Food Act & Regulation

sfda_gov_sa · regulation · processed · 55 chunks

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

Food Act & Regulation
Promulgated by a Resolution of the SFDA Board of
Directors
No. (3-16-1439) Date 27/12/2017

Disclaimer: The English version is a translation of the original in Arabic for information purposes only.
In case of discrepancy, the Arabic original will prevail.

ⓘ Saudi_FDA | www.sfda.gov.sa
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SFDA

# Chapter One: Interpretation

## Article 1

In Addition to the definitions stated under the Food Act, the following terms and expressions shall have the meanings assigned there-against, unless where the context otherwise requires:

**Competent Authorities:** Government bodies which are related to food safety directly or indirectly and responsible for applying provisions and regulation.

**Report (or Notification):** Specific information exchanged among focal points regarding a food article which is unsafe or poses direct or indirect risk to human health.

**Food establishment operators:** Any individual in charge of an establishment and to whom is assigned the legal responsibility of ensuring that such establishment is in compliance with the the provisions and regulations under this Act.

**Good Manufacturing Practices (GMPs):** Precautionary measures and procedures developed by government or international bodies to ensure the safety and quality of food throughout the food chain, including (GMPs) and (GAPs) and others.

**Requirements:** A required standards and conditions issued by the competent bodies that are related to food handling that include the public health protection and consumer protection.

**Conformity:** Achieving compliance with the statutory requirements, technical regulation, and mandatory standards.

---

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# Saudi Food & Drug Authority

**Conformity Assessment:** a system of validation to ensure that a product, service, process, system or entity meets relevant necessary requirements as per existing laws and regulations.

**Agricultural production inputs:** Inputs for agricultural production of feed, pesticides, veterinary medicines, complementary feed, seeds, fertilizer, hormones, and any other supplies other than buildings, equipment, fixtures, and accessions.

**Healthy food certificate:** A document (hard or soft) issued by competent authority in the country of origin or country of export, which indicates food safety and suitability according to the requirements of gulf technical regulations, that may include food establishment registration number or in accordance with any approved equivalent alternative measures.

**Seizure:** An action taken by the Saudi Food & Drug Authority (SFDA) in case of doubts, to seize any shipment of imported or local food or any part of thereof in case of inconformity with the requirements imposed by the competent body.

**Cross contamination:** the transfer of harmful substances and microorganisms to ready-to-eat foods (or raw ingredients and substances of ready-to-eat food), as a result of unsanitary handling or through dirty contact surfaces, equipment or tools.

**Control:** A well-planned and calibrated inspection process which provides an all-around perspective of the extent of compliance of an establishment with the food laws.

**Harmful food:** Food which does not meet the applicable technical standards and regulations, and adversely affect consumer health due to properties of risks existing naturally in the food or introduced into food at any handing stage.

**Unsafe food:** Food unfit for human consumption and injurious to consumer health for reasons which may include spoilage or incorporation of harmful substances.

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# الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

**Food not fit for human consumption:** Food which is not suitable for human consumption as per the intended use due to spoilage, contamination with foreign materials or inadvertent changes to its physical or sensory properties

**Fraud:** Any change made to the food commodity either by removing, adding, or mixing elements in a manner that alters its nature or is contrary to the labelling requirements.

**Special dietary use:** A Product mainly processed to meet specific nutritional needs arising from specific physical or physiological conditions or/and diseases and disorder, and clearly differ in its composition from ordinary products if found.

**Food with special medicinal use:** Food products for special dietary uses tailored specifically for patients with nutritional needs and administered under medical supervision only. It is intended for total or partial feeding of patients with limited or inexistent digestive or metabolic ability to eat or absorb regular food, or a specific component of the food, or patients who have needs of special medicinal prescribed nutrition items which could not be met by modification of regular food or special diets.

**Formal training programs:** Training and authorization program of food safety officially approved by the competent body.

**Energy drinks:** Carbonated or non-carbonated beverages primarily produced by natural water, natural carbohydrate, caffeine, and some other elements, such as vitamins, mineral salts, amino acids, and other permitted food additives including juices or fruit pulp and natural plant extracts.

**Transportation:** Trucks, containers, tanks and cars of any kind or size which are used for transportation of chilled, frozen foods, or foods stored at room temperature.

**Re-exportation:** Exporting imported food in the same state as previously imported from the free trade zone, premises for inward processing, or industrial free zones direct to the rest of the world and from premises for customs warehouses or commercial free zones to the rest of the world.

**Halal food:** Food products that are allowed according to Islamic Sharia rules and that in conformity with requirements of technical regulations and standards.

**Halal certificate:** A document issued by the competent body that is approved by the Kingdom In country of origin and country of export, which certifies that the meat, meat products, ingredients

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SFDA

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
SFDA

are prepared and produced according to Islamic law requirements (Halal) and the relevant technical
regulations and standards, including all the conditions and equipment used in thereof preparation.

**Consignment:** A quantity of food products included in one official certificate.

**Lot:** A specific amount of food produced mainly under the same conditions.

**Batch (Production batch Number):** The quantity of food produced mainly under the same
conditions during a specific time period, which usually comes from a particular line or unit of
production.

**Storage (warehouse):** a building where food is stored or kept until it is placed on the market.

**Clearance permission:** Allowing the entry of food into the kingdom after all the requirements, as
approve by relevant regulations, are met.

**Microbiological contamination:** Contamination by microorganisms or biotoxins on the surface
or inside food at any stage of production, manufacture, preservation, preparation, treating, filling,
packaging, transportation, or retention.

