Ministerial Decree No. 1018 of 2013 concerning registration, handling and use of agricultural pesticides in Egypt

1 / 37     The Arab Republic of Egypt Ministry of Agriculture and Land Reclamation Minister's Cabinet Ministerial Decree No. 1018 of 2013 Concerning Registration, Handling and Use of Agricultural Pesticides in Egypt 2 / 37 Minister of Agriculture & Land Reclamation; Having Reviewed: •The Law of Agriculture No. 53 of 1966; • The Ministerial Decree No. 2188 of 2011, constituting the Agricultural Pesticides Committee; • The Ministerial Decree No. 1835 of 2011, concerning registration, handling and use of agricultural pesticides; and • The recommendation of the Agricultural Pesticide Committee adopted at its session No. 6/2013 held on 30/4/2013. Article (1): The Agricultural Pesticides Committee (hereafter referred to as APC) is the sole statutory agency responsible for registration and handling of agricultural pesticides in the Arab Republic of Egypt. The APC's resolutions are binding to all stakeholders and concerned parties, each within its mandate, through assignments, procedures, regulations and directives issued by the APC. Paola Evidenziato 3 / 37 Article (2): APC monitors the laboratory and agriculture practices conducted by designated agencies for quality assurance, in line with the criteria determined by the APC and based on the International Code of Conduct issued by the Food and Agriculture Organization (FAO) in this regard. Article (3): APC endorses every action that contributes to the rational use of pesticides and the implementation of IPM policies and strategies. Article (4): APC upholds the FAO's definition of the term "Pesticide" and the concept of "Safety" referred to in the Code of Conduct issued by FAO, wherein safety implies that a pesticide must be safe to human health, the environment and the benignity of agricultural crops and products. Paola Evidenziato Paola Evidenziato 4 / 37 Article (5): APC registers active ingredients of agricultural pesticides in their "crude" or "formulated" forms, according to the registered pesticide database of the U.S. Environmental Protection Agency or the European Commission, or any other international agency accepted by the APC. Article (6): APC is entitled, according to the conditions it sets, to restrict the handling and use of registered pesticides, especially highly toxic pesticides, to protect the public and environmental health and the safety of the agricultural crops and products. In such a case, APC specifies the permissible amounts of those pesticides and regulates their modes of handling, trade and application, in line with the "Code of Conduct" issued by the FAO. Paola Evidenziato 5 / 37 Article (7): APC regularly reviews the situation of registered pesticides or those under the process of registration and takes appropriate actions in the light of any new development pertaining to the safety of those pesticides to human health, the environment and the benignity of agricultural crops and products. Article (8): Producing, formulating, repacking, importing, trading, handling or using of agricultural pesticides in their crude or formulated forms is prohibited unless these pesticides are registered with APC according to the conditions and procedures stipulated in the present decree. 6 / 37 Article (9): The application for the registration of any agricultural pesticide is submitted to the APC’s Rapporteur along with the primary file of technical information and a receipt indicating the payment of the registration fee for each crude or formulated pesticide for which registration is requested. The APC’s Rapporteur scrutinizes the application against the conditions stipulated in article (5) of this decree and decides on whether or not to proceed with the registration procedures. The submission of the application is considered to be an implicit approval of the applicant to comply with all the rules, regulations and procedures governing the implementation of this decree’s provisions. Article (10): The pesticide for which an application for registration is filed should not be given a common name or code number; nor should it be similar or identical to the commercial name of an already registered pesticide. Paola Evidenziato 7 / 37 Article (11): When APC accepts the technical data of the pesticide for which a registration application is filed, the applicant is obliged to submit samples of the active ingredient and the major impurities that may co exist with it from certified sources for use as reference standards, in case of compounds that are still under Intellectual Property Rights (IPR) protection period. In case of compounds that are beyond IPR protection period, the Central Agricultural Pesticides Laboratory (CAPL) should secure the active ingredient and the major impurities that may co-exist with it from approved sources. The applicant is also obliged to submit free of charge- samples for analyzing and experimenting the pesticide for which the application is filed, in quantities determined by APC. A custom release "free of charge" of the required samples is issued based on an official letter signed by the APC’s Rapporteur or whoever is authorized to act on his behalf. 