food establishment shall reregister when any change is made to the food, its source, or the country of origin.
Article 12 of the Regulation
The authority shall specify food that does not require registration, which must meet the following conditions:
1․ Food for personal use as specified in the technical regulations.
2․ Samples of imported food for the purpose of conducting scientific studies and research that will not be used for human consumption.
3․ Display and marketing samples not intended for sale, accompanied by health documents and labeled on their information label as: “Free sample”.
4․ Food samples used in exhibitions and festivals, provided that:
– The importer guarantees the suitability of those foods for their intended purpose.
– They are not sold or distributed outside the venue of the exhibition or after its end.
Article 13 of the Regulation
A food establishment shall update any new information related to the registered food.
Article 14 of the Regulation
The authority shall establish a register for registered food.
Article 10
Laboratories handling food shall register with the authority, and the regulation must specify the conditions and procedures for registration.
Article 15 of the Regulation
Laboratories handling food shall register with the authority in accordance with the following conditions and procedures:
1․ Submitting a registration application and filling out the relevant forms.
2․ That it is licensed by the authority.
3․ That it has obtained an accreditation certificate from the competent entity.
4․ Determining the types of approved tests.
5․ Fulfilling the data of the laboratory.
6․ Any other requirements specified by the authority that are published on its website.
Article 16 of the Regulation
A private laboratory shall update any new information related to the registration of the laboratory and the types of approved tests.
Article 17 of the Regulation
The authority shall establish a register for private laboratories registered with it.
Article 18 of the Regulation
The registration period for a private laboratory handling food is five years, renewable.
Article 19 of the Regulation
Private laboratories handling food shall not start commercial operation before registering with the authority.
Article 20 of the Regulation
The authority may suspend the registration of a private laboratory in the event of failure to renew its license.
Article 11
It is not permitted to advertise food except with the approval of the authority, in accordance with the conditions and requirements specified by the regulation.
Article 21 of the Regulation
Food establishments wishing to advertise any food product in any media outlet, whether audio, visual, or print, shall obtain approval from the authority, in accordance with the following conditions and requirements:
1․ That the food to be advertised is registered with the authority and conforms to the technical regulations, food standard specifications, circulars issued by the authority, or matters decided by the authority in this regard.
2․ That the advertisement does not contain anything contrary to the principles of Islamic Sharia or public morals.
3․ That the information available in the advertisement is reliable, accurate, truthful, and verifiable.
4․ That the advertisement does not contain any nutritional or health claims that violate the technical regulations or circulars issued by the authority.
5․ That the food advertisement does not conflict with the commercial advertising regulations of the Ministry of Culture and Information in the Kingdom of Saudi Arabia.
6․ That the advertisement does not encourage bad eating habits or unhealthy lifestyles, especially among children.
7․ That the advertisement directed at children does not contain aggressive or dangerous scenes.
8․ That the advertisement does not contain written information, pictures, scenes, or any other form that leads to misleading a consumer, including claiming the presence of ingredients that are not naturally part of its composition.
9․ That the name or logo of the authority is not used directly or indirectly in the content of the advertisement.
10․ The image of the food used in the advertisement must match its actual form available in the markets or that will be made available.
11․ That the advertisement does not disparage any other food, directly or indirectly.
12․ That the Arabic language is the language used in the advertisement, and other languages may be used, provided that they are consistent with the content of the Arabic advertisement.
Article 12
A laboratory shall not handle food before obtaining a license from the authority, in accordance with the conditions and requirements specified by the regulation.
Article 22 of the Regulation
A laboratory shall not handle food before obtaining a license from the authority, in accordance with the following conditions and requirements:
1․ Submitting a licence application indicating the type and location of the activity and filling out the relevant forms.
2․ Submitting a copy of the commercial registration indicating the laboratory activity.
3․ Obtaining the approvals of the competent entities.
4․ Fulfilling the technical requirements and specifications stipulated in the technical regulations and standards adopted by the authority that pertain to laboratories.
5․ Fulfilling any other conditions or requirements specified by the authority that are published on its website.
Article 23 of the Regulation
It is not permitted to use the license granted to the laboratory for any unauthorized purposes.
Article 24 of the Regulation
The period of a laboratory license is five years, renewable for a similar period or periods. The renewal applicant shall submit its application at least 90 days before the expiry of the license, provided that it meets the requirements stipulated in article 22. The period of the renewed license must be counted from the date of expiry of the previous license.
Article 25 of the Regulation
The registration of a license must be valid for the license to be renewed.
Article 26 of the Regulation
Private laboratories handling food shall comply with the Manual for Licensing and Registering Private Laboratories Handling Food and the circulars issued by the authority.
Article 13
A food establishment shall not handle food before obtaining a technical license from the authority, in accordance with the requirements, conditions, and procedures specified by the regulation.
