Peru Regulatory News

Peru has issued a Supreme Decree (DS 031-2023-SA) that complements the Decree 1570 for management of Chemical Substances, introducing comprehensive regulations for hazardous substances used in househ...

Peru has issued a Supreme Decree (DS 031-2023-SA) that complements the Decree 1570 for management of Chemical Substances, introducing comprehensive regulations for hazardous substances used in household, industrial, and public health applications. The decree adopts the Globally Harmonized System (GHS) for classification and labeling, covering products such as industrial chemicals, disinfectants, pesticides, and hazardous substances under the Rotterdam Convention.

The Regulation applies to both individuals and companies involved in activities related to the import, manufacturing, formulation, elaboration, distribution, commercialization, storage, use, handling, and disposal of hazardous substances designated for domestic, industrial, and/or public health applications as classified in the new Decree.

The new Decree encompasses the following finished products:

• Chemical Products for Industrial Use
• Disinfectants for inert surfaces in domestic, industrial, and/or public health settings, including disinfectant products for water in swimming pools.
• Pesticide products for domestic, industrial, and/or public health use.
• Hazardous products falling under the Rotterdam Convention.

The initial exemption section specifies that the new rules do not extend to:

a) Pharmaceutical products, including narcotic drugs, medicines for human use, and psychotropic substances.

b) Food additives.

c) Hydrocarbons and their derivatives.

d) Disinfection products for medical devices.

e) Products for agricultural and veterinary use.

f) Chemical inputs and controlled products.

g) Radioactive chemical substances.

h) Chemical substances susceptible to use in chemical weapons as per national laws.

i) Methyl and ethyl alcohol regulated by local laws on methyl alcohol.

The new Decree signifies the adoption of GHS for the classification, labeling, and Safety Data Sheets (SDS) for the covered substances.

The new Decree also outlines detailed requirements and processes for authorization, renewal, and modification of authorization for various product categories, including:

• Sanitary Authorization for chemical products for industrial use.
• Sanitary Authorization for disinfectants intended for commerce in domestic, industrial, and/or public health applications.
• Sanitary Authorization for pesticides intended for commerce in domestic, industrial, and/or public health applications.
• Sanitary Authorization for the importation of disinfectants or pesticides for industrial use and/or public health not intended for commerce.
• Sanitary Authorization for the importation of hazardous products within the framework of the Rotterdam Convention. 

Effective Date The new Regulation will come into effect within six months of its publication date, which is December 2, 2023.

Peru's General Directorate of Environmental Health and Food Safety (DIGESA) has introduced a new set of regulations designed to establish authorization and labeling standards for paints and coatin...

Peru's General Directorate of Environmental Health and Food Safety (DIGESA) has introduced a new set of regulations designed to establish authorization and labeling standards for paints and coatings containing lead. These regulations, which were officially unveiled in a notification to the World Trade Organization (WTO) on August 16, aim to implement a law enacted in 2021 that imposed restrictions on lead levels in such products.

Under the 2021 law (No. 31182), a maximum lead content limit of 90 ppm or 90 mg/kg by weight of the total content was imposed on products manufactured, imported, distributed, and marketed within the country. Interested stakeholders and the public have the opportunity to submit comments on these proposed regulations until October 15.

Key provisions within the proposed regulations include:

Sanitary Authorizations:

• Manufacturers, importers, and distributors of lead-containing paints and coatings would be obliged to secure sanitary authorizations from the National Health Authority before engaging in production or commercialization.
• The authorization application process would necessitate the submission of company information, details of the legal representative, product trade names, safety data sheets, and more.
• A power of attorney would also be required when the process is conducted by a proxy.
• Sanitary authorizations would be valid for five years, with new authorizations required in cases involving formula modifications.

Labelling Requirements:

• Lead-containing paints and coatings would need to incorporate specific information on their labels, including trade names, health authorization numbers, manufacturer information, details of the sanitary authorization holder, net content, lot numbers, production dates, preparation, dosage, application methods, instructions for use, storage conditions, and relevant pictograms, symbols, and danger phrases.
• Labeling information must adhere to the UN Globally Harmonized System (GHS) of classification and labeling of chemicals, which Peru adopted in May 2023.

Sanctions:

• The proposed regulations outline actions that would be considered violations and stipulate corresponding penalties, ranging from fines to the revocation of sanitary authorizations.
• A database of offenders would also be established, with information retained for a period of four years from the date of registration, after which the National Health Authority would take over data collection.

