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DECISION 436 Andean Standard on the Registration and Control of Agricultural-use Chemical Pesticides The ANDEAN COMMUNITY COMMISSION Upon considering Articles 72, 99 and 100 of the Andean Subregional Integration Agreement (Cartagena Agreement), Decisions 328 and 419 of Article 7 of the Commission’s Decision 418, and Proposal No. 5/1 (as amended) by the General Secretariat; and, WHEREAS One of the objectives of Andean integration in the field of agriculture is to reach a higher degree of food security at the subregional level by increasing production of basic foods and productivity levels while substituting imports and diversifying and increasing exports; Among other factors the above requires an effective application of agricultural inputs such as pesticides while minimizing risks to human health and the environment; Standards on registration and control of agricultural-use pesticides in the Andean Group need to be harmonized while taking into consideration the health, economic and environmental conditions of the Member Countries based on the principles set forth in the FAO’s International Code of Conduct on the Distribution and Use of Pesticides and the guidelines of appropriate international bodies, as agreed by the Member Countries; That a harmonized scheme for the registration and control of agricultural-use chemical pesticides contributes to the improvement of production, marketing, use and final disposal conditions in the Member Countries in the Subregion by raising quality, efficacy and safety standards for human health and the environment; RESOLVES: To approve the following Decision relating to the Registration and Control of Agricultural-Use Chemical Pesticides: CHAPTER I OBJECTIVES Article 1.- The objectives of this Decision are: To lay down harmonized requirements and procedures for the registration and control of agricultural-use chemical pesticides; to orientate proper use and handling so as to prevent and minimize health and environmental damage under authorized conditions, and to facilitate trade in the Subregion.

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CHAPTER II DEFINITIONS AND SCOPE OF APPLICATION Article 2.- The definitions contained in Annex 1 shall be used in the interpretation of this Decision. Article 3.- This Decision applies to all agricultural-use chemical pesticides, whether or not they are sourced in the Subregion, including technical grade active ingredients and formulations thereof. Biological agents used in pest control are excepted. CHAPTER III COMPETENT AUTHORITIES AND ADVISORY COMMITTEES Article 4.- The Ministry of Agriculture of each Member Country, or in its place, the official entity designated by the pertaining government shall be the Competent National Authority in charge of enforcing this Decision. Article 5.- The Competent National Authority shall lay down the full interaction mechanisms required to fulfill the registration and control requirements and procedures set forth in this Decision in coordination with health and environmental authorities or any other relevant authorities in the pertaining country, without prejudice to the jurisdiction pertaining to each entity in the control of all activities in connection with agricultural-use chemical pesticides at the national level. Article 6.- The Competent National Authority shall convene a Technical Advisory Committee to support the coordination of actions resulting from the enforcement of this Decision within no more than ninety (90) working days after this Decision becomes effective. Article 7.- The Andean Community’s General Secretariat is the subregional-level Competent Authority in charge of the “Registration in the Subregional Register” of agricultural-use chemical pesticides. Among other functions, the General Secretariat is in charge of administering the enforcement of this Decision and of permanently promoting further harmonization of standards, regulations, procedures, methods, protocols and other elements that contribute to the phased adoption of a Harmonized Agricultural-Use Chemical Pesticide Registration and Control Scheme. Article 8.- Each Member Country shall adopt the pertaining technical, legal, and other measures aimed at developing the instruments required for the enforcement of this Decision.

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Article 9.- Pursuant to the provisions of Annex IV of Decision 328 on Agricultural Health, the Subregional Working Group on Pesticides is hereby created, which shall be composed of experts appointed by the Competent National Authority in each of the Member Countries. CHAPTER IV COMPULSORY REGISTRATION OF MANUFACTURERS, FORMULATORS, IMPORTERS, EXPORTERS, PACKAGERS AND DISTRIBUTORS Article 10.- Regardless of whether natural persons or corporate bodies, manufacturers, formulators, importers, exporters, packagers and distributors of agricultural-use chemical pesticides shall be registered with the Competent National Authority. Only natural persons or corporate bodies who have been issued the pertaining registration by the Competent National Authority in accordance with the provisions of this Article shall be authorized to manufacture, formulate, import, export, package and distribute agricultural-use chemical pesticides. Article 11.- For purposes of the registration referred to in the preceding Article, applicants shall submit the following information to the Competent National Authority for verification: 1. Name, address and identification information for the person or corporate body

and the legal representative thereof. 2. The location of manufacturing plants or factories, warehouses and stores. 3. A Description of the facilities and equipment used in the manufacturing,

formulation or packaging, storage, handling and waste disposal, as applicable. 4. A certification attesting that a company-owned laboratory is available or of

reliance on the services provided by a laboratory certified by the Competent National Authority or by a authorized for product-quality control.

5. A copy of the license, permit or authorization issued by the national-level health

or environmental agency or equivalent authorities. 6. In all applicable cases, applicant shall include occupational health programs. 7. Name of technical advisor in charge (must have college degree or an

equivalent thereof). Article 12.- Registrations shall be valid for an undefined period and shall be subject to periodical assessments by the Competent National Authority, which may

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suspend or cancel any such registration if the terms upon which it was issued are infringed or modified. CHAPTER V SPECIAL PERMITS Section I RESEARCH PERMITS Article 13.- Imports of coded substances in the development stage for research in agricultural-use chemical pesticides into the Andean Subregion’s countries are prohibited as long as, in the opinion of the Competent National Authority, the national capacities and regulations indispensable for ensuring minimum health and environmental risks are not present. The Competent National Authority shall inform of such situations to the General Secretariat, which shall in turn inform the remaining Member Countries. Section II EXPERIMENTAL PERMITS Article 14.- As a prerequisite for the commercial registration of an agricultural-use chemical pesticide either being produced in, or entering a Member Country for the first time, the Competent National Authority may authorize limited quantities of such pesticide to be imported and used in experimental efficacy tests. Permits authorized for such purpose shall comply with specific protocols approved by the aforementioned authority, which shall supervise the testing. In the event of institutional jurisdiction issues, the Competent National Authority shall coordinate the issuance of such permit with the health and environmental sectors. The following information shall be submitted with the permit application: - Name, address and identity of permit applicant; - Name, address and identification information of manufacturer, formulator or

importer; - Name of product, if any; - Common name of pesticide; - Chemical name; - Structural formula; - Chemical composition: active ingredients and additives (description and

content);

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- Physical and chemical characteristics; - Type of formulation; - Required product quantity to be imported; - Efficacy test protocol in accordance with the provisions of the Technical Manual; - Indications on acute oral, dermal and respiratory toxicity, 90-day subchronic

toxicity and chronic toxicity, and mutagenesis tests (2 minimum); and neurotoxicity, where applicable;

- Data on product ecotoxicity, acute toxicity in birds, aquatic organisms and

honey bees; - Data on basic residuality, degradability and persistence studies. - Use precautions. - Protection equipment for handling and applicator health monitoring; - Waste and residue treatment and disposal; - Mode of elimination from treated crops; - Recommendations for physicians and recommended treatment; The experimental permit shall be issued within no more than thirty (30) working days after all requested data is submitted. This permit shall be valid for one year and may be renewed for an equal period, through the submission of a substantiated application within thirty (30) working days prior to its expiry date. Each Member Country shall establish the terms and procedures for the issuance of experimental permits. Section III PHYTOSANITARY EMERGENCIES Article 15.- In the event of an officially declared phytosanitary emergency, the Competent National Authority shall, in coordination with health and environmental authorities, authorize imports, production, formulation and use of agricultural-use chemical pesticides not registered in-country, only for the crop/pest combination the object of the emergency and only while the emergency situation lasts. The aforementioned authorities shall decide on the fate of any unused quantities.