**Food irradiation:** Exposing food to a sufficient dose of radiation to eliminate microbial
contaminations, in accordance with the technical requirements as deemed appropriate.

**Unsanitary conditions:** any situation, state or condition which exposes food to contamination
with physical chemical or biological factors and thus makes it injurious to health, hazardous or
unfit for human consumption.

**Novel food:** Any food or food ingredient which fits the following descriptions:

1. Modified or has a new molecular structure.
2. Contains or extracted germs, fungus, or algae.
3. Contains or is extracted from plant material. In addition to food extracted from animals,
 except for components obtained in traditional production and breeding methods, which is
 Considered safe for consumption.
4. Obtained in entirely new unexperimented ways which may potentially change its
 composition or structure or compromise its inherent nutritional or metabolic value, or
 incorporate inappropriate level of nutrients.

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

**Mutual recognition agreements:** An agreement by and between the SFDA and external government bodies to recognize the equivalent procedures of food control on both parties and specialized in specific procedures.

**Contact Points:** A representative of a public or private agency appointed to facilitate and expedite communication between SFDA and that agency.

**Rapid Alert System for Food:** A system concerned with collecting analyzing and communicating food safety information with internal and external stakeholders for the purpose of safeguarding consumers' health and safety.

---

## Article 2

This Act aims the following:

1. Ensuring food safety and quality.
2. Protecting consumer's health through minimizing food-related risks and spreading sound nutritional awareness.
3. Protecting consumers from harmful, adulterated, or otherwise implicated foodstuff.
4. Preventing any barriers to food trade.

---

## Article 2

The SFDA shall set technical standards and regulations for food, food establishments and employees. If such regulations and standards are absent at the national or GCC level or are still at draft stage, the SFDA shall adopt equivalent international food standards and regulations in the following order:

1. International legislations, standards or documents issued by Codex Alimentarius Commission (CAC), Food and Agriculture Organization (FAO), World Health Organization (WHO), World Organization for Animal Health (WOAH), International Plant Protection Convention (IPPC), or joint committees.
2. International Organization for Standardization (ISO).

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

3. Legislation or specifications issued by competent regional authorities.
4. Technical regulations, standards, or requirements approved by any other country.
The SFDA shall issue an amendment annex of the approved technical regulations and standards,
if needed.

***

### Article 3

The Provisions of this Act shall apply to all the stages of food chain.

***

## Chapter Two: Food Regulations and Standards

### Article 4

The SFDA shall develop technical regulations and standards for foodstuff, food businesses and
food employees.

### Article 5

Taking into account relevant international standards, the SFDA shall develop and update food
standards and regulations.

### Article 6

The SFDA shall adopt Risk-Based Analysis approach when issuing and updating regulations and
standards of food.

### Article 7

Imported food shall only be released after obtaining the approval of the SFDA as prescribed
under this Act. The SFDA shall lay down the framework for clearing imported food products.

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SFDA

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
SFDA

# Article 3

Imported food shall be released upon approval of the Authority if the following requirements, conditions, and procedures are met:

1. The imported food is compliant with this Act and its bylaws, in addition to any further requirements and conditions stipulated in SFDA approved standards, regulations, circulars or terms of agreements or memorandums of understanding signed between Saudi Arabia and the exporting country.
2. The exporting establishment is licensed and registered with SFDA.
3. The imported food is registered with SFDA.
4. The imported food consignment is accompanied by the official documents and certificates required by SFDA approved standards, regulations, circulars and decisions.
5. The imported food is not included in the list of products banned by the SFDA.

This article does not apply to food products imported for non-commercial purposes as shown in the following:

1. Foods for personal use only as set out in relevant SFDA technical regulations.
2. Samples for testing or research purposes, and not for human consumption.
3. Food promotion samples for non-commercial distribution, accompanied by a health document labelled as “Free Sample".
4. Food samples used in fairs and festivals, where:
 a. The samples satisfy relevant requirements and regulations.
 b. The importer provides assurances that the samples are suitable as per their intended use.
 c. The samples shall by no means be sold or distributed outside their designated venue or when the event is over.

# Chapter Three: Registration and Licenses

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Saudi Food & Drug Authority

# Article 8

Food business establishments shall register their information, and primary production facilities with SFDA according to the registration conditions and procedures laid down under this Act.

# Article 4

To register with the SFDA, food business operators need to do the following:

1. Apply to SFDA and fill out the registration forms.
2. The establishment has a food license from the SFDA.
3. Appoint the persons in charge of the business and those acting on their behalf upon their absence.
4. Provide all the documents and meet all the registration requirements for food businesses and their employees as laid down in the Registration Guide.
5. Comply with any other requirements set forth and published on-line (via the official website) by the SFDA.

# Article 5

Food business operators shall update the information registered with SFDA in case of any change, including suspension of food business practice.

# Article 6

The registration shall remain valid for five years and can be extended for further periods.

# Article 7

The SFDA has the right to suspend the registration of a food establishment if the license is not renewed.

# Article 8

Food establishments shall not start their food activities prior to registering with SFDA.

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

## Article 9

The SFDA shall keep a special log for all registered food businesses, including their primary production facilities.

---

## Article 9

Food establishment shall register their products with the SFDA. The regulation shall define the registration conditions, procedures and exemptions shall be defined under this Act.