8 / 37 Article (12): The concerned person is obliged to submit the complete file of the pesticide, for which registration application is being processed, including: documents, data, technical studies, authentic certificate attesting to the registration and use of the pesticide in its country of origin, a quality assurance certificate for the pesticide formulation from the manufacturing company, all the information pertaining to methods of analyzing the pesticide and the impurities that may co-exist with it, values of its physical and chemical properties, risk assessment and all necessary documents issued by the responsible authorities. Article (13): APC designates the agricultural research stations to experiment, for two consecutive agricultural seasons, the pesticides for which registration applications are filed. Consecutiveness of the experimenting seasons may be exempted for reasons deemed Paola Evidenziato Paola Evidenziato 9 / 37 acceptable by APC. Attractants, however, are experimented for one agricultural season. The CAPL is assigned to analyze the samples submitted for experimentation and issue the pertinent analysis certificate at each stage of experimentation. Experimentation results of samples that are proven non-conforming with the physical and chemical properties, upon which registration has been undertaken, will not be accepted. Article (14): When the pesticide passes all the experimentation stages at the set levels of effectiveness, APC issues the “Biological Assessment Certificate", signed by the APC’s Rapporteur or whoever is authorized to act on his behalf. The certificate is then endorsed by the APC’s Chairman or whoever is authorized to act on his behalf. The certificate will be issued in duplicate: one for the APC’s record, and the other will be securely handed over to the concerned person. 10 / 37 Article (15): The APC issues pesticide registration certificates, valid for six renewable years as of the issuing date, for the crude product or formulated pesticide, having completed all the necessary requirements of registration. Effectiveness of the formulated pesticide should be re assessed at the beginning of the third year as of the date of issuing the registration certificate. The certificate will be renewed upon the request of the concerned person, provided that the conditions stipulated in the present decree are still applicable to the crude product or the formulated pesticide, together with re-evaluation of the formulated pesticide at the beginning of the sixth year as of the date of issuing the certificate. The crude pesticide will not be re-registered unless a registration certificate has been issued for one of its formulated preparations. In all cases, the APC’s Rapporteur, or whoever is authorized to act on his behalf, signs the registration certificate or the renewal thereof. The certificate is endorsed by the APC’s Chairman or whoever is authorized to act on his behalf. 11 / 37 Article (16): APC is entitled to issue registration certificates for a period of one renewable year for the purpose of exportation of registered pesticides that are locally manufactured or formulated. It may also issue such certificates for pesticides that are under registration, after ensuring the analytical conformity with the standards, and the successful fulfillment of the biological assessment tests in the first season, and the approval of the files thereof. Article (17): The pesticide's label should contain all the technical and instructive information. Its color follows the toxicity classification of pesticides recommended by the WHO. The label is signed by the APC’s Rapporteur or whoever is authorized to act on his behalf. It will be valid for two years as of the date of its issuance, without exceeding the expiration date of the registration certificate. In case of pesticides whose use is Paola Evidenziato 12 / 37 "restricted" according to article (6) of this decree, the label should contain, in addition to the technical and instructive information, the phrase "restricted use" in a clearly-readable and inerasable writing, together with a reference to conditions of the restricted use. APC may allow the concerned person to correct errors without violating the essence of the procedures and regulations of registration and handling. Article (18): Pesticides should be handled in packages onto which labels are affixed. CAPL is designated to test the quality of those packages according to the certified standards. Article (19): It is not permissible to relinquish the registration certificate to another party except in case of ownership transfer of the corporate entity in whose name the pesticide is registered to that party provided that all the official documents specified by APC in this regard are fully submitted. 