Decreto Ejecutivo 43838 — Technical Regulation RTCR 509:2022 Agricultural Inputs. Formulated Synthetic Pesticides, Pesticides of Mineral or Inorganic Chemical Origin, Technical Grade Active Ingredient, Adjuvants, Physical Vehicles and Related Substances for Agricultural Use. Registration

The complete text of the regulation - Full Text of Norm 43838 Technical Regulation RTCR 509:2022. Agricultural Inputs. Synthetic Formulated Pesticides, chemical pesticides of mineral or inorganic origin, Technical Grade Active Ingredient, Adjuvants, Physical Vehicles and Related Substances for Agricultural Use. Registration Nº 43838-MAG-S-MINAE THE PRESIDENT OF THE REPUBLIC THE MINISTER OF AGRICULTURE AND LIVESTOCK, THE ACTING MINISTER OF HEALTH AND THE ACTING MINISTER OF ENVIRONMENT AND ENERGY Based on the powers and authorities conferred in articles 46, 47, 50 and 140, subsections 3) and 18) and 146 of the Political Constitution; articles 27.1 and 28.2.b) of the General Public Administration Law, No. 6227 of May 2, 1978; article 2 subsection e), article 5, subsections c), d) and o), from 23 to 39, and related articles of the Phytosanitary Protection Law, No. 7664 of April 8, 1997; articles 1, 2, 4, 7, 244, 245, 252 of the General Health Law, No. 5395 of October 30, 1973; articles 2 subsections b), c) and g) of the Organic Law of the Ministry of Health, and related articles, No. 5412 of November 8, 1973; article 50 of the Biodiversity Law, No. 7788 of April 30, 1998; Law on Soil Use, Management and Conservation, No. 7779 of April 30, 1998; Organic Law of the Ministry of Environment and Energy, No. 7152 of June 5, 1990; articles 1, 2, 4, 60 of the Organic Law of the Environment, No. 7554 of October 4, 1995; Law of the National Quality System, No. 8279 of May 2, 2002; Law for the Promotion of Competition and Effective Consumer Protection, No. 7472 of December 20, 1994; Law for the Protection of Citizens from Excessive Administrative Requirements and Procedures, No. 8220 of March 4, 2002; Law on Trademarks and Other Distinctive Signs, No. 7978 of January 6, 2000; Law on Undisclosed Information No. 7975 of January 4, 2000; Law No. 7475 of December 20, 1994, Approval of the Final Act Incorporating the Results of the Uruguay Round of Multilateral Trade Negotiations and Law No. 9981 of May 21, 2021, by which the "Agreement on the Terms of Accession of the Republic of Costa Rica to the Convention of the Organisation for Economic Co-operation and Development" is ratified.

I.That article 50 of the Political Constitution enshrines the right of all persons to a healthy and ecologically balanced environment, it being the State's duty to guarantee, defend, and preserve that right.

II.That article 46 of the Political Constitution establishes the constitutional right of consumers and users to the protection of their health, environment, safety, and economic interests, as well as to receive adequate and truthful information, freedom of choice, and equitable treatment.

III.That Costa Rica is experiencing a setback of several years, during which it has not been possible to timely register phytosanitary products of interest that were previously evaluated by an authority that meets the same phytosanitary, health, and environmental standards as our own, or may even be authorities more strict than our own.

IV.That the current average in Costa Rica for registering new molecules is more than 10 years, while in highly developed countries such as the United States of America and the members of the European Union, where very exhaustive and comprehensive evaluations are made regarding the safety of molecules for health and the environment, the average period for registering new molecules is 3 years.

V.That if the current situation in the country continues, not only will farmers continue to be deprived of the more than 50 new innovative molecules, whether protected by patents or already post-patent, existing today in the world market, but the lag will also become increasingly greater, with its consequent loss of commercial, social, and environmental competitiveness compared to the rest of the world.

VI.That the recognition (homologación) mechanism minimizes the duplication of effort for both industries and governments, so that there is agility in verifying the data required for the recognition procedure for agrochemical registrations, which must already be widely harmonized in their country of origin, OECD member countries, and countries adhering to that organization's Mutual Acceptance of Data System.

VII.That agricultural inputs, especially chemical, biological, or related substances for use in combating and controlling pests that affect agriculture, represent an important component in production costs and therefore influence the competitiveness of our agricultural products in international markets, as well as in domestic food production to ensure local consumption and the food security of our population.

VIII.That the complexity of the matter of registering chemical, biological, or related substances for agricultural use, as a result of the abundant international reference regulations, necessitates a multidisciplinary approach in the administration, operation, and regulatory reform, allowing us to have a safe, comprehensive system capable of guaranteeing the quality, identity, efficacy, and safety of the chemical, biological, or related substances for agricultural use marketed in our country.

IX.That the MAG-SFE, MINAE, and MINSA are responsible for issuing the directives, guides, or guidelines for the evaluations that the ministries apply for the review provided by applicants, in the matters specific to their competencies.

X.That the Law for the Conversion of the Ministry of Industry, Energy and Mines into the Ministry of Environment and Energy and its reforms, the Organic Law of the Environment and its reforms, the Wildlife Conservation Law and its reforms, the Law on Soil Use, Management and Conservation and its reforms, the Forestry Law, and the Biodiversity Law and its reforms confer upon the Ministry of Environment and Energy the power to formulate, plan, and execute the environmental protection policies of the government of the Republic.

XI.That the General Health Law, in its articles 7, 239, 240, 241, 244, 245, 252, and 345.8, confers upon the Ministry of Health the power to formulate, plan, and execute health protection policies.

XII.That it is essential, in the interest of the competitiveness of the agricultural sector, as well as in the protection of human health, the environment, and plant health, to have a balanced and modern registration system that operates with clear regulations and in accordance with the international obligations acquired by our country.

XIII.That the simplification of administrative procedures and regulatory improvement aim to rationalize the procedures carried out by individuals before the Public Administration, improve their efficiency, relevance, and usefulness in order to achieve greater speed and functionality in processing, reducing operational costs, in accordance with Law No. 8220 "Law for the Protection of Citizens from Excessive Requirements and Administrative Procedures."

XIV.That the Organisation for Economic Co-operation and Development (OECD) prepared guides for the submission of information with the objective of facilitating the evaluation of Technical Grade Active Ingredients, minimizing the duplication of effort for both industry and governments; these guides are based on the verification that the data required for the registration of agrochemicals are widely harmonized among the member countries of the organization.

XV.That in accordance with the provisions of article 12 bis of Executive Decree No. 37045-MP-MEIC of February 22, 2012 and its reform "Regulation to the Law for the Protection of Citizens from Excessive Requirements and Administrative Procedures," this regulation complies with the principles of regulatory improvement, according to report No. DMR-DAR-INF-167-2022 of December 14, 2022, issued by the Directorate of Regulatory Improvement and Technical Regulations of the Ministry of Economy, Industry and Commerce.

THEREFORE;

CONSIDERING:

DECREE:

RTCR 509:2022. Agricultural Inputs. Synthetic Formulated Pesticides, chemical pesticides of mineral or inorganic origin, Technical Grade Active Ingredient, Adjuvants, Physical Vehicles and Related Substances for Agricultural Use. Registration

(As amended in its title by article 5 of Executive Decree No. 45007 of April 24, 2025. Previously stated: "RTCR 509:2022. Agricultural Inputs. Synthetic Formulated Pesticides, Technical Grade Active Ingredient, Adjuvants, Physical Vehicles and Related Substances for Agricultural Use. Registration.")

1. PURPOSE To regulate the registration of Technical Grade Active Ingredient as a raw material and the registration of synthetic formulated pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use, for the purpose of approving them for marketing and use.

(As amended, point 1) above, by article 6 of Executive Decree No. 45007 of April 24, 2025) 2. SCOPE OF APPLICATION This regulation applies to:

2.1. Technical grade active ingredients, synthetic formulated pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use must be registered prior to their importation, exportation, manufacture, formulation, storage, distribution, transportation, repackaging, refilling (reenvasado), handling, mixing, sale, and use.

(As amended, point 2.1) above, by article 6 of Executive Decree No. 45007 of April 24, 2025) 2.2. Individuals or legal entities that register, market, import, export, formulate, manufacture, refill, repackage, store, distribute, and handle synthetic formulated pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use.

(As amended, point 2.2) above, by article 6 of Executive Decree No. 45007 of April 24, 2025) 2.3. The following are excluded from the application of this technical regulation:

2.3.1. The products indicated in numeral 2.1. above when entering in transit.

2.3.2. Samples imported for research development, including products in the early research phase identified by manufacturers with internal codes.

2.3.3. Those imported for combating specific phytosanitary problems in accordance with the provisions of article 24 of Law No. 7664 "Phytosanitary Protection Law".

2.3.4. Analytical standards.

2.3.5. Registrations granted under Executive Decree No. 39461-MAG "Registration of Technical Grade Active Ingredient imported into the country for the formulation of chemical pesticides in national formulation plants, under the Temporary Admission for Inward Processing Regime, Free Zone or similar for export purposes." 2.3.6. Waxes classified as food additives according to the Codex Alimentarius and the RTCA 67.04.54:18 Processed Foods and Beverages. Food Additives." 3. REFERENCES This regulation is complemented by the following:

3.1. Executive Decree No. 24715-MOPT-MEIC-S, Regulation for the Land Transportation of Dangerous Products, of October 6, 1995, published in the Official Gazette La Gaceta No. 207 of November 1, 1995.

3.2. Executive Decree No. 34740-H-COMEX, Regulation of the Duty Drawback Regime, of August 29, 2008, published in the Official Gazette La Gaceta No. 181 of September 19, 2008.

3.3. Executive Decree No. 40198-H-COMEX, Regulation of the Temporary Admission for Inward Processing Regime, of December 13, 2016, published in the Official Gazette La Gaceta No. 36 supplement 37 of February 20, 2017.

3.4. Executive Decree No. 26503-MAG, Regulation of Agricultural Stewardships (Regencias Agropecuarias) of the College of Agronomists of Costa Rica, of October 24, 1997, published in the Official Gazette La Gaceta No. 242 of December 16, 1997.

3.5. Executive Decree No. 27037-MAG-MEIC, Standard RTCR 321:1998 Registration and Examination of Application Equipment for Chemical, Biological, Biochemical or Related Substances, of January 5, 1998, published in the Official Gazette La Gaceta No. 174 of September 7, 1998, Supplement 59a.

3.6. Executive Decree No. 27041-MAG-MEIC, Standard RTCR 176:1991 Agrochemicals. Sampling, of January 5, 1998, published in the Official Gazette La Gaceta 176 of September 9, 1998.

3.7. Executive Decree No. 27056-MAG-MEIC, Standard RTCR 213:1997 Sampling for analysis of pesticide residues in vegetable crops, of January 5, 1998, published in the Official Gazette La Gaceta No. 178 of September 11, 1998.

3.8. Executive Decree No. 27763-MAG, Setting of Service Fees of the Ministry of Agriculture and Livestock, of March 10, 1999, published in the Official Gazette La Gaceta No. 68 of April 9, 1999, Supplement 26 3.9. Executive Decree No. 27973-MAG-MEIC-S, RTCR 318:1998 Laboratory Analysis of Chemical and Biological Substances for Use in Agriculture, May 19, 1998, published in the Official Gazette La Gaceta No. 139 of July 19, 1999.

3.10. Executive Decree No. 31520-MS-MAG-MINAE-MOPTMGPSP, Regulation for Agricultural Aviation Activities, of October 16, 2003, published in the Official Gazette La Gaceta 241 of December 15, 2003.

3.11. Executive Decree 31961 COMEX-MAG, Resolution 118-2004 (COMIECO), Standard Protocol for Trials on the Biological Efficacy of Pesticides for Agricultural Use, of July 26, 2004, published in the Official Gazette La Gaceta No. 179 of September 13, 2004.

3.12. Executive Decree 35301-MAG-MEIC-S. RTCR 424-2008. Technical Regulation on Maximum Residue Limits of Pesticides in Vegetables of April 28, 2009, published in the Official Gazette La Gaceta No. 129 of July 6, 2009.

3.13. Executive Decree No. 42932-COMEX-MEIC-MAG, "Resolution No. 434-2020 (COMIECO-XCIII) dated December 10, 2020 and its Annex: "Central American Technical Regulation RTCA 65.05.67: 18 Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants and Physical Vehicles for Agricultural Use. Requirements for the Preparation of Labels and Leaflets".

4. DEFINITIONS The terms and concepts used in this regulation shall be defined, interpreted and applied in the form and sense indicated below:

4.1. Biocidal action (acción biocida): the interference action exerted by a pesticide on the vital processes or development of an organism considered a pest.

4.2. Physiological action (acción fisiológica): mobility and metabolic activity of a chemical substance in the organism considered a pest.

4.3. Additives: components added to the active substance before manufacturing the formulated product for the purpose of maintaining its stability and facilitating its handling.

4.4. Causal agent (agente causal): organism capable of producing a specific symptomatology in the plant that causes disease.

4.5. Storage (almacenamiento): the action of storing, gathering, conserving, keeping, or depositing synthetic formulated pesticide, technical grade active ingredient, adjuvants, related substances, and physical vehicles for agricultural use in warehouses, storage facilities, customs facilities, or vehicles under the conditions stipulated in this regulation.

4.6. Ecophysiological aspects (aspectos ecofisiológicos): physiological processes of living organisms (crop, causal agent, vectors, antagonistic and mutualistic organisms, which may influence the performance of the molecule) under the influence of environmental factors.

4.7. Regulatory authority (autoridad reguladora): the agency, institution, or department of an OECD member country or one adhering to the Mutual Acceptance of Data System of that organization, competent for the authorization and/or approved registration of the TGAI or synthetic formulated pesticide requested for registration in Costa Rica.

4.8. Change in formulation (cambio en la formulación): a change in the chemical composition of a synthetic formulated pesticide, where the active ingredient and its content, as well as the type of formulation and agronomic use, remain the same. Such change, according to its nature or extent, may be of two types: non-significant changes, or significant changes.

4.9. Non-significant changes (cambios no significativos): the exchange of co-formulants that are chemically equivalent, in the same quantity.

4.10. Significant changes (cambios significativos): those changes in which co-formulants are exchanged, added, omitted, or their nominal content is changed. The new co-formulant need not necessarily have the same function as the previous one, belong to the same chemical class, or already be contained in another previously authorized crop protection product.

4.11. Pesticide class (clase de plaguicida): Refers to the type of activity or target organism for which the pesticide is used.

4.12. Adjuvant (coadyuvante): chemical substance that contributes, assists, or helps to perform a better action when mixed appropriately with a synthetic formulated pesticide.

4.13. Adjuvants and related substances of minimum risk (coadyuvantes y sustancias afines de mínimo riesgo): corresponds to adjuvants and related substances whose main components and co-formulants are found in their entirety on the "List of Authorized Components for Synthetic Formulated Pesticides, Adjuvants and Related Substances" visible on the SFE website www.sfe.go.cr.

4.14. Co-formulant (inert ingredient) (coformulante (ingrediente inerte)): non-active ingredient composing a synthetic formulated pesticide, adjuvant, or related substance.

4.15. Main component of the related substance or adjuvant (componente principal de la sustancia afín o coadyuvante): substance(s) that exert(s) the main action for the intended use of the adjuvant or related substance.

4.16. Median lethal concentration (CL50) (concentración letal media (CL50)): concentration of a substance that causes 50% mortality in test organisms, usually under exposure over a determined period of time.

4.17. Similar agroecological conditions (condiciones agroecológicas similares): defined as the resemblance in the set of characteristics and factors that establish the development conditions of a crop. This similarity is based on combinations of soil, physiography, and climatic characteristics, which together limit the potential for land use for the production of a specific crop.

4.18. Reference crop (cultivo de referencia): major or minor crop for which there is a biological efficacy trial with its respective approval resolution from the SFE Control Unit.

4.19. Minor crop (cultivo menor): a crop for which, due to its planting area, there is little or no supply of related substances or formulated chemical pesticides for agricultural use for phytosanitary protection, which are published on the SFE website, and which will be subject to updates or modifications according to the country's conditions, after analysis by the SFE. Such updates or modifications will be kept published on the SFE website.

4.20. Representative crop (cultivo representativo): the crop with the largest acreage in the country, based on the latest available report from data provided by SEPSA or another formal organization recognized by the SFE.

4.21. Test data (datos de prueba): for the application and interpretation of this regulation, test data is undisclosed information that includes information, data, or documents on the safety and efficacy of a technical grade active ingredient, the preparation of which requires considerable effort, which has not been disclosed to the public, and which is required by the SFE for the purpose of granting registration in the country for said technical grade active ingredient. This information is provided within the technical information dossier. This information, data, or documents includes the following: toxicological studies, ecotoxicological studies, environmental fate studies, studies on physical-chemical properties, and analytical methods on the safety and efficacy of a technical grade active ingredient.

4.22. Notarized sworn statement (declaración jurada notarial): a statement given under oath before a Notary Public and duly notarized.

4.23. Median lethal dose (DL50) (dosis letal media (DL50)): amount of a substance that produces 50% mortality in test animals, over a given period of time.

4.24. Product efficacy (eficacia del producto): degree of effect that a synthetic formulated pesticide, adjuvant, related substance, or physical vehicle has in relation to the organism considered a pest.

4.25. Packaging/container (empaque/envase): any container that holds synthetic formulated pesticides, technical grade active ingredient, adjuvants, related substances, and physical vehicles for agricultural use for delivery as a single product, covering them totally or partially, and which includes packaging and wrappers. A package may contain several units or types of pre-packaged synthetic formulated pesticides, adjuvants, related substances, and physical vehicles when offered to the consumer.

4.26. Efficacy trial (ensayo de eficacia): investigation on a specific crop whose objective is to evaluate the lethal effect or inhibition of development of a causal agent by the action of a synthetic formulated pesticide, related substance for agricultural use, or physical vehicle.

4.27. Chemical entity (entidad química): the active ingredient responsible for the biocidal or physiological action.

4.28. Application equipment (equipo de aplicación): device used for the application of substances for agricultural use for combating pests and diseases in plants, whether in liquid or solid form, in the form of mist or aerosols, in any of the known application methods.

4.29. Equivalence (equivalencia): determination of the similarity of the purity/impurity profiles, and toxicological/ecotoxicological profiles when necessary, for supposedly similar technical materials generated by different manufacturers and by different manufacturing routes, to establish whether they present similar levels of risk.

4.30. Label: written, printed, or graphic material on the surface of the container, adhered (glued) or stamped to the product container, that identifies and describes the product contained in the container.

4.31. Manufacturer (fabricante): an individual or collective person, natural or legal, engaged in the synthesis or production of a technical grade active ingredient.

4.32. Formulation (formulación): preparation of synthetic formulated pesticides, adjuvants, related substances that may contain one or more active ingredients, uniformly distributed in one or more components or co-formulants in a form suitable for use, with or without the aid of formula conditioners.

4.33. Formulator (formulador): an individual or legal entity engaged in the formulation of synthetic formulated pesticides, adjuvants, and related substances.

4.34. Business group (grupo empresarial): a set of one or more companies that are legally independent of each other, but which are owned by, or under the control or subordination exercised by, a parent, controlling, or proprietary company.

4.35. Chemical group or family of pesticide (grupo o familia química de plaguicida): The chemical group or family of a pesticide is understood to be the group based on the chemical structure or groups of chemical products that share common characteristics and mode of action, using as a reference what is established by recognized international organizations.

4.36. Recognition (homologación): the official procedure carried out by the SFE to register the TGAIs and the synthetic formulated pesticides registered or authorized by the Regulatory Authority of an OECD member country or adherents to the Mutual Acceptance of Data System of that organization.

4.37. Impurities (impurezas): a by-product arising from the manufacture of the technical grade active ingredient or derived from the technical grade active ingredient during formulation or storage.

4.38. Relevant impurities (impurezas relevantes): a by-product from the manufacture or storage of a pesticide which, compared to the active ingredient, is toxicologically significant to health or the environment, is phytotoxic to treated plants, causes staining of food crops, affects the stability of the pesticide, or causes any other adverse effect. An impurity may be non-relevant in one pesticide or product and relevant in another, even though it occurs in both, because relevance is determined by the hazards of impurities relative to that of the active ingredient. In general, relevant impurities are those defined as such and made public by international and intergovernmental reference bodies such as the FAO, EFSA, APVMA, EPA, and BVL.

4.39. Non-relevant impurities (impurezas no relevantes): impurities that, compared to the active ingredient, are not toxicologically significant for health or the environment. In general, non-relevant impurities have manufacturing specification limits equal to or greater than one gram per kilogram (1 g/kg).

4.40. Administrative information (información administrativa): all information qualified and classified as such by this regulation. Personnel involved in the evaluation, third parties to whom the law confers that right, and those authorized by the applicant shall have access to this information.

4.41. Confidential information (información confidencial): all information qualified and classified as such by this regulation and the current regulations on undisclosed information. Only the officials that the SFE keeps in the signature registry shall have access to this information.

(As amended, the previous point, by article 1 of Executive Decree No. 45674 of March 23, 2026)

4.42 Reference information (información de referencia): information issued by an Internationally Recognized Authority (EFSA, EPA, FAO, APVMA, Canada) which must contain the toxicological, ecotoxicological characteristics, environmental fate, minimum concentration of the TGAI, and maximum of relevant impurities taken from one or more specifications, reports, or studies as a reference for the TGAI registration modality using reference information from Internationally Recognized Authorities.

(As added, point 4.42 above, by article 1 of Executive Decree No. 45007 of April 24, 2025)

4.43. Technical information (información técnica): all information qualified and classified as such by this regulation. Personnel indicated in this regulation, third parties to whom the law confers that right, and those authorized by the applicant shall have access to this information.

(As renumbered by article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from the old point 4.42 to point 4.43)

4.44. Active ingredient (ingrediente activo): for the purposes of this regulation, it shall be understood as a chemical entity.

(As added, the previous subsection, by article 1 of Executive Decree No. 45007 of April 24, 2025)

(As renumbered by article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from the old point 4.43 to point 4.44)

4.45. Technical grade active ingredient (TGAI) (ingrediente activo grado técnico (IAGT)): the technical grade active ingredient can be found under two designations, TC (technical material), and TK (technical concentrate). The TC normally has a high concentration of active ingredient; it may have essential additives such as stabilizers, but contains no diluents or solvents. The TK, for its part, normally contains a lower concentration, either because a solvent has been added to a TC or because it may be impractical or undesirable to isolate the active ingredient from the solvent, impurities. In addition, the TK may have essential additives such as stabilizers, as well as diluents and solvents.

(As renumbered by article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from the old point 4.44 to point 4.45)

4.46. Equivalent technical grade active ingredient (ingrediente activo grado técnico equivalente): for the application and interpretation of this regulation, a technical grade active ingredient equivalent to the technical grade active ingredient from different manufacturers or from different manufacturing processes or different origins is considered one whose purity/impurity profiles meet the criteria established in the equivalence determination process.

(As renumbered by article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from the old point 4.45 to point 4.46)

4.47. Maximum Residue Limit (MRL) (Límite máximo para residuos (LMR)): It is the maximum level of residues of a pesticide that is legally permitted in food or feed (both inside and on the surface) when pesticides are applied correctly in accordance with good agricultural practices.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.46 to point 4.47)

4.48. Certified reference material of TC ingredient and related substances (Material de referencia certificado de IAGT y sustancias relacionadas): reference material of the TC ingredient and related substances, accompanied by a certificate, where one or several values of its specified properties are certified by a procedure that establishes their traceability to an accurate realization of the unit in which the values of the specific properties are expressed, and for which each certified value is accompanied by an uncertainty with an indication of a confidence level.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.47 to point 4.48)

4.49. Modification to the registration (Modificación al registro): change to the current registration in accordance with the provisions of this regulation; said change shall retain the registration number under which it was approved.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.48 to point 4.49)

4.50. Trade name (Nombre comercial): is the name by which the applicant identifies a specific product for its commercialization.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.49 to point 4.50)

4.51. Generic or common name (Nombre genérico o común): is the common name of the TC active ingredient approved by some official international standardization body.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.50 to point 4.51)

4.52. Chemical name (Nombre químico): refers to the name of the molecule(s) of the active ingredient of a product approved by some official international standardization body, for example, IUPAC.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.51 to point 4.52)

4.53 CAS Number (Número CAS): is a unique numerical identifier that designates only one substance; it has no chemical meaning. It is a link to a large amount of information about a specific chemical substance. It provides a reliable common link between the various nomenclature terms used to describe substances.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.52 to point 4.53)

4.54. Countries adhering to the OECD Mutual Acceptance of Data (MAD) System (Países adherentes al Sistema de Aceptación Mutua de Datos (AMD) de la OCDE): are the non-OECD member countries where studies are conducted using standard OECD test methods and that have been evaluated and approved regarding Good Laboratory Practices and are full adherents to that organization's MAD system. The following countries are full adherents of the MAD system: India, Argentina, Brazil, Malaysia, South Africa, and Singapore, as well as countries that in the future are approved by the OECD under that condition.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.53 to point 4.54)

4.55 Use pattern (Patrón de uso): manner in which a formulated synthetic pesticide, adjuvant, related substance, and physical vehicle must be used, which includes the following information: crop, causal agent it controls or effect it produces on the plant (in the case of growth regulators), dose, number of applications, application interval, application method, application type, application timing, pre-harvest interval, re-entry to the area.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.54 to point 4.55)

4.56. Impurity profile (Perfil de impurezas): maximum concentrations of all impurities (including unknown ones) in a technical grade active ingredient produced by a manufacturer using a unique process, derived from the analysis of production batches. In general, impurities are those with manufacturing specification limits greater than 1 g/kg, but lower limits apply to relevant impurities.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.55 to point 4.56)

4.57. Ecotoxicological profile (Perfil ecotoxicológico): a summary of the ecotoxicological data at the endpoints that may have consequences for aquatic and terrestrial organisms, due to possible exposure depending on the intended uses, for a given pesticide.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.56 to point 4.57)

4.58 Reference profile or source (Perfil o fuente de referencia): is the information of a technical grade active ingredient registered under the modality of full data, TC ingredient homologation, or recognition of TC ingredient studies and upon which the quality and hazard analysis was based and for which a regulatory decision was made and the corresponding registration was granted, and which will be used as the basis for registration by equivalence, in accordance with the provisions of this regulation. Said reference profile or source must correspond to the same form (TC or TK) of the TC ingredient for which the registration by equivalence is being determined."

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.57 to point 4.58)

(As thus amended the preceding point by Article 1 of Executive Decree No. 45811 of May 20, 2026)

4.59. Toxicological profile (Perfil toxicológico): a summary of the data at the toxicological endpoints that may have consequences for human health, due to exposure through various routes, for a given pesticide.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.58 to point 4.59)

4.60 Chemical pesticide of mineral or inorganic origin (Plaguicida químico de origen mineral o inorgánico): Products used for the control of agricultural pests that come from minerals extracted from the earth and are not obtained by chemical synthesis.

