Bayan Taxonomy Explorer

Pesticides Law System and its Implementing Regulation in the Gulf Cooperation Council

sfda_gov_sa · executive_regulation · processed · 54 chunks

date_gregorian=2019-06-29 date_hijri=1440-10-26 document_type=executive_regulation entity=format:application/pdf language=en taxonomy_l1=health taxonomy_l2=pharmaceuticals taxonomy_l3=food_drug_safety validity=valid validity_confidence=0.6

الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Cooperation Council for the Arab States of the Gulf Secretariat General Pesticides Law (System) and its Implementing Regulation in the Gulf Cooperation Council 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. 2015 1 Saudi_FDA | www.sfda.gov.sa الاهم نهم الهييه العامه للغذاء والحواد Saudi Food & Drug Authority SEDA AT/T Gulf Cooperation Council, Secretariat General, Economic Affairs Department, Agriculture Administration. 50GN Pesticides Law and its Implementing Regulation in the Gulf Cooperation Council / Riyadh: Secretariat General, 2015 The GCC Publication Unified number: 093-0525/ H/K/ 2015. Pesticides/ Herbicide/ Fungicide/ Agriculture/ Laws and regulations/ Systems / Cooperation Council for the Arab States of the Gulf 2 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Introduction As part of the integrated efforts to harmonize the GCC systems, the Agricultural Department at the GCC Economic Affairs is honored to present the GCC pesticide law and regulation. As part of a set of rules adopted by Gulf countries in relation to agriculture, and as a complementary framework to the GCC Plant & Veterinary Quarantine Act, this regulation came into full force and effect during the 25 \( ^{th} \) round of the Supreme Council meeting held in Bahrain in December 2005. Undoubtedly, agricultural pesticides are double-edged weapons as they are hazardous chemicals and can cause harm if not administered according to instructions. In addition to its indirect effect on the environment, they can directly affect public health as they can easily stick to vegetations and the soil. Therefore, it is essential to control and regulate the way they are formulated, used, marketed, stored and handled to stave off any potential risks. Teamwork among the GCC states is essential to come up with a unified set of laws which can benefit the residents and citizens at the GCC states, ensure the supply of safe food and safeguard the environment against any sources of contamination. Finally, the GCC Secretariat would like to take this opportunity to thank all the technical committees for the efforts and contributions they exerted to produce this unified legislation. May God Grant us Success... Agriculture and Fish Resources Administration Economic and Development Affairs Department Cooperation Council for the Arab States of the Gulf 3 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والمواد Saudi Food & Drug Authority SEDA 4 Saudi_FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Pesticides Law and its Implementing Regulation in the Gulf Cooperation Council Objective Article (1) The Law herein aims to organize operations of producing, importing and handling pesticides in the GCC. Definition Article (2) The following words and expressions shall have the meanings hereby assigned to them, except where the context otherwise requires: Council: Cooperation Council for the Arab States of the Gulf. Council Countries: Countries in the Gulf Cooperation Council. Supreme Council: The Supreme Council of the Gulf Cooperation Council. Secretariat General: The Secretariat General of the Gulf Cooperation Council. Country: One member state in the Gulf Cooperation Council. Ministry: The Ministry of Agriculture or the committee responsible for Agriculture in the country. Minister: The minster in charge of Agriculture or the president of the committee responsible. Competent Authority: The authority in charge of pesticides matters. 5 Saudi FDA | www.sfda.gov.sa الامن نعتن الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Law: Pesticides Law and its Implementing Regulation in the Gulf Cooperation Council (GCC). Registration: A comprehensive scientific assessment process established to identify pesticide's type effectiveness and potential risks on human, animal and the environment according to the intended use as prescribed on the approved label. It includes confirmation that the raw material and final form of the pesticide are documented and registered with the competent authority in the country of origin according to specific application forms and under a specific number of issuance and registration, which underpins the approval of the pesticide to be locally manufactured, exported, distributed and handled. Pesticide: Any chemical product that is used for pest-control (including attractants and repellents) either this product was organic or non-organic, fabricated or natural, a biological product that contains components of microorganism elements, a plant growth regulator, a chemical defoliant, a dehydrating product or a transpiration regulator. Restricted Pesticide: A pesticide, which is, owing to its dangerous use, is included in a list of restricted products as issued by the minister, and is only authorized to be administered by certified individuals under the supervision of the relevant government agency or companies approved by the Ministry. Banned Pesticide: A pesticide, which is, owing to its high toxicity or impact on the various environmental component, included in a list of banned products to be issued by the Minister. Distribution: the act of displaying, selling, possessing either permanently or temporarily, or moving by any means of transport. Importation: The entry of pesticides into the country for the interest of a public or private entity using postal services, direct shipment or shipment through importing agents. Pest: Any biological strain, type or pattern originating from plants or animals, or a pathological factor with detrimental or damaging effect on plants or animals or their products The Regulation: The regulation to be implemented for the purpose of this Law. 6 Saudi_FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (3) The state competent authority shall take over the framework for pesticide registration, importation, exportation, manufacturing, distribution and use. Article (4) It is strictly prohibited to import or manufacture any pesticide without a license issued by the state competent authority as set forth in this Law and Regulation. Article (5) As per the recommendations of the competent authority, the Ministry shall make decisions with regard to the following: 1. The type of pesticides falling into the category of products which are prohibited from importation, distribution, or manufacturing, (to be called banned pesticides) and type of pesticides falling into the category of products which are used under restrictions (to be called restricted pesticides). 2. The procedure and conditions for pesticide registration and the cancellation process. 3. The procedure and conditions for manufacturing, importing, distributing and handling pesticides. 4. The procedure for sampling and analysing pesticides, and the rules of appeal and aggrievance. 5. The procedure and conditions for using pesticides and determining the pesticide residue limits permissible in agricultural products. 