Peru Regulatory News

Peru’s Ministry of Health has introduced new exemptions to streamline the importation of personal-use cosmetic and hygiene products, as part of efforts to modernise regulatory processes and facilita...

Peru’s Ministry of Health has introduced new exemptions to streamline the importation of personal-use cosmetic and hygiene products, as part of efforts to modernise regulatory processes and facilitate non-commercial trade.

In a public statement released Monday, the General Directorate of Medicines, Supplies and Drugs (DIGEMID), through its Directorate of Medical Devices and Health Products, confirmed that individuals importing small quantities of specific sanitary goods will no longer be required to present a Mandatory Health Notification (Notificación Sanitaria Obligatoria) or Health Registration Certificate.

The measure applies exclusively to natural persons using simplified customs regimes, including postal packages, express delivery services, and simplified import schemes.

Scope and Limitations

To qualify for the exemption, the following conditions must be met:

• The importer must be a private individual, not a business entity.

• The products must be declared for personal use only.

• Shipments must not exceed four (4) units per package.

• No more than three (3) such shipments may be made per calendar year, regardless of product type.

DIGEMID further clarified that if multiple parcels addressed to the same individual exceed the unit threshold under a single manifest, the exemption will no longer apply. In such cases, standard import requirements, including health registration, would be enforced.

Individual Responsibility Emphasised

Authorities emphasised that responsibility for the use and safety of imported products lies solely with the individual requesting entry. "The use of health products declared for personal use is under the exclusive responsibility of the applicant," the notice stated.

The updated guidance was previously communicated to the National Superintendency of Customs and Tax Administration (SUNAT) via Official Letter No. 355-2018-DIGEMID-DG-EA/MINSA. Further details can be found here (in Spanish). 

From March 18 to 20 2025, Peru actively participated in the Regional Preparatory Meeting for the 25th Conference of the Parties (PreCOP 2025) on the Basel, Stockholm, and Rotterdam Conventions, held i...

From March 18 to 20 2025, Peru actively participated in the Regional Preparatory Meeting for the 25th Conference of the Parties (PreCOP 2025) on the Basel, Stockholm, and Rotterdam Conventions, held in Port of Spain, Trinidad and Tobago. During this meeting, key issues related to the management of chemical products and hazardous waste were discussed, particularly the progress made in the implementation of the Rotterdam, Stockholm, and Basel Conventions, as well as the Minamata Mercury Convention.

In this context, the creation of a roadmap to improve chemical management in the region was proposed, in line with commitments made at the Sixth United Nations Environment Assembly. Additionally, strategies to strengthen the Global Framework for Chemicals and the sustainable management of waste were discussed.

Peru, represented by the Ministry of the Environment (Minam), presides over the Intergovernmental Network on Chemicals and Waste for Latin America and the Caribbean. Under this responsibility, Peru has promoted the coordination of public policies and international cooperation strategies for the sustainable management of chemicals and waste.

Gari Pascual, Director General of Environmental Quality at Minam, highlighted the impact of Peru's leadership in the region, stating, "... We are currently developing the 2026-2029 Action Plan, which will be presented at the XIV Forum of Ministers of Environment in Lima this October."  He also shared that a survey had been conducted to identify the priorities of different countries for the next four years. Preliminary results highlight areas such as training to prevent the illicit trafficking of such products, the development of specialized inventories, and the generation of information on chemicals in plastics, among other relevant topics.

The COP 2025 will take place from April 28 to May 9, 2025, in Geneva, Switzerland. During this event, agreements will be made regarding proposed amendments, inclusions, and exemptions under international conventions, which were presented during preliminary meetings and aim to support environmental goals. For more information, the article can be found here (in Spanish).

The General Secretariat of the Andean Community has issued Resolution No. 2458, postponing the enforcement date of Resolution No. 2310, which establishes the Andean Technical Regulation on the Labeli...

The General Secretariat of the Andean Community has issued Resolution No. 2458, postponing the enforcement date of Resolution No. 2310, which establishes the Andean Technical Regulation on the Labeling of Cosmetic Products. The new compliance deadline is now set for December 17, 2025.

Background on Resolution 2310

Resolution 2310, originally published on December 16, 2022, set out harmonized labeling requirements for cosmetic products in the Andean Community (Bolivia, Colombia, Ecuador, and Peru). The regulation aims to prevent misleading claims and protect consumer health and safety, ensuring that product labels contain clear and accurate information.

Key labeling requirements include:

• Product name and function
• Manufacturer or importer details
• Country of origin
• List of ingredients using the International Nomenclature of Cosmetic Ingredients (INCI)
• Expiry date or shelf life
• Warnings and usage instructions (where applicable)

Additionally, the regulation prohibits misleading statements regarding therapeutic properties and ensures that compliance does not create unnecessary technical barriers to trade.

Decision to Extend the Deadline

The regulation was initially set to take effect 24 months after publication, making it enforceable from December 16, 2024. However, industry stakeholders expressed concerns over the time required for compliance, particularly regarding labeling modifications and process adjustments.