(As thus added point 4.60) above by Article 1 of Executive Decree No. 45007 of April 24, 2025) 4.61. Pest (Plaga): any living organism that competes with or causes damage to plants or their products and that may be considered as such, due to its economic, invasive, or extensive nature.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.59 to point 4.61)

4.62. Formulated synthetic pesticide (Plaguicida sintético formulado): commercial product intended for agricultural use for pest control, which has been prepared from one or more technical grade active ingredients plus the other components of the formulation or another production process.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.60 to point 4.62)

4.63. Pesticide (Plaguicida): understood for the purposes of this regulation, any substance or mixture of chemical substances with biocidal or physiological action, intended to prevent, destroy, or control any pest that affects planting, crops, and their harvests, or that interferes in any other way in production, likewise includes those chemical substances applied to the product after harvest.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.61 to point 4.63)

(*) 4.64 Molecules not authorized for registration under the homologation modality (Moléculas no autorizadas para registrarse por la modalidad de homologación): molecules that cannot be used in 70% of OECD countries. To establish the 70%, the status in the following information sources must be considered:

1. In the case of the United States, the cancellation of all registrations of the molecule by the EPA must be recorded.

2. In the case of European Union member countries, the condition shall be "not approved." 3. For the other countries, the condition must be that the product is prohibited according to official databases or, failing that, when deemed pertinent by the three ministries, the PAN (Pesticide Action Network International) database will be used.

Excepted from the above condition is that molecule for which the registrant company demonstrates that it has never been registered in the OECD country.

Innovation molecules with less than 10 years on the market are excepted, except in cases where a competent authority, by means of studies, has determined their cancellation or disauthorization.

(*)(As thus added point 4.64) above by Article 1 of Executive Decree No. 45007 of April 24, 2025) 4.65. New agrochemical product (Producto agroquímico nuevo): is that technical grade active ingredient that contains a chemical entity not found in a registration or authorization that has been previously granted in Costa Rica, as a technical grade active ingredient or forming part of a formulated synthetic pesticide or physical vehicle.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.62 to point 4.65)

4.66. Safeners (Protectores): biologically active co-formulant that mitigates the effect of the formulated synthetic pesticide on crops.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.63 to point 4.66)

4.67. Recognition of the approved evaluation of technical studies (Reconocimiento de la evaluación aprobada de los estudios técnicos): is the process by which the competent Reviewing Authorities verify the content, results, and bibliographic references of the technical studies indicated in the Assessment Report conducted by the Regulatory Authority of the OECD member country or a country that is a full adherent to that organization's MAD system.

For the recognition of the evaluation of technical studies, the TC ingredient registered or authorized previously by the Regulatory Authority must be from the same manufacturer, same origin, same minimum concentration, and same registration holder, as the one for which registration is requested in Costa Rica.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.64 to point 4.67)

4.68. Registration (Registro): process by which the SFE approves the sale and use of a formulated synthetic pesticide, technical grade active ingredient, adjuvants, related substances, and physical vehicles for agricultural use, prior to a comprehensive evaluation of scientific data demonstrating that the product is effective for its intended purpose and does not entail an unacceptable risk for human or animal health or the environment.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.65 to point 4.68)

4.69. Renewal (Renovación): procedure by which the validity of the phytosanitary registration of an already approved product is renewed, in accordance with the provisions of this regulation.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.66 to point 4.69)

4.70. Assessment Report(s) (Reporte (s) de evaluación): official report, monograph, or document by which the regulatory authority of an OECD member country or a country that is a full adherent to that organization's MAD system, integrates and approves the results and bibliographic references of all test reports, studies, and other relevant information submitted by the person requesting the approval of a TC ingredient or formulated synthetic pesticide.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.67 to point 4.70)

4.71. Residue (Residuo): is any specific substance present in food, agricultural products, or animal feed as a consequence of the use of pesticides. The term includes any derivative of a pesticide, active ingredient, conversion products, metabolites, and reaction products, and impurities considered of toxicological significance. (Note: The term "pesticide residue" includes residues from unknown or unavoidable sources (e.g., environmental origin), as well as known uses of the chemical).

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.68 to point 4.71)

4.72. Synergist (Sinergista): substance that, together with another, results in a superior effect compared to the effects of each when applied separately.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.69 to point 4.72)

4.73. OECD Mutual Acceptance of Data (MAD) System (Sistema de Aceptación Mutua de Datos (AMD) de la OCDE): is a multilateral agreement comprising three OECD instruments: i) the Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals of 1981 (revised in 1997); ii) the Council Decision-Recommendation on Compliance with the Principles of Good Laboratory Practice of 1989, and; iii) the Council Decision on the Adherence of Non-Member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals of 1997.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.70 to point 4.73)

4.74. Applicant (Solicitante): natural or legal person who requests from the SFE the registration of a TC ingredient, formulated synthetic pesticide, adjuvant, related substance, or physical vehicle for agricultural use.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.71 to point 4.74)

4.75. Related substance (Sustancia afín): for the purpose of the application and interpretation of this regulation, related substances are not formulated synthetic pesticides, but rather are substances intended for use on crops as repellents of synthetic origin, attractants, sunscreens, substances applied to the product after harvest to protect it against deterioration during storage and transport, sealing-healing agents, seed protectants prior to planting against the action of chemical substances, phytotoxicity protectants, as well as growth regulators and physiological inducers, desiccants, and defoliants. In those cases where a related substance has a biocidal effect or toxicological or ecotoxicological relevance, it must be evaluated as a formulated synthetic pesticide.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.72 to point 4.75)

4.76. Data holder (Titular de la información): Natural or legal person who holds a property right over the information submitted for registration, and therefore can control and dispose of it, including test data.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.73 to point 4.76)

4.77. Registration holder (Titular del registro): natural or legal person who owns the registration of a technical grade active ingredient, the registration of a formulated synthetic pesticide, adjuvant, related substance, or physical vehicle for agricultural use before the SFE.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.74 to point 4.77)

4.78. Toxicity (Toxicidad): property of a substance and its metabolic or degradation products to cause damage to an organism exposed to it, by any route.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.75 to point 4.78)

4.79. Physical vehicle containing pesticide or related substance (Vehículo físico que contiene plaguicida o sustancia afín): inert medium that provides the adequate contact surface or that is used as a carrier for a previously registered technical grade active ingredient, or related substance.

(As amended in its numbering by Article 1 of Executive Decree No. 45007 of April 24, 2025, which transferred it from former point 4.76 to point 4.79)

(*)5. SYMBOLS AND ABBREVIATIONS For the purposes of this Regulation, the following shall be understood as:

AMD: Mutual Acceptance of Data.

AOAC: Association of Official Agricultural Chemists.

APVMA: Australian Pesticides and Veterinary Medicines Authority.

ASTM: American Society for Testing and Materials.

BVL: Federal Office of Consumer Protection and Food Safety, Germany (Federal Office of Consumer Protection and Food Safety, Germany).

BPL: Good Laboratory Practices.

CAS: Chemical Abstracts Service number.

CIPAC: Collaborative International Pesticides Analytical Council.

DIGECA: Dirección de Gestión de Calidad Ambiental of the Ministry of Environment and Energy.

EC: European Commission.

EFSA: European Food Safety Authority (European Food Safety Authority).

EPA: Environmental Protection Agency (Environmental Protection Agency United States).

FAO: Food and Agriculture Organization of the United Nations.

FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act.

IAGT: Technical grade active ingredient.

IR: Infrared spectrophotometry.

ISO: International Organization for Standardization.

IUPAC: International Union of Pure and Applied Chemistry.

LMR: Maximum Residue Limit.

MAG: Ministerio de Agricultura y Ganadería.

JMAFF: Ministry of Agriculture, Forestry and Fisheries of Japan.

MASAS: Mass spectrometry.

MINAE: Ministerio de Ambiente y Energía.

MINSA: Ministerio de Salud.

OCDE: Organisation for Economic Co-operation and Development.

OCSPP (OPPTS): Office of Chemical Safety and Pollution Prevention (Office of Prevention, Pesticides and Toxic Substances of the United States of America).

OMS: World Health Organization.

RMN: Nuclear magnetic resonance.

SANTE (SANCO): Directorate-General for Health and Food Safety of the European Union.

SEPSA: Secretaría Ejecutiva de Planificación Sectorial Agropecuaria.

SFE: Servicio Fitosanitario del Estado.

TC: Technical Material.

TK: Technical Concentrate.

UV-VIS: Ultraviolet-visible spectrophotometry.

(*)(As thus amended point 5 above by Article 1 of Executive Decree No. 43961 of March 7, 2023)

6. GENERALITIES OF REGISTRATION ADMINISTRATION 6.1. Administration of registrations.

The SFE is the competent Authority to grant the registration of TC ingredients and the registration of formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use.

(As thus amended point 6.1) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 6.2. Place of submission of requests Any act or request related to the application or interpretation of this regulation must be submitted to the registration unit of the SFE, which shall be the competent body to receive it, hear it, and process it.

6.3. Custody of the registration dossier The SFE shall take the necessary measures to safeguard the registration dossier for TC ingredients and formulated synthetic pesticides, adjuvants, related substances, and physical vehicles against any unfair commercial use and prevent such information from being disclosed or transferred, especially the information that is part of the confidential information file.

The SFE shall prevent third parties without authorization from the holder of the protected test data submitted in the registration dossier from accessing that protected information. Personnel assigned to the registration procedures may not disclose the test data, except when necessary to protect the public, the environment, and agriculture, provided that in the event of such disclosure, the test data is protected against unfair commercial use. The SFE shall protect the test data against disclosure for the term and under the conditions established in this Regulation subject to the provisions of the Law on Undisclosed Information and the Regulation to that Law.

6.4. Access to the registration application and the registration dossier. The following shall have access to the registration application and the dossier for a formulated synthetic pesticide, technical grade active ingredient, adjuvants, related substances, physical vehicles, and pesticides of mineral or inorganic origin: its holder and those authorized by the holder, as well as officials of the SFE, MS, and MINAE, provided that it does not interfere with the review of any of the parts. Likewise, third parties with a legitimate interest demonstrated before said unit. Regarding the confidential information file, there are no third parties with a legitimate interest.

(As thus amended point 6.4) above by Article 10 of Executive Decree No. 45007 of April 24, 2025) 6.5. Management of the registration dossier The institutions involved in the registration process shall prevent third parties without authorization from the holder of the protected test data incorporated in the dossier from accessing said information. Personnel assigned to the registration procedures may not disclose the test data, except when necessary to protect people and agriculture, provided that in the event of such disclosure, the test data is protected against unfair commercial use. The institutions shall protect the test data against disclosure for the term and under the conditions established in this Regulation subject to the provisions of the Law on Undisclosed Information and the Regulation to that Law.

(*) 6.6. Public access information.

6.6.1. The following information is considered public access. The SFE shall keep said information updated and available to the public through its website: www.sfe.go.cr.

6.6.1.1 List of registered active ingredients, including the name of the active ingredient and whether it has data protection, start date and expiry date of the protection.

6.6.1.2. The list of technical grade active ingredients with test data protection, indicating registration number, common name of the TC ingredient that is registered, registration modality, applicant name, start date and expiry date of the protection.

6.6.1.3. List of reference profiles approved by the SFE, indicating the name of the technical grade active ingredient, its minimum concentration, registration number, modality by which it was registered, name of the holder, and date on which it was approved as a reference profile.

6.6.1.4. Information on natural or legal persons registered with the SFE in the respective registry of natural or legal persons.

6.6.1.5. List of analytical methodologies available to the SFE, to be used for quality control enforcement and residue analysis purposes. This list must be updated and published by the SFE annually.

6.6.1.6. List of authorized components for formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use. Said list shall be updated as new components are authorized.

6.6.2 The following information is considered public access. The SFE shall keep said information available to the public upon request, when it has been established as a requirement for the registration of technical grade active ingredient, formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use. Subjects requiring the following information must do so by means of a written request, which will be registered and filed.

6.6.2.1. The label of formulated synthetic pesticides and of technical grade active ingredient in its different modalities, in case the TC ingredient is imported as such, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use, with a valid registration.

6.6.2.2. The leaflet of formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical vehicles for agricultural use, with a valid registration.

6.6.2.3. The technical reports prepared by the SFE, MINAE, and MS excluding information from the confidential file and test data.

6.6.2.4. Method of analysis for relevant impurities.

6.6.2.5. Method of analysis for the active ingredient in the formulated synthetic pesticide.

6.6.2.6. The list of public officials with access to confidential information.

6.6.2.7. The maximum limit of relevant impurities of the technical grade active ingredient.

6.6.2.8. Safety Data Sheet" 6.6.2.9. Method of analysis for the active ingredient in the chemical pesticide of mineral or inorganic origin.

(*)(As thus amended point 6.6) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 6.7. Certified Reference Material of TC Ingredient and related substances requested in the residue control monitoring program.

The SFE may require applicants for the Certified Reference Material of the substances included in the residue definition adopted by Costa Rica for the active ingredient, and of the relevant impurities, if present. The Certified Reference Material must comply with the guidelines of the international standard ISO 17034 in its current version or comply with Good Laboratory Practices (BPL), or at a minimum must supply a certificate of analysis containing the following information: result and its uncertainty, batch number, container sealing date, expiration or expiry date, analysis date, and signature of the person responsible for the laboratory that performed the analysis. The Certified Reference Material may be supplied by the manufacturer or standard institutions or companies that sell reference substances. In the event that the certified reference material is not available on the market, the delivery of analytical standards prepared by the manufacturer under the guidelines of the Good Laboratory Practices established by the OECD shall be permitted. Applicants shall provide the standard and the samples upon prior technical justification from the SFE.

7. ON THE REGIME OF PROTECTION FOR TEST DATA 7.1. Protection of test data.

The protection of test data, in accordance with the provisions of the Law on Undisclosed Information, Law No. 7975 of January 4, 2000, the Regulation to the Law on Undisclosed Information, Executive Decree No. 34927-J-COMEX-S-MAG, or the regulations that are in force and in this Regulation, shall be applicable to new agrochemical products. The protection period for test data shall be for a period of 10 years and shall apply from the registration in Costa Rica.

No protection shall be granted to a chemical entity that is found in a registration or authorization previously granted in Costa Rica, as a TC ingredient or forming part of a formulated synthetic pesticide or physical vehicle.

Registrations of new agrochemical products that are requested in the country shall have a protection period of 10 years from the moment of registration in the country.

When registration is requested by recognition (homologación) of a TC active ingredient based on evidence of prior marketing approval in another country or based on test data previously submitted to obtain marketing approval in that other country, the approval must be requested within five years of having obtained marketing approval in the country that granted the authorization. For registration applications by recognition of a TC active ingredient that are submitted more than five years after the marketing approval in another country, the term of test data protection shall not exceed the remaining protection term in that country.

(Thus amended the previous paragraph by Article 7 of Executive Decree No. 45007 of April 24, 2025)

When registration by recognition of a TC active ingredient is requested based on registration in a third country, authorization from the owner of the test data must be obtained, if such data are still protected.

(Thus amended the previous paragraph by Article 7 of Executive Decree No. 45007 of April 24, 2025)

The SFE shall prevent third parties without authorization from the data owner from using or accessing such information during the term of protection. Personnel involved in authorization procedures must refrain from disclosing test data without the applicant's authorization, except when necessary to protect the public interest, public health, and the environment, and the test data are protected against unfair commercial use.

While the protection of test data in the dossier is in effect, this information may not be used by other applicants to support their registrations, unless authorized by the applicant. Once the protection period has expired, authorization from the applicant is not required to support the registration of formulated synthetic pesticides.

7.2. Requirements for requesting test data protection.

Any applicant that has a chemical entity eligible for test data protection must request the SFE to protect such data by means of a notarized sworn statement (declaración jurada notarial) made before a Notary Public, signed by its legal representative, stating:

7.2.1. the chemical entity for which data protection is requested, indicating the common and IUPAC chemical name, CAS identification number. If the CAS identification number is not available, the company must justify this.

7.2.2. the test data supporting the chemical entity to be protected, indicating whether the applicant: i) generated the test data; ii) obtained the rights to such test data; or iii) is authorized by the data owner to use them, as applicable.

7.3. Limitations In order to ensure the protection of test data for a chemical entity, the SFE shall not permit the use of test data with current protection as evidence or supporting information for authorization by an applicant different from the registration holder, unless the latter has authorized in writing the use of such test data.

7.4. Analysis of the test data protection petition.

The FE shall verify that it is a new agrochemical product not found in a registration previously granted in Costa Rica, as a TC active ingredient or forming part of a formulated synthetic pesticide or physical vehicle, and shall include it in a list of new TC active ingredients, indicating:

7.4.1. registration number 7.4.2. registration modality, 7.4.3. common name of the TC active ingredient 7.4.4. name of the registration holder, 7.4.5. start and expiration date of the test data protection period.

7.5. Publicity and test data protection period.

The SFE shall make available to the public the list of agrochemical products with test data protection, indicating the name of the protected chemical entity, the start and expiration date of the protection.

8. GENERALITIES OF THE REGISTRATION OF FORMULATED SYNTHETIC PESTICIDES, CHEMICAL PESTICIDES OF MINERAL OR INORGANIC ORIGIN, TECHNICAL GRADE ACTIVE INGREDIENT, ADJUVANTS, PHYSICAL VEHICLES, AND RELATED SUBSTANCES, FOR AGRICULTURAL USE 8.1. Generalities 8.1.1. The SFE, MINAE, and MS must review the registration application, analyze the submitted documentation, and issue the respective binding opinions, as appropriate for the registration modality, in order to verify that the registration application meets the applicable administrative, technical, and confidential requirements for this registration modality provided in this regulation; the foregoing with the objective of verifying that the Technical Grade Active Ingredient, formulated synthetic pesticide, chemical pesticide of mineral or inorganic origin, adjuvant and related substances, and physical vehicles do not affect human health, the environment, or agriculture. All information and studies required shall be accepted for evaluation, provided they are conducted by companies, professionals, universities, national bodies, and international bodies with the corresponding studies or protocols in accordance with what this regulation indicates and that they are conducted with the product to be registered. For these purposes, the corresponding studies and/or protocols must be submitted.

For ecotoxicological and environmental fate studies, if the applicant company has more than one study for any of the indicated requirements, it may submit one or several studies provided that the study with the most critical value (the lowest concentration causing a toxic effect or the highest persistence) is included among them, which will be analyzed by the SFE and MINAE as established in numeral 17 of the decree. If more than one study is provided, the technical justification must be submitted to demonstrate that in the environmental risk assessment a value different from the most critical one supported by the additional studies may be used, which will be analyzed by MINAE at the time of analyzing the environmental risk." (Thus amended point 8.1.1) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 8.1.2. In cases where there are differences in the addresses, sponsors, manufacturers, or sample origin of the studies required in the technical dossier, the notarized sworn statement with the information indicated in Annex M must be attached. For the studies comprising the confidential dossier, these must be conducted on the product to be registered; therefore, the sample or samples used for determining these studies must be synthesized or produced by the manufacturer or formulator to be registered.

8.1.3. The documents and information contained in the technical and confidential dossier submitted to the SFE to support the registration shall be accepted in English or Spanish. In languages other than the above, a translation into Spanish must be submitted.

(Thus amended the previous point by Article 1 of Executive Decree No. 43961 of March 7, 2023)

8.1.4. The certificates or attestations supporting the application must have been issued within a period of less than two years prior to the date of their submission to the SFE.

These documents must be submitted duly legalized or apostilled when originating from abroad.

8.1.5. The applicant must designate an email address as the sole means for receiving notifications related to the registration process. The security of the designated account is the applicant's responsibility. The electronic means may be modified by the applicant at any time, without prejudice to the legal consequences arising up to that point as a result of notifications made to the previously designated permanent electronic means.

8.1.6. The studies, assays, and methods for physical and chemical, toxicological, ecotoxicological, and environmental fate analysis required in this regulation must preferably have been conducted following Good Laboratory Practices (BPL) and the established guideline, which must be stated in the documents submitted. In the event BPL were not applied, the study must have been conducted following the guidelines mentioned in the following numeral.

8.1.7. The guidelines, studies, assays, and methods for physical and chemical, and toxicological analysis required in this regulation shall be conducted following the guidelines established by OCSPP (OPPTS), CIPAC, AOAC, JMAFF, OECD, EC, ASTM, SANTE (SANCO), or other internationally recognized organizations, clearly indicating the name, number, and year of the guideline used.

(Thus amended point 8.1.7) above by Article 2 of Executive Decree No. 44213 of June 5, 2023) 8.1.8. If a guideline different from the recommended one is used, the format of the information to be submitted must contain the following sections: study title, name and number of the guideline or protocol used, date of performance, author, laboratory name and signature of the study director, sponsor name, identity of the test substance (IUPAC chemical name, common name, CAS number, purity (concentration) of the active ingredient, batch number, name of the formulator of the substance used and its origin), introduction, materials, methods, results consistent with what was observed along with consolidated results tables, discussion, and conclusions. The studies to be submitted must be accompanied by the results obtained, including a sample calculation, spectra, and chromatograms, if applicable. The requirements for toxicological and ecotoxicological studies will be specified in the respective section according to the registration modality and type of study.

8.1.9. Regarding the label and leaflet, the Central American Technical Regulation RTCA 65.05.67:18 Agricultural Inputs. Technical Grade Active Ingredient, Formulated Chemical Pesticides, Related Substances, Adjuvants, and Physical Vehicles for Agricultural Use shall apply; as well as the requirements for the preparation of labels and leaflets defined in Resolution No. 434-2020 (COMIECO-XCIII), Executive Decree No. 42932-COMEX-MEIC-MAG, published in the Official Gazette La Gaceta No. 114, Scope No. 120 of June 15, 2021, or the regulation in force. The information on the label and leaflet must match what is indicated in the dossier.

8.1.10. Each registration shall have a single registration holder and may market it with more than one trade name or brand.

8.1.11. TC active ingredients found on the "List of Molecules not authorized for registration under the recognition modality" (Lista de Moléculas no autorizadas para registrarse por la modalidad de homologación), which MINAE, MS, and SFE will keep published and updated every 12 months from the entry into force of this regulation, shall not be registered in the country under the recognition modality. Likewise, TC active ingredients not found on the "List of molecules authorized for registration under the TC active ingredient modality with reference information from an internationally recognized authority" shall not be registered under the modality with reference information.

(Thus added point 8.1.11) above by Article 2 of Executive Decree No. 45007 of April 24, 2025) 8.2. Generalities for the Registration of formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, or physical vehicles:

(Thus amended point 8.2) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 8.2.1. Agricultural producers registered with the MAG or formally constituted agricultural producer organizations may also directly import products with a current registration in Costa Rica for their own use or that of their members.

8.2.2. The applicant must demonstrate that the requested use pattern of the formulated synthetic pesticide and chemical pesticide of mineral or inorganic origin complies with the Maximum Residue Limit (Límite Máximo de Residuos, LMR) authorized in the country. This demonstration may be made by providing technical justifications or references for residues in other products having the same active ingredient, the same crop, or an extrapolatable crop in accordance with one of the following bodies: CODEX, EPA, or EFSA, and have been evaluated in a region with similar agroecological conditions and Good Agricultural Practices (Buena Práctica Agrícola, BPA) to those to be registered or modified, which will be assessed by the MS on a case-by-case basis. In situations where the applicant cannot provide the above, the corresponding tests must be provided, such as residue studies or decline curves for the product to be registered or modified, as appropriate, in order to determine that the LMR will be met according to the proposed use. In cases where a decrease in the LMR occurs, the applicant shall have 6 months to request the change in the use pattern when applicable.

(Thus amended point 8.2.2) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 8.2.3. In the case of efficacy and phytotoxicity assays submitted to the SFE, these must have been developed in accordance with the standard protocol for biological efficacy assays for agricultural use pesticides, according to the current regulations.

8.2.4. Efficacy assays conducted abroad will be accepted if they were developed under agroecological conditions similar to those required by the crop and the pest manifestation in Costa Rica, and must comply with all the requirements stipulated in the current regulations. The assays, protocols used, and their results must be assessed by the SFE Inspection Unit prior to their acceptance. Such studies must include proof of efficacy and the final report or document with the results that gave rise to the registration approval in the country. They must have the approval of the researcher or institution that conducted them and must also be duly legalized or apostilled.

The applicant must also submit a justification comparing the conditions under which the assay was conducted and the conditions in Costa Rica for the crop under study.

8.2.5. When the registration holder has submitted efficacy assays for a specific commercial product to the SFE, they may, for its analysis, submit a request for validation of such assays for other crops of the same botanical family and for the same pest or phytopathological complex, attaching the information and documents supporting the request.

8.2.6. In the case of uses already approved by the SFE for the same pest, efficacy assays will not be necessary to add new crops when the use pattern and ecophysiological aspects of the crop do not interfere with efficacy, which will be assessed by the SFE, according to the crop grouping published on the SFE website at the time of publishing this regulation and according to the following indications:

8.2.6.1. That the pest to be controlled is the same (genus and species) and that the damage caused in the minor crop(s) to be extended is identical and affects the same part of the reference crop (root system, reproductive part, and vegetative part) for the product already registered or in the registration process, consistent with the efficacy test of the reference crop. The foregoing must be demonstrated through scientific publications or other documentation or information, which will be assessed by the SFE.

8.2.6.2. Use extension may be made from a minor crop that has the respective efficacy test to another minor crop within the same group, even if a reference crop exists. The SFE will only accept applications for use extension for minor crops according to the crop grouping.

8.2.6.3. The crop grouping will be subject to updates or modifications according to the country's conditions, upon analysis by the SFE. Such updates or modifications will be kept published on the SFE website.

8.2.7. For the registration of adjuvants and related substances established in numeral 10.8.2, in the event that the co-formulants as well as the main components of the product to be registered are not found on the "List of components authorized for formulated synthetic pesticides, adjuvants, and related substances" (Lista de componentes autorizados para plaguicidas sintéticos formulados, coadyuvantes y sustancias afines) for health-only or environment-only reasons, the non-submission of toxicological or ecotoxicological and environmental fate studies may be technically and scientifically justified. This shall be assessed by MINSA or MINAE, as applicable.

(Thus added subsection 8.2.7) above by Article 1 of Executive Decree No. 44213 of June 5, 2023) 9. REGISTRATION MODALITIES The following registration modalities are established, which shall have a validity of ten years from their registration.

9.1. For the registration of Technical Grade Active Ingredient, there are six modalities:

(Thus amended point 9.1) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 9.1.1. Recognition (Homologación) of registrations or authorizations of TC active ingredients based on full data from OECD member countries and countries adhering to the Mutual Acceptance of Data System of that organization.

9.1.2. Registration of Technical Grade Active Ingredient through full data evaluation.

9.1.3. Registration of TC active ingredient by equivalence.

9.1.4. Registration of TC active ingredient by Recognition of a TC active ingredient by equivalence registered or authorized in OECD member countries and Adherents.

