sfda_gov_sa · regulation · processed · 19 chunks
الهييه العامه للغذاء والدواء Saudi Food & Drug Authority Conditions and Requirements for Food Clearance Operations Sector SFDA # Saudi Food and Drug Authority ## Vision and Mission ### Vision To be a global leader based on scientific foundations to enhance and protect public health. ### Mission To protect society through effective legislation and a regulatory system that ensures the safety of food, drug, medical devices, cosmetics, pesticides, and animal feed. # Table of Contents * Definitions * Mandatory General Requirements for Food Clearance * General Notes * Conditions for Clearance of Non-Commercial Products * Food Products for Manufacturing Purposes * Mandatory Regulations and Specifications According to Food Groups * Supplementary References * Supportive Links * **Introduction** Based on the Saudi Food and Drug Authority's system issued under the esteemed Cabinet Resolution No. (31) dated 24/1/1428H, ratified by Royal Decree No. (M/6) dated 25/1/1428H, the authorization for clearing imported food, pharmaceutical products, medical devices, pesticides, and everything related to the Authority's scope of work, after conducting the necessary inspections and analyses, falls within the executive tasks assigned to the Authority. This guide has been prepared to assist individuals involved in the food sector in understanding the requirements and conditions for food clearance, as well as the procedures followed, in order to facilitate and expedite the completion of their transactions. It aims to prevent rejection, delays, or losses that may arise from a lack of knowledge of these * **Scope** All food imported for commercial, non-commercial, industrial, and consumption purposes. * **Objective** To clarify the conditions and requirements for food clearance through customs ports. # Definitions: **The Authority:** The Saudi Food and Drug Authority. **Food:** Anything intended for human consumption as food or drink, whether fresh, processed, semi-processed, or raw. It also includes milk and any substance used in the manufacturing, preparation, or processing of food. **Clearance:** The decision issued regarding approval or denial of imported shipments through customs ports. **Health Certificate:** A document (paper or electronic) issued by the competent authority in the country of origin or export country, indicating the safety and suitability of the exported food according to the requirements of relevant technical regulations. It may include the registration number of the food establishment or alternative equivalent measures that are approved. **Halal Slaughter Certificate:** A certificate accompanying shipments of meat, poultry, and their products, containing information such as the slaughter date, expiry, etc. **Halal Certificate:** A document certifying that a product, service, or systems comply with halal requirements in Islamic law, including certificates for halal slaughter, halal-certified establishments, farms, slaughterhouses, and facilities, as well as certificates for primary product ingredients, additives, and components that include meat derivatives, rennet, gelatine, animal fats, oils, and their derivatives or any product that requires a halal certificate according to technical regulations. # Technical Regulation: A mandatory document that describes the characteristics of food or its production and manufacturing methods, including the regulations governing it. It also includes terms, symbols, packaging, or labelling of the product or its production method. # Certificate of Conformity: Third-party certification for products, operations, systems, or individuals. # Port of Entry: The location where the shipment arrives and is cleared for entry into the Kingdom. # Proficiency Test (PT): A proficiency test based on inter-comparison used to assess the performance of participants (which may include laboratories for inspection and calibration, inspection authorities, or individuals) in specific tests or measurements, and to monitor their ongoing performance. # Mandatory General Requirements for Food Clearance: Before importing food, the importer must ensure that: * The imported food complies with the approved technical regulations and the circulars published on the Authority's website. * The importer has registered their establishment on "Ghad" platform with the Saudi Food and Drug Authority (SFDA). * The importer has registered the food items and products they wish to import on "Ghad" platform. * Clearance requests are submitted via the Authority's electronic systems. * Clearance requests are submitted through the "Fasah" trade platform. * A licensed warehouse is available in accordance with the Authority's requirements. (Exemptions apply for local factories importing raw materials that are used in manufacturing their products, as well as importers whose total number of shipments per calendar year does not exceed 5 shipments, with a combined weight not exceeding 2,000 kg). # Mandatory General Documents for Food Clearance to be Submitted Electronically via the Fasah Platform: | Document (Paper/Electronic) | Notes # General Notes: 1. Compliance with the conditions for clearing organic food products is required. [here](here) 2. Adherence to the list of food establishments exporting to the Kingdom of Saudi Arabia. [here](here) 3. Compliance with circulars issued by the authority and published on the website. 