Peru Regulatory News

The Peruvian Ministry of Health, MINSA, has issued Resolution No. 734-2024-MINSA, announcing the publication of draft regulations aimed at enhancing the registration, control, and health monitoring of...

The Peruvian Ministry of Health, MINSA, has issued Resolution No. 734-2024-MINSA, announcing the publication of draft regulations aimed at enhancing the registration, control, and health monitoring of medical devices. This initiative aligns with Peru’s national health policies and international commitments, particularly those connected to World Trade Organization standards.

The draft regulation is now available on the Ministry’s website for a 90-day public consultation period. During this time, citizens, public institutions, and private organizations are invited to review the draft and provide feedback via email until the 24th of January 2025. The Directorate of Medicines, Supplies, and Drugs (DIGEMID) will oversee the feedback collection and work on finalizing the regulations based on these contributions.

This public consultation marks an essential step toward enhancing the safety, quality, and accessibility of medical devices in Peru, reinforcing the Ministry’s commitment to public health and international standards.

The full Draft Regulation can be found at: Resolución Ministerial N° 734-2024-MINSA (Parte 1), Resolución Ministerial N° 734-2024-MINSA (Parte 2)

On October 25, 2024, the Ministry of Health (MINSA) of Peru issued Ministerial Resolution No. 733-2024/MINSA, introducing crucial updates to Annexes I, II, and III of the "Regulation on Permissible Ex...

On October 25, 2024, the Ministry of Health (MINSA) of Peru issued Ministerial Resolution No. 733-2024/MINSA, introducing crucial updates to Annexes I, II, and III of the "Regulation on Permissible Exposure Limits for Chemical Agents in the Work Environment," initially established by Supreme Decree No. 015-2005-SA. The existing regulation (D.S. No. 015-2005-SA) outlines acceptable exposure limits to chemical agents in workplaces across Peru, ensuring workers are not exposed to harmful levels of hazardous or carcinogenic chemicals. The recent updates are in response to scientific and technological advancements and aim to enhance protections based on the latest health and safety research.

The updated annexes classify permissible exposure limits for various chemical agents to which workers may be exposed, prioritizing quantitative evaluation and control measures, especially for substances primarily absorbed through inhalation. The revisions include newly identified hazardous substances, refined exposure limits, and updated toxicity thresholds, aligning them with global standards.

The new permissible exposure limits will apply to all work environments where chemical or carcinogenic agents pose potential health and safety risks. This update obligates employers to adopt stricter control measures, implement adequate personal protective equipment (PPE), and ensure continuous monitoring of hazardous substances.

The full details of the Ministerial Resolution are available at: Resolution No. 733-2024/MINSA

Update: Public comment period extended till 24 October 2024.   On 26 July 2024, the Peruvian Ministry of the Environment has announced the publication of the draft Regulation of Legislative Dec...

Update: Public comment period extended till 24 October 2024.

On 26 July 2024, the Peruvian Ministry of the Environment has announced the publication of the draft Regulation of Legislative Decree 1570, which enacts the Comprehensive Chemical Management Law and its annex.

Key Points

The regulation sets out the obligations, powers, and responsibilities of public entities and users of chemicals for their comprehensive management. The primary objective is to protect public health and the environment by implementing measures and mechanisms to reduce the risks associated with the comprehensive management of chemicals throughout their life cycle.

The draft regulation includes:

• Obligations of Public Entities: Defines the roles and responsibilities of government bodies in overseeing and enforcing chemical management practices.

• User Responsibilities: Outlines the duties of individuals and organizations that use chemicals to ensure compliance with safety standards.

• Risk Reduction Measures: Specifies the necessary steps to mitigate potential hazards associated with the handling, use, and disposal of chemicals.

Public Consultation

The draft regulation is available for public review on the Ministry of the Environment’s digital platform (www.gob.pe/1024-consultas-publicas-de-proyectos-normativos-minam). Interested parties are invited to submit their opinions and suggestions within ten (10) business days from the day following the publication of this Ministerial Resolution in the official newspaper, El Peruano.

The proposed regulation is important for enhancing the safety and sustainability of chemical management. By establishing clear guidelines and responsibilities, it aims to minimize the risks to human health and the environment, thus ensuring a safer future for all.

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.