Regulatory summary — position as at 17 July 2026

Fertilisers, soil amendments and productos afines de uso agrícola — abbreviated F.ES.PAUA in the Ecuadorian texts — are regulated by the Agencia de Regulación y Control Fito y Zoosanitario (ARCFZ, operating as Agrocalidad), an entity of the Ministerio de Agricultura y Ganadería constituted under the Ley Orgánica de Sanidad Agropecuaria of 2017.

The operative instrument is the Manual Técnico adopted under Resolución 218, now in its eighth edition, approved 23 May 2026. Biostimulants are not fertilisers in this scheme: §4.1.3 places bioestimulantes first among twenty-seven subtypes of producto afín, with elicitores and growth regulators as separate categories alongside them. The manual excludes products a farmer makes in Ecuador for his own exclusive use, and growth regulators whose function is pest control (§2.2).

Registration is mandatory and operates on two tiers.

Operator registration must precede any activity as manufacturer, formulator, packager, importer, exporter or distributor, is administered through the Sistema GUIA, carries indefinite validity, is non-transferable, and is verified by post-registration inspection against the Anexo 1 checklist (§§3.1–3.7).

Product registration is then required before any F.ES.PAUA or raw material may be commercialised, the sole exemption being raw materials consumed directly in manufacturing another registered product (§5.1(a)).

The dossier (Cuadro 3) comprises the application, GUIA verification of the operator registration, a certificado de composición y vida útil signed by the manufacturer in the country of origin, and a laboratory report from an ISO/IEC 17025-accredited laboratory of appropriate scope, assessed against NTE INEN 211 tolerances. An ensayo interno conducted in Ecuador is required only for products containing biological inoculants or growth regulators of natural origin. Composition must be declared as fixed values, never ranges (§5.1(k)).

Two thresholds govern composition. Cuadro 1 sets declarable minima of 3% for N, P₂O₅ and K₂O, but for biostimulants macronutrients are declared only where they exceed 50% of those figures (§4.2(c)); there is accordingly no nutrient floor a biostimulant must clear to be registrable. Cuadro 2 caps heavy metals, the limits for productos afines being arsenic 50 mg/kg, lead 150, nickel 100, mercury 2, non-phosphatic cadmium 10 and hexavalent chromium 2.5.

Pesticidal properties may not be declared anywhere in the dossier (§5.1(o)); such a claim moves the product into the plaguicidas regime of Codificación 2004-11, whose Article 2 defines producto afín by reference to pest control — a homonym of the fertiliser-side term, not an overlap. An organic listing such as OMRI confers nothing: the phrase “Permitido para la Producción Orgánica” requires separate evaluation after registration (§5.1(w)).

The official fee for product registration is USD 441.6259, excluding IVA; the manual fixes no amounts, referring throughout to the tarifario vigente. No statutory approval deadline exists.

What is fixed is that, once the Agency issues its first unfavourable response, the applicant has 365 calendar days to obtain the certificate, failing which the process must be recommenced under the norms then in force (§5.2(i)). Realistic end-to-end duration is unpublished and should be estimated through a local agent.

Reference texts

Manual Técnico para el Registro y Control de Fertilizantes, Enmiendas de Suelo y Productos Afines de Uso Agrícola, Edición No. 8, approved 23/05/2026, adopted under Resolución 218 and authorised by Memorando AGR-AGROCALIDAD/DE-2026-000360-M of 24/05/2026: agrocalidad.gob.ec/wp-content/uploads/2026/05/document.pdf · Ley Orgánica de Sanidad Agropecuaria, RO Suplemento 27, 03/07/2017: agrocalidad.gob.ec/wp-content/uploads/2024/10/Ley-Organica-de-Sanidad-Agropecuaria.pdf · Codificación 2004-11, Ley para Formulación, Fabricación, Importación, Comercialización y Empleo de Plaguicidas y Productos Afines de Uso Agrícola, certified 17/03/2004, consolidating Ley 73 (RO 442, 22/05/1990), Decreto Ley 02 (RO-S 930, 07/05/1992) and Ley 93 (RO-S 764, 22/08/1995) ·

Fee and procedure: gob.ec/arcfz/tramites/solicitud-registro-fertilizantes-enmiendas-suelo-productos-afines-uso-agricola ·

Tarifario: agrocalidad.gob.ec/tarifario ·

Submission platform: guia.agrocalidad.gob.ec

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The sciBASICS Team.