Article 27 of the Regulation
A food establishment shall not handle food before obtaining a technical license from the authority, in accordance with the following requirements, conditions, and procedures:
1․ Submitting a licence application indicating the type and location of the activity and filling out the relevant forms.
2․ Submitting a copy of the commercial registration including the food handling activity.
3․ Obtaining the approvals of the competent entities.
4․ Fulfilling the necessary health and environmental requirements for food handling and the requirements provided in the technical regulations and standards adopted by the authority that pertain to food establishments.
5․ That there is no decision to suspend or cancel the license of any food establishment belonging to the license applicant for the same activity for which licensing is being sought.
6․ Any other conditions or requirements specified by the authority that are published on its website.
Article 28 of the Regulation
Food establishments, including primary production facilities, shall fulfill the requirements and conditions of the adopted technical regulations and standard specifications, and must be capable of implementing good operating practices.
Article 29 of the Regulation
It is not permitted to use the license granted to a food establishment for any unauthorized purposes.
Article 30 of the Regulation
The period of a license is one year, renewable for a similar period or periods. The renewal applicant shall submit its application at least 60 days before the expiry of the license, provided that it meets the requirements stipulated in articles 27 and 28. The period of the renewed license must be counted from the date of expiry of the previous license.
Article 31 of the Regulation
The registration of a food establishment must be valid for the license to be renewed.
Chapter 4
Food Handling
Article 14
It is not permitted to export food except from an establishment licensed by the authority to do so.
Article 32 of the Regulation
For an establishment to obtain a license to export food, the following must be met:
1․ That it is licensed and registered with the authority.
2․ That the commercial registration of the establishment includes the food export activity.
3․ That the imported food is registered with the authority.
4․ If the food exporting establishment does not manufacture, produce, or import it, a written agreement between the establishment and the manufacturer, producer, or importer is required. This agreement must be prepared in accordance with the Manual for Issuing Export Suitability Certificates for Food Products adopted by the authority.
Article 33 of the Regulation
The authority shall issue a food export or re-export suitability certificate, in accordance with the following conditions:
1․ Submitting an application to the authority to obtain a food export or re-export suitability certificate for each consignment separately.
2․ Submitting a list of foods to be exported.
3․ In the case of re-export, the import consignment release form must be provided in advance, along with the official certificates and accompanying documents for the consignment upon its entry into the Kingdom.
4․ Any additional documents and records requested by the authority.
5․ An establishment licensed for export shall comply with the procedures of the Manual for Issuing Export Suitability Certificates for Food Products adopted by the authority.
Article 15
An individual shall not work in food handling activities without obtaining a license to practice food-related activities, and the regulation must specify the requirements and conditions for obtaining such a license.
Article 34 of the Regulation
The following requirements and conditions must be met by an applicant for a license to practice food-related activities:
1․ That he is medically fit and free from diseases or disease symptoms that may pose a risk to food safety, by virtue of a medical report from an approved entity.
2․ That he passes the training programs or tests approved by the authority.
3․ Fulfilling the conditions and requirements provided in the relevant technical regulations and specifications.
Article 35 of the Regulation
The period of the license to practice food circulator work is two years, renewable.
Article 36 of the Regulation
A food circulator shall immediately notify the supervisor of the food establishment in the event of contracting an illness or the appearance of any disease symptoms, including wounds and injuries.
Article 37 of the Regulation
A food handler shall follow good hygienic practices in relation to food handling.
Article 38 of the Regulation
The authority may cancel or suspend the license to practice food handler work if it is proven that he violated the provisions of the law and its regulation.
Chapter 5
Food Handling
Article 16
It is not permitted to handle food in the following cases:
1․ If it is contrary to the principles of Islamic Sharia.
2․ If it is harmful to health or unfit for consumption.
3․ If it is contrary to the technical regulations or standard specifications of the food.
4․ If it is adulterated, or contains deceptive methods or means or a practice that misleads the consumer.
5․ If it is not packaged in the manner specified by the technical regulations, except for what is excluded in the regulation.
6․ If it is not accompanied by a food label and the explanatory information, except for what is excluded in the regulation.
7․ If it is not registered with the authority.
Article 39 of the Regulation
Food is considered to be contrary to the principles of Islamic Sharia in any of the following cases:
1․ If the source of the food or one of its ingredients is non-halal food in accordance with the technical regulations.
2․ The mixing of halal food with non-halal food at any stage of its handling.
3․ Any other cases specified by the authority that are published on its website.
Article 40 of the Regulation
It is prohibited to handle meat and its products unless they are from animals slaughtered in accordance with the principles of Islamic Sharia and in conformity with the technical regulations.
Article 41 of the Regulation
Food is considered harmful to health or unfit for human consumption in any of the following cases:
1․ If it contains any toxic substance.
2․ If it contains any source of danger that could cause harm to consumer health.