9.1.5. Registration of TC active ingredient with reference information from an Internationally Recognized Authority.

(Thus added the previous subsection by Article 2 of Executive Decree No. 45007 of April 24, 2025)

9.1.6. Registration of active ingredient of mineral or inorganic origin.

(Thus added the previous subsection by Article 2 of Executive Decree No. 45007 of April 24, 2025)

9.2. For the registration of formulated synthetic pesticides, there are four modalities:

(Thus amended point 9.2) above by Article 6 of Executive Decree No. 45007 of April 24, 2025) 9.2.1. Registration of formulated synthetic pesticides through recognition of registrations or authorizations approved by the regulatory authorities of OECD member countries and countries adhering to the Mutual Acceptance of Data System of that organization.

9.2.2. Registration of formulated synthetic pesticides through recognition of the evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to the Mutual Acceptance of Data System of that organization.

9.2.3. Registration of formulated synthetic pesticides with full evaluation.

9.2.4. Registration of chemical pesticides of mineral or inorganic origin.

(Thus added the previous subsection by Article 2 of Executive Decree No. 45007 of April 24, 2025)

9.3. For adjuvants and related substances, there are two registration modalities:

9.3.1. Minimum risk adjuvants and related substances.

9.3.2. Adjuvants and related substances with evaluation by MINSA and MINAE.

9.4. Registration of physical vehicles with incorporated TC active ingredient or related substance.

10. SPECIFIC ASPECTS OF EACH REGISTRATION MODALITY.

10.1. Recognition of registrations or authorizations of TC active ingredients based on full data from OECD member countries and countries adhering to the Mutual Acceptance of Data System of that organization.

The SFE shall register the use of TC active ingredients that are authorized by any OECD member country and countries adhering to the Mutual Acceptance of Data System of that organization (with the exception of molecules indicated in the "List of Molecules not authorized for registration under the recognition modality"), provided that the TC active ingredient has the same concentration, same qualitative-quantitative composition, originates from the same source, and the same manufacturer that was authorized or registered in the OECD member country or adherent to the Mutual Acceptance of Data System of that organization, as applicable.

(Thus amended the previous paragraph by Article 8 of Executive Decree No. 45007 of April 24, 2025)

10.1.1. Requirements for registering the TC active ingredient based on full data through the recognition of registrations or authorizations approved by the regulatory authorities of OECD member countries or countries adhering to the Mutual Acceptance of Data System of that organization.

The TC active ingredient must come from the same company or data holder and have the same minimum concentration as the TC active ingredient approved or registered by the Regulatory Authority.

The interested party in applying for the registration of a TC active ingredient through recognition must submit their application to the unit that administers registration at the SFE, using the form visible in Annex A of this regulation, and comply with the following requirements:

10.1.1.1. Duly complete and submit the TC active ingredient registration application form found in Annex A of this regulation, in each of its sections.

10.1.1.2. Submit the studies, documents, or certificates corresponding to the administrative information dossier, technical dossier, and confidential information dossier indicated in Annex B of this regulation. Such studies and information must be provided by means of data from assays or studies conducted on the product to be registered and must be those that supported and gave rise to the registration or authorization by the Regulatory Authority of the OECD country or adherent to the Mutual Acceptance of Data System of that organization, in accordance with its regulations, which allows the dossier supporting the recognition to be formed and that can be assessed by the SFE, MINSA, and MINAE subsequent to the granting of registration.

If issued in a language other than Spanish or English, a translation into Spanish must be submitted.

(Thus amended point 10.1.1.2) above by Article 2 of Executive Decree No. 44213 of June 5, 2023) 10.1.1.3. Provide the Evaluation Report(s) issued by the Regulatory Authority, which must contain the evaluations of the studies used for the TC active ingredient registered by the Regulatory Authority and the requirements listed in the technical information dossier of Annex B of this regulation. If the Evaluation Report does not contemplate some of the requirements requested in Annex B, the presentation of the Evaluation Report from other Regulatory Authorities may be permitted, stating the results of the studies used for the registered TC active ingredient, provided they correspond to the same origin, concentration, and manufacturer.

In addition, if the Regulatory Authority does not issue an Evaluation Report as specified above such that all the studies, documents, or certificates corresponding to what is indicated in Annex B of this regulation are contemplated, it will be accepted to accompany said Evaluation Report with a report of results signed by the applicant's legal representative in the OECD member country or country adhering to the MAD system that they wish to recognize; the foregoing must come legalized in Costa Rica and be endorsed by the applicant's legal representative in Costa Rica by means of a notarized sworn statement in which it must be attested that what is stated in said report is truthful and fully supported by the technical studies submitted. This must be done under notarized sworn statement. Likewise, this report must detail the results and bibliographic references of all the test reports and studies submitted to the Regulatory Authority, which must contain at least the information established in the Technical and Confidential Dossier of Annex B.

If the Evaluation Report or the report of results was issued in a language other than Spanish or English, an official translation into Spanish must be submitted.

10.1.1.4. Be up to date with all employer-employee obligations with the Costa Rican Social Security Fund (Caja Costarricense de Seguro Social) and the Family Allowances and Development Fund (Fondo de Desarrollo y Asignaciones Familiares, FODESAF), a situation that will be verified by the SFE through consultation in the corresponding virtual office.

10.1.1.5. Submit proof of payment of the current fee.

10.1.1.6. Submit the notarized sworn statement indicated in Annex M of this regulation.

10.2. Registration of Technical Grade Active Ingredient through full data evaluation 10.2.1. Generalities 10.2.1.1. The SFE must review the substantive aspects of the registration application, analyze the submitted documentation, and issue the respective binding opinions, in order to verify that the registration application meets the applicable administrative, technical, and confidential requirements for this registration modality provided in this regulation; the foregoing with the objective of verifying that the Technical Grade Active Ingredient does not affect human health, the environment, or agriculture.

10.2.2. Requirements for authorization of Active Ingredient through full data evaluation.

10.2.2.1. To process the registration application under this modality, the applicant must complete and submit physically the application form in Annex A; likewise, they must comply with the submission of all the requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, found in Annex B of this regulation.

10.2.2.2. The documents and information contained in the technical and confidential dossier submitted to the SFE to support the registration shall be accepted in English or Spanish. In languages other than the above, a translation into Spanish must be submitted.

(Thus amended the previous point by Article 1 of Executive Decree No. 43961 of March 7, 2023)

10.2.2.3. The certificates or attestations supporting the application must have been issued within a period of less than two years prior to the date of their submission to the SFE. These documents must be submitted duly legalized when originating from abroad.

10.2.2.4. The applicant must designate an email address as the sole means for receiving notifications related to the TC active ingredient registration process through full data. The security of the designated account is the applicant's responsibility. The electronic means may be modified by the applicant at any time, without prejudice to the legal consequences arising up to that point as a result of notifications made to the previously designated permanent electronic means.

10.2.2.5. (Repealed by Article 19 of Executive Decree No. 45007 of April 24, 2025) 10.2.2.6. (Repealed by Article 19 of Executive Decree No. 45007 of April 24, 2025) 10.2.2.7. (Repealed by Article 19 of Executive Decree No. 45007 of April 24, 2025) 10.2.3. Analytical methodologies for authorization of TC active ingredient through full data evaluation.

The analytical methodologies for determining physical-chemical quality, determining the purity of the TC active ingredient or main component, and determining impurities equal to or greater than 1 g/kg and relevant impurities associated with the TC active ingredient, must be submitted to the SFE as indicated in Annex B.

Such methods must be validated in compliance with the established guideline mentioned in the document, indicating the results obtained; in addition, chromatograms must be submitted. Methods validated by CIPAC or other international bodies do not require analytical validation, unless they undergo alterations or modifications.

(Thus amended point 10.2.3) above by Article 1 of Executive Decree No. 43961 of March 7, 2023) 10.3. Registration modality of TC active ingredient by equivalence.

Equivalence shall be evaluated under the following terms:

10.3.1. Reference profile or source The reference profile or source must be a TC active ingredient registered with full data. There may be two or more reference profiles that meet the aforementioned conditions. The registrant must clearly indicate in the registration application (Annex A) the registration number of the reference profile with which comparison is desired.

The reference profile will be maintained, even if the registration is subsequently cancelled at the holder's request or the validity period expires without renewal. In these cases, the SFE will be responsible, guaranteeing the registrant that the information will not be used unfairly, and releasing it from liability regarding the use of the information deposited with the SFE. The SFE will publish the available reference profiles on its website so that the registrant can decide which reference profile to adopt. Only those reference profiles found on the website will be accepted to initiate the equivalence process.

(Thus amended the previous point by Article 1 of Executive Decree No. 45674 of March 23, 2026)

10.3.2. Determination of equivalence Registration of a TGAI by equivalence will be granted to any TGAI that demonstrates the similarity of the impurity profiles under the parameters of the application, which are presented for equivalent technical materials, to establish whether they present similar levels of risk.

The determination of equivalence involves a comparative evaluation of impurity profiles, either of the TGAIs (TC/TK), or by comparing the acute toxicological and ecotoxicological profiles.

10.3.2.1. Cases in which the equivalence evaluation must be performed.

This registration modality applies in the following cases:

10.3.2.1.1. When a registrant requests to register by equivalence a technical grade active ingredient against the reference profile previously registered as a TGAI by complete data under Executive Decrees No. 33495-MAG-S-MINAE-MEIC, No. 40059-MAG-MINAE-S, No. 42769-MAG-MINAE-S and its amendment, No. 43469-MAG-MINAE-S, or under this decree.

10.3.2.1.2. When the manufacturer makes a change in the synthesis process of a previously registered technical grade active ingredient, under the complete data or recognition modality. Changes in the production site, maintaining the same synthesis route and supervision by the holder, do not require an equivalence evaluation.

The foregoing provided that the protection period granted in Costa Rica for the test data of the technical grade active ingredient that the SFE uses as evidence or supporting information for registration has expired; or the registrant is the holder of the registration of the technical grade active ingredient that has test data protection; or the holder of said registration has authorized the use of such test data.

10.3.2.2. Application for registration by equivalence The registrant must submit the registration application in accordance with the requirements of Annex A.

10.3.2.2.1 General, administrative, technical, and confidential requirements The analytical methodologies for determining the purity of the TGAI or main component, determining impurities greater than or equal to 1 g/kg, and relevant impurities associated with the TGAI, must be submitted to the SFE along with the registration application. Such methods must be validated in compliance with the established guide mentioned in the document, indicating the results obtained; in addition, the chromatograms must be submitted. Methods validated by CIPAC or other international organizations do not require analytical validation, unless they undergo alterations or modifications.

To process the registration application under this modality, the registrant must complete and submit the form in Annex A of this regulation. Likewise, they must comply with the general requirements, as well as the initial submission of the requirements defined in the administrative information dossier, the chemical requirements of the technical information dossier, and the confidential information dossier, which are found in Annex C of this regulation. If chemical equivalence is not met, they may submit the toxicological and ecotoxicological requirements of the technical information dossier in Annex C within a period of 90 business days.

The registrant must review the list of existing reference profiles issued by the SFE and published on the website: www.sfe.go.cr.

(Thus amended the previous point 10.3.2.2.1) by Article 1 of Executive Decree No. 43961 of March 7, 2023) 10.3.2.2.2. Parameters applicable for determining equivalence based on purity/impurity profiles The evaluation will be carried out with the requirements requested for this modality in Annex C. Within the technical analysis, the new source is considered equivalent to the reference source if it meets the following list of requirements:

a. The certified minimum purity of the active ingredient is not less than that of the reference source (taking into account the isomer ratio, when appropriate).

b. No new impurities are present.

c. The limits of relevant impurities, as certified by the reference source, have not been increased.

d. The certified limits for all non-relevant impurities, as certified in the reference source, must not be exceeded beyond the following levels:

Concentration of the non-relevant impurity in the reference source	Maximum permitted level for the new source
Up to 10 g/kg	+ 50 % of the limit
>10 g/kg up to 100 g/kg	+ 20 % of the limit
>100 g/kg	+ 10 g/kg of the limit

10.3.2.2.3 Decision-making Based on the criteria mentioned above, the analysis may lead to the following conclusions:

a. The evaluated profile is equivalent to the reference profile; therefore, a positive opinion is issued by the SFE.

b. The evaluated profile is not equivalent because the minimum concentration of the TGAI is lower than the TGAI concentration of the reference profile; therefore, a negative opinion is issued by the SFE and the procedure is archived.

c. The evaluated profile is not equivalent because it presents new relevant impurities or in a higher concentration compared to the reference profile; therefore, a negative opinion is issued by the SFE and the procedure is archived.

d. The evaluated profile is not equivalent to the reference profile based solely on the chemical evaluation; therefore, the toxicological and ecotoxicological part will be evaluated to technically analyze whether the alteration of the impurity profile leads to an unacceptable increase in risk, making the new source not equivalent to the reference source. In cases where the opinion is negative, the applicant may make improvements to its synthesis process, on a commercial scale, in order to reduce or eliminate the impurities present in its molecule that prevent achieving chemical equivalence. Once the improvements to its process have been made, they resubmit the new improved process to the SFE, as well as the new evidentiary elements, so that the chemical evaluation can be carried out again. In this case, the case will be processed as a new registration application, and the interested party must carry out all administrative procedures contemplated in this regulation for this registration modality.

10.3.2.2.4. Parameters applicable for determining toxicological and ecotoxicological equivalence.

a. Equivalence of the toxicological profiles of a technical grade active ingredient The toxicological profile will be considered equivalent to the reference profile when the toxicological information provided for the new source (Toxicological Requirements for evaluation, Annex C) does not differ by more than a factor of 2 compared to the reference profile, or by a factor greater than the appropriate dose increments in the reference profile studies (if greater than 2). There must be no changes in the evaluation of studies that produce categorical results (e.g., dermal irritation, eye irritation, or sensitization).

b. Equivalence of the ecotoxicological profiles of a technical grade active ingredient b.1 The analysis must be based on any available ecotoxicological information, applying what is indicated in the document: "Procedure for determining the ecotoxicological equivalence of technical grade active ingredients (TGAI)" which is published on the SFE website. The new source is considered equivalent to the reference source if for each of the terrestrial organisms (birds and bees) and aquatic organisms (fish, daphnia, and algae) one of the following results was obtained:

b.1.1 The ecotoxicological data of the new source obtained from its own studies do not differ by more than a factor of 5 compared to the reference profile (or by a factor greater than the appropriate dose increments, if greater than 5), when determined with the same species.

b.1.2 The increase in toxicity of the new source based on the information of the impurities present is less than a factor of 2 compared to the reference profile.

b.2 If for one or more organisms results were obtained indicating that there is no equivalence, the new source TGAI will not be considered equivalent to the reference profile TGAI.

10.4. Registration of TGAI by Recognition of TGAI by equivalence registered or authorized in OECD member countries and Adherents.

10.4.1. Generalities TGAIs by equivalence authorized or registered in an OECD member country or adherents to the Mutual Acceptance of Data System of that organization may be registered. The foregoing, provided that the TGAI has the same concentration, same qualitative and quantitative composition, comes from the same origin and manufacturer that was authorized or registered in the OECD member country and countries adherent to the Mutual Acceptance of Data System of that organization, as applicable. Furthermore, for the application to be admitted, the TGAI that was used as the reference profile in the OECD member country and countries adherent to the Mutual Acceptance of Data System of that organization must be registered as a TGAI by complete data under Executive Decrees No. 33495-MAG-S-MINAE-MEIC, No. 40059-MAG-MINAE-S, No. 42769-MAG-MINAE-S and its amendment, No. 43469-MAG-MINAE-S, or under this decree in Costa Rica.

The information submitted by the applicant must be that which supported or gave rise to the authorization or registration in the OECD member country, and contain the confidential information indicated in Annex C of this decree.

10.4.2. Requirements for registration of TGAI by Recognition of TGAI by equivalence registered or authorized in OECD member countries and countries adherent to the Mutual Acceptance of Data System of that organization.

The TGAI must come from the same company or data holder and have the same minimum concentration as the TGAI approved by the Regulatory Authority.

The party interested in applying for TGAI registration via recognition must submit their application to the unit that administers the registration of authorizations in the SFE, using the form visible in Annex A of this regulation and comply with the following requirements:

10.4.2.1 Submit the studies, documents, or certificates corresponding to the administrative information dossier and the confidential information dossier indicated in Annex C of this regulation. The information in the confidential dossier must be provided through studies carried out on the product to be registered and must be those that supported and gave rise to the registration or authorization by the Regulatory Authority of the OECD country or adherent to the Mutual Acceptance of Data System of that organization, in accordance with its regulations, which allows for the creation of the file supporting the recognition and which may be evaluated by the SFE, MINSA, and MINAE after the granting of the registration.

In case it was issued in a language other than Spanish or English, a translation into Spanish must be submitted.

(Thus amended the previous point 10.4.2.1) by Article 2 of Executive Decree No. 44213 of June 5, 2023) 10.4.2.2. Link or database where the approval of the TGAI authorized by equivalence can be consulted; if the link is not available, the document certifying the approval by the regulatory authority in the OECD country or adherents, duly legalized or apostilled, must be provided.

10.4.2.3. Be up to date with all their employer-employee obligations with the Costa Rican Social Security Fund (Caja Costarricense de Seguro Social) and the Family Development and Allowances Fund (Fondo de Desarrollo y Asignaciones Familiares, FODESAF), a situation that will be verified by the SFE.

10.4.2.4. Submit the notarized sworn statement indicated in Annex M of this regulation.

10.4.2.5. Indicate the registration number of the TGAI granted in Costa Rica, which must correspond to the profile used in the country of origin of the OECD member country or adherent to the Mutual Acceptance of Data System of that organization.

10.5. Registration of formulated synthetic pesticides through the recognition of registrations or authorizations approved by the regulatory authorities of OECD member countries and countries adherent to the Mutual Acceptance of Data System of that organization.

10.5.1. This modality applies to formulated synthetic pesticides that are registered or authorized in an OECD member country and countries adherent to the Mutual Acceptance of Data System of that organization that meet the following conditions:

10.5.1.1. The formulated synthetic pesticide must come from the same company or data holder and have the same concentration, origin, and type of formulation as the one approved or registered by the Regulatory Authority. It may contain more than one technical grade active ingredient, which must be registered with the SFE.

10.5.1.2. The use pattern approved by the Regulatory Authority corresponds to the same use pattern intended to be registered in Costa Rica.

10.5.1.3. That at least one of the requested crop(s) is (are) planted in Costa Rica.

10.5.1.4. The agroecological conditions of the crop in the country where the product is registered or authorized must be similar to those of Costa Rica.

10.5.1.5. The annual chemical load of the product to be registered in Costa Rica must be equal to or less than that registered in the OECD country and countries adherent to the Mutual Acceptance of Data System of that organization.

10.5.1.6. The Regulatory Authority issues an ERA report (covering non-target organisms: fish, aquatic invertebrates, algae, birds, bees, and earthworms) for the use pattern to be registered.

10.5.1.7. The Regulatory Authority issues a human health risk assessment report.

10.5.2. Must submit the following requirements in printed form. They may be submitted digitally once the SFE implements the computer or digital system enabled for such purposes:

10.5.2.1. Submit the duly completed application form for the registration of a formulated synthetic pesticide found in Annex D of this regulation, in each of its sections.

10.5.2.2. Be up to date with all their employer-employee obligations with the Costa Rican Social Security Fund (Caja Costarricense de Seguro Social) and the Family Development and Allowances Fund (Fondo de Desarrollo y Asignaciones Familiares, FODESAF), a situation that will be verified by the SFE through consultation in the corresponding virtual office.

10.5.2.3. Submit the notarized sworn statement indicated in Annex M of this regulation.

10.5.2.4. Link or database where it can be verified that the formulated synthetic pesticide is current in the OECD country or adherents; if the link is not available, a document issued by the competent authority of the OECD country certifying that it is current must be provided, and said document must be duly legalized or apostilled.

10.5.2.5. Proof of payment of the current fee.

10.5.2.6 Submit the studies, documents, or certificates corresponding to the administrative information dossier, technical dossier, and confidential information dossier indicated in Annex E of this regulation. Such studies and information must be provided through data from trials or studies carried out on the product to be registered and must be those that supported and gave rise to the registration or authorization by the Regulatory Authority of the OECD country or adherent to the Mutual Acceptance of Data System of that organization, in accordance with its regulations, which allows for the creation of the file supporting the recognition and which may be evaluated by the SFE, MINSA, and MINAE after the granting of the registration.

In case it was issued in a language other than Spanish or English, a translation into Spanish must be submitted.

(Thus amended the previous point 10.5.2.6) by Article 2 of Executive Decree No. 44213 of June 5, 2023) 10.5.2.7. Label and leaflet approved by the regulatory authority of the OECD country and countries adherent to the Mutual Acceptance of Data System of that organization, whose content must match that indicated on the label and leaflet proposed for Costa Rica.

10.5.2.8. The report issued by the Regulatory Authority containing the environmental risk assessment that addresses the non-target organisms: fish, aquatic invertebrates, algae, birds, bees, and earthworms for the use pattern to be registered.

10.5.2.9. The report issued by the Regulatory Authority containing the human health risk assessment.

10.5.2.10. The origin, concentration, and manufacturer of the TGAI used to formulate the formulated synthetic pesticide in the country of origin must be indicated.

Said active ingredient must be registered in Costa Rica as indicated in this regulation.

10.6. Registration of formulated synthetic pesticides by recognition of the evaluation of studies used by the regulatory authorities of OECD member countries and countries adherent to the Mutual Acceptance of Data System of that organization.

10.6.1. Administrative, technical, and confidential requirements To process the registration application under this modality, the applicant must complete and submit the application form in Annex D; likewise, they must comply with the submission of all requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex E of this regulation.

All documents must be submitted in physical form, and once the SFE implements the computer or digital system for such purposes, they may be submitted digitally. The formulated synthetic pesticide must come from the same company or data holder and have the same concentration, origin, and type of formulation as the one authorized by the Regulatory Authority. It may contain more than one technical grade active ingredient, which must be registered by the SFE. It must meet the following requirements:

(Thus amended the previous point 10.6.1) by Article 1 of Executive Decree No. 43961 of March 7, 2023) 10.6.1.1. Submit the duly completed application form for the registration of the formulated synthetic pesticide found in Annex D of this regulation, in each of its sections.

10.6.1.2. Submit the studies, documents, or certificates corresponding to the administrative information dossier, technical dossier, and confidential information dossier indicated in Annex E of this regulation. Such studies and information must be provided through data from trials or studies carried out on the product to be registered and must be the same ones that were used for registration or authorization by the Regulatory Authority.

In case it was issued in a language other than Spanish or English, a translation into Spanish must be submitted.

10.6.1.3. Provide the Evaluation Report(s) issued by the Regulatory Authority, which must contain the evaluations of the studies used for the formulated synthetic pesticide registered by the Regulatory Authority and the requirements listed in the technical information dossier of Annex E of this regulation. If the Evaluation Report does not cover some of the requirements requested in Annex E, the submission of the Evaluation Report from other Regulatory Authorities containing the results of the studies used for the registered formulated synthetic pesticide may be allowed, provided they correspond to the same origin, concentration, formulator, and type of formulation.

Furthermore, if the Regulatory Authority does not issue an Evaluation Report as specified above in a way that covers all the studies, documents, or certificates corresponding to what is indicated in Annex E of this regulation, it will be acceptable to present a results report signed by the legal representative of the applicant in the OECD member country or country adherent to the MAD system they wish to recognize. The foregoing must be legalized in Costa Rica and endorsed by the legal representative of the applicant in Costa Rica through a notarized sworn statement in which they must attest that what is stated in said report is truthful and fully supported by the technical studies submitted and must be the same ones that were used for registration or authorization by the Regulatory Authority. The foregoing must be carried out in accordance with the corresponding template of the sworn statement established in Annex M of this regulation.

10.6.1.4. Be up to date with all their employer-employee obligations with the Costa Rican Social Security Fund (Caja Costarricense de Seguro Social) and the Family Development and Allowances Fund (Fondo de Desarrollo y Asignaciones Familiares, FODESAF), a situation that will be verified by the SFE through consultation in the corresponding virtual office.

10.6.1.5. Submit the notarized sworn statement indicated in Annex M of this regulation.

10.6.1.6. The origin, minimum concentration, and manufacturer of the TGAI used to formulate the formulated synthetic pesticide in the country of origin must be indicated. Said TGAI must be registered in Costa Rica as indicated in this regulation.

Registration will not be granted to a formulated synthetic pesticide when any protection period for the test data of the technical grade active ingredient(s) used to formulate the formulated synthetic pesticide has not expired, unless the holder of the registration(s) of said technical grade active ingredient(s) has authorized the use of said TGAI.

10.7. Registration of formulated synthetic pesticides with full evaluation.

10.7.1. General, administrative, technical, and confidential requirements To process the registration application under this modality, the applicant must complete and submit the form in Annex D; likewise, they must comply with what is indicated in the general requirements, in addition to the submission of all requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex E of this regulation.

The documents and information contained in the technical and confidential dossiers submitted to the SFE to support the registration will be accepted in English or Spanish. For languages other than the above, a translation into Spanish must be submitted.

All documents must be submitted in physical form, and once the SFE implements the computer or digital system for such purposes, they may be submitted digitally.

For the purposes of this regulation, a formulated synthetic pesticide may contain more than one active ingredient, which must be registered by the SFE.

(Thus amended the previous point 10.7.1) by Article 1 of Executive Decree No. 43961 of March 7, 2023) 10.8. Registration of adjuvants and related substances The registration of adjuvants and related substances has the following modalities:

a)Adjuvants and related substances of minimum risk b) Adjuvants and related substances with evaluation by MINSA and MINAE.

10.8.1. Adjuvants and related substances of minimum risk This modality applies to adjuvants and related substances whose main components and co-formulants in their entirety are found in the "List of authorized components for formulated synthetic pesticides, adjuvants, and related substances," visible on the SFE website www.sfe.go.cr. Said list will be updated and validated by MINSA and MINAE and must be consulted by the applicant prior to submitting the application. The application will not be admitted if it does not comply with the above.

10.8.1.1. Administrative, technical, and confidential requirements To process the registration application under this modality, the applicant must complete and submit the form in Annex F; likewise, they must comply with the submission of all requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex G of this regulation.

All documents must be submitted in physical form, and once the SFE implements the computer or digital system for such purposes, they may be submitted digitally.

10.8.2. Adjuvants and related substances evaluation by MINSA and MINAE.

This modality applies to adjuvants and related substances whose main components and co-formulants are not considered minimum risk as established in the "List of authorized components for formulated synthetic pesticides, adjuvants, and related substances" visible on the SFE website www.sfe.go.cr.

10.8.2.1. Administrative, technical, and confidential requirements To process the registration application under this modality, the applicant must complete and submit the form in Annex F; likewise, they must comply with the submission of all requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex H of this regulation.

All documents must be submitted in physical form, and once the SFE implements the computer or digital system for such purposes, they may be submitted digitally.

10.9. Registration of physical carriers with incorporated TGAI or related substance.

10.9.1. General, administrative, technical, and confidential requirements To process the registration application under this modality, the applicant must complete and submit the form in Annex I; likewise, they must comply with what is indicated in the general requirements, in addition to the submission of all requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex J of this regulation.