6. The advertisement and publication conditions for registered pesticides, including the conditions for use as recommended by the competent authority. 7. The procedure and conditions for disposing of pesticides as coordinated with the relevant agencies. 7 Saudi_FDA | www.sfda.gov.sa الامم نعتو الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (6) The state competent authority shall establish fees to be incurred in relation to the implementation of provisions under this Law and Regulation. Article (7) The Minister may allow the importation of restricted or banned pesticides for research purposes to be defined according to the provisions laid down in this Law and Regulation. Article (8) The Ministry has the right to assign designated personnel in the agricultural quarantines or at the borders, or any entity with an official delegation from the Ministry, to inspect all imported and exported consignments of pesticide, pesticide premises, manufacturing and distribution facilities for pesticides in order to ensure compliance with and control violations against the provisions set forth herein. Article (9) Any individual with the judicial inspection power shall have access to any facility to which the provisions stated herein apply, for the purpose of implementing and enforcing this Law and Regulation. 8 Saudi_FDA | www.sfda.gov.sa الاهم نعتي الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (10) Any of the following acts, whether carried out in person or by delegation, is considered violative to this Law and Regulation: 1. Deliberate change or misbranding or obliteration of the information declared on the label. 2. Opening or repacking a package without prior consent from the competent authority. 3. Advertising or promoting a pesticide without prior consent from the competent authority. 4. Obstruction or prevention of a duty carried out by a government official for the purpose of implementing this Law and Regulation. 5. Importing, handling, or manufacturing unlicensed pesticide. 6. Importing, handling or manufacturing damaged, adulterated or expired pesticides. Article (11) It is up to each member state to establish the penalties and fines imposed on offenses committed in relation with the provisions under this Law and Regulation. Article (12) 1- The Minister shall issue the Regulations for this Law and make amendments as deemed appropriate for the sake of public interest and in accordance with the requirements and criteria laid down in relevant international agreements. 2- The GCC Secretariat shall notify the Regulation of this Law and any thereof amendments. 9 Saudi_FDA | www.sfda.gov.sa الامن نعتي الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (13) Any individual to which damaged is inflicted as a result of implementing this Law and Regulation has the right to appeal to the Minister according to the legislative norms applied in each member state. Article (14) Any amendments to this Law shall be made by unanimous consensus of all member states and shall not come into force prior to adoption of the Supreme Council and shall be effective according to the provisions stated under Article (15). Article (15) This Law shall be in full force and effect six months from the date of adoption by the Supreme Council. 10 Saudi_FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والحواد Saudi Food & Drug Authority SEDA The Implementing Regulation of Pesticides Law in the Gulf Cooperation Council 11 Saudi_FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA The Implementing Regulation of Pesticides Law in the Gulf Cooperation Council \(1^{st}\) Chapter Definitions Article (1) For the purpose of implementing this Regulation, the following words and phrases shall have following meanings in line with the definitions set forth in the GCC pesticide law, unless the context requires otherwise: Ingredient: any chemical substances added to pesticide to fortify the composition, and to enhance extermination and improve the natural properties of the product rather than creating eradicative effect. It includes adjuvants, carriers, inert ingredients, solvents, emulsifiers, and any other substances that are not parts of the active ingredients. Committee: Member State Pesticide registering committee. Announcement: any promotional offer for sale or use of a pesticide through electronic platforms or printouts including pamphlets, banners, scientific presentation, or verbal communications Sale: all activities in relation to product's possession, promotion, transportation, dispatching, collecting, or exchanging or any other arrangements made between individuals or groups either for research or other purposes. Equivalence: The extent of similarity between impurity and toxicity, in addition to other existing or supposedly and technically identical properties of the chemical substance which may originate from the same manufacturer, and therefore can be expected to be pose similar levels of risk. 12 Saudi FDA | www.sfda.gov.sa الامن نعتي الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Package Label: all the information printed, drawn or illustrated or attached to the pesticide which shows the product's composition, properties, uses, and other precautionary information which must be considered when administering the product, in addition to the safe period, name of manufacturing or importing company, methods of disposal and any other required data. Marketing: the whole marketing process including advertisement, public relation and mass information services, distribution, and placing on local and foreign markets. Combination: a mixture of various properties formulated to make the end product useful, effective or to achieve the intended purpose of the product. Boucher/Brochures: anything other than the label containing printed or illustrated articles or information accompanying the product or enclosed within the packaging for a particular use along with the product. Inspection: checking for conformity of pesticides to the provisions set forth herein. Inspector: the person carrying out the inspection of pesticides. Transportation: moving pesticides from one place to another inside the country or from the country of origin to the country of import. Repackaging: putting pesticide in a different commercial package or container, mostly of a smaller size, for the purpose of selling or disposing the product or in case the original packaging is ruined. Pesticides Manufacturing: producing pesticide from its main ingredients. Pesticides Preparation: preparing pesticide in different forms such as liquid, powder, wettable powder or granules...etc. Pesticide Industry: all enterprises and individuals working in the manufacturing formulation and distribution of pesticides and their associated products. Residues: the amount of pesticide left after application on different mediums. Concentration: The amount of active ingredient in the pesticide. 