13 / 37 Article (20): The registration of a pesticide or any of its recommendations is suspended or cancelled by an APC's resolution and the concerned person will be given a grace period until the end of the agricultural season that follows, without exceeding the expiration date of the registration certificate, in any of the following cases: a. Not fulfilling any of the registration conditions stipulated in this decree; b. Reduced effectiveness of the pesticide against the target pest; c. Occurrence of clear natural imbalance in favor of the pest; 14 / 37 d. Occurrence of unexpected harms of the pesticide on human health, the environment or on the benignity of agricultural crops and products; and e. Publishing scientific reports by well-trusted reference agencies indicating that the pesticide is hazardous to human health and the environment or exceeds its MRL values on agricultural products. The concerned person will be notified of the APC's decision within 15 days of the date of the decision-making, by a registered letter with a return receipt, to the mail address stated in his registration application. He may appeal against the APC's decision to suspend or cancel registration within 30 days of receiving the APC's letter of notification. APC resolves the appeal within 60 days from the date of its submission and its decision in this regard is final. Article (21): In response to demands of farms producing export-oriented crops, APC may issue an additional recommendation to control a pest on another crop (off-label) by using a pesticide registered in Egypt to control the same pest on a different crop. In such a case, the recommendation is valid for one renewable year, provided that the pesticide is proven safe 15 / 37 on the would-be treated crop. This article is not applicable to herbicides. Article (22): When importing a pesticide for the purpose of trade, the applicant, or the person in whose name importation will be undertaken, must hold a license for trading in agricultural pesticides according to the provisions of this decree. The APC’s Rapporteur, or whoever is authorized to act on his behalf, signs the technical import permit and his signature is endorsed by the APC’s Chairman or whoever is authorized to act on his behalf. The permit is valid for six months and may be renewed for another six months by the APC’s Chairman or whoever is authorized to act on his behalf. The imported shipments are released from Customs upon the approval of the APC’s Rapporteur or whoever is authorized to act on his behalf after CAPL’s verification that these shipments fulfill the technical standards. 16 / 37 Article (23): APC may approve re-exportation of imported pesticide shipments upon a request from the concerned person and for reasons or justifications acceptable by the APC. 17 / 37 Article (24): APC may approve the importation of a pesticide not included in its registry for use on green areas or in farms producing export-oriented crops, provided that it is registered in the data base of any internationally recognized reference agency referred to in article (5) of this decree. APC determines the importable volume according to the would-be treated area and the technical import permit is issued under the following conditions: a. The concerned person must submit an approved and authentic certificate from the organization importing the export-oriented crop, approving the application this pesticide on that crop; b. He must submit a statement signed and stamped by the relevant Directorate of Agriculture (DA), indicating the area of the land owned, rented or used under a farming contract agreement, and the type of export-oriented crops to be grown; c. The concerned DA must monitor pesticide application and submit a certified report to APC at the end of the season; d. The phrase "Not for Sale or Trading" must be written in clear, 18 / 37 inerasable Arabic writing, proportionate to the package's size. In addition to the label's information, the name of the importer must be clearly stated; e. In case of farms whose output is export-oriented, the concerned person should submit a Customs certificate attesting to the exportation of the agricultural products on which the pesticide has been applied, f. A technical Import permit for private use is cancelled if and when the concerned person violates any of the conditions stipulated in this article; or if side effects, as a result of the pesticide's application are deemed hazardous by APC, in which case the concerned person bears the legal consequences of damage incurred; and g. The same pesticide, or any other pesticide with the same active ingredient, will not be re-imported for the same purpose, unless the concerned company initiates procedures for registration of that pesticide according to the normal procedure and the provisions of this decree. 19 / 37 Article (25): To meet any critical need of the Ministry of Agriculture and Land Reclamation (MALR) or when a pest becomes epidemic and causes economic damage, APC may approve, upon a request set forward by the relevant research institute or laboratory, or any concerned department in the MALR, to issue temporary registration certificate and label for the use of a pesticide not registered in Egypt, provided that it is registered in the data base of any international reference organization, referred to in article (5) of this decree. Article (26): APC may permit the import of agricultural pesticides not registered in Egypt for research purposes upon the request of any of the research agencies and in volumes determined by the APC. Experiments and research must be conducted at the stations and laboratories affiliated to those agencies. In all cases, the aforementioned agencies should 20 / 37 bear full responsibility for any possible hazard or risk. APC must be informed with the experimentation results