The documents and information contained in the technical and confidential dossiers submitted to the SFE to support a registration or authorization will be accepted in English or Spanish. For languages other than the above, a translation into Spanish must be submitted.

All documents must be submitted in physical form, and once the SFE implements the computer or digital system for such purposes, they may be submitted digitally.

(Thus amended the previous point 10.9.1) by Article 1 of Executive Decree No. 43961 of March 7, 2023) (*) 10.10. Registration of TGAI with reference information from an internationally recognized authority.

10.10.1. This modality only applies to TGAIs (TC or TK) that do not have a reference profile or source in Costa Rica or whose profile approved by the SFE differs in the form of manufacture (TC or TK), which contains a chemical entity found in a registration previously granted in Costa Rica and that does not have current test data protection, as a TGAI (TC or TK) or forming part of a formulated synthetic pesticide or physical carrier, and is found in the "List of molecules authorized to be registered under the TGAI modality with reference information from an internationally recognized authority," and published by the SFE. The registrant may opt for this registration modality for 4 years from the entry into force of this amendment.

Products whose registrations are granted under this modality will be monitored twice a year for quality aspects by the SFE. Furthermore, said registration will be valid for 10 years, and for its renewal, the requirements indicated in numeral 14 must be submitted.

To process a registration application under this modality, the applicant must complete and submit the application form in Annex A; likewise, they must comply with the submission of all the requirements defined in Annex P of this regulation.

(Thus amended point 10.10.1 above by article 1 of executive decree No. 45811 of May 20, 2026)

10.10.2. The reference information to be used shall be that from specifications, reports, or assessments of EFSA, EPA, FAO, APVMA, Canada, or New Zealand, in which the minimum content of the TGAI and the maximum content of significant impurities (where they exist) are indicated. Additionally, this report, assessment, or specification must be the most current.

Preferably, the specification, report, or assessment from one of the indicated authorities (EFSA, EPA, FAO, APVMA, Canada, or New Zealand) should be submitted, but if any of the data requested for this modality is not available in the reference information, the registrant may use another specification, report, or assessment from the aforementioned Authorities.

The registrant may use one or more sources from the indicated authorities, even when these present differences in the significant impurity profile or in their maximum values, provided that the minimum TGAI content of the application is equal to or greater. For cases where significant impurities are different or have different concentrations, the most critical value shall be adopted, and the 5-batch study must include the analysis of all significant impurities indicated in the evaluation reports. In the event that it is not included in the 5-batch study, another study may be presented.

(Thus amended point 10.10.2 above by article 1 of executive decree No. 45811 of May 20, 2026)

10.10.3. The toxicological, ecotoxicological, and environmental fate information of the TGAI shall be that from the information sources indicated in the previous point, provided that the minimum TGAI content of the application is equal to or greater, the significant impurity content is equal to or less, there are no new significant impurities, and compliance with the provisions of numeral 10.10.4 is met; these sources must provide all the data required to complete the tables in Annex Q. Such data must coincide with the most critical value reported in the reference information and will be used for the evaluation of the formulated synthetic pesticide. This information will be verified by the ecotoxicological and toxicological areas of the SFE during the TGAI registration process. Only in exceptional cases and with due technical justification, the SFE will accept for review proprietary studies from the registrant company when the reference information used does not contemplate any of the requirements indicated in Annex B, and it will issue the respective report indicating the data considered approved for this TGAI. Likewise, for the data required in Annex Q, the justifications issued in the specifications, reports, or assessments of EFSA, EPA, FAO, APVMA, Canada, or New Zealand will be accepted.

(Thus amended point 10.10.3 above by article 1 of executive decree No. 45811 of May 20, 2026)

10.10.4. Applicable parameters for the evaluation of the reference information from an Internationally Recognized Authority. The evaluation shall be carried out with the requirements requested for this modality in Annex P.

10.10.4.1. Within the technical analysis, it is considered that the TGAI to be registered may use the same technical information as the reference TGAI if it meets the following:

10.10.4.1.1 It was demonstrated through information presented by the registrant that the certified limits of all impurities greater than 1 g/kg (other than those already considered significant) contained in their product are toxicologically and ecotoxicologically non-significant, in accordance with the provisions of Annex P.

(Thus amended point 10.10.4.1.1 above by article 1 of executive decree No. 45811 of May 20, 2026)

10.10.4.1.2 No new significant impurities are found, or impurities in a higher concentration, when compared to the reference information.

10.10.4.1.3 The certified minimum purity of the active ingredient is not less than the reference information (taking into account the isomer ratio, when appropriate).

10.10.5 During the registration process and subsequent to it, in the event that the SFE becomes aware that an impurity that could affect health or the environment has not been reported, it must request additional information or corresponding clarifications from the registrant.

10.10.6 The registrant must clearly indicate in the registration application (Annex A) the reference(s) used and shall provide the link or links through which the SFE can verify the information.

10.10.7 The reference information must contain the data on the physicochemical properties of the active ingredient requested in Annex B. When the data of a physicochemical property of the active ingredient to be registered, as indicated in the safety data sheet, does not match the data of the same physicochemical property of the active ingredient from the reference specification, report, or assessment, the studies of the physicochemical properties indicated in Annex B where that discrepancy exists must be submitted.

(*) (Thus added point 10.10 above by article 2 of executive decree No. 45007 of April 24, 2025)

(*) 10.11. Registration of active ingredient of mineral or inorganic origin.

10.11.1. To process the registration application under this modality, the applicant must complete and submit the application form in Annex A; likewise, they must comply with the submission of all the requirements defined in the administrative information dossier and the confidential information dossier, which are found in Annex N of this regulation.

(*) (Thus added point 10.11 above by article 2 of executive decree No. 45007 of April 24, 2025)

(*) 10.12 Registration of chemical pesticide of mineral or inorganic origin.

10.12.1 To process the registration application under this modality, the applicant must complete and submit the form in Annex D; likewise, they must comply with the requirements defined in the administrative information dossier, the technical information dossier, and the confidential information dossier, which are found in Annex O of this regulation.

(*) (Thus added point 10.12 above by article 2 of executive decree No. 45007 of April 24, 2025)

11. Technical evaluation procedure for the application.

11.1. General procedure for all modalities 11.1.1. Admissibility procedure.

Once the registration application has been submitted, the SFE must conduct an admissibility review, for which it will verify that the applicant provides all the administrative, technical, and confidential requirements provided for in this regulation according to the corresponding registration modality, without analyzing the substantive content of such information. For these purposes, the SFE must conduct the admissibility review of the application within the following 21 calendar days from the submission of the application.

In the case of applications for the recognition of registrations or authorizations for TGAI by complete data, TGAI by equivalence, and formulated synthetic pesticides from OECD member countries and countries adhering to the Mutual Acceptance of Data System of that organization, the SFE will verify the requirements and review the label and leaflet (when applicable according to the modality) within a period of 30 calendar days.

Once the admissibility process is completed and if it is determined that the procedure was admitted, the registration application will be processed under the terms provided in this regulation. In the case of applications for recognition of TGAI by complete data, recognition of TGAI by equivalence, and recognition of formulated synthetic pesticides, the approval resolution will be issued according to numeral 11.1.6 of this regulation once the edict stage indicated in numeral 11.1.5 has been passed.

11.1.2. Single prevention (prevención única).

Within the aforementioned period, the SFE must prevent (prevenir) the applicant, on a single occasion, regarding the submission of any missing document or the correction of any established documentary or technical requirement relating to the registration application, granting for this purpose a period of 40 working days to comply with the prevented aspects, a period that may be extended by 20 additional working days and on a single occasion through a duly justified request.

Such prevention shall be carried out based on the respective admissibility instructions defined by the SFE for each registration modality, which will be available on the SFE website.

11.1.3. Archiving of the procedure at the admissibility stage.

Once the period indicated in the preceding numeral has expired, if the SFE verifies that the original non-compliances or inconsistencies were not fully addressed, it shall order the definitive archiving of the procedure, an act that must be communicated to the applicant in accordance with the provisions of article 264 of the General Law of Public Administration. This resolution shall have the ordinary and extraordinary remedies contemplated in said law.

11.1.4. Request for clarification or addition of technical information.

As part of the technical evaluation process, the SFE, MINSA, and MINAE have the authority to request, within their respective areas of competence, on a single occasion and in a justified manner, clarifications and additional technical information to that provided in the registration application, provided that this information is essential to be able to carry out the substantive analysis of the application and, therefore, verify that the product does not affect health, the environment, or phytosanitary heritage, and without this implying establishing additional requirements beyond those previously required. Such requests for clarification and addition will be sent to the SFE to be notified to the registrant. For these purposes, the applicant will be granted a period of 60 working days, which may be extended at their express request on a single occasion and for an additional period of 30 working days.

Once the above period has expired, if the applicant has not submitted the required information or clarifications, or has not complied with the submission of all the information in the required terms, the corresponding procedure shall be declared forfeited for lack of right (sin derecho), in accordance with the provisions of article 264 of the General Law of Public Administration. This resolution shall have the ordinary and extraordinary remedies contemplated in said law.

11.1.5. Publication of edicts and oppositions for the registration of technical grade active ingredients, formulated synthetic pesticides, chemical pesticides of mineral or inorganic origin, adjuvants, related substances, and physical carriers.

(Thus amended the preceding paragraph by article 6 of executive decree No. 45007 of April 24, 2025)

If the recommendation of the SFE, MINAE, and MINSA is for the approval of the information submitted in the registration application, the SFE proceeds to prepare the edict, which will be notified to the interested party within five calendar days by resolution.

The same must be published on a single occasion in the Official Gazette La Gaceta by the interested party. Said edict must contain a brief description of the product to be registered.

Once the edict is published, the period for oppositions opens, which is 10 working days counted from the day following the publication, within which any third party demonstrating legitimate interest may oppose the registration of the product.

Oppositions must be reasoned and substantiated, as well as clearly and precisely express the aspects and points on which the granting of the registration is opposed. Furthermore, the opponent must provide all documentary evidence and legal, technical, or scientific grounds that support their opposition.

The opposition brief must indicate the name and qualifications of the opponent, and the place or means for receiving notifications.

The SFE, within a term of seven calendar days from receipt of the opposition, will notify the registrant so that they may pronounce on the oppositions within a period of fifteen working days and provide the exculpatory evidence they deem pertinent in defense of their interests.

Once the period for oppositions is closed, the SFE will proceed to conduct the analysis and valuation of the case within its area of competence. If the opposition pertains to matters within the competence of MINSA and MINAE, the SFE will communicate accordingly so that they may issue a technical opinion on the matter.

11.1.5.1 Communication of edict between authorities.

For registration applications for TGAI, formulations, and equivalence under the recognition modality, once the review and admissibility process is completed, the edict will be prepared, which the SFE will notify to the area coordinator of MINSA and MINAE via email. The SFE must guarantee access to the information submitted during the edict process.

(Thus added subsection 11.1.5.1 above by article 1 of executive decree No. 44213 of June 5, 2023)

11.1.6. Approval resolution Once the technical evaluation process of the applications is completed and the required positive reports according to the modality have been received, the SFE shall issue the approval resolution within a maximum period of 4 calendar days, an act that will be issued and communicated to the applicant within a maximum period of 3 calendar days from the issuance of said resolution.

11.2. Technical evaluation procedure for the registration application of technical grade active ingredient with complete data evaluation, equivalence, and TGAI registration with reference information from an Internationally Recognized Authority.

(Thus amended the preceding paragraph by article 6 of executive decree No. 45007 of April 24, 2025)

Once it has been determined that the application meets the admissibility process provided for in numeral 11.1.1 of this regulation, it shall proceed under the terms indicated below:

The analysis of the information shall be carried out in accordance with what is requested in the requirements corresponding to each registration modality in this regulation, as applicable, following this order:

11.2.1. Chemical analysis.

11.2.2. Toxicological, ecotoxicological, and environmental fate analysis simultaneously.

11.2.3. Agronomic analysis.

The chemical requirements set out in Annex B, Annex C, or Annex P of this regulation, according to the modality, shall be analyzed. For these purposes, the reviewing official has a period of 60 calendar days for the TGAI by complete data modality, and 40 calendar days for the equivalence modality and TGAI registration with reference information from an Internationally Recognized Authority.

Once said analysis is carried out, and if the report is positive, it must be communicated to the applicant within a period of 3 calendar days, and in the case of the TGAI by equivalence registration modality, the approval resolution will be issued according to numeral 11.1.6 of this regulation once the edict stage indicated in numeral 11.1.5 has been passed. In the event that the report is negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

For the TGAI by equivalence modality, if the chemical report concludes that it can proceed to the evaluation of toxicological and ecotoxicological equivalence, it shall be transferred to the toxicological and ecotoxicological areas of the SFE for their evaluation.

For the TGAI by complete data modality and TGAI registration with reference information from an Internationally Recognized Authority, once the positive chemical report is incorporated into the file, the registration application shall be simultaneously transferred to the toxicological and ecotoxicological areas of the SFE.

For all modalities, within a period of 42 calendar days, both areas shall carry out the technical evaluation of the information presented, according to their competence, corresponding to the analysis of the requirements set out in Annex B, Annex C, or Annex P of this regulation, according to the modality.

Once said analysis is carried out, and if the reports are positive, they must be communicated to the registrant within a period of 3 calendar days. In the event that any of the reports are negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

Once the positive ecotoxicological and toxicological reports are incorporated into the file, the agronomic area of the SFE must be notified immediately, which will carry out the agronomic analysis and label verification with the information approved by each area (Annex B, Annex C, or Annex P according to the applicable modality) within a period of 15 calendar days.

Once said analysis is carried out and if the report is positive, the approval resolution will be issued according to numeral 11.1.6 of this regulation once the edict stage indicated in numeral 11.1.5 has been passed. In the event that the report is negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

(Thus amended point 11.2.3 above by article 6 of executive decree No. 45007 of April 24, 2025)

11.3. Technical evaluation procedure for the registration application of formulated synthetic pesticides by recognition of study evaluations used by the regulatory authorities of OECD member countries and countries adhering to the mutual acceptance of data system of that organization.

Once it has been determined that the application meets the admissibility process provided for in numeral 11.1.1 of this regulation, it shall proceed under the terms indicated below:

The analysis of the technical information shall be carried out in accordance with what is requested in the requirements corresponding to this registration modality in this regulation, following this order:

11.3.1. Chemical analysis.

11.3.2. Toxicological, ecotoxicological, and environmental fate analysis simultaneously.

11.3.3. Agronomic analysis.

The application shall be transferred to MINAE for the environmental risk assessment and to MINSA for the evaluation of toxicological aspects relating to the pre-harvest interval, re-entry interval, and toxicological category. For the issuance of technical reports, both MINSA and MINAE have a period of 28 calendar days.

Once the environmental and toxicological evaluation indicated above is carried out, and if the reports are positive, it must be communicated to the applicant within a period of 3 calendar days. In the event that any of the reports are negative, the definitive archiving of the procedure shall proceed, prior to the issuance of a final resolution to deny the registration application. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

Once the approval report from MINAE and MINSA is incorporated into the file, the agronomic area shall be notified immediately for the corresponding review. For these purposes, the competent SFE department has a period of 30 calendar days to carry out the agronomic analysis.

Once said analysis is carried out and if the report is positive, the edict shall be issued as indicated in numeral 11.1.5 of this regulation. In the event that there is no opposition or if it is not applicable, the SFE shall issue the registration resolution under the terms indicated in numeral 11.1.6 of this regulation. In the event that the report is negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

11.4 Technical evaluation procedure for the registration application of adjuvants and related substances of minimum risk, and for the technical evaluation of the registration application of Active Ingredient of mineral or inorganic origin.

Once it has been determined that the application meets the admissibility process provided for in numeral 11.1.1 of this regulation, it shall proceed under the terms indicated below:

The analysis of the information shall be carried out in accordance with what is requested in the requirements corresponding to this registration modality in this regulation. The registration application shall be transferred simultaneously to the chemical and agronomic areas of the SFE for their respective analysis.

For these purposes, the reviewers have a period of 30 calendar days to carry out the chemical analysis and the agronomic analysis, corresponding to the analysis of the requirements set out in Annex G and Annex N of this regulation.

Once said analysis is carried out, and if the reports are positive, the edict shall be issued as indicated in numeral 11.1.5 of this regulation. In the event that there is no opposition or if it is not applicable, the SFE shall issue the registration resolution under the terms indicated in numeral 11.1.6 of this regulation. In the event that the report is negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

(Thus amended point 11.4 above by article 6 of executive decree No. 45007 of April 24, 2025)

11.5. Technical evaluation procedure for the registration application of formulated synthetic pesticides with complete evaluation, adjuvants, related substances, physical carriers with incorporated TGAI or related substance, and chemical pesticides of mineral or inorganic origin.

Once it has been determined that the application meets the admissibility process provided for in numeral 11.1.1 of this regulation, it shall proceed under the terms indicated below:

The analysis of the information shall be carried out in accordance with what is requested in the requirements corresponding to this registration modality in this regulation, following this order:

(Thus amended point 11.5 above by article 6 of executive decree No. 45007 of April 24, 2025)

11.5.1. Chemical analysis by the SFE.

11.5.2. Toxicological analysis by MINSA and environmental analysis by MINAE, which will be carried out simultaneously.

11.5.3. Agronomic analysis by the SFE.

The application shall be transferred to the competent department of the SFE for the analysis of chemical aspects. For these purposes, the reviewer has a period of 30 calendar days to carry out the chemical analysis corresponding to the analysis of the requirements set out in Annex E, Annex H, Annex J, or Annex O, as applicable, of this regulation.

(Thus amended the preceding paragraph by article 6 of executive decree No. 45007 of April 24, 2025)

Once said analysis is carried out, and if the report is positive, it must be communicated to the applicant within a period of 3 calendar days. In the event that the report is negative, the final resolution denying the registration application and archiving it shall be issued. The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

Once the positive chemical report is incorporated into the file, MINSA and MINAE shall be notified simultaneously, and within a period of 28 calendar days, the evaluations corresponding to the requirements set out in Annex E, Annex H, or Annex J, as applicable, of this regulation shall be carried out.

Once said analyses are carried out and if the reports are positive, they will be communicated to the applicant within a period of 3 calendar days. In the event that any of the reports is negative, the final resolution denying the registration application and archiving it shall be issued.

The foregoing is without prejudice to the administrative remedies that may apply against the denial act, as established on the matter in the General Law of Public Administration.

Once the positive reports from MINSA and MINAE are incorporated into the file, the agronomic area shall be notified to continue with the corresponding evaluation. For these purposes, there is a period of 30 calendar days to carry out the agronomic analysis, and verification of the label and leaflet with the information approved in each report according to the requirements of Annex E, Annex H, or Annex J, as applicable.

12. MODIFICATIONS TO THE REGISTRATION The registration may be modified at the request of its holder. For this purpose, a request must be submitted indicating the proposed change, the reason for it, and complying with the requirements and procedures indicated in this chapter.

Current registrations in any of their modalities may be modified by their holder, upon compliance with the requirements and formalities established in this regulation, without such modifications implying processing a new registration. With any modification made, the registration shall retain its corresponding number, as well as its date of grant and validity.

The procedure shall be archived when a change is made to the last approved composition in the registration for all modifications, except for the modification in numeral 12.3.6.

The grounds for modifying a registration and the requirements for each are as follows:

12.1. Administrative modifications 12.1.1. For the assignment of registration or procedures in process of registration 12.1.1.1. Application duly signed by the legal representative.

12.1.1.2. Original or certified copy of the document evidencing the assignment. A simple copy may also be submitted together with the original for certification.

12.1.1.3. Proof of payment of the current fee.

12.1.2. For the change, addition, or removal of the trade name of the product 12.1.2.1. Application duly signed by the legal representative.

12.1.2.2. Proof of payment of the current fee.

12.1.3. For the inclusion or exclusion of marketing presentations or type of packaging.

12.1.3.1. Application indicating the type, material, and capacity of the requested packaging, signed by the legal representative.

12.1.3.2. Document describing the new material to be used.

12.1.3.3. Proof of payment of the current fee 12.1.4. For the change of corporate name of the manufacturer or formulator 12.1.4.1. Application indicating the new corporate name of the manufacturer or formulator, signed by the legal representative.

12.1.4.2. Proof of payment of the current fee.

12.1.4.3. Notarized sworn statement using the format found in Annex M of this regulation.

12.2. Modifications for TCGs and formulated synthetic pesticides registered via the recognition (homologación) of registrations or authorizations approved by the regulatory authorities of OECD member countries and adherents to that organization's Mutual Acceptance of Data System.

Applicants for TCGs and formulated synthetic pesticides authorized through the modality of recognizing registrations or authorizations approved by the regulatory authorities of OECD member and adherent countries may request modifications to what was initially approved by the regulatory authority in the country of origin, for which they must submit the following:

12.2.1. Application indicating the modification, signed by the legal representative.

12.2.2. Proof of payment.

12.2.3. Link or database where the authorized change can be consulted; if the link is not available, the document evidencing the modification approved by the regulatory authority in the OECD country and countries adherent to that organization's Mutual Acceptance of Data System, duly legalized or apostilled, must be provided.

12.3. Technical Modifications 12.3.1. For modification of agronomic use (crops, pests, doses, application intervals, pre-harvest interval, application type) 12.3.1.1. Agronomic use modifications will not be evaluated regarding the toxicological part by MINSA and the environmental part by MINAE provided they comply with the following:

12.3.1.1.1. The modification implies a change in dose, number of applications per annual cycle, addition of a pest or disease, interval between applications, without an increase in the chemical load (carga química) and without changing the application type. Furthermore, it must not entail a decrease in the interval between applications, the pre-harvest interval (período de carencia), the re-entry period to the treated area, on the same crop, without an increase in the chemical load and without changing the application type.

12.3.1.1.2. The modification implies an addition of a crop and maintains or reduces the chemical load: lower or equal dose, lower or equal number of applications per annual cycle, greater or equal interval between applications, greater or equal pre-harvest interval (período de carencia), greater or equal re-entry period to the treated area. The modification does not imply a change in the application type regarding the uses already authorized for said product.

12.3.1.1.3. In the event of non-compliance with sub-sections 12.3.1.1.1 and 12.3.1.1.2 of numeral 12.3.1.1, the application shall be evaluated for the toxicological part by MINSA and the environmental part by MINAE. In these cases, MINSA will use the toxicological information indicated in Annex E; on the other hand, MINAE will carry out the evaluation using the ecotoxicological and environmental fate information indicated in Annex B of the constituting TCG. 12.3.1.2. Requirements for modification of agronomic use

(Point 12.3.1.1.3 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.1.2.1. Modification application stating the proposed change and the reason for it, signed by the legal representative.

12.3.1.2.2. Leaflet in accordance with the provisions of the current Central American Technical Regulation incorporating the requested changes.

12.3.1.2.3. Indicate the approval resolution number of the product efficacy trial, issued by the SFE Control Unit (Unidad de Fiscalización del SFE). This requirement does not apply to adjuvants.

12.3.1.2.4. Demonstrate that the requested use pattern of the formulated synthetic pesticide complies with the MRL adopted by the country for the requested crop, complying with the provisions of numeral 8.2.2 of this regulation.

12.3.1.2.5. Proof of payment of the current tariff.

12.3.2. For the toxicological reclassification of the technical-grade active ingredient or a formulated synthetic pesticide, adjuvant, or related substance, based on new acute toxicology information more appropriate to the product. The requirements are:

12.3.2.1. Modification application signed by the legal representative.

12.3.2.2. Label and leaflet in accordance with the provisions of the current Central American Technical Regulation on labeling, incorporating the requested changes.

12.3.2.3. Study of the acute oral LD50 in rats.

12.3.2.4. Study of the acute dermal LD50 in rats.

12.3.2.5. Study of the acute inhalation LC50 in rats. Applies only to fumigant products that form mist, gas, vapors, or dust.

12.3.2.6. Proof of payment of the current tariff.

12.3.3. For the following changes in the formulated synthetic pesticide, adjuvant, or related substance, or physical vehicle: A) Substitution of one formulator for another; and B) Increase in the number of formulators. The following must be submitted:

12.3.3.1. Application form indicated in Annex K, provided by the applicant for the formulated synthetic pesticide, adjuvant, or related substance, or physical vehicle, indicating the registration number of the product for which the modification is sought and a description of the change to be made.

12.3.3.2. Proof of payment of the current tariff.

12.3.3.3. Certificate of the quali-quantitative composition (composición cuali-cuantitativa) of the formulated synthetic pesticide, adjuvant, or related substance, or physical vehicle, original or copy certified by a notary public, issued less than two years prior by the parent company or the company that formulates the product, and signed by the responsible professional. It must contain:

12.3.3.3.1. Nominal content expressed as a percentage w/w or w/v of active ingredient calculated based on the minimum concentration declared in the active ingredient registration, as well as, if applicable, the corresponding content of variants (such as salts and esters) of the active substances. For the case of adjuvants and related substances, it must be the nominal content expressed as a percentage w/w or w/v of the main components.

12.3.3.3.2. Nominal content of each co-formulant (coformulante) expressed as a percentage w/w or w/v.

12.3.3.3.3. Function of each of the co-formulants (coformulantes) included in the formulation.

12.3.3.3.4. The identity of the co-formulants (coformulantes), active ingredient, or main component must be indicated according to its IUPAC chemical name and CAS number when available. If not available, the chemical structure must be attached. If codes are used to identify the co-formulants (coformulantes), the function must be described and the safety data sheet for the co-formulant (coformulante) must be provided, only if it lacks a CAS number or IUPAC name. When the co-formulants (coformulantes) are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted instead.

12.3.3.3.5. Density of the formulation (must indicate units and temperature).

12.3.3.3.6. Maximum content of relevant impurities, when present.

12.3.3.4. Certificate of analysis (for formulated synthetic pesticides and physical vehicles) issued less than two years prior by the parent company or the product formulator, original or copy certified by a notary public and signed by the responsible professional. It must include the batch number, analysis date, result obtained for the active ingredient(s). If the certificate of analysis was issued by the parent company, it must indicate the location where the product was formulated.

12.3.3.5. Description of the formulation process: The company must submit information regarding the formulation process of the product subject to the modification.

For the process, the following information must be provided:

12.3.3.5.1. Name and address of the formulator involved in the process.

12.3.3.5.2. General description of the process: a written description in prose that must explain the steps necessary to carry out the formulation of the product.

12.3.3.5.3. Indicate the ingredients used to formulate the product.

12.3.3.5.4. Description of the equipment used.

12.3.3.5.5. Description of the conditions controlled during the process.

12.3.4. For expanding the origin of synthesis of a registered technical-grade active ingredient, in cases where the synthesis process remains the same and is under the supervision of an entity within the same business group that owns the information.

12.3.4.1. Application by the registrant of the technical-grade active ingredient indicating the registration number of the product for which the modification is sought and a description of the change to be made.