13 Saudi FDA | www.sfda.gov.sa الامن نعتن الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Packaging: a specified amount of pesticide filled in a container covered with protective packaging materials and sold to end-users in retailers or at wholesale levels. Package: The container in which the pesticide is filled at different amounts and in different forms (solid, liquid or gas). Active Ingredient: a part of the compound which is biologically active. Disposal: Any process of reusing, repackaging, destructing, or isolating pesticide residues, or pesticide used containers and contaminated materials. Distribution: The process of placing pesticides on local and international markets through commercial channels. Extension Department: Responsible units in the concerned countries for delivering information, technologies, and consultation regarding enhancing agriculture methods including producing, handling, storing and marketing agriculture goods. Good Agricultural Practices: A set of officially recommended and technically certified practices, which are applied under appropriate conditions to effectively combat pests resulting in as minimum residues as possible and covering a wide spectrum of applications extending to the highest level of certified use. Integrated Pest Control: An accurate and comprehensive pest control study, followed by an integration of appropriate measures to inhibit pest growth and ensure using the product at economically justifiable levels, while reducing as much as possible any arising environmental or public health concerns. Integrated Pest Control is mainly concerned with growing healthy crops and encouraging naturally oriented pest control methods without compromising the ecosystem. Maximum Residue Levels: the highest concentration level of residues which is legally tolerated in or on food feeds and agricultural products. Personal Protective Equipment (PPE): Any apparel, substances, equipment that provides protection from being exposed to handle or use pesticides. Which is included in the (International Code of Conduct) All specifically designed protective equipment and specific apparel for handling and using peptides. 14 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Toxins: Substances that cause a disorder in structure or performance in humans, animals and plants that lead to damage or death when a relatively little amount of the substance is absorbed. Poisoning: Toxins impact by causing damage or disorder including simple poisoning cases. Pesticide Products Effective pesticide substance(s) and other substances filled and sold in the same form. Risk: The possibility of causing adverse health or environmental effects and the intensity of these effects when being exposed to the pesticide. Toxicity: A physiological feature that defines the capability of the chemical substance to cause damage or injury to the living creature other than the mechanical methods Dealer: Every individual who works in trade whether in exporting, importing or local distributing. Use Pattern: A set of aspects of using the pesticide including the active substance concentration level in the used preparation, ratio, duration and times of usages, adding other substances, methods of usages and places that defined the required amount, use timing and the period needed before harvest. Safety Period: The pre-harvest period is the lowest period of time to be achieved between the application of the pesticide and the production collection recommended by the manufacturer to ensure the disposal of the pesticide effects or the arrival of a non-harmful concentration on the consumer to reduce the residue to the extent permitted. Registration Period: The period from the date of the pesticide registration approval to till expiry as provided for in the approved procedures. Trade Name: The name under which the pesticide is registered within the country and leaflets and labels are issued and proposed by the registrar/company to whom the pesticide registration is granted under these regulations, which may be used by this person to distinguish the product from other products containing the same effective material and may not be waived to others by the producing company. License: the approval process administered by the Ministry in accordance with relevant procedures. 15 Saudi FDA | www.sfda.gov.sa لاهم نعت الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Permit: The prior technical approval issued by the Ministry for pesticides importation and exportation. \(2^{\mathrm{nd}}\) Chapter Pesticides Registration Article (2) Pesticides Registration Committee Each member state shall set up a committee to register pesticides named “Pesticides Registration Committee” (PRC) that is responsible for registering pesticides in the country, conducting tasks entrusted by this Regulation. Article (3) PRC Membership The Minister shall order a decision to form a Pesticide Registration Committee consisting of members from several relevant bodies, and with well-defined terms and action plan. 16 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (4) PRC Terms of Reference - Reviewing registration requests submitted to each state competent authority. - Ensuring that the data included in the registration forms meet the registration requirements laid down under Article Six of this Regulation, while seeking expert advice for that matter and as deemed necessary. - Adopting pesticide registration forms according to a model to be established for this purpose. - Identifying the list of pesticides included in the registration program. - delegating professionals to evaluate the efficacy of pesticides and their effects on human and animal health and the environment. - Receiving pesticide assessment results. - Holding regular meetings to go through incoming registration requests and providing the state competent authority with their recommendations for the approval of requests which meet all the registration conditions prescribed in this Regulation. - Accepting or rejecting pesticide registration requests and defining the rules governing the confidentiality of information, record-keeping of classified files, and the persons eligible to have access to such information. Confidentiality and Data Protection: - Information given in the pesticide application shall be handled as if the information is a property of the applicant and shall be preserved in a confidential file in the competent authority and used for inspection purposes. - Information shall not be revealed or used to assess the registration of another pesticide in a manner that harms the interests of the applicant unless there is a written approval by the information holder or protection period of this information has expired. - Any publicly known information shall not be handled as a confidential one. - Confidential information will be defined in the documentations and the documentations list presented by the applicant. 17 Saudi FDA | www.sfda.gov.sa لاهم نعتي الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (5) Registration Pesticides shall not be produced, imported, repackaged, or distributed prior to registering the product in the competent authority as set forth in the rules and provisions of this Law and Regulation. When registering pesticide products, consideration shall be given to the guidelines of the UN Food and Agriculture Organization (FAO) and World Health Organization (WHO). Article (6) Registering Application and Terms Companies, institutions or factories wishing to register, re-register or change the registration of a pesticide or a raw material shall apply to the competent authority using the form prepared for such purpose, as well as a file containing the following documents: 1. Compound name. 2. Sufficient information on the natural and chemical properties of the compound. 