3․ If it contains contaminants or any residues of substances or agricultural production inputs in a proportion exceeding the permitted limit in the technical regulations.
4․ If it contains a food additive that is prohibited from use in accordance with the technical regulations.
5․ If it contains a food additive that is permitted for use, but in a proportion exceeding the permitted limit in the technical regulations.
6․ If it is spoiled, rotten, or contaminated with any contaminant in a proportion exceeding the permitted limit approved by the authority.
7․ If it is handled in an environment or under conditions that could make it harmful to health or susceptible to contamination.
8․ If it is the product of a sick animal or an animal carrying a disease that does not permit the use of its product for human consumption, or from an animal that died before being slaughtered.
9․ If the packaging containing it is not made from safe materials that are permitted for use in packaging that food.
10․ If it contains ingredients that may cause allergies or any warnings that could affect consumer health, and the required information does not include explanatory information about this.
11․ If it is contaminated or treated with radioactive materials and the level of radioactivity in it is higher than the permitted limit approved by the authority.
12․ If the expiry date stated on the food label has passed.
13․ If it is unsuitable or unacceptable in accordance with its intended use.
14․ If the food is damaged, spoiled, decomposed, contaminated with dirt, or its color or smell has changed in a way that negatively affects its quality.
15․ If it contains foreign substances in a proportion exceeding the permitted limit in the technical regulations, leading to a change in its distinctive characteristics in accordance with its intended use.
16․ If it contains or is suspected of containing a biological or chemical contaminant that leads to food poisoning, and its incubation period is consistent with the symptoms caused by a biological contaminant or its toxins in those infected.
17․ Any other cases specified by the authority that are published on its website.
Article 42 of the Regulation
Food establishments, in the event of food poisoning or suspected food poisoning, shall adhere to the rules and protocols issued by the authority in agreement with the Ministry of Municipalities and Housing.
Article 43 of the Regulation
In the event of food poisoning or suspected food poisoning, an establishment is prohibited from cleaning, removing, or discarding any equipment, materials, or products within the establishment.
Article 44 of the Regulation
In the event of food poisoning or suspected food poisoning, an establishment shall not allow employees in the establishment to leave the Kingdom. It shall also notify the concerned entity—each according to its mandate—with a list of the employees of the establishment. The concerned entity shall then forward this to the entities competent with travel bans to issue a travel ban order until the competent entities complete the investigations into the food poisoning incident.
Article 45 of the Regulation
It is not permitted to handle food if it is contrary to the adopted mandatory technical regulations and standard specifications.
Article 46 of the Regulation
Food transportation means must meet the requirements specified by the relevant technical regulations and standard specifications, as well as the requirements of the competent entity.
Article 47 of the Regulation
Food is considered adulterated in any of the following cases:
1․ If it contains a permitted food additive that is not authorized for use in that food in accordance with the technical regulations.
2․ If the explanatory information of the food does not match its actual contents.
3․ If any of its ingredients were removed, any changes were made to it, or it was recomposed, without stating that on the food label, even if these procedures are permitted in accordance with the technical regulations.
4․ If it contains a substance that reduces the nutritional value.
5․ If it contains a substance that leads to concealing a defect or a change in volume or weight.
6․ If the food contains any pork meat and fat products, alcoholic substances, or other non-halal foods without stating that on the food label.
7․ If any modification is made to the validity period of the food without obtaining prior written approval from the authority, after the expiry date stated on the food label has passed.
8․ Any other cases specified by the authority that are published on its website.
Article 48 of the Regulation
Practices are deemed misleading to a consumer in the following cases:
1․ If its description is incorrect.
2․ If the explanatory information contains unintelligible words, phrases, symbols, pictures, or indications, is not clearly visible, or contains inaccurate information.
3․ The content of the explanatory information in Arabic does not match its original language.
4․ If the food label includes any health or nutritional claim not permitted by the authority.
5․ If it is produced using irradiation technology, genetic modification, or other modern technologies without stating that on the food label, in accordance with the requirements of the technical regulations.
6․ Any other cases specified by the authority that are published on its website.
Article 49 of the Regulation
Without prejudice to the requirements and conditions for food handling, special approval must be obtained from the authority for each of the following products, after fulfilling the specific conditions for that product:
1․ Food additives.
2․ Food for special nutritional and medical uses.
3․ Food related to infants and children.
4․ Energy drinks.
5․ Any other products specified by the authority that are published on its website.
Article 17
A food establishment is responsible for ensuring the application of the provisions of this law and its regulations within the food activity under its responsibility.
Article 50 of the Regulation
A food establishment shall appoint a food establishment official who is responsible for ensuring food safety and its fitness for human consumption, and the application of the provisions of this law and its regulation. He is also responsible for the works of food handlers working in the food establishment and its facilities, as specified in the law and the regulation. In particular, he shall do the following:
1․ Training food handlers and explaining the necessary knowledge and skills required for them in the field of food safety and good operating practices, each according to the tasks assigned to him.
