sfda_gov_sa · regulation · processed · 21 chunks
[Non-Text] الهييه العامه للغذا، واللواحي Saudi Food & Drug Authority SIDA Feed Act & Regulation Promulgated by SFDA Board Decision No (2-16-1439) on (Rabi II 9, 1439 corresponding to Dec 27 2017 GC) This document is a draft, therefore, it is subjected to alteration and modification. Disclaimer: The English version is a translation of the original in Arabic for information purposes only. In case of a discrepancy, the Arabic original will prevail. العربيه العامه للغذاء واللواحي Saudi Food & Drug Authority SIDA Article one The following words and phrases, whenever used in this document, shall have the following meaning specified, unless the context otherwise requires: Act: Feed Act, Regulation: Regulation of the Feed Act, SFDA: the Saudi Food & Drug Authority, Board: SFDA Board of Directors, CEO: SFDA Chief Executive Officer, Feed: any approved (single or multiple) material of animal or plant origin or from aquatic animals, whether processed, semi-processed, raw, or a material introduced into feed manufacturing, preparation or treatment, which is intended for oral animal feeding. Feed Components: any approved ingredient or a mixture of ingredients constituting feeds, including feed additives, originating from animals, plants or aquatic animals, consisting of organic or non-organic materials, which may or may not have a certain nutritional value. Animals: all food producing or non-producing animals, including aquatic animals. العربيه العامه للغذا، واللواحي Saudi Food & Drug Authority SIDA Handling: the stages, through which feed and feed ingredients undergo, from primary production to the end user, including importation, exportation, manufacturing, processing, packing, packaging, storing, transporting, distributing, seizing, placing on the market and selling. Feed additives: any components, whether or not they have a nutritional value, intentionally added to feed for technical purposes or to improve product's taste, nutritive value, or to ramp up animal's production. Premix: a mixture of vitamins, trace minerals, amino acids, enzymes, or other substances diluted by water or by permitted carriers of plant or animal origin in order to improv production. GMO: Genetically Modified Organisms— of animal or plant origin – used in the oral feeding of animals, including GMO feeds or feeds containing ingredients derived from GMOs. Establishment: any legal entity involved (in full or in part) in feed handling stages. اللغه العامه للغه, واللغه Saudi Food & Drug Authority SIDA Traceability: all operational procedures and measures applied to trace feeds, their source or ingredients or any component introduced thereto at any stage of feed handling. Label: any statement, sign, trade mark or any representation or description whether written, printed, painted, marked, stuck, engraved, compressed, or attached to a container or lid or package. Withdraw: a procedure applied by SFDA to withdraw a feed from the market. Recall: a procedure applied by feed establishments to remove their respective products from the market and prevent their sale. Good Manufacturing Practices: integral segments of quality assurance, which ensure that production process is maintained along the lines of sound and well-organized quality standards as per the intended production outcome and approved technical standards. Hazard Analysis Critical Control Points (HACCP): a control and preventive approach to food and feed safety which identifies the critical points affecting the production, safety and quality of products. العربيه العامه للغذاء واللغه Saudi Food & Drug Authority S Technical Standards: mandatory documents, which describe the characteristics of feeds, their production and manufacturing methods, and any relevant regulatory information, including expressions, symbols, and feed-related labeling, and packaging requirements. Standard Specifications: non-obligatory document, which contain requirements, accredited or adopted by SFDA. Risk Analysis: a scientific approach, which involves three interlinked factors (risk assessment, risk management and risk communication) to control the potential risks associated with feed. Feed Raw Materials: any substance (of permitted animal/plant/mineral origin), which is not mixed with other substances, intended to be fed to animals. Hazards: any factors (biological, physical, chemical ...etc.) the presence of which in feeds may pose risk to animals. Licensing: an official document issued by SFDA to authorize any feed-related activities. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA Contaminant: any substance – chemical (e.g.: heavy metals, dioxin, and pesticides) physical (e.g.: foreign objects, or insects) microbial (e.g.: Salmonella, Colon Bacteria), or aflatoxin and other – the presence of which may lead to the contamination of feeds. Lot: one or more batches, or part of a batch, produced within a specified period as a part of on-going operations designed in such a way to ensure uniformity of end-product characteristics and quality standards. Batch: a specific quantity of feed manufactured (produced) within a specific period as a part of a single process or subsequent series of homogenous processes. Animal byproducts: animal wastes come from different sources including: a. Animal farms: (Poultry litter or bedding, horse manure, or manures from cows, goat, sheep, camels or poultry wastes, fallen chicks or rotten eggs). العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA b. Butcher's and Slaughterhouse wastes: (entire bodies, or parts of an animal, or other products obtained from animals that are not intended for human consumption, hide hair wool, horns, hooves, viscera, intestinal contents, bladder, blood, womb, fallen stock, or animal droppings in slaughterhouses) c. Poultry slaughterhouses: (entire bodies, or parts of an animal, or other products obtained from animals that are not intended for human consumption, fallen birds, broiler litters and blood). Plant Wastes: plant wastes may come from different sources including: a. Byproducts of plant origin. (For example: hays and espaliers) this type of waste includes post-harvest wastes and wastes produced during harvest and pre-sale preparations. b. Byproducts of agricultural manufacturing. They are produced accidentally as a result of agricultural preservation and manufacturing processes such as wheat milling. c. Byproducts of the food industry (e.g.: such as starch glucose and oil extraction factories.) Consignment: a quantity of feed products covered by a single health certificate Article two The purpose of this legislation is to achieve the following: 1. To ensure the safety and wholesomeness of feeds. 