12.3.4.2. Proof of payment.

12.3.4.3. Certificate of quali-quantitative composition (composición cualitativa cuantitativa) of the TCG, issued by the parent company or the manufacturer and signed by the responsible professional, issued less than two years prior. It must be submitted as an original, or a copy certified by a notary public, and will contain:

12.3.4.3.1. Minimum concentration of the TCG expressed as a percentage w/w (or g/kg) or percentage w/v. If concentration is indicated in w/v, the density must be declared.

12.3.4.3.2. Maximum concentration of each impurity equal to or greater than one gram per kilogram (1 g/kg) or 0.1% w/w.

12.3.4.3.3. Maximum concentration of relevant impurities; if not present, the absence of these must be stated.

12.3.4.3.4. Minimum and maximum concentration of other additives present, expressed in g/kg or percentage, as appropriate and applicable to the specific case. Must state the function (e.g., stabilizer).

12.3.4.3.5. Identity of the active ingredient, impurities, and additives (the latter as appropriate and applicable to the specific case) according to their IUPAC chemical name and CAS number when available; if not available, the chemical structure must be submitted.

12.3.4.3.6. If the active ingredient is a TK, the concentration on a dry basis must also be submitted. The specification of the active ingredient must be presented with a maximum and minimum limit.

12.3.4.4. Summary of the manufacturing pathway; the following information must be provided:

12.3.4.4.1. Name and address of the manufacturer involved in the process.

12.3.4.4.2. General description of the process: a written description in prose which must explain the necessary steps to carry out the synthesis of the product.

12.3.4.4.3. Manufacturing flow diagram.

12.3.4.4.4. Identification of the materials used to produce the product.

12.3.4.4.5. General description of the conditions controlled during the process, as applicable: temperature, pressure, pH, and humidity.

12.3.5. For the change or expansion of the origin of synthesis of a registered technical-grade active ingredient, for cases where the synthesis process is different.

For the approval of this modification application, the registrant must demonstrate, in accordance with what is described in this regulation, the equivalence (equivalencia) of the new technical-grade active ingredient.

12.3.6. For a change in the formulation composition of formulated synthetic pesticides, adjuvants, and related substances.

(Point 12.3.6 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.1. Generalities 12.3.6.1.1. Both significant and non-significant changes apply only to changes of co-formulants (coformulantes); the active ingredient, protectant, or synergist, and the formulation type cannot be changed.

(Point 12.3.6.1.1 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.1.2 For cases where a series of "non-significant" changes are made in the formulation representing a change of 10% or more of the declared content of the original content, the application must comply with the requirements indicated in the section for significant changes.

(Point 12.3.6.1.2 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.1.3 The reference against which the comparison is always made will be the formulation with which the registration was granted, the updated one, or the latest one approved in a modification. The SFE must review the registration each time a modification is requested, to identify if the sum of the non-significant changes does not exceed 10% of the declared content of the quali-quantitative composition (composición cuali-cuantitativa) of the originally registered formulated product; in such case, it must be processed as a significant change.

(Point 12.3.6.1.3 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.1.4. Applications for formulation changes will not require evaluation by MINSA and MINAE if the new co-formulant(s) (coformulante(s)) is (are) on the "List of authorized components for formulated synthetic pesticides, adjuvants and related substances" visible on the SFE website www.sfe.go.cr. Said list will be updated and validated by MINAE and MINSA and must be consulted by the registrant prior to submitting the application. Likewise, evaluation by these Ministries is not required if the change in the formulation corresponds to the elimination of a co-formulant (coformulante).

(Point 12.3.6.1.4 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.1.5 In the event that a co-formulant (coformulante) has not been included in the list published by the SFE, the applicant may provide the respective information for assessment by MINAE and MINSA.

(Point 12.3.6.1.5 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2. Non-significant changes Any change in the composition of a formulated synthetic pesticide must be notified to the SFE and must be authorized by it. For these cases, the applicant must submit an application to the SFE, and it must analyze the documentation.

The procedures described below for changing the composition of formulated synthetic pesticides, adjuvants, or related substances apply only to the change of co-formulants (coformulantes). For other types of changes, the provisions of this regulation shall apply.

(Point 12.3.6.2 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1. Non-significant changes apply in the following cases:

(Point 12.3.6.2.1 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1.1. Co-formulants (Coformulantes) with the same chemical composition and the same or lower risk classification (see note 1).

(Point 12.3.6.2.1.1 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1.1.1.

12.3.6.2.1.1.2.

12.3.6.2.1.1.3.

12.3.6.2.1.2. Interchange of cation in anionic surfactant/dispersant.

(Point 12.3.6.2.1.2 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1.3. Change in the amount of the same solvent or vehicle used: This change in solvent or vehicle must not be greater than ±10% with respect to the original formulation to be considered a non-significant change.

(Point 12.3.6.2.1.3 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1.4. Updating of the CAS number in accordance with information updated by the Chemical Abstract Service.

(Point 12.3.6.2.1.4 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.1.5. If the variation in the concentration of the co-formulants (coformulantes) falls within the ranges indicated in Table 2.

Note 1: Co-formulants (Coformulantes) are considered chemically equivalent when they have the same CAS number, or if they have different CAS numbers but the same IUPAC name.

The applicant may demonstrate that co-formulants (coformulantes) can be considered equivalent based on technical and scientific criteria, which will be analyzed by the SFE. In the event that new chemical equivalences are authorized in a new version of SANCO 12638/2011 or another international guide recognized by the SFE, the analysis of those cases will be accepted. When the applicant submits a justification, the established deadline for the response from the competent reviewing authority is suspended for the purpose of conducting consultations at the national or international level.

Note 2: Numerals 12.3.6.2.1.3, 12.3.6.2.1.4, and 12.3.6.2.1.5 do not require evaluation by MINSA and MINAE.

(Point 12.3.6.2.1.5 above as added by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.2. For non-significant changes, submission of an efficacy trial will not be required. In the following cases, the applicant must submit the technically and scientifically supported information it deems competent to justify that the requested change does not present alterations in the biological properties of the product:

(Point 12.3.6.2.2 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.2.1 Changes in salt formulations: provide non-phytotoxicity results.

(Point 12.3.6.2.2.1 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.2.1.1.

12.3.6.2.2.2 Changes in bait formulations: data on non-alterations in palatability.

(Point 12.3.6.2.2.2 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.2.3 Changes in seed treatments: germination percentage data.

(Point 12.3.6.2.2.3 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.2.2.4 Changes in fumigant products: gas release rate and velocity data.

For these results and data, for example, tests conducted in nurseries, fields, or laboratories generated at any latitude may be submitted.

(Point 12.3.6.2.2.4 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

12.3.6.3. Significant changes Significant changes apply when the change implies: addition, substitution, elimination, variation in the concentration of co-formulants (coformulantes) greater than the ranges indicated in Table 2.

For these cases, the applicant must submit the application to the SFE and requires analysis and approval.

(Point 12.3.6.3 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

(*)12.3.6.3.1. Changes that do not require the submission of physicochemical property and use studies For the following cases, studies for use or physicochemical properties are not required:

a.1 Change of a dye, pigment, or coloring material <5% of the formulation.

a.2 Addition of antifoaming agent <5% of the formulation.

a.3 Change from ethylene glycol to propylene glycol.

The applicant may submit a justification based on technical and scientific criteria for other cases of formulation changes where new studies are not required, which will be analyzed by the SFE to verify that the change indeed does not require studies; otherwise, the justification will be rejected.

b. Changes that require the submission of studies or certificate of analysis for physical and chemical properties:

b.1 Changes to the antifoaming agent: the study or certificate of analysis with the result obtained for foam persistence must be submitted.

b.2 Changes related to the acid, base, or buffer: the study or certificate of analysis with the corresponding result obtained for pH must be submitted.

b.3 Changes related to the thickener, gelling agent: the study or certificate of analysis with the result obtained for viscosity, as applicable, must be submitted.

b.4 Changes related to the solvent, co-solvent, or vehicle, filler agent:

the study or certificate of analysis must be submitted with the result obtained for emulsion stability, foam persistence, dissolution stability, dispersibility, viscosity, as applicable.

b.5 Surfactant, dispersant, wetting agent, emulsifier: the study or certificate of analysis with the result obtained for the emulsion stability test, as applicable, must be submitted.

b.6 Stabilizer/solubilizer: the study or certificate of analysis must be submitted with the result obtained for wettability, wet sieve analysis, dispersion stability, dispersibility and spontaneity of dispersion, degree of dissolution and/or solution stability, suspensibility, as applicable.

b.7 Physical vehicle: the study or certificate of analysis must be submitted with the result obtained for dustiness, flowability, dry sieve analysis, as applicable.

b.8 Corrosion inhibitor: the study or certificate of analysis must be submitted with the result obtained for corrosivity, as applicable.

b.9 In the event that the composition change includes the use of a Water-Soluble Bag: the study or certificate of analysis must be submitted with the result obtained for foam persistence, wet sieve analysis, suspensibility, solution stability, and wettability, as applicable.

c. Toxicological hazard evaluation.

The following variations in the initial concentration of the co-formulant (coformulante) will be possible without requesting new toxicological studies, subject to verification by MINSA.

Table 2: Changes without effect on risk classification

Initial Concentration Range (%)	Permitted Relative Variation (%)	Example
? 2.5	± 30	Co-formulant at 2% w/w, can vary 1.4 - 2.6%
2.5 < [ ] ? 10	± 20	Co-formulant at 5% w/w, can vary 4 - 6%
10 < [ ] ? 25	± 10	Co-formulant at 20% w/w, can vary 18 - 22%
25 < [ ] ? 100	± 5	Co-formulant at 60% w/w, can vary 57 - 63%
For co-formulants at very low concentration in the formulation
? 1.0	± 50	Co-formulant at 0.6% w/w, can vary 0.3 - 0.9%
? 0.5	± 100	Co-formulant at 0.2% w/w, can vary 0 - 0.4%

Source: European Union, EC 1272/2008 In cases of changes greater than 10% w/w (absolute) with respect to the original formulation, new toxicological studies (studies required for formulated synthetic products) might be required. This evaluation will be conducted by MINSA.

For other cases not considered in the previous table and that are greater than 10% w/w (absolute) with respect to the original formulation, new toxicological studies (studies required for formulated synthetic products) might be required. This evaluation will be conducted by MINSA, with the applicant being able to present a technically justified case demonstrating that they are not necessary, either by applying GHS criteria or other duly recognized criteria.

d. Evaluation by the SFE Control Unit.

For the modification application for a formulation change, the following assumptions will be followed:

d.1 If the modification is less than 10% of the declared content of the composition, no efficacy trial will be required.

d.2 If the change is greater than 10% of the declared content of the composition, the applicant may submit a technical justification to the Control Unit, arguing that the agronomic efficacy and phytotoxicity are maintained or improved, by virtue of the physical and chemical properties or other characteristics of the resulting formulation related to efficacy not being adversely affected. This justification must be assessed by said unit, which will issue the corresponding resolution. In the event of a technically substantiated rejection, an efficacy trial must be carried out on the most representative crop.

d.3 In the event that the SFE Control Unit rejects the justification mentioned in the previous point, the efficacy trial must be submitted for its respective analysis by this same department.

When submitting the modification application for a change in composition, the approval resolution number issued by the SFE Control Unit must be indicated.

(Point 12.3.6.3.1 above as amended by Article 2 of Executive Decree No. 44213 of June 5, 2023)

(*)12.3.6.4. Requirements to be submitted for the application for changes in the formulation:

a. Requirements for non-significant changes a.1 The applicant must submit an application indicating the reason for and description of the change, trade name, and registration number of the formulated synthetic pesticide for which the change is sought. The application must be signed by the legal representative.

a.2 Certificate of the quali-quantitative composition (composición cuali-cuantitativa) of the formulated synthetic pesticide, original or copy certified by a notary public, issued less than two years prior by the parent company or the company that formulates the product, and signed by the responsible professional. If issued by the parent company, it must include the name of the formulator. It must contain:

a.2.1 Nominal content expressed as a percentage w/w or w/v of active ingredient calculated based on the minimum concentration declared in the active ingredient registration, as well as, if applicable, the corresponding content of variants (such as salts and esters) of the active substances.

a.2.2 Nominal content of each co-formulant (coformulante) in the formulation expressed as a percentage w/w or w/v.

a.2.3 Function of each of the co-formulants (coformulantes) included in the formulation.

a.2.4 The identity of the co-formulants (coformulantes) and the active ingredient must be indicated according to its IUPAC chemical name and CAS number when available. If not available, the chemical structure must be attached.

If codes are used to identify the co-formulants (coformulantes), the function must be described and the safety data sheet provided. When the co-formulants (coformulantes) are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted instead.

a.2.5 Density of the formulation (must indicate units and temperature).

a.2.6 Maximum content of relevant impurities, when present.

Note: for registration cases whose composition does not detail the co-formulant (coformulante) information according to "point a.2" above, the applicant must submit the current detail of the co-formulants (coformulantes) and the new composition certificate.

a.3 Proof of payment of the current tariff.

a.4 Provide the data and/or results according to point 12.3.6.2.2, if applicable.

a.5 If applicable, provide the respective information if a co-formulant (coformulante) not on the "List of authorized components for formulated synthetic pesticides, adjuvants and related substances" is to be included.

b. Requirements for significant change:

b.1 The applicant must submit an application indicating the reason for and description of the change, trade name, and registration number of the formulated synthetic pesticide for which the change is sought. The application must be signed by the legal representative.

b.2 Certificate of the quali-quantitative composition (composición cuali-cuantitativa) of the formulated synthetic pesticide, original or copy certified by a notary public, issued less than two years prior by the company that formulates the product, and signed by the responsible professional. If issued by the parent company, it must include the name of the formulator. It must contain:

b.2.1 Nominal content expressed as a percentage w/w or w/v of active ingredient calculated based on the minimum concentration declared in the active ingredient registration, as well as, if applicable, the corresponding content of variants (such as salts and esters) of the active substances.

b.2.2 Nominal content of each co-formulant (coformulante) in the formulation expressed as a percentage w/w or w/v.

b.2.3 Function of each of the co-formulants (coformulantes) included in the formulation.

b.2.4 The identity of the co-formulants and active ingredient must be indicated according to their IUPAC chemical name and CAS number when available. If they are not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet for the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be presented instead.

b.2.5 Density of the formulation (must indicate the units and temperature).

b.2.6 Maximum content of relevant impurities, when present.

Note: for cases of registrations whose composition does not have detailed information on the co-formulants according to "point b.2" above, the applicant must submit the current detail of the co-formulants and the new certificate of composition.

b.3 Description of the formulation process: The company must submit information on the formulation process of the formulated synthetic pesticide subject to the modification. The following information must be provided:

b.3.1 Name and address of the formulator involved in the process.

b.3.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the formulation of the product.

b.3.3 Indicate the ingredients used to formulate the product (may refer to the information in the certificate of composition present in the application).

b.3.4 Description of the equipment used.

b.3.5 Description of the conditions controlled during the process (pressure, temperature, pH, or other quality controls employed).

b.4 Proof of payment of the current fee.

b.5 If applicable, provide the technical information that supports the cases where a justification is required to be submitted.

b.6 Studies or original certificate of analysis, signed by the responsible professional, with the methodology used, result(s) obtained for the active ingredient(s), date and batch number (CoA), with its respective chemical endorsement, required according to the modification made and taking into consideration what is indicated in this regulation.

b.7 Label in the event that the risk assessment determines that there is a change in the toxicological classification.

b.8 Indicate the resolution number or numbers approving the efficacy trial, if applicable, according to numeral 12.3.6.3.1.d, where it is confirmed that, with the new change in the formulation, efficacy is maintained in accordance with the current registration.

b.9 If applicable, provide the respective information in the event that a co-formulant not on the "Lista de componentes autorizados para plaguicidas sintéticos formulados, coadyuvantes y sustancias afines" is to be included.

b.10 If applicable, provide the toxicological studies as indicated in numeral 12.3.6.3.1.c." (*)(Thus amended point 12.3.6.4) above by article 2 of Decreto Ejecutivo N° 44213 of June 5, 2023) 12.4. Procedure and deadlines for registration modifications 12.4.1. Administrative modifications The applicant must submit their application before the SFE, submitting the requirements indicated in each of the grounds for modification.

The SFE, within a maximum period of 15 calendar days, counted from the submission of the registration modification application, must review the submitted requirements. If, as part of this review process, it is concluded that there are missing documents or it is necessary to rectify any requirement, the interested party will be granted a period of ten business days to comply with the preventive aspects, a period that may be extended by 5 additional business days and only once through a duly justified request from the registration holder.

Once the previous period has expired, if the SFE verifies that the original non-compliances or inconsistencies were not resolved, it will order the definitive archiving of the application in accordance with the last paragraph of article 264 of the Ley General de Administración Pública, an act that must be communicated to the interested party 6 calendar days after the reception of the resolution. This resolution will have the ordinary and extraordinary remedies contemplated in the Ley General de la Administración Pública.

If the application meets the requested requirements, the SFE will issue the final resolution within a maximum period of 5 calendar days, an act that will be issued and communicated to the interested party within a maximum period of 3 calendar days from the issuance of said resolution.

12.4.2. Modifications for inclusion of use and toxicological reclassification.

The applicant must submit their application before the SFE, submitting the requirements indicated in each of the grounds for modification.

The SFE will forward it within a period of 3 calendar days, if applicable, to MINSA and MINAE for the purpose of them pronouncing on the aspects referring to their competence.

Within a period of 28 calendar days, MINSA and MINAE must carry out the technical analysis of the submitted information, according to their competence.

Once the technical reports from the aforementioned areas are incorporated into the case file, it will be forwarded within a period of 3 calendar days to the agronomic area of the SFE for the corresponding agronomic analysis.

For such purposes, there is a period of 28 calendar days to conduct the agronomic analysis. Once said analysis is completed, the respective report must be issued, which must be incorporated into the case file of the registration modification application.

If, as part of this review process, it is concluded that there are missing documents on the part of the applicant or it is necessary to request clarification from the applicant on some requirement or additional information is needed, the applicant will be granted a period of 60 business days to comply with the preventive aspects, a period that may be extended by 30 additional business days before its expiration and only once through a duly justified request from the applicant.

If the SFE verifies that the original non-compliances or inconsistencies were not resolved, it will order the definitive archiving of the application in accordance with the last paragraph of article 264 of the Ley General de Administración Pública, an act that must be communicated to the interested party within a period of 6 calendar days. This resolution will have the ordinary and extraordinary remedies contemplated in the Ley General de la Administración Pública.

12.4.3. For changes in the formulated synthetic pesticide, coadjuvants and related substances: A) Substitution of one formulator for another. B) Expansion of formulators and for expansion of the origin of synthesis of a technical grade active ingredient that is under the supervision of an entity of the same business group holding the information The applicant must submit their application before the SFE, submitting the requirements indicated in each of the grounds for modification.

The application is forwarded to the chemical area of the SFE which, within a maximum period of 28 calendar days counted from the submission of the registration modification application, must review the submitted requirements.

If, as part of this review process, it is concluded that there are missing documents or it is necessary to rectify any requirement, the interested party will be granted a period of 30 business days to comply with the preventive aspects, a period that may be extended by 15 additional business days and only once through a duly justified request from the registration holder.

Once the previous period has expired, if the SFE verifies that the original non-compliances or inconsistencies were not resolved, it will order the definitive archiving of the application, an act that must be communicated to the applicant. This resolution will have the ordinary and extraordinary remedies contemplated in the Ley General de la Administración Pública.

If the application meets the requested requirements, the SFE will issue the final resolution within a maximum period of 5 calendar days, an act that will be issued and communicated to the applicant within a maximum period of 3 calendar days from the issuance of said resolution.

12.4.4. For a change in the composition of the formulation of formulated synthetic pesticides, coadjuvants and related substances (Thus amended point 12.4.4) above by article 2 of Decreto Ejecutivo N° 44213 of June 5, 2023) 12.4.4.1 Non-significant changes The applicant must submit their application before the unit that administers the registration in the SFE, submitting the requirements indicated in the respective section.

The SFE will forward the registration modification application 3 calendar days after receipt of the application to the chemical area of the SFE for the analysis of the chemical aspects. For such purposes, the reviewer has a period of 28 calendar days.

Once the chemical report is incorporated into the case file, the SFE will forward the registration modification application, in the cases of points 12.3.6.1.5 or 12.3.6.2.1 according to Note 2, to MINAE and MINSA as applicable, to carry out the technical evaluation of the information submitted so that within a maximum period of 28 calendar days they issue their corresponding report, which is incorporated into the case file.

Once the technical reports from MINSA and MINAE are issued, if applicable, they will be forwarded to the SFE within a period of 3 calendar days after the issuance of the report with the objective of continuing with the process.

For the exception cases indicated in subsection 12.3.6.2.2, the information submitted by the applicant will be reviewed by the competent unit of the SFE in charge of the agronomic analysis. For such purposes, the reviewer has 28 calendar days.

If, as part of this review process, it is concluded that there are missing documents or it is necessary to request clarification of any requirement or additional information is needed, the interested party will be granted a period of 30 business days to comply with the preventive aspects, a period that may be extended by 15 additional business days before its expiration and only once at the applicant's request. Said request will suspend the Administration's resolution period.

Once the response is received, if the SFE verifies that the original non-compliances or inconsistencies were not resolved, it will order the definitive archiving of the application in accordance with the last paragraph of article 264 of the Ley General de Administración Pública, an act that must be communicated to the interested party within a period of 6 calendar days. This resolution will have the ordinary and extraordinary remedies contemplated in the Ley General de la Administración Pública.

If the application meets the requested requirements, the SFE will issue the modification approval resolution within a maximum period of 5 calendar days.

(Thus amended point 12.4.4.1) above by article 2 of Decreto Ejecutivo N° 44213 of June 5, 2023) 12.4.4.2 Significant changes The procedure for this case is the same as for non-significant changes, except that the reviewer in the chemical area has a period of 42 calendar days and it will be sent for evaluation by MINSA and MINAE, except when what is indicated in numeral 12.3.6.1.4 applies.

(Thus amended point 12.4.4.2) above by article 2 of Decreto Ejecutivo N° 44213 of June 5, 2023) 13. POST-REGISTRATION CONSIDERATIONS FOR ALL REGISTRATION MODALITIES 13.1. The SFE has the authority to request the registration or authorization holder to provide certified reference material of the substances included in the definition of residue adopted by Costa Rica for the active ingredient, and of the relevant impurities, if present. The producer of the certified reference material must comply with the guidelines of the international standard ISO 17034 in its current version and must be accompanied by the documentation, uncertainty, and traceability specified by the standard, in a sealed container and with a current expiration date. In the event that the certified reference material is not available on the international market, the delivery of analytical standards prepared by the manufacturer under the good laboratory practice guidelines established by the OECD and adherents of analytical standard quality substances will be permitted, if traceability of the assay is demonstrated through the application of a standardized method, accepted internationally as a reference, and participation in proficiency tests or other comparisons for said method.

13.2. The SFE, MS and MINAE may examine, ex officio or at the technically and scientifically justified request of third parties, the approved registrations or authorizations of IAGT or formulated synthetic pesticide, coadjuvants, related substances, chemical pesticides of mineral or inorganic origin, and physical vehicles, in the following cases: a) When information becomes known that was not considered as a requirement during the evaluation that granted the registration or was subsequent to it, and that is important for safeguarding health, the environment, and agriculture, and b) when the possibility of affectation to human health, the environment, or agriculture is evidenced. For all the above, the SFE, MS and MINAE may require the administered party to provide additional information or analyses and supporting documentation during the validity of the registration.

(Thus amended point 13.2) above by article 6 of Decreto Ejecutivo N° 45007 of April 24, 2025) 13.3. The SFE, MINSA and MINAE may request at any time the documents that support the information recorded in the sworn statements requested in this regulation, and in the event that they are not submitted, the registration or authorization of both the IAGT or formulated synthetic pesticides, as well as the coadjuvants, related substances and physical vehicles, as applicable, will be suspended in accordance with numeral 20 of this regulation.

14. RENEWAL OF REGISTRATION AND REQUIREMENTS 14.1. General Provisions 14.1.1. Registrations valid under any of the modalities provided for in this decree and under Decreto Nº 33495 MAG-S-MINAE-MEIC "Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola", Decreto Ejecutivo Nº 42769-MAG-S-MINAE and its amendments "Reglamento para optar por el Registro de Ingrediente Activo Grado Técnico mediante el reconocimiento de la evaluación de los estudios técnicos aprobados por las Autoridades Reguladoras de los países miembros de la OCDE y los países adherentes de la OCDE" and Decreto Ejecutivo Nº 43469-MAG-MINAE-S "Reglamento para el Registro de Insumos Agrícolas. Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes, Sustancias Afines y Vehículos Físicos de Uso Agrícola.", may be renewed for equal and consecutive periods of ten years through this procedure.

14.1.2. The manufacturer or formulator of the product to be renewed must be the same one that gave rise to the registration or the one that has been approved by the SFE for the corresponding modification indicated in this regulation.

14.1.3. Within the six months prior to the expiration date of a registration, granted under any of its modalities, the registration holder must request renewal from the SFE, as appropriate to the type of modality.

14.2. General requirements for all registration renewal modalities 14.2.1. Registration renewal form, signed by the registration holder, in which the registration number subject to renewal must be indicated. The forms are those found in the annexes to this regulation according to the corresponding registration modality.

14.2.2. Proof of payment of the current fee.

14.3. Specific requirements for each registration modality.

14.3.1. Renewal for IAGTs and formulated synthetic pesticides registered through the homologation of the product authorized or registered in an OECD member country or a country adherent to the Mutual Acceptance of Data System of that organization.

Link or database where it can be verified that the IAGT or formulated synthetic pesticide is current; if the link is not available, the document proving it is current must be provided, and said document must be duly legalized or apostilled.

14.3.2. Renewal for technical grade active ingredients The manufacturer of the product to be renewed must be the same one that gave rise to the registration or the one that has been approved by the SFE for the corresponding modification indicated in this regulation.

14.3.2.1. Qualitative-quantitative certificate of composition of the IAGT issued by the parent company or the manufacturer and signed by the responsible professional, having been issued less than two years ago. It must be submitted in original, or a copy certified by a notary public, which will contain:

14.3.2.1.1. Minimum concentration of the active ingredient expressed in percentage m/m (or g/kg) or percentage m/v. If the concentration is indicated in m/v, the density must be declared.

14.3.2.1.2. Maximum concentration of each impurity greater than or equal to one gram per kilogram (1 g/kg) or 0.1% m/m.

14.3.2.1.3. Maximum concentration of relevant impurities; if they are not present, their non-presence must be indicated.

14.3.2.1.4. Minimum and maximum concentration of other additives present, expressed in g/kg or percentage, when corresponding and applicable to the specific case. The function must be indicated (for example, stabilizer).

14.3.2.1.5. Identity of the active ingredient, impurities and additives (the latter when corresponding and applicable to the specific case) according to their IUPAC chemical name and CAS number when available; if not available, the chemical structure must be presented.

14.3.2.1.6. In the event that the active ingredient is a TK, the concentration on a dry basis must also be presented. The specification of the active ingredient must be presented with a maximum and minimum limit.