2․ Not allowing food handlers in the establishment suspected of having a disease or carrying an infection that could pose a risk to food safety to work in the food establishment except after their recovery, in accordance with the provisions of the law and the regulation.
3․ Implementing food safety management systems.
4․ Facilitating the tasks of an inspector during the performance of his work tasks in supervision and inspection works.
5․ Maintaining the necessary records and documents specified by the authority and providing them upon request.
6․ Immediately reporting any food that he suspects may pose harm to consumer health, and the procedures taken to prevent it from reaching the consumer.
7․ Adhering to implementing tracing, recall, and withdrawal systems.
8․ Reporting any new activities or changes in the food establishment, its products, or its employees, or those that are suspended.
Chapter 6
Responsibilities of a Food Establishment
Article 18
A food establishment must be able to identify the source of the food under its supervision, identify the food establishments that supply it, and provide the authority with the required information if necessary.
Article 51 of the Regulation
A food establishment must be able to trace food and provide the authority with the information it requests in accordance with the following:
1․ Establishing its own food traceability manual that includes the minimum requirements of the Food Traceability Manual approved by the authority, provided that it includes the following:
(a) Procedures that ensure the identification of food sources and the identification of the establishments that supply it with food.
(b) Recording all operations that are carried out on the food at all handling stages that fall under its supervision.
(c) Recording all raw materials and additives used in the composition of the food and its sources, including packing and packaging materials.
2․ The commitment of the food establishment to implementing systems for food traceability one-step-back-one-step-forward (including the records of the manufacturer or supplier and places of display or sale).
3․ A register of information specific to suppliers and the food supplied by them—one-step-back—including the name of the supplier and address, date of receipt, nature and quantities of the received products, their transportation and storage data, and any other information the authority deems necessary.
4․ A register of information specific to customers and the food supplied to them—one-step-forward—including the name of the customer and address, date of delivery, nature and quantities of the delivered products, their transportation and storage data, and any other information the authority deems necessary.
5․ Information on the food being handled, including the name of the food, brand name, product identification number (barcode), product volume and weight, production date, expiry date, batch number, and other information necessary to identify it and trace it.
Article 52 of the Regulation
A food establishment shall comply with the following:
1․ Keeping records and information related to traceability for a period not less than 180 days after the expiry date and providing them upon request, and the authority may specify other periods for certain foods.
2․ Ensuring the efficiency of traceability procedures, reviewing them periodically, and updating them if necessary.
Article 53 of the Regulation
The authority may, where necessary, carry out the following:
1․ Ensuring that the food establishment has put in place and implemented effective traceability procedures for its products in the handling stages to which they are subject.
2․ Excluding some food establishments from certain traceability requirements.
Article 19
The authority may assess food before its marketing, during it, and after marketing if the matter so requires, and it may—in light of the assessment result—take the measures specified by the regulation.
Article 54 of the Regulation
The authority may assess food before its marketing, during its marketing, and after its marketing, especially in the following cases:
1․ When new hazards or global or regional events emerge that may pose potential risks to food safety.
2․ The availability of any data or information about disease cases resulting from the presence or potential presence of sources of food-related hazards.
3․ Availability of data or information based on the results of inspection and the various detection programs.
4․ The need to conduct technical studies by the authority or jointly with relevant entities or authorities.
5․ Novel or non-traditional food products resulting from the use of modern technologies.
6․ Any other case the authority deems necessary.
Article 55 of the Regulation
The authority may be guided by international scientific food assessment studies issued by official entities or published in the form of peer-reviewed scientific research.
Article 56 of the Regulation
The authority may request any information relating to food from the food manufacturer, producer, marketer, or importer.
Article 57 of the Regulation
The authority may, in accordance with the result of the assessment, take one or more of the following procedures:
1․ Obtaining an undertaking from the food possessor not to dispose of it until the assessment results are available.
2․ Not permitting release of the food.
3․ Suspending its handling.
4․ Imposing corrective measures to ensure food safety, suitability, and conformity to the technical regulations.
5․ Temporarily closing the food establishment or part of it until the violation is corrected or for the period specified by the authority.
6․ Ordering the recall of the food.
7․ Withdrawing the food.
8․ Any other measures specified by the authority.
Article 20
If a food establishment knows or suspects that food is not in conformity with the conditions and requirements imposed by the authority, it shall notify the authority of this and take the necessary measures to withdraw the food as specified by the regulation.
Article 58 of the Regulation
A food establishment shall, immediately upon knowing or suspecting that food does not comply with the conditions and requirements imposed by the authority, take the necessary measures to recall the food in accordance with the following:
1․ Immediately starting the procedures for withdrawing the food, including recalling it in the event that it reaches the consumer.