2. To protect animal health. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 3. To safeguard human and public health against harmful substances traced back to feeds unfit to animal consumption. Article three The provisions of this legislation shall apply to all stages of handling and using feeds and feed ingredients whether produced locally, imported or prepared for export. The SFDA shall set rules and procedures for the following: 3.1. Identification of feeds and their storage and packaging conditions. 3.2. Registration of imported feeds, for example: feed additives, premixes, and ready to use concentrated and compound feeds. 3.3. Registration of locally produced feeds, whether they are consumed domestically or destined for export. 3.4. Inspection of feed business operations. 3.5. Traceability system and documentation. Article four This regulation shall establish the conditions and requirements, which must be met prior to obtaining an SFDA license to start any feed business activities, apart from activities within the agricultural field. 4.1 The license shall cover the following activities: a. Importation and exportation. b. Manufacturing, including processing and preparations, treatment, packing and packaging. c. Storage, distribution, transportation and sale العربيه العامه للغذا واللواحي Saudi Food & Drug Authority SIDA 4.2 The license shall only be issued if the applicants have met the following requirements. a. Complete the application form. b. Provide the documents required by SFDA. c. Obtain the necessary approvals from the concerned agencies as set by their own laws and regulations. d. Pledge to comply with the technical requirements determined by SFDA. e. Pay the licensing fees. 4.3 The license shall be valid for 3 years. 4.4 The license may be extended for a similar period or successive periods upon an advance notice of 90 days from the termination date. The extension shall take effect as of the termination date of the preceding one. It shall only be granted if the requirements set forth in Article 4.2 of this regulation are met. Article Five 5.1 This regulation shall establish the requirements for obtaining SFDA approval to release imported feeds or to allow the export of feeds. When applying for an SFDA approval to release imported feeds or feed ingredients, the following conditions and procedures shall be met: a. The establishment subject to the approval shall have a valid import license. b. The products or additives subject to the approval shall be registered in SFDA. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA c. The products or additives subject to the approval shall be in compliance with the provisions set forth herein, and the relevant technical regulations and decisions published on the official SFDA website. d. The products or additives subject to the approval shall be accompanied by the documents and official certificates where required by SFDA. 5.2 When applying for an SFDA approval to export feed and feed additives, the following conditions and procedures shall be met: a. The establishment subject to the approval shall have a valid export license. b. The products or additives intended for export shall be registered in SFDA. c. The products or additives intended for export shall meet the provisions set forth herein and the relevant regulations and decisions published on the official SFDA website. d. The products intended for export shall not be subsidized by the government, in which case export shall only be allowed after the subsidy is returned to the source. 5.3 Upon exporter's request, SFDA shall issue a health certificate for feeds and feed additives intended for export if the applicant has satisfied the following conditions: e. Apply to SFDA for a certificate for one consignment at a time. f. Complete the application form. g. Enclose a list of all feeds and feed additives intended for export. h. Make available any documents to be requested by SFDA. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 5.4 Where feeds and feed additives have been undergone previous clearance, an approval to allow for the export of these products shall only be granted if the documents and certificates accompanying their consignments at the time of clearance are made available. Article six 6.1 For laboratories conducting feed-related activities, an SFDA license shall only be granted if the requirements set forth by this Regulation are met. To license laboratories conducting feed-related activities, the following must be met: a. Complete the application form. b. Make available the documents required by SFDA. c. Obtain the necessary approvals from the concerned agencies as defined by their own rules and regulations. d. Pledge, on the part of the applicant, to comply with the technical requirements as determined by SFDA. e. Pledge, on the part of the applicant, to appoint a full-time technical manager with laboratorial qualifications and a Saudi citizenship. f. Pledge, on the part of the applicant, that the laboratory is staffed with qualified technicians and provided with the necessary equipment as deemed appropriate with the size and nature of the task and where determined by SFDA. g. Pay the license fees. 6.2 The license shall be valid for 3 years. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 6.3 The license may be extended for a similar period or successive periods upon an advance notice of 90 days from the termination date. The extension shall take effect as of the termination date of the preceding one. It shall only be granted if the requirements set forth in Article 6.1. Article Seven 7.1 Feed may only be advertised after obtaining an SFDA authorization and if the requirements and conditions set forth in this Regulation are met. The product to be advertised shall be registered in SFDA as per relevant technical regulations. 