14.3.3. Requirements for renewal of registration of formulated synthetic pesticides with complete evaluation and by recognition of evaluation of studies used by the regulatory authorities of OECD member countries or countries adherent to the mutual acceptance of data system of that organization.

14.3.3.1. That the IAGT with which it is formulated is duly registered and current in Costa Rica.

14.3.3.2. Certificate of analysis having been issued less than two years ago by the parent company or by the formulator of the product, original or copy certified by a notary public and signed by the responsible professional. It must include the batch number, date of analysis, result(s) obtained for the active ingredient(s), and methodology used for the analysis. In the event that the methodology used is different from the registered one, the method of analysis and its validation must be submitted. Official methods may be submitted provided precision and accuracy are demonstrated. In the event that the certificate of analysis was issued by the parent company, the place where the product was formulated must be indicated in it.

14.3.3.3. Certificate of the qualitative-quantitative composition of the formulated synthetic pesticide, original or copy certified by a notary public, issued less than two years ago by the parent company or the formulating company of the product and signed by the responsible professional. It must contain:

14.3.3.3.1. Nominal content expressed in percentage m/m or m/v of active ingredient calculated from the minimum concentration declared in the registration of the active ingredient, as well as, if applicable, the corresponding content of variants (such as salts and esters) of the active substances.

14.3.3.3.2. Nominal content of each co-formulant expressed in percentage m/m or m/v.

14.3.3.3.3. The identity of the co-formulants and the active ingredient must be indicated according to their IUPAC chemical name and CAS number when available. If they are not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet for the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be presented instead.

14.3.3.3.4. Function of each of the co-formulants included in the formulation.

14.3.3.3.5. Density of the formulation (must indicate the units and temperature) 14.3.3.3.6. Maximum content of relevant impurities, when present.

14.3.4. Requirements for the renewal of registration of related substances, coadjuvants and physical vehicles.

14.3.4.1. Certificate of composition of the related substance, coadjuvant or physical vehicle, original or copy certified by a notary public, issued less than two years ago by the parent company, manufacturer or formulator, as applicable, and signed by the responsible professional. It must contain:

14.3.4.1.1. Nominal content expressed in percentage m/m or m/v of the main component.

14.3.4.1.2. Nominal content of each co-formulant expressed in percentage m/m or m/v (matching the main component).

14.3.4.1.3. Function of each of the co-formulants and main component included in the formulation.

14.3.4.1.4. The identity of the co-formulants and main component must be indicated according to their IUPAC chemical name and CAS number when available. If they are not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet for the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be presented instead.

14.3.4.1.5. Density of the formulation with its respective units and temperature.

14.4.4. The certified limits for all non-relevant impurities, as they have been certified in the registered specification, must not be exceeded beyond the following levels:

Table 3. Decision criteria for the IAGT renewal process

Certified limits of non-relevant impurities in the technical specifications of the registered specification	Maximum acceptable increase
6 g/kg	3 g/kg
>6 g/kg	50% of the certified limit

(Thus amended point 14.4.4) above by article 2 of Decreto Ejecutivo N° 44213 of June 5, 2023) 14.4.1. The concentration of the active ingredient reported in the certificate of composition is equal to or greater than the minimum registered concentration.

14.4.2. No new impurities are presented.

14.4.3. The limits of relevant impurities are not increased as certified by the registered specification.

14.4.4. The certified limits for all non-relevant impurities, as they have been certified in the registered specification, must not be exceeded beyond the following levels:

Table 2. Decision criteria for the IAGT renewal process | 15. GROUNDS FOR SUSPENSION OF REGISTRATION.

The SFE will suspend the registration of the IAGT, active ingredient of mineral or inorganic origin, or a formulated synthetic pesticide, coadjuvant, related substance, chemical pesticides of mineral or inorganic origin, or physical vehicle if one or more of the following grounds concur:

(Thus amended the previous paragraph by article 6 of Decreto Ejecutivo N° 45007 of April 24, 2025)

15.1. When the required information is not provided within the period granted by the SFE.

15.2. When the SFE has efficacy trials demonstrating that the product is ineffective according to the authorized use, guaranteeing due process and the right to defense, prior to ordering the suspension of the registration. The suspension will be for one or all uses as applicable.

15.3. By order of the judicial, environmental, or health authority notified to the SFE by the authority ordering the suspension act.

15.4. When the applicant is not up to date with the payment of the annual fee and renewal for individuals and legal entities.

15.5. When the registration holder of the product does not have an authorized manufacturer or formulator.

15.6. When the applicant does not provide the Certified Reference Material of IAGT and related substances within the period granted by the SFE.

15.7. When any of the aspects declared and included in the sworn statement does not correspond to the registered IAGT, active ingredient of mineral or inorganic origin, formulated synthetic pesticide, coadjuvant, related substance, chemical pesticide of mineral or inorganic origin, or physical vehicle.

(Thus amended point 15.7) above by article 6 of Decreto Ejecutivo N° 45007 of April 24, 2025) 15.8. When there is a technically justified doubt in the event that new studies conclude that there is some change related to health and the environment in the declared technical information of the product. The SFE, MINAE and MS may review the registrations of IAGT, active ingredient of mineral or inorganic origin, formulated synthetic pesticide, coadjuvant, related substance, chemical pesticide of mineral or inorganic origin, or physical vehicle. In the event that this new information is grounds for cancellation, the process will follow what is indicated in numeral 16.

(Thus amended the previous paragraph by article 6 of Decreto Ejecutivo N° 45007 of April 24, 2025)

The suspension of the registration prevents commercialization and use during the suspension period. Products may also not be formulated, reformulated, imported, packaged, repackaged, or repacked, except when these actions are necessary to correct the ground for which the registration was suspended.

The SFE will order the suspension of the registration by issuing a technically and legally supported resolution, indicating the reason that originates it, and it will be maintained until the reason for the suspension is corrected. However, if such correction has not been made within a period of six months from its notification, the cancellation of the registration will proceed in accordance with numeral 16, except for those suspensions ordered by the judicial instance.

16. GROUNDS FOR CANCELLATION OF REGISTRATION.

Registrations granted under any of their modalities that are valid or suspended may be cancelled if they incur any of the grounds established in this regulation. The SFE will cancel, following due process, the registration of IAGT, active ingredient of mineral or inorganic origin, formulated synthetic pesticides, related substance, coadjuvants, physical vehicles, and pesticides of mineral or inorganic origin if one or more of the following grounds concur:

(Thus amended the previous paragraph by article 6 of Decreto Ejecutivo N° 45007 of April 24, 2025)

16.1. By express request of the applicant.

16.2. When the registration was granted with defects of absolute, evident, and manifest nullity and did not comply with the requirements set forth in this regulation.

16.3. When it is determined that the product, even when used under the recommendations for use, represents an unacceptable risk to health, the environment, and agriculture, upon prior technical and scientific justification by MINSA, MINAE, and SFE according to their competencies.

16.4. When renewal of the registration has not been requested and its validity period expires.

16.5. When the SFE, MINAE or MINSA demonstrate that the information submitted under oath does not coincide with what was declared.

16.6. When the IAGT or the formulated synthetic pesticide registered through the home rule modality is canceled or disauthorized by the regulatory authority of the OECD member country and country adhering to the Mutual Acceptance of Data System of that organization that authorized it and was submitted to home rule in Costa Rica, for reasons of harm to health or the environment, following a prior scientific assessment by the SFE, MINAE, and MINSA.

16.7. When the causes that gave rise to the suspension of the registration are not rectified within the period granted by the SFE.

16.8. When it is demonstrated that the product is ineffective for all uses approved by the SFE.

16.9. When the grounds that gave rise to the suspension according to numeral 15 are not rectified.

16.10. When the Codex Alimentarius, the EPA, or EFSA eliminate, for all authorized uses, the maximum residue limit (MRL) adopted as official in Costa Rica according to the corresponding regulations.

16.11. When, by means of a technical study, the Ministries (MINAE-MS-MAG) jointly and by consensus determine the cancellation of the registration. Said study must be carried out on a mandatory basis when the technical-grade active ingredient is on the "Lista de Moléculas no autorizadas para registrarse por la modalidad de homologación," published on the website of the Servicio Fitosanitario del Estado.

(Thus amended the former point 16.11 by Article 8 of Executive Decree No. 45007 of April 24, 2025)

In these cases, the SFE shall issue the respective cancellation resolution for the registrations of IAGTs and formulated synthetic products, whereby the natural or legal persons to whom this cause for cancellation applies must notify the SFE-MAG, within a maximum, non-extendable period of one calendar month, counted from the issuance of the cancellation resolution, of the inventories of products held under the canceled registrations as well as products that are in documented transit, so that they are authorized a period not exceeding 12 months for their final disposal. Upon expiration of this period, the MAG, through the SFE and the MS, shall proceed to seize all products that have been canceled under this numeral.

16.12. When the information for the update, indicated in the second transitional provision of this regulation, has not been submitted.

17\. COMPETENT AUTHORITIES 17.1. The SFE is responsible for the administration of the registrations of formulated synthetic pesticides, technical-grade active ingredients, active ingredients of mineral or inorganic origin, adjuvants, related substances, physical vehicles, and pesticides of mineral or inorganic origin for agricultural use.

(Thus amended the former point 17.1 by Article 6 of Executive Decree No. 45007 of April 24, 2025)

17.2. The SFE, MINSA, and MINAE shall be responsible for issuing the technical criterion regarding requests for registration modalities and registration modifications.

The criterion issued by MINSA and MINAE is binding for the SFE.

17.3. For those requests in which only the SFE participates, as established in this regulation, the decision-making criteria and technical procedures developed by the MS and MINAE related to human health and the environment, in accordance with their legal competencies, must be respected and applied. MINAE's decision-making criteria and procedures are published by ministerial resolution and available on the DIGECA website. The MS's decision-making criteria shall be issued by ministerial resolution and the procedures shall be published on the MS website.

(Thus amended the former point 17.3 by Article 9 of Executive Decree No. 45007 of April 24, 2025)

17.4. The MAG must coordinate with MINSA and MINAE the promulgation of any modification or repeal of this regulation, the scope of which has some degree of impact on the environment and human health, so that it is issued jointly.

17.5. The Servicio Fitosanitario del Estado (SFE) of the Ministry of Agriculture shall analyze the substantive aspects according to its competencies, as established in:

17.5.1. Section 14, Registration Renewal and Requirements, in its entirety.

17.5.2. Section 12, Modifications to the Registration, in its entirety.

17.5.3. Annex A. Application form for the registration of a Technical-Grade Active Ingredient.

17.5.4. Annex B. Requirements for the registration of a Technical-Grade Active Ingredient with a complete data package evaluation; subsection A) Administrative dossier, subsection B) Technical Information Dossier; Chemical Requirements for SFE Evaluation, subsection C) Confidential Dossier.

17.5.5. Annex D. Application Form for the Registration of Formulated Synthetic Pesticides.

17.5.6. Annex E. Requirements for the Registration of Formulated Synthetic Pesticides.

17.5.7. Annex F. Application form for the registration of related substances and adjuvants.

17.5.8. Annex G. Requirements for the registration of Adjuvants and minimum-risk related substances.

17.5.9. Annex 1-I. Requirements for the registration of coadjuvants and related substances with toxicological evaluation by MINSA and ecotoxicological evaluation by MINAE.

17.5.10. Annex I. Application form for the registration of a physical vehicle with IAGT or related substance incorporated.

17.5.11. Annex J. Requirements for the Registration of Physical Vehicles with IAGT or Related Substance Incorporated, subsection B) Administrative Dossier of the File; subsection C) Confidential Information Dossier of the File; subsection D) Technical Information Dossier of the File.

17.5.12. Annex K. Form for the application for modification to the registration according to numeral 17.2.3.

17.5.13. Annex L. Protocol Review Form for Efficacy Trials of Related Substances and Physical Vehicles for use in agriculture for registration purposes.

17.5.14. Annex M. Sworn Declarations.

17.5.15. Annex N. Requirements for the Registration of an active ingredient of mineral or inorganic origin.

(Thus added the former point 17.5.15 by Article 2 of Executive Decree No. 45007 of April 24, 2025)

17.5.16. Annex O. Requirements for the Registration of Chemical Pesticides of mineral or inorganic origin.

(Thus added the former point 17.5.16 by Article 2 of Executive Decree No. 45007 of April 24, 2025)

17.5.17. Annex P. Registration modality for IAGT with reference information from an Internationally Recognized Authority.

(Thus added the former subparagraph by Article 2 of Executive Decree No. 45007 of April 24, 2025)

17.5.18. Annex Q. Summary form of the toxicological, ecotoxicological, and environmental fate information endpoints supporting the IAGT registration, extracted from the specification or report of the reference information.

(Thus added the former point 17.5.18 by Article 2 of Executive Decree No. 45007 of April 24, 2025)

17.6. MINSA shall analyze the substantive aspects according to its competencies, as established in:

17.6.1. Section 12 Modifications to the Registration: 12.3.1 For the modification in agronomic use (crops, pests, doses, application intervals, pre-harvest interval, type of application). 12.3.2 For the toxicological reclassification of the technical-grade active ingredient or of a formulated synthetic pesticide, adjuvant, or related substance, when new acute toxicology information more appropriate to the product becomes available. 12.3.6 For a change in the formulation composition of formulated synthetic pesticides.

17.6.2. Annex D. Application form for the registration of Formulated Synthetic Pesticides and Chemical Pesticides of Mineral or Inorganic Origin. In cases where the reason for the application is indicated as: registration of formulated synthetic pesticides by recognition of the evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to the mutual acceptance of data system of that organization, or registration of formulated synthetic pesticides with complete evaluation, or Chemical Pesticides of Mineral or Inorganic Origin.

(Thus amended the former point 17.6.2 by Article 6 of Executive Decree No. 45007 of April 24, 2025)

17.6.3. Annex E. Requirements for the Registration of a Formulated Synthetic Pesticide, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, subsection C) Technical Information Dossier of the File; Human Health Requirements for MINSA evaluation; subsection D) Confidential Information Dossier, point 1 Certificate of the quali-quantitative composition of the formulated synthetic pesticide, original or a copy certified by a notary public. In cases where the reason for the application is indicated as: registration of formulated synthetic pesticides by recognition of the evaluation of studies used by the regulatory authorities of OECD member countries or countries adhering to the mutual acceptance of data system of that organization, or registration of formulated synthetic pesticides with complete evaluation.

17.6.4. Annex F. Application form for the registration of related substances and adjuvants.

17.6.5. Annex H. Requirements for the Registration of Adjuvants and Related Substances with evaluation by MINSA and MINAE, Subsection A) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, Subsection B) Technical Information Dossier; Toxicological Requirements, and C) Confidential Dossier; Certificate of quali-quantitative composition of the related substance or adjuvant.

17.6.6. Annex I. Application form for the registration of a physical vehicle with IAGT or related substance incorporated.

17.6.7. Annex J. Requirements for the Registration of Physical Vehicles with IAGT or Related Substance Incorporated, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet; subsection C) Confidential Information Dossier of the File, point 1 Certificate of the quanti-qualitative composition of the physical vehicle to be registered; subsection D) Toxicological Requirements.

17.6.8. For all registration modalities, MINSA may consult and use data from other sections of the administrative, technical, and confidential dossiers necessary to verify that the product does not affect human health and to issue the respective report.

17.6.9. Annex O. Requirements for the Registration of chemical pesticides of mineral or inorganic origin, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, subsection C) Technical Information Dossier of the File; Toxicological Requirements; subsection D) Confidential Information Dossier, point 1 Certificate of the quali-quantitative composition of the chemical pesticide of mineral or inorganic origin, or a copy certified by a notary public.

(Thus added the former point 17.6.9 by Article 2 of Executive Decree No. 45007 of April 24, 2025)

17.7. MINAE shall analyze the substantive aspects according to its competencies, as established in:

17.7.1. Section 12 Modifications to the Registration: 12.3.1 For the modification in agronomic use (crops, pests, doses, application intervals, pre-harvest interval, type of application). 12.3.6 For a change in the formulation composition of formulated synthetic pesticides.

17.7.2. Annex D. Application form for the registration of Formulated Synthetic Pesticides and Chemical Pesticides of Mineral or Inorganic Origin. In cases where the reason for the application is indicated as: registration of formulated synthetic pesticides by recognition of the evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to the mutual acceptance of data system of that organization, registration of formulated synthetic pesticides with complete evaluation, or Chemical Pesticides of Mineral or Inorganic Origin.

(Thus amended the former point 17.7.2 by Article 6 of Executive Decree No. 45007 of April 24, 2025)

17.7.3. Annex E. Requirements for the Registration of a Formulated Synthetic Pesticide, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, subsection C) Technical Information Dossier of the File; Environmental Requirements for MINAE evaluation; subsection D) Confidential Information Dossier, point 1 Certificate of the quali-quantitative composition of the formulated synthetic pesticide, original or a copy certified by a notary public.

In cases where the reason for the application is indicated as: registration of formulated synthetic pesticides by recognition of the evaluation of studies used by the regulatory authorities of OECD member countries or countries adhering to the mutual acceptance of data system of that organization, or registration of formulated synthetic pesticides with complete evaluation.

17.7.4. Annex F. Application form for the registration of related substances and adjuvants.

17.7.5. Annex G. Requirements for the Registration of Adjuvants and Related Substances with evaluation by MINSA and MINAE, Subsection A) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, Subsection B) Technical Information Dossier; Ecotoxicological and Environmental Fate Requirements, and C) Confidential Dossier; Certificate of quali-quantitative composition of the related substance or adjuvant.

17.7.6. Annex I. Application form for the registration of a physical vehicle with IAGT or related substance incorporated.

17.7.7. Annex J. Requirements for the Registration of Physical Vehicles with IAGT or Related Substance Incorporated, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet; subsection C) Confidential Information Dossier of the File, point 1 Certificate of the quanti-qualitative composition of the physical vehicle to be registered; subsection D) Agronomic Requirements for evaluation by SFE and MINAE, and Ecotoxicological and Environmental Fate Requirements.

17.7.8. For all registration modalities, MINAE may consult and use data from other sections of the administrative, technical, and confidential dossiers necessary to verify that the product does not affect the environment and to issue the respective report.

17.7.9. Annex O. Requirements for the Registration of chemical pesticides of mineral or inorganic origin, subsection B) Administrative Dossier of the File, point 3 Safety Data Sheet, point 4 Label, and point 5 Pamphlet, subsection C) Technical Information Dossier of the File; Ecotoxicological and Environmental Fate Requirements; subsection D) Confidential Information Dossier, point 1 Certificate of the quali-quantitative composition of the chemical pesticide of mineral or inorganic origin, or a copy certified by a notary public.

(Thus added the former point 17.7.9 by Article 2 of Executive Decree No. 45007 of April 24, 2025)

18\. CONCORDANCES This document does not coincide with any international standard because no such regulation exists at the time of drafting this regulation.

19\. BIBLIOGRAPHY For the drafting of this regulation, the following international standards, guides, and guidelines were used as bibliographic references:

19.1. Annex I. OCDE Test Guidelines for Studies Included in the SIDS. Manual for Investigation of HPV chemicals.

19.2. Ashby J and Tennant RW (1991): Defesinitive relationships among chemical structure, carcinogenicity ad mutagenicity of 302 chemicals tested by the U.S. NTP. Mutation Research 257, 229-306.

19.3. International Code of Conduct on Pesticide Management.

Revised Version, Rome, 2014.

19.4. Guidelines on Efficacy Evaluation for the Registration of Plant Protection Products.

(Guidelines on Efficacy Evaluation for the Registration of Plant Protection Products).

Rome, 2006.

19.5. Directrices sobre la Legislación para el Control de Plaguicidas (Guidelines on Pesticide Legislation), Rome 2015.

19.6. Directrices sobre la Introducción Inicial y Elaboración Posterior de un Sistema Nacional Sencillo de Registro y Control de Plaguicidas (Guidelines- Initial introduction and subsequent development of a simple national pesticide registration and control scheme), Rome, August 1991.

19.7. ECB (2003): Uso de ((Q)SAR) (Quantitative Structure Activity Relationships) en Análisis de Riesgo in: 93/67 / EEC « Technical Guidance Document on Risk Assessment in Support of Commission Directive on Risk Assessment for new notified substances (EC) Nº 1488/94" Commission Regulation on Risk Assessment for existing substances of the European Parliament and of the Council concerning. the placing of biocidal products in the market Part III, Chapter 4, European Commision, Joint Research Centre, lnstitute for Health and Consumer Protection, European Chemicals Bureau.

19.8. ECETOC (2003): (Q)SARs: evaluación del software comercialmente disponible para la salud humana y los endpoints del medio ambiente, con respecto a las aplicaciones de gerenciamiento químico. Technical Report No. 89. European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels.

19.9. FAO/WHO. Manual on the development and use of FAO and WHO specifications for chemical pesticides. Second edition. Rome and Geneva, 2022.

19.10. Regulation (EC) No 1107/2009 of the European Parliament and of the Council, of 21 October 2009, concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

19.11. Guidance document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107 /2009 SANCO/10597 /2003 -rev. 10. l. 13 July 2012 19.12. Tennant RW and Ashby J (1991): Classification according to chemical structure, mutagenicity to Salmonella and level of carcinogenicity of a further 39 chemicals tested for carcinogenicity by the US National Toxicology program. Mutation Research 257, 209-227.

19.13. Van der Berg, M. et al (1998): Toxic Equivalency Factors (TEFs) for PCBs, PCDDS, PCDFs for humans and wildlife. Environmental Health Perspective, 106 (12), 775-792.

19.14. OCDE (2008). OCDE Guidance for Country Data Review Reports on Plant Protection Products and their Active Substances - Revision 3, April 2008 19.15. SANCO 12638/2011, rev 2. 2012. Guidance document on significant and non-significant changes of the chemical composition of authorised plant protection products under Regulation (EC) No 1107/2009 of the EU Parliament and Council on placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. European Commission.

19.16. European and Mediterranean Plant Protection Organization (EPPO). 2020. PP 1/307(2) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products. Bulletin OEPP/EPPO Bulletin (2020) O (O), 1-7. ISSN 0250-8052. DOI: 10.1111/epp. 12693.

APPLICATION FORM FOR THE REGISTRATION OF AN ACTIVE INGREDIENT TECHNICAL GRADE AND ACTIVE INGREDIENT OF MINERAL OR INORGANIC ORIGIN.

1. General information about the application
1.1 Reason for application:
( ) Registration of IAGT by home rule of registrations or authorizations of IAGT with a complete data package from OECD member countries and Adherents to the Mutual Acceptance of Data System of that organization.	( ) Renewal of IAGT by home rule of registrations or authorizations of IAGT with a complete data package from OECD member countries and adherents to the Mutual Acceptance of Data System of that organization.	( ) Update of IAGT by home rule of registrations or authorizations of IAGT with a complete data package from OECD member countries and adherents to the Mutual Acceptance of Data System of that organization. Registration number of the IAGT (if applicable): Registration number of the formulated synthetic pesticide:
( ) Registration of IAGT by home rule of the IAGT by equivalence authorized or registered in an OECD member country and a country adherent to the Mutual Acceptance of Data System of that organization. Indicate profile registration number.	( ) Renewal of IAGT by home rule of the IAGT by equivalence authorized or registered in an OECD member country and a country adherent to the Mutual Acceptance of Data System of that organization.	( ) Update of IAGT by home rule of the IAGT by equivalence authorized or registered in an OECD member country and a country adherent to the Mutual Acceptance of Data System of that organization. Registration number of the IAGT (if applicable): Registration number of the formulated synthetic pesticide:
( ) Registration of IAGT by complete data package evaluation.	( ) Renewal of IAGT by complete data package evaluation.	( ) Update of IAGT by complete data package evaluation. Registration number of the IAGT (if applicable): Registration number of the formulated synthetic pesticide:
( ) Registration of IAGT by equivalence. Indicate profile registration number.	( ) Renewal of IAGT by equivalence.	( ) Update of IAGT by equivalence. Indicate profile registration number: Registration number of the IAGT (if applicable):
		Registration number of the formulated synthetic pesticide:
( ) Registration of IAGT with reference information from an Internationally Recognized Authority.	( ) Renewal of IAGT with reference information from an Internationally Recognized Authority.	( ) Update of IAGT with reference information from an Internationally Recognized Authority. Registration number of the IAGT (if applicable): Registration number of the formulated synthetic pesticide:
( ) Registration of active ingredient of mineral or inorganic origin	( ) Renewal of active ingredient of mineral or inorganic origin	( ) Update of active ingredient of mineral or inorganic origin
1.2 About the applicant
Company registration number:	Name or corporate name (natural or legal person):
1.3 About the legal representative
Full name:	Identification number:
2. Product data:
2.1 Common or generic name, proposed or accepted by ISO, if none exists, provide that used by IUPAC or that proposed by the Chemical Abstract Convention, or lastly that proposed by the manufacturer:	2.2 Product name or trade name:	2.3 CAS Number
2.4 IUPAC Name:
2.5 Molecular mass	2.6 Synonyms:	2.7 Molecular formula
2.8 Class	2.9 IUPAC Chemical Group:	2.10 CIPAC Number:
2.11 Minimum concentration of the IAGT:	2.12 Maximum concentration of relevant impurities from their limit of detection:
2.13 Product density for products with m/v concentration:

2.14. Toxicological Category (indicate toxicological category and band color as established in the current RTCA labeling standard):
2.15. Web address of the Regulatory Authority of the OECD member country, where the IAGT that is the object of the application is registered or authorized (the applicant must indicate the exact address where the Administration can make this consultation). Applies only for the registration modalities of IAGT by home rule of registrations or authorizations of IAGT with a complete data package from OECD member countries and Adherents to the Mutual Acceptance of Data System of that organization, and registration of IAGT by home rule of the IAGT by equivalence authorized or registered in an OECD member country and a country adherent to the Mutual Acceptance of Data System of that organization.
2.16 Web address or addresses where the reference information for the IAGT is located. Applies only for the registration modality of IAGT with reference information from one or several Internationally Recognized Authorities.
3. Synthesis of the IAGT
3.1 Country of origin of the IAGT factory:
3.2 Name, address, and origin of the IAGT manufacturing plant, including street, district or area, state, city, country:
3.3 Experimental code number that was assigned by the manufacturer, if it exists (the experimental code number is the designation used by the manufacturer to identify the pesticide's active ingredient during the early stages of development):
4. Packaging or container for commercialization in Costa Rica:
4.1 Material:	4.2 Type:	4.3 Capacity:
5. Place or means to receive notifications (Electronic Address):
6. Observations:
Legal representative's signature:

(Thus amended by Article 11 of Executive Decree No. 45007 of April 24, 2025)

REQUIREMENTS FOR THE REGISTRATION OF A TECHNICAL-GRADE ACTIVE INGREDIENT WITH COMPLETE DATA PACKAGE EVALUATION A) ADMINISTRATIVE DOSSIER 1. Submit the fully completed application form for Active Ingredient registration (Annex A), in each of its sections.