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Each country shall gather and evaluate the data required for making the pertaining decision relating to the phytosanitary emergency. The Competent National Authority shall forward a copy of the emergency declaration and the list of the import permits to the remaining Member Countries. CHAPTER VI NATIONAL REGISTRATION OF AGRICULTURAL-USE CHEMICAL PESTICIDES Section I COMPULSORY REGISTRATION Article 16.- All applicants intending to manufacture, formulate, import, export, package or distribute an agricultural-use pesticide in any of the Member Countries shall obtain the product’s registration or be authorized by the owner to such end, subject to meeting the requirements set forth in Article 10 of this Decision. As for all imports of finished pesticides or technical grade active ingredients, the importer shall also have the import permit issued by the Competent National Authority. The Issuance or refusal of such permit shall be dealt with within no more than five (5) working days following the submission date. Section II REGISTRATION REQUIREMENTS Article 17.- A National Registration shall be issued to formulations that meet all applicable requirements in the context of the provisions of this Decision. Article 18.- When seeking to obtain the National Registration of an agricultural-use chemical pesticide, natural persons or corporate bodies shall submit an application to the Competent National Authority according to the form shown in Annex 3a, while attaching the data pertaining to the technical requirements set forth in Annex 2 of this Decision in accordance with the guidelines of the Technical Manual. Article 19.- The Competent National Authority shall issue a National Registration Certification for an agricultural-use chemical pesticide as shown in the form included in Annex 3b where the results of the assessment prove that the benefits outweigh the risks involved in using the pesticide. Article 20.- Formulations bearing the same name as the product shall not be issued a registration where they have different active ingredients. Registrations shall also not be issued for products whose name belongs to a banned pesticide or a pesticide that has already been registered by another person or corporate body.

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Article 21.- The Competent National Authority shall announce its decision concerning the fulfillment of the requirements within fifteen (15) working days after receiving the application. Upon agreement, the Competent National Authority shall start the pesticide’s risk/benefit assessment process and shall announce its decision concerning the registration within one-hundred and eighty (180) working days, which term may be extended for up to a similar period, provided that there are substantiated technical reasons to do so. Section III PROPRIETOR RIGHTS AND OBLIGATIONS Article 22.- Ownership of the National Registration shall only be granted to natural persons or corporate bodies registered with the Competent National Authority as an importer, manufacturer, formulator, packager or exporter subject to the fulfillment of the full requirements established for issuance of the product’s registration. The ownership of a National Registration constitutes a transferable and assignable right. Upon petition by the applicant, the Competent National Authority shall authorize such transfer. The holder of a registration may authorize a dully-registered third party to conduct importing, manufacturing, formulation, and exporting and distribution activities for a registered product. Upon being informed, the holder of the National Registration shall give notice of the situation to the Competent National Authority of any and all prohibitions or restrictions involved in the use of the product in any other country as a result of health or environmental hazard. Article 23.- The holder of a Registration assumes the full responsibility inherent in the product if such product is used in accordance with the recommendations stated on the label. In this regard the holder shall be liable for any adverse effects on health and the environment resulting from infringements of the provisions of this Decision. The Competent National Authority shall make coordinated efforts with the pertaining sectors for adopting internal procedures aimed at investigating and establishing the degrees of responsibility in such cases. SECTION IV VALIDITY, MODIFICATION AND CANCELLATION OF THE NATIONAL REGISTRATION Article 24.- Registrations shall be valid for an undefined period without prejudice to the powers of national Agriculture, Health and Environmental authorities for conducting studies based on post-registration follow-up and surveillance programs and adopting the pertaining provisions under the law.

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Article 25.- National Registration of an agricultural-use chemical pesticide may be modified by submitting a substantiated application where: a) The Registration is transferred to a new holder, for which purpose the applicant shall submit the data contained in the Technical Manual to the Competent National Authority. b) Changes are made to data on a company manufacturing or formulating the product or on the country of origin of such product. In these cases the holder shall submit the same technical specifications of the originally registered product by means of a certification of the qualitative and quantitative chemical analysis of the active ingredient, as well as a certification of the chemical composition of the formulated product issued by a reputed or authorized national or international laboratory. A modification to the registration shall apply where the level of impurities in the profile for the technical grade active ingredient is within the range of the technical specifications for the originally registered product. c) Changes are made or new uses are added to the original registration purposes (incorporation of new crops or pests for treatment and control as well as withdrawal from use), in which case the applicant shall submit the pertaining information contemplated in the Technical Manual to the Competent National Authority, including the results of the efficacy tests and the required technical support; d) The product is reclassified in a toxicological category different from the original category through the enforcement of the Andean Standard. In any case, the applicant shall submit a new proposed label including the proposed changes. The National Registration number assigned to the product shall not change in any of the aforementioned cases. Article 26.- Resolutions by the Competent National Authority in the matter of issuance, suspension or cancellation of the National Registration of a pesticide may be subject to the defensive appeals stipulated in national legislation. Article 27.- Upon a petition by Health or Environmental authorities or upon a petition by an interested party, the Competent National Authority may, by operation of law, suspend a product’s Registration based on reasons founded on technical and scientific opinions of an agricultural, environmental or health nature. The Authority shall make a decision on the validity of the Registration within no more than ninety (90) working days after giving notice of the suspension and, according to the evaluation of the case, it may remove the suspension, or modify or cancel the Registration of the product in question.