7.2 The advertisement shall not incorporate anything to be contrary to Sharia (Islamic law) or public decency law. 7.3 The information advertised shall be reasonably reliable, precise, authentic and verifiable. 7.4 The data contained in the advertisement material shall be consistent with the information included on the label of the product. 7.5 The advertisement shall not bear any nutrition or health claims contrary to relevant technical regulations. 7.6 Whether expressly or implicitly, the advertisement shall not offend another product. 7.7 It is strictly prohibited to use any misleading information _ printed photographed recorded or otherwise _ or to claim that the product advertised has ingredients, which are not introduced naturally into the product's composition. 7.8 It is strictly prohibited to directly or indirectly use SFDA logo. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority S 7.9 The picture of the product used in the advertisement shall be an identical reflection of the real-world products placed in the market. Article Eight SFDA shall take all the necessary measures to ensure the safety of feeds, including: 1. Enforcing all the requirements and provisions of relevant laws and regulations on feeds and their products exported to Saudi Arabia. 2. Enforcing relevant SFDA laws and regulations on irradiated feeds. 3. Reviewing the latest modern technologies in the feed industry and taking the necessary decisions to achieve the objectives of this Regulation. 8.1 Upon clearance, GMO feeds and their products shall be subject to the latest trends and regulations as deemed required by SFDA. 8.2 SFDA shall impose all technical regulations related irradiation on irradiated feeds. Article Nine SFDA shall have a rapid alert system in place meeting the conditions set forth herein to communicate any direct or indirect risk to human, animal or public health originating from feeds. العربيه العامه للغذا، واللواحي Saudi Food & Drug Authority SIDA 9.1 A Rapid Alert System for Feed (RASF) shall be established at SFDA to notify any direct or indirect risk to human animal or public health originating from feed. 9.2 The RASF shall operate in accordance with the following: a. The system shall be operational around the clock to gather and review all the information related to the hazards, which may, either directly or indirectly, pose risk to human animal or public health. b. For the purpose of this System, RASF contact points at public and private agencies concerned with feed shall be identified. c. Upon request from RASF, all the information associated with feed and feed manufacturing, production exportation importation and distribution shall be made readily available by the concerned feed businesses. d. Businesses' trade secrets shall not stand in the way of providing RASF with the information associated with the product(s) under suspicion as deemed necessary to ensure the safety of human animal or public health. e. The RASF contact points shall be provided with all the information available and measures taken against the product notified as soon as possible and no later than 24 hours. f. Feed business operators shall immediately contact RASF, if they have reasons to believe that a certain feed, whether processed produced imported exported or distributed, may pose risk to human animal or public health or safety. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA g. Any risk or risk information, even if incomplete, associated with a product in the market shall be notified to RSAF contact points within 24 hours according to the notification categories stated in the RASF Guidance document. h. As deemed applicable and appropriate, the RASF shall take whatever necessary to ensure that notifications are submitted to the contact points and the concerned establishment(s) within 24 hours. i. The head of the concerned border control shall notify the RASF of any feed consignment(s) rejected at the points of entry, stating the reasons for rejection. Article ten Feed business operators shall ensure the following: 1. Byproducts of animal farms and slaughterhouses are not to be used. 2. Plant wastes are to be used only as per the controls determined by SFDA. 10 3. The HACCP principle is appliedFeed manufacturers may use feeds derived from plant wastes only if, and whenever applicable, they meet following conditions: a. Satisfy the phytosanitary requirements. b. Show irradiations levels within the permitted limits as defined by SFDA. c. Are free from hazardous substances. d. Show levels of antimicrobial residues within the maximum permitted limits as defined by SFDA. العربيه العامه للغذاء واللоги Saudi Food & Drug Authority SIDA e. Show levels of pesticide residues within the maximum permitted limits as established by SFDA. f. Show contamination levels of heavy metals within the permitted limits as established by SFDA. g. Show contamination levels of aflatoxins with the permitted limits as established by SFDA. h. Show contamination levels of pathogenic microorganisms within the permitted limits as established by SFDA. 10.2 SFDA shall timely check compliance of feed businesses with the HACCP principle. Article Eleven Fish farms – involved in the production of aquaculture feeds – shall not handle feed wastes beyond the boundaries of their facilities except in the form of fishmeal and in accordance with the provisions of this Regulation. 11.1 Fish farms shall include farms, where marine and freshwater fish, crustaceans, mollusks, seashells, and aquatic plants are cultivated. 11.2 Each unit producing aquaculture feeds inside the entire facility shall be treated as a single entity to which the provisions stated in this Regulation apply. 