Peru Regulatory News

In an effort to protect the health of workers and update regulations in line with scientific and technological advances, the Peruvian Ministry of Health (MINSA) has announced a proposed revision of An...

In an effort to protect the health of workers and update regulations in line with scientific and technological advances, the Peruvian Ministry of Health (MINSA) has announced a proposed revision of Annexes I, II, and III of the Regulation on Permissible Limit Values for Chemical Agents in the Work Environment, approved by Supreme Decree No. 015-2005-SA. The revision (Ministerial Resolution No. 454-2024-MINSA) is open for public comment for 15 days from 4 July 2024.

Background and Considerations

The proposal is based on File No. 2024-0103450, which includes reports from the Directorate General of Strategic Interventions in Public Health and the General Office of Legal Advice of MINSA. The initiative complies with several legal and regulatory frameworks, including the Political Constitution of Peru, ILO Convention No. 139 on Occupational Cancer and Andean Decision 584.

These frameworks require the State to regulate and protect the health of workers, particularly from chemical substances and carcinogenic agents, and to ensure a safe working environment.

Proposed Revision

Supreme Decree No. 015-2005-SA requires that the permissible limits be updated every two years to include new substances based on scientific progress. The Directorate General of Strategic Interventions in Public Health, through the Occupational Health and Disability Unit, has requested the publication of these updated projects in order to gather feedback from both public and private entities as well as the general public.

Publication and Consultation Procedure

The proposal will be published for fifteen calendar days in the Official Gazette El Peruano and the relevant electronic portals, allowing interested parties to comment on the proposed measures. This procedure is in accordance with the Regulation for the Publication and Dissemination of General Legal Norms, approved by Supreme Decree No. 001-2009-JUS.

Importance of the Update

Updating the permissible limit values for chemical agents is essential to reduce exposure risks and protect workers' health. This effort not only meets the legal and constitutional obligations, but also reinforces the Peruvian State's commitment to promoting a safe and healthy working environment.

Comments received during the consultation period will be evaluated for the final implementation of the updated values, ensuring that the regulations reflect the current needs and realities of the working environment.

On December 2, 2023, the Peruvian government published Supreme Decree No. 031-2023-SA, approving the "Regulation for the Regulation and Oversight of Hazardous Substances for Domestic, Industrial, and ...

On December 2, 2023, the Peruvian government published Supreme Decree No. 031-2023-SA, approving the "Regulation for the Regulation and Oversight of Hazardous Substances for Domestic, Industrial, and Public Health Use." According to its final complementary provision this regulation will come into force on June 1, 2024,  six months after its publication in the Official Gazette "El Peruano."

Key Aspects of the New Regulation

The new regulation introduces strict requirements for the authorization of disinfectants and pesticides used in domestic, industrial and public health settings. Additionally, it covers industrial chemicals and substances subject to the Prior Informed Consent (PIC) procedure.

The implementation of this regulation is a significant step in improving public safety and environmental protection in Peru. By establishing clear guidelines and oversight mechanisms, the government aims to ensure that hazardous substances are handled, used, and disposed of in a manner that minimizes risks to health and the environment.

Key aspects of the regulation include:

1. Authorization Requirements: All products classified as disinfectants and pesticides for domestic, industrial or public health use must obtain proper authorization. This ensures that only products that meet safety and efficacy standards are available on the market.

2. Industrial Chemicals: The Regulation also applies to chemicals used in industrial processes, ensuring that these substances are managed safely to prevent harm to workers, communities, and the environment.

3. PIC Procedure: For certain hazardous chemicals, the Regulation enforces the Prior Informed Consent (PIC) procedure. This international mechanism ensures that countries are informed about the import and export of hazardous chemicals and can consent or deny their entry, thus preventing unwanted and potentially harmful substances from entering the country.

Preparing for Compliance

As the June 1, 2024, implementation date approaches, companies and stakeholders involved in the production, distribution and use of these substances are advised to familiarize themselves with the new requirements and ensure compliance. The Peruvian government is expected to provide further guidance and support to facilitate the transition to this new regulatory framework.

In an effort to streamline regulations and improve environmental protection, member countries of the Andean Community are proposing to synchronize standards for household cleaners and absorbent person...

In an effort to streamline regulations and improve environmental protection, member countries of the Andean Community are proposing to synchronize standards for household cleaners and absorbent personal hygiene products. The initiative aims to establish a consistent framework across the four countries that make up the trading bloc– Bolivia, Colombia, Ecuador, and Peru. 

Proposed Regulations for Household Products 

Under the proposed draft, a unified set of regulations would govern the production, processing, packaging, importation, storage, sale and marketing of various products including soaps, detergents, fabric softeners, air fresheners, sanitary towels and diapers. Key measures outlined in the draft include the mandatory submission of health notifications to national authorities prior to import, export, and marketing of these items. 

Focus on Environmental Integration 

Furthermore, the draft requires national authorities to seek approval from the General Secretariat of the Andean Community before imposing restrictions or bans on ingredients used in covered products. The overarching goal of these measures is to integrate the principles of circular economy into production and commercial processes, thereby balancing environmental protection and product safety. 

Andean Community Seeks Feedback 

The draft Regulation, which has been submitted to the WTO, invites feedback from stakeholders until the deadline of June 15. This collaborative effort underscores the Andean Community's commitment to promoting sustainable practices while ensuring the safety and quality of everyday consumer products. 

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