2․ Notifying the authority immediately and providing it with all information about the food to be withdrawn.
3․ Complying with the measures received from the authority in this regard.
4․ Announcing the withdrawal process in at least two daily newspapers, one of which is located at the headquarters of the establishment, if the authority deems this necessary.
5․ Completing the withdrawal process within a period of time specified by the authority, and providing it with a report on this.
Article 59 of the Regulation
An establishment shall establish procedures for the withdrawal and recall of its food products, in accordance with its manual for withdrawal and recall of food, feed, or packing and packaging materials approved by the authority.
Chapter 7
Food Control
Article 21
The authority shall establish and manage a rapid alert system for the reporting of any direct or indirect risk to human health originating from food, and raise consumer awareness by the means it deems appropriate, in accordance with the procedures specified by the regulation.
Article 60 of the Regulation
The Rapid Alert Center for Food within the authority is responsible for operating and managing the rapid alert system for food in accordance with the following procedures:
1․ The rapid alert system for food must operate around the clock to collect and study information related to risks that may directly or indirectly affect human health or public health.
2․ The system must have subsidiary focal points in government entities and the related private entities designated by the authority. These entities shall appoint those responsible for these points (a person and his alternate) and shall provide the center with any changes to them. They must be granted the authority to communicate directly with the center and provide it with the relevant information.
3․ The center may request the food establishment to provide information required by the rapid alert system regarding food that it manufactures, produces, imports, exports, or distributes.
4․ The focal points shall provide the center with all available information related to the reported food and the measures taken in this regard as quickly as possible, not exceeding twenty-four hours.
5․ The establishment shall directly notify the center when there is reason to believe that the food it has manufactured, produced, imported, exported, or distributed may pose a risk to human health and safety or public health, and about the measures being taken or that have been taken.
6․ The center shall notify the focal points (within 24 hours) when there is a risk associated with a food that may be present in the markets, and of all available information on food, even if the available information is incomplete, in accordance with the classification of complaints provided in the Manual of the Rapid Alert System for Food and Feed.
7․ The center shall, when necessary, take the necessary measures to ensure that the focal points and the concerned establishment have received the complaint within 24 hours.
8․ The port directorates in the authority shall notify the rapid alert system of any rejection of a food shipment at the border crossings, stating the reason for the rejection.
9․ The center may publish a warning to consumers not to consume or use the reported product, in accordance with the mechanism adopted by the authority.
10․ The center shall not publish information that is considered part of the trade secrets of an establishment, unless its publication is a fundamental requirement for protecting consumer health and safety. The protection of the trade secrets of an establishment must not impede the provision of information related to the reported product to the rapid alert center if this is necessary to protect human health and safety or public health.
Article 22
The authority is the legally authorized entity to inspect food establishments and facilities regarding the application of the provisions of this law and its regulations, and it may seek assistance from security agencies when necessary.
Article 61 of the Regulation
The authority shall inspect food establishments and facilities in accordance with the following:
1․ The authority shall issue the procedures for inspecting food and its establishments.
2․ Carrying out periodic inspections of food and its handling operations in food establishments and facilities.
Article 23
Inspectors—named by a decision issued by a decision by the president—shall undertake control, inspection, and violation policing activities, and they have the powers and authorities of criminal policing officers.
Article 24
An inspector, upon presenting their job identification card, has the right to enter food establishments and facilities for the purpose of inspection. They may access documents and records and retain copies if necessary, and they may also take samples of food for analysis. The food establishment or facility shall enable the inspector to do so and shall not obstruct him.
If it appears to the inspector that there is food that violates the provisions of this law or its regulations, he may seize it and take the necessary measures in accordance with the procedures specified by the regulation. Seizure is mandatory if the food is unsafe.
Article 25
Article 62 of the Regulation
An inspector shall seize the unsafe food, and he may seize the food if he finds that it violates the provisions of the law and its regulations, in accordance with the following:
1․ Drawing up a violation report, and specifying the type of violation and the type and quantity of food, and it must be signed by the inspector and the food establishment official or his representative. In the event of their absence or refusal to sign, this must be noted in the report, and a copy must be given to the establishment.
2․ Obtaining an undertaking from the food establishment official or his representative not to dispose of the seized food except after the approval of the authority.
3․ Collecting samples of food for analysis if the need arises.
Article 63 of the Regulation
An inspector may recommend one or more of the following:
1․ Closing the food establishment or part of it.
2․ Discarding the violating food at the expense of the food establishment.
3․ Granting the violator a grace period to correct the violation if possible.
4․ Re-exporting the violating imported food.
5․ Any other recommendation that the inspector deems appropriate.
Article 26
An inspector shall comply with the following:
1․ Not disclosing any information he obtained due to his work, unless the authority or competent court requests him to do so.