11.3 Fishmeal produced inside the facility shall be in conformity with the technical regulations. اللغه العامه للغذا واللواح Saudi Food & Drug Authority SIDA Article Twelve Feed business operators shall: 1. Register their products in SFDA as set forth in this Regulation. 2. Meet all the requirements stated in this Act and its bylaws, and comply with good manufacturing practices. 3. be able to identify the source and suppliers of their respective feed commodities, and to provide, upon official request, any relevant information of interest to SFDA. 4. Comply with the maximum limits for feed additives as laid down in this Regulation. 12.1 Feed registration: a. Feeds shall not be handled unless they are registered in SFDA. b. Feed business establishments shall register their products – including their imported feed products – in accordance with the following: a. Where applicable, the products to be registered shall be in conformity with SFDA approved technical regulations and standards. b. The products to be registered shall not be on the list of prohibited feeds. العربيه العامه للغذا، واللواحي Saudi Food & Drug Authority SIDA c. All the relevant documents required by SFDA shall be made readily available upon request. d. The requirements and conditions as outlined in the approved Feed Registration Guide shall be met. c. Prior to making any change or modification to the information pertaining to a registered product as specified in the Feed Registration Guide, an SFDA authorization shall be requested and the concerned product shall be re-registered. 12.2 Compliance with Good Manufacturing Practices (GMP): a. Feed business establishments, including its facilities and manufactured or imported products, shall be in conformity with all the requirements set forth in this Act and its bylaws. b. Feed business establishments shall implement the good manufacturing practices or equivalent systems approved by SFDA. 12.3 Identification of feed sources and suppliers, and submission of information: Feed business establishments shall set in place standard procedures to identify the source and suppliers of their feed commodities, and provide their relevant information upon request from SFDA. a. Feed business establishments shall develop traceability systems for feeds. b. Feed business establishments shall base their traceability systems on the approved SFDA model as a minimum requirement for tracing their feed products. العربيه العامه للغدا، واللواحي Saudi Food & Drug Authority SIDA c. Feed business establishments shall document all the processes and procedures carried out at all stages of production. d. Feed business establishments shall keep a record of all the raw materials, ingredients introduced into the composition of their products, including their sources and the packing and packaging materials used. e. Feed business establishments shall conduct a timely review and update of the traceability system used to ensure maximum optimization. f. Feed business establishments shall maintain a record for at least 180 days after the expiration date of the shelf life of the traceable products. g. The minimum information to be included in the traceability documents shall be: a. Product's information (name, trade mark, lot and batch number, size, weight, production date, expiry date, and any other information to help identify and trace the product). b. Feed ingredients and their source including packing and packaging material. c. Contact information of the exporter, producer, manufacturer, packer, as well as the establishment where the product has undergone final treatment. d. Name and contact information of the establishment to which the product is sold (delivered). e. Quantity of the products sold (delivered) per establishment. f. Storage conditions and locations within the establishment, transportation and distribution data. اللغه العامه للغه, واللغه Saudi Food & Drug Authority S h. Feed business establishments shall provide SFDA with all traceability information and records of their products whenever requested. i. SFDA shall ensure that feed business establishments have a traceability system in place applicable to their respective products at all stages of production. 12.4 Compliance with the maximum limits for feed additives as laid down in this Regulation. SFDA shall adopt maximum limits for feed additives, considering the following: a. Technical regulations and standards. b. Scientific studies recognized by SFDA. c. Manufacturers' recommendations. d. Standards and regulations of International competent agencies. Feed business establishment shall comply with these limits. Article Thirteen اللغه العامه للغه, واللغه Saudi Food & Drug Authority SIDA Feed business establishments shall only introduce medications or feed ingredients to boost digestion metabolism or growth if they are licensed to do so in accordance with the controls laid down in this Regulation. Any practices, which involve the introduction of medications or feed ingredients to boost digestion or metabolism or growth, are not allowed except for establishments licensed to do so in line with the following controls: 13.1 Producing mixtures of feed additives at low concentrations, using the appropriate equipment. 13.2 Introducing only approved medications. 13.3 Using only approved feed additives. 13.4 Taking considerations of the target species, age group and established ratios per animal. Article Fourteen Feed business owners – or the individuals in charge of the business operations - shall immediately recall a product and notify SFDA in accordance with provisions set forth in this Regulation, if they know or suspect the product in question is incompliant with the SFDA laws and regulations. The recall process shall include: العربيه العامه للغذا والطاوي Saudi Food & Drug Authority SIDA 14.1 Initiating the recall immediately as planned. 14.2 Notifying SFDA immediately. 14.3 Abiding by the relevant SFDA guidance and directions 14.4 Reporting the recall in two daily newspapers, one of which is in the same area where the concerned establishment is located as deemed appropriate by SFDA. 14.5 Completing the recall process within a timeframe to be agreed upon by both the SFDA and the concerned establishment. Article Fifteen Feeds and feed ingredients, subject to the following, shall not be handled: 1. They contain prohibited ingredients or components. 