---

## Article 10

All businesses involved in the production processing or importation of food shall register their imported and locally produced products in line with the following conditions:

1. Requesting the registration and filling out the related forms.
2. Food establishment shall be licensed and registered by the Authority.
3. Food to be registered should meet the Law and technical regulations or the approved standards by the Authority, except for exporting whenever is compatible with the countries exported to.
4. Providing detailed information on food products including ingredients, nutritional facts, and a copy of the nutritional label.
5. There shall not be any restrictions or suspension issued regarding the manufacture of food that the facility wants to register;
6. Comply with any other requirements set forth and published on-line (via the official website) by SFDA.

---

## Article 1

Where any change is made to their products or the source or country of origin of their products, Food establishments shall apply for a re-registration.

---

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
SFDA

# Article 12

The SFDA shall identify foods exempted from registration and to which the following conditions apply:

1. Foods for personal use only as set out in relevant SFDA technical regulations.
2. Samples for testing or research purposes, and not for human consumption.
3. Food promotion samples for non-commercial distribution, accompanied by a health document labelled as "Free Sample".
4. Food samples used in fairs and festivals, where:
 a. The samples satisfy relevant requirements and regulations.
 b. The importer provides assurances that the samples are suitable as per their intended use.
 c. The samples shall by no means be sold or distributed outside their designated venue or when the event is over.

# Article 13

The food establishment shall be obliged to update new information related to the registered food.

# Article 14

The SFDA shall keep a special log for all registered foods.

# Article 10

Food laboratories shall register with the SFDA. The registration conditions and procedures shall be defined under this Act.

# Article 15

Food laboratories shall register with the SFDA according to the following:

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1. To apply for registration to the SFDA and fill out the forms.
2. To be licensed by the SFDA.
3. To be accredited by the competent body.
4. To determine what type of accredited tests are conducted.
5. To meet the laboratorial information requirements.
6. To comply with any other requirements set forth and published on-line (via the official
website) by the SFDA.

**Article 16**

Private laboratory Shall be committed to timely updating lab testing and registration
information.

**Article 17**

The SFDA shall keep a special log for all registered laboratories.

**Article 18**

The registration of private food labs is valid for five years and can be extended to further periods.

**Article 19**

Private food laboratories shall by no means operate commercially prior to registering with the
SFDA.

**Article 20**

The SFDA retains the right to suspend the registration of private labs which fail to renew their
licenses.

**Article 11**

It is prohibited to advertise food without the consent of the SFDA or contrary to the
requirements and conditions outlined under this Act.

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
Article 21
Food businesses interested in advertising their products by any media channel, whether audio-
visual broadcast, printed or otherwise, shall seek the consent of the SFDA in line with the
following requirements:
1- The product to be advertised is registered with the SFDA and in compliance with its
regulations, standards, circulars or directions as deemed relevant.
2- The advertisement does not contain any information or elements in contravention of the
Sharia (Islamic Law) or common decency.
3- The information included in the advertisement is trusted, accurate, authentic and
substantiated.
4- The advertisement does not bear any nutritional or health claims contrary to the technical
regulations and directives issued by the SFDA.
5- The advertisement does not contradict the regulatory controls of commercial advertising
as set forth by the Saudi Ministry of Media.
6- The advertisement does not encourage any bad dietary habits or unhealthy lifestyles
especially in children.
7- For advertisements where the target groups are young children, it is strictly prohibited to
show any scenes which involve violence or dangerous actions.
8- The advertisement does not incorporate any information, written, drawn, filmed or
otherwise, which mislead the consumer. This includes false statements about a product
containing ingredients which in reality are not natural part of the product's composition.
9- It is strictly prohibited to use the logo of the SFDA either directly or indirectly in the
advertisement.
10- The picture of the advertised food is identical to the physical image of the product in the
market or destined to be placed in the market.
11- The advertisement doesn't, either expressly or implicitly, offend any other food products.
12- The language of the advertisement is Arabic. Other languages may also be used if they
match the Arabic version in terms of content.
Article 12
Any laboratory may only start practicing food lab activities upon the approval of the SFDA and
after meeting the conditions and requirements laid down under this Act.
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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

# Article 22

may only start practicing food lab activities upon the approval of the SFDA and after meeting
the conditions and requirements laid down under this Act:

1. Apply for a and fill out the required forms, indicating what type of activity is to be
 carried out and where.
2. Provide a copy of the commercial register that indicate the laboratory activity.
3. Obtain approvals of the competent authorities.
4. Comply with the the technical regulations and standards for laboratories as approved by
 SFDA.
5. Comply with any other requirements set forth and published on-line (via the official
 website) by the SFDA

# Article 23

The license granted to the lab shall not be used for any purposes other than those authorized.

# Article 24

The lab license is valid for five years which can be renewed for similar periods, provided that
the application is submitted 90 days in advance of the expiry date and that all the requirements laid
down under Article (22) are satisfied. The renewed license comes into effect immediately after the
expiry date of the previous one.

# Article 25

To be liable for a renewed licence, the laboratory shall have a valid registration.

# Article 26

Private food laboratories shall adhere to the Guidelines for the Licensing and Registration of
Private Food Laboratories and circulars issued by the SFDA.

# Article 13

Food establishment shall not practice food handling activity before obtaining a technical license
issued by the SFDA in accordance with conditions and procedures defined under this Act.