2․ Complying with the provisions and procedures stipulated in this law and its regulations.
3․ Drawing up a violation report if there is a violation of the provisions of this law and its regulations, a copy of which must be delivered to the violator.
Chapter 8
Collection and Analysis of Samples
Article 27
The authority may collect samples of food without charge to verify their conformity to the provisions of this law and its regulations, and to analyze them if necessary in its laboratories or in laboratories registered with it.
Article 64 of the Regulation
When collecting a sample of food to verify its conformity to the provisions of the law and the regulation, the following procedures must be followed:
1․ Documenting the sample collecting incident by a report signed by both the inspector or whoever the authority authorizes and the owner of the establishment or its official.
2․ Collecting samples in accordance with the collection mechanism adopted by the authority, and the quantity of the sample taken must be limited to the amount needed for analysis and without charge.
3․ Referring the sample for examination and analysis in laboratories belonging to the authority or registered with it, whether inside or outside the Kingdom, if necessary.
Article 28
If the results of the sample analysis show a violation of the provisions of this law and its regulations, the authority shall issue a report to that effect. The authority may take the necessary measures in light of the findings of the report, including notifying the food establishment.
Article 65 of the Regulation
The authority shall issue a technical report if the results of the analysis of food samples show a violation of the provisions of the law and its regulation.
Article 66 of the Regulation
The authority may notify the violating food establishment of the results of the report it issues, and the food establishment has the right to object to it with the authority within ten working days from the date of the notification.
Article 67 of the Regulation
The right of the food establishment to object to the results of the report is without prejudice to the procedures and measures that the authority must take in accordance with the provisions of the law and the regulation.
Article 68 of the Regulation
The procedures taken by the authority must be proportionate to the nature and danger of the violation, taking into account the frequency of the violations of the food establishment.
Article 69 of the Regulation
If it is found from the report of the authority that the results of the analysis of the sample show the existence of a violation of the law, the regulation, or the technical regulations, the authority may take one or more of the following procedures:
1․ Suspending the handling of the violating food.
2․ Requesting the correction of the violation if the authority deems this possible.
3․ Closing the food establishment or part of it until the violation is corrected.
4․ Ordering the withdrawal or recall of the food.
5․ Discarding the violating food at the expense of the food establishment.
6․ Preventing the violator from practicing any work relating to food handling.
7․ Canceling the licence.
8․ Canceling the registration.
9․ Suspending the license of the food establishment.
10․ Permitting the temporary release of imported food if the authority deems it possible to correct the violation.
11․ Re-exporting the imported food.
12․ Any other measures specified by the authority.
Chapter 9
Preventive Procedures and Precautionary Measures
Article 29
The authority shall adopt the appropriate preventive approach to ensure food safety throughout the stages of the food chain, and it has the power to impose the necessary technical systems to achieve this.
Article 70 of the Regulation
The authority shall adopt the appropriate preventive approach throughout the stages of the food chain to ensure food safety by requiring food establishments to implement systems that contribute to this, including good operating practices, food safety management systems, and any other similar systems.
Article 30
If the authority has reason to believe that food may cause harm to consumer health or public health, and conclusive scientific evidence is not available to confirm this, it may take the necessary precautionary measures to control the risks, taking into account the magnitude of the potential harm, avoiding the imposition of unnecessary restrictions, and reviewing those measures within a reasonable period in light of the results of the risk assessment.
Article 71 of the Regulation
When the authority has reason to believe that there are hazards in food that may cause harm to human health or public health, the authority may identify the suspected food and determine its locations, and take any of the following precautionary measures:
1․ Temporarily banning the imported food.
2․ Seizing the violating food, preventing its handling, or not releasing it until its safety is confirmed.
3․ Temporarily closing the establishment or part of it.
4․ Ordering the recall or withdrawal of the food.
5․ Conducting an assessment of the risks expected from the food.
Article 72 of the Regulation
The authority shall review the measures taken in accordance with article 69 within a reasonable period of time that can be determined based on the nature of the potential health hazards and the extent to which new information is available that allows for a more comprehensive risk assessment.
Article 31
The authority may, if there is a potential risk threatening consumer health or public health in a food establishment, its facilities, any of its contents, or its products, issue an order to close this establishment or any of its facilities in accordance with the procedures specified by the regulation.
Article 73 of the Regulation
The authority may, when there is a potential hazard threatening consumer health or public health in a food establishment, any of its facilities, its contents, or its products, issue a closure order in accordance with the following procedures:
1․ Establishing the facts by means of a report prepared for this purpose, which includes a description of the potential hazard and its location.
2․ Recommending the type of closure that is appropriate for the nature of the potential hazard.
3․ The authority shall issue a closure order and its type.
4․ The closure must continue until the potential hazard is eliminated or the corrective actions imposed by the authority are completed.