These regulations represent a vital step in aligning Peru with global standards in managing lead-based paints and coatings to ensure the safety and well-being of the public.

Peru is taking significant steps to regulate the import and production of fertilizers, aiming to enhance sustainable soil management, promote domestic agricultural competitiveness and sustainability, ...

Peru is taking significant steps to regulate the import and production of fertilizers, aiming to enhance sustainable soil management, promote domestic agricultural competitiveness and sustainability, and improve food and nutrition security while ensuring safety, quality, and efficient use of these substances. A notified draft regulation has been proposed, which aims to establish provisions that govern the entire life cycle of fertilizers and similar substances, with a focus on minimizing adverse health and environmental impacts.  

The primary objective of the proposed regulation is to protect farmers and agricultural workers by ensuring the safety, quality, and efficient use of fertilizers. By establishing stringent guidelines for importers and manufacturers, Peru seeks to reduce the potential health risks associated with the use of fertilizers. The regulation aims to enhance farmer awareness and provide them with safe and reliable products, thereby safeguarding their well-being and promoting sustainable agricultural practices. 

Peru recognizes the importance of promoting the competitiveness and sustainability of its domestic agriculture sector. The proposed regulation seeks to create a level playing field for farmers and increase their access to high-quality fertilizers. By encouraging sustainable soil management practices, the regulation aims to enhance soil fertility, reduce environmental degradation, and preserve natural resources. These measures will contribute to long-term agricultural productivity, economic growth, and the country's overall food security. 

Food and nutrition security is a pressing concern globally, and Peru is no exception. The proposed regulation addresses this urgent problem by focusing on the efficient use of fertilizers to improve crop quality and yield. By optimizing the nutritional value of agricultural products, Peru aims to enhance the availability of diverse and nutritious food for its population. This regulation will help combat malnutrition, promote healthier diets, and contribute to the overall well-being of the nation. 

The proposed regulation recognizes the potential adverse health and environmental impacts associated with the use of fertilizers. To mitigate these risks, the regulation sets forth strict standards for import, production, labeling, handling, storage, and distribution of fertilizers. Compliance with these standards will help ensure that fertilizers meet safety and quality requirements, minimizing the presence of harmful substances in food and reducing environmental contamination. By adopting responsible practices, Peru aims to safeguard human health, protect ecosystems, and preserve water resources and biodiversity. 

The draft resolution is in its consultation phase since June 2023 for a period of 90 days and will also be analyzed by the Andean Community (CAN) and the World Trade Organization (WTO). 

On 28 May 2023 the Peruvian Ministry of the Environment (MINAM) issued Legislative Decree No. 1570. The decree establishes the legal framework for the comprehensive management of chemical substances i...

On 28 May 2023 the Peruvian Ministry of the Environment (MINAM) issued Legislative Decree No. 1570. The decree establishes the legal framework for the comprehensive management of chemical substances in Peru. By issuing the Decree Peru has bypassed the parliamentary process and have thereby achieved a faster implementation of the legislation. Peru hereby becomes the third country in Latin America, after Chile and Colombia, to adopt REACH-inspired regulations. In Brazil similar legislation was recently approved in the Chamber of Deputies and is now in consideration in the Senate.

Decree No. 1570 sets the framework for Peru’s chemicals management system including the following:

• Creation of a national inventory for hazardous substances: the National Registry of Chemical Substances (RENASQ).

• Implementation of the UN’s Globally Harmonized System (GHS) for classification and labelling of chemicals

• Implementation of a process for risk evaluation of priority substances

Many details regarding elements of the framework will be included in a future regulation which is expected to be issued within a year. These include:

• A classification list for hazardous chemical substances

• The scope, implementation and operation of RENASQ including the technical conditions under which certain activities are exempted from RENASQ

• The procedure for approval of risk assessments 

• The course of action for risk management 

Peru has been working on its national chemical policy at least since 2020. In recent months, Peru approached the United Nations Environment Programme (UNEP) for funding its implementation and enforcin...

Peru has been working on its national chemical policy at least since 2020. In recent months, Peru approached the United Nations Environment Programme (UNEP) for funding its implementation and enforcing mechanisms.

UNEP has been holding a special Chemical and Waste Management Programme since 2015 to support countries in developing effective frameworks for legislation and regulations addressing chemicals. Overall, the Programme has already funded projects in 57 countries worldwide.