4. Adherence to the general guidelines for the transportation of food to the Kingdom. [here](here) 5. A copy of the Halal Certificate: For food products that require a Halal certificate according to the conditions and requirements, in addition to products that carry the label or logo of "Halal" issued by Halal centres designated by the Saudi Halal Center. 6. A copy of the Halal slaughter certificate for meat, poultry, and raw gelatine intended for food, issued by recognized Halal centres accredited by the Saudi Halal Center. [here](here) 7. A copy of the Phytosanitary Certificate for grains/agricultural crops/fresh vegetables and fruits. 8. A certificate must be provided to prove the authenticity of any logo placed on food product labels as per the Saudi Gulf Technical Regulation No. SFDA FD. GSO 9 " Labelling of Pre-packaged Food Stuffs ", Section 3.4. When using any specific Halal logo, quality mark, or organic product... etc., proof of the authenticity of such claims must be provided. SFDA 9. According to the Food Law and its Executive Regulation issued by the Board of Directors of the Saudi Food and Drug Authority under Resolution No. (03- 16-1439) dated 9/4/1439H, and based on what is stated in Article 27, "The authority has the right to withdraw food samples free of charge to verify their compliance with the provisions of this law and its regulations, and analyse them if necessary in its laboratories or in laboratories registered with it", and Article 43 "The authority may consult with any other government entity or the private sector to carry out any task assigned to it under this law and its regulations." To verify that food meets the authority's requirements, samples may be withdrawn from the imported shipment and sent to the laboratories designated by the authority for analysis to ensure compliance with the authority's conditions. The importer is responsible for the cost of analysis and sample testing. 10. Compliance with Circular No. 41072 dated 21/05/1440H regarding the regulations and conditions to be followed when importing meat, poultry, fish, shellfish, and aquatic life. 11. Compliance with Circular No. 41072 dated 21/05/1440H regarding the regulations and conditions to be followed when importing meat, poultry, fish, shellfish, and aquatic life. 12. Importers must retain the original clearance documents for five years from the clearance date. The authority has the right to request additional documents for clearance if necessary. 13. The importer must pay the costs for sample analysis and testing to avoid delays or facing violations and fines. # Conditions for Clearing Non-Commercial Products: ## First: Personal Use Products * Ensure the shipment is not displayed in local markets and is used only for its intended purpose. * The importer is fully responsible for the safety and security of the imported products. ## Second: Imported Food Samples for Scientific Studies and Research (Not for Human Consumption) * A letter must be submitted via the "Fasah" platform detailing the imported samples and their intended use, along with a commitment from the establishment/importer not to sell or display them in local markets. * A copy of the research/study approval from the regulating authority must be provided. * A commercial invoice and bill of lading must be submitted. * In the case of research samples, proof must be attached showing the samples are for scientific research, provided by the institution to which the researcher belongs. ## Third: Display and Marketing Samples Not for Sale * The labels of food products must include the phrase 'Free Sample'. * A commitment must be submitted via the "Fasah" platform from the establishment/importer ensuring the samples are only for the intended purpose and will not be sold in local or international markets after the intended use is completed. * Import of display and marketing samples from animal-origin products is only allowed from accredited establishments, and approval must be obtained from the authority by sending a request via email at CEC@SFDA.GOV.SA before importation. # Fourth: Requirements for Clearing Proficiency Test (PT) Samples and Standard Materials for Food Product Analysis * A copy of the invoice from the manufacturer or packager indicating the quantities and the name of the proficiency test being sent. * A copy of the letter from the requesting