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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
Article 27
Food establishment shall not practice any food handling activities before obtaining a technical
license issued by the SFDA in accordance with following requirements, conditions, and
procedures:
1. Apply for a license and fill out the required forms, indicating what type of activity is to
be carried out and where.
2. Provide a copy of the commercial register that indicates the laboratory activity.
3. Obtain approvals of the competent authorities.
4. Comply with the technical regulations and standards for laboratories as approved by the
SFDA.
5. Ensure that none of the establishments, in relation to the applicant and where the same
activities to be licensed are carried out, are subject to license suspension or revocation.
6. Comply with any other requirements set forth and published on-line (via the official
website) by the SFDA
Article 28
Food establishments including their primary production facilities shall meet requirements and
conditions as approved in relevant technical regulations, and standards and to be able to follow
Good Manufacturing Practices (GMPs).
Article 29
Food establishments shall not use their license for any other purposes other than those authorized.
Article 30
The License is valid for one year and can be renewed for similar period or periods, provided
that the application is submitted 60 days in advance of the expiry date and that all the requirements
and conditions laid down in Article (27/28) are satisfied. The license enters into effect immediately
after the expiry date of the previous one.
Article 31
To be liable for a renewed licence, Food establishment shall have a valid registration.
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الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
Chapter Four: Food Handling
Article 14
Foods may only be exported from establishment certified by the SFDA.
Article 32
To be certified as a food exporter, the business operator shall:
1. Have a valid licence and registration with the SFDA.
2. Have a commercial register indicating that the establishment is engaged in food exporting
activities.
3. Have their products registered with the SFDA.
 * Where the manufacturer producer or importer is not the same person(s) as the applicant,
 provide a written agreement with the manufacturer, producer or importer taken into
 account the SFDA Guidelines for the issuance of food export certificates for food
 commodities.
Article 33
The SFDA shall issue export/re-export certifications for food if the following is provided:
1. A completed export/re-export certificate application submitted to the SFDA for each
 consignment separately.
2. A list of the products intended for exportation.
3. In the event of re-exportation, a clearance permit of the previously imported consignment
 along with the official documents and certificates required for shipments entering the
 Kingdom.
4. Any additional documents requested by the SFDA.
5. For licenced establishments, an Assurance of compliance with the SFDA Guidelines for
 the Issuance of Food Export Certificate.
Article 15
Individuals may only engage in food handling activities after obtaining a licence to handle food
according to the requirements and conditions laid down under this Act.
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# Article 34

To be liable for a licence to handle food, the applicant shall:

1. Provide a written documentation from a recognised medical centre indicating that the applicant is fit and free from any diseases which may pose risk to food safety.
2. Pass the SFDA-approved examinations and training programs.
3. Meet all the requirements and conditions stipulated under relevant standards and regulations.

# Article 35

The licence is effective for two years extendable for further periods.

# Article 36

Food handlers shall immediately report to the person in charge of the food establishment if they have illnesses or disease symptoms including wounds or injuries.

# Article 37

Workers, when handling foods, shall apply Good Hygienic Practices.

# Article 38

The Food Handler Licence shall be immediately revoked or suspended by SFDA if there is evidence of noncompliance to the provisions laid down under this Act and its relevant regulations.

# Chapter Five: Handling Food

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# Article 16

Food shall not be handled in the following cases:

1. If it violates the Islamic Law provisions.
2. If it is harmful to health or unsafe for consumption.
3. If it violates the technical regulations or food standards.
4. If it is adulterated, involves deceptive methods, means or otherwise practices that may mislead the consumers.
5. If it is not packed according to relevant regulations, taking into account any exemptions outlined under this Act.
6. If it lacks the required nutritional labelling or information, taking into account any exemptions outlined under this Act.
7. If it is not registered with SFDA.

# Article 39

A food is considered in violation of the Islamic Law provisions in any of the following cases:

1. If the food source or one of its components are non-halal according to the technical regulations.
2. If a halal food is mixed with non-halal foods at any stage of the food chain.
3. Any other cases defined by SFDA and published on its website.

# Article 40

It is prohibited to handle meat and meat products if they are non-compliant to the relevant technical regulations or if they originate from animals slaughtered in a manner contrary to the Islamic Law provisions.

# Article 41

A food is considered injurious to health or unfit for human consumption in any of the following cases:

1. If it contains any toxic substance.

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Saudi Food & Drug Authority

2. If it is derived from a hazardous source that may harm consumer health.
3. If it has contaminants or agricultural production inputs at levels exceeding the permitted
limits as set forth by relevant technical standards.
4. If it contains a food additive restricted from use as per relevant standards and regulations.
5. If it contains food additives at levels higher than the acceptable limits.
6. If it is spoiled, rotten or contains contaminants at levels exceeding the acceptable limits set
by SFDA.
7. If it was handled in an environment or under conditions that may render it injurious to
health or susceptible to contamination.
8. If it is derived from sick animals or animals with zoonotic factors affecting the product's
suitability for human consumption, or from animals died before slaughter
9. if the packing or packaging materials used are unsafe or permitted for use with foods.
10. If it contains allergens or any sources of risk to consumer health unless clearly indicated
on the label.
11. If it has or is contaminated with radioactive materials at rates of radioactivity higher than
the acceptable limits approved by SFDA.
12. If it passes the expiry date indicated on the label.
13. If it is inappropriate or unacceptable according to the intended use.
14. If it is damaged, spoiled, dissolved, contaminated with dirt or if there is a change of colour
or odour to an extent which may compromise the quality its quality.
15. If it contains foreign materials that exceed the allowed limit as stipulated in relevant
technical regulations, and lead to a change in the distinctive properties of food according
to the intended use.
16. Any other cases defined by SFDA and published on its website.

## Article 42

Food shall not be handled if it violates approved technical standards and regulations.

## Article 43

The means of transport used for food shall be in compliance with the requirements and
provisions stated in relevant technical regulations, and standards as laid down by the competent
authority.