Peru has filed a project request with a 30-month duration and financing of around 250 thousand dollars. In return, the country will disburse 134 thousand dollars, totaling about 384 thousand dollars. Peru is successfully expected to develop, adopt, monitor, and enforce the necessary activities to bring the national chemical legislation into practice with this amount.

In June 2020, the Ministry of Health drafted the sound national chemical management bill which was submitted for public comments until September 2020.  The Regulation and Control of Dangerous Substances proposes to classify and sort substances according to the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, to create a national register of chemicals, to impose substances to health and environmental assessment, and provide risk management measures for hazardous substances. In addition, Peru intends to implement a certification for those who deals with chemicals (called sanitary authorization), which would have to be renewed every three years.

Another relevant point is the recent Organisation for Economic Co-operation and Development (OECD) discussion to evaluate Peru's membership. In Latin America, OECD plays a crucial role in developing each country's chemical regulations; for example, Chile and Colombia are the only countries in the region that have adopted comprehensive chemical regulations – and have actively participated in the organization since 2010 and 2020, respectively.

On November 18, 2021, the Ministry of Environment approved complementary provisions to Decree 9/2019, which is the current legislative instrument for the management and handling of Waste from Elec...

On November 18, 2021, the Ministry of Environment approved complementary provisions to Decree 9/2019, which is the current legislative instrument for the management and handling of Waste from Electrical and Electronic Equipment (WEEE). Decree 35/2021 brings obligations for lighting appliances and medical/laboratory equipment to an Extended Producer Responsibility (EPR) perspective. 

Altogether, WEEE is divided into 11 categories. Each Electrical and Electronic Equipment (EEE) category is exemplified below: 

The Ministry of Environment (MINAM) established an annual progressive collection goal per year for 2020-2024 according to WEEE categories calculated as an annual manufacturing/import average, considering the last 3 years as a baseline: 

Besides the recollection goals, the regulations also impose obligations to producers, distributors, marketers, and operators. It is relevant to note that: 

• Producers (whether manufacturer, assembler, or importer) are requested to submit a Waste Management Plan for Electrical and Electronic Equipment to MINAM. Additionally, producers must prepare an annual declaration, which must be submitted through the Information System for the Management of Solid Waste (SIGERSOL). It is also expected from the producer to take, free of charge, WEEE back from end-users, regardless of whether it is from a third-party generation.  
• Distributors and marketers are required to implement collection points for take-back articles, redirect collected WEEE to waste management schemes, and educate customers about the proper handling, segregation, and delivery on collection points.  
• Operators responsible for WEEE recovery plants are in charge of collecting, transporting, and recovering (dismantling/disassembling) WEEE. The operator's annual declaration is similar to the producer's declaration, yet, more detailed in terms of treated WEEE amounts, origin and categories. 

It is recommended for target groups under imposed responsibilities to align with the aforementioned obligations, consult integrally the legislations, and if necessary, request support from an advisory team. Finally, consumers also have the duty to cooperate. They can collaborate simply by retuning WEEE to a registered collection point among the various available in Peru.  

Last Update: 2021-12-20

On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish). The new...

On July 24, Peru’s Ministry of the Environment (MINAM) published Decree 18/2021. By this Decree, Peru creates the Pollutant Release and Transfer Register (RETC by its acronym in Spanish).

The new database constitutes a new informational tool for potentially harmful chemical products and substances. The purpose is to facilitate public access to information on releases and transfers of pollutants while contributing to decision-making processes on environmental management.

Since the new regulation is broad in scope, different economical activities are required to comply. It includes agriculture, mining, manufacture, suppliers, providers, transport, and storage facilities. A complete list of those who need to comply is displayed in Annex 1.

The report must include three parameters: chemical substances, their physicochemical characteristics, and total hazardous waste produced. Annex 2 give further details on such elements.

Altogether, the declaration content must have:

• Company information, operations, and processes
• Water and energy consumption
• Emissions amount (air, water, and soil)
• Sewage and waste amounts
• Company’s environmental practices and certificates

Declarants have until March 31st of each year to report. The declaration must be made once a year through the RETC digital platform.

The Decree foresees a 3-year adaptation period becoming mandatory in July 2024. Companies can still report voluntarily until then. The Peruvian authorities published a guideline to assist in reporting.

The initiative is linked towards enhanced chemical management in Peru. The Ministerial Resolution 439/2020, which proposes the National Regulation and Control of Dangerous Substances and the GHS adoption underwent public comments in September 2020. This may indicate a new version coming to light in 2021.