2. Proof of payment of the current fee.

3. Safety data sheet for the technical-grade active ingredient; it must contain the internationally standardized requirements using as a model the guidelines of the "Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations." 4. Label: The label must be submitted only if the IAGT is to be imported into the country. The information on the label must be consistent with what is indicated in the dossier.

B)TECHNICAL INFORMATION DOSSIER CHEMICAL REQUIREMENTS 1. Structural formula (must include the stereochemistry of active isomers if known).

2. Studies for the determination of physical and chemical properties, as well as their respective chemical endorsement.

2.1. Physical state. The study conducted with the IAGT must be provided.

2.2. Color. The study conducted with the IAGT must be provided.

2.3. Odor. The study conducted with the IAGT must be provided.

2.4. Melting point in °C (solids). The study conducted with the pure active ingredient must be provided.

2.5. Boiling point in °C (liquids) or decomposition point. The study conducted with the pure active ingredient must be provided.

2.6. Bulk density for solids and relative density for liquids. The study conducted with the IAGT must be provided.

2.7. Vapor pressure, for substances with a boiling point greater than or equal to 30°C. The study conducted with the pure active ingredient must be provided.

2.8. Water solubility. The study conducted with the pure active ingredient must be provided.

2.9. Solubility in organic solvents, in a polar solvent of choice and also a non-polar solvent of choice. It may be conducted with the pure active ingredient or with the IAGT.

2.10. Flammability (solids) or Flash point (liquids). The study conducted with the IAGT must be provided.

2.11. Surface tension. It may be conducted with the pure active ingredient.

2.12. Explosive properties. The study conducted with the IAGT must be provided.

2.13. Oxidizing properties. The study conducted with the IAGT must be provided.

2.14. Viscosity (for liquid substances). The study conducted with the IAGT must be provided.

3. Analytical methods 3.1. Analytical method and its respective validation for determining the purity of the technical-grade active ingredient. The analytical method used in the analysis of five batches must be presented.

3.2. Analytical method and its respective validation for determining relevant impurities, including those below 0.1%.

TOXICOLOGICAL REQUIREMENTS The following studies must be presented, including the cover page, introduction, materials, methods, results, references, and consolidated data tables supporting the results.

The annexes with the recording of daily data, photos, figures, protocols, chromatograms, and statistical sheets are not necessary for the analysis.

1. Acute oral median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline Number 423). This study shall be required in all cases unless the product is a gas or is highly volatile.

2. Acute dermal median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline Number 402). This study shall be required unless:

2.1. The product is a gas or is highly volatile.

2.2. The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

3. Acute inhalation median lethal concentration (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (OECD Technical Guideline Number 403). This shall be requested when any of the following characteristics are met:

The product is a gas or liquefied gas, is a preparation that generates smoke or a fumigant, is used with nebulization equipment, is a preparation that releases vapor, is an aerosol, is a powder containing a significant proportion of particles with a diameter less than 100 µm. To justify not submitting the test, it must be demonstrated that the product does not meet the cited properties.

(Thus amended point 3) above by Article 12 of Decreto Ejecutivo N° 45007 of April 24, 2025) 4. Dermal irritation (Technical Guide number 404 OECD). This study will be required unless:

4.1. The product is a gas or is highly volatile.

4.2. The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

5. Ocular irritation (Technical Guide number 405 OECD). This study will be required unless:

5.1. The product is a gas or is highly volatile.

5.2. The product is corrosive to the eyes or has a pH less than 2 or greater than 11.5.

6. Skin sensitization (Technical Guide number 406 OECD). This study will be required in all cases, except when: The product is known to be a skin sensitizer.

7. Dermal absorption of the active ingredient (Technical Guide number 427 or 428). This study shall be submitted when exposure through the skin constitutes an important exposure route.

The interested party may justify, based on technical and/or scientific information, the non-submission of said study, with the Competent Reviewing Authority being responsible for reviewing whether it is accepted or not.

8. Study on Absorption, distribution, excretion or metabolism in mammals (Technical Guide number 417 OECD).

8.1 This study should be preferably conducted in rats.

8.2 Provide information on rates and extent of absorption and distribution in different tissues.

8.3 Provide information on rate and extent of excretion, including relevant metabolites.

8.4 Identify metabolites and the metabolic pathway.

*In particular cases, the SFE may require additional studies in other species, such as chicken or goat.

3. Acute median lethal concentration by inhalation (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (Technical Guide number 403 OECD). This will be requested when:

9. Subchronic toxicological studies.

9.1. Oral toxicity study, 90 days (Technical Guide number 408 OECD).

* In particular cases, the SFE may require, with prior justification and by reasoned resolution, the following studies:

9.1.1 90-day oral study (OECD Technical Guide 409).

9.1.2 28-day oral study (OECD Technical Guide 407).

9.1.3 28-day dermal study (OECD Technical Guide 410).

9.1.4 90-day dermal study (OECD Technical Guide 411).

9.1.5 28-day inhalation study (OECD Technical Guide 412).

9.1.6 90-day inhalation study (OECD Technical Guide 413).

10. Genotoxic studies (mutagenicity)*:

* The SFE may require other mutagenicity studies, with prior technical and duly reasoned justification in case of positive results, this information being indispensable to proceed with the registration process.

(Thus amended point 10) above by Article 12 of Decreto Ejecutivo N° 45007 of April 24, 2025) 10.1. Bacterial reverse mutation assay (OECD Technical Guide 471).

10.2. Mammalian cell gene mutation assay (OECD Technical Guide 476).

10.3. Micronucleus assay (OECD Technical Guide 474).

11. Chronic toxicological studies. Long-term toxicity and carcinogenesis must be determined.

11.1 24-month oral carcinogenicity study (OECD Technical Guide 451).

11.2. Chronic toxicity study (OECD Technical Guide 452).

11.3. Combined chronic toxicity/carcinogenicity study (OECD Technical Guide 453). * * If a combined chronic toxicity/carcinogenicity study according to OECD Guide 453 is submitted, it is not necessary to submit the study indicated in subsections 11.1 and 11.2.

12. Studies on reproduction.

12.1. Reproductive toxicity study, using the rat as the test animal and conducted in at least two generations (Technical Guide number 416 OECD).

* The SFE may require other studies, with prior technical and duly reasoned justification, this information being indispensable to proceed with the registration process. It may request complementary studies on: dominant lethal assay for male fertility; studies on cross-matings of dosed males with undosed females and vice versa; effects on spermatogenesis, effects on oogenesis; studies on sperm motility and morphology; study on hormonal activity.

13. Studies on teratogenicity (Technical Guide number 414 OECD).

14. Studies on neurotoxicity for compounds having effects on the nervous system.

14.1. If the Technical Grade Active Ingredient is an organophosphate:

14.1.1. Acute neurotoxicity study (Technical Guide number 418 OECD).

14.1.2. 90-day subchronic delayed neurotoxicity study (Technical Guide number 419 OECD).

14.2. If the Technical Grade Active Ingredient is not an organophosphate:

Neurotoxicity study in rodents (Technical Guide number 424 OECD).

ECOTOXICOLOGICAL AND ENVIRONMENTAL FATE REQUIREMENTS The following studies must be submitted, including the cover page, introduction, materials, methods, results, references, and consolidated data tables supporting the results.

Annexes with daily data logs, photos, figures, protocols, chromatograms, statistical sheets are not necessary for the analysis and should not be provided.

Regarding the guides indicated in this section, they are recommended and are cited for the applicant's clarity on the type of study required. However, the studies may have been conducted using any other recognized guide that meets similar parameters.

1. Ecotoxicological studies 1.1. Acute oral toxicity study in birds. Must comply with the provisions of guide OCSPP 850.2100.

1.2. Study on effects on reproduction in birds. Must comply with the provisions of guides OECD 206 and OCSPP 850.2300.

1.3. Acute oral toxicity study for bees. Must comply with the provisions of guide OECD 213.

1.4. Acute contact toxicity study for bees. Must comply with the provisions of guides OECD 214 and OCSPP 850.3020.

1.5. Toxicity study for earthworm. Must comply with the provisions of guides OCSPP 850.3100, OECD 222 or OECD 207.

1.6. Toxicity study for the soil microorganism community: nitrogen transformation. Must comply with the provisions of guides OECD 216 and OCSPP 850.5100.

1.7. Toxicity study for the soil microorganism community: respiration. Must comply with the provisions of guides OECD 217 and OCSPP 850.5100.

1.8. Acute toxicity study in fish. Must comply with the provisions of guides OECD 203 and OCSPP 850.1075.

1.9. Prolonged toxicity study for fish. It is preferable that the study be conducted with the same species presented in the acute toxicity study. One of two types of studies must be presented, as applicable according to the properties of the TGAI indicated:

1.9.1. In all cases, a study on toxicity in the early life stages of fish must be submitted. Must comply with the provisions of guides OECD 210 and OCSPP 850.1400.

1.9.2. A study on the full life cycle of fish must be submitted, complying with the provisions of guide OCSPP 850.1500, when any of the following conditions are met:

1.9.2.1. The bioaccumulation factor is greater than 1000.

1.9.2.2. The substance is persistent in water or sediment (DT50 > 60 days).

1.9.2.3. The acute toxicity study in fish yields EC50 values below 0.1 mg/L.

1.10. Bioaccumulation study in fish. Must comply with the provisions of guides OECD 305 and OCSPP 850.1730 or any other internationally recognized guide. It must only be submitted if any of the following criteria are met:

1.10.1. When the n-octanol/water partition coefficient (LogPOW) is greater than or equal to 3.

1.10.2. The product is persistent in water (DT50 >60 days).

1.11. Acute immobilization study in Daphnia magna. Must comply with the provisions of guides OECD 202 and OCSPP 850.1010.

1.12. Chronic toxicity study in Daphnia magna. Must comply with the provisions of guides OECD 211 and OCSPP 850.1300.

1.13. Toxicity study in algae. Must comply with the provisions of guides OECD 201 and OCSPP 850. 5400.

Note. To meet requirements 1.6 and 1.7, studies conducted with the TGAI or with the formulated synthetic pesticide containing it may be submitted, which must be performed at the maximum TGAI concentration that will be applied in the field.

(Thus added the above note by Article 3 of Decreto Ejecutivo N° 45007 of April 24, 2025)

2. Environmental fate studies:

2.1. Study on aerobic degradation in soil. Must comply with the provisions of guides OECD 307 and OCSPP 835.4100 or any other internationally recognized guide.

2.2. Study on adsorption and desorption. Must comply with the provisions of guides OECD 106 and OCSPP 835. 1230 or any other internationally recognized guide.

2.3. Study on leaching in soil. Must comply with the provisions of guides OECD 312 and OCSPP 835. 1240. It is only required if the data obtained from the adsorption and desorption study determine a Koc value < 15 ml/g.

2.4. Study on aerobic degradation in water. Must comply with the provisions of guides OECD 308 and OCSPP 835.4400 or OCSPP 835 4300 or any other internationally recognized guide.

2.5. Study on hydrolysis. Must comply with the provisions of guides OECD 111 and OCSPP 835.2120 or 835.2130 or any other internationally recognized guide.

2.6. Study on aqueous photolysis. Must comply with the provisions of guides OECD 316 and OCSPP 835.2210 or 835.2240 or any other internationally recognized guide.

2.7. Study of the n-octanol / water partition coefficient (KO/W). Must comply with the provisions of guide OECD 107 or OECD 117 or any other internationally recognized guide.

2.8. In the event that the environmental fate studies on the TGAI to be registered report degradation products that are increasing or at more than 10% at the end of the studies, the applicant must submit a report on the ecotoxicological characteristics and behavior in soil and water of those degradation products. Said report must be based on scientific documents or data on the characteristics of these substances, allowing the determination of persistence.

C)CONFIDENTIAL DOSSIER The following information must be submitted:

1. Qualitative and quantitative composition certificate of the technical grade active ingredient issued by the parent company or by the manufacturer and signed by the responsible professional. It must be submitted with an original signature or a copy certified by a notary public, which will contain:

1.1 Minimum concentration of the technical grade active ingredient expressed as percentage m/m (or g/kg) or percentage m/v. If the concentration is indicated in m/v, the density must be declared.

1.2 Maximum concentration of each impurity greater than or equal to one gram per kilogram (1 g/kg) or 0.1% m/m.

1.3 Maximum concentration of relevant impurities; if they are not present, the non-presence thereof must be indicated.

1.4 Minimum and maximum concentration of other additives present, expressed in g/kg or percentage, when applicable and relevant to the specific case. The function must be indicated (e.g., stabilizer).

1.5 The identity of the active ingredient, impurities, and additives (the latter when applicable and relevant to the specific case) must be indicated according to their chemical name per IUPAC and the CAS number when available; if not available, the chemical structure must be provided.

1.6 In case the active ingredient is a TK, the concentration on a dry basis must also be presented, and the maximum and minimum limits must be indicated.

2 Five-batch study conducted with the TGAI to be registered. Typically, the unidentified and unaccounted-for fraction of the technical grade active ingredient TC/TK must not exceed twenty grams per kilogram. The chromatograms (with their respective area) corresponding to each sampled batch must be attached and must comply with the provisions of numeral 8.1.7 regarding the study's presentation format. In case the guide is not indicated or a different one is used, it must comply with the provisions of point 8.1.8. The results obtained in the five-batch study must comply with the limits established in the composition certificate.

3 Justification for the determination of the manufacturing limits established for the technical grade active ingredient and impurities. The statistical bases or other technical criteria used to establish the manufacturing limits must be explained, and the respective technical justification of how they were obtained must be provided for evaluation by the SFE. In case a statistical criterion is not used, supporting data must be provided to give greater justification to the technical specification. Expert criteria must be technically justified.

4 Identity analysis of the purified active ingredient, which will consist of a set of analytical determinations allowing the composition and constitution of the active ingredient to be unequivocally established. For this, two spectra of the active ingredient with their proper interpretation must be submitted, from among the following: IR, NMR, Mass and UVVIS, with at least one of NMR or Mass being required. Both may also be submitted if available. In case of doubt, the SFE, by reasoned resolution, may request an additional test.

5 Identity of the impurities or eventually groups of related impurities present in the active ingredient synthesized by the manufacturer or under the manufacturer's supervision, which are listed in the composition certificate, must be identified by chemical and spectroscopic analyses with their proper interpretation, allowing the identity of each impurity or group of related impurities to be concluded indubitably and unequivocally.

6 Justification for the presence of impurities: the applicant must provide the necessary technical explanations regarding the presence of impurities in the product. The justification must be based on chemical principles. If the SFE determines that a relevant impurity may be present, it will request the technical justification for why it has not been declared, with prior technical and duly reasoned justification. This information being indispensable to proceed with the registration process.

7 Analytical Methods and their respective validation used in the five-batch study, to determine impurities greater than or equal to one gram per kilogram (1 g/kg) or 0.1% m/m.

8 Summary of the manufacturing pathway. For each process resulting in a technical grade active ingredient, the following information must be provided:

8.1 Name and address of the manufacturer involved in the process.

8.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the synthesis of the product.

8.3 Manufacturing flow diagram.

8.4 Identification of the materials used to produce the product.

8.5 General description of the conditions controlled during the process, as applicable: temperature, pressure, pH, and humidity.

(Thus amended by Article 4 of Decreto Ejecutivo N° 44213 of June 5, 2023)

REQUIREMENTS FOR THE REGISTRATION OF TECHNICAL GRADE ACTIVE INGREDIENT BY EQUIVALENCE A) GENERAL REQUIREMENTS The option for the registration of technical grade active ingredient by equivalence may be chosen, provided that the SFE has a reference profile, in accordance with the provisions of this regulation. The application will not be admitted if it does not comply with the above.

B)ADMINISTRATIVE DOSSIER OF THE FILE 1. Submit the duly completed application form for registration of TGAI by equivalence (Annex A), in each of its sections.

2. Proof of payment of the current fee.

3. Label. The label must be submitted only if the TGAI is to be imported into the country. The information on the label must match what is indicated in the file.

C)TECHNICAL INFORMATION DOSSIER OF THE FILE The guides and methodologies indicated here are a recommendation for use; however, other internationally recognized ones could be accepted by the SFE.

CHEMICAL REQUIREMENTS 1. Structural formula (must include the stereochemistry of active isomers if applicable or known).

2. Analytical method and its respective validation for the determination of the purity of the technical grade active ingredient. The analytical method used in the five-batch analysis must be submitted.

3. Analytical method and its respective validation for the determination of relevant impurities, including those below 0.1%.

TOXICOLOGICAL REQUIREMENTS 1. Studies for the toxicological profile. The following requirements must be submitted:

1.1 Acute oral median lethal dose (LD50). (Technical Guide number 423 OECD). This study will be required in all cases unless the product is a gas or is highly volatile.

1.2 Acute dermal median lethal dose (LD50). (Technical Guide number 402 OECD). This study will be required unless the product is a gas or is highly volatile; is corrosive to the skin or has a pH less than 2 or greater than 11.5.

1.3 Acute median lethal concentration by inhalation (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (Technical Guide number 403 OECD). This will be requested when any of the following characteristics are met: The product is a gas or liquefied gas, is a preparation that generates smoke or a fumigant, is used with nebulization equipment, is a preparation that releases vapor, is an aerosol, is a powder containing a significant proportion of particles with a diameter less than 100 µm. To justify not submitting the test, it must be demonstrated that the product does not meet the cited properties.

(Thus amended point 1.3) above by Article 13 of Decreto Ejecutivo N° 45007 of April 24, 2025) 1.4 Dermal irritation study (Technical Guide number 404 OECD). This study will be required unless the product is a gas or is highly volatile; is corrosive to the skin or has a pH less than 2 or greater than 11.5.

1.5 Ocular irritation study (Technical Guide number 405 OECD). This study will be required unless the product is a gas or is highly volatile; is corrosive to the eyes or has a pH less than 2 or greater than 11.5.

1.6 Skin sensitization study (Technical Guide number 406 OECD). This study will be required in all cases, except when the product is known to be a skin sensitizer.

ECOTOXICOLOGICAL REQUIREMENTS(*)

(*) (Thus amended its designation by Article 3 of Decreto Ejecutivo N° 43961 of March 7, 2023. Previously it stated: "ECOTOXICOLOGICAL AND ENVIRONMENTAL FATE REQUIREMENTS")

Studies for the ecotoxicological profile. The available information must be submitted according to the following alternatives:

1. The registrant may submit the technically or scientifically supported information it deems competent to justify that the present impurities do not represent an unacceptable increase in the hazard of the new source compared to the reference profile (e.g.: QSAR/SAR).

2. The registrant may submit the following ecotoxicological studies of the TGAI to be registered, based on the toxicity to aquatic and terrestrial organisms (fish, daphnia, birds, bees, algae). The registrant may justify the non-submission of any of the studies through a report based on the mode and mechanism of action, solubility, volatility, physical state or others, as applicable in each case:

2.1 Acute oral toxicity in birds. The use of guide OCSPP 850.2100 is recommended.

2.2 Acute oral toxicity for bees. The use of guide OECD 213 is recommended.

2.3 Acute contact toxicity for bees. The use of guide OECD 214, OCSPP 850.3020 is recommended.

2.4 Acute toxicity in fish. The use of guide OECD 203, OCSPP 850.1075 is recommended.

2.5 Acute toxicity in Daphnia magna. The use of guide OECD 202 or OCSPP 850.1010 is recommended.

2.6 Effect on the growth of algae or aquatic plants. The use of guide OECD 201, OCSPP 850.5400 is recommended.

3. In case one or several of the applicable studies listed above are not available for the TGAI to be registered, the available ecotoxicological information of the reported impurities must be submitted, based on available recognized databases, or on estimations using models such as QSAR/SAR.

4. If through recognized databases and models such as QSAR/SAR, it is not possible to obtain the ecotoxicological values for the impurities, a report (with its respective references) may be submitted demonstrating whether the toxic action of the TGAI against the considered species is or is not determined by its corresponding mode of action.

D)CONFIDENTIAL DOSSIER OF THE FILE 1. Qualitative and quantitative composition certificate of the technical grade active ingredient issued by the parent company or by the manufacturer and signed by the responsible professional. It must be submitted with an original signature or a copy certified by a notary public, which will contain:

1.1. Minimum concentration of the technical grade active ingredient expressed as percentage m/m (or g/kg) or percentage m/v. If the concentration is indicated in m/v, the density must be declared.

1.2. Maximum concentration of each impurity greater than or equal to one gram per kilogram (1 g/kg) or 0.1% m/m.

1.3. Maximum concentration of relevant impurities; if they are not present, the non-presence thereof must be indicated.

1.4. Minimum and maximum concentration of other additives present, expressed in g/kg or percentage, when applicable and relevant to the specific case. The function must be indicated (e.g., stabilizer).

1.5. The identity of the active ingredient, impurities, and additives (the latter when applicable and relevant to the specific case) must be indicated according to their chemical name per IUPAC and the CAS number when available; if not available, the chemical structure must be provided.

1.6. In case the active ingredient is a TK, the concentration on a dry basis must also be presented, and the maximum and minimum limits must be indicated.

2. Five-batch study conducted with the TGAI to be registered. Typically, the unidentified and unaccounted-for fraction of the technical grade active ingredient TC/TK must not exceed twenty grams per kilogram. The analyses and chromatograms (with their respective area) corresponding to each sampled batch must be attached and must comply with the provisions of numeral 8.1.7. regarding the study's presentation format. In case the guide is not indicated or a different one is used, it must comply with the provisions of point 8.1.8. The results obtained in the five-batch study must comply with the limits established in the composition certificate.

(Thus amended point 2) above by Article 5 of Decreto Ejecutivo N° 44213 of June 5, 2023) 3. Justification for the determination of the manufacturing limits established for the technical grade active ingredient and impurities. The statistical bases or other technical criteria used to establish the manufacturing limits must be explained, and the respective technical justification of how they were obtained must be provided for evaluation by the SFE. In case a statistical criterion is not used, supporting data must be provided to give greater justification to the technical specification. Expert criteria must be technically justified.

4. Identity analysis of the technical grade active ingredient compared to the standard, which will consist of a set of analytical determinations allowing the composition and constitution of the active ingredient to be unequivocally established. For this, two spectra of the active ingredient with their proper interpretation must be submitted, from among the following: IR, NMR, Mass and UV-VIS, with at least one of NMR or Mass being required. Both may also be submitted if available. In case of doubt, the SFE, by reasoned resolution, may request an additional test.

5. Identity of the impurities or eventually groups of related impurities present in the active ingredient synthesized by the manufacturer or under the manufacturer's supervision, which are listed in the composition certificate, must be identified by chemical and spectroscopic analyses with their proper interpretation, allowing the identity of each impurity or group of related impurities to be concluded indubitably and unequivocally.

6. Justification for the presence of impurities: the registrant must provide the necessary technical explanations regarding the presence of impurities in the product. The justification must be based on chemical principles. If the SFE determines that a relevant impurity may be present, it will request the technical justification for why it has not been declared.

7. Analytical Methods and their respective validation used in the five-batch study, to determine impurities greater than or equal to one gram per kilogram (1 g/kg) or 0.1% m/m.

8. Summary of the manufacturing pathway. For each process resulting in a technical grade active ingredient, the following information must be provided:

8.1 Name and address of the manufacturer involved in the process.

8.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the synthesis of the product.

8.3 Manufacturing flow diagram.

8.4 Identification of the materials used to produce the product.

8.5 General description of the conditions controlled during the process, as applicable: temperature, pressure, pH, and humidity

APPLICATION FORM FOR THE REGISTRATION OF SYNTHETIC FORMULATED PESTICIDES AND CHEMICAL PESTICIDES OF MINERAL OR INORGANIC ORIGIN

1. General information about the application
1.1 Reason for the application
( ) Registration of formulated synthetic pesticide with complete evaluation	( ) Renewal of synthetic pesticide	( ) Update of formulated synthetic pesticide
	formulated with complete evaluation	with complete evaluation Indicate the pesticide registration number:
( ) Registration of formulated synthetic pesticide through the homologation of registrations or authorizations approved by the regulatory authorities of OECD member countries and countries adhering to that organization’s mutual acceptance of data system	( ) Renewal of formulated synthetic pesticide through the homologation of registrations or authorizations approved by the regulatory authorities of OECD member countries and countries adhering to that organization’s mutual acceptance of data system	( ) Update of formulated synthetic pesticide through the homologation of registrations or authorizations approved by the regulatory authorities of OECD member countries and countries adhering to that organization’s mutual acceptance of data system Indicate the pesticide registration number:
( ) Registration of formulated synthetic pesticide by recognition of evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to that organization’s Mutual Acceptance of Data System	( ) Renewal of formulated synthetic pesticide by recognition of evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to that organization’s Mutual Acceptance of Data System	( ) Update of formulated synthetic pesticide by recognition of evaluation of studies used by the regulatory authorities of OECD member countries and countries adhering to that organization’s Mutual Acceptance of Data System Indicate the pesticide registration number:
( ) Registration of chemical pesticide of mineral or inorganic origin	( ) Renewal of chemical pesticide of mineral or inorganic origin	( ) Update of chemical pesticide of mineral or inorganic origin Indicate the pesticide registration number:
1.2 About the applicant
Company registration number:	Name or corporate name (individual or legal entity):
Legal identification number:
1.3 About the legal representative
Full name:	Identification number:
2. Product data
2.1 Common or generic name, proposed or accepted by ISO, by its English acronym; if this does not exist, provide the one used by IUPAC or the one proposed by the Chemical Abstracts Convention, or lastly the one proposed by the manufacturer of the active ingredient used:	2.2 Product name or trade name:	2.3 CAS number of the active ingredient:
2.4 IUPAC name of the active ingredient(s):	2.5 Synonyms:
2.6 Class:	2.7 IUPAC chemical group of the active ingredient:	2.8 Type of formulation:
2.9 Crops requested: Accepts crop grouping: yes ( ) no ( )	2.10 MRL for each crop:
2.11 Manufacturer of the active ingredient of the pesticide: formulated synthetic or chemical pesticide of mineral or inorganic origin:	2.12 Minimum concentration of the active ingredient of the formulated synthetic pesticide or chemical pesticide of mineral or inorganic origin:
2.13 Registration number of the active ingredient associated with the formulated synthetic pesticide or chemical pesticide of mineral or inorganic origin:
2.14: Product density for products with m/v concentration:
2.15. Toxicological Category (indicate toxicological category and band color according to the current RTCA labeling regulation):
2.16. Web address of the Regulatory Authority of the OECD member country where the formulated synthetic pesticide subject to the application is registered or authorized (the applicant must indicate the exact address where the Administration can make this consultation). This requirement is exempted for applications for registration of formulated synthetic pesticides with complete evaluation.
2.17 Indicate if the product is: ( ) corrosive ( ) flammable ( ) non-corrosive ( ) non-flammable
2.18 Indicate for which of the following species the product is toxic: ( ) livestock, ( ) fish or crustaceans, ( ) birds and/or ( ) bees
2.19 Indicate if the product is ( ) persistent in water ( ) persistent in soil ( ) non-persistent in water ( ) non-persistent in soil
2.20 Efficacy trial resolution number:
3. Product formulation
3.1 Country of origin of the formulated synthetic pesticide or chemical pesticides of mineral or inorganic origin:
3.2 Name, address, and origin of the formulation plant including street, district or area, state, city, country:
4. Packaging or container
4.1 Material:	4.2 Type:	4.3 Capacity:
5. Place or means to receive notifications (electronic address):
6. Observations:
Signature of the legal representative:

(Thus amended by Article 14 of Executive Decree No. 45007 of April 24, 2025)

REQUIREMENTS FOR THE REGISTRATION OF FORMULATED SYNTHETIC PESTICIDE A) GENERAL REQUIREMENTS 1. To request the registration of formulated synthetic pesticides, it is essential that the technical grade active ingredient(s) that compose(s) it be registered with the SFE under Executive Decrees No. 33495-MAG-S-MINAE-MEIC, No. 40059-MAG-MINAE-S, No. 42769-MAG-MINAE-S and its amendment, No. 43469-MAG-MINAE-S, or under this decree.