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Article 28.- Upon cancellation of the product’s Registration as a result of harm to health or the environment, imports, manufacturing, formulation, sale and use of such product in the pertaining country are automatically prohibited. The Competent National Authority shall inform the General Secretariat of such action within no more than five (5) working days after such measure has been adopted, and the General Secretariat shall in turn inform the Competent National Authorities of the remaining Member Countries immediately. The Competent National Authority shall grant the Registration’s holder a period – according to the seriousness of the case – for withdrawing the product from the market, informing users of the pesticide’s prohibition and proceeding to the final disposal thereof. The Member Countries shall lay down or regulate administrative action procedures on the suspension and cancellation of the Registration and on prohibitions to import, manufacture, formulate or sell a product in each country while taking into consideration the rights granted to the Registration’s holder, without prejudice to the judicial procedures previously established by the Member Countries. Article 29.- Where pesticides are being manufactured or formulated in a Member Country exclusively for export purposes, the Competent National Authority in such country shall provide the importing country the information as to why the product does not have a national registration in the exporting country. Article 30.- Where a Member Country decides to prohibit or severely restrict the use of a pesticide as a result of risk to human health or the environment, such country is required to give notice to the remaining Member Countries and to the General Secretariat within no more than thirty (30) working days after adopting such measure and shall not export such product without the prior consent by the importing country. Article 31.- The cancellation of the National Registration of a pesticide shall not constitute an obstacle to the enforcement of any other pertaining criminal, civil or administrative penalties or actions for relief under applicable national legislation. Article 32.- Where a Member Country intends to sign an international agreement involving compromises which are not contemplated in this Decision in matters relating to the registration and control of agricultural-use chemical pesticides, such country shall state its case before the Subregional Working Group on Pesticides for purposes of exploring the possibility to have all Member Countries sign such an agreement either collectively or simultaneously. If such an agreement should fail to be signed collectively or simultaneously, the Member Country intending to sign it shall put on record the scope thereof as well as of the criteria upon which it has founded its decision. CHAPTER VII

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REGISTRATION IN THE NATIONAL REGISTER Article 33.- The holder of the National Registration of an agricultural-use chemical pesticide may request the pertaining Competent National Authority to register the pesticide in the Subregional Register by attaching the form shown in Annex 3c. Upon approval of the application in compliance with the established procedure for a National Registration, either the Competent National Authority or the holder of the National Registration shall forward copies of the pertaining, properly-validated dossier bearing the reference number issued by the Competent National Authority issuing the National Registration, while the applicant shall meet the resulting costs. The dossier shall consist of the following documents: - A copy of the petition submitted for obtaining the Registration in the

Subregional Register; - The technical dossier; - The technical opinion issued by the Competent National Authority whereby the

National Registration is supported and which contains the result of the technical assessment in compliance with articles 52, 53 and 54 of this Decision;

- A copy of the National Registration Certification; Within five (5) working days after receiving the dossier, the Competent National Authorities of the Member Countries shall forward a Receipt Note to the General Secretariat by using the form shown in Annex 3d of this Decision. If no Receipt Note is sent the General Secretariat shall use the dossier’s forwarding date. Article 34.- Upon receipt of the dossier, the General Secretariat shall issue a “Proceedings Initiation Record” indicating the dates pertaining to the time-frames stated below for announcing a decision on whether the registration in the Subregional Register applies according to the form shown in Annex 3e. The General Secretariat shall set a maximum term of thirty (30) working days from the “proceeding’s initiation date”, within which the Competent National Authorities shall announce a decision or pass remarks to the Competent National Authority issuing the National Registration and shall send a copy of such decision or observations to the General Secretariat. Once the aforementioned period has expired and if any remarks have been passed, both the Competent National Authority issuing the National Registration and the holder shall have available a period not to exceed thirty (30) working days to clarify such remarks and forward them to the Competent National Authorities of the remaining Member Countries and to the General Secretariat.

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Once the aforementioned period has expired, the Competent National Authorities of the remaining Member Countries shall have available a period not to exceed fifteen (15) working days to announce their decisions and forward them to the Competent National Authority issuing the Registration. A copy of such decision shall be forwarded to the General Secretariat. Decisions issued outside the established terms shall be considered favorable to the registration in the Subregional Register. Article 35.- Once the periods stated in the preceding article have expired, the General Secretariat shall register the pesticide in the Subregional Register by Resolution, provided that the application is supported by favorable decisions by three or more Member Countries, including the requesting country, and shall only be valid for marketing and use purposes in the territory of the Member Countries that issue a favorable decision. Article 36.- If a Member Country is being affected by an agricultural-use chemical pesticide with no applicable National Registration in its territory but which is registered in the Subregional Register, such Country shall request that the General Secretariat take the pertaining action aimed at modifying, suspending or canceling the registration of the product in the Subregional Register. The General Secretariat shall give notice of such request to the remaining Member Countries, which shall be provided a period of thirty (30) working days from the date on which they received the notice to announce their opinion to the General Secretariat. During this proceeding the holder of the pesticide registered in the Subregional Register shall be allowed to submit any pertaining arguments and documentation. The General Secretariat shall issue a Resolution for modification, suspension or cancellation of the registration in the Subregional Register upon a favorable decision by the majority of Member Countries concerning such action. If a majority announces no decision, the registration in the Subregional Register shall be maintained. In case of a tie, the General Secretariat shall make a decision based on its technical criteria. The modification, suspension or cancellation measure shall only be valid for the countries that pronounced a decision in favor thereof. CHAPTER VIII LABELLING AND PACKAGING

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Article 37.- The Member Countries shall require the fulfillment of the provisions on labelling and packaging as applicable to the formulated product and technical active ingredient according to the guidelines of the Technical Manual. Article 38.- The label shall contain the information derived from the data provided for the product’s registration and assessment and shall essentially include information on the product’s use and safe handling. Article 39.- Each Member Country shall adopt .all indispensable measures designed to enforce the provisions set forth in Article 37 of this Decision. Article 40.- For purposes of enforcing this Decision, the Member Countries shall refer to the latest pesticide toxicological classification as recommended by the World Health Organization (WHO). The toxicological evaluation criteria shall be set forth in the Technical Manual. CHAPTER IX SUPPORT INFRASTRUCTURE Article 41.- The Competent National Authority in each Member Country shall rely on at least one official analytical laboratory to support regulatory efforts, especially those involving the confirmation of information on product specifications, quality control and monitoring of residues, as well as on a network of laboratories authorized by the Competent National Authority if no laboratories qualified according to the procedures established in Decision 419 on Andean Standards System, Qualification, Testing, Certification, Technical Rules and Metrology and any provisions modifying thereof are available. CHAPTER X REFERENCES, METHODOLOGY AND PROTOCOLS Article 42.- The data referred to in Article 17 as requirements for the National Registration of an agricultural-use chemical pesticide shall be scientifically supported and developed under internationally recognized methods and protocols accepted by the Member Countries. Article 43.- Where recommended and recognized protocols exist for purposes of the National Registration, the Subregional Working Group on Pesticides may develop protocols relating to pertaining studies and tests, which shall be submitted to the consideration of the General Secretariat for their adoption at the subregional level. Article 44.- The Member Countries agree to use the FAO’s technical specifications for plant protection products as the basis for the confirmation of the physical and chemical properties of a pesticide and the use of standard methodologies to be