2. They cause harm to the environment or public health, or if they are unfit to animal consumption. 3. They are in violation of SFDA laws and regulations. 4. They are adulterated, or involve deception or disinformation. 5. They are recalled withdrawn from the market or banned by an SFDA decision. 6. They are not registered in SFDA. 15.1 SFDA shall identify the ingredients and components the introduction of which to feeds is considered prohibited. 15.2 feeds are considered detrimental to the environment and public health in the following cases: العربيه العامه للغدا واللغه Saudi Food & Drug Authority SIDA a. They incorporate additives or contaminants at levels higher than permitted maximum limits. b. They contain restricted substances. c. They have passed their shelf life. d. They are handled or stored in conditions contrary to relevant regulations. e. The packaging materials used are inconsistent with the technical regulations and standards. f. This list is not conclusive and may include cases other than the above as deemed appropriate by SFDA. 15.3 Feeds shall be considered adulterated or involved in deceptive or misleading practices in the following cases: a. They contain feed additives, which are not allowed to be introduced into the feeds of the target animals. b. Any change is made to their components without prior indication on the label. c. They contain any substance, which may undermine their nutritional value. d. The shelf life has been altered. e. The label is missing. f. The target animals included classes or subclasses other than those mentioned in the registered label. g. Any change is made to the color or shape of the label or package. h. This list is not conclusive and may include cases other than the above as deemed appropriate by SFDA. اللغه العامه للغذا واللواح Saudi Food & Drug Authority SIDA Article Sixteen When handling feeds, feed business establishments shall observe the following: 1. meet the labelling requirements as laid down in this Regulation. 2. declare all transport and storage conditions on the label of feed additives and raw materials. 3. never use containers, designated for the storage and transport of feed additives and raw materials, to store or transport any substance which may undermine the safety or quality of these products. 4. never handle feed additives, or intentionally introduce them into their feed products, unless they are registered in SFDA as per the registration and licensing provisions laid down in this Regulation. 5. never handle premixes unless they meet the requirements outlined in this Regulation. 16.1 The label of feed products shall be applied in a manner that they are prominent, indelible, tamper-resistant, and commensurate with the technical regulations related to feed labeling. 16.2 Manufacturers and importers of feed additives and raw materials shall ensure the labelling information of their products incorporate clearly readable transport and storage requirements as recommended by the manufacturer and as deemed consistent with the nature of the product and prevailing environment. 16.3 Upon the transport or storage of feed additives and raw materials, the following shall be observed: a. The containers or facilities used shall be consistent with the nature of the products. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA b. The containers or facilities used shall not have any traces of substances which may have potential adverse effects on the safety or quality of the products. 16.4 Before they are handled or intentionally introduced into feed components, feed additives shall be registered in accordance with the following: a. They shall be on the list of authorized additives. b. Each product shall be registered separately. c. They shall be registered by a licensed establishment. 16.5 The following requirements shall be met for handling premixes: a. The products are registered. b. The establishment where they are handled shall be licensed. c. The products shall only be used within their respective shelf life. d. The products shall be transported and stored in line with the specific technical standards and conditions as laid down by the manufacturer. Article Seventeen As deemed necessary and applicable by this Regulation, SFDA may conduct audits at all stages of the feed chain, and take the appropriate action in light of their findings. 17.1 At any stage of the feed chain, SFDA may carry out audits which involve the following: a. On-site visit to the establishment where the product is handled. b. Documentary check of imported and exported feeds c. Sampling and analyzing the target products as stipulated under Article Thirty of this Regulation. العربيه العامه للغذاء واللоги Saudi Food & Drug Authority SIDA d. Reporting the result of the audit and provide a copy to the establishment concerned as deemed appropriate. 17.2 SFDA may take one or more of the following actions on the basis of the audit results: a. Enforce corrective measures to ensure safety and compliance. b. Require that the audited establishment to provide a pledge not to take action with respect to the concerned products they have in their possession until the lab tests come out. c. Suspend the establishment, or parts of the establishment, temporarily until the areas of concern are sufficiently remedied. d. Issue a decision to withdraw the products subject to the audit. e. Recall the products subject to the audit. Article Eighteen The SFDA may adopt a preventive approach to ensure the safety of feeds at any production stage, and, to that end, may enforce the appropriate controls and regulations. 18.1 The SFDA may adopt a preventive approach to ensure the safety of feeds at any production stage, and, to that end, may enforce the appropriate controls and regulations. Article Nineteen If SFDA has reasons to believe that feeds or a feed product may pose risk to public health, SFDA may take whatever countermeasures it deems appropriate to control that risk, taking into account the extent العربيه العامه للغدا، واللواحي Saudi Food & Drug Authority SIDA of the potential damage without creating unnecessary barriers to trade, and reviewing the measures applied from time to time on the basis of risk assessments. 