Visit the Regulation Details of Ecuador Regulatory Region

In Ecuador there are three main documents that together establish the rules for chemical industry in the country.

The requirements for the transport, storage, and management of hazardous materials are present in the Technical Regulation 078, intended to turn the technical norm mandatory in the country.

Ecuador elaborated Acuerdo Ministerial 099 which provides instructions for the registration of hazardous chemical substances and environmental obligations since 2015. It involves two levels of participation. Level 1 for those that import, export, manufacture, transfer or provide storage and/or transport services for dangerous chemical substances; and Level 2 for those interested in industrial, artisanal, or academic research use of hazardous chemical substances. In sum, those that deal with chemicals considered hazardous have to apply for the Certificate of Registration of Hazardous Chemical Substances to do so.

Another important regulation is the Reglamento al Código Orgánico del Ambiente (gestión integral de sustancias químicas) – Decreto 752/2019. It states the creation of a chemical inventory and a chemical registry. The Undersecretariat of Environmental Quality is responsible for establishing the Register of Hazardous Chemical Substances.

Additionally, Ecuador is part of the Andean Community, which indicates that the communal regulation for chemical pesticides for agriculture is in place (Resolución 2.075/2019).

Business applicants considering activities in Ecuador shall pay closer attention to this set of regulations.

Country	Ecuador
National Regulation
Status	In force (theoretically)
Regulation name	Regulation to the Organic Code of the Environment (comprehensive management of chemical substances) Reglamento al Código Orgánico del Ambiente (gestión integral de sustancias químicas) - Decreto 752 Ministerial agreement 099 (Acuerdo Ministerial 099 - link)
Objective	Establish the provisions to guarantee environmentally sound management of pure chemical substances, in the form of mixtures or contained in products or materials
Implementation date	June 12, 2019
Scope	Individuals who participate in any of the chemical management phases
Further substance lists	The environmental authority will publish a list of prohibited and severely restricted substances Acuerdo Ministerial 142 Hazard Chemical Substances (Annex A) Hazard Waste List (Annex B) Special Waste List (Annex C)
Exemption	-
Affected stakeholders	Individuals intended to import, manufacture, produce, formulate, storage, transport, use, and export chemicals
Requirements	Individuals are required to present: chemical substance information intended activity (import, manufacture, produce, formulate, storage, transport, use, and export) environmental Administrative Authorization other information determined by the National Environmental Authority report monthly movements of chemical substances apply risk prevention measures
Non-compliance	Non-compliance may lead to suspension, revocation, or extinction of the registry
Comments	The chemical management in Ecuador is embedded in the “general” environmental legislation. Individuals must register in the national register with the National Environmental Authority through the Sistema Único de Información Ambiental

Adoption of GHS

The GHS standard is mandatory since February 1^st, 2018.

SDS / GHS Regulation
Status	In force (GHS 1st version)
Regulation name	Standards: NTE INEN 2.266/2013 (transport & storage) - link
Implementation date	February 2018
Language	Spanish
Comments	In Ecuador, GHS is implemented by the Ecuadorian Standardization Institute (INEN)

Ecuador Reach Regulation for Various Sectors

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