On December 2, 2023, Supreme Decree No. 031-2023-SA was published in the Official Gazette El Peruano approving the “Regulation and Control of Hazardous Substances for Domestic, Industrial and/or Public Health Use” (hereinafter “the Regulation”).
The purpose of the Regulation is to regulate and control the health control of hazardous substances for domestic, industrial and/or public health use established in Chapter VI of Title II of Law No. 26842, General Health Law.
The regulation applies to natural and legal persons that carry out activities related to the importation, manufacture, formulation, elaboration, manufacture, distribution, commercialization, storage, use, handling and destruction of the following products containing hazardous substances:
– Chemical products for industrial use.
– Disinfectant products for inert surfaces for domestic, industrial and/or public health use, and disinfectant products for swimming pool water.
– Pesticide products for domestic, industrial and/or public health use.
– Hazardous products under the Rotterdam Convention.
On the other hand, it is noted that the Regulation does not apply with respect to the following products:
– Pharmaceutical products, including narcotic drugs, medicinal products for human use and psychotropic substances.
– Food additives.
– Hydrocarbons and their derivatives.
– Disinfection products for medical devices.
– Products for agricultural and veterinary use.
– Chemical inputs and controlled products.
– Radioactive chemical substances.
– Chemical substances controlled by Law No. 29239.
– Methyl and ethyl alcohol regulated by Law No. 27645.
Likewise, among others, the Regulation provides that the conditions under which the health authorization was granted must be maintained during the manufacture, importation, storage, distribution and commercialization of hazardous substances for domestic, industrial and/or public health use. The health authorization is granted per formulated product.
Finally, the Regulation regulates the competence of DIGESA to issue the “Certificate of free sale of hazardous substances for domestic, industrial and/or public health use”, as well as the supervisory and sanctioning power of this authority to enforce the Regulation.
For further information, please contact Maritza Reategui (mreategui@estudiorodrigo.com).