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followed when analyzing each such properties. If such specifications are unavailable or may not be applied, the methods of the Collaborative International Pesticides Analytical Council (CIPAC)/Association of Official Analytical Chemists (AOAC) shall be used, or by lack of such methods, the information provided by the manufacturer or formulator. Article 45.- As for toxicological tests and studies, the FAO guidelines on “Ecological Criteria for the Registration of Pesticides” shall be taken into consideration and, wherever convenient, other methods accepted by international bodies may be used as reference. CHAPTER XI RESIDUES AND MAXIMUM RESIDUE LIMITS (MRL) Article 46.- The methods provided by the manufacturer or formulator shall be used in the determination of residues for registration purposes, establishing MRL and monitoring activities. The FAO references on “Pesticide Residue Trials to Provide Data for the Registration of Pesticides and the Establishment of Maximum Residue Limits” or any other references adopted by the Member Countries may also be used as reference provided that they are in line with the content set forth in the Technical Manual. Article 47.- For control purposes, the Competent National Authority may adopt the maximum allowable levels in environmental elements as established by the pertaining authority in a Member Country for such purpose. Article 48.- As long as no maximum residue limits (MRL) are established or adopted in the Andean Subregion those set forth in the Codex Alimentarius shall be adopted. For products for which no information is available, the maximum residue limits suggested by the manufacturer or formulator shall be used. CHAPTER XII EFFICACY TESTS Article 49.- Efficacy tests shall be conducted under protocols established and authorized by the Competent National Authority in accordance with standard protocols set forth in the Technical Manual. The Competent National Authority shall have the power to supervise such tests during the performance stage. Article 50.- The applicant for the National Registration of an agricultural-use chemical pesticide shall submit a full report on the tests conducted to the Competent National Authority in order to prove that the product in question meets the stated purposes without causing any harmful effects on crops. The agricultural-

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use chemical pesticides used in such tests are subject to the prior experimental authorization stated in Article 14. Article 51.- The efficacy tests shall be conducted by persons or corporate bodies authorized by the Competent National Authority. Article 52.- The Member Countries shall accept the efficacy tests conducted by another Member Country whenever the protocols used are in line with the standard protocol set forth in the Technical Manual and pertain to similar agroecological conditions. CHAPTER XIII EVALUATION Article 53.- For purposes of the National Registration of an agricultural-use chemical pesticide, the technical data submitted by the applicant shall be evaluated by the Competent National Authority, which shall take the technical grade active ingredient, the formulation and the additives into consideration as the subjects for evaluation. Article 54.- According their legislation and internal procedures, each Member Country shall base its decision on the technical opinions issued by the aforementioned institutions or on the opinions of experts convened to advise on the matter, where relevant. Article 55.- Agricultural-use chemical pesticides registered prior to the effective date of this Decision shall be subject to a re-evaluation process by the Competent National Authority for a period of five (5) years following the effective date of this Decision. CHAPTER XIV CONFIDENTIALITY OF THE INFORMATION Article 56.- The Member Countries shall safeguard the data submitted by applicants on a confidentiality basis for registration purposes by treating such data in accordance with the provisions of the Andean Community’s legal system. Article 57.- The data contained in the dossiers for National Registrations of agricultural-use chemical pesticides shall be public. However, the Competent National Authority should abstain from divulging any information submitted if the person or corporate body submitting such information has requested that a confidential treatment be given to the information. Documents containing confidential information shall be kept separate from the main dossier and third parties shall have no access to such confidential information.

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Article 58.- The following information shall at no time be classified as confidential information: - The denomination and content of the active substance(s) and the denomination

of the pesticide; - The denomination of additional substances considered as hazardous

substances; - The physical and chemical data relating to the active substance, the formulated

product and the additives of toxicological importance; - The methods used to deactivate the technical grade active ingredient or the

formulated product; - The methods used in tests for determining the product’s efficacy and its toxicity

to humans, animals, plants and the environment; - The recommended methods and precautions for reducing handling, storage,

transport or fire risks; - The methods for the elimination of the product and containers thereof; - The decontamination actions to be taken in case of accidental spillage or leaks; - The appropriate first aid and medical treatment to be given in case of bodily

injuries; - The data and information stated on the labeling and on the directions sheet. Article 59.- Applicants who request that certain information be treated as confidential shall state the reasons for such request and shall attach a non-confidential summary of such information or an explanation as to why the information may not be summarized. If an applicant fails to comply with the requirements set forth in the preceding paragraph or if the information fails to qualify as confidential, the Competent National Authority shall give substantiated notice of the situation to the applicant, while granting him a reasonable period of time to withdraw the documents whose confidentiality status has been refused. Once this period expires, such documents shall be incorporated into the public dossier. Article 60.- Confidential information may only be made available for, or disclosed to, third parties by judicial order. CHAPTER XV

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The ANDEAN INFORMATION EXCHANGE SYSTEM Article 61.- The Andean Group’s information-exchange system for agricultural-use chemical pesticides has been created, which is to be coordinated by the General Secretariat with technical support by the Subregional Working Group on Pesticides to provide computerized support to the registration and control management of pesticides and follow up on the activities of the subregional harmonization process as well as to provide overall information of relevance to the objectives sought by this Decision. Article 62.- The Member Countries shall establish national information systems comprised by the Agricultural, Health, Environmental and Foreign Trade sectors integrated to the Andean System. CHAPTER XVI FOLLOW UP OF POST-REGISTRATION ACTIVITIES Article 63.- The Subregional-level General Secretariat and the Competent National Authorities shall develop comprehensive training programs on pesticides aimed at reducing risks to health and the environment. Article 64.- The Competent National Authority shall establish the mechanisms required to coordinate post-registration follow-up activities with the sectors involved. Article 65.- The Member Countries shall establish the legal framework relating to penalties to be imposed on national-level infringements of this Decision. Article 66.- The Competent National Authority shall monitor and control agricultural pesticides in matters relating to import, manufacture, formulation, distribution, handling, use and final disposal in coordination with the sectors involved. Article 67.- The Member Countries shall promote the establishment and improvement of epidemiological surveillance programs and the creation or strengthening of health services and toxicological information, diagnosis, treatment and research centers. The Member Countries shall also ensure that such services and toxicological centers carry out the registration and follow up of pesticide poisonings. Article 68.- The Member Countries shall promote the establishment or strengthening of pesticide environmental impact and monitoring programs in line with national legislation. Article 69.- The Member Countries shall establish a surveillance system for pesticide residue levels that enables to ensure that internal-consumption foodstuffs do not exceed the maximum residue limits referred to in Article 48 of this Decision.

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Article 70.- This Decision shall become effective upon the approval of the Andean Technical Manual, which shall be prepared within a period of six (6) months following the publication of this Decision. During the preparation stage, the Manual shall be submitted to the consideration of the Member Countries and of the Subregional Working Group on Pesticides and shall be subsequently adopted through a Resolution by the General Secretariat. Article 71.- Any procedures pending at the effective date of this Decision shall be subject to the stages, terms and requirements set forth therein. Notwithstanding the preceding paragraph, the evaluations and stages already fulfilled shall be taken into consideration in the issuance of the Registration and only the unfulfilled requirements shall be required for completing the proceeding in accordance with the provisions of this Decision. Article 72.- The General Secretariat shall update Annex 1 of this Decision by Resolution subject to consultation with the Subregional Working Group. The international definitions shall be adopted, where in existence. TRANSITORY PROVISIONS Article 73.-The Subregional Committee on Standardization, Qualification, Testing, Certification, Technical Regulations and Metrology established through Decision 376 shall, in coordination with the Subregional Working Group on Pesticides, harmonize the standards on pesticide packaging at the subregional level within no more than one hundred and eighty (180) working days following the issuance of this Decision. Article 74.- Agricultural-use chemical pesticides registered prior to the effective date of this Decision shall maintain their pertaining registrations up to their expiry dates. Given in the city of Lima, Peru on the eleventh day of June, nineteen thousand and ninety-eight. ANNEX 1

GLOSSARY

Action mechanism means the way in which a chemical pesticide acts. Accordingly, a chemical pesticide may be systemic, translaminar, healing, protective, and be adsorbed through roots, ingestion, contact, inhalation or similar routes.

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Active ingredient means the biologically active part of the pesticide present in a formulation.

Additive means any substance that is added to an active ingredient during the formulation process, so as to make it fit for the expected purposes without altering the pesticide’s characteristics.

Adjuvant means any adhesive, deposit-forming, emulsifying, diluting, synergic or wetting substance designed to enable the application and action of a formulated pesticide.

Agricultural-Use Chemical Pesticide means any substance or mixture of substances intended for preventing, destroying or controlling any pest, including vectors of human or animal disease, unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products or animal feedstuffs, or which may be administered to animals for the control of insects, arachnids or other pests in or on their bodies. The term includes substances intended for use as a plant growth regulator, defoliant, desiccant, or agent for thinning fruit or preventing the premature fall of fruit, and substances applied to crops either before or after harvest to protect the commodity from deterioration during storage and transport.

Agroecosystem means a set of biotic and abiotic elements and their interrelation with humans in an area where an agricultural activity is pursued.

Biological Agent for Pest Control means any natural or genetically modified agents which are set apart from conventional chemical pesticides by their unique modes of action, by the small quantities in which they are used and their specificity for the targeted species. According to the FAO Guidelines for Biological Pest Control Agents they may be grouped into two main categories: a) biochemical agents, and b) microbial agents. Parasitoids and predators are included.

Common name means the name assigned to a pesticide active ingredient by the International Standards Organization or the Andean Standards Committee, or adopted by national standards authorities to be used as a generic or non- proprietary name for that particular active ingredient only.

Competent National Authority means the government body in charge of issuing the National Registration and of coordinating and regulating actions arising out of this Decision.

Competent Subregional Authority is the General Secretariat of the Andean Community.

Control means any monitoring, follow-up and surveillance activities whereby compliance with the provisions set forth in this Decision is verified.

Country of origin means the country wherein the active ingredient or formulation of an agricultural-use chemical pesticide is manufactured or formulated.

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Distinguishing name means the name under which the pesticide is labeled, registered and promoted by the manufacturer.

Distributor means a person or corporate body that supplies pesticides through commercial channels on national or international markets.

Environment means surroundings, including water, air, soil and their relationship as well as all relationships between them and living organisms.

Formulated product means the pesticide preparation in the form in which it is packaged and sold; generally contains one or more active ingredients plus the additives and may require to be diluted prior to use.

Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed.

Formulator means a person, corporate body or public or private individual engaged in the formulation of end products.

Harmonization is the process aimed at establishing, recognizing and enforcing common technical requirements for the registration and control of agricultural-use chemical pesticides in the Member Countries.

Hazard means the ability of a pesticide to cause an adverse effect on an organism or the environment due to its intrinsic properties.

Hazardous waste or residues is a term comprising obsolete pesticides, i.e. pesticides whose valid date or technical specifications have expired, containers or packaging previously containing, remnants, surpluses, byproducts of such pesticides; residues resulting from washing or cleaning objects, or elements that have been in contact with the pesticides such as: clothing, application equipment, processing equipment, etc.

Label means the written, printed or graphic matter on, or attached to, the pesticide; or the immediate container thereof and the outside container or wrapper of the retail package of the pesticide.

Manufacture means the synthesis or production of a pesticide active ingredient.

Manufacturer means a corporation or other entity in the public or private sector or any individual engaged in the business or function (whether directly or through an agent or through an entity controlled by or under contract with it) of manufacturing a pesticide active ingredient or preparing its formulation or product.

Marketing means the overall process of product promotion, including advertising, product public relations and information services as well as distribution and selling on local or international markets.

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Maximum Residue Limit (MRL) is the maximum concentration of a pesticide residue recommended or recognized as acceptable to be legally permitted in or in food commodities and animal feeds.

Median Lethal Dose (DL 50) means a statistically derived minimum dose that can be expected to cause death in 50% of a given population of laboratory test animals under a defined set of controlled conditions. It is stated in milligrams of toxic substance per animal weight while indicating the specie, gender and age of the animals used in experimental tests. It is administered through oral, dermal, mucous and parentheral routes.

Mode of action means the biochemical molecular way in which a chemical pesticide acts, as for example the inhibition of acetylcholinesterase, ergosterol synthesis, mitochondrial respiration or other.

National Pesticide Registration means the technical-administrative process whereby the Competent National Authority approves the use and sale of an agricultural-use chemical pesticide at the national level under the provisions of this Decision.

National Technical Committee means the advisory committee for the Competent National Authority (CNA) concerning all matters relating to the Registration and Control of Pesticides.

Packager means an authorized person or corporate body whose activity consists in transferring a chemical pesticide from any container into a commercial package for subsequent sale without altering the pesticide’s characteristics.

Packaging means the container together with the protective wrapping used to carry and protect pesticide products while facilitating handling during transport and storage and identifying the contents thereof.

Pest means any animal or plant specie, breed or biotype, or pathogenic agent harmful to plants and plant produce.

Pesticide Industry means all persons or corporate bodies engaged in manufacturing, formulating and marketing pesticides and pesticide products.

Pesticide legislation means any laws or regulations introduced to regulate all activities relating to pesticides.

Protocol, is an arranged set of basic technical guidelines and procedures established to conduct pesticide tests.

Re-evaluation means the technical process whereby the Competent National Authority conducts a new evaluation of the risks and benefits of a pesticide registered prior to the effective date of this Decision upon request by the applicant, for purposes of registration in the Subregional Register. The process also applies to pesticide reviews as required by the Competent National Authority for post-registration activities.

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Registration in the Subregional Register.- is an administrative action whereby the General Secretariat registers a registered pesticide in a Member Country in accordance to the provisions of this Decision following the qualification of such National Registration by three or more Member Countries.

Residuality means the time during which a chemical pesticide or the metabolites thereof remain biologically active following their application.