3. Registration certificate (in Arabic or English) stating that the pesticide is registered and used in the country of origin, as approved by the competent authority of the country of origin and certified by the embassy in that country. If the pesticide is not registered in the country of origin and produces only an active substance or a preparation to be exported and is imported directly from the same manufacturer, official documents shall be submitted indicating that the pesticide has been registered in at least two countries of the European Union, Japan, the United States of America or Canada and must be submitted and approved by embassy in that country. 4. (Arabic/English) request for testing the pesticide subject to the registration (especially the list of tests connected with the registration). The request shall be made via a standardized form as prepared by the Registration Committee, where all the required tests are shown on a check list. 18 Saudi FDA | www.sfda.gov.sa لاهم نعتي الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA 5. Information about how to store the pesticide and how to dispose of the container and the remaining substance after use, in addition to any other data required for the purpose of registration. 6. A manufacturer's warranty confirming product's quality substantiated by an attestation from the embassy of the respective country. 7. Certificate of pesticide preparation analysis approved by the competent authority in the country of origin. The certificate must be detailed mentioning active and filling substance (s). The certificate shall be in accordance with the methods adopted by the International Union of Pure and Applied Chemistry (IUPAC) and (CI-PAC), and Food and Agriculture Organization (FAO). The test shall be conducted in an unbiased laboratory that is classified as a Quality Standardization Laboratory (GLP-Goddess Laboratory Activity) which states that the preparations materials are qualitatively and actively compatible with the pesticide components and certified by the embassy in the country of origin. 8. Source data of (the active material) and a certificate from a governmental authority to validate the Source of (the manufacturer of the active substance). 9. Letter from the originating company that confirms that (the active substance) is manufactured and composed in the head office or any of the company branches which is applied to pesticides that are manufactured or prepared in another country different from where the head office is located. 10. Detailed studies on the active substance and the preparation methods issued from an official and relevant local or international bodies and unbiased and approved laboratories on the following: 11. Acute sepsis, malnutrition, chronic sepsis and carcinogenesis, delayed neurotoxicity, teratogenicity, reproductive defects, mutations. 12. Compound impact on plants and environment components. 13. Risk assessment on the consumer of agriculture pesticides (MRLs-NOAEL-PHI) 14. -Environmental poisoning (impacting non-targeted creatures, poisoning aquaculture, accumulation in aquaculture, impact on earthworms, birds, biological pest control and bees and pollinators.) 15. Original copy of the pesticide technical data dossier in both Arabic and English that shall include detailed data about the pesticide according to the Food and Agriculture Organization and World Health Organization. 19 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA 16. Published studies, reports or research about effectiveness experiments to support the recommended usages of the pesticide issued by accredited scientific authorities form one of the countries of the European Union, United States of America, Japan, Canada or any other authority accredited by the competent authority. 17. Copy of the label proposal that includes the pesticide active ingredient and the trade name that will be used in the country. 18. Copy of the registered pesticide label in the country of origin that contain all information about the pesticide (English or Arabic). 19. Defined number and quantity of the pesticide original samples based on the type of the required experiments that shall be conducted. 20. Standard samples of the active substance (s) with an original sample of the pesticide preparation to ensure quality tests. 21. Delegation permits from the producing company to register the concerned pesticide. 22. Copy of the assessment summaries (monograph) issued by one of the reference checks in case of request from the competent authority. Appendix (1) includes a list of the required technical information for registration. 23. Tests and technical information shall be defined according to appendix (2). 24. Any current data required by the competent authority. 20 Saudi_FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (7) Committee Report on Registration Request After scrutinizing the submitted field, lab and administrative documents, the committee shall recommend the following: - That the competent authority approves registering or re-registering the product. Upon registration/re-registration, the committee shall: - Assign a number to the product after it is registered/re-registered. - advise the minutes taker to include the product in the list of registered pesticides. OR - reject the registration/re-registration, providing the concerned applicant with the justification for the rejection which may include, but may not be limited to, the following: - incomplete or incorrect information, - The residues are excessively stable or toxic during breakdown. - The pesticide is ineffective or toxic to plants. - The pesticide poses risk to humans, animals health and the environment. - Availability of other products in the market with the same potency or more but less likely to present risk to the humans, animals health and the environment. - The pesticide is banned or highly restricted in another country which has a system of pesticide registration, or that the risks associated with the pesticide outweigh the expected benefits under certain socioeconomic conditions. - The analysis methods applied to the product is not recognized in UN Food & Agriculture Organization/World Health Organization. 21 Saudi_FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (8) Upon approval of registration, the committee shall take the following into consideration: - How useful is the pesticide in terms of the expected benefits? - What is the estimated minimum risk it may have on human, and animal health and the environment? - Is it prohibited by the Ministry or other countries? This can be verified by communicating with UN FA/WHO or any other international organizations related to the environment. Article (9) Field and Laboratory Tests - No pesticide shall be registered unless it has been verified that it meets the chemical and natural standards as stipulated in the documents accompanying the application. In addition, the registration shall not be carried out. The pesticide shall not be registered until a conformation to the chemical and natural standards is verified that are mentioned in the documents accompanying the registration request. The pesticide shall be imprinted to be registered on the basis of the analysis results carried out by the competent authorities. Once the pesticide is proven to be efficient according to the experiments carried out by the "experimenters" identified by the Committee for three consecutive and similar agricultural seasons, including biocides. In any event, the last seasons of the experiment are at on the expansionist level. - The registration or re-registration applicant shall bear the cost of the laboratory and field experiments and office work carried out to register the pesticide in coordination with the competent committee or authority and the scientific authority (s) in the country that will conduct the tests. 