June 23, 2023
By Rafael Sosa, regulatory specialist, Supply Chain team, UL Solutions
On May 28, 2023, Decree No. 1570 immediately entered into force the day after being published in the National Gazette. The main purpose of this Legislative Decree is to establish obligations, powers, and responsibilities of public entities and users of chemical substances for their comprehensive management.
To accomplish the goal of protecting the health of individuals and the environment, the Decree adopts measures to reduce the risks associated with the comprehensive management of chemical substances, and covers the following points:
- Classification of Hazards, Labeling of Chemical Substances, and Safety Data Sheet aligned with United Nations Globally Harmonized System of Classification (GHS),
- National Registry of Chemical Substances (RENASQ),
- Risk Assessment of Chemical Substances for Health and the Environment.
Classification of Hazards, Labeling of Chemical Substances, and Safety Data Sheet
The Hazard Classification, Labeling, and Safety Data Sheet (SDS) of chemical substances are now carried out in accordance with the United Nations GHS (the Purple Book) without any Revision adopted yet, and the provisions of the regulations of this Legislative Decree. Regulations related to consumer protection are also taken into consideration.
National Registry of Chemical Substances (RENASQ)
To systematize information regarding hazardous chemical substances and to effectively manage associated risks, the creation of RENASQ has been declared with a non-constitutive or restrictive intent towards rights. RENASQ serves as a mechanism for obtaining up-to-date data on chemical substances manufactured and imported within the country, as well as information on their respective manufacturers and importers. The administration of RENASQ falls under the jurisdiction of The Ministry of the Environment (MINAM) and it is seamlessly integrated into the National Environmental Information System (SINIA).
The information to be registered in RENASQ includes, at a minimum, the following:
- Data of the manufacturer or importer, as well as the supplier in case of importation.
- Identification of the chemical substance, including the IUPAC (International Union of Pure and Applied Chemistry) nomenclature and CAS (Chemical Abstracts Service) number, if applicable.
- Recommended use of the chemical substance.
- Quantity of the chemical substance manufactured or imported.
- Contents of the SDS.
- Risk assessment of the chemical substances for health and the environment, when applicable, in accordance with Article 9 of this Legislative Decree.
By adhering to these registration requirements, RENASQ aims to facilitate the management of risks associated with hazardous chemical substances by ensuring accurate and up-to-date information is readily available within the system.
Risk Assessment of Chemical Substances for Health and the Environment
The risk assessment of chemical substances for health and the environment is carried out according to the guidelines established by The Ministry of Health (MINSA), approved by Supreme Decree with the endorsement of MINAM.
These guidelines, at a minimum, include:
- Determination of the physical and chemical properties of the chemical substance.
- Its effects on biotic systems.
- Its mobility and behavior in the environment.
- Its effects on human health.
The approval procedure of such assessments will be carried out within a maximum of 75 business days following submission of a completed portfolio.
The transportation of hazardous chemicals follows the provisions stated in Law No. 28256, which regulates the terrestrial transportation of materials and hazardous waste.
Refer to Decree No. 1570 for further information about:
- Chemical substances that are excluded from classification of hazards, labeling of chemical substances, and SDS.
- Manufacturing or importation activities exempt from RENASQ.
- Treatment of confidential business information regarding the registration of substances.
What can be expected in the future?
A forthcoming regulation, scheduled to be released within the next year, will cover various aspects of the framework in detail. The regulation will focus on the following areas:
- A detailed classification list for substances that are considered hazardous.
- The scope of RENASQ and provide information on how it will be implemented and operated.
- Technical conditions under which certain activities will be exempted from compliance with RENASQ.
- Procedure for obtaining approvals related to risk assessments, outlining the necessary steps, data requirements, and evaluation criteria to be followed.
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