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SFDA

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
Article 44
A food is considered adulterated in any of the following cases:
1. If it contains food additives the introduction of which is contrary to regulations.
2. If the labelling information is not consistent with the actual content of the product.
3. If any of the components is removed, changed or recomposed without prior indication on the
label even if such action is carried out in line with relevant regulations.
4. If it contains substances which may undermine its nutritional value.
5. If it contains any substances which may conceal a defect or lead to a change in terms of
weight or size.
6. If it contains pork or pork products, lard, alcohol or any forbidden (not halal) ingredients
without indicating so on the label.
7. If the expiry date has been altered or pushed beyond the shelf life shown on the label without
prior written consent from SFDA.
8. Any other cases defined by SFDA and published on its website.
Article 45
The following practices are considered misleading to the consumer:
1. Incorrect description.
2. The nutritional information contains words, phrases, symbols, pictures, or signs that are
incomprehensible, ambiguous, blurred or invisible, or inaccurate
3. Discrepancy between the Arabic and English nutritional information.
4. The label contains health or nutritional claims that are not allowed by SFDA.
5. The food is produced by irradiation technology, genetic modifications, or other modern
technologies without indicating that on the food label as per technical regulations requirements.
6. Any other cases defined by SFDA and published on its website.
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SFDA

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

Article 46

Without prejudice to the requirements and conditions of food handling, the following products
must be approved by SFDA.

1. Nutritional additives.
2. Food for special dietary and medicinal uses.
3. Food for infants and children.
4. Energy drinks.
5. Any other products defined by SFDA and published on its website.

Article 17

Food business operators are accountable for ensuring that food activities, carried out under
their supervision, are in compliance with the regulations under this Act.

Article 47

For the purpose of implementing this Act and regulation and to ensure that food is safe and fit
for human consumption, the establishment shall appoint a person who, in addition to supervising
food handlers and food handling activities, is responsible for the following:

1. Train food handlers, and identify the required qualifications and skills they need in the field
of food safety and GMPs as deemed relevant to their duties,
2. Suspend from work any employee suffering from an illness or infection, that may compromise
food safety, until that employee is fully recovered.
3. Apply food safety management system.
4. Cooperate fully with food inspectors as they conduct their inspections and audits
5. Keep a record of all the documents and certificates required by the SFDA and make them
available upon request.

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SFDA

الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority
6. Immediately notify any food that presents risk to consumers' health and report the
countermeasures applied.
7. Maintain a system of product traceability recall and withdrawal.
8. Report any activities introduced changed or otherwise suspended with regard to premises,
processes or employees.

# Chapter Six: Business Operators Liabilities

## Article 18

Food business operators shall be able to trace their food products back to the source, identify
their suppliers and provide SFDA with the required information upon request.

## Article 48

Food business operators shall have a system of food traceability in place and provide SFDA
with the relevant information, in addition to the following:

1. A Food Traceability Manual incorporating the minimum traceability requirements prescribed
 by the SFDA, include the following:
 a. A set of procedures for the identification of food sources and food suppliers.
 b. A documentation system of the processes that food undergoes at all food handling stages
 supervised by the establishment.
 c. A list of all the raw materials and the additives introduced into the composition of food, their
 sources and the packing packaging materials used.
2. A guarantee to apply a "one step forward, one step back" traceability approach, and to keep a
 record of manufacturers/supplier, points of sale, distribution or display.
3. A step back register of all food suppliers and the products they supply, names of suppliers,
 their contact information, the collection date, in addition to the nature of the products collected,

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their quantities, transport and storage conditions as well as any other information deemed
necessary by SFDA.
4. A step forward register of all clients and the food they procure, including names of clients,
their contact information, the date of delivery, in addition to the nature of products delivered,
their quantities, transport and storage conditions as well as any other information deemed
necessary by SFDA.
5. Information about the food handled, its name, trademark, barcode, size, weight, production
date, shelf-life, lot and batch numbers and any other traceability information.

## Article 49

Food business operators shall comply with the following;

1. keep a record of all traceable items for a minimum of 180 days from the expiry date and make
them available upon request. The SFDA may set other periods for different food products.
2. timely calibrate and update the traceability system to ensure its efficiency as deemed
appropriate.

## Article 50

The SFDA, where applicable and as deemed necessary, shall:

1. make sure that food establishments have in place effective and operational traceability systems
applicable to all stages of food handling activities in their respective facilities.
2. exempt some food businesses from some traceability requirements.

<br>

## Article 19

SFDA may conduct assessments before, after and upon placing food on the market, and may
take the appropriate controls, considering the assessment results and the provisions of this Act
and regulation.

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SFDA

# Article 51

The SFDA shall, prior to/after and upon the placing of food on the market, initiate risk assessments particularly when:

1. There is an outbreak or regional/international incident that may present potential hazards to food safety,
2. There are reports or information stating or suggesting a relationship between an illness and a food-related source of risk.
3. The risk information and reports are substantiated by various inspection surveys and monitoring programs.
4. There is a need for technical studies carried out solely by SFDA or jointly with other bodies of interest.
5. The use of new technologies lead to the creation of novel or untraditional foods.
6. Any other cases SFDA deems necessary.

# Article 52

The SFDA may draw upon scientific food risk assessments developed by well-known international organizations or published in robust scientific journals.

# Article 53

The SFDA shall have the right to ask food establishments for any information about the products they manufacture produce import or place on the market.