19.1 If there are reasons to believe that a feed, or feed component, may cause harm to human animal or public health, SFDA shall may take any of the following controls: a. Narrow down and locate suspicious products. b. Take samples according to the provisions stated in Article Thirty of this Regulation. c. Seize and prevent the handling or release of the implicated products until confirmation is made that they are safe. d. Recall the products under investigation. e. Withdraw the products under investigation. f. Temporarily close down the establishment, or part of it. 19.2 The above controls in (19.1) shall be reviewed by SFDA within a reasonable period of time, depending on the nature of the potential risk, the availability of new information and the existence of more comprehensive assessments. Article Twenty SFDA may withdraw feeds from any feed establishment, if there is evidence that such products put human animal or public health at a risk that cannot be prevented by other applicable measures and controls SFDA may withdraw and prevent handling feed products, or any of their components, if there is evidence that such products pose risk to human, animal or public health that cannot otherwise be controlled. العربيه العامه للغذاء واللواح Saudi Food & Drug Authority SIDA Article Twenty-One: If there is a potential risk to human animal or public health originating from a feed business establishment or any of its facilities, SFDA may order the temporary closure of that establishment according to the provisions laid down in this Regulation. 21.1 SFDA may order a temporary closure of a feed business establishment, if such establishment, or any of its facilities or products, constitute a potential risk to human, animal or public health. 21.2 The following is an non-exhaustive list of potential situations involving risk to human animal and public health, and leading to temporary closure of feed businesses: a. Engaging in activities, which are not covered by the license b. Failing to comply with the license terms and conditions. c. Placing on the market or producing products, which are incompliant with their relevant technical regulations. d. Failing to apply good manufacturing practices or equivalent systems. e. Changing a product's specification without notifying SFDA. f. An SFDA decision to restrict an establishment's activity or prevent handling any of its products. g. The existence of damage to the environment originating from any establishment. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 21.3 The decision to close down an establishment shall be based on an SFDA report specifying the reasons and the situations in which the establishment, or any of its facilities or products, constituted a potential risk. Article Twenty-Two If there is a suspicion that a feed product has resulted in the death infection or harm of an animal, SFDA may order a decision to restrict handling such product at source or in the market and confiscate it until the lab tests come out. In case of suspicion that a feed product has resulted in the death, infection or harm of an animal, the SFDA shall apply the following: 22.1 order a decision to restrict handling the suspected product at source or in the market. 22.2 Coordinated with the Ministry of Environment Water and Agriculture to investigate the association between the suspected product and the incident of death infection or harm. 22.3 Sample and analyze the suspected product as laid down in Article Thirty of this regulation. 22.4 If the lab tests reveal an association between the suspected product and the reported incident, SFDA shall identify the source (batch or lot), order a product recall within a specified period, or withdraw the implicated product from the market at the expense of the establishment concerned. 22.5 If the lab tests refute any relationship between the suspected product and the reported incident, SFDA shall lift its restrictions and allow handling the product in question. العربيه العامه للغذا، واللواحي Saudi Food & Drug Authority SIDA Article Twenty-Three If there is evidence that a feed product or products are detrimental to human animal or public health, SFDA may withdraw or order the recall or prevent handling such product(s) as laid down in this Regulation. 23 SFDA Shall take the following measures if it has evidence that a product causes direct or indirect damage to human animal or public health: 23.1 Order a decision, which prohibits handling or clearing the product. 23.2 Require the concerned establishment to recall the product within a specific timeframe. 23.3 Ensure that the recall process is complete. 23.4 Recall the product at the expense of the concerned establishment if the above point (23.3) is not satisfied. 23.5 Seek the assistance of any agency to carry out the recall within the specified timeframe. In all cases, SFDA shall post a warning on its official website describing the product recalled or withdrawn, and where deemed appropriate have the recall information published in at least two local newspaper selected by SFDA, with the publication cost being incurred by the establishment concerned. Article Twenty -Four SFDA shall order the disposal of any feed where a potential risk to human animal or public health may occur because of handling such product based on verifiable test results. The disposal shall be performed العربيه العامه للغذاء واللواح Saudi Food & Drug Authority SIDA under SFDA supervision and at the expense of the establishment concerned as laid down in this Regulation. A full report shall be issued in this regard. 24 If any feeds are found to have adverse effects on human animal or public health based on lab test results, SFDA shall order that they are disposed of where: 24.1 The process is carried out according to the relevant technical procedures approved by SFDA. 24.2 The process is carried out under the supervision of a technical team, to be appointed by SFDA on a case-by-case basis. 