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National Regulation
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Status
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Draft (public consultation ended on September 24, 2020)
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Regulation name
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Regulation and control of dangerous substances and similar for domestic, industrial, and/or public health use
Reglamento de regulación y control de sustancias peligrosas y similares de uso doméstico, industrial y/o en salud pública - link
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Objective
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Regulate Chapter VI of Title II of Law 26.842, General Health Law, developing the regulation and control of dangerous substances and similar for domestic, industrial, and/or public health use; to ensure the protection of human health, safety, and hygiene to prevent damage that could be caused by these products due to their improper selection, handling, and use
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Scope
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Chemicals and mixtures (imported and produced)
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Further
substance lists
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Draft article 39 deals with several prohibited and restriction list with special arrangements to comply
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Exemption
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The Decree does not apply to pharmaceutical products (narcotic drugs, medicines for human use, and psychotropic substances), food additives, hydrocarbons and their derivatives, products for disinfection of medical devices, agricultural and veterinary use, and chemicals supplies and controlled products
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Affected stakeholders
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Individuals interested in manufacturing, importing, distributing, trading, and storing chemicals
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Requirements
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The following information is requested to be presented:
· company's information
· chemical toxicity information
· classification and labeling
· health and environmental risk assessment
· risk management (for CMR or hazard substances)
· SDS
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Non-compliance
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Non-compliance is addressed with a fine (slight, serious, and very serious), in addition to civil and penal sanctions. Fines' value is between 10 and 40 UIT. 1 UIT ≈ 1.000 EUR
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Comments
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Main authority is Dirección General de Salud Ambiental (DIGESA). It is necessary to acquire a sanitary authorization (valid for 3 years) through which manufacturing, importation, distribution, trade, and storage are possible
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SDS / GHS Regulation
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Status
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Draft (public consultation ended on September 24, 2020)
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Regulation name
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Legislation:
Reglamento de regulación y control de sustancias peligrosas y similares de uso doméstico, industrial y/o en salud pública – link
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Language
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Spanish
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Comments
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The implementation of GHS and chemical regulation will happen concomitantly in Peru (based on the current draft)
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