# Article 54

When carrying out risk assessments, the SFDA shall do one or more of the following controls:

1. Order the owner, or the person in possession of the food in relation to which the assessment is made, to make an official promise that no action will be taken against that food until the assessments are concluded.

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2. Prevent release of the product subject to the assessment.
3. Prohibit handling the product subject to the assessment.
4. Impose corrective measures to ensure food safety and compliance with standards and regulations.
5. Shut down the entire facility or part of it for a period of time to be decided by SFDA and to remain in effect until the corrective measures are satisfactorily apply.
6. Order a food recall.
7. Withdraw the product(s).
8. Any other precautionary measures SFDA deems appropriate.

**Article 20**

If food business operators have doubts or reasonable belief that food is incompliant to SFDA requirements and conditions, they shall notify SFDA and take the appropriate recalls as laid out in this Act and regulation.

**Article 55**

As soon as food business operators know or suspect that food is in violation of the SFDA regulations and requirements, the shall immediately recall it along with the following lines:

1. Initiate the recall process all the way to the end consumer.
2. Immediately notify SFDA reporting all the information related to the product recalled.
3. Follow all SFDA directions and advice in relevance with this matter.
4. Where SFDA deems it necessary, publish recall announcement in at least two official gazette, one of which is located within the same geographical region as the recalling establishment.
5. Complete the recall process within the period defined by SFDA and provide a report about it.

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Article 56
Food business operators shall have in place a food recall system as per SFDA regulatory
guidance for recalling and withdrawing food and feed or packing and packaging materials.

Chapter Seven: Control of Food
Article 21

SFDA shall set up and run a rapid alerts system to notify any direct and indirect threat to
human health arising from a food source, and use all available means it considers appropriate to
keep consumers informed according to the provisions under this Act and regulation.

Article 57
The SFDA Rapid Alert Center for Food shall undertake the mission of operating and running a
Rapid Alert System for Food (RASFF) along the following lines:

1. The Center shall work around the clock to collect and study all information about hazards that
may either directly or indirectly affect human or public health.
2. The RASFF shall have focal points representing local stakeholders in the private and public
sectors to be selected by the SFDA. Each focal point shall appoint first and second contact persons
authorized with a direct channel of communication with the Center to report any changes made by
the entity they represent and to exchange any information of relevance.
3. The Center may ask food businesses to provide any data about the food they manufacture,
produce, import, export or distribute as deemed required by the RASFF system.
4. Within no later than 24 hours, the focal points shall provide the Center with the available
information they have about the product notified and the measures taken.
5. If food business operators have reasons to believe that the food they manufacture, produce,
import, export or distribute may pose risks to public health or human safety, they shall immediately
notify it and report on-going or already applied measures.

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6. If there is a potential risk connected to a food product that has possibly reached the market, the
Center shall, within 24 hours and as per the alert categories outlined in the RASFF Guide,
disseminate all the information - even if incomplete - about that product to all the focal points.
7. Where deemed appropriate & applicable, the center shall take the necessary steps to enforce the
maximum 24 period for submitting alerts to the concerned establishments and focal points.
8. The BIP management shall report to RASFF any shipments rejected at the borders, stating the
reasons for rejection.
9. The Center shall post alerts to warn consumers against the consumption of the product notified
as per the procedures adopted by SFDA.
10. The Center shall not disclose any information considered establishment's trade secrets unless
the disclosure of which is a key to protect consumer health. Trade secrets shall not stand on the
way of providing the Center with any information about a notified product if this information is
necessary for human safety and public health.

Article 22

For the purpose of implementing this Act and regulation, the SFDA is the body that has the legal
power to inspect food establishments and facilities, and if necessary may seek assistance from
security agencies.

Article 58

The SFDA shall undertake the responsibility of inspecting food establishments and facilities,
according to the following:

1. SFDA shall develop a standard operational procedure for inspecting food premises and
facilities.
2. The inspection shall be applied periodically to food products and food handling activities.

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## Article 23

The SFDA inspectors – to be nominated by the CEO – shall control inspect and penalize with a power equivalent to that of a criminal investigator,

## Article 24

An inspector, when presenting his/her badge, is allowed into food establishments and facilities for inspection and shall have access to documents and records and, if necessary, request copies, and may as well take samples for analysis. The food business operators shall cooperate with the inspectors and remove any obstacles that may hinder their missions.

## Article 25

If the inspection shows that food is in violation of the provisions of this Act and regulation, the inspector shall, in accordance with the provisions of this Act and regulation, seize the food and take the necessary actions, including mandatory confiscation of unsafe food.

## Article 59

The inspector shall seize unsafe food or food which is in violation of this Act and regulation, as shown in the following:

1. Write a seizure report stating the offense, the type and quantity of the implicated food, and provide a copy to the concerned establishment. The inspector may impose penalties on food business operators if they, or their representatives, fail to show up or refuse to sign the report.
2. Order the person in charge of the business under inspection, or his/her representative, to take a pledge not to take any action against the seized product(s). without prior consent from SFDA.
3. Take samples for analysis if needed.

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Saudi Food & Drug Authority
Article 60

One or more of the following shall be recommended by the inspector:
1. Business shut down, either the entire establishment or part of its facilities.
2. Disposal of violative products at the expense of the establishment.
3. Grant a grace period to take remedial actions if applicable.
4. Re-export violative imported food.
5. Any other recommendations as deemed appropriate.

Article 26

The inspector shall adhere to the following:
1. Non-disclosure of any information arising from or as a result of the inspection process, unless the information is needed as part of a court hearing or required by a competent judicial tribune.
2. Compliance with the provisions stated under this Act and regulations.
3. Writing seizure reports in case of offences to the provisions of this Act and regulation, and providing a copy of the report to the offenders.