5․ Withholding the food inside the food establishment.
6․ Conducting an assessment of the potential hazards from the food, including collecting samples and analyzing them.
Article 74 of the Regulation
It is not permitted to practice the activity in a closed food establishment except based on an approval from the authority.
Article 32
If it becomes apparent to the authority that the food poses a risk to consumer health or public health, and this risk cannot be avoided by the available measures and procedures, it may order the withdrawal of the food or take appropriate procedures in accordance with the nature of the situation.
Article 75 of the Regulation
If it becomes apparent to the authority that the food poses a risk to consumer health or public health, and this risk cannot be avoided by the available measures and procedures, it may take one or more of the following procedures:
1․ Issuing an order to the establishment to immediately withdraw or recall the food, within the period specified by the authority.
2․ Issuing an order prohibiting the handling of the food or not permitting its release.
3․ Withdrawing and recalling the food at the expense of the establishment in the event that it does not comply with the specified period.
4․ Verifying the completion of the withdrawal or recall process.
5․ Publishing a warning announcement to consumers about the food that has been withdrawn or recalled.
6․ Preventing any advertisement of the product by the food establishment.
7․ Undertaking any procedure that the authority deems appropriate in accordance with the nature of the situation.
8․ Food that poses a risk to consumer health or public health must be treated in accordance with article 34 of the law.
Chapter 10
Withdrawal and Traceability of a Food Product
Article 33
If the authority has evidence that a food product may cause harm to consumer health or public health, it may order the withdrawal or recall of the product and prevent its handling, in accordance with the procedures specified by the regulation.
Article 76 of the Regulation
The authority may, when it has evidence that the food may cause harm to consumer health or public health, take any of the following:
1․ Issuing an order prohibiting the handling of the food or not permitting its release.
2․ Issuing an order to the establishment to withdraw and recall the food within a period specified by the authority.
3․ Verifying the completion of the withdrawal and recall process.
4․ Withdrawing and recalling the food at the expense of the establishment in the event that it does not comply with that.
5․ Informing consumers about the withdrawal or recall and its reasons.
6․ Preventing any advertisement of the product by the food establishment.
7․ Any other procedure that the authority deems necessary to take.
Article 34
The authority may administratively order the discarding of any food product that violates the provisions of this law and its regulations whenever its handling causes harm to consumer health or public health, and the regulation must specify the procedures for discarding.
Article 77 of the Regulation
The authority may order the discarding of any food that violates the provisions of this law and its regulation whenever its handling causes harm to consumer health or public health, in accordance with the following:
1․ Drawing up a report indicating the type and quantity of the food and the reason for discarding.
2․ Discarding must be in accordance with the procedures adopted by the authority and under its supervision.
3․ The food establishment shall bear all the expenses resulting from the discarding process.
4․ The discarding must be in the presence of the food establishment official or his representative.
Article 35
It is not permitted to handle any food product that the authority decides to withdraw or recall from the market or to prohibit its handling.
Chapter 11
Punishments
Article 36
First
(a) Without prejudice to any punishment stipulated in any other law, the perpetrator of any violation of the provisions of this law or its regulations must be punished by one or more of the following punishments:
1․ A fine not exceeding 1,000,000 Riyal.
2․ Preventing the violator from practicing any food business, for a period not exceeding 180 days.
3․ Suspending the license for a period not exceeding one year.
4․ Canceling the license.
(b) It is permitted to double the punishment if the violation is repeated.
(c) If the violation involves intentionally causing the handling of a food item that is harmful to health, adulterated, or prohibited, the punishment must be imprisonment for a period not exceeding ten years, or a fine not exceeding 10,000,000 Riyal, or both, in addition to the application of any of the punishments stipulated in clauses First(a)(2), (3), and (4) of this article.
Second
The authority shall impose the punishments stipulated in clauses First(a)(1), (2), (3), and (4) of this article, in accordance with the classification of violations and the determination of punishments approved by the board. These punishments are not effective until they are approved by the president or whoever he authorizes, and the regulation of this law must specify the controls and procedures for this. This does not prejudice the right of the authority to take any precautionary measures it deems necessary.
Third
If the violation warrants a punishment of imprisonment, it must be referred to the Bureau of Investigation and Public Prosecution for investigation, and it must be referred to the competent court if it deems it appropriate.
Fourth
A final judgment or decision must be published at the expense of the violator in three local newspapers, taking into account the headquarters of the food establishment and the place where the violation occurred.
Fifth
Anyone against whom the authority has issued a punishment decision may file a grievance against it before the committee stipulated in clause Sixth of this article within 30 days from the date of being notified of the decision.