Residue means any specified substances in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxicological significance. The term "pesticide residue" includes residues from unknown or unavoidable sources (e.g. environmental) as well as known uses of the chemical.

Risk means the expected frequency of undesirable effects to health and the environment as a result of toxicity and exposure levels.

Technical Dossier means a set of technical requirements in support of the registration of a product.

Technical grade active ingredient means the ingredient containing the chemical elements and the natural or manufactured compounds thereof, including the related impurities and compounds inevitably resulting from the manufacturing process.

Toxicity means a physiological or biological property, which determines the capacity of a chemical to do harm or produce injury to a living organism by other than mechanical means.

Use pattern embodies the combination of all factors involved in the use of a pesticide, including the concentration of active ingredient in the preparation being applied, rate of application, time of treatment, number of treatments, use of adjuvants and methods and sites of application which determine the quantity applied, timing of treatment and interval before harvest, etc.

ANNEX 2 TECHNICAL REQUIREMENTS FOR THE REGISTRATION OR RE-EVALUATION OF AGRICULTURAL-USE CHEMICAL PESTICIDES (The requirements set forth in this Annex shall be enforced by taking into consideration the phased-registration criteria and specifications established in the Technical Manual). In each case, reference shall be made to the information’s source. The requirements for studies and experimental data relevant to each case and the specific characteristics thereof shall be defined in the Technical Manual. A) TECHNICAL GRADE ACTIVE INGREDIENT:

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1. IDENTITY

1.1 Applicant;

1.2 Manufacturer and country of origin;

1.3 Common name: accepted by ISO or similar;

1.4 Chemical name: proposed or accepted by IUPAC:

1.5 Experimental code number assigned by manufacturer;

1.6 Empirical formula, molecular weight;

1.7. Structural formula;

1.8 Chemical group;

1.9 Degree of purity (according to chemical origin);

1.10 Isomers (identify);

1.11 Impurities (identify);

1.12 Additives (e.g. stabilizers) (identify);

2. PHYSICAL AND CHEMICAL PROPERTIES 2.1 Appearance;

2.1.1 Physical state;

2.1.2 Color;

2.1.3 Odor;

2.2 Melting point;

2.3 Boiling point;

2.4 Density;

2.5 Vapor pressure;

2.6 Absorption spectra;

2.7 Solubility in water;

2.8 Solubility in organic solvents;

2.9 Partition coefficient in n-octanol/water;

2.10 Flashpoint;

2.11 Superficial tension;

2.12 Explosive properties;

2.13 Oxidation properties;

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2.14 Reactivity to packaging materials;

2.15 Viscosity;

3. ASPECTS RELATED TO USE

3.1 Action mechanism;

Effect on organisms-pests (e.g. toxic by inhalation, contact, systemic or other);

3.2 Controlled harmful organisms;

3.3 Mode of action on pests;

3.4. Expected scope of application (e.g. field, greenhouse, or other);

3.5 Phytosanitary and environmental conditions for use;

3.6 Resistance (data on resistance development and monitoring strategies);

4 TOXIC EFFECTS ON MAMMAL SPECIES

4.1 Acute toxicity;

4.1.1 Oral;

4.1.2 Dermal;

4.1.3 Respiratory;

4.1.4 Skin and eye irritation;

4.1.5 Sensitization;

4.2 Subchronic toxicity (13-90 days);

4.2.1 Cumulative oral;

4.2.2 Oral administration on rodents and non-rodents;

4.2.3 Other routes (if relevant : dermal inhalation);

4.3 Chronic toxicity;

4.3.1 Long-term oral toxicity (2 years);

4.4 Carcinogenicity;

4.5 Mutagenicity (in vivo and in vitro);

4.6 Toxicological compatibility: potentiation, synergy, additivity (for

active-ingredient mixtures);

4.7 Effects on reproduction;

4.7.1 Teratogenicity;

4.7.2 A study over a minimum of two generations in mammals;

4.8 Metabolism in mammals;

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4.8.1 Studies on oral and dermal administration;

4.8.1.1 Adsorption;

4.8.1.2 Distribution;

4.8.1.3 Excretion;

4.8.2 Explanation of metabolic routes;

4.9 Compulsory medical information;

4.9.1 Poisoning diagnosis and symptoms;

4.9.2 Proposed treatment;

4.9.2.1 First aid;

4.9.2.2 Medical treatment;

4.9.2.3 Antidotes, when in existence;

4.10 Additional studies;

4.10.1 Neurotoxicity studies;

4.10.2 Toxic effects of metabolites of toxicological importance proceeding from the treated plants where different from those identified in studies on animals;

4.10.3 Special justified studies;

4.11. Additional medical information available;

4.11.1 Poisoning diagnosis;

4.11.1.1 Observations of clinical cases (accidental and deliberate;

4.11.1.2 Observations from epidemiological studies;

4.11.1.3 Observations on allergies;

4.12 Biodegradation;

5 TOXIC EFFECTS ON OTHER SPECIES

5.1 Effects on birds;

5.1.1 Acute oral toxicity in pheasants, quail, wild duck or other validated species;

5.1.2 Short-term toxicity (8-day study in one specie) in pheasants, quail, wild duck or other validated species;

5.1.3 Effects on reproduction in pheasants, quail, wild duck or other validated species;

5.2 Effects on aquatic organisms;

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5.2.1 Acute toxicity for fish, rainbow trout, carp, or other validated species;

5.2.2 Chronic toxicity for fish, rainbow trout, carp, or other validated species;

5.2.3 Effects on reproduction and growth rate for rainbow trout, carp, or other validated species;

5.2.4 Bioaccumulation in fish, rainbow trout, carp, or other validated species;

5.2.5 Acute toxicity for Daphnia magna;

5.2.6 Chronicity studies in Daphnia magna;

5.2.7 Effects on growth of Selenastrum capricornutum algae or other validated species;

5.3 Effects on organisms other than target;

5.3.1 Acute toxicity for honey bees, oral and by contact;

5.3.2 Acute toxicity for beneficial arthropods (e.g. predators);

5.3.3 Toxicity for earthworms, Eisetia foetida or other validated species;

5.3.4 Toxicity for soil microorganisms (nitrifiers);

5.4 Additional studies;

5.4.1 Development of experimental field designs, either real or simulated for studying specific effects, where relevant;

6. RESIDUES IN TREATED PRODUCTS

6.1 Identification of degradation products and metabolite reaction in treated plants or produce;

6.2 Behavior of active substance residues and metabolites thereof from the time of application to crop, when relevant. Adsorption, distribution or mixing with plant ingredients and dissipation of product into the environment;

6.3 Data on residues, obtained through controlled tests;

7. EFFECTS ON THE ABIOTIC ENVIRONMENT

7.1 Behaviour in soil; data for 3 types of standard soils;

7.1.1 Degradation rate and routes (up to 90%) including the identification of:

7.1.1.1 Intervening processes;

7.1.1.2 Metabolites and degradation products;

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7.1.1.3 Adsorption/desorption and mobility of the active substance and of the metabolites thereof, when relevant;

7.1.2 Magnitude and nature of the residues; final disposal methods for remanent residues and products whose specifications have expired;

7.2 Behaviour in water and air;

7.2.1 Rates and routes of degradation in the aquatic environment;

7.2.2 Hydrolysis and photolysis (where not specified in the physical and chemical properties);

8. DATA CONCERNING SAFETY

8.1 Treatment schemes for contaminated soil and waters;

8.2 Procedures for destruction of active substance and decontamination;

8.3 Expected recovery (where available);

8.4 Expected neutralization;

8.5 Controlled incineration (conditions);

8.6 Water depuration;

8.7 Recommended management methods and precautions during handling, storage, transport, and in case of fire;

8.8 Response products and combustion gases in case of fire;

8.9 Data on individual protection equipment;

8.10 Safety sheet prepared by the manufacturer (in Spanish);

9. ANALYTICAL METHODS

9.1 Analytical method for determining the pure active substance;

9.2 Analytical method for determining degradation products, isomers, impurities (of toxicological and ecotoxicological significance) and additives (e.g. stabilizers);

9.3 Analytical method for determining level of residues in treated plants, agricultural products, processed foodstuffs, soil and water, to include recovery rates and methodological sensitization limits;

9.4 Analytical methods for air, animal or human tissue and fluids (where available);

B) FORMULATED PRODUCT:

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1. GENERAL DESCRIPTION

1.1 Name and address of applicant;

1.2 Name and address of formulator;

1.3 Name of product;

1.4 Name of active substance and quality specifications of item A) 1 and 2, and manufacturer document thereof authorizing applicant to use the information in support of the formulation’s registration, where relevant;

1.5 Type of use intended (e.g. herbicide, insecticide);

1.6 Type of formulation (e.g. wettable powder, emulsifiable concentrate);

2. COMPOSITION

2.1 Content of technical grade active substance(s) stated in % w/w. or w/v. Analytical composition certification issued by a laboratory authorized by the Competent National or Subregional Authority, as relevant, or by the manufacturer’s laboratory;

2.2 Content and nature of other components included in the formulation. Analytical certification of composition issued by a laboratory authorized by the Competent National Authority or by a reputed laboratory;

2.3 Analytical method for the determination of active substance content.

3. PHYSICAL AND CHEMICAL PROPERTIES

3.1 Appearance;

3.1.1 Physical state;

3.1.2 Color;

3.1.3 Odor;

3.2 Storage stability (as concerns composition and physical properties relating to usage);

3.3 Relative density;

3.4 Flammability;

3.4.1 Flashpoint (for liquids);

3.4.2 For solids, specify whether or not product is flammable;

3.5 pH;

3.6 Explosivity;

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4. PHYSICAL PROPERTIES OF THE FORMULATED PRODUCT RELATING TO USAGE

4.1 Humidity and wettability for dispersible dusts;

4.2 Foaming (for water-applied formulations);

4.3 Suspendibility for dispersible dusts and suspended concentrates;

4.4 Wet sieve analysis/dusting (for dispersible dusts and suspended concentrates);

4.5 Dry sieve analysis for granules and dusts;

4.6 Emulsion stability (for emulsifiable concentrates);

4.7 Corrosiveness;

4.8 Known incompatibilities with other products (e.g. phytosanitary and fertilizers);

4.9 Density at 20º C in g/ml (for liquid formulations);

4.10 Flashpoint (for oils and solutions);

4.11 Viscosity (for suspensions and emulsions);

4.12 Sulphonation rate (oils);

4.13 Dispersion (for dispersible granules);

4.14 Gas release (only for gas-generating granules or similar products);

4.15 Looseness or flowability for dried dusts;

4.16 Iodine rate and soaping rate (for vegetable oils);

5. DATA ON APPLICATION OF THE FORMULATED PRODUCT

5.1 Scope of Application;

5.2 Effect on pests and crops;

5.3 Conditions under which the product may be used;

5.4 Dose;

5.5 Number and times of application;

5.6 Application methods;

5.7 Directions for use;

5.8 Date of reentry to treated area;

5.9 Lack or waiting periods (pre-harvest intervals);

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5.10 Effects on successive crops;

5.11 Phytotoxicity;

5.12 Proposed and approved usage in other countries, especially in the Andean Subregion;

5.13 Status of registration in the Andean Subregion and in third countries;

5.14 Report on the results of efficacy tests conducted in-country according to the Protocol set forth in the Technical Manual (dates of tests are not to exceed five years);

6. LABELING OF FORMULATED PRODUCT

Proposed label and, when relevant, the proposed instructions sheet according to the specifications set forth in the Technical Manual;

7. PROPOSED CONTAINERS AND PACKAGING FOR THE FORMULATED PRODUCT

In accordance with the Subregional Standard developed, while taking the following basic aspects into consideration:

7.1 Containers;

7.1.1 Type;

7.1.2 Material;

7.1.3 Capacity;

7.1.4 Resistance;

7.2 Packaging;

7.2.1 Type;

7.2.2 Materials;

7.2.3 Capacity

7.2.4 Resistance;

7.3 Action of the product on container materials;

7.4 Decontamination and container destruction procedures;

8. DATA ON THE HANDLING OF FORMULATED PRODUCT SURPLUSES

8.1 Procedures for destruction of active substance and decontamination;

8.2 Methods for final disposal of residues;

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8.3 Expected recovery (where available);

8.4 Expected neutralization;

8.5 Controlled incineration (conditions);

8.6 Water depuration;

8.7 Recommended management methods and precautions during handling, storage, transport, and in case of fire;

8.8 Response products and combustion gases in case of fire;

8.9 Data on individual protection equipment;

8.10 Cleaning procedures concerning application equipment;

9. DATA ON FORMULATED PRODUCT RESIDUES

9.1 Data on residues obtained based on standardized tests according to international standards (FAO Guidelines for the establishment of Maximum Residue Limits (MRL), (According to the guidelines of the Technical Manual).

10. TOXICOLOGICAL DATA ON FORMULATED PRODUCT

10.1 Acute mammalian toxicity;

10.1.1 Oral;

10.1.2 Dermal;

10.1.3 Respiratory;

10.1.4 Skin and eye irritation (when materials being assessed are corrosive these studies shall be omitted);

10.1.5 Skin sensitization;

10.2 Genotoxicity;

10.2.1 Compulsory medical information;

10.2.2 Poisoning diagnosis and symptoms, proposed treatment – first aid, antidotes and medical treatment;

10.3 Additional medical information available;

10.3.1 Poisoning diagnosis;

10.3.2 Information on clinical cases (accidental and deliberate, when available);

11. DATA ON THE EFFECTS OF FORMULATED PRODUCT ON THE ENVIRONMENT

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11.1 Toxic effects on non-mammals;

11.1.1 Toxic effects on birds;

11.1.1.1 Single-dose median lethal oral toxicity in pheasants, quail, wild duck or other validated species;

11.1.1.2 Median lethal oral dietary toxicity in pheasants, quail, wild duck or other validated species;

11.1.2 Toxic effects on aquatic organisms:

11.1.2.1 Median 94-hour lethal concentration in rainbow trout, carp or other validated species;

11.1.2.2 Median lethal concentration in microcrustaceans - Daphnia magna or other validated species;

11.1.2.3 Median inhibitory concentration in algae- Selenastrum capricornutum magna or other validated species;

11.1.3 Toxic effects on honey bees;

11.1.3.1 Median lethal oral toxicity en Apis mellifera;

11.2 Toxic effects on mammal species (see item 10);

11.3 Effects on the environment;

11.3.1 Behavior in soil:

11.3.1.1 Residuality;

11.3.1.2 Leaching;

11.3.1.3 Degradability;

11.3.2 Behavior in water and air;

11.3.2.1 Residuality;

11.3.2.2 Degradability;

11.3.2.3 Volatility;

11.4 Risk Assessment Report and Environmental Management Plan according to the guidelines of the Technical Manual.

12. ADDITIONAL INFORMATION ON ADDITIONAL SUBSTANCES COMPOSING THE FORMULATION 12.1 Data on solvents, emulsifiers, adhesives, stabilizers, colorants and any other

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substances of toxicological and ecotoxicological importance; 13. Safety sheet prepared by the manufacturer or formulator (in Spanish); A summary of the product’s evaluation (technical grade and formulation). Summary of the technical-scientific interpretation of the chemical data on the agricultural pesticide correlated with the data resulting from toxicological, ecotoxicological and environmental efficacy tests; Annex 3a NATIONAL REGISTRATION APPLICATION FORM Place and date: To: (Competent National Authority) “The undersigned (Name and office address of the applicant: Street, number, postal code and PO Box, city, country, phone No., fax No.), In compliance with the provisions of Decision 436 by the Andean Community Commission I hereby request the National Registration of the pesticide... “ “For such purpose I am attaching the following information and the dossier: ACTIVITY OF APPLICANT: (Manufacturer, formulator, importer, exporter, distributor, re-packager) (specify); ADDRESS OF THE FACILITY: (Street, number, postal code and PO Box, city, country, phone No.; fax No.); NAME AND ADDRESS OF MANUFACTURING OR FORMULATING COMPANY: PRODUCT NAME: NAME OF ACTIVE INGREDIENT: COUNTRY OR COUNTRIES OF ORIGIN: PROPOSED USE (S): FORMULATION TYPE AND CODE: COUNTRY OR COUNTRIES OF SOURCE: _____________________________________

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Applicant’s signature ANNEX 3b NATIONAL PESTICIDE REGISTRATION - CERTIFICATION FORM COUNTRY SYMBOL OR EMBLEM COMPETENT NATIONAL AUTHORITY: NATIONAL REGISTRATION CERTIFICATION No. ____________________ In compliance with the provisions of Decision 436 by the Andean Community Commission, this National Registration Certification is issued to the pesticide for an undefined term: NAME OF PRODUCT: COMMON NAME OF THE ACTIVE INGREDIENT(S): CHEMICAL NAME OF THE ACTIVE INGREDIENT(S): STATED COMPOSITION: COUNTRY OF ORIGIN: NAME AND ADDRESS OF MANUFACTURER OR FORMULATOR: AUTHORIZED USE (S): TYPE OF FORMULATION: TOXICOLOGICAL CLASS: Registered in the National Pesticides Register, on page .............. dated .../.../.... REGISTRATION HOLDER: ADDRESS: Place, ...... ........ of 200...... ___________________________ Signature of the Competent

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National Authority ANNEX 3c FORM FOR REQUESTING THE REGISTRATION IN THE SUBREGIONAL REGISTER Place and date: To: (Competent National Authority) “The undersigned (Name and office address of the applicant: Street, number, postal code and PO Box, city, country, phone No., fax No.), In compliance with the provisions of Decision 436 by the Andean Community Commission I hereby request that you process the pesticide’s Registration in the National Register... “ “For such purpose I am attaching the following information and the dossier: ACTIVITY OF APPLICANT: (Manufacturer, formulator, importer, exporter, distributor, re-packager) (specify); ADDRESS OF THE FACILITY: (Street, number, postal code and PO Box, city, country, phone No., fax No.); NAME AND ADDRESS OF MANUFACTURING OR FORMULATING COMPANY: PRODUCT NAME: NAME OF ACTIVE INGREDIENT: COUNTRY OR COUNTRIES OF ORIGIN: PROPOSED USE (S): FORMULATION TYPE AND CODE: NATIONAL REGISTRATION No. _____________________________________ Applicant’s signature ANNEX 3d NATIONAL PESTICIDE REGISTRATION - CERTIFICATION FORM

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DOSSIER RECEPTION NOTE FOR PROCEEDING FOR REGISTRATION IN THE SUBREGIONAL REGISTER The ....(pertaining Ministry) ...................................... The Competent National Authority Of................................................................., (Member Country) Hereby gives notice to the General Secretariat of the Andean Community that on (date) ........... it has received from the ........................................ (Year/Month/Day) .............................................. it has received from the .................................................. (Year/Month/Day) .................................................. (National Authority) of .................................................. (Holder) that issued the Registration of Dossier No. .................................................. pertaining to the Agricultural-Use Chemical Pesticide.................................................. (Name) With National Registration of .................................................., No. ..............., (Member Country) for purposes of starting the RSR proceeding. _______________________________ Authorized Signature Competent National Authority

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......................, ..............................., ...of .................. 200... (Place) (Member Country) ANNEX 3e RECORD OF INITIATION OF PROCEEDING FOR REGISTRATION IN THE SUBREGIONAL REGISTER The Andean Community’s General Secretariat hereby places on record that On ......... (date) ............................., the ................................................. ................................................ ................................................ (Year/Month/Day) (Competent National Authority) of............................................., has submitted dossier No. ........................, (Member Country) Owned by ................................................, who requests the (Holder) Registration in the Subregional Register for the following Agricultural-Use Chemical Pesticide: ..................................... Registered in ................................................ (Member Country) With National Registration No. ................................ The copy of the submitted dossier consists of the following documents: [ ] [ ] Technical Opinion Application [ ] A Copy of the National Registration Certification [ ] Dossier For purposes of following-up and enforcement of the terms set forth in Chapter VII of Decision 436 by the Andean Community Commission, the following date is established as the date of initiation of the proceeding for registration in the Subregional Register: ............................., and for the subsequent stages and terms, the maximum periods (Year/Month/Day)

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stated next: _________________________ Authorized Signature The General Secretariat of the Andean Community Lima, Peru, ..... ..... of 200..... 农

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