In response, the Andean Committee on Quality and the Group of Government Experts on Health Legislation Harmonization reviewed the issue in meetings held on November 29 and December 3, 2024. Both bodies endorsed the one-year extension, acknowledging the industry's need for additional time to adapt to the new standards.

Implications for the Cosmetic Industry

This extension provides cosmetic manufacturers and distributors additional time to ensure compliance with the regulation. It aims to prevent potential supply chain disruptions and facilitate a smoother transition to the updated labeling requirements. Gonzalo Gutiérrez Reinel, Secretary General of the Andean Community, signed the resolution, confirming its immediate entry into force upon publication in the Official Gazette of the Cartagena Agreement, for further details you can find the Resolution here (in Spanish). 

In recent years, Peru has intensified its efforts around the Globally Harmonized System (GHS) and its management of chemicals. On July 26, 2024, the Peruvian Ministry of the Environment announced the ...

In recent years, Peru has intensified its efforts around the Globally Harmonized System (GHS) and its management of chemicals. On July 26, 2024, the Peruvian Ministry of the Environment announced the publication of the draft Supreme Decree to approve Legislative Decree 1570, which establishes the Comprehensive Chemical Management Law and sets the framework for the implementation of the GHS. This is a significant development in the country’s chemical safety regulation.

Initially, a 10-day public consultation period was provided for stakeholders to submit their opinions and suggestions, which was subsequently extended until October 24, 2024. The Ministry is currently reviewing the feedback, and the final version is expected to be published in early 2025. 

A core element of the Decree is the creation of the National Registry of Chemical Substances (RENASQ), which will integrate and systematize information on hazardous chemicals manufactured or imported into the country. The Decree also aligns with the sixth revised edition of the Globally Harmonized System, ensuring a standardized approach to the classification, labeling and communication of hazardous chemical substances.

Key News 2024

• Peru Proposes New Standards for Recyclable Plastic Tableware
  Peru's draft regulation on recyclable plastic tableware aims to reduce environmental impact by promoting sustainable production and distribution practices. Key measures include the use of mono-materials to improve recyclability, bans on oxo-degradable plastics and hazardous substances, and mandatory recycled content with traceability. Manufacturers must comply with labeling and certification requirements. Read more here.

• Peru Improves Worker Safety with Updated Chemical Exposure Limits
  In Peru, the Ministry of Health (MINSA) issued Ministerial Resolution No. 733-2024/MINSA on October 25, 2024, revising permissible exposure limits for chemicals in the workplace. These updates reflect advances in health and safety research and aim to improve worker protection from hazardous and carcinogenic substances. Employers will be required to implement stricter controls, provide personal protective equipment (PPE), and ensure continuous monitoring of chemical exposures in the workplace. Read more here.

• Peru Enforces New Hazardous Substances Regulation from June 2024
  Peru’s Supreme Decree No. 031-2023-SA, entered into force on June 1, 2024, six months after its publication in the Official Gazette.  The regulation requires the authorization for disinfectants, pesticides, and industrial chemicals, ensuring safer handling and use. It also introduces the Prior Informed Consent (PIC) procedure to regulate the import and export of certain hazardous substances, thereby strengthening public safety and environmental protection. Companies and stakeholders are advised to familiarize themselves with the new requirements and prepare for compliance. Read more here.

Peru's Draft Technical Regulation on Recyclable Plastic Tableware and Utensils outlines new standards aimed at fostering a circular economy while addressing environmental concerns associated with...

Peru's Draft Technical Regulation on Recyclable Plastic Tableware and Utensils outlines new standards aimed at fostering a circular economy while addressing environmental concerns associated with single-use plastics. This regulation forms part of the implementation of Law No. 30884, and sets strict standards for the production, importation, and distribution of recyclable plastic products, targeting a greener future.

Key Highlights of the Regulation:

1. Material Standards

   • Products must use monomaterials, avoiding combinations that hinder recycling.
   • Prohibited substances include those generating microplastics or containing hazardous materials like lead or cadmium, to a maximum  100 ppm.
   • Ban oxo-degradable plastics that fragment into microplastics. 

2. Recycled Content

   • Manufacturers must incorporate pre-consumer and post-consumer recycled materials
   • Manufacturers must maintain detailed traceability documentation

3. Labeling Obligations

   Labels must include:
   • Disposal instructions urging users to recycle responsibly.
   • Details on recycled material percentages.
   • The term "RECICLABLE."

4. Ban on Single-Use Plastic Items 

   • Prohibits single-use straws, plates, and utensils that contribute to microplastic contamination, unless explicitly exempted.

Compliance Requirements for Manufacturers and Importers

To adhere to the regulation:

• A Certification of Conformity is mandatory, proving compliance with technical and recyclability standards.
• Testing is performed in accordance with international ISO guidelines.
• Products must undergo recyclability evaluation to verify compatibility with local recycling infrastructure.

This regulation is a transformative initiative for Peru, targeting waste reduction while fostering an eco-conscious consumer base and driving industries toward sustainable innovation. By promoting responsible production and consumption practices, it marks a crucial step in Peru's journey toward a greener, more sustainable future, aligning with global environmental goals and supporting the shift to a circular economy. For additional details, you can find the Draft Regulation (in Spanish) here

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