Chapter Eight: Collection and Analysis of Samples
Article 27

The Authority is entitled to withdraw food samples free of charge, to check the extent of compliance with the provisions of this Act and regulations, and to analyse the samples in SFDA laboratories or other labs registered with SFDA as deemed necessary.

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# الهييه العامه للغذاء والدواء
Saudi Food & Drug Authority

## Article 61

For the purpose of ensuring compliance with the provisions of the Act and regulation, food samples shall be taken along the following lines:

1. The sampling shall be documented in a report signed by both the inspector, or whomever is authorized by the SFDA, and the establishment owner, or whomever is officially acting on their behalf.
2. The sampling shall be carried out free of charge and according to the framework adopted by the SFDA, provided that the quantity of samples collected is limited to the analytical needs.
3. The samples shall be sent to SFDA laboratories for analysis, or, as deemed appropriate, to other SFDA-registered laboratories located in the Kingdom or abroad.

---

## Article 28

If the analysis shows any non-compliances, SFDA shall report the results and take actions accordingly which include the notification of the concerned establishment.

---

## Article 62

The SFDA shall draw up a technical report if the results of food sample analysis reveals non-compliances to the provisions of this Act and regulations.

---

## Article 63

The SFDA shall report their findings and notify the establishment in relation to which the offence is committed. The concerned establishment has the right to appeal against the reported results, under the condition that the appeal is submitted to SFDA within ten days of work from the date of notice.

---

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## Article 64

The right of the food establishment to challenge the SFDA report does not constitute a prejudice to the controls entrusted to SFDA by law.

## Article 65

The measures applied by SFDA shall be consistent with the level and nature of risk as well as the reoccurrence of the offence committed by the concerned establishment.

## Article 66

If the results of the sample analysis revealed a violation of the Law provisions, regulations, or the technical regulations, the SFDA shall carry out one or more of the following:

1. Prevent handling of the implicated foods.
2. Requiring corrective actions where applicable.
3. Closing down the entire facility or part of it until corrective actions are fully implemented.
4. Food withdrawal and recall.
5. Disposal of the implicated product(s) at the expense of the offenders.
6. Prohibiting the offenders from engaging in any food handling activities.
7. Revocation of a licence.
8. Cancellation of registration.
9. Suspension of a food licence.
10. Provisional release of the imported food if SFDA considers it possible for the situation to be rectified.
11. Re-exportation of imported food.
12. Any other measures as deemed appropriate.

# Chapter 9: Preventive Actions and Precautionary Measures

## Article 29

The SFDA should adopt the appropriate precautionary approach to ensure the safety of food throughout the food chain, and to that effect enforce preventive controls and technical regulations.

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## Article 67

The SFDA shall adopt the appropriate preventive approach at all stages of the food chain to ensure food safety, and to enforce safeguards on food business which may include: Good Manufacturing Practices (GMPs), Food Safety Management System (FSMS) and or any other equivalent systems.

---

### Article 30

If the SFDA has reasonable doubts that food may pose risk to consumers or public health, and these doubts are not substantiated by scientific evidence, the SFDA may take the appropriate controls to ward off the potential risk, considering the extent of the damage while avoiding any unnecessary restrictions and timely reviewing the measures taken on the basis of risk assessment results.

---

## Article 68

When SFDA has doubts that food that may pose risks to humans or public health, it shall restrict the suspected food, identifying its whereabouts and taking any of the following precautionary measures:

1. Imposing a ban on the imported product.
2. Confiscating detaining or preventing handling of the implicated product until safety confirmations are made.
3. Closing down the facility or part of it.
4. Recalling or withdrawing the product.
5. Conducting risk assessments.

---

## Article 69

SFDA shall review Article (66) within a reasonable period of time to be determined by the expected health hazards and the availability of more comprehensive assessments.

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# Article 31

If there is a potential risk to consumer or public health originating in a food establishment, facility
or attributed to any of its products, the SFDA shall order a business shutdown with respect to the
entire establishment or any of its facilities, in accordance with the procedures outlined in this Act
and regulation.

# Article 70

If there is a likely threat to consumer safety or public health in, on or at, any food premise or
part, or product, thereof, the SFDA may serve on the person in charge of the premises a “closure
order" notice. The closure process shall, as appropriate, involve:

1. A notice describing the particulars of the closure and the matters giving rise to the said
danger and its locality.
2. A recommendation of the type of closure to be administered, based on the potential risks.
3. An official order and type of closure adopted by SFDA.
4. A continued suspension of business operations until the source of risk is eliminated or
remedied as prescribed by the SFDA.
5. Confiscation of the concerned products.
6. An assessment of the possible risk, which may include collecting and analyzing samples.

# Article 71

No food business shall be allowed to resume operations without authorization from SFDA.