that will not be binding when evaluating those pesticides for registration. The technical import permit is signed by the APC’s Rapporteur, or whoever is authorized to act on his behalf, and endorsed by the APC’s Chairman, or whoever is authorized to act on his behalf. The permission to clear those pesticides from the Customs area "Free of charge" is signed by the APC’s Rapporteur or whoever is authorized to act on his behalf. Article (27): APC approves the import of intermediates or the crude product, solvents, additives and adjuvants needed to synthesize or formulate an agricultural pesticide, in quantities proportionate to the factory's production capacity and the volume of the final product. Synthesis and repacking must be undertaken in factories licensed in accordance with the provisions of this decree. The file submitted for the registration of the synthesized pesticide must include names and sources of the 21 / 37 aforementioned substances. The technical import permit is signed by the APC’s Rapporteur or whoever is authorized to act on his behalf, and endorsed by the APC’s Chairman or whoever is authorized to act on his behalf. The permission to clear those substances from the Customs will be issued by the APC’s Rapporteur or whoever is authorized to act on his behalf. Article (28): Maximum Residue Limits (MRLs) of the Codex Alimentarius or the EU, or the tolerance values set by the US-EPA apply to the agricultural crops and products in the same order. If these values are not available for a pesticide on/in a certain crop or product, the values of this pesticide on/in the closest group of crops or products are applied in the aforementioned preferential order. 22 / 37 Article (29): When licensing or renewing the license of a factory for synthesizing, formulating or repacking agricultural pesticides registered in Egypt, the concerned person submits an application to APC, along with the required approvals, documents and forms. APC designates CAPL to prepare a report including a recommendation for possible licensing. In case all the conditions are met, APC issues the factory's license which will be valid for a renewable four-year term. The manager in-charge must hold a B.Sc. in agricultural sciences and a certificate approved by APC attesting to his successful completion of the required training courses. The licensed factories are not permitted to synthesize, formulate, repack or store any substances other than the pesticides licensed by the APC. 23 / 37 Article (30): Renewal of the license referred to in the above-cited article follows the same conditions and procedures. The renewal application must be submitted at least three months before the license's expiration date. The license's validity will be suspended by an APC's decision for a period it determines if any condition stipulated in this decree is violated. If this period elapsed without rectifying the violation, the license is cancelled and should not be restored unless new licensing procedures are undertaken. Article (31): Whoever is licensed to synthesize, formulate or repack agricultural pesticides registered in Egypt must keep a registry numbered and stamped by the DA within the jurisdiction of which the factory is located, for a period of four years preceding the date of last entry, so as to trace the movement of those pesticides. This registry must be made available to CAPL’s inspection personnel upon its demand. APC must be informed with any violations in this regard. 24 / 37 Article (32): Registered agricultural pesticides should be stored in storehouses or traded in retail shops designed for these purposes, fulfilling the licensing provisions of Law No. 453 of 1954 concerning the industrial and commercial shops disturbing neighborhood comfort. The manager in-charge must be a holder of a B.Sc in agricultural sciences or an equivalent university degree, or a member of the Agricultural Profession Syndicate. He also should obtain a certificate approved by APC, attesting to his successful completion of the required training courses. This certificate must be renewed every four years. The application for licensing must be submitted to the DA in whose jurisdiction the storehouse or the retail shop is located. The application must be enclosed with the approvals, documents and forms determined by APC. The DA issues a license valid for four years as of the date of issuance. The license is renewed fulfilling the same conditions 25 / 37 and following the same procedures. The application for license renewal must be filed at least three months before the license’s expiration date. The DA should inform APC with its approval or rejection of the license, in which latter case reasons must be stated clearly. The DA should keep a special registry for storehouses or retail shops located within its area of jurisdiction. Article (33): When requesting to introduce a change in a licensed storehouse or retail shop, the concerned person should submit an application to the concerned DA to undertake the necessary inspection of the place. In case the change is approved by the DA, the approval is entered into the original license and into the DA's registry of licensed storehouses and retail shops. If the change has been made without prior consent of the DA, the license will be suspended for one year. In all cases, the DA must inform CAPL with whatever action has been taken in this regard. 