authority, detailing the request for the samples or standard materials to be cleared, or any document proving the same. * A copy of the bill of lading. * All of the above documents should be submitted via the "Fasah" platform (Tabadul) and referred to the authority to complete the clearance procedures. # Fifth: Imported Food Samples for Analysis in private laboratories within the Kingdom * A letter from the requesting authority for analysis must be submitted via the "Fasah" platform (Tabadul) detailing the products to be cleared and the purpose of importation, along with the name of the laboratory. * A copy of the invoice must be provided. * Only the specified quantities for analysis are allowed to be imported. * The laboratory must be accredited by the SFDA. * A commitment from the accredited laboratory must be submitted on the "Fasah" platform (Tabadul) stating that the imported products will not be displayed, sold, or used in any way other than for analysis purposes. Additionally, any remaining samples must be destroyed after completing the required analyses. # Food Products for Manufacturing Purposes, Including Factories and Restaurants These include food products not intended for direct display or sale to consumers but imported for the following purposes: * Manufacturing in licensed food factories in the Kingdom. * Restaurants, where the imported food product will not be served or consumed directly by the consumer and will undergo processing/preparation. (The exception applies only to products used within food preparation areas and does not include products displayed on the consumer's table, such as sauces and flavourings.) ## Requirements: * The materials used for manufacturing purposes must comply with the approved technical regulations. * These products are exempt from clause 1.2.7 of the "SFDA.FD/GSO 9" Technical Regulation (Labelling of Pre-packaged Food Stuffs) which states: "The labels of food products and their accompanying information must be in Arabic, and if another language or languages are used alongside Arabic, all data in the other languages must match the Arabic version." An exception allows submission of a commitment via the Fasah platform that the label will be in English. ## Mandatory Technical Regulations (Specifications Store): These regulations are updated regularly, and it is essential to review the updates before importing food products. ## General Specifications Applicable at the Clearance Stage: | Specification Number | General Specifications | Specification Name (in English) | | :------------------- | :--------------------- | :------------------------------ | | GSO 9 | | Labeling of Prepackaged Food Stuffs | | SFDA.FD/GSO 150-1 | | Expiration dates for food products – Part 1: Mandatory expiration dates | | SFDA.FD/GSO 2500 | | Additives Permitted for Use in Food Stuffs | | SFDA.FD 2233 | | Requirements of nutritional labeling | | SFDA.FD 2333 | | Requirements for Health and Nutrition Claims on Food Products | | SFDA.FD/GSO 1016 | | Microbiological Criteria for Foodstuffs | | SFDA.FD 382 | | Maximum Limits of Pesticide Residues in Agricultural and Food Products | | SFDA.FD/GSO 2055-1 | | HALAL FOOD - Part 1: General Requirements | | SFDA.FD/GSO 2481 | | Maximum Residues Limits (Mrls) of Veterinary Drugs in Food | | SFDA.FD/GSO 2359 | | Extraction solvents and it's residue limits in the production foodstuffs and food ingredients | | SFDA.FD 193 | | Contaminants and toxins in food and feed | | SFDA.FD/GSO 1366 | | General requirements for handling of foods for special medical purposes. | # Mandatory Regulations and Specifications Applied in the Clearance Stage According to Food Groups | Food Categories | Subgroups | GSO / SFDA | Mandatory "Additional" Certificates / Required Certificates | |---|---|---|---| | **Grains and Grain Products** | Grains, whole grains, flour (wheat, rice, corn, barley, sorghum) | GSO 2329:2013 / GSO 2383:2014 GSO 2384:2014/ GSO 677:2008 GSO ISO 6575:2008 / GSO 1864:2008 | - When using any Halal logo, quality marks, or organic product labels, evidence must be provided to verify the claim. <br> - Gluten-free certificate is required if the product claims to be gluten-free according to GCC Technical Regulation GSO 1021 for gluten-free foods. | | | Grain Products (bread, pasta, noodles, tortillas, etc.) | GSO 838:2015 / GSO 1925:2009 GSO 2513:2016 / GSO 259:2015 | - Organic production certificate is required if the product meets organic production requirements. | | | Biscuits, cakes, doughs, pastries | GSO 2205:2012 / GSO 1879:2008 GSO 843:2008 / GSO 1917:2009 GSO 2384:2014/ GSO 1357:2002 GSO 1357:2002- COR 1:2015 GSO 1417:2013 / GSO 844:1997 GSO 1354:2008/ GSO 342:2016 GSO 342:1994- AMD 1:2012 | - A certificate of conformity from certain countries is required for clearance; please check the website via the link (Certificates of Conformity). | | | Breakfast cereals | GSO 852:1997 / GSO 1370:2013 GSO 989:2016 / GSO 2052:2010 GSO 2534:2016 / GSO 2272:2012 | | | | Starch | | | | **Vegetables and Their Products** | Roots, tubers, dried legumes, pulses & their products | | | | | Fresh vegetables (cucumbers, tomatoes, etc.) | GSO 1927 / GSO 2457 / GSO 1878 / GSO 1134 / GSO 6664 / GSO 1039 / GSO 1038 / GSO 1031 / GSO 1029 / GSO 1815 / GSO 1991 / GSO 1989 / GSO 2433 / GSO 2432 / GSO 873 / GSO 1036 / GSO 1868 / GSO 1987 / GSO 1972 / GSO 2430 / GSO 2137 / GSO 1975 / GSO 2131 / GSO 1037 / GSO 874 / GSO 123 / GSO 124 / GSO 125 / GSO 6661 / GSO 2045 / GSO 1032 / GSO 1033 / GSO 2436 / GSO 2044 / GSO 38 / GSO 2040 / GSO 2464 | - Pesticide residue-free certificate is required if requested for frozen and processed vegetable products. <br> - Organic production certificate is required if the product meets organic production requirements. <br> - A certificate of conformity from certain countries is required for clearance; please check the website via the link (Certificates of Conformity). | | | Processed vegetables (frozen, dried, processed, canned) such as tomato sauce | | - Import from approved establishments in some countries. | | | Vegetable juices | | - When using any Halal logo, quality marks, or organic product labels, evidence must be provided to verify the claim. | | | Mushrooms (e.g., button mushrooms) | | | | | Leafy vegetables | | | | | Potatoes, sweet potatoes & their products | | | # Fruits and Their Products | Category | Standards | Requirements | |---|---|---| | Fresh fruits (berries, citrus, etc.) | | - Pesticide residue-free certificate is required if requested for frozen and processed fruit products. <br> - Organic production certificate is required if the product meets organic production requirements. | | Processed fruits (frozen, dried, processed, canned) | | - A certificate of conformity from certain countries is required for clearance; please check the website via the link (Certificates of Conformity). <br> - Import from approved establishments in some countries. <br> - When using any Halal logo, quality marks, or organic product labels, evidence must be provided to verify the claim. | | Jam, jelly & marmalade (citrus fruit jam with peel) | GSO 2402 / GSO 2401 / GSO 2400 / GSO 2399 / GSO 464 / GSO 640 / GSO 2038 / GSO 1862 / GSO 466 / GSO 185 / GSO 204 / GSO 225 | - When using any Halal logo, quality marks, organic product labels, etc., proof of the claim must be provided. <br> - A gluten-free certificate is required if the product claims to be gluten-free, in accordance with the Saudi Gulf Technical Regulation No. GSO 1021 for gluten-free foods. <br> - An organic production certificate is required if the product meets the requirements of organic production. | | Juices (fresh, nectar & fruit drinks) | | | # Nuts & Seeds | Category | Standards | Requirements | |---|---|---| | Hazelnuts, Almonds, Pistachios, Cashews, Walnuts | (GSO 2318) - (GSO 1073) - (GSO 643) - (GSO 2377) - (GSO 2306) - (GSO 274) - (GSO 1358) - (GSO 7911) - (GSO 6756) - (GSO 2188) | - When using any Halal logo, quality marks, organic product labels, etc., proof of the claim must be provided. <br> - An organic production certificate is required if the product meets the requirements of organic production. | # Oils & Fats | Category | Standards | Requirements | |---|---|---| | Vegetable oils and fats (seed oils, oilseeds & margarine) | (GSO 2229) - (GSO 1754-1:2015) - (GSO 1754-1:2015/COR 1:2015) - (GSO 1754-2:2013) - (GSO 1754-3:2014) - (GSO 1754-4:1997) - (GSO 1754-5:1998) - (GSO 2389:2014) - (GSO 1018:1998) - (GSO 2325:2013) - (GSO 1019:2015) - (GSO 670:2015) - (GSO 2483:2015) - (GSO ISO 5507:2015) | - When using any Halal logo, quality marks, organic product labels, etc., proof of the claim must be provided. <br> - An organic production certificate is required if the product meets the requirements of organic production. <br> - A certificate confirming that the product is free from partially hydrogenated fats is required. | | Animal oils and fats (ghee, butter & marine oils) | | | # Fish & Seafood | Category | Standards | Requirements | |---|---|---| | Fish | (GSO 514) - (GSO 1922) - (SFDA.FD 1753) - (GSO 1398) - (GSO 1920) - (GSO 1973) - (GSO 524) - (GSO 1979) - (SFDA.FD 582) - (SFDA.FD 1361) - (GSO 1388) - (GSO 2043) - (GSO 1999) - (GSO 836) - (GSO 1998) - (SFDA.FD 380) - (GSO 270) - (GSO 2207) - (GSO 1817) - (GSO 1331) - (GSO 2317) - (GSO 1750) - (GSO 2427) - (SFDA.FD 1410) - (GSO 1360) - (GSO 2297) - (GSO 1387) | - A copy of health certificates for the source of raw materials is required.<br>- In case of claiming that fish and seafood products contain a halal claim, symbol, logo, or mark, or are organic products, proof of the validity of this claim must be provided.<br> - Import permit.<br> - Import from accredited establishments.