24.3 The process is reported by an SFDA-appointed technical team. 24.4 All disposal costs shall be incurred by the establishment concerned. Article Twenty-five SFDA shall be the competent authority with the legal power to inspect feed establishments in relation to the implementation of this Act and its executive regulations. To that end, SFDA may seek the assistance of the security agencies as deemed necessary. اللغه العامه للغذاء واللغه Saudi Food & Drug Authority SIDA Article Twenty-Six A team of inspectors – to be nominated by a CEO decision – shall be assigned with the surveillance inspection and control of offenses. SFDA inspectors, as nominated by a CEO decision, shall, either individually or collectively, undertake the responsibility of surveillance inspection and control of offenses in respect with the provisions stated in this regulation, whether their action is part of fieldwork or is initiated in response to a complaint. Article Twenty-Seven Feed business operators and employees shall enable SFDA inspectors to do their duties and provide them with full and unobstructed access to the required facilities information documents and samples. 27 Feed business operators and employees shall cooperate fully with the SFDA inspectors, upon presentation of satisfactory proof of identity, and shall help them carry out their duties including, but not limited to, the following: a. Entering and inspecting premises, and warehouses, storerooms, and means of transport, in addition to providing them with access to sealed packages. b. Providing access to any documents or information related to the establishment and its products. c. Taking statements from employees, and if deemed appropriate, request them to be summoned for that matter. d. Writing an incident report in case of a food offense as deemed applicable. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA e. Closing down the business or any associated facilities if access to the premises or execution of the inspection duties are denied or obstructed. The business shall resume operation once the inspectors are granted access to carry out their jobs. Article Twenty-Eight If the inspection of a feed establishment reveals a non-compliance to this Regulation attributed to a feed product or ingredient, the inspectors may take whatever measure is appropriate, including product seizure, in accordance with the provisions stated herein. 28 If a food product or ingredient is found to be incompliant with this Regulation during inspection of a feed establishment, the inspectors shall take appropriate measures including, but not limited to, the following: a. Seizing the product as a precaution. b. Writing an incident report describing the violation, the implicated products or ingredients and their amounts. c. Sampling and analyzing the products or ingredients in violation according to the framework outlined in Article Thirty of this Regulation. Article twent- nine Feed inspectors are liable to the following: 1. Not to disclose any information resulting from the inspection unless requested by SFDA concerned officials or a competent judicial body. 2. Comply with the rules and procedures stated in this Regulation. العربيه العامه للغذاء واللоги Saudi Food & Drug Authority SIDA 3. Write an incident report in case of non-compliance to any of the provisions stated herein, and provide a copy to the offender 29 Feed inspectors shall abide by the following: a. Maintain integrity, impartiality, meticulousness and objectivity in the way they conduct their business. b. Keep secrets of the trade and not to disclose any information resulting from their duties unless required by job demands or a competent court, provided that such disclosure is kept to a minimum. c. Write incident reports upon non-compliance according to the framework approved by SFDA. d. Provide the person in charge of the concerned establishment – business owner or his/her representative – with a copy of the incident report and take an acknowledgement of receipt. Article Thirty 30 To ensure compliance with this Regulation, SFDA may take free-of-charge feed samples, and run the necessary lab tests in SFDA or any labs registered in SFDA To ensure compliance with this Regulation, SFDA has the right to delegate feed inspectors – or any entity to whom authority is العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA delegated – to sample and analyze feeds in SFDA labs or SFDA-registered labs in accordance with the following: a. The sampling shall be documented in a report to be signed by the inspector and the person in charge of the food business. b. The sampling shall be carried out in line with the SFDA approved framework, free of charge and involve quantities sufficient to satisfy the analytical needs. c. Send the samples taken for analysis in SFDA labs or any domestic or foreign labs approved by SFDA as deemed appropriate. Article thirty- one If the sampling results reveal non-compliances, SFDA shall write a detailed report about their findings and take appropriate measures in light of the report and as applicable under this Act. The business, in relation to which the contravention was committed, has the right to challenge the SFDA decision as guaranteed by law. 31.1 SFDA shall produce a detailed technical report about the violations they find on the basis of the sampling results. 31.2 SFDA shall notify their findings to the business in relation to, which the violation was committed, and indicate the right for concerned business to object within ten working days from the notification date. 31.3 The right to challenge the technical report shall not compromise the duties and controls entrusted to SFDA under this Act. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 31.4 The measures taken by SFDA shall be proportionate with the nature, risk level and frequency of the contravention committed. Article Thirty - Two 1. Without prejudice to severer punishments prescribed by any other laws, any offense to this Act or any of the provisions under this Act shall be punishable by the following: a. A fine no exceeding S.R. one million (1,000,000). b. A suspension of any feed-related activities lasting for no longer than 180 days. 2. Revocation of the license issued by SFDA. 3. If the contravention involves deliberate handling of feed which is injurious to health, fraudulent, or prohibited, the offense is punishable by imprisonment for 10 years at most, or a fine between S.R. one – ten million (1,000,000 – 10,000,000), or by both, in addition to the provisions stated above in subsection 1 (a, and b). 4. SFDA shall undertake the execution of the provisions stated in subsection 1 (a, and b) according to a classification table of offences and their corresponding penalties approved by the SFDA board. Without prejudice to SFDA's right to take whatever precautionary measure deemed necessary and as appropriate, a penalty shall only be executable if approved by the CEO, and the relevant execution procedures and controls shall be laid down under this Act. 5. The violations described above in (3) of this Article shall be reported to the Commission for Investigation and Public Prosecution and may be filed in the competent tribunal as deemed appropriate. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 6. The final ruling or decision may be published at the expense of the offender(s) in three local gazettes, considering the location of the implicated facility and the area where the violation was committed. 7. The person to whom a penalty notice is issued has the right to appeal to the panel described below in (8) of this Article, within sixty days from date of notice. 8. The SFDA Board shall form a panel (or several panels) of at least three members, including one legal advisor, commissioned with looking into grievances filed against SFDA penalty decisions. The panel shall resolve each case within 60 days at most. if the case remained unresolved or settled for up to 60 days, the appellant cant take it up to the Court of Appeals. 32.1 Without prejudice to severer penalties prescribed by other laws, any violation to this Act or regulation is punishable by one or more of the penalties stated in subsection (1) under Article Thirty Two of this Act. 32.2 The violations and their respective penalties shall be considered along the following lines: a. The offender, or whomever is delegated to act on his/her behalf, shall be heard before the competent SFDA department after the seizure procedures are concluded. b. After arriving at a decision with regard to a violation, the competent SFDA department shall refer their verdict to the SFDA CEO for approval. c. If the decision made by the competent department involves any of the penalties stated in subsection (1) of Article Thirty Two under this Act, the verdict shall only be enforced upon the approval of the SFDA CEO. العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA 32.3 The offender has the right to appeal against the verdict to the panel indicated in subsection (8) of Article Thirty Two under this Act. The appeal shall not set an obstacle to the execution of the verdict unless otherwise is decided by the panel. Article Thirty- Three SFDA inspectors, upon a Board decision and after coordination with the Ministry of Finance, may be awarded financially, as set forth in this Act and regulation, in exchange for exceptional acts which involve warding off hazards of a large-scale impact on consumer or public health. 33.1 The SFDA shall coordinate with the Ministry of Finance to establish the rules for granting financial rewards to SFDA inspectors. 33.2 The rules shall also determine what hazards are likely to have large-scale impact on human and public health, and what acts are considered exceptional safeguards against such hazards. 33.3 The rules shall be adopted by an SFDA Board decision. The board shall establish the rules underpinning the criteria for rewarding inspectors in exchange for acts which involve warding off hazards of a large-scale impact on consumer and public health. Article Thirty-Four According to a framework to be outlined by the SFDA Board and within the financial resources available to SFDA, a special reward, the amount of which shall not be greater than 25% of the fine issued, may be granted to any person – other than SFDA inspectors or officials from other agencies working in collaboration with SFDA – who helps in the detection of any violation to the provisions stated in this Act and regulations. The SFDA Board shall set up a framework for rewarding those – other than SFDA inspectors or officials from other agencies working in collaboration with SFDA – who help in the detection of any violations to this Act and regulation. اللغه العامه للغه, واللغه Saudi Food & Drug Authority SIDA Article Thirty-Five For the purpose of implementing this Act and regulation, the SFDA may seek assistance and support from other government agencies to carry out any of the tasks assigned to it. Article thirty six The SFDA shall set technical regulations and standards for the use and distribution of feeds and feed ingredients, feed establishments and thereof employees, taking the following into account: 1. the introduction of risk analysis and HACCP principles. 2. the relevant international agreements to which the Kingdom of Saudi Arabia is a party. Article Thirty- Seven العربيه العامه للغدا، واللغه Saudi Food & Drug Authority SIDA The SFDA shall coordinate with relevant stakeholders in feed standard-setting projects before they are approved by the CEO and issued by the Board. The SFDA shall, via any means deemed appropriate, present its feed standard-setting projects to the concerned stakeholders for comments and suggestions prior to the approval and adoption decision of the SFDA board. Article Thirty-Eight The SFDA Shall, within 90 days from the date of publication in official gazette, set forth the regulation of this Act and submit it to the SFDA Board for adoption. Article Thirty-Nine This Act and Regulation shall enter force 180 days from the date of publication and shall, upon entry into force, nullify any laws contrary to the provisions stated herein. الهييه العامه للغذا، واللواح Saudi Food & Drug Authority SIDA شكرا لكم