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Chile became the first country in Latin America to introduce a national regulation for chemical substances and mixtures in February 2021. Decree No. 57, together with implementing Resolution No. 777/2021, established the Regulation on the Classification, Labelling and Notification of Hazardous Chemicals and Mixtures, formally adopting the seventh revised edition of the GHS for chemical products.
The new legislation, issued by MINSAL-MMA, targets chemical substances and hazardous mixtures. It provides for the development of a substance notification and prioritization system, enabling risk assessments to be conducted for selected substances following their manufacture and/or importation. Notifiers are requested to provide information on chemicals when dealing with 1 ton per year or above via the environmental authority portal. The notification is made on a biennial basis concerning the import or produced quantity every two years with the deadline on August 30th. On 30 December 2024, Chile officially published its first National Chemical Inventory under Resolution No. 7595/2024, comprising more than 860 industrial hazardous substances. The second notification deadline is set for 30 August 2026.
Regulatory Briefing
Chile officially published its first National Chemical Inventory (Inventario Nacional de Sustancias Químicas) on December 30, 2024, marking a significant milestone as the first country in Latin America to establish a centralized chemical inventory [202].
News
Chile Approves New Technical Standard for the Sanitary Registration of Hemoderivative Pharmaceuticals
The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed at ensuring the...
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Chile Strengthens Medical Device Regulations
The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted through Decree 5 Exempt, was...
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