26 / 37 Article (34): Whoever is licensed to trade in agricultural pesticides must keep a registry numbered and stamped by the concerned DA for a period of four years preceding the date of last entry so as to trace movement of those pesticides. This registry must be made available to CAPL's inspection personnel upon its demand. APC must be informed with any violations in this regard. Article (35): Registered “restricted-use pesticides” must not be sold without an 27 / 37 official approval issued by the concerned DA. This approval includes the following: a. The recommended pesticide's trade name, registration number and quantity; b. Type of crop and the area to be treated; and c. Name of the target pest(s) and the pesticide's application rate. In all cases, the trader must give the buyer an invoice including trade name of the pesticide, its quantity, its formulation and the percentage of active ingredient, together with the number and date of the approval stipulated in this article. The trader must keep, for a period of four years starts on the DA’s approval date, copies of the invoices of sold pesticides, the analysis certificates issued by CAPL and the approvals issued by the concerned DA for the sale of registered pesticides marked with the phrase “for restricted use”. Article (36): The pesticides' inspection official, alone or jointly with a representative of another public agency possessing the status of judicial search and seizure, controls, monitors and inspects retail shops, storehouses and factories that synthesize, manufacture and repack agricultural 28 / 37 pesticides to verify the fulfillment of licensing conditions, and the presence of all the documents stipulated in this decree and any additional documents required by APC. APC must be informed regularly with the inspection reports in order for it to take any necessary actions. Article (37): The pesticides' inspection official has the right to take samples of the suspected pesticides, free of charge, based on a "suspicion-seizure" report to be signed by him and the concerned person. The suspected pesticide quantities will be either seized at the same place or transferred to the concerned DA. Samples of the suspected pesticides along with the “suspicion-seizure” report will be sent to CAPL for analysis to ascertain compliance with the standards upon which these pesticides have been formerly registered. The quantities seized will not be released, except after receiving an analysis certificate that confirms 29 / 37 their compliance with the standards. If the analysis has proven otherwise, the concerned person will be notified accordingly by means of a registered letter with a return receipt. Seizure will persist and all legal actions will be taken against the violator. In all cases, APC must be informed with a copy of the "suspicion-seizure" report together with a detailed report on the related consequences and procedures to consider their possible endorsement. Article (38): APC may approve extending the validity of any pesticide for a period of one year, based on an application submitted by the concerned person to the APC’s Rapporteur, or whoever is authorized to act on his behalf, after verification by CAPL that the volumes for which the application is submitted fulfill the physical and chemical standards upon which the pesticide has been registered. In case of compliance, APC extends the pesticide's expired validity for one more year, either by placing stickers on the old packages or by repacking according to the concerned person's request. CAPL will, however, be instructed to analyze samples 30 / 37 of the repacked materials to ascertain their quality before permitting any handling. Article (39): APC designates CAPL to analyze agricultural pesticides for the purpose of: registration, clearance from the Customs, handling, experimentation or ascertaining their validity after payment of the set expenses. In case of suspicion, samples will be exempted from such expenses. The analysis will be conducted in accordance with standardized techniques approved by APC. Analysis techniques stated in the pesticide's file may be applied. The analysis is to be conducted on three replicates from each individual sample. The results of those replicates will be stated individually in the analysis certificate, provided that the average thereof determines the final result of analysis. Regardless of the result, the analysis certificate should be issued in triplicate: CAPL keeps one, APC receives the second and the concerned party should be handed over 31 / 37 the third copy or should receive it by means of a registered letter with a return receipt. Article (40): When it is not possible to conduct all or some of the analyses at CAPL, APC may accept analysis certificates issued by accredited reference laboratories and authenticated in the country of origin. Article (41): The pesticides' inspection official draws samples at the rate of one sample for each of 25 tons or less from each batch of the imported pesticide shipment or from domestically-formulated or repacked 32 / 37 pesticides or from pesticides for which extension of validity is requested. The