Sixth
The board shall form a committee—or more—with a minimum of three members, including a legal adviser. The committee has the mandate to consider the following:
1․ Violations and the imposition of any of the punishments stipulated in clause First(c) of this article, excluding the punishment of imprisonment, and issuing the appropriate decision accordingly. It is permitted to file a grievance against this decision before the Administrative Court within 60 days from the date of being notified of it.
2․ Grievances from those concerned regarding punishment decisions issued against them by the authority, provided that the committee decides on the grievance within a period not exceeding 60 days. In the event that this period expires without a decision being made on the grievance, or if the violator does not accept the decision of the committee, he may file a grievance against the punishment decision before the Administrative Court.
In the event that the Administrative Court sets aside the punishment decision issued by the committee or the authority, the court shall consider the violation and impose the appropriate punishment stipulated in this article.
Article 78 of the Regulation
If the violation involves intentionally causing the handling of a food item that is harmful to health, adulterated, or prohibited, the violation must be referred to the Bureau of Investigation and Public Prosecution for investigation, and it must be referred to the competent court if it deems it appropriate.
Article 79 of the Regulation
If a judgment is issued regarding the violation referred to in article 75 of this regulation, or if the Bureau of Investigation and Public Prosecution deems it not necessary to refer the violation to the competent court, the violation must be referred to the committee stipulated in article 36(Sixth) of the law to review the violation and apply any of the punishments stipulated in article 36(First)(c) of the law.
Article 80 of the Regulation
Referring the violation to the Bureau of Investigation and Public Prosecution the “Public Prosecution” or to the committee stipulated in article 36(Sixth) of the law does not prevent the authority from taking the precautionary measures it deems necessary.
Article 81 of the Regulation
Subject to the provisions of articles 78 and 79 of this regulation, the authority shall impose the punishments stipulated in article 36(First)(a)(1), (2), (3), and (4) of the law in accordance with the classification of violations and punishments approved by the board.
Article 82 of the Regulation
The following procedures must be followed in the review of violations and the imposition of punishments, which the authority undertakes to impose on the violator:
1․ The competent directorate shall review the violation after completing the procedures for its policing, and it may hear the statements of the violator or his representative.
2․ The competent directorate shall issue its decision in regard to the violation, and submit it to the president or whoever he authorizes for approval.
3․ The punishment is not effective until after the approval of the decision by the president or whoever he authorizes.
4․ The violator must be notified of the punishment decision in one of the following ways:
(a) Delivering it to the violator by hand with confirmation of receipt or proving his refusal.
(b) Delivering it to the violating establishment at its site with proof of delivery from any of the subordinates of the establishment at the site.
(c) Sending it to the address of the violator registered with the authority.
(d) Sending it to the email of the violator registered with the authority.
The procedures for reviewing the violation do not prejudice taking the measures that the authority deems necessary to address the impact of the violation or deal with its consequences.
Article 37
Anyone harmed by any violation of the provisions of this law has the right to claim compensation for the damages caused by that violation before the competent court.
Chapter 12
Final Provisions
Article 38
The authority may enter into mutual recognition agreements, memorandums of understanding, or other bilateral or multilateral cooperation methods and mechanisms in the field of food, and it is the legally authorized entity to implement these agreements.
Article 39
The board shall determine the fee for the services provided by the authority and for the licenses, registration certificates, and approvals issued by it.
Article 40
It is permitted to grant the inspectors of the authority financial rewards by a decision of the board for the work they perform that leads to the avoidance of harm to the consumer or to public health.
Article 83 of the Regulation
The board shall approve the rules for granting financial rewards to the inspectors of the authority in return for works that lead to preventing grave harm to human health or public health. These rules must specify the criteria for granting such rewards.
Article 41
It is permitted to grant an incentive reward not exceeding 25% of the amount of the fine due by a decision of the board to those—other than the inspectors of the authority or the entities it enlists—who assist in discovering a violation of the provisions of this law and its regulations.
Article 84 of the Regulation
The board shall issue a mechanism for granting incentive rewards to those who—other than the inspectors of the authority or the entities it enlists—assist in the discovery of any violation of the provisions of the law, the regulation, the technical regulations, and the mandatory approved standard specifications.
Article 42
The authority shall present draft technical regulations and standard specifications for food to the public in the manner it deems appropriate before adopting or issuing them, in order to receive comments and proposals.
Article 85 of the Regulation
The authority shall present draft technical regulations and standard specifications for food to the relevant entities in the manner it deems appropriate, in order to express views and comments on them before their adoption and issuance by the board.
Article 43
The authority may seek the assistance of any other government entity or the private sector to carry out any task entrusted to it by virtue of this law and its regulation.
Article 44
The board shall issue the regulation within 180 days from the date of publication of this law in the official gazette, and it comes into force from the date of its entry into force.
Article 45
This law comes into force after 180 days from the date of its publication in the official gazette, and it repeals all provisions in conflict with it.
Published in Umm Al-Qura 5072 issued on 21 February 2025.