<br>- When using any halal logo or quality marks or organic product labels, etc., proof of the validity of this claim must be provided. | | Mollusks | | | | Crustaceans | | | | Shellfish | | | | Processed seafood products (dried, salted, smoked & canned) | | | | Seaweed & algae | | | # Meat & Meat Products | Category | Standards | Requirements | |---|---|---| | Various types of red meat | | - A copy of health certificates for the source of raw materials is required. | | Poultry | | - A halal slaughter certificate for non-processed meat and poultry is required.<br>- A health certificate is required.<br>- A halal slaughter certificate.<br>- A quality certificate is required if a quality logo is present on the product label.<br>- An organic production certificate is required if the product meets organic production standards.<br>- A conformity certificate from some countries is required for clearance. Please review the website via the link (Conformity Certificates).<br>- An import permit for poultry and its products only.<br>- Import from accredited establishments.<br>- When using any halal logo or quality marks or organic product labels, etc., proof of the validity of this claim must be provided. | | Edible offal (brain, heart, kidney, liver, lung, etc.) | (GSO 322) - (GSO 1870) - (GSO 1327:2002) - (GSO 1328:2002) - (GSO 1389:2002) - (GSO 986:1998) - (GSO 1390:2002) - (GSO 2300:2013) - (GSO 2203:2012) - (GSO 2206:2012) - (GSO 2204:2012) - (GSO 2036:2010) - (GSO 1924:2009) - (GSO 1921:2009) - (GSO 1329:2002) - (GSO 1816:2007) - (GSO 996:1998) - (GSO 997:1998) - (SFDA.FD 948) - (GSO 814:1997) - (GSO 834:1997) - (GSO 1293:2002) - (GSO 504:1994) - (GSO 993:2015) - (GSOCAC/RCP 58:2007) - (GSO 1399:2002) - (GSO 1060:2002) - (GSO 1860:2008) - (GSO 323:1994) - (GSO 714:1997) - (GSO 1330:2002) | | | Processed meat products | | | # Coffee, Tea, and Herbal Drinks | Category | Standards | Requirements | |---|---|---| | Coffee and its products | GSO 2197, GSO 978, GSO 2096, GSO 2326, GSO 2516, GSO 1391, GSO 2138, GSO 783, GSO 2388, GSO 442 | - When using any halal logo or quality marks or organic product labels, etc., proof of the validity of this claim must be provided. <br> - An organic production certificate is required if the product meets organic production standards. | | Tea and its products | | | | Herbal drinks and their products | | | # Honey and Bee Products | Category | Standards | Requirements | |---|---|---| | Honey | GSO 147, GSO 2290, GSO 2097 | - A health certificate proving that the honey's source is from an area free from the small hive beetle disease (applies to 8 countries only). (link) <br> - Health certificate confirming no veterinary drug residues. <br> - Quality certificate if a quality logo is present on the product label. <br> - Organic production certificate. <br> - Certificate proving that honey produced in New Zealand complies with permissible limits for tutin toxin. <br> - Importation from approved facilities. <br> - If any halal logo, quality marks, or organic product claims are used, supporting evidence must be provided. | | Pollen, royal jelly, propolis, beeswax | | | # Eggs and Egg Products | Category | Standards | Requirements | |---|---|---| | Fresh eggs | | - Health certificate required. <br> - If any halal logo, quality marks, or organic product claims are used, supporting evidence must be provided. | | Egg products (frozen/dried/pasteurized eggs and parts thereof) | GSO 1002:2006, GSO 2351:2014 | - Organic production certificate if the product meets organic production requirements. <br> - Import permit required. <br> - Import from accredited establishments. | # Honey and Bee Products | Product | Standards | Requirements | |---|---|---| | Honey | GSO 147, GSO 2290, GSO 2097 | - A health certificate proving that the honey's source is from an area free from the small hive beetle disease (applies to 8 countries only). (here)<br>- Health certificate confirming no veterinary drug residues.<br>- Quality certificate if a quality logo is present on the product label.<br>- Organic production certificate.<br>- Certificate proving that honey produced in New Zealand complies with permissible limits for tutin toxin.<br>- Importation from approved facilities.<br>- If any halal logo, quality marks, or organic product claims are used, supporting evidence must be provided. | | Pollen, royal jelly, propolis, beeswax | | | # Eggs and Egg Products | Product | Standards | Requirements | |---|---|---| | Fresh eggs | | - Health certificate required.<br>- If any halal logo, quality marks, or organic product claims are used, supporting evidence must be provided. | | Egg products (frozen/dried/pasteurized eggs and parts thereof) | GSO 1002:2006, GSO 2351:2014 | - Organic production certificate if the product meets organic production requirements.<br>- Import permit required.<br>- Import from accredited establishments. | # Milk and Dairy Products | Category | Standards | | | | | 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