sfda_gov_sa · regulation · processed · 4 chunks
الهييه العامه للغذا والفوا Saudi Food & Drug Authority SFDA Requirements and Conditions for the Clearance of Organic Food Products SFDA Introduction Based on the General Authority for Food and Drug's regulations issued by Royal Decree No. (M/6) dated 25/01/1428H, which stipulates that the authority grants permission for the clearance of imported food, pharmaceutical products, medical devices, pesticides, and anything related to the authority's scope of work, after conducting the necessary inspections and tests. Additionally, based on the Agriculture System issued by Royal Decree No. M/64 dated 10/08/1442H, which states in Paragraph (3) of Article 13 as follows: The General Authority for Food and Drug, in coordination with the Ministry, shall: A. Establish the conditions and procedures for the examination and analysis of organic products. B. Set the labeling requirements for organic products, specifying the necessary data and information to be included on the product label. C. Determine the requirements for the import and export of organic products. This document has been issued, outlining the requirements and conditions for the clearance of organic food products as defined within the scope and definitions. SFDA Scope These requirements and conditions apply to all shipments of food products that carry descriptive data, labels, or indications on their packaging referring to organic production methods. A product is considered to bear indicators of being produced organically when it is described in the information provided on its packaging or claimed — including advertising materials and commercial documents — with terms such as "organic," "biological," "biodynamic," "ecological," or similar terms with the same meaning. This includes phrases that suggest to the consumer that the product or its components have been produced according to organic methods. This covers food products of plant origin, food products of animal origin, including crop production, livestock production, poultry production, beekeeping, aquaculture, seaweed production, and processed food production. Objective This document aims to: 1. Protect consumers from any fraud or deception related to unsubstantiated claims about organic food products. 2. Strengthen control measures and ensure the safety and quality of organic food products. 3. Define the technical requirements and conditions to facilitate the clearance processes for importers. SFDA Definitions: The terms and expressions listed below, wherever they appear in these conditions, shall have the meanings specified next to them, unless the context otherwise requires: - The Authority: The General Authority for Food and Drug. - The Ministry: The Ministry of Environment, Water, and Agriculture. - Clearance: The decision to approve the entry of an imported shipment. - Organic Food Products: Products produced under a production system that is subject to monitoring and inspection according to certification programs based on clear and specific legal regulations. This includes monitoring all stages of the production chain. The system ensures the production of high-quality products while preserving natural and environmental resources, human health, and respecting the natural capacity of plants, animals, and nature. The system aims to reduce external inputs by avoiding the use of manufactured fertilizers, pesticides, chemical drugs, growth hormones, and genetically modified organisms (GMOs). Ionizing radiation and preservatives are also prohibited. This system applies from production to harvesting, processing, packaging, transportation, marketing, and ultimately to the consumer. Organic food products also include food manufactured from organic ingredients using mechanical or biological processing methods, such as steaming, smoking, or fermentation, to ensure their nutritional value. The use of additives or other substances during manufacturing that chemically react with organic foods or alter their properties is prohibited. Irradiation methods are banned, and only modern preservation and storage methods, such as controlling humidity and temperature and using approved drying techniques (per organic production standards), are allowed. Packaging and wrapping materials that may cause food contamination are also prohibited. SFDA - Organic Food Product Certificate: A document issued by the regulatory or accredited authorities in the country of origin or exporting country, stating that the product specified in the certificate is "organic." - Organic Production Unit Certificate: A document issued by the regulatory or accredited authorities in the country of origin or exporting country, indicating that the facility is engaged in organic production. - Organic Food Export Certificate: A document issued by the regulatory or accredited authorities in the country of origin or exporting country, indicating that the product specified in the certificate is "organic." - Accredited Organic Certification Bodies: Entities accredited by the Ministry of Environment, Water, and Agriculture to conduct inspections and certification for all organic agricultural activities, including import and export. CFDA - Requirements and Conditions for the Clearance of Organic Food Products: Without prejudice to the requirements of the technical regulations for food products of this type, and the accompanying documents and certificates required for the clearance process, organic food shipments must meet the following requirements: 1. Certificates Required: A. A copy of the Organic Food Product Certificate, indicating that the products specified in the certificate are "organic." B. A copy of the Organic Production Unit Certificate (Organic Certificate), indicating that the facility is engaged in organic production. C. A copy of the Organic Food Export Certificate (Certificate of Transaction), indicating that the products specified in the certificate are "organic." All three certificates must be issued by the regulatory or accredited authorities in the country of origin or exporting country. 2. Proof of Inspection and Certification: The importer in the Kingdom of Saudi Arabia must provide evidence of having undergone inspection and certification by accredited certification bodies recognized by the Ministry of Environment, Water, and Agriculture in Saudi Arabia. 3. Exclusion from Import Ban: The product must not be one of the items included in the import ban decisions. 4. Registration Requirement: The product must be registered in the electronic system for imported food with the Authority. 5. Compliance with Technical Regulations: The product must comply with the requirements of the approved technical regulations. 6. Non-Organic Ingredient Limits: Any organic food product containing ingredients derived from non-organic sources must adhere to the allowable limits as per the specifications and approved technical regulations. 7. Processing Restrictions: The product or its ingredients must not have been subjected to treatments involving ionizing radiation or materials not listed as permissible according to the specifications outlined in the Agricultural System. SFDA ■ Labeling Information: Without prejudice to the requirements of the Gulf Technical Regulation No. (GSO 9 " Labeling of Prepackaged Food Stuffs"), the organic product label must include the following information: - The name, number, and logo of the certifying body that issued the Organic Product Certificate. - The approved organic product logos used in the country of origin. - If the organic ingredients make up less than 95% but more than 70%, the percentage of ingredients produced organically must be specified, in accordance with Section 5.1.4 of the GSO 2374/2014 standard, "Guidelines for the Production, Manufacturing, Marketing, and Labeling of Organic Foods." ■ Transport and Storage: Without prejudice to the general requirements for food transport, the product must be safeguarded during any transport, storage, or handling process by taking the following precautions: - Organic food products must be protected at all times from contamination or mixing with non-organic products. - Organic bulk food products must be separated from non-organic products during transport, storage, and handling stages. - Storage areas and transport containers for organic food products must be cleaned using methods and materials that are permitted for use in organic production. SFDA ■ Sample Collection for Testing: The Authority has the right, when necessary, to collect samples from shipments of organic food products and subject them to routine laboratory tests and national monitoring program tests, either at the Authority's laboratories or at accredited private laboratories, both domestically and internationally. The importer shall bear the costs of these tests, as determined by the Authority in accordance with the requirements of the approved technical regulations. ■ General Requirements: - Originals of the documents must be retained by the importer for a period of five years from the date of clearance. - All procedures, requirements, and circulars issued by the Authority must be adhered to. - If a certificate proving that the product is organic is not attached with the shipment, the product will be treated as a conventional food product, the organic label must be removed, and it will be prohibited from being marketed as an organic product.