inspection official prepares a report in three copies, stating that five similar samples have been drawn for the necessary analyses from each patch of the pesticide under testing. The samples are secured with a red wax marked with the seal of inspection official and that of the concerned person or his authorized representative. A copy of the report should be sent to APC, the second to the concerned person, and the third should be kept by CAPL. The Laboratory conducts the required analyses on one sample, keeps two samples, and the concerned person keeps the remaining two samples. In the case of verifying conformity of the sample with the standards upon which the pesticide has been registered, APC issues a permit signed by the APC’s Rapporteur or whoever is authorized to act on his behalf to clear the imported pesticide shipment from the Customs. 33 / 37 Article (42): If the sample is not conforming with the technical standards upon which the pesticide has been registered, the concerned person is entitled to appeal against the analysis result within a period not exceeding one month as of the date of his notification; otherwise the result of analysis will be considered final. The concerned person must submit his appeal to CAPL along with the following: a. Identical copy of the analysis certificate commutated to him; b. The two samples that were kept with him; c. The receipt indicating the payment of the appeal fee; and d. The receipt indicating the payment of the re-analysis costs. Re-analysis should be conducted at CAPL by a technical committee not including any of the persons who conducted the first analysis and in the presence of the appellant, or whoever acts on his behalf by a power of attorney, having been notified of the set date and time via a certified letter with a return receipt. Re-analysis will be conducted on one of the two samples that were formerly kept by the concerned person after ascertaining their conformity with the two samples kept with CAPL. A sample conformity report is prepared and signed by the representative 34 / 37 of the analysis department, the representative of pesticides' inspection and the appellant or his representative, before the analysis is conducted. The analysis results will be considered final, unless it becomes evident to APC that there has been a clear violation of any procedure relating to the implementation of the provisions of this decree. Article (43): Agricultural pesticides must be transported in vehicles fulfilling the standards and technical conditions for the transportation of hazardous materials stipulated in the executive by-laws of the Law of the Environment. Documents indicating purchase, the vehicle's point of embankment and destination and copies of analysis certificates issued by CAPL must be present. Inspection and samples’ withdrawal may be undertaken and in case of suspicion, the transported pesticides may be placed under seizure. 35 / 37 Article (44): In case of illegal trading in agricultural pesticides, or violating the rules and criteria set by APC, or fudging with the documents issued by APC, or submitting false documents and data, a penalty proportionate to the magnitude and consequences of the contravention and the frequency of its recurrence, without prejudice to any other more accentuated penalties stipulated in the operative laws in this regard, will be undertaken against the offender. Article (45): The concerned person or any other entity is not allowed to publish any information about agricultural pesticides in the form of advertisement, poster, pamphlet or newsletter or any other means of advertising unless approved by the APC’s Rapporteur or whoever is authorized to act on his behalf. The publishing agencies are required to verify APC approval of the would-be published information. Violators of the provisions of this article will be subjected to penalties proportionate to the magnitude, consequences and recurrence of the contravention, 36 / 37 without prejudice to any other more accentuated penalties stipulated in the operative laws in this regard. Article (46): APC reviews the situations of agricultural pesticides that were registered or were under registration before issuing the present decree and sets the governing rules for reconciling these situations with a view to ensure consistency with the provisions of the present decree. Article (47): The forms issued by APC for documenting the steps and stages of implementing the provisions of the present decree are used to enable APC to manage and facilitate its duties. Article (48): The APC’s Chairman, or whoever is authorized to act on his behalf, assumes the responsibility of managing all the organizational, supervisory, technical and financial affairs of APC. 37 / 37 Article (49): The Ministerial Decree No. 1835 of 2011 referred to in the preamble of this decree is hereby rescinded, and so are all the provisions that are different or contradictive with the provisions of the present decree. Article (50): The present decree should be published in the Egyptian Official Gazette and will be enforceable as of the day following its publication. Prof. Dr. Ayman Fareed Abu Hadeed Minister of Agriculture and Land Reclamation The Arabic version was issued on: August, 4 th 2013 This version is issued on: