sfda_gov_sa · regulation · processed · 5 chunks
العربيه العامه للدفاع، والدول Saudi Food & Drug Authority SFDA Process for Approving Foreign Competent Control Authorities and Establishments Interested in Exporting Food Products to the Kingdom of Saudi Arabia (KSA) > Purpose To verify the procedures carried out by the competent control authority responsible for food safety in countries interested in exporting food products to the KSA. This step paves the way for assigning the competent authority the responsibility of approving the establishments interested in exporting food products to Saudi market, or the SFDA approves establishments interested to export to the Kingdom. Scope: 1. Establishment exporting beef and beef products. 2. Establishment exporting sheep meat and its products. 3. Establishment exporting poultry meat and its products. 4. Establishment exporting fishery products and other aquatic products of animal origin. 5. Establishment exporting honey and its products. 6. Establishment exporting milk and its products. 7. Establishment exporting breast milk substitutes. 8. Establishment exporting table eggs and its products. 9. Establishment exporting processed fruit and vegetables. 10. Establishment exporting grains and crop yields. 2 First: Requirements for approving a foreign competent control authority: ① The competent control authority seeking an approval must be in a country from which the import of the intended food products is not subject to a temporary ban. ② Completion of all the requirements listed in the Competent Authority Evaluation form (Annex 1) by the competent authority in the country wishing to export food products to KSA. Second: Approval Process for Competent control authority 1. Application: The competent control authority submits an application for approval to the (SFDA) through the Ministry of Foreign Affairs accompanied by a completed competent authority evaluation questionnaire. Indicating all the possible contact information (Tel No., Fax No., Email Address... etc.), and person(s) who will be communicated and a soft copy (WORD) of the questionnaire is sent to the ICD@SFDA.GOV.SA. 2. Evaluation of the Questionnaire: After the receiving of the competent authority evaluation questionnaire, it will be evaluated. The competent authority will be informed of any comments if required. 3 3. Inspection services fees: A. The competent authority in the exporting country provides the SFDA with a list of food establishments registered with it and subject to its control and interested to export to the Kingdom and apply the following: - Food Hygiene Requirements which is published on the following link: https://www.sfda.gov.sa/en/regulations/68665 - Technical Regulation. (SFDA FD. 21:2018) Hygienic Regulations for Food Plants and Their Personnel - Standard No. ((SFDA.FD/GSO 1694:2005)) General Principles of Food Hygiene - Technical Regulations and standards related to the food product. Best Aquaculture Practices (BAP) for establishment exporting aquaculture products. B. The establishments mentioned in list above point (1) shall pay the fees mentioned in the table below for inspection services, based on the Board of Directors Decision No. (8-26-1442) dated 8/11/2020, according to the countries as mentioned in the table below. <table><tr><td>Country</td><td>Inspection Fees</td></tr><tr><td>Arabic countries</td><td>17500</td></tr><tr><td>African countries (except for the Arab countries), EU countries, Russia, Turkey and East Asia</td><td>27000</td></tr><tr><td>Countries in North and South America, Australia, New Zealand and Japan</td><td>33000</td></tr></table> C. Any establishment that has not been approved is not entitled to claim the return of the fee. 4 4. Technical Team Visit: Upon the completion of all the required documents, and fulfilling the fee, requirement the SFDA communicates with the competent control authority in the exporting country to coordinate an SFDA Technical Team visit (if required). A professional Technical Team is formed by SFDA to visit the control body and a number of food products establishments in order to ensure that the competent control authority in the exporting country is actually conducting supervision to these facilities as per the technical regulations and health requirements approved in Saudi Arabia. The visit shall also include relevant facilities such as central reference labs, quarantines, animal farms and other control bodies. 5. Final Report: The professional technical team shall comprehensively report their observations about the visit. In case the report incorporates some incompliances, the competent control authority is informed and requested to provide a report of the corrective actions taken supported by the necessary documents as per the Monitoring Form for cases of non-conformity and immediate containment (Annex 2). 6. Post-visit Approval of the Control Authority A competent control authority is considered for approval by SFDA when the assessment questionnaire is finalized and the post-visit observations (if any) were taken into account. The SFDA provides the competent authority with the approved health certificate form for the products to be exported for approval and setting the implementation date. In the event that the official competent authority is approved, it will be granted an authorization to approve the establishments wishing to export their products to the Kingdom (with the exception of poultry meat, fish and table eggs products as they are included in the import permits). 5 Third: Procedure for Approving Establishments interested to export Food Products 1. When the competent control authority in the exporting country granted an approval by SFDA: The competent control authority must provide in advance, a list of accredited establishments interested in exporting food products to KSA for SFDA, provided that these establishments are subject to its control and in line with the SFDA approved technical regulations and standard specifications mentioned in point (3), through the ministry of foreign affairs according to the "form to update establishments of food products" for the product intended for export to KSA (Annex 3-8), to consider the possibility of export permission. The SFDA will consider the possibly to approve the establishments and publish the list of approved establishments on the SFDA website prior export without a technical team visit (if required). SFDA retains the right to conduct random on-site audits for these establishments at any time deemed appropriate based on article 8 of the conditions and requirements for exporting food to KSA. The visit will be arranged after fulfilling the fee requirement in coordination with the competent control authority in the exporting country. 2. When the competent control authority in the exporting country is not granted an approval by SFDA: ① The competent authority should submit an application to approve establishments interested to export to KSA according to the "form to update establishments of food products" accompanied with a verified self audit form by the competent authority through the ministry of foreign affairs and a soft copy (WORD) sent to the ICD@SFDA.gov.sa. 6 ② The self-audit form will be evaluated after it is received officially and a visit will be arranged to the establishments interested to be approved by the SFDA after fulfilling the fee requirement in coordination with the competent control authority in the exporting country as stated in the aforementioned points (3.4.5). ③ The SFDA will consider the possibility to approve the establishments and publish the list on the SFDA website. ④ The competent authority will review the health certificate related to the products included in the conditions and requirements for exporting food to KSA and confirm their acceptance and the implementation date. Forth: Procedure for amendments on the list of approved establishments ① The Competent authority shall fill the update request (Annex 8) to the list of approved food of animal origin establishments (and send it the SFDA via appropriate channels in case of any addition, delisting, and amendments. ② The SFDA will revise the request and update the establishment list based on the information received from the competent authority. 7 Annexes: Annex 1: Evaluation Questionnaire of Competent Authorities Annex 2: Monitoring Form for cases of non-conformity and immediate containment Annex 3: Form to update the list of approved establishments for food products - Meat Annex 4: Form to update the list of approved establishments for food products – Honey. Annex 5: Form to update the list of approved establishments for Diary Products. Annex 6: Form to update the list of approved establishments for breast milk substitute and children complementary food. Annex 7: Form to update the list of approved establishments for gelatin and collagen. Annex 8: Forms to update the list of approved establishments for food products – Fish. Annex 9: Self Audit Form. 8 بالاهي نفتي