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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.

 

Introduction to Chile Regulatory Regions

News

Chile Updates Technical Standards for Hypodermic Needles and Syringes
Chile Updates Technical Standards for Hypodermic Needles and Syringes

Chile’s Ministry of Health has announced updated regulations to strengthen quality and safety controls on hypodermic needles and syringes, bringing the country’s standards in line with international medical devices standards. According...

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Chile Approves New Technical Standard for the Sanitary Registration of Hemoderivative Pharmaceuticals
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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ACF GHS Report