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Article 32
If it appears to SFDA, on reasonable grounds, that food poses risk to human and public health
and it cannot be averted by existing remedial procedures; The SFDA then shall resort to extreme
measures which may involve product recall or other measures as the case may be.
Article 72
If it appears to SFDA, on reasonable grounds, that food presents risks to consumer safety
or public health and that such risks cannot be averted by existing remedial procedures, the
SFDA may take one or more of the following measures:
1. Order the responsible food business to recall or withdraw the product immediately or
within a specified period of time.
2. prohibit handling of the product or prevent its release.
3. Recall the product at the expense of the responsible party if the deadline stated in (1)
above is not met.
4. Make sure that the recall/withdraw process is followed through.
5. post a public alert to inform the consumers about the recalled/withdrawn product(s).
6. Stop the responsible establishment from advertising the recalled/withdrawn product(s).
7. Take any further measures as deemed appropriate.
8. Applying Article (34) under the Food Act to any food presenting risk to consumer safety
or public health.
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Chapter Ten: Recall and Traceability of Food Products
Article 33
If there is evidence that food is likely to be injurious to consumer or public health, the SFDA
has the right to recall withdraw or stop handling the product as set forth under this Act and
regulation.
Article 73
If there is evidence that food is likely to be injurious to consumer or public health, the SFDA may
take one or more of the following;
1. Order that the product shall not be distributed or released.
2. Order the responsible party to recall and withdraw the product within a specified period of
time.
3. Make sure that the product recall/withdraw process is followed through.
4. Recall/withdraw the product at the expense of the responsible party if the requirement in
subsection (2) under this article is not met.
5. Notify the public about the recall and the justifications for the recall.
6. Stop the responsible establishment from advertising the recalled/withdrawn product(s).
7. Any other measures as deemed necessary.
Article 34
If food does not comply with this Act and regulation or found to be injurious to consumer or
public health, the SFDA may order it to be disposed of as set forth herein.
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Article 74

The SFDA may order food to be disposed of in line with the following provisions, if the food is noncompliant to this Act and regulation or injurious to consumer or public health:

1. The SFDA shall service a disposal notice describing the type and quantity of products as well as the reasons for the disposal.
2. The SFDA shall supervise the disposal process to ensure it is carried out as prescribed by the SFDA.
3. The concerned establishment shall bear all the costs incurred by the disposal process.
4. The disposal process shall be witnessed by the establishment owner or any person acting on his/her behalf.

***

Article 35

It is strictly prohibited to handle any food with respect to which SFDA has ordered a recall, withdrawal or ban.

***

Chapter Eleven: Penalties

Article 36

I:

(a) Any violation to this Act and regulations shall be punishable by the following penalties, without prejudice to any other laws:

1. A fine of up to S.R 1000,000 (one million Saudi Riyals).
2. Suspending the offender from practicing any food-related activities for a maximum period of 180 days.
3. A License suspension for a maximum period of one year.
4. License revocation.

(b) The penalty in terms of time and sum may double if the same offence is repeated.

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(c) If the violation involves deliberate handling of a harmful, prohibited or adulterated food
product, the penalty may include imprisonment for a period of no more than 10 years or a fine of
no more than S.R 10 million (or both), in addition to the above provisions stated in subsection
2,3,4 under (a) of this Article.

II:
SFDA shall be responsible for enforcing subsection 2,3,4 under (a) of this Article according to a
scale of severity to be approved by the Board. The penalty shall not be imposed prior to a decision
from the CEO of SFDA or whoever is designated to act on his/her behalf. The relevant rules and
procedures shall be laid out in this Act and regulations and they shall not prevent SFDA from
taking other measures as it deems appropriate.

III:
If the punishment involves imprisonment, the case shall come before the General Investigation
and Prosecution Commission for further investigation and, if deemed necessary, is transferred to
the competent judicial authority.

IV:
The court ruling reached in connection with the case is to be published in three official gazettes at
the expense of the offender, indicating the implicated food establishment and the place where the
violation has taken place.

V:
Whoever is found guilty for any offence punishable by this Act, may appeal, within a period of no
more than 30 days from the date of notice, to the panel referred to in paragraph VI.

VI:
A panel, of at least three members including one legal advisor, shall be commissioned by a decision
from the SFDA Board. The panel shall be assigned to the following:

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1. Looking into offenses and relevant penalties covered by sub-paragraph (c) of paragraph I
above, except for imprisonment, and determining the appropriate course of action against the
offenses presented, without prejudice to the appellant's right to appeal to the administrative
court within a maximum period of 60 days from the date of notice.
2. Looking into appeals against SFDA decisions. The deadline for the panel to decide the appeals
is 60 days. In case the deadline is not met, the appellant has the right to take the case to the
administrative court. If the SFDA ruling or panel's decision is overturned by the administrative
court, the court shall take over the case and decide the appropriate penalty stated in this Act.

Article 75

The Bureau of Investigation and Public Prosecution (BIPP) shall take over cases where the
offence involves deliberate handling of harmful, adulterated or restricted foodstuffs, and may refer
it to the competent tribunal if deemed appropriate.

Article 76

If the BIPP is in the opinion that an offence, submitted under Article (75), does not qualify for
a referral to a higher court, the Bureau may send it back to the panel described in paragraph VI
under Article (36) of this Act for further considerations and application of clauses stated in sub-
paragraphs (c) of paragraph I under Article (36) of this Act.

Article 77

The transfer of offences to the BIPP or the panel described in paragraph VI under Article (36) of
this, does not prevent the SFDA from taking any precautionary measures as deemed appropriate.

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## Article 78

Considering what was stated in the Articles (75), (76) of this Act and regulation, the penalties
shall be imposed by the SFDA stipulated in Sub-paragraphs (1), (2), (3) and (4) of (a) under I of
Article (36) of the Act, according to the classification of violations and the penalties adopted by
the Board.

## Article 79

The offences and penalties imposed by the SFDA, shall be considered along the following lines:

1. The Competent Department shall examine the offences after the conclusion of the seizure
 process, and the offender, or whoever is delegated to act upon his/her behalf, has the right
 for a hearing session
2. The Competent Department shall decide on the offences and submit their decision to the
 CEO or

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