The application will not be admitted if it does not comply with the above.

2. Registration will not be granted to a formulated synthetic pesticide when any protection period for the test data of the chemical entity contained in the technical grade active ingredient(s) used to formulate the formulated synthetic pesticide has not expired, unless the holder of the registration of the technical grade active ingredient(s) has authorized the use of the chemical entity.

B)ADMINISTRATIVE FILE OF THE DOSSIER 1. Submit the duly completed application form for registration of the formulated synthetic pesticide (Annex D), in each of its sections.

2. Proof of payment of the current fee.

3. Safety data sheet for the formulated synthetic pesticide, which must contain the internationally standardized requirements using the guidelines of the "Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations" as a model.

4. Label. The information on the label must match what is indicated in the dossier.

5. Pamphlet. The information in the pamphlet must match what is indicated in the dossier and the efficacy trial approval resolution, issued by the SFE Inspection Unit.

C)TECHNICAL INFORMATION FILE OF THE DOSSIER The guides and methodologies indicated here are a recommendation to use; however, other internationally recognized ones may be accepted by the SFE and MINSA.

CHEMICAL REQUIREMENTS 1. Analytical method(s) used for the determination of the active ingredient contained in the formulated synthetic pesticide, from five batches with their respective validation.

2. Studies on the determination of physical and chemical properties.

2.1 Appearance.

2.2 Color.

2.3 Odor.

2.4 Storage stability, must indicate the container material.

2.5 Density (solids and liquids).

2.6 Flammability or flash point.

2.7 pH.

2.8 Explosiveness.

2.9 Corrosiveness.

2.10 Viscosity (for liquid substances) For the preparation of the studies, it is recommended to use the CIPAC, EEC, FIFRA, OECD, OCSPP (OPPTS) guides and other internationally recognized ones.

3. Studies on the determination of physical properties related to their use. Submit the study when applicable.

3.1 Wettability. Applicability: all solid formulations to be dispersed or dissolved in water. Methodology: MT 53.3 Wetting of wettable powders or current version or another internationally recognized one.

3.2 Foam persistence. Applicability: All formulations intended for dilution with water before use. Methodology: MT 47.3 Foam persistence or current version or another internationally recognized one.

3.3 Wet granulometric analysis. Applicability: To wettable powders (WP), suspension concentrates including those intended for seed treatment and oil-based (SC, FS and OD); water dispersible granules (WG), aqueous capsule suspensions (CS), dispersible concentrates (DC), suspo-emulsions (SE), water soluble tablets and dispersible tablets (ST and WT); and emulsifiable granules and powders (EG and EP). Methodology: MT 182 Wet sieving using recycled water; MT 185 Wet sieve test, the preferred method, a revision of methods MT 59.3 and MT 167 or current version or another internationally recognized one.

3.4 Dry granulometric analysis. Applicability: Powders and granules intended for direct application. Methodology: MT 170 Dry sieve analysis of water dispersible granules (WG) or current version or another internationally recognized one.

3.5 Dispersibility and spontaneity of dispersion. Applicability: To suspension concentrates (SC), aqueous capsule suspensions (CS) and water dispersible granules (WG).

Methodology: MT 160 Spontaneity of dispersion of suspension concentrates; MT 174 Dispersibility of water dispersible granules or another internationally recognized one.

3.6 Suspensibility. Applicability: Wettable powders (WP), suspension concentrates (SC), flowable concentrate for seed treatment (FS) that is diluted for use, capsule suspensions (CS), water dispersible granules (WG) and water dispersible tablets (WT). Methodology: MT 184 Suspensibility for formulations that form suspensions on dilution in water (a harmonization of methods MT 15, MT 161 and MT 168) or current version or another internationally recognized one.

3.7 Emulsion stability and re-emulsification. Applicability: To emulsifiable concentrates (EC), oil-in-water emulsions (EW) and microemulsions (ME). Methodology: MT 36.3 Emulsion characteristics of emulsifiable concentrates or current version or another internationally recognized one.

3.8 Flowability. Applicability: Water dispersible granules (WG), water soluble granules (SG), granules (GR) and emulsifiable granules (EG). Methodology: MT 172.1 The flowability of granular preparations after accelerated storage under pressure or current version or another internationally recognized one.

AGRONOMIC REQUIREMENTS Indicate the resolution number approving the product's efficacy trial, issued by the SFE Inspection Unit, for each of the uses requested for registration or the representative crop of the corresponding group.

In the case of the registration modality of formulated synthetic pesticide by homologation, the efficacy tests that supported the registration or authorization in the OECD country and countries adhering to the Mutual Acceptance of Data System of that organization are submitted.

TOXICOLOGICAL REQUIREMENTS FOR EVALUATION BY MINSA The following complete studies must be submitted, including the cover page, introduction, materials, methods, results, references, and the consolidated data tables that support the results. Annexes with the record of daily data, photos, figures, protocols, chromatograms, statistical sheets are not necessary for the analysis.

1. Acute oral median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline number 423). This study will be required in all cases unless the product is a gas or is highly volatile.

2. Acute dermal median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline number 402). This study will be required unless:

2.1. The product is a gas or is highly volatile.

2.2. The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

3. Acute median lethal concentration by inhalation (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (OECD Technical Guideline number 403). This will be requested when any of the following characteristics are met: The product is a gas or liquefied gas, is a smoke-generating preparation or a fumigant, is used with nebulization equipment, is a vapor-releasing preparation, is an aerosol, is a powder containing a significant proportion of particles with a diameter less than 100 ?m. To justify the non-submission of the trial, it must be demonstrated that the product does not meet the cited properties.

(Thus amended point 3) above by Article 15 of Executive Decree No. 45007 of April 24, 2025) 4. Dermal irritation (OECD Technical Guideline number 404). This study will be required unless:

4.1. The product is a gas or is highly volatile.

4.2. The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

5. Ocular irritation (OECD Technical Guideline number 405). This study will be required unless:

5.1. The product is a gas or is highly volatile.

5.2. The product is corrosive to the eyes or has a pH less than 2 or greater than 11.5.

6. Skin sensitization (OECD Technical Guideline number 406). This study will be required in all cases, except when:

The product is known to be a skin sensitizer.

7. Demonstrate that the requested use pattern of the formulated synthetic pesticide complies with the MRLs adopted by the country for the requested crop, complying with what is indicated in numeral 8.2.2 of this regulation.

8. The human health risk assessments presented by the applicant will be analyzed for the case of the registration modality with complete evaluation, recognition of formulated synthetic pesticide, and registration of chemical pesticide of mineral or inorganic origin. A qualitative or quantitative human health risk assessment based on the product's hazardousness and the type of handling and the proposed use pattern must include the following information:

- Identity of the pesticide, its metabolites when applicable, and the other components of the formulation that may affect adverse effects in humans.

- Population that may be affected by the application of the pesticide, considering at least: operators, workers, residents of adjacent areas, bystanders, and consumers.

- Indicative critical data or values used as a reference or estimated by the applicant to define the toxicity of the pesticide, such as: Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD), Tolerable Daily Intake (TDI), tolerable weekly and monthly intake (PTWI, PTMI), limit intake in water, Operator Exposure Levels (AOEL), maximum residue limits (MRLs), etc. The reference from which these data were taken must be indicated.

- Routes of exposure by which contact with the pesticide could occur, for example, inhalation, ingestion, dermal contact, etc.

- The expected duration and frequency of exposure. The registrant is expected to identify whether it is acute, chronic, subchronic, or if all durations apply.

- Mitigation actions proposed by the company to be implemented by users or the regulatory entities in charge to avoid harm to human health.

The applicant may provide human health risk assessments from other regulatory entities, including the URL addresses of the respective report, provided they have been carried out with the same product to be registered and that they contain at least what is requested in this section. The MS will have available an example guide for the presentation of the risk analysis, which can be consulted on that ministry's website. For the case of the registration modality of formulated synthetic pesticide by homologation, the human health evaluation carried out by the OECD and adhering country in which it is registered or authorized will be accepted.

(Thus amended point 8) above by Article 15 of Executive Decree No. 45007 of April 24, 2025) ENVIRONMENTAL REQUIREMENTS FOR EVALUATION BY MINAE.

Environmental Risk Assessment (ERA) report based on data on the application of the formulated synthetic pesticide duly supported in the approval resolution issued by the SFE Inspection Unit, as well as the ecotoxicological and environmental fate data of the technical grade active ingredient(s) (IAGT) that compose(s) it according to what is indicated in Annex B. The ERA must be carried out applying what is indicated in the document: "General procedure and guidelines to be followed by MINAE for the environmental risk assessment of agricultural inputs", available on the DIGECA website, www.digeca.go.cr. Likewise, the registration holder may use other procedures and models, provided they are accepted by other regulatory authorities of OECD countries, providing the corresponding technical justification of why they are better adapted to the conditions of Costa Rica and the requested use pattern, which will be evaluated by MINAE. In case refinement of the ERA to higher tiers is required, the additional technical and scientific information used must be provided.

In the case of the registration modality of formulated synthetic pesticide by homologation, the ERA carried out by the OECD country and countries adhering to the Mutual Acceptance of Data System of that organization where it is registered or authorized will be accepted.

D)CONFIDENTIAL INFORMATION FILE Requirements:

1. Certificate of the quali-quantitative composition of the formulated synthetic pesticide, original or copy certified by a notary public, issued less than two years ago by the parent company or the formulator and signed by the responsible professional, and must contain:

1.1 Nominal content expressed as a percentage m/m or m/v of active ingredient calculated from the minimum concentration declared in the registration of the active ingredient, as well as, if applicable, the corresponding content of variants (such as salts and esters) of the active substances.

1.2 Nominal content of each co-formulant of the formulation expressed as a percentage m/m or m/v.

1.3 Function of each of the co-formulants included in the formulation.

1.4 The identity of the co-formulants and the active ingredient must be indicated according to their IUPAC chemical name and the CAS number when available. If not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet of the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted instead.

1.5 Density of the formulation (must indicate the units and temperature).

1.6 Maximum content of relevant impurities, when present.

Note: For the case of the registration modality of formulated synthetic pesticide by homologation, the composition certificate with the issuance date that supported the registration or authorization in the OECD country and countries adhering to the Mutual Acceptance of Data System of that organization will be accepted.

2. Analysis of five (as a minimum) typical batches of the formulated product to be registered, attaching the corresponding analysis results of the active ingredient of each analyzed batch of the formulated synthetic pesticide, not older than 5 years from formulation. Likewise, the chromatograms of the active ingredient corresponding to each batch must be attached, identifying them with the analysis date and formulation date, formulator, and the results obtained from each one, with the areas of each chromatogram peak and data from the formula used to obtain the result, or sample calculation.

Note: For the case of the registration modality of formulated synthetic pesticide by homologation, the number of batches with their formulation date that supported the registration or authorization in the OECD country and countries adhering to the Mutual Acceptance of Data System of that organization will be accepted.

3. Description of the formulation process: The company must submit information on the formulation processes of the formulated synthetic pesticide subject to registration. For each process, the following information must be provided:

3.1 Name and address of the formulator involved in the process.

3.2 General characterization of the process.

3.3 Indicate the ingredients used to formulate the product.

3.4 Description of the equipment used.

3.5 Description of the conditions controlled during the process

(Thus amended by Article 7 of Executive Decree No. 44213 of June 5, 2023)

APPLICATION FORM FOR REGISTRATION OF RELATED SUBSTANCES AND ADJUVANTS

REQUIREMENTS FOR THE REGISTRATION OF ADJUVANTS AND RELATED SUBSTANCES OF MINIMUM RISK A) ADMINISTRATIVE FILE OF THE DOSSIER 1. Submit the duly completed application form for registration of adjuvants and related substances (Annex F), in each of its sections.

2. Proof of payment of the current fee.

3. Label. The information on the label must match what is indicated in the dossier.

4. Pamphlet, in cases that apply. The information in the pamphlet must match what is indicated in the dossier and the efficacy trial approval resolution when applicable, issued by the SFE Inspection Unit.

B)TECHNICAL INFORMATION FILE The guides and methodologies indicated here are a recommendation to use; however, other internationally recognized ones may be accepted by the SFE.

CHEMICAL REQUIREMENTS 1. Studies on the determination of physical and chemical properties. If not applicable, the respective justification for why the study is not submitted must be presented.

1.1. Physical state.

1.2. Color.

1.3. Density.

1.4. Flammability for solid substances or flash point for liquid substances.

1.5. Corrosiveness.

1.6. Explosiveness.

1.7. Solubility (indicate in which solvent it is soluble and the result with its respective units).

1.8. Indicate if it produces foam (Study not required) 1.9. Vapor pressure (for volatile products) AGRONOMIC REQUIREMENTS In cases where it is necessary to verify the efficacy of related substances (growth regulators, repellents, attractants, seed protectants), the resolution number approving the efficacy trial, issued by the SFE Inspection Unit, will be required. See Annex L. The efficacy trial does not apply for adjuvants.

C)CONFIDENTIAL FILE 1. Each co-formulant and main component of the composition certificate is on the "List of authorized components for formulated synthetic pesticides, adjuvants, and related substances" visible on the SFE website. If the main component or any of the co-formulants indicated in the composition are not on the indicated list, the product will not be considered minimum risk certified and the final resolution denying the registration request and its archiving will be issued.

2. Quali-quantitative composition certificate of the related substance or adjuvant, original or copy certified by a notary public, issued less than two years ago by the parent company, the manufacturer or formulator, as applicable, and signed by the responsible professional. Must include:

2.1 Nominal content of each of the co-formulants and the main component included in the formulation expressed as a percentage m/m or m/v, must indicate the density with its respective units and temperature.

Function of each of the co-formulants included in the formulation.

2.2 Identity of the co-formulants and main component according to their IUPAC chemical name and the CAS number when available. If not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet of the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted instead.

3. Description of the formulation process: The company must submit information on the formulation processes of the adjuvant or related substance subject to registration. For each process, the following information must be provided:

3.1. Name and address of the formulator involved in the process.

3.2. General description of the process: written description in prose which must explain the necessary steps to carry out the formulation of the product.

3.3. Indicate the ingredients used to formulate the product.

3.4. Description of the equipment used.

3.5. Description of the conditions controlled during the process 3.6. Description of the method used or the way to quantify, identify, or characterize each component in the formulation.

REQUIREMENTS FOR THE REGISTRATION OF ADJUVANTS AND RELATED SUBSTANCES WITH EVALUATION BY MINSA AND MINAE A) ADMINISTRATIVE FILE OF THE DOSSIER 1. Submit the duly completed application form for registration of adjuvants and related substances (Annex F), in each of its sections.

2. Proof of payment of the current fee.

3. Safety data sheet for the adjuvant or related substance, must contain the internationally standardized requirements using the guidelines of the "Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations" as a model.

4. Label. The information on the label must match what is indicated in the dossier.

5. Pamphlet, in cases that apply. The information in the pamphlet must match what is indicated in the dossier and the efficacy trial approval resolution, issued by the SFE Inspection Unit.

B)TECHNICAL INFORMATION FILE The guides and methodologies indicated here are a recommendation to use; however, other internationally recognized ones may be accepted by the SFE, MINSA, and MINAE.

CHEMICAL REQUIREMENTS 1. Studies on the determination of physical and chemical properties. If not applicable, the respective justification for why the study is not submitted must be presented.

1.1 Physical state.

1.2 Color.

1.3 Density.

1.4 Flammability for solid substances or flash point for liquid substances.

1.5 Corrosiveness.

1.6 Explosiveness.

1.7 Solubility (indicate in which solvent it is soluble and the result with its respective units).

1.8 Indicate if it produces foam (study not required).

1.9 Vapor pressure (for volatile products) AGRONOMIC REQUIREMENTS In cases where it is necessary to verify the efficacy of related substances (growth regulators, repellents, attractants, seed protectants), the resolution number approving the efficacy trial, issued by the SFE Inspection Unit, will be required. See Annex L. The efficacy trial does not apply for adjuvants.

TOXICOLOGICAL REQUIREMENTS 1. Acute oral median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline number 423). This study will be required in all cases unless the product is a gas or is highly volatile.

2. Acute dermal median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline number 402). This study will be required unless:

2.2 The product is a gas or is highly volatile.

2.3 The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

3. Acute median lethal concentration by inhalation (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (OECD Technical Guideline No. 403). This shall be requested when any of the following characteristics are met: The product is a gas or liquefied gas, is a preparation that generates smoke or is a fumigant, is used with nebulization equipment, is a preparation that releases vapor, is an aerosol, is a powder containing a significant proportion of particles with a diameter less than 100 ?m. To justify the non-submission of the test, it must be demonstrated that the product does not meet the cited properties.

(Point 3) above as amended by Article 16 of Decreto Ejecutivo N° 45007 of April 24, 2025) 4. Dermal irritation (OECD Technical Guideline No. 404). This study shall be required unless:

4.1 The product is a gas or is highly volatile.

4.2 The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

5. Ocular irritation (OECD Technical Guideline No. 405). This study shall be required unless:

5.1 The product is a gas or is highly volatile.

5.2 The product is corrosive to the eyes or has a pH less than 2 or greater than 11.5.

6. Skin sensitization (OECD Technical Guideline No. 406). This study shall be required in all cases, except when the product is known to be a skin sensitizer.

ECOTOXICOLOGICAL AND ENVIRONMENTAL FATE REQUIREMENTS 1. Ecotoxicological studies.

1.1 Acute oral toxicity study in birds. The use of OCSPP guideline 850.2100 is suggested.

1.2 Acute oral toxicity study for bees. The use of OECD guideline 213 is suggested.

1.3 Acute contact toxicity study for bees. The use of OECD guideline 214 and OCSPP guideline 850.3020 is suggested.

1.4 Acute toxicity study in fish. The use of OECD guideline 203 and OCSPP guideline 850.1075 is suggested.

1.5 Acute immobilization study in Daphnia magna. The use of OECD guideline 202 and OCSPP guideline 850.1010 is suggested.

1.6 Toxicity study in algae. The use of OECD guideline 201 and OCSPP guideline 850.5400 is suggested.

2. Environmental fate studies.

2.1 Study on aerobic degradation in soil. The use of OECD guideline 307 and OCSPP guideline 835.4100 is suggested.

2.2 Study on aerobic degradation in water. The use of OECD guideline 308 and OCSPP guideline 835.4400 or OCSPP 835.4300 is suggested.

2.3 Study of the n-octanol/water partition coefficient (KO/W). The use of OECD guideline 122 is suggested.

In the event that one or more of the studies indicated above are not available, a technical report may be submitted that includes the ecotoxicological and environmental fate data generated from computer models that predict qualitative structure-activity relationships (structural alerts, SAR) or quantitative structure-activity relationships (QSAR), expert computer systems, and the extrapolation of properties by structural similarity, using analogues and categories.

C)CONFIDENTIAL FILE 1. Certificate of quali-quantitative composition of the related substance or adjuvant, original or a copy certified by a notary public, issued less than two years ago by the parent company, the manufacturer, or the formulator, as applicable, and signed by the responsible professional. It must include:

1.1 Nominal content of each of the co-formulants and the main component included in the formulation, expressed as a percentage m/m or m/v; the density must be indicated with its respective units and temperature.

1.2 Function of each of the co-formulants included in the formulation.

1.3 Identity of the co-formulants and the main component according to their IUPAC chemical name and the CAS number when they are available. If they are not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet for the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted in its place.

2. Description of the formulation process: The company must submit information on the formulation processes of the adjuvant or related substance subject to registration. For each process, the following information must be provided:

2.1 Name and address of the formulator involved in the process.

2.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the formulation of the product.

2.3 Indicate the ingredients used to formulate the product.

2.4 Description of the equipment used.

2.5 Description of the conditions that are controlled during the process.

2.6 Description of the method used or the way to quantify, identify, or characterize each component in the formulation.

APPLICATION FORM FOR REGISTRATION OF A PHYSICAL CARRIER WITH INCORPORATED T-GAI OR RELATED SUBSTANCE

REQUIREMENTS FOR THE REGISTRATION OF PHYSICAL CARRIERS WITH INCORPORATED TECHNICAL GRADE ACTIVE INGREDIENT OR RELATED SUBSTANCE A) GENERAL REQUIREMENTS 1. For the application for registration of physical carriers with incorporated Technical Grade Active Ingredient or incorporated related substance, it is essential that the technical grade active ingredient(s) (T-GAI) that compose(s) it is (are) registered with the SFE under Decretos Ejecutivos Nº 33495-MAG-S-MINAE-MEIC, Nº 40059-MAG-MINAE-S, Nº 42769-MAG-MINAE-S and its amendment, Nº 43469-MAG-MINAE-S, or under this decree. The application will not be admitted if it does not comply with the foregoing.

2. Registration of a physical carrier shall not be granted when any term of protection for the test data of the chemical entity contained in the technical grade active ingredient(s) used to formulate the synthetic formulated pesticide has not expired, unless the holder of the registration of the technical grade active ingredient(s) has authorized the use of the chemical entity(ies).

B)ADMINISTRATIVE FILE OF THE DOSSIER 1. Submit the duly completed application form for registration of physical carriers with incorporated Technical Grade Active Ingredient or related substance (Annex I), in each of its sections.

2. Proof of payment of the current fee.

3. Safety data sheet for the physical carrier; it must contain the internationally standardized requirements using the guidelines of the "Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations" as a model.

4. Label. The information on the label must match what is indicated in the dossier.

5. Pamphlet. The information on the pamphlet must match what is indicated in the dossier and the approval resolution for the efficacy trial, issued by the Oversight Unit of the SFE.

C)CONFIDENTIAL INFORMATION FILE OF THE DOSSIER CHEMICAL REQUIREMENTS 1. Certificate of qualiquantitative composition of the physical carrier to be registered, original or a copy certified by a notary public, issued less than two years ago by the parent company or the formulating company and signed by the responsible professional, which shall contain:

1.1 The nominal content, expressed as a percentage m/m or m/v, of the T-GAI or related substance and the nominal content of each co-formulant in the product.

1.2 It must indicate the function of each co-formulant.

1.3 Both the T-GAI or related substance, and the other co-formulants must be identified with a CAS number and IUPAC name. If this is not available, the chemical structure must be attached. If codes are used to identify the co-formulants, the function must be described and the safety data sheet for the co-formulant must be provided, only if it does not have a CAS number or IUPAC name. When the co-formulants are mixtures, their composition must be indicated. In the event that it is a proprietary mixture protected under industrial secrecy, the safety data sheet may be submitted in its place.

1.4 Concentrations must be reported as a percentage m/m or m/v; the density must be indicated with its respective units and temperature.

2 Production process.

2.1 In the case where the physical carrier is produced with a masterbatch, the manufacturing process of the masterbatch and its composition must be submitted, indicating the manufacturer and the minimum concentration of the T-GAI used. Additionally, for the production process of the bag or other physical carrier, the following information must be submitted:

2.1.1 Name and address of the formulator involved in the process.

2.1.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the formulation of the product.

2.1.3 Indicate the ingredients used to formulate the product.

2.1.4 Description of the equipment used.

2.2 Description of the conditions that are controlled during the process.

2.3 Manufacturing process for a physical carrier with an included related substance. The company must submit information on the formulation processes of the physical carrier subject to registration.

For each process, the following information must be provided:

2.3.1 Name and address of the formulator involved in the process.

2.3.2 General description of the process: a written description in prose which must explain the steps necessary to carry out the formulation of the product.

2.3.3 Indicate the ingredients used to formulate the product.

2.3.4 Description of the equipment used.

2.3.5 Description of the conditions that are controlled during the process.

2.3.6 Description of the method used or the way to quantify, identify, or characterize each component in the formulation.

D)TECHNICAL INFORMATION FILE OF THE DOSSIER CHEMICAL PART REQUIREMENTS 1. Methods of analysis for the active ingredient content (only for the case of physical carriers with T-GAI), together with the validation parameters according to the established guide and the results obtained.

2. Certificate of analysis issued less than two years ago by the parent company or by the formulator of the product for the T-GAI content (only for the case of physical carriers with T-GAI), original or a copy certified by a notary public and signed by the responsible professional, which shall contain the detail regarding the nominal concentration of the main component(s) or T-GAI expressed as mass/mass or mass/volume percentages, date of analysis, and batch number analyzed. In the event that the certificate of analysis was issued by the parent company, the location where the product was formulated must be indicated in it.

3. Physical and chemical properties of the bags or physical carrier.

3.1. Color.

3.2. Storage stability; the storage conditions of the product (relative humidity, temperature) must be submitted in order to guarantee its quality and the half-life.

AGRONOMIC PART REQUIREMENTS FOR EVALUATION BY THE SFE AND MINAE.

Indicate the resolution number for the approval of the product's efficacy trial, issued by the Oversight Unit of the SFE, for each of the uses for which registration is requested.

PHYSICAL CARRIERS WITH INCORPORATED RELATED SUBSTANCE In the case of physical carriers whose related substance is not on the "List of Authorized Components for Synthetic Formulated Pesticides, Adjuvants, and Related Substances," in addition to the foregoing, the following requirements must be submitted:

TOXICOLOGICAL REQUIREMENTS 1. Acute oral median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline No. 423). This study shall be required in all cases unless the product is a gas or is highly volatile.

2. Acute dermal median lethal dose (LD50), expressed in mg/kg of body weight (OECD Technical Guideline No. 402). This study shall be required unless:

2.4 The product is a gas or is highly volatile.

2.5 The product is corrosive to the skin or has a pH less than 2 or greater than 11.5.

3. Acute median lethal concentration by inhalation (LC50), expressed in mg/l of air or mg/m3, for 4 hours of exposure (OECD Technical Guideline No. 403). This shall be requested when any of the following characteristics are met: The product is a gas or liquefied gas, is a preparation that generates smoke or is a fumigant, is used with nebulization equipment, is a preparation that releases vapor, is an aerosol, is a powder containing a significant proportion of particles with a diameter less than 100 m. To justify the non-submission of the test, it must be demonstrated that the product does not meet the cited properties.

(Point 3) above as amended by Article 17 of Decreto Ejecutivo N° 45007 of April 24, 2025) 4. Dermal irritation (OECD Technical Guideline No. 404). This study shall be required unless: