A Safety Data Sheet (SDS) for an Ecuador market has to follow the format and content requirements of the GHS-aligned NTE INEN-ISO 11014 standard. A SDS in fluent Spanish that does not follow the standard will be sent back by the receiving safety officer, the procurement reviewer, or the regulator.
This note covers what NTE INEN-ISO 11014 requires, the 16-section GHS format, and the translation and review process for an SDS portfolio.
The 16-section GHS format
A GHS-aligned SDS has 16 standardized sections, in a defined order, with defined headings. The Spanish version has to use the same section numbers, the same section headings (in the standardized Spanish), and the same order as the source. The 16 sections are:
- Identificación del producto — Identification of the substance or mixture and of the supplier
- Identificación de los peligros — Hazards identification
- Composición / información sobre los componentes — Composition / information on ingredients
- Primeros auxilios — First-aid measures
- Medidas de lucha contra incendios — Firefighting measures
- Medidas en caso de vertido accidental — Accidental release measures
- Manipulación y almacenamiento — Handling and storage
- Controles de exposición / protección personal — Exposure controls / personal protection
- Propiedades físicas y químicas — Physical and chemical properties
- Estabilidad y reactividad — Stability and reactivity
- Información toxicológica — Toxicological information
- Información ecotoxicológica — Ecotoxicological information
- Consideraciones relativas a la eliminación — Disposal considerations
- Información relativa al transporte — Transport information
- Información reglamentaria — Regulatory information
- Otra información — Other information
The Spanish section headings are standardized. A translation that uses a non-standard heading for a section (for example, "Información sobre eliminación" for Section 13 instead of "Consideraciones relativas a la eliminación") creates a SDS that does not match the receiving safety officer's checklist.
The standardized statements
The GHS system also standardizes the language of the hazard statements (H-statements) and the precautionary statements (P-statements). The Spanish version of each H-statement and P-statement is standardized and has to be used verbatim.
For example:
- H302 is "Nocivo en caso de ingestión" in Spanish (Harmful if swallowed).
- H315 is "Provoca irritación cutánea" (Causes skin irritation).
- P264 is "Lavarse las manos concienzudamente tras la manipulación" (Wash hands thoroughly after handling).
A translation that paraphrases a standardized statement (for example, "H302: Puede ser dañino si se ingiere" instead of the standardized "Nocivo en caso de ingestión") creates a SDS that does not match the source's classification. The receiving safety officer's automated SDS management system, and any GHS-aligned downstream tool, will not match the SDS to the source.
The Ecuador-specific regulatory references
Section 15 (Información reglamentaria) is where the SDS references the applicable Ecuador regulations. The standard references are:
- NTE INEN-ISO 11014 — the Ecuador GHS-aligned SDS standard.
- Reglamento de Seguridad y Salud de los Trabajadores y Mejoramiento del Medio Ambiente de Trabajo (Decreto Ejecutivo 2393) — the workplace safety and health regulation.
- Reglamento para la Prevención y Control de la Contaminación por Desechos Peligrosos (Decreto Ejecutivo 2635) — the hazardous waste regulation, where applicable.
- Ley Orgánica del Ambiente and its regulations — the environmental framework law.
- Acuerdo Ministerial 142 (and subsequent reforms) — the chemicals and hazardous waste management framework.
A SDS that omits the Ecuador-specific regulatory references, or references the U.S. OSHA or EU CLP regulations in their place, will be sent back by the receiving safety officer.
The translation process
The translation of an SDS portfolio is different from the translation of a manual or a SOP. A few patterns to keep in mind:
- The source SDS is the source of truth. The translation has to match the source's classifications, statements, and regulatory references. A translation that "improves" a classification creates a SDS that does not match the source.
- A master template drives the format. The 16-section structure, the heading text, the standard phrases (e.g., "Ver sección 8 para los equipos de protección personal") are populated from a master template. Only the substance-specific content (Section 1 product identifiers, Section 2 hazard classification, Section 3 composition, Section 9 physical properties, etc.) is translated per product.
- A glossary per product family. Products in the same family (e.g., a portfolio of solvents, a portfolio of resins) share a glossary. The translator handles the first product of the family in full and reuses the standardized language for the rest.
- A regulatory review is part of the deliverable. The Ecuador-specific regulatory references in Section 15 are checked against the current regulatory framework, not just translated. A regulatory change (e.g., a new Acuerdo Ministerial) is reflected in the next quarterly update.
A specialist translation service runs the SDS portfolio as a structured program, not as a set of one-off files. The first SDS of the product family takes longer; the rest of the family moves faster because the template and the glossary are in place.
The review process
A SDS portfolio goes through three reviews before delivery:
- The translator's review. A cross-check of the Spanish against the source for each of the 16 sections, the standardized statements, and the regulatory references.
- The safety officer's review. A check of the Spanish against the GHS classification, the standardized statements, and the Ecuador regulatory framework. This is typically done by a Spanish-speaking safety specialist.
- The receiving party's review. The first SDS of the family is reviewed by the receiving safety officer or the procurement reviewer to confirm the format and the regulatory references. Once confirmed, the rest of the family moves through reviews 1 and 2 only.
A SDS portfolio that has all three reviews delivers in a predictable cadence and is accepted on the first review by the receiving party.
What to send your translator
To get an SDS portfolio that meets NTE INEN-ISO 11014 and passes the receiving safety officer's review, send:
- The source SDS for each product, in the original language.
- The product family glossary, if the company maintains one.
- The applicable regulatory references for the portfolio's market.
- A statement of the receiving party's expectations (safety officer, procurement reviewer, regulator).
- The prior SDS portfolio in Spanish, if the company has one.
A translation that has all of these inputs is one the receiving safety officer will accept on the first review.
See our technical glossary for the working Spanish-English reference, or start a technical translation request with your SDS portfolio.