22 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (10) Issuance of Registration Certificate The competent authority shall issue the pesticide registration certificate after receiving notification of PRC approval. Article (11) Package Label Based on PRC recommendations, the pesticide label shall be approved by the competent authority to be effective for the same period as the product's shelf-life. The following information shall appear on the label (either in Arabic or English) in clear indelible font suitable to the size of the package: - Trade name-Common name-The compound-Active substance and ratio-Surface activity substance -Solvent or aquatic substance-Uses and methods of usage-Safety precautions-First aid-Anti-poisoning drug- Preharvest Safety period as determined by the country competent laboratory-Hazard characterization of the compound according to World Health Organization classification-Compound identification data for risks-Empty packaging disposal methods-The producing company and address- Importing company and address-Date of manufacturing-Expiry date- Local registration number- Capacity-Markings that indicate the precautions needed for trading and using the compound. - In the case of a highly concentrated pesticide that has already been registered and whose original registration certificate contains the lower concentrations that have been recorded and used in the country of origin, less concentrations of this pesticide can be allowed to be imported. A separate safety information card must be prepared for the compound contents, the information shall be adequate, and a new registration number shall be given. - When it is proposed to change the trade name, label, bulletin, packaging or use of a pesticide that has a registration number, the person whose registration has been approved shall notify the Committee in writing as provided for in the regulation herein. 23 Saudi_FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والحواد Saudi Food & Drug Authority SEDA Article (12) Validity of the Registration Certificate The registration certificate is valid for five years from the date of issue, to be extended further, provided that the applicant requests a biological potency reassessment commencing earlier in the fifth year of the certificate intended to be renewed. Article (13) Waive of Registration Certificate The certification shall only be transferrable if the certificate holder has already transferred business ownership to another body and only after taking the approval of the competent authority Article (14) Rejection of Pesticide Registration - The committee shall notify (in writing) the applicant about the reasons for rejecting the registration request if such reasons fall under article (7) of this Regulation. If it is about missing information, the applicant shall be given a deadline to complete what is missing. - If all the registration conditions and requirements are not met within the specified period, the application shall be cancelled automatically, and a new application shall be required. 24 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Article (15) Cancellation or Amendment of Registration Cancellation: The registration is considered canceled in the following cases: IF: - Registration certificate is not renewed in the country of origin within six months from the date of expiry. - It was proven that the registering and handling the pesticide is cancelled in the country of origin or that the use of the product is prohibited by the Ministry as recommended by the Food and Agriculture Organization, World Health Organization, United States Environmental Protection Agency or European Union. In such case that pesticide shall be allowed a two-month period to re-exportation. If the importer fails to report the aforementioned pesticide situation, an appropriate legal action shall be taken against the importer. - Registration is based on false information or documents. - Importing party did not commit to the labelling requirements as approved by the PRC (Pesticide Registration Committee), or that the label is not completed, or the expiry date is tampered with. - The Ministry may cancel registration of the pesticide according to the committee recommendations, the committee shall clarify the reasons of deregistration. - Applicant requested a deregistration. - Committee noticed that the registrations is unwanted owing to the pesticide hazardous impact on humans. animals or environment. - Pesticide became ineffective for the purposes that was registered for. - There is any breach to the conditions that allowed the registration - Committee discovered new facts or circumstances that was not clear that after the registration, that require a deregistration. 25 Saudi_FDA | www.sfda.gov.sa الاهم نتج الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA - Purpose of the pesticide is unwanted according to the hazardous impact on humans, animals and environment health, the committee is entitled to modify the registration. The competent authority shall define the mechanism required to treat the consequent of such deregistration and the responsibility of the concerned parties. - Competent authority shall define the required mechanism to treat the consequent of such deregistration and define the responsibility of the concerned parties. Amendment of Registration: 1. Amendment request shall be treated as a new request if substantial changes are made as: - Trade name, active ingredient name, concertation ration and the preparation type. - Modifications in the physical and chemical characteristics of the pesticide. - Modification in manufacturing such as the manufacturing processes of the degree of purity in the active ingredient or installation processes for which the equivalent had not been determined. - Other modifications seen as influential by the concerned authority. 2. If the amendment request is linked to the usages, add crops, insects, diseases, herbs, utilization rate, or preharvest interval (PHI), the applicant shall apply to the competent authority using a form with attaching the documentation and the data as follows: - Registration number and the pesticide name. - Full name and address of the applicant. - Reasons of amendment. - New recommended usages in comparison to the current usages. 26 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA - Copy of the new proposed label and the current one. - Registration certificate. - Scientific information to support the application as study of residues and effectiveness. - Quality information or biological assessment if added to new pests. - If the amendment is relevant to addition of new crop or an increase in the dose of use, attach data on the effectiveness on the target pests, crops safety, and information about the remaining pesticide on corps. - If the amendment is relevant to the reduction of the pre-harvest period, attach data about the maximum residues on the crop, the data shall be approved by the producing company or country of origin and inscribed on the original label. The main experiments results are the ones conducted in the country. 3. In case of a change to the name or address of the applicant, package design, component, size or otherwise minor changes, the applicant shall provide the following documents and data, along with the application: - Documentation and data required: - Registration number and the pesticide name. - Full name and address of the applicant. - Reasons of amendment. - Define what shall be modified with comparing the old and new product. - The amendment dates. - When using a different applicant's name, a copy of the new commercial register as issued by the relevant competent agency shall be provided. 27 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والحواد Saudi Food & Drug Authority SEDA Article (16) Re-registration In case of re-registering the pesticide, the previous registration shall be submitted, supported by the following documentations: - Valid registration certificate issued by the concerned authorities in the pesticide country of origin. - Valid registration certificate request issued by the concerned authorities in the pesticide country of origin if it was issued there. This application shall be considered in the same procedures used in the first registration. The natural and chemical properties and footprint of the registered pesticide must be matched. Experiments are limited to the re-evaluation of bioactive efficiency for two agricultural seasons. Article (17) Banned and Restricted Pesticides Banned and restricted pesticides types shall be defined according to both appendix (3&4) which represent the minimum thereof. 28 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Article (18) Registration Fees - Responsible ministry shall collect the un-refundable registration fees according to the appendix (5) which represents the minimum fee. - Fees shall include all the costs of the field and laboratory experiments and office work that is required for registering the pesticide. 3 \( ^{rd} \) Chapter Manufacturing and Preparing Pesticides Article (19) Conditions of Manufacturing and Preparing Pesticides - Pesticides shall not be manufactured or prepared unless they are registered in the country and licensed for manufacturing and preparing from the competent authority. - Banned pesticide by the ministry shall not be manufactured or prepared, banned from manufacturing or handling in the country of origin or not recommended to be manufactured, prepared or handled between relevant organization or international committees. - The legislations of manufacturing in each country shall be considered. 29 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والحواد Saudi Food & Drug Authority SEDA Article (20) The applicant of manufacturing or preparing the pesticide shall apply to the competent authority and attach the documentations and justifications hereto: - Pesticide name: common name, chemical name, the group that the pesticide belongs to. - Pesticide type: Insecticide, fungicide, bactericide, rodenticide, herbicide or acaracide. - Nature of Pesticide: Chemical or Biological - Active ingredient name and ratio - Processing type: Liquid, powdered, wettable powder, gas, granules...etc. - Adequate information about the active ingredient(s) - Type of container material: aluminum paper, hard paper, plastic...etc. - Packaging size weight: kilograms, liters, pounds or parts thereof. - Chemical and natural properties as outlined from the manufacturing company. - Toxicity on humans, animals and environment and impact on bees, fishes, earthworms, and other beneficial creatures and side effects. - Pesticide and residues analysis methods in plants, soil and surrounding environment. - Impact of the pesticide on the environment, use on crops and pests, usages rate the intervals between workers per crop. - Proposed label that will be attached to the pesticide package. - Valid license of the registration certificate in the country of origin. - Standard sample terms of the pesticide by the pesticide committee of quality control test. - Pesticide valid registration in the country. 30 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Article (21) Issue a License for Establishing Factories of Manufacturing and Preparing Pesticide - If the assigned authority approved to grant a license for manufacturing or preparing pesticides, a decision shall be issued by the Minister or the head of the competent authority on recommendations given by the competent authority to issue a permit and shall notify the applicant in writing. - Registered pesticides shall not be manufactured, prepared or repackaged except in a dedicated factory thereof. The license request to manufacture, prepare or repackage shall be submitted to the competent authority of the country with meeting all the requirements of the relevant authorities. - Validity of the license runs for three years from the issuing date, the license may be renewed with the same conditions and procedures for the same period of time, the renewing application shall be submitted before the expiry of the license. The license will be canceled by a decision made by the competent authority in case violations are made. - License fees are left to be decided by the concerned country. 31 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذا والدول Saudi Food & Drug Authority S Article (22) Conditions of Practicing Activities of Manufacturing or Preparing Pesticides - Handling any type of local-made pesticides, whether manufactured, prepared or repackaged, shall not be permitted until samples have been analyzed by specialized and country-accredited laboratories and, if this is not possible, sent to an international reference laboratory. - Licensee of manufacturing or preparing in pesticides trade may not operate in respect of highly hazardous pesticides registered in the country except after obtaining a special permit for manufacturing, preparing or trading pesticides from the competent authority. - Such authorization shall be applied during licensing, preparing or trading, the authorization shall be renewed under the same conditions and procedures as provided in these regulations. Packages may be featured with colored index cards different than other index cards in other pesticides, the responsible technical manager of the factory or the store shall be qualified (A high degree of agriculture qualification). - Factories, shops and storehouses authorized to manufacture, prepare or trade in pesticides in accordance with the provisions of the Law herein may not manufacture, prepare or trade in any material other than the registered or licensed pesticides. - Whomever licensed for manufacturing, preparing and trading in pesticides shall obtain a numbered and stamped record by the ministry stamp to restrict actions of manufactured and prepared and traded pesticides, records shall be preserved for five years from the restriction date, and shall be submitted to whom has a judicial control in every application. - Each factory of manufacturing or preparing pesticides shall put a serial number for each quantity products demonstrating the date of manufacturing and validity, LOT number, and total quantity. The competent authority shall be informed of the monthly production, including information on each quantity manufactured or prepared. - The applicant for a pesticide manufacturing or preparing license must undertake to designate specialized scientific competencies in the field of pesticides, such as chemical engineering, chemistry or agriculture specialized in pesticide. 32 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والمواد Saudi Food & Drug Authority SEDA Article (23) The manufacturer shall conduct testing operations and quality control per pesticide quantity that is manufactured, prepared and supply the competent authority with copies of the following: - Concentration and active substance ration (weight/ weight or size/ weight size/ size) and mistake ratio shall not exceed +-5% of the active substance as defined in the international organization. - Physicochemical properties as stated in the international organization. - Pesticide stability and validity under high levels of heat (after two weeks under 45c heat) - Test other pesticide properties as mixing with other pesticides, emulsification degree, spreading in water and other tests recommended by international organization. Article (24) The following is required in manufacturing and preparing pesticides factories: - Obtain the required approvals to establish a factory from the implementing regulation of the country. - Availability of required and capable laboratories to conduct quality assurance tests. - Factory units that are capable of disposing pesticides, recycling or contracting a specialist in this field. - First aid abilities. - Availability chambers to shower and change apparel for workers. - Periodic medical experiments for the factory workers. - Conformity with any progress in the factory building conditions. 33 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذا والمواد Saudi Food & Drug Authority SEDA Article (25) Amendment in a Pesticide Storehouse or Store The licensee, if intending to make any changes to a licensed pesticide storehouse, shall notify the competent authority in writing within 30 days prior to the date on which the changes are intended to be made. The approval, if granted, shall be indicated on both the original license and the logbook where commercial storehouses and shops are recorded. \(4^{\text{th}}\) Chapter Conditions, Usages, Analysis of Pesticides and the Maximum Residues Article (26) - Operations mentioned in the pesticide package label shall be executed by the farmer or the assigned individual in regard of methods of usages, the safety period and corps to be handled and sprayed, and the precautions that shall be conducted during handling and spraying. - Handled corps shall not be marketed internally or externally before the end of the safety period mentioned in the package label. - Competent minster shall issue a decision including the maximum of different pesticides residues on corps according to the recommendations of the competent authority. - Minster shall issue a decision that prevent selling plant and animal products that contains more than the maximum of pesticides residues allowed in markets and department stores. - Other conditions the competent authority sees necessary. 34 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذا والدواج Saudi Food & Drug Authority SEDA Article (27) Maximum Pesticides Residues The competent authority shall take in consideration the charts of Food and Agriculture Organization and World Health Organization as a guide to decide the maximums level of pesticide residues allowed on plant and animal products in the country. Article (28) Pesticides Analysis - Competent laboratories shall analyze samples according to the approved international methods of analyzing pesticides and recorded in the pesticide registration profile and issue an analysis certificate to be send to the competent authority. - Competent authority shall notify the person concerned about the analysis results. - Analysis is conducted for registration, re-registration, re-packaging, customs release, allow handling, experimenting, manufacturing or preparing. - Pesticide analysis includes quality control, residues, impurities and other analysis required in different stages of registering, importing, exportin, manufacturing, controlling in marketing, or using the pesticide, which must be conducted in reference laboratories in or outside the country using the internationally approved usages by the international organization (Food and Agriculture Organization and World Health Organization) for this kind of analysis. 35 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذا والمواد Saudi Food & Drug Authority S.A.F.D.A. \(5^{\text{th}}\) Chapter Conditions, Importation and Exportation Methods, Inspection and Release of Pesticides Article (29) Issuance of a Pesticide Importing License After receiving a request of pesticide importing license or renewal of a license according to the model prepared thereby as set out in the articles of the regulation herein, the competent authority shall conduct the following: - Approving the request, the license shall run for a single Gregorian year and shall be renewed with the same conditions or refusing the request and notifying the applicant with reasons of refusal as follows: - Request is in relation of a non-registered pesticide in the country. - Information attached is uncompleted. - Location of selling or storing is not suitable for such purpose, using such place can endanger human, animal and environment health. - In case of refusing the license request owing to inadequate information, the competent authority shall notify the applicant in writing demonstrating the inadequacy of information. The applicant can update the information during a defined period of time. The application is considered canceled and the applicant shall apply for a new request if the information is not fulfilled in the time allocated. 36 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذا والمواد Saudi Food & Drug Authority SEDA Article (30) License Revocation The competent authority may revoke the license if found that new factors and unexpected changes happened in the surrounding circumstances or breach of the conditions that granted the license after issuing the license. Article (31) Importing and Exporting Pesticides - Importing and exporting pesticide shall not be allowed unless it is registered in the ministry. The importer or the exporter shall be licensed by the competent authority. - In case of importing for trading purposes, the applicant shall be licensed for pesticide trading according to the provisions of the Law herein. - Companies, committees, and licensed general institutions, universities, scientific research centers are allowed to import pesticides for studying and researching purposes. The imported quantities shall be limited to no more than 20 kilograms/litter for every case or concertation and once for every type. Studies and experiments results are not obligated to the pesticide committee in registering the pesticide. - Importation may not be allowed for any type of pesticides unless they conform to Food and Agriculture Organization and World Health Organization standards. 37 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزرا Saudi Food & Drug Authority SEDA Article (32) Importing pesticides application form shall contain the following information: - Pesticide commercial name. - Chemical group. - Name of substance and rate. - Pesticide preparation (powdered, liquid, granules.... etc.) - Duration of pesticide registration in the country. - Registration number of the pesticide used in the ministry. - Purpose of usage. - Quantity in size and weight. - Container type and package sizes and weight. - Total value of the exported and imported quantity. - Points of entry and exit in the country. Article (33) Importing Use-Restricted Pesticides Individuals who request importing use-restricted pesticides shall have the experience and capacity to use these pesticides in limited quantities and for a defined purpose under the supervision of the competent authority. 38 Saudi FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (34) Importing Carriers Importing the required carriers for manufacturing or preparing the pesticide may not be allowed unless the components are in the registered pesticide and assured by the attached documents used in the registration request and after approval by the competent authority with a defined quantity. Article (35) Pesticide Package and Label Standards - Product shall be filled in a firm, sealed from a non-glass material, nontransparent to light or sunlight packages and shall bear the transporting and storing circumstances and the content shall not be leaked or filtrated according to the standardization. - Package shall be made of a nonreacting material that does not react and change the nature and features of the pesticide and test shall be conducted on these packages in terms of validity as pesticides package that will be filled with the pesticides by approved laboratories and packages that contain pesticides in the form of solid, granules, tablets and cubes and walls shall prevent moisture leakage, fracture or laceration. - Labels shall be pinned in a good manner that prevent removing, substituting or modifying the label. The label shall be approved by the pesticide committee and the importing or exporting body is the responsible for the label. Pesticides sold in the market shall be confiscated in case of the non-conformity of the package label with the conditions recorded in Article (11) of the regulation herein. - Substituting or modifying the pesticide package label may not be conducted without a prior permit from the competent authority, either after importation or before exportation. 39 Saudi FDA | www.sfda.gov.sa الاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (36) Information that Must Be Recorded in the Package Label of the Locally Imported, Manufactured or Prepared Pesticide - Name of manufacturer, preparer, importer or exporter. - Trade name, Chemical group, and the chemical compound. - Active substance name, ratio and preparation type. - Pesticide registration number in the ministry. - Net weight of the package (kilogram/litter). - Production and expiry date in months and years stamped by the country of origin and LOT number. - Pesticides and corps that is used for, methods of use and utilization rate, safety period and post-entry period. - Precautions that must be taken when using the pesticide, first aid for sepsis cases and kind of treatment that shall be taken. - Adverse effect of the pesticide on surrounding plants, bees and fishes. - Possibilities of mixing the pesticide with other ones and other relevant information. - Phrase (Toxic Substances) shall be written on the pesticide package with a sign that demonstrate toxicity. - Circumstances of storing pesticide. - Information that the committee deems necessary. - Methods of disposing packages. - Warning signs. 40 Saudi FDA | www.sfda.gov.sa لاهم نهم الهييه العامه للغذاء والزراع Saudi Food & Drug Authority SEDA Article (37) Cases of Confiscating the Pesticide The pesticide can be confiscated for re-exporting or disposing purposes on the costs of the importer or the seller in the following cases: - If the pesticide entered the country without a release permit from the competent authority. - If the pesticide was found without a label that contain the requirements mentioned in the articles of the regulation herein. - If the pesticide was not registered and found in the markets or entry points or pesticide found with passengers with any quantity. Article (38) Pesticide Inspection The minster shall nominate individuals that will work as a judicial control in accordance with the recommendations of the competent authority: - Regular inspection shall be done by all institutions that import, export, manufacture, fill or re-fill, make labels, distribute, use or advertise pesticides to ensure that the Law and implementing regulations herein are adhered. - Request showing, scanning, inspecting or copying certificates/licenses and records or other documentations around the Law herein. - Take samples of any substances in relation with the regulation herein as described and submit these samples for analysis. - Preserve equipment, pesticides, record, documentations or other things that the inspector believes that will support an evidence of violating the regulation herein, the inspector is entitled to close the stores, storehouses, factories in coordination with the competent authority. 41 Saudi_FDA | www.sfda.gov.sa لاهم نهتم الهييه العامه للغذا والاداء Saudi Food & Drug Authority SEDA - Ask the assistance of customs or police officers in executing the responsibilities of the inspectors within the regulation herein. - Submitting report of violations of the regulation herein to the competent authority is the responsibility of the inspector. - Courts decisions within the regulation herein shall be applied to the inspector. - Review all documents that are relevant to pesticides handling. - Notify merchants and agents three months prior to the pesticides expiry date and oblige merchants and agents to dispose expired pesticides from the markets in no more than two months on their cost in coordination with the competent authority supervision according to the guidelines of the Food and Agriculture Organization in this regard and to announce about the expiry in the media. - Any person who trades in pesticides in the country is obliged to refill the leaky or leaking pesticide, clean the contaminated places under the supervision of the competent authority and pay the financial compensation approved in accordance with the Law of the country concerned in case of any damage that is punishable by Law. - The inspector shall take samples of shipments of pesticides imported, manufactured, processed, packaged or repackaged locally and performs the necessary analysis on them in competent laboratories accredited in the country or other specialized laboratories accredited in the Council countries. If such is not possible, samples can be sent to a specialized international reference laboratory to verify their conformity with the technical specifications and requirements. The analysis results are sent to the competent authority to weather release the shipment to be imported, manufactured, prepared, filled ore refilled locally. - The inspector inspects the pesticide shops to verify that shops meet the licensing requirements. The inspector shall be entitled to free sampling of the handled pesticides as described in the Law herein to verify the validity and conformity of pesticides with the technical specifications registered thereof. In case the pesticide does not conform to the technical specifications registered therein, the concerned person shall be notified of a copy of the analysis certificate and the reservation of pesticides that violate …(59,101 more chars)